AbstractBackgroundThough infrequent, incomplete left atrial appendage closure (LAAC) may result from residual leaks. Percutaneous closure has been described though data is limited.MethodsWe compiled a registry from four centers of patients undergoing percutaneous closure of residual leaks following LAAC via surgical means or with the Watchman device. Leak severity was classified as none (no leak), mild (1–2 mm), moderate (3–4 mm), or severe (≥5 mm). Procedural and clinical success was defined as the elimination of leak or mild residual leak at the conclusion of the procedure or follow‐up, respectively.ResultsOf 72 (age 72.2 ± 9.2 years; 67% male) patients, 53 had undergone prior LAAC using the Watchman device and 19 patients surgical LAAC. Mean CHADS2‐VA2Sc score was 4.0 ± 1.8. The median leak size was 5 mm, range: 2–13). A total of 13 received Amplatzer Vascular Plug‐II, 18 received Amplatzer Duct Occluder‐II and 40 patients received coils. One underwent closure using a 21 mm‐Watchman. Procedural success was 94%. Zero surgical and nine Watchman patients (13%) had a residual leak at procedural‐end (five mild, three moderate, and one severe)—only one patient had no reduction in leak size. Overall leak size reduction was 94%. Two (3%) had intraoperative pericardial effusion. There were no device embolizations, device‐related thrombi, or procedural deaths. Clinical success was maintained at 94%. Two had cerebrovascular accidents—at 2 days (transient ischemic attack) and 10 months postprocedure. Two had major bleeding outside the 30‐day periprocedural window.ConclusionPercutaneous closure of residual leaks following left atrial appendage closure is feasible and associated with good outcomes. The procedural risk appears to be satisfactory.
Treatment Effect of Percutaneous Coronary Intervention in Men Versus Women With ST‐Segment–Elevation Myocardial Infarction
Background Women are less likely to receive primary percutaneous coronary intervention (pPCI) than men. A potential reason is risk aversion because of the worse outcomes with pPCI among women. However, whether pPCI is associated with a comparable mortality benefit in men and women remains unknown. Methods and Results We selected patients admitted with a principal diagnosis of ST‐segment–elevation myocardial infarction in the National Inpatient Sample (2016–2018). We used propensity‐score matching to calculate average treatment effects of pPCI for in‐hospital mortality, major complications, length of stay, and cost. As a sensitivity analysis, we used logit models followed by a marginal command to calculate the average marginal effect. We included 413 500 weighted hospitalizations (30.7% women, 69.3% men). Women had more comorbidities except smoking and prior sternotomy. Compared with men, women were less likely to undergo angiography (81.0% versus 87.0%; adjusted odds ratio [OR], 0.77; 95% CI, 0.74–0.81; P <0.001) or pPCI (74.0% versus 82.0%; adjusted OR, 0.76; 95% CI, 0.73–0.79; P <0.001). There were no significant differences in average treatment effects of pPCI on mortality between men (−8.4% [−9.3% to −7.6%], P <0.001), and women (−9.5% [−10.8% to −8.3%], P <0.001) ( P interaction=0.16). This persisted in age‐stratified analyses (≥85, 65–84, 45–64, <45 years) and sensitivity analysis, excluding emergent admissions. The average treatment effects of pPCI on major complications were comparable except for acute stroke, leaving against medical advice, and palliative encounter. There were no differences in the average treatment effects of pPCI on length of stay, but the proportional increase in cost with pPCI was higher in women. Conclusions pPCI results in a comparable reduction in in‐hospital mortality in men and women. Nonetheless, risk‐adjusted rates of pPCI remain lower in women in contemporary US practice.
Trends in outcomes, cost, and readmissions of transcatheter edge to edge repair in the United States (2014–2018)
AbstractIntroductionDespite the growth in transcatheter edge‐to‐edge repair (TEER) volume in the United States, data on the temporal changes in procedural outcomes are lacking.MethodsWe utilized the National Readmission Database to assess the annual changes in patient's characteristics, in‐hospital outcomes, cost, and readmissions for patients who underwent TEER between January 1, 2014 and December 31, 2018. Outcomes of interest included mortality, major adverse cardiovascular events (MACE) and any adverse event (AE). We also assessed length of stay and cost.ResultsA total of 22,692 hospitalizations were included. The mean age increased from 75.2 ± 12.9 in 2014 to 78.1 ± 9.8 years in 2018. Changes in the prevalence of risk factors were heterogenous. The incidence of in‐hospital mortality decreased from 4.0% in 2014 to 2.0% in 2018. Both MACE and any AE decreased significantly. Although the incidence of 30‐day readmission remained stable, there was a trend towards a temporal increase in both 90‐day and 180‐day. The adjusted median length of stay of the index admission decreased by 50% and this trend was associated with a $2100 reduction in risk and inflation adjusted in‐hospital cost, however, this reduction was offset by the increased total cost of readmissions within the first 6 months resulting in similar net‐cost.ConclusionThe volume of TEER has grown substantially between 2014 and 2018 coupled with a temporal improvement in in‐hospital outcomes and reduction in cost and length of stay. Re‐hospitalization rates after TEER remained steady at 30‐day and trended towards worsening overtime at 90‐ and 180‐days.
Association of Transcatheter Mitral Valve Repair Availability With Outcomes of Mitral Valve Surgery
Background Transcatheter mitral valve repair (TMVr) is currently offered at selected centers that meet certain operator and institutional requirements. We sought to explore the hypothesis that the availability of TMVr is associated with improved outcomes of MV surgery. Methods and Results We used the Nationwide Readmissions Database to identify patients who underwent MV surgery at centers with or without TMVr capabilities between January 1 and December 31, 2017. The primary end point was in‐hospital mortality. Secondary end points were postoperative complications, resource use, and 30‐day readmissions. A total of 24 477 patients from 595 centers (446 TMVr, 149 non‐TMVr) were included. There were modest but statistically significant differences in the prevalence of comorbidities between the groups. Patients at non‐TMVr centers had higher unadjusted in‐hospital mortality than those at TMVr centers (5.6% versus 3.6%, P <0.001). They also had higher rates of postoperative complications, longer hospitalizations, higher cost, and fewer home discharges but similar 30‐day readmission rates. After propensity matching, mortality remained higher at non‐TMVr centers (5.5% versus 4.0%, P <0.001). Rates of postoperative complications, prolonged hospitalizations, and nonhome discharges also remained higher. Postoperative mortality was consistently higher at non‐TMVr centers in multiple risk‐adjustment analyses incrementally accounting for differences in risk factors, surgical volume, availability of surgical repair, and excluding concomitant procedures. In the most comprehensive model, surgery at non‐TMVr centers was associated with higher odds of death (odds ratio, 1.41; 95% CI, 1.14–1.73; P =0.002). Conclusions Mitral valve surgery at TMVr centers is associated with improved in‐hospital outcomes compared with non‐TMVr centers.
Determinants of Morbidity and Mortality Associated With Isolated Tricuspid Valve Surgery
Background Whether the poor outcomes of isolated tricuspid valve surgery are related to the operation itself or to certain patient characteristics including late referral is unknown. Methods and Results Adult patients who underwent isolated tricuspid valve surgery were identified in the Nationwide Readmissions Database (2016–2017). Patients who had redo tricuspid valve surgery, endocarditis, or congenital heart disease were excluded. Multivariable logistic regression was performed to identify contributors to postoperative mortality. A total of 1513 patients were included (mean age 55.7±16.6 years, 49.6% women). Surrogates of late referral were frequent: 41% of patients were admitted with decompensated heart failure, 44.3% had a nonelective surgery status, 16.8% had advanced liver disease, and 31% had an unplanned hospitalization in the prior 90 days. The operation was performed on day 0 to 1 of the hospitalization in only 50% of patients, and beyond day 10 in 22% of patients. In‐hospital mortality occurred in 8.7% of patients. Median length of stay was 14 days (7–35 days), and median cost was $87 223 ($43 122–$200 872). In multivariable logistic regression analysis, surrogates for late referrals (acute heart failure decompensation, nonelective surgery status, or advanced liver disease) were the strongest predictors of in‐hospital mortality (odds ratio [OR], 4.75; 95% CI, 2.74–8.25 [ P <0.001]). This was also consistent in a second model incorporating unplanned hospitalizations in the 90 days before surgery as a surrogate for late referral (OR, 5.50; 95% CI, 2.28–10.71 [ P <0.001]). Conclusions The poor outcomes of isolated tricuspid valve surgery may be largely explained by the late referral for intervention. Studies are needed to determine the role of early intervention for severe isolated tricuspid regurgitation.
Sex‐stratified analysis of the safety of percutaneous left atrial appendage occlusion
AbstractObjectives and BackgroundThere is insufficient current evidence about whether sex impacts outcomes of percutaneous left atrial appendage occlusion (LAAO). The aim of this study was to investigate the association between sex and short‐term outcomes of LAAO.MethodsPatients who were hospitalized and underwent LAAO from October 2015 to December 2017 in the National Readmission Database were queried. The primary endpoint of interest was major in‐hospital adverse events. Secondary endpoints included, 30‐day readmission rate, nonhome discharge, and cost of hospitalization. Propensity score matching (1:1) was performed to compare the outcomes among women and men.ResultsA total of 9,281 patients were included in the current analysis [women = 3,659 (39%); men = 5,622 (61%)]. Comparing women to men, women had lower prevalence of diabetes mellitus (30.6% vs 35.7%, p < .01), heart failure (28.6% vs 30.8%, p = .03), vascular disease (55.5% vs 69.6%, p < .01) and renal failure (18.3% vs 21.2%, p < .01), and higher CHA2DS2VASc score (5 [IQR4‐6] vs 4 [IQR3‐6], p < .01). After propensity‐score matching, women had higher rate of major in‐hospital adverse events (2.8% vs 1.9%; p < .01), and nonhome discharges (11.4% vs 6.7%; p < .01). Additionally, 30‐day readmission rate was higher among women (10% vs 8.6%, p = .03).ConclusionAmong hospitalized patients undergoing LAAO, women carry higher risk for major in‐hospital adverse events, nonhome discharge, and 30‐day readmission rates.
Temporal Trends in the Incidence and Outcomes of Pacemaker Implantation After Transcatheter Aortic Valve Replacement in the United States (2012–2017)
Background Nationwide studies documenting temporal trends in permanent pacemaker implantation (PPMI) following transcatheter aortic valve replacement (TAVR) are limited. Methods and Results We selected patients who underwent TAVR between 2012 and 2017 in the National Readmission Database. The primary end point was the 6‐year trend in post‐TAVR PPMI at index hospitalization and at 30, 90, and 180 days after discharge. The secondary end point was the association between PPMI and in‐hospital mortality, stroke, cost, length of stay, and disposition. Among the 89 202 patients who underwent TAVR, 77 405 (86.8%) with no prior pacemaker or defibrillator were included. Patients who required PPMI had a higher prevalence of atrial fibrillation (43.6% versus 38.7%, P <0.001) and conduction abnormalities (28.4% versus 15.3%, P <0.001). The incidence of PPMI during index admission increased from 8.7% in 2012 to 13.2% in 2015, and then decreased to 9.6% in 2017. The incidence of inpatient PPMI within 30 days after discharge increased from 0.5% in 2012 to 1.25% in 2017 ( P trend <0.001). Inpatient PPMI beyond 30 days remained rare (<0.5%) during the study period. After risk adjustment, PPMI was not associated with in‐hospital mortality or stroke but was associated with increased nonhome discharge, longer hospitalization, and higher cost. The incremental expenditure associated with post‐TAVR PPMI during index admission increased from $9.6 million to $72.2 million between 2012 and 2017. Conclusions After an upward trend, rates of PPMI after TAVR in the United States stabilized at ~10% in 2016 to 2017, but there was a notable increase in PPMI within 30 days after the index admission. PPMI was not associated with increased in‐hospital morbidity or mortality but led to longer hospitalization, higher cost, and more nonhome discharges.