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BACKGROUND: The use of predilation during transcatheter aortic valve replacement (TAVR) is variable, and its association with outcomes remains unknown. We evaluated the impact of predilation versus no predilation (direct TAVR) in the low-risk population enrolled in the PARTNER 3 trial (Placement of Aortic Transcatheter Valves). METHODS: In the PARTNER 3 trial, 495 patients with severe symptomatic aortic stenosis underwent TAVR with the SAPIEN 3 valve. The use of predilation was left to operator discretion. The primary end point was a composite of all-cause death, stroke, or rehospitalization. Secondary end points included valve hemodynamic performance and the need for postdilation. Propensity score matching was performed. RESULTS: Predilation and direct TAVR were performed in 286 (57.8%) and 209 (42.2%) patients, respectively. Before matching, the primary end point occurrence at 30 days (3.8% versus 4.8%, P=0.604) and 1 year (8.7% versus 8.1%, P=0.831) was similar in the predilation versus direct TAVR groups. Similar results were observed after matching (202 patients in each groups). Incidence of ≥ mild paravalvular regurgitation was similar in both groups. Incidence of severe prosthesis-patient mismatch was low but higher in the predilation group versus the direct TAVR group (8.2% versus 2.6%, P=0.023). Compared with direct TAVR, the use of predilation was associated with longer procedure duration (63.2 versus 51.4 minutes, P=0.001), while the rate of postdilation did not differ between the 2 groups (24.8% versus 18.8%, P=0.150). CONCLUSIONS: Predilation and direct TAVR are safe in patients with low surgical risk and favorable aortic valve anatomy. Direct TAVR decreased the procedure duration and did not predispose to more postdilation. [ABSTRACT FROM AUTHOR]

BACKGROUND: Transcatheter edge-to-edge mitral valve (MV) repair (TEER) is an effective treatment for patients with primary mitral regurgitation at prohibitive risk for surgical MV repair (MVr). High-volume MVr centers and high-volume TEER centers have better outcomes than low-volume centers, respectively. However, whether MVr volume predicts TEER outcomes remains unknown. We hypothesized that high-volume MV surgical centers would have superior risk-adjusted outcomes for TEER than low-volume centers. METHODS: We combined data from the American College of Cardiology/Society of Thoracic Surgeons Transcatheter Valve Therapy registry and the Society of Thoracic Surgeons adult cardiac surgery database. MVr was defined as leaflet resection or artificial chords with or without annuloplasty and was evaluated as a continuous variable and as predefined categories (<25, 25–49, and ≥50 MV repairs/year). A generalized linear mixed model was used to evaluate risk-adjusted in-hospital/30-day mortality, 30-day heart failure readmission, and TEER success (mitral regurgitation ≤2+ and gradient <5 mm Hg). RESULTS: The study comprised 41 834 patients from 500 sites of which 332 (66.4%) were low, 102 (20.4%) intermediate, and 66 (13.2%) high-volume surgical centers (P <0.001). TEER success was 54.6% and was not statistically significantly different across MV surgical site volumes (P =0.4271). TEER mortality at 30 days was 3.5% with no significant difference across MVr volume on unadjusted (P =0.141) or adjusted (P =0.071) analysis of volume as a continuous variable. One-year mortality was 15.0% and was lower for higher MVr volume centers when adjusted for clinical and demographic variables (P =0.027). Heart failure readmission at 1 year was 9.4% and was statistically significantly lower in high-volume centers on both unadjusted (P =0.017) or adjusted (P =0.015) analysis. CONCLUSIONS: TEER can be safely performed in centers with low volumes of MV repair. However, 1-year mortality and heart failure readmission are superior at centers with higher MVr volume. [ABSTRACT FROM AUTHOR]

Background--This study sought to evaluate the impact of atrial fibrillation (AF) on clinical outcomes in patients undergoing transcatheter aortic valve replacement. Methods and Results--Data were evaluated in 1879 patients with baseline and discharge ECGs who underwent transcatheter aortic valve replacement in the Placement of AoRTic TraNscathetER Valve (PARTNER) trial. A total of 1262 patients manifested sinus rhythm (SR) at baseline/SR at discharge, 113 SR baseline/AF discharge, and 470 AF baseline/AF discharge. Patients who converted from SR to AF by discharge had the highest rates of all-cause mortality at 30 days (P<0.0001 across all groups; 14.2% SR/AF versus 2.6% SR/SR; adjusted hazard ratio [HR]=3.41; P=0.0002) and over 2-fold difference at 1 year (P<0.0001 across all groups; 35.7% SR/AF versus 15.8% SR/SR; adjusted HR=2.14; P<0.0001). The presence of AF on baseline or discharge ECG was a predictor of 1-year mortality (adjusted HR=2.14 for SR/AF group and HR=1.88 for AF/AF groups; P<0.0001 for both groups versus SR/SR). For patients discharged in AF, those with lower ventricular response (ie, <90 bpm) experienced less 1-year all-cause mortality (HR=0.74; P=0.04). Conclusions--After transcatheter aortic valve replacement, the presence of AF at discharge, and particularly, the conversion to AF by discharge and higher ventricular response are associated with increased mortality. These data underscore the deleterious impact of AF, as well as the need for targeted interventions to improve clinical outcomes, in patients undergoing transcatheter aortic valve replacement. [ABSTRACT FROM AUTHOR]

Background--Although transcatheter aortic valve replacement (TAVR) is an effective treatment for aortic stenosis, long-term mortality after TAVR remains high and challenging to predict. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a health status measure, assessed directly from patients, that integrates 2 clinically relevant factors (symptoms and functional status) that may predict TAVR outcomes. Methods and Results--Among 7769 patients from 286 sites in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, we examined the association between preprocedure (baseline) patient health status, as assessed by the KCCQ, and 1-year mortality after TAVR. The KCCQ Overall Summary Score was categorized as very poor: <25, poor: 25 to 49, fair: 50 to 74, or good: ≥75. Before TAVR, health status was rated as very poor in 28%, poor in 38%, fair in 24%, and good in 10%. Patients with worse health status were more likely to be women and had more comorbidities and higher STS mortality risk scores. Compared with those with good health status before TAVR and after adjusting for a broad range of baseline covariates, patients with very poor health status had a 2-fold increased hazard of death over the first year after TAVR (adjusted hazard ratio, 2.00; 95% confidence interval, 1.58-2.54), whereas those with poor and fair health status had intermediate outcomes (adjusted hazard ratio, 1.54; 95% confidence interval, 1.22-1.95 and adjusted hazard ratio, 1.20; 95% confidence interval, 0.94-1.55, respectively). Conclusions--In a national, contemporary practice cohort, worse preprocedure patient health status, as assessed by the KCCQ, was associated with greater long-term mortality after TAVR. These results support the measurement and integration of the KCCQ into mortality risk assessments for patients considering TAVR. [ABSTRACT FROM AUTHOR]

Objective: Risk algorithms were used to identify a high-risk population for transcatheter aortic valve implantation instead of standard aortic valve replacement in patients with aortic stenosis. We evaluated the efficacy of these methods for predicting outcomes in high-risk patients undergoing aortic valve replacement. Methods: Data were collected on 638 patients identified as having isolated aortic valve replacement between January 1, 1998 and December 31, 2006, using The Society of Thoracic Surgeons (STS) database. Long-term survival was determined from the Social Security Death Index or family contact. Operative risk was calculated using the STS Predicted Risk of Mortality, the EuroSCORE logistic and additive algorithms, and the Ambler Risk Score. Patients at or above the 90th percentile of risk (8.38% for STS, 33.47% for logistic, 12% for additive, 14.3% for Ambler) were identified as high risk. We then compared actual with predicted mortality and each algorithm’s ability to identify patients with the worst long-term survival. Results: Operative mortality was 24 of 638 (3.76%). An additional 121 (19.0%) patients died during the follow-up study period (mean 4.2 ± 2.7 years). Overall mortality was 145 of 638 (22.7%). Expected versus observed mortality for the high-risk group by algorithm was 13.3% versus 18.8% for STS, 50.9% versus 15.6% for logistic, 14.0% versus 11.9% for additive, and 19.0% versus 13.4% by Ambler. Long-term mortality, per high-risk group, was 64.1% in the STS Predicted Risk of Mortality, 45.3% in the logistic, 45.2% in the additive, and 40.2% in Ambler Risk Score. Logistic regression showed that the STS algorithm was the most sensitive in defining the patients most at risk for long-term mortality. Conclusion: The STS Predicted Risk of Mortality most accurately predicted perioperative and long-term mortality for the highest risk patients having aortic valve replacement. [Copyright &y& Elsevier]

Background: We analyzed data from patients undergoing off-pump isolated coronary artery bypass grafting surgery (OPCABG) to determine if immediate extubation in the operating room affected the incidence of postoperative atrial fibrillation. Methods: The study group comprised 2,376 consecutive OPCABG patients operated on between January 1, 2000, and December 31, 2004, by 22 surgeons at 18 hospitals. The data were subjected to univariate, multivariate analysis of variance, and logistic analysis. Logistic regression of matched groups was used to eliminate the effect of some confounding variables. Results: Patients immediately extubated after surgery had a reduced incidence of atrial fibrillation (10.6% versus 18.5%; p < 0.001), shorter length of stay (4.8 ± 3.5 versus 6.3 ± 5.2 days; p < 0.001), and also reduced mortality (1.1% versus 2.4%; p = 0.04). Logistic analysis identified as significant factors for postoperative atrial fibrillation, postoperative ventilator usage (p < 0.001; odds ratio [OR] = 1.63; 95% confidence interval [CI]: 1.24 to 2.14), male sex (p = 0.002; OR = 1.51; 95% CI: 1.17 to 1.96), previous CABG (p = 0.005; OR = 0.43; 95% CI: 0.24 to 0.78). Congestive heart failure may also be a contributing factor. In patient groups matched for their risk of mortality, postoperative ventilator use (p < 0.001; OR = 1.80; 95% CI: 1.31 to 2.47), increasing age, and male sex were all statistically significant risk factors. When patient groups were matched on a combination of factors including preoperative β-blocker usage, pulmonary disease, and smoking, postoperative ventilator use (p = 0.005; OR = 1.66; 95% CI: 1.16 to 2.38), along with increasing age, male sex, and previous CABG (reduced odds of atrial fibrillation developing) were statistically significant. Conclusions: Immediate extubation after OPCABG appears to reduce the incidence of postoperative atrial fibrillation independent of comorbidities. [Copyright &y& Elsevier]

Background: Data from outcomes registry databases are being increasingly used for peer review and public reporting. However, administrative and clinical databases are mostly unaudited; thus, their accuracy has not been verified.Methods: Outcomes data from all coronary artery bypass operations from a single cardiac surgery practice were entered into The Society of Thoracic Surgeons (STS) National Cardiac Database. From our practice of 18 surgeons, we audited 247 (10%) of the clinical records of patients undergoing surgery in 2001 and correlated them with all 315 elements of the STS National Cardiac Database for verification of accuracy. Inaccuracies were defined as a disagreement with a nominal or categorical variable or, for continuous variables, as the value not being within a predetermined window. When discrepancies existed, the hospital clinical record was assumed to be accurate. Outcomes discrepancies were then analyzed by four major categories: components of the preoperative risk algorithm, operative mortality, major complications, and other outcomes.Results: Discrepancies were noted in 5% (16) or fewer of the audited fields for 98.8% of the records. Of the 32 variables in the mortality risk algorithms, discrepancies were present in fewer than 10% of the audits on 30 of the 32 variables. More than 95% of the audited charts had zero or one discrepancy in the seven most important variables in the mortality risk models. Operative mortality was determined to be completely accurate with no discrepancies between the database and the audited clinical record. Among major complications, the error rate was less than 1% for all complications except prolonged ventilation (4.0%). A higher rate of discrepancies did exist in some of the other variables, including discharge medications (14.1%) and ventilator time (36.4%).Conclusions: A detailed audit of a clinical outcomes registry database demonstrated that the major fields within this specific database including operative mortality, major complications, and the significant factors in the risk algorithm were highly accurate. Process improvement factors were identified to further increase the accuracy of data collection. [Copyright &y& Elsevier]

: BackgroundCurrent practice, trends, and early outcomes in patients undergoing surgical and percutaneous coronary interventions (PCI) are changing and subject to speculation.: Methods148,396 consecutive patients in 69 HCA, Inc hospitals who underwent either PCI or coronary artery bypass grafting (CABG) were tracked in the HCA Casemix Database from 1999 through the first quarter of 2002. Comorbid conditions, procedures, complications, and outcome variables were defined through International Classification of Diseases, Ninth Revision coding. Odds ratios (OR) for death and other procedure-related complications were estimated using logistic regression adjusting for age, sex, and 31 other patient clinical and procedural characteristics.: ResultsNow 65.4% of all coronary revascularization is by PCI with a 6.8% annual rate of increase whereas CABG volume is declining by 1.9% per year. However the majority of these changes occurred between 1999 and 2000 with only small changes in the last 3 years. Coronary artery bypass grafting is still utilized primarily for multivessel disease (3.38 bypasses per patient) whereas PCI is predominately (83%) still limited to single-vessel intervention. Unadjusted mortality rates over the full 13-quarter period were 1.25% for PCI and 2.63% for CABG (p < 0.001), with PCI rates remaining constant and CABG mortality declining. Twenty-three percent of CABG is performed off pump with a lower mortality than conventional on-pump CABG (2.37% versus 2.69%, p < 0.001). Percutaneous coronary intervention patients have lower mortality (OR 0.51), and fewer acute renal failure (OR 0.39), neurologic (OR 0.12), and cardiac (OR 0.16) complications than CABG patients (p < 0.001).: ConclusionsInterventions for coronary artery disease continue to rise primarily due to an increase in PCI. The volume of PCI continues to increase relative to CABG. Although adverse outcomes are higher after CABG, the proportion of multivessel disease treated is greater. The difference in adverse outcomes between CABG and PCI remains small and continues to decline. [Copyright &y& Elsevier]

Background. Coronary artery bypass graft (CABG) surgery performed without cardiopulmonary bypass (CPB) is currently increasing in clinical practice. Decreased morbidity associated with off-pump (OP) CABG in selected risk groups examined in relatively small, single institution groups has been the focus of most recent studies. The purpose of this study was to determine the independent impact of CPB on early survival in all isolated multivessel CABG patients undergoing surgery in two large institutions with established experience in OPCABG techniques.Methods. A review of two large databases employed by multiple surgeons in the hospitals of two institutions identified 8,758 multivessel CABG procedures performed from January 1998 through July 2000. In all, 8,449 procedures were included in a multivariate logistic regression analysis to determine the relative impact of CPB on mortality independent of known risk factors for mortality. Procedures were also divided into two treatment groups based on the use of CPB: 6,466 had CABG with CPB (CABG-CPB), 1,983 had CABG without CPB (OPCABG). Disparities between groups were identified by univariate analysis of 17 preoperative risk factors and treatment groups were compared by Parsonnet’s risk stratification model. Finally, computer-matched groups based on propensity score for institution selection for OPCABG were combined and analyzed by a logistic regression model predicting risk for mortality.Results. CABG-CPB was associated with increased mortality compared with OPCABG by univariate analysis, 3.5% versus 1.8%, despite a lower predicted risk in the CABG-CPB group. CPB was associated with increased mortality by multiple logistic regression analysis with an odds ratio of 1.79 (95% confidence interval = 1.24 to 2.67). An increased risk of mortality associated with CPB was also determined by logistic regression analysis of the combined computer-matched groups based on OPCABG-selection propensity scores with an odds ratio of 1.9 (95% confidence interval = 1.2 to 3.1).Conclusions. Elimination of CPB improves early survival in multivessel CABG patients. Rigorous attempts to statistically account for selection bias maintained a clear association between CPB and increased mortality. Larger multiinstitutional studies are needed to confirm these findings and determine the most appropriate application of OPCABG. [Copyright &y& Elsevier]

Supplemental Digital Content is available in the text. Background: In the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), treatment of heart failure (HF) patients with moderate-severe or severe secondary mitral regurgitation with transcatheter mitral valve repair (TMVr) using the MitraClip plus guideline-directed medical therapy (GDMT) reduced 2-year rates of HF hospitalization and all-cause mortality compared with GDMT alone. Whether the benefits of the MitraClip extend to patients with previously implanted cardiac resynchronization therapy (CRT) is unknown. We sought to examine the effect of prior CRT in patients enrolled in COAPT. Methods: Patients (N=614) with moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated doses of GDMT were randomized 1:1 to the MitraClip (TMVr arm) versus GDMT only (control arm). Outcomes were assessed according to prior CRT use. Results: Among 614 patients, 224 (36.5%) had prior CRT (115 and 109 randomized to TMVr and control, respectively) and 390 (63.5%) had no CRT (187 and 203 randomized to TMVr and control, respectively). Patients with CRT had similar 2-year rates of the composite of death or HF hospitalization compared with those without CRT (57.6% versus 55%, P =0.32). Death or HF hospitalization at 2 years was lower with TMVr versus control treatment in patients with prior CRT (48.6% versus 67.2%, hazard ratio, 0.60 [95% CI, 0.42–0.86]) and without CRT (42.5% versus 66.9%, hazard ratio, 0.52 [95% CI, 0.39–0.69]; adjusted P interaction=0.23). The effects of TMVr with the MitraClip on reducing the 2-year rates of all-cause death (adjusted P interaction=0.14) and HF hospitalization (adjusted P interaction=0.82) were also consistent in patients with and without CRT as were improvements in quality-of-life and exercise capacity. Conclusions: In the COAPT trial, TMVr with the MitraClip improved the 2-year prognosis of patients with HF and moderate-severe or severe secondary mitral regurgitation who remained symptomatic despite maximally tolerated GDMT, regardless of prior CRT implantation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01626079. [ABSTRACT FROM AUTHOR]

: BackgroundAtrial septal defects (ASDs) have been surgically closed with low mortality utilizing the conventional sternotomy approach (CSA). The technical ease of ASD closure has triggered interest in minimally invasive closure (MIC) to obviate the morbidity associated with sternotomy. Our study assesses the safety and efficacy of minimally invasive ASD closure.: MethodsPreoperative, intraoperative, and postoperative data were collected on 68 patients (39 CSA, 29 MIC) who underwent ASD closure from January 1997 to August 2002. Using univariate analysis of 17 preoperative risk factors there was no statistically significant difference between the two groups.: ResultsMIC resulted in equivalent success rates in ASD closures, with similar morbidity, no mortality, and a significant difference in postoperative length of stay (3.93 ± 1.6 days versus 5.36 ± 2.51 days, p = 0.006).: ConclusionsIn experienced hands, MIC is an excellent alternative to CSA in ASD closure. [Copyright &y& Elsevier]

Supplemental Digital Content is available in the text. Background—: Stroke is a serious complication of both transcatheter aortic valve replacement (TAVR) and carotid artery disease (CD). The implications of CD in patients undergoing TAVR are unclear. Methods and Results—: The Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapies Registry, consisting of data from consecutive US TAVR cases during the years 2013 to 2015, was linked to Medicare claims data to ascertain 30-day and 1-year cumulative incidence rates of stroke and all-cause mortality. We compared 30-day and 1-year stroke and mortality outcomes between patients with no-CD and patients with moderate, severe, and occlusive CD and adjusted for baseline covariates using proportional hazards models. Among 29 143 patients undergoing TAVR across 390 US sites, 22% had CD. Patients with CD had higher rates of prior hypertension, diabetes mellitus, stroke, and myocardial infarction. Observed in-hospital stroke rates were 2.0% among no-CD, 2.5% among moderate CD, 3.0% among severe CD, and 2.6% among occlusive CD. There was no association between the presence of CD and 30-day stroke (adjusted hazard ratio, 1.16; 95% confidence interval, 0.94–1.43) or mortality (adjusted hazard ratio, 1.10; 95% confidence interval, 0.95–1.28). There was no association between CD and 1-year stroke (adjusted hazard ratio, 1.03; 95% confidence interval, 0.86–1.24) or mortality (adjusted hazard ratio, 1.02; 95% confidence interval, 0.93–1.12). Furthermore, there was no significant risk-adjusted association between severity of CD and 30-day or 1-year stroke or mortality. Conclusions—: CD is common among TAVR patients, present in 1 of 5. CD was not associated with an increased risk of stroke or mortality at 30 day or 1 year. Post-TAVR stroke seems to be because of mechanisms other than CD. [ABSTRACT FROM AUTHOR]