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Current methods to identify cardiac implantable electronic devices (CIED) lead failure include post-approval studies, which may be limited in scope, participant numbers, and attrition; studies relying on administrative codes, which lack specificity; and voluntary adverse event reporting, which cannot determine incidence or attribution to the lead.To determine whether adjudicated remote monitoring (RM) data can address these limitations and augment lead safety evaluation.Among 48,191 actively monitored patients with CIEDs, we identified RM transmissions signifying incident lead abnormalities and, separately, identified all leads abandoned or extracted between 4/1/19-4/1/21. We queried electronic health record (EHR) and Medicare fee-for-service claims data to determine if patients had administrative codes for lead failure. We verified lead failure through manual EHR review.Of 48,191 patients, 1170 (2.4%) had incident lead abnormalities detected on RM. Of these, 409 patients had administrative codes for lead failure, and 233 (57.0%) of these patients had structural lead failure verified through chart review. Among the 761 patients without administrative codes, 167 (21.9%) had structural lead failure verified through chart review. Thus, 400 (66.7%) total patients with RM transmissions suggestive of lead abnormalities had structural lead failure. In addition, 200 patients without preceding abnormal remote transmissions had leads abandoned or extracted for structural failure. Patients with isolated right atrial or left ventricular lead failure were less likely to have lead replacement and administrative codes reflective of lead failure.Remote monitoring may strengthen real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.

Cardiogenic shock (CS) is a highly morbid condition with mortality remaining greater than 30% despite improved pathophysiologic understanding and access to mechanical circulatory support (MCS). In response, shock teams modeled on successful multidisciplinary care structures for other diseases are being implemented nationwide.Primary data supporting a benefit of shock team implementation on patient outcomes are relatively limited and entirely observational. Four single-center before-and-after studies and one multicenter registry study have demonstrated improved outcomes in patients with CS, potentially driven by increased pulmonary artery catheter (PAC) utilization and earlier (and more appropriate) initiation of MCS. Shock teams are also supported by a growing body of literature recognizing the independent benefit of the interventions they seek to implement, including patient phenotyping with PAC use and an algorithmic approach to CS care. Though debated, MCS is also highly likely to improve CS outcomes when applied appropriately, which further supports a multidisciplinary shock team approach to patient and device selection.Shock teams likely improve patient outcomes by facilitating early patient phenotyping and appropriate intervention. Institutions should strongly consider adopting a multidisciplinary shock team approach to CS care, though additional data supporting these interventions are needed.

Background: Current important regulatory resources and methods to identify cardiac implantable electronic devices (CIED) lead failure include post-approval studies, which may be limited in scope, participant numbers, and by attrition; studies relying on administrative codes, which lack specificity in multi-chamber systems; and voluntary adverse event reporting, which cannot determine incidence or attribution to the lead. We determined whether adjudicated remote monitoring (RM) data can help to address these limitations and augment lead safety evaluation. Methods: We evaluated 48,148 patients from the Veterans Affairs National Cardiac Device Surveillance Program (VANCDSP), 4/1/19-4/1/21. We identified RM transmissions signifying incident lead abnormalities (possible lead failure, failure to capture, impedance out of range). We queried VA electronic health record (EHR) and Medicare fee-for-service claims data to determine if patients had administrative codes for lead failure. We verified structural lead failure through manual EHR review. Among patients with EHR-confirmed lead failure, we categorized subsequent clinical actions by cardiac chamber. Results: Of 48,148 actively monitored patients with CIEDs, 1174 (2.4%) had incident lead abnormalities detected on RM; 356 (30.3%) with administrative codes for lead failure and 818 (69.7%) without. Of the 356 patients, 220 (62%) had lead failure verified through chart review (positive predictive value [PPV], 62%). Among 276 patients randomly selected from 818 without administrative codes, 58 (26%) had EHR-confirmed lead failure (PPV, 21%). Patients with isolated right atrial or left ventricular lead failure were less likely to have claims and lead replacement procedures than those with right ventricular high-energy lead failure (Table). Conclusion: Remote monitoring may strengthen accurate real-world assessment of lead failure, particularly for leads where patients do not undergo replacement.

Structured Abstract Background While percutaneous closure is preferred in adults with a patent ductus arteriosus (PDA), the extent of cardiac remodeling following percutaneous PDA closure in adults is not well understood. We performed a meta-analysis to characterize cardiac remodeling following percutaneous PDA closure in adults. Methods MEDLINE and EMBASE were systematically searched for original studies that reported echocardiographic variables at baseline, immediately post-procedure (24 h), and at follow-up (>1 month) in adults undergoing percutaneous PDA closure. Additionally, we included data from patients >18 years of age that underwent percutaneous PDA closure between January 2015–December 2019 at our centre. Weighted averages were calculated for parameters with sufficient data. Pooled differences were presented as weighted mean differences (WMD). Results After screening 278 abstracts, 5 studies were identified. When combined with our cohort, our meta-analysis encompassed 244 patients. Immediately post-procedure, LVEF was the only parameter to change significantly (64 vs 52%, WMD -8.64 95%, CI -14.04 to −3.25). All parameters significantly decreased from baseline to follow-up: LVEF: 64 vs 60% (WMD -3.95, CI -5.80 to −2.09), LVEDD: 62 vs 53 mm (WMD -8.79, CI -12.78 to −4.81) LVEDVI 172 vs 123 mL/m2 (WMD -26.60, CI -45.4 to −7.85), LVESD 42 vs 36 mm (WMD -4.64, CI -9.10 to −0.17) and LA dimension: 42 vs 37 mm (WMD -5.87, CI -9.85 to −1.90). Conclusions As compared to the baseline values, left ventricular and left atrial sizes decreased. The LVEF decreased immediately following PDA closure and, while it recovers, it remained lower on follow-up testing.

Introduction: Patent ductus arteriosus (PDA) is often recognized and treated with percutaneous closure in adults. However, the impact on cardiac reverse remodeling following PDA closure in adults is not clear. We performed a meta-analysis to characterize the extent of cardiac remodeling following percutaneous PDA closure in adults. Methods: MEDLINE and EMBASE were systematically searched for original studies that reported echocardiographic variables at baseline, immediately post-procedure (within 24 hours), and at follow-up (>1 month) in adults undergoing percutaneous PDA closure. Additionally, we included echocardiographic data from a cohort of patients >18 years of age that underwent percutaneous PDA closure between 01/2015 and 12/2019 at our centre. For parameters with sufficient data for pooling, weighted averages were calculated, and pooled differences were presented as weighted mean differences. Heterogeneity was assessed using the I 2 statistic. Results: After screening 278 abstracts, 5 studies were identified. When combined with our own cohort of 13 patients, our meta-analysis encompassed 244 patients. The weighted mean age of all patients was 33 years with all studies predominantly comprised of female patients and the median follow-up was 12 months (ranging from 1 month- 5 years across the studies). When compared to baseline, left ventricular ejection fraction (LVEF) decreased significantly immediately post-procedure and all parameters significantly decreased at follow-up (Table 1). Conclusions: As demonstrated by the decreases in the left ventricular and left atrial sizes, reverse remodeling was observed in adults who underwent percutaneous PDA closure. The significantly lower LVEF immediately post-procedure could reflect withdrawal of chronic volume overload or increased afterload. The clinical significance of the statistically significant lower LVEF on follow-up testing is unclear and requires further evaluation.

OBJECTIVES This study evaluates in-hospital, 30-day, and 1-year outcomes post-transcatheter aortic valve replacement (TAVR) in end stage liver disease (ESLD) and/or end stage renal disease (ESRD) compared with patients without these comorbidities. BACKGROUND TAVR is an alternative to surgical aortic valve replacement in patients with ESLD and ESRD, though current outcomes data are limited. METHODS We compared 309 patients (N = 29 ESLD and/or ESRD, N = 280 control) age > 18 who underwent transfemoral TAVR from 2014 to 2020 have been compared. RESULTS Patients with ESLD and ESRD were younger (69.9 ± 11.7 vs. 79.1 ± 9.8, p

Objectives This study compares 30-day, 1-year, and 3-year echocardiographic findings and clinical outcomes of transcatheter pulmonary valve-in-valve replacement (TPVR) and repeat surgical pulmonary valve replacement (SPVR). Background In patients with adult congenital heart disease and previous pulmonary valve replacement (PVR) who require redo PVR, it is unclear whether TPVR or repeat SPVR is the preferred strategy. Methods We retrospectively identified 66 patients (TPVR, n = 36; SPVR, n = 30) with bioprosthetic pulmonary valves (PVs) who underwent either TPVR or repeat SPVR at Emory Healthcare from January 2007 to August 2017. Results The TPVR cohort had fewer men and more patients with baseline New York Heart Association (NYHA) functional class III or IV. There was no difference in mortality, cardiovascular readmission, or post-procedural PV reintervention at 30 days, 1 year, or 3 years. Post-procedural echocardiographic findings showed no difference in mean PV gradients between the TPVR and SPVR groups at 30 days, 1 year, or 3 years. In the TPVR cohort, there was less right ventricular dysfunction at 30 days (2.9% vs. 46.7%; p Conclusions In patients with bioprosthetic PV dysfunction who underwent either TPVR or SPVR, there was no difference in mortality, cardiovascular readmission, or repeat PV intervention at 30 days, 1 year, or 3 years. Additionally, TPVR and SPVR had similar intermediate-term PV longevity, with no difference in PV gradients or PVR. The TPVR cohort also had less right ventricular dysfunction at 30 days despite a higher baseline NYHA functional classification. These intermediate-term results suggest that TPVR may be an attractive alternative to SPVR in patients with previous bioprosthetic surgical PVs.

Objectives This study sought to investigate predictors and safety of next-day discharge (NDD) after transcatheter aortic valve replacement (TAVR). Background Information about predictors and safety of NDD after TAVR is limited. Methods The study reviewed 663 consecutive patients who underwent elective balloon-expandable TAVR (from July 2014 to July 2016) at our institution. We first determined predictors of NDD in patients who underwent minimalist transfemoral TAVR. After excluding cases with complications, we compared 30-day and 1-year outcomes between NDD patients and those with longer hospital stay using Cox regression adjusting for the Predicted Risk of Mortality provided by the Society of Thoracic Surgeons. The primary endpoint was the composite of mortality and readmission at 1 year. Results A total of 150 patients had NDD after TAVR and 210 patients had non-NDD. Mean age and the Society of Thoracic Surgeons Predicted Risk of Mortality were 80.7 ± 8.8 years and 6.6 ± 3.7%, respectively. Predictors of NDD were male sex (odds ratio [OR]: 2.02; 95% confidence interval [CI]: 1.28 to 3.18), absence of atrial fibrillation (OR: 1.62; 95% CI: 1.02 to 2.57), serum creatinine (OR: 0.71; 95% CI: 0.55 to 0.92), and age (OR: 0.95; 95% CI: 0.93 to 0.98). As expected, 84% of patients with complications had non-NDD. After excluding cases with complications, there was no difference in hazard rates of the 30-day composite outcome between NDD and non-NDD (hazard ratio: 0.62; 95% CI: 0.20 to 1.91), but the hazard of the composite outcome at 1 year was significantly lower in the NDD group (hazard ratio: 0.47; 95% CI: 0.27 to 0.81). This difference in the composite outcome can be explained by the lower hazard of noncardiovascular related readmission in the NDD group. Conclusions Factors predicting NDD include male sex, absence of atrial fibrillation, lower serum creatinine, and younger age. When compared with patients without complications with a longer hospital stay, NDD appears to be safe, achieving similar 30-day and superior 1-year clinical outcomes.

Objective In high- or extreme-risk patients undergoing transcatheter aortic valve replacement, readmissions have not been adequately studied and are the subject of increased scrutiny by healthcare systems. The objectives of this study were to determine the incidence of 30-day and 1-year cardiac and noncardiac readmissions, identify predictors of readmission, and assess the association between readmission and 1-year mortality. Methods A retrospective review was performed on 714 patients who underwent transcatheter aortic valve replacement from September 2007 to January 2015 at Emory University. Results Patients' median age was 83 years, and 46.6% were female. Early all-cause readmission for the cohort was 10.5%, and late readmission was 18.8%. Anemia was related to both early all-cause (hazard ratio [HR], 0.74) and cardiovascular-related readmission (HR, 0.60). A 23-mm valve implanted was associated with early all-cause readmission (HR, 1.73). Length of hospital stay was related to late all-cause (HR, 1.14) and cardiovascular-related readmission (HR, 1.21). Postoperative permanent stroke had an impact on late cardiovascular-related readmission (HR, 3.60; 95% confidence interval, 1.13-11.49). Multivariable analysis identified anemia as being associated with 30-day all-cause readmission, and anemia and postoperative stroke were associated with 30-day cardiovascular-related readmission. Readmissions seemed to be related to 1-year mortality (HR, 2.04; 95% confidence interval, 1.33-3.12). Conclusions We show some baseline comorbidities and procedural complications that are directly associated with early and late readmissions, and anemia and postoperative stroke were associated with an increase in mortality. Moreover, we found that readmission was associated with double the hazard of death within 1 year. Whether treatment of identified risk factors could decrease readmission rates and mortality warrants further investigation.

Background New conduction abnormalities necessitating pacemaker implantation (PMI) is a common occurrence after TAVR. There is an increased rate of PMI in the those receiving the most contemporary implanted valve, the Edwards Sapien-3 (S3), compared to prior generation balloon expandable valves. We previously described predictors of PMI in a large cohort. Herein we sought to validate these predictors of PMI in a subsequent validation cohort. Methods We evaluated all patients undergoing first time elective TAVR with S3 at our institution (n=326). We developed a risk score based on a predictive model we have previously described. Patients received one point for each of the following: history of syncope, oversizing of the valve >16%, baseline right bundle branch block morphology, and two points for a QRS duration >115 ms. We performed regression analysis of the risk score and need for PMI. We also evaluated the performance of the risk score using ROC analysis. Results Thirty patients (8%) of the total cohort had need for PMI after S3 implantation. Those with PMI had a higher rate of pre-existing infra-nodal conduction system disease – including QRS duration >115ms (57% vs. 20%, p15.7% (47% vs. 23%, p Rate of PMI Stratified by Risk Score Conclusions The PMI risk score was strongly predictive of the need for PMI after implantation of the S3 valve in a large validation cohort. The PMI risk score performed well in sensitivity analysis. This PMI risk score represents a simple tool to help further risk stratify patients being considered for TAVR.

The aim of this study was to define risk factors and develop a predictive risk score for new pacemaker implantation (PMI) after transcatheter aortic valve replacement (TAVR).TAVR has become an accepted treatment alternative for patients with severe aortic stenosis at elevated surgical risk. New PMI is a common occurrence after TAVR and is associated with poorer outcomes.All patients without prior valve procedures undergoing elective TAVR with the Edwards SAPIEN 3 at a single institution (n = 1,266) were evaluated. Multivariate analysis was performed to evaluate for predictors of PMI in this population in a derivation cohort of patients with complete data (n = 778), and this model was used to develop the Emory risk score (ERS), which was tested in a validation cohort (n = 367).Fifty-seven patients (7.3%) in the derivation cohort required PMI. In a regression model, history of syncope (odds ratio [OR]: 2.5; p = 0.026), baseline right bundle branch block (OR: 4.3; p 0.001), QRS duration ≥138 ms (OR: 2.5; p = 0.017), and valve oversizing15.6% (OR: 1.9; p = 0.041) remained independent predictors of PMI and were included in the ERS. The ERS was strongly associated with PMI (per point increase OR: 2.2; p 0.001) with an area under the receiver-operating characteristic curve of 0.778 (p 0.001), which was similar to its performance in the derivation cohort.A history of syncope, right bundle branch block, longer QRS duration, and higher degree of oversizing are predictive of the need for PMI after TAVR. Additionally, the ERS for PMI was developed and validated, representing a simple bedside tool to aid in risk stratification for patients for undergoing TAVR.

Objectives To compare outcomes after minimalist and standard transfemoral transcatheter aortic valve replacement (TF-TAVR) in patients with severe chronic obstructive pulmonary disease (COPD). Background TF-TAVR is increasingly performed with conscious sedation and transthoracic echocardiography guidance (minimalist). The safety/efficacy of this technique in patients with severe COPD is unknown. Methods We compared demographics, 30-day outcomes and 1-year survival of patients with severe COPD (FEV1% ≤50) who underwent minimalist vs. standard TF-TAVR between 2008 and 2015 at our institution. Results Of 88 patients with severe COPD, 46 underwent minimalist and 42 underwent standard TF-TAVR. There were no differences on baseline characteristics, except for more history of coronary artery bypass grafting (45.5% vs. 20.6%, P = 0.03) and less history of cerebrovascular disease (16.7% vs. 45.5%, P = 0.03) in the standard TF-TAVR. Seventeen minimalist TF-TAVR patients (41.0%) were transferred directly to the general medical ward with telemetry monitoring (without ICU stay); all standard TF-TAVR patients went to the ICU. Minimalist TF-TAVR patients had shorter procedure time (97 vs. 129 min, P

Currently, there are no recommendations regarding the selection of valve type for a transcatheter heart valve (THV)-in-THV procedure. A supra-annular valve design may be superior in that it results in a larger effective orifice area and may have a lower chance of valve thrombosis after THV-in-THV. In this report, we describe the use of a supra-annular valve strategy for an early degenerated THV.

There are minimal data regarding clinical outcomes and echocardiographic findings after transcatheter mitral valve-in-valve replacement (TMVR) compared with redo surgical mitral valve replacement (SMVR).TMVR therapy has emerged as therapy for a degenerated bioprosthetic valve failure.The authors retrospectively identified patients with degenerated mitral bioprostheses who underwent redo SMVR or TMVR at 3 U.S. institutions. The authors compared clinical and echocardiographic outcomes of patients who had TMVR with those of patients who underwent redo SMVR.Sixty-two patients underwent TMVR and 59 patients underwent SMVR during the study period. Mean age and the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) scores were significantly higher in patients with TMVR than in those with SMVR (age 74.9 ± 9.4 years vs. 63.7 ± 14.9 years; p 0.001; STS PROM 12.7 ± 8.0% vs. 8.7 ± 10.1%; p 0.0001). Total procedure time, intensive care unit hours, and post-procedure length of stay were all significantly shorter in the TMVR group. There was no difference in mortality at 1 year between the 2 groups (TMVR 11.3% vs. SMVR 11.9%; p = 0.92). Mean mitral valve pressure gradient and the grade of mitral regurgitation (MR) were similar between the TMVR group and the SMVR group (mitral valve pressure gradient 7.1 ± 2.5 mm Hg vs. 6.5 ± 2.5 mm Hg; p = 0.42; MR [≥moderate] 3.8% vs. 5.6%; p = 1.00) at 30 days. At 1 year, the mitral valve pressure gradient was higher in the TMVR group (TMVR 7.2 ± 2.7 vs. SMVR 5.5 ± 1.8; p = 0.01), although there was no difference in the grade of MR.Despite the higher STS PROM in TMVR patients, there was no difference in 1-year mortality between the TMVR and SMVR groups. Echocardiographic findings after TMVR were similar to SMVR at 30 days. There was a statistically significant difference in mitral gradient at 1 year, though this is likely not clinically important. TMVR may be an alternative to SMVR in patients with previous mitral bioprosthetic valves.

A 76-year-old obese man (body mass index 30.8 kg/m2, body surface area 2.35 m2) with a history of mitral valve replacement and coronary artery bypass grafting was admitted to our hospital with decompensated heart failure. The patient underwent surgical mitral valve replacement with a 25-mm Mosaic

Higher body mass index is reported to be related to early degeneration of bioprostheses. However, there are minimal data regarding the relationship between overweight/obese compared to normal weight patients and their outcomes after transcatheter aortic valve replacement (TAVR) with a current

End stage renal disease (ESRD) portends worse outcomes including early bioprosthetic degeneration after either surgical or transcatheter aortic valve replacement (TAVR). There are minimal data about THE impact of hemodialysis (HD) on early valve degeneration and clinical outcomes after TAVR. We

Minimalist (MA) TAVR has contributed to wider acceptance of TAVR. Previous reports of MA-TAVR confirmed its safety and less resource utilization. These reports compared local and general anesthesia, and patients were treated either with an older generation self-expandable or balloon-expandable valve

To compare outcomes after minimalist and standard transfemoral transcatheter aortic valve replacement (TF-TAVR) in patients with severe chronic obstructive pulmonary disease (COPD).TF-TAVR is increasingly performed with conscious sedation and transthoracic echocardiography guidance (minimalist). The safety/efficacy of this technique in patients with severe COPD is unknown.We compared demographics, 30-day outcomes and 1-year survival of patients with severe COPD (FEV1% ≤50) who underwent minimalist vs. standard TF-TAVR between 2008 and 2015 at our institution.Of 88 patients with severe COPD, 46 underwent minimalist and 42 underwent standard TF-TAVR. There were no differences on baseline characteristics, except for more history of coronary artery bypass grafting (45.5% vs. 20.6%, P = 0.03) and less history of cerebrovascular disease (16.7% vs. 45.5%, P = 0.03) in the standard TF-TAVR. Seventeen minimalist TF-TAVR patients (41.0%) were transferred directly to the general medical ward with telemetry monitoring (without ICU stay); all standard TF-TAVR patients went to the ICU. Minimalist TF-TAVR patients had shorter procedure time (97 vs. 129 min, P 0.001), ICU time (21.8 vs. 29.8 hr, P = 0.001) and length of stay (2 vs. 5 days, P = 0.001). There were no differences in procedure complications and 30-day mortality between groups. In our multivariate analysis, minimalist TF-TAVR (HR 0.28, 95%CI 0.08-0.97) and previous coronary revascularization (HR 0.24, 95%CI 0.09-0.65) were associated with increased 1-year survival. In contrast, moderate paravalvular leak (HR 7.73, 95%CI 1.94-30.84) was associated with decreased 1-year survival.In patients with severe COPD, Minimalist TF-TAVR results in less resource utilization and improved 1-year survival compared to standard approach. Our findings should be validated in a larger cohort of patients with severe COPD. © 2016 Wiley Periodicals, Inc.

There is no previous report comparing clinical or echocardiographic outcomes in patients with a history of prior surgical pulmonary valve replacement (SPVR) who undergo repeat SPVR or transcatheter pulmonary valve replacement (TPVR). We retrospectively identified patients who had previous SPVR and

Transfemoral (TF) transcatheter aortic valve replacement is increasingly performed with conscious sedation and transthoracic echo guidance in the cath lab (Minimalist, MA-TAVR). We studied whether MA-TAVR results in better outcomes than standard TF-TAVR (SA-TAVR) in patients with severe chronic