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Use of peripheral vascular intervention (PVI) for intermittent claudication (IC) continues to expand, but there is uncertainty whether baseline demographics, procedural techniques and outcomes differ by sex, race, and ethnicity. This study aimed to examine amputation and revascularization rates up to 4 years after femoropopliteal (FP) PVI for IC by sex, race, and ethnicity. Patients who underwent FP PVI for IC between 2016 and 2020 from the PINC AI Healthcare Database were analyzed. The primary outcome was any index limb amputation, assessed by Kaplan-Meier estimate. Secondary outcomes included index limb major amputation, repeat revascularization, and index limb repeat revascularization. Unadjusted and adjusted hazard ratios (HRs) were estimated using Cox proportional hazard regression models. This study included 19,324 patients with IC who underwent FP PVI, with 41.2% women, 15.6% Black patients, and 4.7% Hispanic patients. Women were less likely than men to be treated with atherectomy (45.1% vs 47.8%, p = 0.0003); Black patients were more likely than White patients to receive atherectomy (50.7% vs 44.9%, p <0.001), and Hispanic patients were less likely than non-Hispanic patients to receive atherectomy (41% vs 47%, p = 0.0004). Unadjusted rates of any amputation were similar in men and women (6.4% for each group, log-rank p = 0.842), higher in Black patients than in White patients (7.8% vs 6.1%, log-rank p = 0.007), and higher in Hispanic patients than in non-Hispanic patients (8.8% vs 6.3%, log-rank p = 0.031). After adjustment for baseline characteristics, Black race was associated with higher rates of repeat revascularization (adjusted HR 1.13, 95% confidence interval 1.04 to 1.22) and any FP revascularization (adjusted HR 1.10, 95% confidence interval 1.01 to 1.20). No statistical difference in amputation rate was observed among comparison groups. Women and men with IC had similar crude and adjusted amputation and revascularization outcomes after FP PVI. Black patients had higher repeat revascularization and any FP revascularization rates than did White patients. Black and Hispanic patients had higher crude amputation rates, but these differences were attenuated by adjustment for baseline characteristics. Black patients were more likely to receive atherectomy and had higher rates of any repeat revascularization and specifically FP revascularization. Further study is necessary to determine whether these patterns are related to disease-specific issues or practice-pattern differences among different populations., Competing Interests: Declaration of competing interest Dr. Hess has received research funding to CPC Clinical Research from Merck, Bayer, and Amgen. Dr. Julien discloses equity in Johnson and Johnson and Shockwave Medical. Dr. Curtis has a contract with the American College of Cardiology for his role as Chief Scientific Advisor, National Cardiovascular Data Registry; and holds equity interest in Medtronic. The remaining authors have no competing interests to declare., (Copyright © 2024. Published by Elsevier Inc.)

Background: The association of hospital and physician procedure volume with outcome has not been well evaluated for atrial fibrillation (AF) ablation in contemporary practice., Objective: This study aimed to determine the association between hospital and physician AF ablation volume and procedural success (isolation of all pulmonary veins) and major adverse events (MAEs)., Methods: Procedures reported to the National Cardiovascular Data Registry AFib Ablation Registry between July 2019 and June 2022 were included. Hospital and physician procedural volumes were annualized and stratified into quartiles to compare outcomes. Three-level hierarchical (patient, hospital, and physician) models were used to assess the procedural volume-outcome relationship., Results: A total of 70,296 first-time AF ablations at 186 US hospitals were included. Overall, procedural success and MAE rates were 98.5% and 1.0%, respectively. With hospital volume (Q4) as a reference, the likelihood of procedural success was lower for Q1 (odds ratio [OR], 0.44; 95% CI, 0.29-0.68), Q2 (OR, 0.50; 95% CI, 0.33-0.75), and Q3 (OR, 0.60; 95% CI, 0.40-0.89); the results were similarly significant for physician volume. With MAE for hospitals, there was an inverse procedural volume relationship for Q1 (OR, 1.78; 95% CI, 1.26-2.52) but not for Q2 (OR, 1.06; 95% CI, 0.77-1.46) or Q3 (OR, 1.19; 95% CI, 0.89-1.58) and similarly for physicians in Q1 and Q2 but not in Q3. An adjusted MAE ≤1% was predicted by an annual volume of approximately 190 for hospitals and 60 for physicians., Conclusion: In this national cohort, hospital and physician AF ablation procedural volumes were directly related to acute procedural success and inversely related to rates of MAE., Competing Interests: Disclosures Dr Freeman reports advisory board/consulting fees from Boston Scientific, Medtronic, Biosense Webster, and PaceMate; and equity in PaceMate. Dr Zeitler reports nonfinancial research support from Biosense Webster, Boston Scientific, and Sanofi; travel/speaking for Abbott, Biosense Webster, Medtronic, and Philips; and advisory board/consulting fees from Biosense Webster and Medtronic. Dr Zei reports consulting fees from Biosense Webster, Abbott, Volta Medical, and Medtronic. Dr Sanders served on the advisory board of Medtronic, Abbott, Boston Scientific, PaceMate, and CathRx; the University of Adelaide, Australia has received on his behalf lecture, research funding, and/or consulting fees from Medtronic, Abbott, Boston Scientific, and Becton-Dickenson., (Published by Elsevier Inc.)

The practice patterns and outcomes of protected left main (PLM) and unprotected left main (ULM) percutaneous coronary intervention (PCI) are not well defined in contemporary US clinical practice. Data were collected from all Veteran Affairs catheterization laboratories participating in the Clinical Assessment Reporting and Tracking Program between 2009 and 2019. The analysis included 4,351 patients who underwent left main PCI, of whom 1,306 pairs of PLM and ULM PCI were included in a propensity-matched cohort. Selected temporal trends were also assessed. The primary outcome was major adverse cardiovascular event (MACE) outcomes at 1 year, which was defined as a composite of all-cause mortality, rehospitalization for myocardial infarction (MI), rehospitalization for stroke, or urgent revascularization. Patients who underwent ULM PCI compared with patients who underwent PLM PCI were older (age 71.5 vs 69.2 years, p <0.001), more clinically complex, and more likely to present with acute coronary syndrome. In the propensity-matched cohort, radial access was used more often for ULM PCI (21% [273] vs 14% [185], p <0.001) and ULM PCI was more likely to involve the left main bifurcation (22% vs 14%, p = 0.003) and require mechanical circulatory support (10% [134] vs 1% [17], p <0.001). The 1-year MACEs occurred more frequently with ULM PCI than PLM PCI (22% [289] vs 16% [215], p ≤0.001) and all-cause mortality was also higher (16% [213] vs 10% [125], p ≤0.001). In the matched cohort, there was a low incidence of rehospitalization for MI (4% [48] ULM vs 4% [48] PLM, p = 1.000) or revascularization (7% [94] ULM vs 6% [84] PLM, p = 0.485). In this real-world experience, patients who underwent PLM PCI had better 1-year outcomes than those who underwent ULM PCI; however, in both groups, there was a high rate of mortality and MACEs at 1 year despite a relatively low rate of MI or revascularization., Competing Interests: Declaration of competing interest Dr. Shah receives investigator-initiated research support from Abbott Vascular and the Food and Drug Administration. Dr. Waldo has received investigator-initiated research support from Abiomed, Cardiovascular Systems Incorporated, Janssen Pharmaceuticals, National Institutes of Health, and VA Health Services Research & Development. Dr. Curtis receives salary support from the American College of Cardiology for his role as Chief Scientific Advisor of the National Cardiovascular Data Registry. Dr Curtis has equity interest in Medtronic, a maker of cardiac stents. The remaining authors have no competing interests to declare., (Published by Elsevier Inc.)

Background: Procedure volumes are associated with outcomes for many cardiovascular procedures, leading to guidelines on minimum volume thresholds for certain procedures; however, the volume-outcome relationship with left atrial appendage occlusion is poorly understood. As such, we sought to determine the relationship between hospital and physician volume and WATCHMAN left atrial appendage occlusion procedural success overall and with the new generation WATCHMAN FLX device., Methods: We performed an analysis of WATCHMAN procedures (January 2019 to October 2021) from the National Cardiovascular Data Registry LAAO Registry. Three-level hierarchical generalized linear models were used to assess the adjusted relationship between procedure volume and procedural success (device released with peridevice leak <5 mm, no in-hospital major adverse events)., Results: Among 87 480 patients (76.2±8.0 years; 58.8% men; mean CHA 2 DS 2 -VASc score, 4.8±1.5) from 693 hospitals, the procedural success rate was 94.2%. With hospital volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (odds ratio [OR], 0.66 [CI, 0.57-0.77]) and Q2 (OR, 0.78 [CI, 0.69-0.90]) but not Q3 (OR, 0.95 [CI, 0.84-1.07]). With physician volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (OR, 0.72 [CI, 0.63-0.82]), Q2 (OR, 0.79 [CI, 0.71-0.89]), and Q3 (OR, 0.88 [CI, 0.79-0.97]). Among WATCHMAN FLX procedures, there was attenuation of the volume-outcome relationships, with statistically significant but modest absolute differences of only ≈1% across volume quartiles., Conclusions: In this contemporary national analysis, greater hospital and physician WATCHMAN volumes were associated with increased procedure success. The WATCHMAN FLX transition was associated with increased procedural success and less heterogeneity in outcomes across volume quartiles. These findings indicate the importance of understanding the volume-outcome relationship for individual left atrial appendage occlusion devices., Competing Interests: Disclosures Dr Friedman has received research grants from Abbott, American Heart Association, Biosense Webster, Boston Scientific, Medtronic, Merit Medical, National Cardiovascular Data Registry, and the National Institutes of Health (NIH) and consulting fees from Abbott, AtriCure, NI Medical, Microport, and Sanofi. Dr Freeman reported receiving consulting fees from Medtronic, Boston Scientific, Pacemate, and Biosense Webster; equity from Pacemate; and funding from the NIH. JPC reported an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the National Cardiovascular Data Registry (NCDR) and equity interest in Medtronic. Dr Curtis is supported by R01AG074185 from the National Institutes of Aging. He also receives grants for clinical research from Abbott, the American Heart Association, the Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, iRhythm, and Philips and serves as a consultant to Abbott, Abbvie, ARCA Biopharma, Bayer, Boston Scientific, Bristol Myers Squibb (Myokardia), Element Science, Itamar Medical, LivaNova, Medtronic, Milestone, ElectroPhysiology Frontiers, ReCor, Sanofi, Philips, and UpToDate. Dr Masoudi reported an institutional contract with the American College of Cardiology for his role as Chief Scientific Advisor of the NCDR. Dr Vemulapalli has received grants from the American College of Cardiology, Society of Thoracic Surgeons, Cytokinetics, Abbott Vascular, Boston Scientific, NIH (R01 and SBIR [Small Business Innovation Research]) and Food and Drug Administration (NEST cc [National Evaluation System for Health Technology Coordinating Center]) and serves as a consultant for Medtronic, Edwards Lifesciences, Total CME, and American College of Physicians. The other authors report no conflicts.

Background: The National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry (LAAO) includes the vast majority of transcatheter LAAO procedures performed in the United States. The objective of this study was to develop a model predicting adverse events among patients undergoing LAAO with Watchman FLX., Methods: Data from 41 001 LAAO procedures with Watchman FLX from July 2020 to September 2021 were used to develop and validate a model predicting in-hospital major adverse events. Randomly selected development (70%, n=28 530) and validation (30%, n=12 471) cohorts were analyzed with 1000 bootstrapped samples, using forward stepwise logistic regression to create the final model. A simplified bedside risk score was also developed using this model., Results: Increased age, female sex, low preprocedure hemoglobin, no prior attempt at atrial fibrillation termination, and increased fall risk most strongly predicted in-hospital major adverse events and were included in the final model along with other clinically relevant variables. The median in-hospital risk-standardized adverse event rate was 1.50% (range, 1.03%-2.84%; interquartile range, 1.42%-1.64%). The model demonstrated moderate discrimination (development C-index, 0.67 [95% CI, 0.65-0.70] and validation C-index, 0.66 [95% CI, 0.62-0.70]) with good calibration. The simplified risk score was well calibrated with risk of in-hospital major adverse events ranging from 0.26% to 3.90% for a score of 0 to 8, respectively., Conclusions: A transcatheter LAAO risk model using National Cardiovascular Data Registry and LAAO Registry data can predict in-hospital major adverse events, demonstrated consistency across hospitals and can be used for quality improvement efforts. A simple bedside risk score was similarly predictive and may inform shared decision-making., Competing Interests: Disclosures Dr Faridi receives research funding from the National Institutes of Health (NIH)/National Heart, Lung and Blood Institute (NHLBI;K23HL161424). Dr Friedman reports receiving research grants from Abbott, American Heart Association, Biosense Webster, Boston Scientific, Medtronic, Merit Medical, National Cardiovascular Data Registry, Phillips, and NIH, and consulting fees from Abbott, NI Medical, Microport, and Sanofi. Dr Hsu reports receiving honoraria from Medtronic, Abbott, Boston Scientific, Biotronik, Janssen Pharmaceuticals, Bristol-Myers Squibb, Pfizer, Sanofi, Altathera, Zoll Medical, Hillrom, iRhythm, Acutus Medical, Galvanize Therapeutics, and Biosense-Webster, research grants from Biotronik and Biosense-Webster, and has equity interest in Vektor Medical. Dr Mortazavi receives research funding from the National Science Foundation (IIS #2014475) and the NIH (R21EB028486, R01HL151240, R01EB028106, and R01HL142765). Dr Lakkireddy reports being a consultant for Abbott, Boston Sci, Atricure, Biosense Webster, and Acutus. Dr Curtis has a contract with the American College of Cardiology (ACC) for his role as Chief Scientific Advisor of the ACC’s National Cardiovascular Data Registry. He holds equity interest in Medtronic. Dr Freeman reports receiving research grants from the N NHLBI and the ACC National Cardiovascular Data Registry and consulting/advisory board fees from Boston Scientific, Biosense Webster, Medtronic, and PaceMate. and equity in PaceMate.

Background Complex percutaneous coronary intervention (PCI) is increasingly performed in older adults (age ≥75 years) with stable ischemic heart disease. However, little is known about clinical outcomes. Methods and Results We derived a cohort of older adults undergoing elective PCI for stable ischemic heart disease across a large health system. We compared 12-month event-free survival (freedom from all-cause death, nonfatal myocardial infarction, stroke, and major bleeding), all-cause death, target lesion revascularization, and bleeding events for patients receiving complex versus noncomplex PCI and derived risk estimates with Cox regression models. We included 513 patients (mean age, 81±5 years). Patients receiving complex PCI versus noncomplex PCI did not significantly differ across a host of clinical characteristics including cardiovascular disease features, noncardiac comorbidities, guideline-directed medical therapy use, and frailty. Patients receiving complex PCI versus noncomplex PCI experienced worse event-free survival (80.4% versus 86.8%), which was not significant in adjusted analyses (hazard ratio [HR], 1.38 [95% CI, 0.88-2.16]). All-cause death at 1 year for patients undergoing complex PCI was nearly double that seen for patients receiving noncomplex PCI (10.2% versus 5.9%), and the risk was significant in models adjusted for clinical characteristics (HR, 1.97 [95% CI, 1.02-3.79]). Target lesion revascularization risk was lower for patients receiving complex PCI (2.2% versus 3.5%, adjusted HR), but bleeding events were not statistically different between groups (25.3% versus 20.5%; P =0.19). Conclusions Complex PCI in older adults with stable ischemic heart disease was associated with lower risk of target lesion revascularization but higher all-cause death compared with noncomplex PCI.

Background: Left ventricular (LV) lead implantation is often the most challenging aspect of cardiac resynchronization therapy (CRT) procedures; early studies reported implant failure rates in ∼10% of cases., Objective: The purpose of this study was to define rates, reasons for, and factors independently associated with LV lead implant failure., Methods: We studied patients with left bundle branch block and ejection fraction ≤ 35% who underwent planned de novo transvenous CRT implantation (2010-2016) and were reported to the National Cardiovascular Data Registry ICD Registry. Independent predictors of LV lead implant failure were determined using logistic regression; age, sex, and variables with a univariable P value of <.15 were considered for inclusion in the model., Results: Of the 111,802 patients who underwent a planned CRT procedure, 3.6% of patients (n = 3979) had LV lead implant failure. Reasons for implant failure included venous access (7.5%), coronary sinus access (64.3%), tributary vein access (13.5%), coronary sinus dissection (7.6%), unacceptable threshold (4.4%), and diaphragmatic stimulation (1.7%). Significant independent predictors of LV lead implant failure included younger age (odds ratio [OR] 1.01; 95% confidence interval [CI] 0.1.01-1.02), female sex (OR 1.38; 95% CI 1.29-1.47), black race (vs white, OR 1.44; 95% CI 1.32-1.57), Hispanic ethnicity (OR 1.23; 95% CI 1.08-1.40), QRS duration (OR 1.055 per 10 ms; 95% CI 1.038-1.072 per 10 ms), obstructive sleep apnea (OR 1.14; 95% CI 1.04-1.24), and implantation by a physician without specialized training (vs electrophysiology trained, OR 1.53; 95% CI 1.34-1.76)., Conclusion: LV lead implant failure is uncommon in the current era and is most commonly due to coronary sinus access failure. Predictors of LV lead implant failure included younger age, female sex, black race, Hispanic ethnicity, increased QRS duration, sleep apnea, and absence of electrophysiology training., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Acute kidney injury (AKI) is the most common complication after percutaneous coronary intervention (PCI). Accurately estimating patients' risks not only creates a means of benchmarking performance but can also be used prospectively to inform practice., Objectives: The authors sought to update the 2014 National Cardiovascular Data Registry (NCDR) AKI risk model to provide contemporary estimates of AKI risk after PCI to further improve care., Methods: Using the NCDR CathPCI Registry, we identified all 2020 PCIs, excluding those on dialysis or lacking postprocedural creatinine. The cohort was randomly split into a 70% derivation cohort and a 30% validation cohort, and logistic regression models were built to predict AKI (an absolute increase of 0.3 mg/dL in creatinine or a 50% increase from preprocedure baseline) and AKI requiring dialysis. Bedside risk scores were created to facilitate prospective use in clinical care, along with threshold contrast doses to reduce AKI. We tested model calibration and discrimination in the validation cohort., Results: Among 455,806 PCI procedures, the median age was 67 years (IQR: 58.0-75.0 years), 68.8% were men, and 86.8% were White. The incidence of AKI and new dialysis was 7.2% and 0.7%, respectively. Baseline renal function and variables associated with clinical instability were the strongest predictors of AKI. The final AKI model included 13 variables, with a C-statistic of 0.798 and excellent calibration (intercept = -0.03 and slope = 0.97) in the validation cohort., Conclusions: The updated NCDR AKI risk model further refines AKI prediction after PCI, facilitating enhanced clinical care, benchmarking, and quality improvement., Competing Interests: Funding Support and Author Disclosures Dr Anezi Uzendu is supported by the National Heart, Lung and Blood Institutes of Health under Award Number 5T32H110837. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr Chertow serves on the Board of Directors of Satellite Healthcare, a nonprofit dialysis provider; has served as a steering committee member or chair for clinical trials sponsored by Akebia, AstraZeneca, CSL Behring, Gilead, Sanifit, and Vertex; has served as an advisor to Ardelyx, Durect, Eliaz Therapeutics, Miromatrix, Outset, Reata, Renibus, and Unicycive; and has served as a Data Safety and Monitoring Board member or chair for trials sponsored by Bayer, Gilead, Mineralys, Palladio, and ReCor. Dr Giri has received research funds to his institution; and has served on advisory boards for Boston Scientific, Abiomed, Abbott Vascular, Inari Medical, Biosense Webster, and Recor Medical. Dr Rymer has served on the advisory board for Chiesi; has received a research grant from Chiesi; and receives research funding from Idorsia, Pfizer, and Abbott. Dr Bangalore discloses has served on the advisory board for Abbott Vascular, Boston Scientific, Amgen, Pfizer, Merck, Inari, and Truvic. Dr Wang has received research grants to the Duke Clinical Research Institute from Abbott, AstraZeneca, Bristol Myers Squibb, Boston Scientific, Artivion (formerly Cryolife), Chiesi, Merck, Portola, and Regeneron; and has received consulting honoraria from AstraZeneca, Bristol Myers Squibb, Artivion (formerly Cryolife), CSL Behring, and Novartis. Dr Curtis has an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR; and has equity in Medtronic. Dr Spertus has provided consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Meyers Squibb, Edwards Lifesciences, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; holds research grants from Bristol Meyers Squibb, Abbott Vascular, and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Frailty is rarely assessed in clinical trials of patients who receive dual antiplatelet therapy (DAPT) after percutaneous coronary intervention. This study investigated whether frailty defined using claims data is associated with outcomes following percutaneous coronary intervention, and if there is a differential association in patients receiving standard versus extended duration DAPT. Methods and Results Patients ≥65 years of age in the DAPT (Dual Antiplatelet Therapy) Study, a randomized trial comparing 30 versus 12 months of DAPT following percutaneous coronary intervention, had data linked to Medicare claims (n=1326), and a previously validated claims-based index was used to define frailty. Net adverse clinical events, a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding, were compared between frail and nonfrail patients. Patients defined as frail using claims data (12.0% of the cohort) had higher incidence of net adverse clinical events (23.1%) compared with nonfrail patients (10.7%; P <0.001) at 18-month follow-up and increased risk after multivariable adjustment (adjusted hazard ratio [HR], 2.24 [95% CI, 1.38-3.63]). There were no differences in effects of extended duration DAPT on net adverse clinical events for frail (HR, 1.42 [95% CI, 0.73-2.75]) and nonfrail patients (HR, 1.18 [95% CI, 0.83-1.68]; interaction P =0.61), although analyses were underpowered. Bleeding was highest among frail patients who received extended duration DAPT. Conclusions Among older patients in the DAPT Study, claims-defined frailty was associated with higher net adverse clinical events. Effects of extended duration DAPT were not different for frail patients, although comparisons were underpowered. Further investigation of how frailty influences ischemic and bleeding risks with DAPT are warranted. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00977938.

Background: In patients with intermittent claudication (IC), short-term amputation rates from clinical trial data following lower extremity femoropopliteal (FP) peripheral vascular intervention (PVI) are <1% with unknown longer-term rates., Objectives: The aim of this study was to identify revascularization and amputation rates following PVI in the FP segment and to assess 4-year amputation and revascularization rates after FP PVI for IC., Methods: From 2016 to 2020, 19,324 patients undergoing FP PVI for IC were included from the PINC AI Healthcare Database and evaluated by treatment level (superficial femoral artery [SFA], popliteal artery [POP], or both). The primary outcome was index limb amputation (ILA) assessed by Kaplan-Meier estimate. The secondary outcomes were index limb major amputation and repeat revascularization. HRs were estimated using Cox proportional hazard regression., Results: The 4-year index limb amputation rate following FP PVI was 4.3% (95% CI: 4.0-4.7), with a major amputation rate of 3.2% (95% CI: 2.9-3.5). After POP PVI, ILA was significantly higher than SFA alone (7.5% vs 3.4%) or both segment PVI (5.5%). In multivariate analysis, POP PVI was associated with higher ILA rates at 4 years compared with isolated SFA PVI (HR: 2.10; 95% CI: 1.52-2.91) and index limb major amputation (HR: 1.98; 95% CI: 1.32-2.95). Repeat FP revascularization rates were 15.2%; they were highest in patients undergoing both SFA and POP PVI (18.7%; P < 0.0001) compared with SFA (13.9%) and POP (17.1%) only., Conclusions: IC patients undergoing FP PVI had 4-year rates of index limb repeat revascularization of 16.7% and ILA rates of 4.3%. Further risk factors for amputation requires further investigation., Competing Interests: Funding Support and Author Disclosures Dr Hess has received research funding to Colorado Prevention Center Clinical Research from Merck, Bayer, and Amgen. Dr Curtis has a contract with the American College of Cardiology for his role as senior medical officer of the National Cardiovascular Data Registry; has received salary support from the American College of Cardiology, National Cardiovascular Data Registry; and holds equity interest in Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Despite strong guideline recommendations for cardiac resynchronization therapy-defibrillator (CRT-D) in select patients, this therapy is underutilized with substantial variation among hospitals, and the association of this variation with outcomes is unknown., Objective: The purpose of this study was to assess whether facility variation in CRT-D utilization is associated with differences in hospital-level outcomes., Methods: We linked Medicare claims data with the National Cardiovascular Data Registry's ICD Registry from 2010 to 2015. We calculated the intraclass correlation coefficient to quantify the degree of variation in patient-level CRT use that can be explained by interfacility variation on a hospital level. To quantify the degree of hospital variation in patient-level outcomes (all-cause mortality, readmissions, and cardiac readmissions) that can be attributed to variations in CRT-D use, we utilized multilevel modeling., Results: The study included 30,134 patients across 1377 hospitals. The median rate of CRT-D implantation in those meeting guideline indications was 89%, but there was a wide variation across hospitals. After adjustment, most of the variation (74%) in hospital rates of CRT-D utilization was attributable to the hospital in which the patient was treated. Differences in hospital CRT-D utilization was associated with 8.76%, 5.26%, and 4.71% of differences in hospital mortality, readmissions, and cardiac readmission rates, respectively (P < .001 for all outcomes)., Conclusion: There is a wide variation in the use of CRT-D across hospitals that was not explained by case mix. Hospital-level variation in CRT-D utilization was associated with clinically significant differences in outcomes. A measure of CRT-D utilization in eligible patients may serve as a useful metric for quality improvement efforts., (Copyright © 2023 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: We assess the rates of device use and outcomes by race among patients undergoing lower extremity peripheral arterial intervention using the American College of Cardiology National Cardiovascular Data Registry-Peripheral Vascular Intervention (PVI) registry., Methods: Patients who underwent PVI between April 2014 and March 2019 were included. Socioeconomic status was evaluated using the Distressed Community Index score for patients' zip codes. Multivariable logistic regression was used to assess factors associated with utilization of drug-eluting technologies, intravascular imaging, and atherectomy. Among patients with Centers for Medicare and Medicaid Services data, we compared 1-year mortality, rates of amputation, and repeat revascularizations., Results: Of 63 150 study cases, 55 719 (88.2%) were performed in White patients and 7431 (11.8%) in Black patients. Black patients were younger (67.9 versus 70.0 years), had higher rates of hypertension (94.4% versus 89.5%), diabetes (63.0% versus 46.2%), less likely to be able to walk 200 m (29.1% versus 24.8%), and higher Distressed Community Index scores (65.1 versus 50.6). Black patients were provided drug-eluting technologies at a higher rate (adjusted odds ratio, 1.14 [95% CI, 1.06-1.23]) with no difference in atherectomy (adjusted odds ratio, 0.98 [95% CI, 0.91-1.05]) or intravascular imaging (adjusted odds ratio, 1.03 [95% CI, 0.88-1.22]) use. Black patients experienced a lower rate of acute kidney injury (adjusted odds ratio, 0.79 [95% CI, 0.72-0.88]). In Centers for Medicare and Medicaid Services-linked analyses of 7429 cases (11.8%), Black patients were significantly less likely to have surgical (adjusted hazard ratio, 0.40 [95% CI, 0.17-0.96]) or repeat PVI revascularization (adjusted hazard ratio, 0.42 [95% CI, 0.30-0.59]) at 1 year compared with White patients. There was no difference in mortality (adjusted hazard ratio [0.8-1.4]) or major amputation (adjusted hazard ratio, 2.5 [95% CI, 0.8-7.6]) between Black and White patients., Conclusions: Black patients presenting for PVI were younger, had higher prevalence of comorbidities and lower socioeconomic status. After adjustment, Black patients were less likely to have surgical or repeat PVI revascularization after the index PVI procedure., Competing Interests: Disclosures Dr Julien discloses equity in Johnson and Johnson and Shockwave Medical stock. Dr Curtis has an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the National Cardiovascular Data Registry; has received salary support from the American College of Cardiology and Centers for Medicaid & Medicare Services; and has equity in Medtronic. Dr Fanaroff has reports a career development award from the American Heart Association, research funding to his institution from Boston Scientific, and consulting fees from the American Heart Association. Dr Khatana has received grant support from under National Heart, Lung, and Blood Institute (5K23 HL153772-02) and the American Heart Association (20CDA35320251). Dr Secemsky has Research grants to Beth Israel Deaconess Medical Center: NIH/National Heart Lung and Blood Institute K23HL150290, Harvard Medical School’s Shore Faculty Development Award, AstraZeneca, Becton Dickinson, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic and Philips. Consulting/Speaking: Abbott, Asahi, Bayer, BD, Boston Scientific, Cook, Cardiovascular Systems Incorporated, Inari, Janssen, Medtronic, Philips, and VentureMed. Dr Vora has received education and research funding from Medtronic. Dr Armstrong has consulted for Abbott Vascular, Boston Scientific, Cardiovascular Systems, Medtronic, and Spectranetics. Dr Jaff is employed on a part time basis by Boston Scientific and shareholder of Boston Scientific Corporation. Dr Giri has served on advisory boards for Astra Zeneca, Philips Medical, Boston Scientific and Inari Medical, and received research funds to the institution from St. Jude Medical, Boston Scientific, Inari Medical, and Recor Medical. The other authors report no conflicts.

Aims: No prior study has been adequately powered to evaluate real-world safety outcomes in those receiving adjunctive ablation lesions beyond pulmonary vein isolation (PVI). We sought to evaluate characteristics and in-hospital complications among patients undergoing PVI with and without adjunctive lesions., Methods and Results: Patients in the National Cardiovascular Data Registry AFib Ablation Registry undergoing first-time atrial fibrillation (AF) ablation between 2016 and 2020 were identified and stratified into paroxysmal (PAF) and persistent AF, and separated into PVI only, PVI + cavotricuspid isthmus (CTI) ablation, and PVI + adjunctive (superior vena cava isolation, coronary sinus, vein of Marshall, atypical atrial flutter lines, other). Adjusted odds of adverse events were calculated using multivariable logistic regression. A total of 50 937 patients [PAF: 30 551 (60%), persistent AF: 20 386 (40%)] were included. Among those with PAF, there were no differences in the adjusted odds of complications between PVI + CTI or PVI + adjunctive when compared with PVI only. Among persistent AF, PVI + adjunctive was associated with a higher risk of any complication [3.0 vs. 4.5%, odds ratio (OR) 1.30, 95% confidence interval (CI) 1.07-1.58] and major complication (0.8 vs. 1.4%, OR 1.56, 95% CI 1.10-2.21), while no differences were observed in PVI + CTI compared with PVI only. Overall, there was high heterogeneity in adjunctive lesion type, and those receiving adjunctive lesions had a higher comorbidity burden., Conclusion: Additional CTI ablation was common without an increased risk of complications. Adjunctive lesions other than CTI are commonly performed in those with more comorbidities and were associated with an increased risk of complications in persistent AF, although the current analysis is limited by high heterogeneity in adjunctive lesion set type., Competing Interests: Conflict of interest: J.C.H. reports receiving honoraria from Medtronic, Abbott, Boston Scientific, Biotronik, Janssen Pharmaceuticals, Bristol-Myers Squibb, Pfizer, Sanofi, Zoll Medical, iRhythm, Acutus Medical, Galvanize Therapeutics, and Biosense Webster, research grants from Biotronik and Biosense Webster, and has equity interest in Vektor Medical. J.V.F. has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; and has received consulting/Advisory Board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster; and has equity interest in PaceMate. J.P.C. has an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the NCDR; has received salary support from the American College of Cardiology and Centers for Medicaid and Medicare Services; and has equity in Medtronic. D.L. reports receiving honoraria from Abiomed, Biosense Webster, Boston Scientific, Biotronik, Janssen, and Abbott Medical. R.G. reports receiving Honoria from Abbott Medical, Boston Scientific, Pfizer, Zoll Medical; Advisory board: Pacemate (no compensation). G.K.F. as Director of the UCSD EP Fellowship Training Program reports fellow stipend support from Biosense Webster, Inc., Biotronik, Inc., Boston Scientific, Inc., Abbott Medical, Inc., and Medtronic, Inc., is a consultant to Acutus Medical, Inc., and Vektor Medical, Inc., and has equity interest in Vektor Medical, Inc. All remaining authors have declared no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Introduction: Incomplete anchoring of the Watchman left atrial appendage closure (LAAO) device can result in substantial device migration or device embolization (DME) requiring percutaneous or surgical retrieval., Methods: We performed a retrospective analysis of Watchman procedures (January 2016 through March 2021) reported to the National Cardiovascular Data Registry LAAO Registry. We excluded patients with prior LAAO interventions, no device released, and missing device information. In-hospital events were assessed among all patients and postdischarge events were assessed among patients with 45-day follow-up., Results: Of 120 278 Watchman procedures, the in-hospital DME rate was 0.07% (n = 84) and surgery was commonly performed (n = 39). In-hospital mortality rate was 14% among patients with DME and 20.5% among patients who underwent surgery. In-hospital DME was more common: at hospitals with a lower median annual procedure volume (24 vs. 41 procedures, p < .0001), with Watchman 2.5 versus Watchman FLX devices (0.08% vs. 0.04%, p = .0048), with larger LAA ostia (median 23 vs. 21 mm, p = .004), and with a smaller difference between device and LAA ostial size (median difference 4 vs. 5 mm, p = .04). Of 98 147 patients with 45-day follow-up, postdischarge DME occurred in 0.06% (n = 54) patients and cardiac surgery was performed in 7.4% (n = 4) of cases. The 45-day mortality rate was 3.7% (n = 2) among patients with postdischarge DME. Postdischarge DME was more common among men (79.7% of events but 58.9% of all procedures, p = .0019), taller patients (177.9 vs. 172 cm, p = .0005), and those with greater body mass (99.9 vs. 85.5 kg, p = .0055). The rhythm at implant was less frequently AF among patients with DME compared to those without (38.9% vs. 46.9%, p = .0098)., Conclusion: While Watchman DME is rare, it is associated with high mortality and frequently requires surgical retrieval, and a substantial proportion of events occur after discharge. Due to the severity of DME events, risk mitigation strategies and on-site cardiac surgical back-up are of paramount importance., (© 2023 Wiley Periodicals LLC.)

Objective: Older, relatively small studies identified female sex as a risk factor for adverse events after catheter ablation for atrial fibrillation (AF). We aimed to assess contemporary sex-based differences in baseline and procedural characteristics, adverse events, and quality of life among adults undergoing catheter ablation for AF., Methods: In this observational cohort study, we evaluated those enrolled in the National Cardiovascular Data Registry AFib Ablation Registry between January 2016 and September 2020. Using logistic regression, we analysed the association between patient sex and in-hospital adverse events., Results: Among 58 960 adults (34.6% women) from 150 centres undergoing AF ablation by 706 physicians, women were older (68 vs 64 years, p<0.001), had more comorbidities, and had lower AF-related quality of life at the time of ablation (mean Atrial Fibrillation Effect on QualiTy-of-life Questionnaire) score: 51.8 vs 62.2, p<0.001). Women had a higher risk of hospitalisation >1 day (adjusted OR (aOR) 1.41 (95% CI 1.33 to 1.49)), major adverse event (aOR 1.60 (95% CI 1.33 to 1.92)) and any adverse event (aOR 1.57 (95% CI 1.41 to 1.75)). Women had a higher risk of bradycardia requiring pacemaker, phrenic nerve damage, pericardial effusion, bleeding and vascular injury, but had no differences in death or acute pulmonary vein isolation., Conclusions: Among almost 60 000 patients in the largest prospective registry of AF ablation procedures, female sex was independently associated with a higher risk of hospitalisation >1 day, adverse events, and reduced quality of life, although there were no differences in death or acute pulmonary vein isolation., Competing Interests: Competing interests: DJF has received educational grants from Boston Scientific, Medtronic and Abbott; research grants from the National Cardiovascular Data Registry, Boston Scientific, Abbott, Medtronic and Biosense Webster; consulting fees from Abbott and AtriCure. EPZ reported consulting for Biosense Webster. JPC reported an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the NCDR. JVF reported salary support from the ACC NCDR and the NHLBI and consulting/advisory board fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, Biosense Webster and Pacemate and equity from Pacemate., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) represent 4% of all PCIs for stable angina in the United States and have been associated with lower success and higher in-hospital event rates compared with non-CTO PCIs. We aimed to examine long-term outcomes of CTO PCI compared with non-CTO PCI, including prespecified subgroups of high-risk non-CTO PCI (atherectomy/saphenous vein graft/unprotected left main)., Methods: Among 551,722 patients in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare (July 2009-December 2016), we evaluated in-hospital events and long-term major adverse cardiovascular events of CTO PCIs (N = 29,407) compared with non-CTO PCIs (N = 522,315). We then evaluated similar outcomes between CTO PCIs and high-risk non-CTO PCIs (N = 53,662). We excluded patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction., Results: Patients undergoing CTO PCI were more likely to be younger and male. CTO PCI was associated with a higher risk of in-hospital events compared with non-CTO PCI (7.0% vs 4.2%; P < .001) and high-risk non-CTO PCI (7.0% vs 6.5%; P = .008). In addition, CTO PCI was associated with a slightly higher risk of long-term repeat revascularization compared with non-CTO PCI (adjusted hazard ratio [aHR], 1.09; 95% CI, 1.05-1.13). However, compared with high-risk non-CTO PCIs, CTO PCIs were associated with a slightly lower risk of long-term major adverse cardiovascular events (aHR, 0.87; 95% CI, 0.84-0.90) and readmission (aHR, 0.87; 95% CI, 0.84-0.90)., Conclusions: In this study, CTO PCI was associated with higher risk of both in-hospital and out-of-hospital events but a slightly lower risk of long-term events compared with high-risk non-CTO PCIs. These findings shed light on the complexity of various PCI procedures that can inform clinicians and patients of expected outcomes., Competing Interests: Zaid I. Almarzooq receives research support from the Kuwait Foundation for the Advancement of Science. Jeptha P. Curtis receives salary support from ACC as Chief Scientific Advisor for the NCDR. Ajay J. Kirtane receives institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, and Bolt Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Ajay J. Kirtane controlled the content. Ajay J. Kirtane receives consulting fees from IMDS, and travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, CSI, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Robert W. Yeh received research grant funding and consulting fees from Abbott Vascular, Boston Scientific, and Medtronic. Hector Tamez, Yongfei Wang, Eric A. Secemsky, and Linda R. Valsdottir declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2023 The Author(s).)

Background: Left atrial appendage occlusion is an important alternative to anticoagulation in select patients with nonvalvular atrial fibrillation. Trends in real-world device sizing and associated short-term complications have not been characterized., Methods: Using the National Cardiovascular Data Left Atrial Appendage Occlusion (NCDR LAAO) Registry, patients who underwent left atrial appendage occlusion with a Watchman 2.5 device from January 1, 2016, to June 30, 2020, were identified. Patients were stratified by device size based on left atrial appendage orifice size, and categorized as receiving a device that was undersized, oversized, or per manufacturer recommendation. Relationships between device sizing and short-term outcomes, including pericardial effusion, device embolism, and significant leak, were assessed., Results: Of the 68 456 patients, 6539 (10.5%) of patients received undersized devices, 17 791 (26.0%) according to manufacturer recommendations, and 44 126 (64.4%) received an oversized device. The 27-mm device was most commonly deployed [21 736 (31.8%)], whereas the smallest and largest devices (21 and 33 mm) were least commonly deployed [7695 (11.2%) and 9077 (13.3%), respectively]. Compared with manufacturer recommended sizing, there was no difference in the odds of pericardial effusion for either undersized (1.048 [95% CI' 0.801-1.372]; P= 0.733) or oversized (1.101 [95% CI' 0.933-1.298]; P= 0.254) devices. Similarly, relative to manufacturer recommended sizing, the odds of a composite adverse outcome of device migration or embolization and significant peridevice leak at 45 days were similar among undersized devices (1.030 [95% CI' 0.735-1.444]; P= 0.863) and favorable for oversized devices (0.701 [95% CI' 0.561-0.876]; P= 0.002) devices, primarily driven by lower odds of leak. Selection of oversized devices increased significantly over the study period (from 60.3% in 2016 to 66.0% in 2020; P <0.001)., Conclusions: Among patients undergoing left atrial appendage occlusion with the first-generation Watchman device, receipt of oversized devices was common and increased over time. The high prevalence of oversizing was associated with lower odds of significant leak or device embolization without increased odds of other adverse events.

Background: Clinical events committee (CEC) evaluation is the standard approach for end point adjudication in clinical trials. Due to resource constraints, large registries typically rely on site-reported end points without further confirmation, which may preclude use for regulatory oversight., Methods: We developed a novel automated adjudication algorithm (AAA) for end point adjudication in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry using an iterative process using CEC adjudication as the "gold standard." A ≥80% agreement rate between automated algorithm adjudication and CEC adjudication was prespecified as clinically acceptable. Agreement rates were calculated., Results: A total of 92 in-hospital and 127 post-discharge end points were evaluated between January 1, 2016 and June 30, 2019 using AAA and CEC. Agreement for neurologic events was >90%. Percent agreement for in-hospital and post-discharge events was as follows: ischemic stroke 95.7% and 94.5%, hemorrhagic stroke 97.8% and 96.1%, undetermined stroke 97.8% and 99.2%, transient ischemic attack 98.9% and 98.4% and intracranial hemorrhage 100.0% and 94.5%. Agreement was >80% for major bleeding (83.7% and 90.6%) and major vascular complication (89.1% and 97.6%). With this approach, <1% of site reported end points require CEC adjudication. Agreement remained very good during the period after algorithm derivation., Conclusions: An AAA-guided approach for end point adjudication was successfully developed and validated for the LAAO Registry. With this approach, the need for formal CEC adjudication was substantially reduced, with accuracy maintained above an 80% agreement threshold. After application specific validation, these methods could be applied to large registries and clinical trials to reduce the cost of event adjudication while preserving scientific validity., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Procedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described., Objectives: The aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device., Methods: The National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX., Results: The study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001)., Conclusions: Transcatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation., Competing Interests: Funding Support and Author Disclosures The Human Investigation Committee of the Yale University School of Medicine approved the use of a limited dataset from the NCDR for research and granted a waiver of the requirement to obtain informed consent. Boston Scientific provided partial support for this study through an investigator-initiated grant; had no role in study design, data analysis, or writing of the manuscript; and were not provided a copy of the manuscript prior to submission. This study was funded by the American College of Cardiology NCDR; National Heart, Lung, and Blood Institute grants R56HL142765 and R01HL142765; and an investigator-initiated grant from Boston Scientific. Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Abbott Vascular and Boston Scientific; has received consulting honoraria from W. L. Gore, Baylis Medical, Biotronik, Philips, Biosense Webster, and Shockwave; has received consulting honoraria and speaker fees from Medtronic; has received speaker fees from ACIST Medical; and has equity interest in Indian Wells. Dr Friedman has received research grants from the American Heart Association, the NCDR, Boston Scientific, Abbott, Medtronic, Merit Medical, and Biosense Webster; and has received consulting fees from Abbott, AtriCure, and Sanofi. Dr Curtis has an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR; and has equity in Medtronic. Dr Freeman has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; has received consulting and advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, Biosense Webster, and PaceMate; and has equity interest in PaceMate. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Percutaneous coronary intervention (PCI) for stable ischemic heart disease (SIHD) in older adults requires a meticulous assessment of procedural risks and benefits, but contemporary data on outcomes in this population is lacking. Therefore, we examined the risk of near-term readmission, bleeding, and mortality in high-risk cohort of older adults undergoing inpatient PCI for SIHD., Methods: We analyzed the National Readmissions Database from 2017 to 2018 to identify index hospitalizations in which PCI was performed for SIHD. Patients were stratified into those ≥ 75 years old (older adults) and those < 75 years old. The primary outcome was 90-day readmission. Secondary outcomes included in-hospital mortality, hospital length of stay (LOS), and total hospital charge., Results: A total of 74,516 patients underwent inpatient PCI for SIHD, of whom 24,075 were older adults. Older adult patients had higher odds of in-hospital mortality (OR = 2.00, 95% CI: 1.68-2.38), intracranial hemorrhage (OR = 2.03, 95% CI: 1.24-3.34), and gastrointestinal hemorrhage (OR = 1.72, 95% CI: 1.43-2.07) during index hospitalization, with longer LOS and in-hospital charge. Older adults also experienced a higher hazard of 90-day readmission for any cause (HR = 1.61, 95% CI: 1.57-1.66) and cardiovascular causes (HR = 1.84, 95% CI: 1.77-1.91)., Conclusion: Older adults undergoing inpatient PCI for SIHD were at increased risk for in-hospital mortality, periprocedural morbidities, higher cost, and readmissions compared with younger adults. Understanding these differences may improve shared decision-making for patients with SIHD being considered for PCI., (© 2022 JGC All rights reserved; www.jgc301.com.)

Atrial cardiomyopathy has been recognized as having important consequences for cardiac performance and clinical outcomes. The pathophysiological role of the left atrial (LA) appendage and the effect of percutaneous left atrial appendage occlusion (LAAO) upon LA mechanics is incompletely understood. We evaluated if changes in LA stiffness due to endocardial LAAO can be detected by LA pressure-volume (PV) analysis and whether stiffness parameters are associated with baseline characteristics. Patients undergoing percutaneous endocardial LAAO ( n = 25) were studied using a novel PV analysis using near-simultaneous three-dimensional LA volume measurements by transesophageal echocardiography (TEE) and direct invasive LA pressure measurements. LA stiffness (dP/dV, change in pressure with change in volume) was calculated before and after LAAO. Overall LA stiffness significantly increased after LAAO compared with baseline (median, 0.41-0.64 mmHg/mL; P ≪ 0.001). LA body stiffness after LAAO correlated with baseline LA appendage size by indexed maximum depth (Spearman's rank correlation coefficient R s = 0.61; P < 0.01). LA stiffness change showed an even stronger correlation with baseline LA appendage size by indexed maximum depth ( R s = 0.70; P < 0.001). We found that overall LA stiffness increases after endocardial LAAO. Baseline LA appendage size correlates with the magnitude of increase and LA body stiffness. These findings document alteration of LA mechanics after endocardial LAAO and suggest that the LA appendage modulates overall LA compliance. NEW & NOTEWORTHY Our study documents a correlation of LA appendage remodeling with the degree of chronically abnormal LA body stiffness. In addition, we found that LA appendage size was the baseline parameter that best correlated with the magnitude of a further increase in overall LA stiffness after appendage occlusion. These findings offer insights about the LA appendage and LA mechanics that are relevant to patients at risk for adverse atrial remodeling, especially candidates for LA appendage occlusion.

Background: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States., Methods: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events., Results: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA 2 DS 2 -VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P =0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication., Conclusions: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.

Background As patients derive variable benefit from generator changes (GCs) of implantable cardioverter-defibrillators (ICDs) with an original primary prevention (PP) indication, better predictors of outcomes are needed. Methods and Results In the National Cardiovascular Data Registry ICD Registry, patients undergoing GCs of initial non-cardiac resynchronization therapy PP ICDs in 2012 to 2016, predictors of post-GC survival and survival benefit versus control heart failure patients without ICDs were assessed. These included predicted annual mortality based on the Seattle Heart Failure Model, left ventricular ejection fraction (LVEF) >35%, and the probability that a patient's death would be arrhythmic (proportional risk of arrhythmic death [PRAD]). In 40 933 patients undergoing GCs of initial noncardiac resynchronization therapy PP ICDs (age 67.7±12.0 years, 24.5% women, 34.1% with LVEF >35%), Seattle Heart Failure Model-predicted annual mortality had the greatest effect size for decreased post-GC survival ( P <0.0001). Patients undergoing GCs of initial noncardiac resynchronization therapy PP ICDs with LVEF >35% had a lower Seattle Heart Failure Model-adjusted survival versus 23 472 control heart failure patients without ICDs (model interaction hazard ratio, 1.21 [95% CI, 1.11-1.31]). In patients undergoing GCs of initial noncardiac resynchonization therapy PP ICDs with LVEF ≤35%, the model indicated worse survival versus controls in the 21% of patients with a PRAD <43% and improved survival in the 10% with PRAD >65%. The association of the PRAD with survival benefit or harm was similar in patients with or without pre-GC ICD therapies. Conclusions Patients who received replacement of an ICD originally implanted for primary prevention and had at the time of GC either LVEF >35% alone or both LVEF ≤35% and PRAD <43% had worse survival versus controls without ICDs.

Background We aimed to characterize the occurrence of major adverse cardiovascular and limb events (MACE and MALE) among patients with peripheral artery disease (PAD) undergoing peripheral vascular intervention (PVI), as well as associated factors in patients with chronic limb threatening ischemia (CLTI). Methods and Results Patients undergoing PVI in the American College of Cardiology's (ACC) National Cardiovascular Data Registry's PVI Registry who could be linked to Centers for Medicare and Medicaid Services data were included. The primary outcomes were MACE, MALE, and readmission within 1 month and 1 year following index CLTI-PVI or non-CLTI-PVI. Cox proportional hazards regression was used to identify factors associated with the development of the primary outcomes among patients undergoing CLTI-PVI. There were 1758 (49.7%) patients undergoing CLTI-PVI and 1779 (50.3%) undergoing non-CLTI-PVI. By 1 year, MACE occurred in 29.5% of patients with CLTI (n=519), and MALE occurred in 34.0% of patients with CLTI (n=598). By 1 year, MACE occurred in 8.2% of patients with non-CLTI (n=146), and MALE occurred in 26.1% of patients with non-CLTI (n=465). Predictors of MACE at 1 year in CLTI-PVI included end-stage renal disease on hemodialysis, congestive heart failure, prior CABG, and severe lung disease. Predictors of MALE at 1 year in CLTI-PVI included treatment of a prior bypass graft, profunda femoral artery treatment, end-stage renal disease on hemodialysis, and treatment of a previously treated lesion. Conclusions Patients ≥65 years old undergoing PVI experience high rates of MACE and MALE. A range of modifiable and non-modifiable patient factors, procedural characteristics, and medications are associated with the occurrence of MACE and MALE following CLTI-PVI.

Background: Data on the impact of residual peri-device leak after left atrial appendage occlusion (LAAO) are limited., Objectives: The goal of this study was to explore the association of peri-device leak with adverse clinical events., Methods: The National Cardiovascular Data Registry LAAO Registry was queried to identify patients undergoing LAAO between January 1, 2016, and December 31, 2019. Patients were classified according to leak size on echocardiography at 45 ± 14 days (0 mm, no leak; >0-5 mm, small leak; and >5 mm, large leak)., Results: A total of 51,333 patients were included, of whom 37,696 (73.4%) had no leak, 13,258 (25.8%) had small leaks, and 379 (0.7%) had large leaks. The proportion of patients on warfarin at 45 days was higher in the large vs small or no leak cohorts (44.9% vs 34.4% and 32.4%, respectively; P < 0.001). At 6 and 12 months, anticoagulant utilization decreased but remained more frequent in patients with large leaks. Thromboembolic and bleeding events were uncommon in all groups. However, compared with patients with no leak, those with small leaks had slightly higher odds of stroke/transient ischemic attack/systemic embolization (adjusted HR: 1.152; 95% CI: 1.025-1.294), major bleeding (HR: 1.11; 95% CI: 1.029-1.120), and any major adverse events (HR: 1.102; 95% CI: 1.048-1.160). There were no significant differences in adverse events between patients with large leaks and patients with small or no leaks., Conclusions: Small (>0-5 mm) leaks after LAAO were associated with a modestly higher incidence of thromboembolic and bleeding events; large leaks (>5 mm) were not associated with adverse events, although higher proportions of these patients were maintained on anticoagulation. Newer devices with improved seal might mitigate the events associated with residual leaks., Competing Interests: Funding Support and Author Disclosures The study was funded by a grant from Boston Scientific; the sponsor had no role in the design of the study or the interpretation of the data. Dr Alkhouli is on the advisory board of Boston Scientific. Dr Freeman has received grants from the National Heart, Lung, and Blood Institute and the American College of Cardiology NCDR during the conduct of the study; and has received personal fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols., Objectives: This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies., Methods: We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression., Results: Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up., Conclusions: In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes., Competing Interests: Funding Support and Author Disclosures This study was funded by the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) and the National Heart, Lung, and Blood Institute (NHLBI) grants R56HL142765 and R01HL142765. Dr Freeman has received salary support from the ACC NCDR and the NHLBI; and has received consulting/advisory board fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster. Dr Friedman has received educational grants from Boston Scientific, Medtronic, and Abbott; has received research grants from the NCDR, Boston Scientific, Abbott, Medtronic, and Biosense Webster; and has received consulting fees from Abbott and AtriCure. Dr Gibson has served as a consultant for Boston Scientific, Abbott, and Biosense Webster. Dr Goldsweig has received grant support from the National Institute of General Medical Sciences (1U54GM115458) and the Center for Heart and Vascular Research, University of Nebraska Medical Center. Dr Price has received consulting/advisory board fees from Boston Scientific, Medtronic, Abbott Vascular, W.L. Gore Medical, and Conformal Medical; has received speaker’s fees from Chiesi USA; and has received research grants (to institution) from Daiichi-Sankyo. Dr Reddy is an unpaid consultant to and has received grant support from Boston Scientific; has served as a consultant for Abbott, Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon Therapeutics, Backbeat, BioSig, Biosense-Webster, Biotronik, Cardiac Implants, CardiaCare, Cardiofocus, Cardionomic, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co, Ltd, East End Medical, EBR, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Fire1, Impulse Dynamics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Medtronic, Middlepeak, Nuvera, Philips, Pulse Biosciences, Sirona Medical, Thermedical, and Valcare; and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, Aquaheart, Atacor, Autonomix, Axon Therapeutics, Backbeat, BioSig, Cardiac Implants, CardiaCare, Circa Scientific, Corvia Medical, Dinova-Hangzhou Nuomao Medtech Co, Ltd, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Manual Surgical Sciences, Middlepeak, Newpace, Nuvera, Sirona Medical, Surecor, Valcare, and Vizaramed. Dr Masoudi has received an institutional contract with the ACC for his role as Chief Scientific Advisor of the NCDR. Dr Curtis has received an institutional contract with the ACC for his role as Senior Scientific Advisor of the NCDR. Dr Doshi has received research grants (to institution) and consulting/advisory board fees from Boston Scientific, Biosense Webster, Conformal Medical, Terumo, and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare outcomes among patients from the PROTECT-AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation) and PREVAIL (Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) left atrial appendage occlusion (LAAO) trials with matched patients from the National Cardiovascular Data Registry LAAO Registry using patient-level data., Background: Patients undergoing LAAO in clinical practice generally have more comorbidities than trial participants., Methods: Propensity-matched analyses, with up to 3 registry patients matched to each trial patient, were performed using Cox proportional hazards and Fine-Gray models., Results: A total of 1,904 registry patients were matched to 667 trial LAAO patients; 1,010 registry patients were matched to 348 warfarin patients. Compared with registry patients, trial LAAO patients experienced more pericardial effusion requiring intervention (3.8% vs 0.6%, P < 0.001), periprocedural ischemic stroke (0.9% vs 0.2%, P = 0.005), and failed device implantation (7.5% vs 3.6%, P < 0.001). The 425-day risk of ischemic stroke in trial LAAO patients was higher than in registry patients (2.70% vs 1.21%; HR: 1.951; P = 0.03); warfarin patients had comparable rates of ischemic stroke compared with registry patients (1.15% vs 1.29%; HR: 0.728; P = 0.57). Hemorrhagic stroke risk was similar among trial LAAO and registry patients (P = 0.88). Hemorrhagic stroke risk was greater among warfarin patients versus registry patients (1.44% vs 0.20%; HR: 5.871, P = 0.03). Mortality was lower in trial LAAO patients than in registry patients (2.92% vs 6.23%; HR: 0.477; P = 0.004), a difference attributable to noncardiovascular deaths. Mortality was similar (P = 0.44) among trial warfarin (4.48%) and registry (5.86%) patients., Conclusion: In clinical practice, patients who meet trial criteria and undergo LAAO experience a lower risk of ischemic stroke, a similar risk of hemorrhagic stroke, and a higher risk of death after implant versus LAAO trial patients. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation [PROTECT-AF], NCT00129545; Evaluation of the WATCHMAN Left Atrial Appendage [LAA] Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL], NCT01182441)., Competing Interests: Funding Support and Author Disclosures This study was funded by the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) and the National Heart, Lung, and Blood Institute (NHLBI) grants R56HL142765 and R01HL142765. The sponsors/funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Sponsors/funders also had no right to veto publication nor to control the decision regarding to which journal the article was submitted. Boston Scientific supported the study by sharing trial data but did not have any additional role in in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Sponsors/funders also had no right to veto publication nor to control the decision regarding to which journal the article was submitted. This research was supported by the American College of Cardiology Foundation’s NCDR. The views expressed in this presentation represent those of the author(s) and do not necessarily represent the official views of the NCDR or its associated professional societies. Dr Friedman has received research support from Boston Scientific, Biosense Webster, Merit Medical, and Abbott; and has received consulting fees from Abbott and AtriCure. Dr Masoudi has an institutional contract with the American College of Cardiology for his role as Chief Scientific Advisor of the NCDR. Dr Reddy serves as a consultant to Boston Scientific; in addition, he reports the following disclosures unrelated to this manuscript: Abbott (consultant), Ablacon (consultant, equity), Acutus Medical (consultant, equity), Affera (consultant, equity), Apama Medical (consultant, equity), APN Health (consultant, equity), Aquaheart (consultant, equity), Atacor (consultant, equity), Autonomix (consultant, equity), Axon Therapies (consultant, equity), Backbeat (consultant, equity), Biosense Webster (consultant), BioSig (consultant, equity), BioTel Heart (consultant), Biotronik (consultant), Cardiac Implants (consultant, equity), CardiaCare (consultant, equity), Cardiofocus (consultant), Cardionomic (consultant), CardioNXT/AFTx (consultant, equity), Circa Scientific (consultant, equity), Corvia Medical (consultant, equity), Dinova-Hangzhou Nuomao Medtech (consultant, equity), East End Medical (consultant, equity), EBR (consultant), EPD (consultant, equity), Epix Therapeutics (consultant, equity), EpiEP (consultant, equity), Eximo (consultant, equity), Farapulse (consultant, equity), Fire1 (consultant), Gore & Associates (consultant), HRT (consultant, equity), Impulse Dynamics (consultant), Intershunt (consultant, equity), Javelin (consultant, equity), Kardium (consultant, equity), Keystone Heart (consultant, equity), LuxMed (consultant, equity), Manual Surgical Sciences (equity), Medlumics (consultant, equity), Medtronic (consultant), Middlepeak (consultant, equity), Newpace (equity), Nuvera (consultant, equity), Philips (consultant), Pulse Biosciences (consultant), Sirona Medical (consultant, equity), Surecor (equity), Valcare (consultant, equity), and Vizaramed (equity). Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Abbott Vascular and Boston Scientific; consulting honoraria and speaker fees from AstraZeneca; consulting honoraria from W.L. Gore, Baylis Medical, and Acutus; consulting honoraria and speaker fees from Medtronic; consulting fees from Biosense Webster and Shockwave; and has equity interest in Indian Wells, Inc. Dr Curtis has an institutional contract with the American College of Cardiology for his role as senior scientific advisor of the NCDR; and has equity interest in Medtronic. Dr Freeman has received consulting fees from Medtronic, Boston Scientific, Pacemate, and Biosense Webster; and has received equity from Pacemate. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Pericardial effusion (PE) is a potential complication of transcatheter left atrial appendage occlusion. The objective of this study was to investigate the incidence, associated characteristics, and outcomes of PE following left atrial appendage occlusion., Methods: Patients in the NCDR LAAO Registry who underwent a Watchman procedure between January 1, 2016 and December 31, 2019 were included. The primary outcome was in-hospital PE requiring intervention (percutaneous drainage or surgery). Odds ratios (ORs) were calculated for adverse event rates associated with PE., Results: The study population consisted of 65 355 patients. The mean patient age was 76.2±8.1 years, and the mean CHA 2 DS 2 -VASc score was 4.6±1.5. PE occurred in 881 patients (1.35%). Clinical variables independently associated with PE included older age, female sex, left ventricular function, paroxysmal atrial fibrillation, prior bleeding, lower serum albumin, and preprocedural dual antiplatelet therapy; procedural variables included number of delivery sheaths used, sinus rhythm during the procedure, and moderate sedation rather than general anesthesia. PE was associated with increased risk of in-hospital stroke (OR, 6.58 [95% CI, 3.32-13.06]; P <0.0001), death (OR, 56.88 [95% CI, 39.79-81.32]; P <0.0001), and the composite of death, stroke, or systemic embolism (OR, 28.64 [95% CI, 21.24-38.61]; P <0.0001). PE during the index hospitalization was associated with increased risk of death (OR, 3.52 [95% CI, 2.23-5.54]; P <0.0001) and the composite of death, stroke, or systemic embolism (OR, 3.42 [95% CI, 2.31-5.07]; P <0.0001) between discharge and 45-day follow-up., Conclusions: In-hospital PE during transcatheter left atrial appendage occlusion is infrequent but associated with a substantially higher risk of adverse events, including in-hospital and early postdischarge mortality. Strategies to minimize PE are critical to improve the risk-benefit ratio for this therapy.

Objectives: The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States., Background: The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported., Methods: Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates., Results: The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA 2 DS 2 -VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure., Conclusions: This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy., Competing Interests: Funding Support and Author Disclosures This study was funded by the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute (grants R56HL142765 and R01HL142765). Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Boston Scientific; has received consulting honoraria from W.L. Gore, Baylis Medical, Philips, Biotronik, Biosense Webster, and Shockwave; has received consulting honoraria and speaker fees from Medtronic; and has equity interest in Indian Wells. Dr Freeman has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; and has received consulting and advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster. Dr Rammohan has received consulting fees from Medtronic and Abbott Vascular. Dr Turi has received honoraria from Coherex for serving on the clinical events committee for the WAVECREST 2 (Wavecrest vs. Watchman Transseptal LAA Closure to Reduce AF-Mediated Stroke 2) trial. Dr Varosy has received salary support from the National Heart, Lung, and Blood Institute. Dr Curtis has an institutional contract with the American College of Cardiology for his role as senior scientific adviser of the NCDR; has received salary support from the American College of Cardiology and CMS; and has equity in Medtronic. Dr Masoudi has had an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022. Published by Elsevier Inc.)

Background: Contemporary data on national trends and outcomes in cardiac resynchronization therapy with defibrillator (CRT-D) recipients following the 2012 updated guidelines has not been studied., Objectives: This study assessed the trends in long-term outcomes among CRT-D Medicare-aged recipients implanted in 2011-2015., Methods: Patients aged ≥65 years undergoing de novo CRT-D implantation in the National Cardiovascular Data Implantable Cardiac Defibrillator Registry from 2011-2015 with follow-up through 2017 using Medicare data were included and stratified by year of implant. Patient characteristics, in-hospital outcomes, and outcomes up to 2 years following implant were evaluated., Results: Among 53,174 patients (aged 75.6-6.4 years, 29.7% women) implanted with CRT-D from 2011 to 2015, there was an increase in implantations based on guideline-concordant recommendations (81.0% to 84.7%, P < .001). Compared to 2011, in-hospital procedural complications decreased in 2015 (3.9% vs 2.9%; adjusted odds ratio, 0.76, 95% confidence interval, 0.66-0.88, P  < .001), driven in part by decreased lead dislodgement (1.4% vs 1.0%). After multivariable adjustment, there was a lower risk of all-cause hospitalization, cardiovascular hospitalization, and mortality at 2-year follow-up in 2015 as compared to 2011, while there were no differences in heart failure hospitalizations at follow-up., Conclusion: Among Medicare beneficiaries receiving CRT-D from 2011 to 2015, there was an increase in implantations based on guideline-concordant recommendations. Furthermore, there has been a reduction in in-hospital complications and long-term outcomes, including cardiovascular hospitalization, all-cause hospitalization, and mortality; however, there has been no difference in the risk of heart failure hospitalization after adjustment., (© 2022 Heart Rhythm Society. Published by Elsevier Inc.)

Background: Implantable cardioverter-defibrillators (ICDs) are recommended for patients with cardiac sarcoidosis (CS) with an indication for pacing, prior ventricular arrhythmias, cardiac arrest, or left ventricular ejection fraction <35%, but data on outcomes are limited., Methods: Using data from the National Cardiovascular Data Registry ICD Registry between April 1, 2010 and December 31, 2015, we evaluated a propensity matched cohort of CS patients implanted with ICDs versus non-ischemic cardiomyopathies (NICM). We compared mortality using Kaplan-Meier survival curves and Cox proportional hazards models., Results: We identified 1,638 patients with CS and 8,190 propensity matched patients with NICM. The rate of death at 1 and 2 years was similar in patients with CS and patients with NICM (5.2% vs 5.4%, P = 0.75 and 9.0% vs 9.3%, P = 0.72, respectively). After adjusting for other covariates, patients with CS had similar mortality at 2 years after ICD implantations compared with NICM patients (RR 1.03, 95% CI 0.87-1.23). Among patients with CS, multivariable logistic regression identified 6 factors significantly associated with increased 2-year mortality: presence of heart failure (HR 1.92, 95% CI 1.44-3.22), New York Heart Association (NYHA) Class III heart failure (HR 1.68, 95% CI 1.16-2.45), NYHA Class IV heart failure (HR 3.08, 95% CI 1.49-6.39), atrial fibrillation/flutter (HR 1.66, 95% CI 1.17-2.35), chronic lung disease (HR 1.64, 95% CI 1.17-2.29), creatinine >2.0 mg/dL (HR 4.07, 95% CI 2.63-6.30), and paced rhythm (HR 2.66, 95% CI 1.07-6.59)., Conclusion: Mortality following ICD implantation was similar in CS patients compared with propensity matched NICM patients. Presence of heart failure, NYHA class, atrial fibrillation/flutter, chronic lung disease, renal dysfunction, and paced rhythm at time of implantation were all predictors of increased 2-year mortality among CS patients with ICDs., Competing Interests: Declaration of interest Dr Minges and Yongfei Wang receive salary support for analytic services provided to the American College of Cardiology. Dr Lampert reports research grants from Medtronic and Abbott Laboratories/St. Jude Medical and serves on Medtronic advisory board and receives moderate honoraria. Dr Rosenfeld reports fellowship support and stock ownership for Abbott Laboratories and fellowship support from Boston Scientific and Medtronic. Dr Jacoby reports being on the speaker's bureau and an advisory board for Alnylam and participating in ongoing funded research with Alnylam; receiving research grant from Myokardia; serving on an advisory board and steering committee for Myokardia; and receiving consulting fees from Abbott. Dr Curtis has a contract with the American College of Cardiology for his role as Senior Medical Officer, NCDR; receives salary support from the American College of Cardiology, NCDR; receives funding from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and holds equity interest in Medtronic. Dr Miller reports grants from Bracco and Eidos, grants and consulting for Alnylam and Pfizer, outside the submitted work. Dr Freeman reports Consulting/Advisory Board fees from Janssen Pharmaceuticals, Medtronic, Boston Scientific and Biosense Webster. He receives salary/research support from the American College of Cardiology, NCDR and the National Heart Lung and Blood Institute. The remaining authors have no disclosures to report., (Copyright © 2021. Published by Elsevier Inc.)

Background: The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking., Objectives: The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD., Methods: The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models., Results: A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161)., Conclusions: In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients., Competing Interests: Funding Support and Author Disclosures This research was supported by the American College of Cardiology’s National Cardiovascular Data Registry (NCDR). The views expressed in this paper represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at CVQuality.ACC.org/NCDR. The ICD Registry is an initiative of the American College of Cardiology with partnering support from the Heart Rhythm Society. Dr Heist has received consulting fees from Abbott, Boston Scientific, Medtronic, and Pfizer; has received research grants from Abbott, Biotronik, and Pfizer; and has received honoraria from Medtronic, Biotronik, and Abbott. Dr Russo has received research support from Boston Scientific and Medilynx; and serves on research steering committees for Apple and Boston Scientific (no honoraria). Dr Ranasinghe has received research grants from the National Heart Foundation and the National Health and Medical Research Council of Australia. Dr Zeitler has received consulting fees from Medtronic Inc; and has received research grants from Boston Scientific and the NCDR. Dr Minges has received salary support from the American College of Cardiology for analytic services performed. Dr Freeman has received salary support from the American College of Cardiology, NCDR, and the National Heart, Lung, and Blood Institute; has received consulting/advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, Pacemate, and Biosense Webster; has equity in Pacemate; has received research grants from the American Heart Association, NCDR, Boston Scientific, Abbott, Medtronic, Merit Medical, and Biosense Webster; and has received consulting fees from Abbott and AtriCure. Dr Curtis has received an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the NCDR; and has equity interest in Medtronic. Dr Al-Khatib has received research fees from Medtronic, Boston Scientific, and Abbott; and has received speaker fees from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Importance: Use of dual-chamber implantable cardioverter-defibrillator (ICD) systems among patients without a pacing indication is an example of low-value care given higher procedural risks, higher costs, and little evidence for benefit from an atrial lead. However, variation in the use of dual-chamber systems was present among patients without a pacing indication., Objective: To examine the temporal trends and hospital variation in use of single- and dual-chamber ICD implantation among patients without a pacing indication undergoing first-time ICD implantation., Design, Setting, and Participants: A multicenter cross-sectional study was conducted using the US National Cardiovascular Data Registry ICD Registry. A total of 266 182 patients undergoing initial implantation of a single- or dual-chamber transvenous ICD without a bradycardia pacing indication, class I or II cardiac resynchronization therapy indication, or history of atrial fibrillation or atrial flutter were included. The study was conducted from April 1, 2010, to December 31, 2018; data analysis was performed from October 19, 2020, to January 5, 2022., Exposures: Implantation of a single- or dual-chamber ICD., Main Outcomes and Measures: Temporal trends among patients undergoing single- vs dual-chamber ICDs were determined using the Cochran-Armitage trend test, and hospital-level variation using adjusted hospital median odds ratios was examined., Results: A total of 266 182 patients (single-chamber ICD, 134 925; dual-chamber ICD, 131 257) were included in this analysis; mean (SD) age was 58.0 (14.0) years and 91 990 patients (68.2%) were men. The use of dual-chamber ICDs decreased from 64.7% (n = 15 694) in 2010 to 42.2% (n = 9762) in 2018 (P < .001). Adjusted for patient characteristics, the median hospital-level proportion of single-chamber ICDs increased from 42.9% (95% CI, 42.6%-45.0%) in 2010 to 50.0% (95% CI, 47.8%-51.0%) in 2018. The median odds ratio for the use of dual-chamber ICDs, adjusted for patient characteristics, was 1.6 (95% CI, 1.6-1.8) in 2010 and 1.5 (95% CI, 1.5-1.8) in 2018, indicating decreasing but persistent variation in use., Conclusions and Relevance: In this national study of US patients undergoing first-time ICD implantation without a clinical indication for an atrial lead, the use of dual-chamber devices decreased. However, institutional variability in the use of atrial leads persists, suggesting differences in individual or institutional cultures of real-world practice and opportunity to reduce this low-value practice.

Importance: Limited data exist regarding the characteristics of hospitals that do and do not participate in voluntary public reporting programs., Objective: To describe hospital characteristics and trends associated with early participation in the American College of Cardiology (ACC) voluntary reporting program for cardiac catheterization-percutaneous coronary intervention (CathPCI) and implantable cardioverter-defibrillator (ICD) registries., Design, Setting, and Participants: This cross-sectional study analyzed enrollment trends and characteristics of hospitals that did and did not participate in the ACC voluntary public reporting program. All hospitals reporting procedure data to the National Cardiovascular Data Registry (NCDR) CathPCI or ICD registries that were eligible for the public reporting program from July 2014 (ie, program launch date) to May 2017 were included. Stepwise logistic regression was used to identify hospital characteristics associated with voluntary participation. Enrollment trends were evaluated considering the date US News & World Report (USNWR) announced that it would credit participating hospitals. Data analysis was performed from March 2017 to January 2018., Main Outcomes and Measures: Hospital characteristics and participation in the public reporting program., Results: By May 2017, 561 of 1747 eligible hospitals (32.1%) had opted to participate in the program. Enrollment increased from 240 to 376 hospitals (56.7%) 1 month after the USNWR announcement that program participation would be considered as a component of national hospital rankings. Compared with hospitals that did not enroll, program participants had increased median (IQR) procedural volumes for PCI (481 [280-764] procedures vs 332 [186-569] procedures; P < .001) and ICD (114 [56-220] procedures vs 62 [25-124] procedures; P < .001). Compared with nonparticipating hospitals, an increased mean (SD) proportion of participating hospitals adhered to composite discharge medications after PCI (0.96 [0.03] vs 0.92 [0.07]; P < .001) and ICD (0.88 [0.10] vs 0.81 [0.12]; P < .001). Hospital factors associated with enrollment included participation in 5 or more NCDR registries (odds ratio [OR],1.98; 95% CI, 1.24-3.19; P = .005), membership in a larger hospital system (ie, 3-20 hospitals vs ≤2 hospitals in the system: OR, 2.29; 95% CI, 1.65-3.17; P = .001), participation in an NCDR pilot public reporting program of PCI 30-day readmissions (OR, 2.93; 95% CI, 2.19-3.91; P < .001), university affiliation (vs government affiliation: OR, 3.85, 95% CI, 1.03-14.29; P = .045; vs private affiliation: OR, 2.22; 95% CI, 1.35-3.57; P < .001), Midwest location (vs South: OR, 1.47; 95% CI, 1.06-2.08; P = .02), and increased comprehensive quality ranking (4 vs 1-2 performance stars in CathPCI: OR, 8.08; 95% CI, 5.07-12.87; P < .001; 4 vs 1 performance star in ICD: OR, 2.26; 95% CI, 1.48-3.44; P < .001) (C statistic = 0.829)., Conclusions and Relevance: This study found that one-third of eligible hospitals participated in the ACC voluntary public reporting program and that enrollment increased after the announcement that program participation would be considered by USNWR for hospital rankings. Several hospital characteristics, experience with public reporting, and quality of care were associated with increased odds of participation.

Background: Differences in patient characteristics, changes in treatment algorithms, and advances in medical technology could each influence the applicability of older randomized trial results to contemporary clinical practice. The DAPT Study (Dual Antiplatelet Therapy) found that longer-duration DAPT decreased ischemic events at the expense of greater bleeding, but subsequent evolution in stent technology and clinical practice may attenuate the benefit of prolonged DAPT in a contemporary population. We evaluated whether the DAPT Study population is different from a contemporary population of US patients receiving percutaneous coronary intervention and estimated the treatment effect of extended-duration antiplatelet therapy after percutaneous coronary intervention in this more contemporary cohort., Methods: We compared the characteristics of drug-eluting stent-treated patients randomly assigned in the DAPT Study to a sample of more contemporary drug-eluting stent-treated patients in the National Cardiovascular Data Registry CathPCI Registry from July 2016 to June 2017. After linking trial and registry data, we used inverse-odds of trial participation weighting to account for patient and procedural characteristics and estimated a contemporary real-world treatment effect of 30 versus 12 months of DAPT after coronary stent procedures., Results: The US drug-eluting stent-treated trial cohort included 8864 DAPT Study patients, and the registry cohort included 568 540 patients. Compared with the trial population, registry patients had more comorbidities and were more likely to present with myocardial infarction and receive 2nd-generation drug-eluting stents. After reweighting trial results to represent the registry population, there was no longer a significant effect of prolonged DAPT on reducing stent thrombosis (reweighted treatment effect: -0.40 [95% CI, -0.99% to 0.15%]), major adverse cardiac and cerebrovascular events (reweighted treatment effect, -0.52 [95% CI, -2.62% to 1.03%]), or myocardial infarction (reweighted treatment effect, -0.97% [95% CI, -2.75% to 0.18%]), but the increase in bleeding with prolonged DAPT persisted (reweighted treatment effect, 2.42% [95% CI, 0.79% to 3.91%])., Conclusions: The differences between the patients and devices used in contemporary clinical practice compared with the DAPT Study were associated with the attenuation of benefits and greater harms attributable to prolonged DAPT duration. These findings limit the applicability of the average treatment effects from the DAPT Study in modern clinical practice.

Background: The Department of Justice (DOJ) investigated implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria, resulting in increased adherence to the NCD criteria. Trends of the specific reasons for patients not meeting the NCD criteria and in-hospital outcomes for those patients are not known., Methods and Results: We analyzed 300,151 primary-prevention ICDs from 2007-2015 at 1809 hospitals. We calculated the rates of in-hospital adverse events and the proportion of ICDs not meeting the 4 NCD criteria before and after the announcement of the DOJ investigation, stratified by whether hospitals paid settlements to the DOJ. Most reductions in the use of devices in patients not meeting NCD criteria were in patients with recently diagnosed heart failure (15.5%-6.8% for settled; 13.5%-7.3% for nonsettled) and who had had a recent myocardial infarction (8.4%-1.3% for settled; 7.4% to 1.5% for nonsettled). Adverse-event rates were significantly higher for ICDs not meeting NCD criteria (odds ratio 1.26 for settled; P < 0.001; 1.18 for nonsettled; P = 0.001)., Conclusions: After the investigation, there was a rapid reduction in the placement of ICDs in patients with recent acute myocardial infarction or recent diagnosis of heart failure. Patients who did not meet NCD criteria experienced more in-hospital adverse events and higher mortality rates., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Whether the volume of coronavirus disease 2019 (COVID-19) hospitalizations is associated with outcomes has important implications for the organization of hospital care both during this pandemic and future novel and rapidly evolving high-volume conditions., Methods: We identified COVID-19 hospitalizations at US hospitals in the American Heart Association COVID-19 Cardiovascular Disease Registry with ≥10 cases between January and August 2020. We evaluated the association of COVID-19 hospitalization volume and weekly case growth indexed to hospital bed capacity, with hospital risk-standardized in-hospital case-fatality rate (rsCFR)., Results: There were 85 hospitals with 15,329 COVID-19 hospitalizations, with a median hospital case volume was 118 (interquartile range, 57, 252) and median growth rate of 2 cases per 100 beds per week but varied widely (interquartile range: 0.9 to 4.5). There was no significant association between overall hospital COVID-19 case volume and rsCFR (rho, 0.18, P = .09). However, hospitals with more rapid COVID-19 case-growth had higher rsCFR (rho, 0.22, P = 0.047), increasing across case growth quartiles (P trend = .03). Although there were no differences in medical treatments or intensive care unit therapies (mechanical ventilation, vasopressors), the highest case growth quartile had 4-fold higher odds of above median rsCFR, compared with the lowest quartile (odds ratio, 4.00; 1.15 to 13.8, P = .03)., Conclusions: An accelerated case growth trajectory is a marker of hospitals at risk of poor COVID-19 outcomes, identifying sites that may be targets for influx of additional resources or triage strategies. Early identification of such hospital signatures is essential as our health system prepares for future health challenges., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Importance: Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation for select patients with atrial fibrillation; however, women have been underrepresented in clinical trials of LAAO, and sex-specific subanalyses are limited., Objective: To evaluate the sex differences in the baseline characteristics of patients undergoing LAAO implant and in the in-hospital outcomes after LAAO implant., Design, Setting, and Participants: A total of 49 357 patients in the National Cardiovascular Data Registry LAAO Registry undergoing LAAO with the Watchman device between January 1, 2016, and June 30, 2019, were included in this study., Exposure: Female or male sex., Main Outcomes and Measures: The primary outcomes were aborted or canceled procedure, major adverse event, any adverse event, prolonged hospital stay longer than 1 day, and death. Unadjusted and multivariable adjusted logistic regression analyses were performed to assess sex differences in in-hospital adverse events., Results: In this cohort study of 49 357 patients (mean [SD] age, 76.1 [8.0] years), 20 388 women (41.3%) and 28 969 (58.7%) men underwent LAAO. Compared with men, women were older and had a higher prevalence of paroxysmal atrial fibrillation, prior stroke, and uncontrolled hypertension but a lower prevalence of congestive heart failure, diabetes, and coronary artery disease. After multivariable adjustment, there were no differences in aborted or canceled procedures between women and men (613 [3.0%] vs 851 [2.9%]; odds ratio [OR] 1.01, 95% CI, 0.90-1.13). Women were more likely than men to experience any adverse event (1284 [6.3%] vs 1144 [3.9%]; P < .001; OR, 1.63; 95% CI, 1.49-1.77; P < .001) or major adverse event (827 [4.1%] vs 567 [2.0%]; P < .001; OR, 2.06; 95% CI, 1.82-2.34; P < .001) owing to pericardial effusion requiring drainage (241 [1.2%] vs 144 [0.5%]) or major bleeding (349 [1.7%] vs 244 [0.8%]). Women were also more likely than men to experience a hospital stay longer than 1 day (3272 [16.0%] vs 3355 [11.6%]; P < .001; adjusted OR, 1.46; 95% CI, 1.38-1.54; P < .001) or death (adjusted OR, 2.01; 95% CI, 1.31-3.09; P = .001), although death was rare and absolute differences were minimal (58 [0.3%] vs 37 [0.1%]; P < .001)., Conclusions and Relevance: This study suggests that, compared with men, women have a significantly higher risk of in-hospital adverse events after LAAO. Further research aimed at risk reduction, particularly strategies to reduce the risk of pericardial effusion and major bleeding, in women undergoing LAAO is warranted.

Primary prevention implantable cardioverter-defibrillators (ICDs) in patients with recent myocardial infarction or coronary revascularization and those with newly diagnosed or severe heart failure (HF) are considered non-evidence-based, as defined by pivotal randomized clinical trials. Although non-evidence-based ICDs have been associated previously with greater risk of in-hospital adverse events, longitudinal outcomes are not known. We used Medicare-linked data from the National Cardiovascular Data Registry's ICD Registry to identify patients discharged alive following first-time primary prevention ICD implantations performed between 2010 and 2013. We compared longitudinal outcomes, including all-cause mortality and all-cause hospital readmission among patients receiving non-evidence-based versus evidence-based ICDs, up to 4.75 years after implantation, using multivariable time-to-event analyses. Of 71,666 ICD implantations, 9,609 (13.4%) were classified as non-evidence-based. Compared to patients receiving evidence-based ICDs, non-evidence-based ICD recipients had greater mortality risk at 90 days (HR = 1.44, CI: 1.37 - 1.52, p <0.0001) and at 1 year (HR = 1.19, CI: 1.15 - 1.24, p <0.0001), but similar mortality risk at 3 years (HR = 1.03, CI: 0.98 - 1.08, p = 0.2630). Risk of all-cause hospitalization was higher in patients with non-evidence-based ICDs at 90 days (HR = 1.17, CI: 1.14 - 1.20, p <0.0001), but the difference diminished at 1 year (HR = 1.04, CI 1.00 - 1.07, p = 0.0272) and at 3 years (HR = 0.94, CI: 0.90 - 0.99, p = 0.0105). In conclusion, among patients undergoing primary prevention ICD implantations between 2010 and 2013, those with non-evidence-based ICDs were at increased risk of mortality and readmission during longitudinal follow-up. Differences in the risk of mortality and hospitalization were highest in the first year following device implantation., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: This study analyzed the predictors of defibrillation safety margin (DSM) testing at the time of implantable cardioverter-defibrillator (ICD) insertion and factors associated with inadequate DSM in patients with congenital heart disease (CHD)., Background: There are few data about the prevalence and safety of DSM testing in those with CHD., Methods: A retrospective analysis was performed of all patients with atrial or ventricular septal defect, tetralogy of Fallot, transposition of the great vessels, Ebstein anomaly, or common ventricle undergoing a transvenous ICD procedure in the National Cardiovascular Data Registry (NCDR) ICD Registry from April 2010 to March 2016, and DSM testing was assessed. Inadequate DSM was defined as a lowest successful energy tested <10 J than the maximum output of the ICD generator., Results: Of all ICD recipients (N = 7,024), DSM testing was performed in 52.0% (n = 3,654). The mean lowest successful energy tested was 20.7 ± 7.3 J. Of those with DSM adequacy data available (n = 3,623), an inadequate DSM occurred in 13.8% (n = 501). After multivariable adjustment, DSM testing was not associated with in-hospital complications or death (odds ratio [OR]: 1.00; 95% confidence interval [CI]: 0.79 to 1.28) but was associated with lower odds of prolonged hospital stay (>3 days) (OR: 0.71; 95% CI: 0.60 to 0.84; p < 0.0001). An inadequate DSM was not associated with in-hospital death or complications (OR: 1.27; 95% CI: 0.79 to 2.04) or prolonged hospital stay (OR: 1.34; 95% CI: 0.995 to 1.81)., Conclusions: DSM testing is being performed less frequently over time and seems safe in those with CHD. An inadequate DSM was not associated with worse in-hospital outcomes., Competing Interests: Funding Support and Author Disclosures This research was supported by the American College of Cardiology’s National Cardiovascular Data Registry (NCDR). The views expressed in the manuscript represent those of the authors and do not necessarily represent the official views of the NCDR or its associated professional societies identified at CVQuality.ACC.org/NCDR. Dr Curtis has a contract with the American College of Cardiology for his role as Senior Medical Officer, NCDR; receives salary support from the American College of Cardiology, NCDR; receives funding from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and holds equity interest in Medtronic. Dr Hsu has received honoraria from Medtronic, Abbott, Boston Scientific, Biotronik, Biosense Webster, Zoll Medical, Pfizer, Bristol Myers Squibb, and Janssen Pharmaceuticals; has received research grants from Biosense Webster and Biotronik; and has equity interest in Acutus Medical and Vektor Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background/objectives: Advanced age is associated with increased susceptibility to acute adverse effects of propofol. The present study aimed to describe patterns of propofol dosing for induction of general anesthesia before endotracheal intubation in a nationwide sample of older adults presenting for surgery., Design: Retrospective observational study using the Multicenter Perioperative Outcomes Group data set., Setting: Thirty-six institutions across the United States., Participants: A total of 350,766 patients aged over 65 years who received propofol for general anesthetic induction and endotracheal intubation between 2014 and 2018., Intervention: None., Measurements: Total induction bolus dose of propofol administered., Results: The mean (SD) weight-adjusted propofol dose was 1.7 (0.6) mg/kg. The mean prevalent propofol induction dose exceeded the upper bound of what has been described as the typical geriatric dose requirement across every age category examined. The percent of patients receiving propofol induction doses above the described typical geriatric range was 64.8% (95% CI 64.6-65.0), varying from 73.8% among patients aged 65-69 to 45.8% among patients aged 80 and older., Conclusion: The present study of a large multicenter cohort demonstrates that prevalent propofol dosing commonly falls above the published typically required dose range for patients aged ≥65 in nationwide anesthetic practice. Widespread variability in induction dose administration remains incompletely explained by known patient variables. The nature and clinical consequences of these unexplained dosing decisions remain important topics for further study. Observed discordance between expected and actual induction dosing raises the question of whether there should be reconsideration of widespread provider practice or, alternatively, whether what is published as the typical propofol induction dose range should be revisited., (© 2021 The American Geriatrics Society.)

[Figure: see text].

Background: Standardization of risk is critical in benchmarking and quality improvement efforts for percutaneous coronary interventions (PCIs). In 2018, the CathPCI Registry was updated to include additional variables to better classify higher-risk patients., Objectives: This study sought to develop a model for predicting in-hospital mortality risk following PCI incorporating these additional variables., Methods: Data from 706,263 PCIs performed between July 2018 and June 2019 at 1,608 sites were used to develop and validate a new full and pre-catheterization model to predict in-hospital mortality, and a simplified bedside risk score. The sample was randomly split into a development cohort (70%, n = 495,005) and a validation cohort (30%, n = 211,258). The authors created 1,000 bootstrapped samples of the development cohort and used stepwise selection logistic regression on each sample. The final model included variables that were selected in at least 70% of the bootstrapped samples and those identified a priori due to clinical relevance., Results: In-hospital mortality following PCI varied based on clinical presentation. Procedural urgency, cardiovascular instability, and level of consciousness after cardiac arrest were most predictive of in-hospital mortality. The full model performed well, with excellent discrimination (C-index: 0.943) in the validation cohort and good calibration across different clinical and procedural risk cohorts. The median hospital risk-standardized mortality rate was 1.9% and ranged from 1.1% to 3.3% (interquartile range: 1.7% to 2.1%)., Conclusions: The risk of mortality following PCI can be predicted in contemporary practice by incorporating variables that reflect clinical acuity. This model, which includes data previously not captured, is a valid instrument for risk stratification and for quality improvement efforts., Competing Interests: Funding Support and Author Disclosures This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry. The views expressed represent those of the author(s) and do not necessarily represent the official views of the National Cardiovascular Data Registry or its associated professional societies. Mr. Wang and Dr. Minges have received salary support for analytic services provided to the American College of Cardiology. Dr. Spertus has served as the principal investigator of a Data Analytic Center for the American College of Cardiology Foundation National Cardiovascular Data Registry, related to this work; has served as a consultant on PROs to Novartis, Amgen, Janssen, Lilly, Merck, and Myokardia, unrelated to this work; has served on the scientific advisory board for United Healthcare; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and has served on the Board of Directors for Blue Cross and Blue Shield of Kansas City. Dr. Messenger has received research support to his institution from Philips Medical Systems. Dr. Clary has received research support to her institution from Novartis and Boehringer Ingelheim; and has received consulting fees from Allergan. Dr. Curtis has a contract with the American College of Cardiology for his role as Senior Medical Officer, National Cardiovascular Data Registry; has received salary support from the American College of Cardiology, National Cardiovascular Data Registry; and holds equity interest in Medtronic. Dr. Cavender has received research support to his institution from Amgen, AstraZeneca, CSL Behring, and Novartis; and has received consulting fees from Amgen, Bayer, Boehringer Ingelheim, Edwards Lifesciences, Merck, and Novo Nordisk., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Importance: After disparate results from observational and small randomized studies, the COMPLETE trial demonstrated superiority of multivessel (MV) percutaneous coronary intervention (PCI) over culprit-only PCI for ST-elevation myocardial infarction (STEMI)., Objective: To describe temporal trends and institutional variation of MV PCI use for STEMI in the United States to inform how new evidence may influence clinical practice., Design, Setting, and Participants: This cohort study included STEMI admissions involving MV disease from 1598 institutions in the National Cardiovascular Data Registry CathPCI Registry from the third quarter of 2009 to the first quarter of 2018. An MV PCI was defined as a PCI to a nonculprit lesion within 45 days of the index procedure., Exposures: Multivessel PCI, defined as placement of coronary stents in 2 or more major epicardial vessels or the staged placement of 1 or more coronary stents in a major epicardial vessel distinct from the index culprit vessel, within 45 days of the index PCI., Main Outcomes and Measures: Outcomes included the proportional use of MV PCI among STEMI admissions with MV disease, and the timing of MV PCI (an index procedure, a staged procedure during index hospitalization, or a postdischarge procedure within 45 days)., Results: Among 359 879 admissions with STEMI and MV disease, MV PCI was performed in 38.5% (n = 138 380; mean [SD] age of patients, 62.3 [12.3] years; 102 266 men [73.9%]) within 45 days. Of those receiving MV PCIs, 30.8% (n = 42 629) had a procedure performed during the index procedure, 31.6% (n = 43 696) as a staged procedure during the index hospitalization, and 37.6% (n = 52 055) within 45 days of discharge. Complete revascularization of all diseased arteries was performed in 76.2% (n = 105 389). From the third quarter of 2009 to the second quarter of 2013, MV PCI use declined by 10%, from 42.7% (3230 of 7572 cases) to a nadir of 32.7% (3386 of 10 342 cases), followed by an increase to 44.0% (5062 of 11 497 cases) by the fourth quarter of 2017. During this time, there was a 13.6% decline in use of postdischarge staged MV PCI (from 23.4% of STEMI cases [1772 of 7572 cases] in the third quarter of 2009 to 9.9% [1094 of 11 171 cases] in the fourth quarter of 2014) and an 12.5% increase in MV PCI performed during the index admission (from 19.3% [1458 of 7572 cases] in the third quarter of 2009 to 31.8% [3557 of 11 171 cases] in the first quarter of 2018). Multivessel PCI use varied substantially across institutions, with a median use of 37.9% (interquartile range, 30.0%-46.5%)., Conclusions and Relevance: In this large, nationwide analysis, MV PCI use for patients with STEMI has been increasing through early 2018 but was used in the minority of patients and with wide variability across US institutions. The adoption of new trial results into guidelines and practice may further promote the growth of MV PCI.

Background: Whether insurance status influences practice patterns in implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) defibrillators, when indicated, is not known., Methods and Results: We analyzed the NCDR ICD Registry to evaluate associations of insurance status with guidelines-based receipt of CRT, as well as device-type, complication rates, and use of optimal medical therapy defined by guidelines. Among 798,028 patients with de novo ICD implants, we included only patients < 65 years (those older have Medicare) and excluded those admitted before 2006 (n=1,835) or with insurance coverage other than Medicare, Medicaid or private insurance (n=25,695) leaving 286,556 for analysis. Inverse probability of treatment weighting was used to control for imbalances between groups. Mean age was 53 years, 29% were female. Patients with private insurance and Medicare were more likely to receive CRT-D when indicated (79.6%, OR 1.19 95% CI 1.09-1.28, P <.001 and 78.5%, OR 1.11 95% CI 1.01-1.21 P = .03, respectively) compared to the uninsured (76.7%). The uninsured were also more likely than other groups to receive a single-chamber device. Complication rates did not differ. Uninsured patients were, however, more likely to receive optimal medical therapy, particularly in the subgroup receiving the implant for primary prevention., Conclusions: In propensity-weighted analysis, uninsured patients are less likely to receive CRT when indicated but more likely to be receiving optimal medical therapy at discharge. Reasons for differences in device implantation practices based on insurance status require further study., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Introduction: The cardiac catheterization laboratory (CCL) is a focal point for cardiovascular programs and the CCL director represents the key personnel. We outline profiles of CCL directors at the 2017 U.S. News & World Report top 100 U.S. cardiovascular hospitals., Methods: Using hospital websites, LinkedIn, Healthgrades, Medicare Provider Utilization and Payment Data 2017, and Scopus, we described CCL directors (in 2017) by age, gender, years since medical graduation, international medical school graduate (IMG) status, academic rank, provider clinical focus, and Hirsch (h)-index., Results: Nearly all CCL directors were male (97%). The median age (interquartile range [IQR]) was 53 (49-61) years and median (IQR) years since medical school graduation was 28 (23-35) years. Over a third of CCL directors (39.4%) were IMGs and 38.4% had completed fellowship training at the same facility where they were CCL director. The median (IQR) h-index was 11 (6-22). Of the 69.7% CCL directors who held faculty positions, 60.9% were professors and 30.4% were associate professors. From Medicare data, 45.5% performed only percutaneous coronary interventions, 41.4% performed structural interventions, 3.0% peripheral interventions, and 2.0% performed both structural and peripheral. CCL directors at the top 25 hospitals had higher h-indexes, and more likely to have completed fellowship training at their own institution., Conclusions: There are very few women CCL directors at the top U.S. cardiovascular hospitals. A third of the CCL directors were IMGs. A significant proportion of CCL directors primarily performed structural interventions and trained at the same institution, more so at the top 25 hospitals., (© 2021 Wiley Periodicals LLC.)