Incidence and severity of thrombocytopenia associated with use of intravascular microaxial ventricular assist devices for treatment of cardiogenic shock.

INTRODUCTION: The use of temporary mechanical circulatory support (MCS) for patients with refractory cardiogenic shock has increased over the past decade. Impella devices (intravascular microaxial ventricular assist devices [VADs]) have become common MCS options but reportedly cause thrombocytopenia. Limited published data regarding the incidence or severity of microaxial VAD-associated thrombocytopenia exists. OBJECTIVES: The goal of this study was to determine the incidence, timing, and severity of thrombocytopenia in a microaxial VAD population. METHODS: A retrospective multicenter review of electronic medical records identified all patients implanted with microaxial VAD at three US academic teaching hospitals between June 2015 and August 2017. Patients were excluded for short-term procedural microaxial VAD use during percutaneous coronary intervention. RESULTS: Sixty-four patients underwent microaxial VAD insertion (95% for left-sided support) during the observed time period. Support was in place for a median duration of 5.2 (interquartile range [IQR]: 2.4-10.0) days. Within 7 days postinsertion, 98.5% of patients developed thrombocytopenia (platelet count <150,000/µl) and 81.3% of patients experienced a >50% platelet decrease. Average platelet count nadir was 68,200/µl or 63.9% from baseline occurring on median day 3.8 (IQR: 2.4-5.4). Twenty-four patients (38.1%) were tested for heparin-induced thrombocytopenia by the heparin-dependent antibody (HDA) test. All HDAs were either negative or had serotonin release assay negative confirmation. Postdevice removal, platelet counts returned to baseline or >150,000/µl in 63% of patients by Day 5. CONCLUSION: Microaxial VAD-associated thrombocytopenia is common. Practitioners should consider this when evaluating supported patients for other causes of thrombocytopenia. Platelet counts return to preimplantation levels within days of device removal.

Small-vessel PCI outcomes in men, women, and minorities following platinum chromium everolimus-eluting stents: Insights from the pooled PLATINUM Diversity and PROMUS Element Plus Post-Approval studies.

OBJECTIVE: We evaluated 1-year outcomes after platinum chromium everolimus-eluting stents (PtCr-EES) in small versus non-small coronary arteries within a large, diverse sample of men, women, and minorities. BACKGROUND: There exists limited outcomes data on the use of second-generation drug-eluting stent to treat small diameter coronary arteries. METHODS: We pooled patients from the PLATINUM Diversity and PROMUS Element Plus stent registries. Small-vessel percutaneous coronary intervention (SV-PCI) was defined as ≥1 target lesion with reference vessel diameter (RVD) ≤2.5 mm. Endpoints included major adverse cardiac event (MACE; death, myocardial infarction [MI] or target vessel revascularization [TVR]), target vessel failure (TVF; death related to the target vessel, target vessel MI or TVR) and definite/probable stent thrombosis (ST). Multivariable Cox regression was used to risk-adjust outcomes. RESULTS: We included 4,155/4,182 (99%) patients with available RVD, of which 1,607 (39%) underwent small-vessel PCI. SV-PCI was not associated with increased MACE (adjHR 1.02; 95%CI 0.81-1.30) or TVF (adjHR 1.07; 95%CI 0.82-1.39). MI risk was lower in white men compared to women and minorities, both in the setting of SV-PCI (adjHR 0.41; 95%CI 0.23-0.74 and adjHR 0.39; 95%CI 0.20-0.75, respectively) and for non-SV-PCI (adjHR 0.61; 95%CI 0.38-0.99 and adjHR 0.45; 95%CI 0.27-0.74, respectively). There was no significant interaction between RVD and sex or minority status for any endpoint. CONCLUSION: In a large diverse contemporary PCI outcomes database, SV-PCI with PtCr-EES was not associated with increased MACE or TVR and did not account for the increased MI risk noted in women and minorities compared to white men.

Trends in hospitalization for takotsubo cardiomyopathy in the United States.

BACKGROUND: Takotsubo (or stress induced) cardiomyopathy is characterized by transient left ventricular systolic dysfunction. Recent trends in patient volume, characteristics, and outcomes in the United States are unknown. METHODS: Using 2007-2012 National Inpatient Sample data, we identified 22,005 adults (≥18 years) with a primary and 31,942 adults with a secondary discharge diagnosis of takotsubo cardiomyopathy (International Classification of Diseases, Ninth Revision, code 429.83) who underwent diagnostic coronary angiography. RESULTS: During 2007 to 2012, the incidence of takotsubo cardiomyopathy increased over 3-fold: 52/million discharges in 2007 to 178/million in 2012 (P < .001). We found a temporal increase in the prevalence of cardiac arrest, cardiogenic shock, cardiovascular risk factors (diabetes, hypertension), and psychiatric disorders (P trend < .0001 for all). In-hospital mortality was 1.1% and remained unchanged over this period (P = .22). Compared to the primary diagnosis group, mortality in the secondary diagnosis group was higher (1.1% vs 3.2%) and was associated with higher incidence of cardiogenic shock, cardiac arrest, and respiratory failure. Men represent 8% of patients in the primary diagnosis group and 12% in the secondary group. In both groups, men had a higher incidence of shock, cardiac arrest, and respiratory failure. Although their mortality was higher than women in the primary group (3.0% vs 0.9%, adjusted odds ratio 3.85, 1.74-8.51), it was comparable in the secondary group (4.8% vs 3.0%). CONCLUSIONS: We found a marked increase in the hospitalization for takotsubo cardiomyopathy in the United States in recent years, suggesting higher incidence than prior reports. Although outcomes have remained favorable, there is an increasing burden of cardiovascular and psychiatric disorders in this population with growing cost of care. Risk of mortality is higher in men and in patients with underlying critical illness. The excess mortality in these groups appears to be mediated by greater severity of disease.

Insulin resistance is associated with significant clinical atherosclerosis in nondiabetic patients with acute myocardial infarction.

OBJECTIVE: The prevalence of insulin resistance (IR) is increasing worldwide because of increasing age, obesity, and physical inactivity. Emerging evidence supports a direct proatherogenic effect of IR on the coronary vasculature, but the relation between IR and angiographic atherosclerosis in a real-world clinical setting is uncertain. In this work, we assessed whether IR is independently associated with clinically significant angiographic atherosclerosis in nondiabetic individuals. APPROACH AND RESULTS: We examined the association between IR and the extent of coronary atherosclerosis determined by angiography in 1073 nondiabetic patients surviving acute myocardial infarction. Patients were divided into quartiles on the basis of the homeostasis model assessment grading of IR, and associations between IR and multivessel coronary artery disease, defined as ≥ 2 arteries with ≥ 70% stenosis (or ≥ 50% left main stenosis), were analyzed in bivariate and multivariable modeling. Overall, the cohort had a median age of 56 years; 28.9% women and 21.8% nonwhite. The crude prevalence of multivessel coronary artery disease was 37.8%, 42.3%, 47.2%, and 48.0% for homeostasis model assessment grading of IR quartiles 1, 2, 3, and 4, respectively (P(trend) = 0.009). In multivariable modeling, compared with quartile 1, both quartile 3 (relative risk [95% confidence interval], 1.31 [1.07-1.60]) and quartile 4 (1.29 [1.03-1.60]) were independently associated with multivessel coronary artery disease. Covariates in the model included patient demographic and clinical characteristics and metabolic factors (low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol, triglyceride, glycosylated hemoglobin, and high-sensitivity C-reactive protein). CONCLUSIONS: We demonstrate an independent association between IR and multivessel coronary artery disease in nondiabetic postmyocardial infarction patients. Our findings strengthen the experimental evidence for a direct atherogenic effect of IR independent of glucose control and other components of the metabolic syndrome.

Temporary-Permanent Pacemakers in the Management of Conduction Abnormalities in Patients Undergoing Transcatheter Aortic Valve Replacement.

Background: Injury to the cardiac conduction system requiring a permanent pacemaker (PPM) implantation is a known adverse outcome of transcatheter aortic valve replacement (TAVR). Temporary-permanent pacemakers (TPPM) have been used as a bridge to PPM implantation in patients with systemic infection; however, there are only a few reports of its routine use in patients undergoing TAVR. This study aimed to assess the utility of routine use of TPPM in patients undergoing TAVR with a high risk of needing a PPM or those who develop high-grade conduction abnormalities during/after TAVR. Methods: Between April 2015 and December 2021, 978 patients underwent TAVR at our institution, of whom 111 patients had TPPM placed before or during/after TAVR during the study period. In total, 89 patients were included in the final analysis. Results: The median age was 78 years (IQR, 71-84 years); 52 (58.4%) patients with preexisting native conduction disease were considered high risk for advanced heart block and had TPPM placed before TAVR. In addition, 37 (41.6%) patients had TPPM placed during/after TAVR. Of the 89 patients who received TPPM, 51 (57.3%) were treated with a balloon-expandable valve and 38 (42.7%) with a self-expandable valve. Of the patients who underwent TPPM placement, only 49 (55.1%) required a PPM, and TPPM was removed in 40 (44.9%) patients. TPPM was in place for a median of 6 days (IQR, 2-11 days). Only 1 of the 89 patients (1.1%) who received a TPPM had lead dislodgment. No other complications were noted. Median length of stay was 3 days (IQR, 2-4 days). Conclusions: In patients with high-risk baseline conduction abnormalities before TAVR and those who develop new high-grade conduction abnormalities during/after TAVR, TPPM provides a feasible and safe method for pacing that could allow early ambulation, facilitate early discharge, and prevent unnecessary PPM implantations in some patients.

Percutaneous Coronary Intervention in Men, Women, and Minorities With a Previous Coronary Artery Bypass Graft Surgery (from the Pooled PLATINUM Diversity and PROMUS Element Plus Registries).

There is limited data on new-generation stent outcomes in patients with previous coronary artery bypass graft (CABG) and the associated risk of gender and race/ethnicity is unclear. We investigated 1-year outcomes after platinum chromium everolimus-eluting stent implantation in a diverse population of men, women, and minorities with previous CABG pooled from the PLATINUM Diversity (NCT02240810) and PROMUS Element Plus (NCT01589978) registries. Our primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target vessel revascularization (TVR) at 1-year post percutaneous coronary intervention (PCI). Secondary end points included all-cause death, MI, TVR, target vessel failure, and stent thrombosis. A total of 4,175 patients were included in the analysis, including 1,858 women (44.5%), 1,057 minorities (25.3%), and 662 (15.9%) with previous CABG. Patients with previous CABG were older, included more men and White patients, and had more co-morbidities compared with patients without previous CABG. At 1 year, patients with previous CABG had a higher risk of MACE (12.6% vs 7.5%, hazard ratio 1.70, 95% confidence interval 1.32 to 2.19, p <0.001) and end points, including death/MI, TVR, and target vessel failure. After multivariate adjustment, no differences were observed in MACE (adjusted hazard ratio 1.11, 95% confidence interval 0.82 to 1.49, p = 0.506) or any secondary end points. No interaction was observed between previous CABG and gender or minority status. In conclusion, in a contemporary PCI population, patients with previous CABG remain at high risk for PCI because of their elevated risk profile. Previous CABG status was however not independently associated with worse outcomes after adjustment, nor was any interaction observed with gender or race/ethnicity.

Indications for percutaneous coronary interventions performed in US hospitals: a report from the NCDR®.

BACKGROUND: There are many factors hypothesized as contributing to overuse of percutaneous coronary intervention (PCI) in the United States, including financial ties between physicians and hospitals, but empirical data are lacking. We examined PCI indications in not-for-profit (NFP), major teaching, for-profit (FP), and physician-owned specialty hospitals. METHODS: A retrospective cohort study of 1,113,554 patients who underwent PCI in 694 hospitals (NFP 471, teaching 131, FP 79, specialty 13) participating in the CathPCI Registry® between January 1, 2004, and December 31, 2007. Percutaneous coronary intervention indications derived from American College of Cardiology Guidelines were classified as survival benefit (patients with primary reperfusion for ST-elevation myocardial infarction), potential quality of life benefit (patients with non-ST-elevation myocardial infarction, acute coronary syndrome (ACS), positive stress test, or chest pain), or unclear indications (patients receiving PCI without an obvious potential survival or quality of life benefit). RESULTS: The percentage of PCI performed for unclear indications was somewhat higher for specialty hospitals (5.1% of all procedures) as compared with other hospital categories (FP 4.7%, NFP 4.2%, major teaching 4.5%; P < .001). Overall, 17% of hospitals had ≥20% of their total PCI procedures performed for unclear indications, but the proportion of FP, NFP, major teaching, and specialty hospitals reaching this threshold was not statistically different (20%, 16%, 17%, and 15%, respectively; P = .84). CONCLUSIONS: A small proportion of PCI procedures were performed in patients with unclear indications, but there was wide variation across hospitals. On average, specialty hospitals performed more PCIs for unclear indications. Efforts to reduce variability should be pursued.

Percutaneous coronary intervention outcomes in US hospitals with varying structural characteristics: analysis of the NCDR®.

BACKGROUND: In the United States, there continues to be debate about whether certain types of hospitals deliver improved patient outcomes. We sought to assess the association between hospital organizational characteristics and in-hospital outcomes for percutaneous coronary intervention (PCI). METHODS: Retrospective analysis of 2004 to 2007 data for 694 US hospitals participating in the CathPCI Registry(®). Our analysis focused on 1,113,554 patients who underwent PCI in 471 not-for-profit (NFP) hospitals, 131 major teaching hospitals, 79 for-profit (FP) hospitals, and 13 physician-owned specialty hospitals. Outcomes included in-hospital mortality, stroke, bleeding, vascular injury, and a composite representing one or more of the individual complications. We used the current CathPCI Registry mortality risk model to calculate risk-standardized mortality ratios (RSMRs) for each category of hospital and compared hospital groupings for all patients in aggregate and in subgroups stratified by patients' indications for PCI. RESULTS: Patients treated in major teaching hospitals were younger, whereas FP hospitals performed a greater proportion of PCI for patients with ST-elevation myocardial infarction (P < .0001). Specialty hospitals treated patients with less acuity, including a lower proportion of patients with ST-elevation myocardial infarction. In unadjusted analyses, specialty hospitals had significantly lower rates of all adverse outcomes compared with NFP, teaching, and FP hospitals including in-hospital mortality (0.7%, 1.2%, 1.4%, and 1.4%, respectively; P < .001) and the composite end point (2.4%, 4.1%, 4.6%, and 4.3%, respectively; P < .001). In adjusted analyses, RSMR was significantly lower for specialty hospitals when compared with the other 3 groups for all patients in aggregate (RSMR 1.05%, 1.30%, 1.38%, 1.39%; P < .001); these differences remained clinically significant but were no longer statistically significant in subgroup analyses. CONCLUSIONS: Specialty hospitals appear to have lower rates of most adverse outcomes for PCI. Specialty hospitals may have developed expertise in narrow procedural areas that could be adapted to the larger population of general hospitals.

Economic outcomes of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with left main or three-vessel coronary artery disease: one-year results from the SYNTAX trial.

OBJECTIVES: To evaluate the cost-effectiveness of alternative approaches to revascularization for patients with three-vessel or left main coronary artery disease (CAD). BACKGROUND: Previous studies have demonstrated that, despite higher initial costs, long-term costs with bypass surgery (CABG) in multivessel CAD are similar to those for percutaneous coronary intervention (PCI). The impact of drug-eluting stents (DES) on these results is unknown. METHODS: The SYNTAX trial randomized 1,800 patients with left main or three-vessel CAD to either CABG (n = 897) or PCI using paclitaxel-eluting stents (n = 903). Resource utilization data were collected prospectively for all patients, and cumulative 1-year costs were assessed from the perspective of the U.S. healthcare system. RESULTS: Total costs for the initial hospitalization were $5,693/patient higher with CABG, whereas follow-up costs were $2,282/patient higher with PCI due mainly to more frequent revascularization procedures and higher outpatient medication costs. Total 1-year costs were thus $3,590/patient higher with CABG, while quality-adjusted life expectancy was slightly higher with PCI. Although PCI was an economically dominant strategy for the overall population, cost-effectiveness varied considerably according to angiographic complexity. For patients with high angiographic complexity (SYNTAX score > 32), total 1-year costs were similar for CABG and PCI, and the incremental cost-effectiveness ratio for CABG was $43,486 per quality-adjusted life-year gained. CONCLUSIONS: Among patients with three-vessel or left main CAD, PCI is an economically attractive strategy over the first year for patients with low and moderate angiographic complexity, while CABG is favored among patients with high angiographic complexity.

Acute Left Atrial Appendage Thrombus Formation During Transcatheter Mitral Valve Edge-to-Edge Repair.

We present a case of a 75-year-old man who developed an acute left atrial appendage thrombus immediately following mitral valve transcatheter edge to edge repair despite adequate intraprocedural anticoagulation. The patient was managed with enoxaparin to warfarin bridging with no obvious thromboembolic events on follow-up. Attention to anticoagulation is important to reduce thromboembolic risk during mitral valve transcatheter edge to edge repair. (Level of Difficulty: Intermediate.).

Prevalence and correlates of smoking cessation pharmacotherapy in hospitalized smokers with acute myocardial infarction.

BACKGROUND: Although current performance measures recommend smoking cessation counseling at the time of acute myocardial infarction (AMI), the American College of Cardiology/American Heart Association guidelines recommend pharmacotherapy as well. The aim of this study was to describe the prevalence and correlates of smoking cessation pharmacotherapy in hospitalized patients with AMI. METHODS: In the 24-center TRIUMPH registry, 4,340 AMI patients underwent detailed interviews; and 1,631 reported smoking within 30 days of admission. Prescription of first-line smoking cessation medications at discharge was assessed by medical record review. All patient-related factors associated with smoking cessation treatment, based on literature review, were included in hierarchical modified log Poisson models. RESULTS: Only 14% (222/1,631) of AMI patients who smoked were prescribed smoking cessation medication at discharge. After multivariable adjustment for patient characteristics, there was significant variation across sites (range 0%-28%, median rate ratio 1.41, 95% CI 1.23-2.67). Independent factors associated with smoking cessation pharmacotherapy included older age (rate ratio 0.81 per 10-year increment, 95% CI 0.71-0.93), high school graduation (rate ratio 1.37, 95% CI 1.10-1.66), heavy cigarette usage (>20/d) (rate ratio 3.08, 95% CI 2.20-4.12), in-hospital revascularization (rate ratio 1.41, 95% CI 1.0-1.94), and instructions on smoking cessation (rate ratio 2.37, 95% CI 1.40-4.01). CONCLUSIONS: Smokers surviving an AMI are infrequently prescribed guideline-recommended smoking cessation treatments, and there is considerable variation across hospitals. Older, less educated, and lighter smokers are less likely to receive aggressive smoking cessation treatment. Novel strategies to augment current practice are needed.

Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Rheumatic Aortic Stenosis.

BACKGROUND: Patients with rheumatic aortic stenosis (AS) were excluded from transcatheter aortic valve replacement (TAVR) trials. OBJECTIVES: The authors sought to examine outcomes with TAVR versus surgical aortic valve replacement (SAVR) in patients with rheumatic AS, and versus TAVR in nonrheumatic AS. METHODS: The authors identified Medicare beneficiaries who underwent TAVR or SAVR from October 2015 to December 2017, and then identified patients with rheumatic AS using prior validated International Classification of Diseases, Version 10 codes. Overlap propensity score weighting analysis was used to adjust for measured confounders. The primary study outcome was all-cause mortality. Multiple secondary outcomes were also examined. RESULTS: The final study cohort included 1,159 patients with rheumatic AS who underwent aortic valve replacement (SAVR, n = 554; TAVR, n = 605), and 88,554 patients with nonrheumatic AS who underwent TAVR. Patients in the SAVR group were younger and with lower prevalence of most comorbidities and frailty scores. After median follow-up of 19 months (interquartile range: 13 to 26 months), there was no difference in all-cause mortality with TAVR versus SAVR (11.2 vs. 7.0 per 100 person-year; adjusted hazard ratio: 1.53; 95% confidence interval: 0.84 to 2.79; p = 0.2). Compared with TAVR in nonrheumatic AS, TAVR for rheumatic AS was associated with similar mortality (15.2 vs. 17.7 deaths per 100 person-years (adjusted hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.09; p = 0.2) after median follow-up of 17 months (interquartile range: 11 to 24 months). None of the rheumatic TAVR patients, <11 SAVR patients, and 242 nonrheumatic TAVR patients underwent repeat aortic valve replacement (124 redo-TAVR and 118 SAVR) at follow-up. CONCLUSIONS: Compared with SAVR, TAVR could represent a viable and possibly durable option for patients with rheumatic AS.

Syncope After Transcatheter Aortic Valve Replacement: Two Faces of Abnormal Intraventricular Conduction.

Conduction system damage is the most common complication of transcatheter aortic valve replacement (TAVR), which frequently requires placement of a permanent pacemaker. Bundle branch reentry (BBR) is a well-recognized mechanism of ventricular tachycardia (VT) in the setting of abnormal intraventricular conduction. We describe a case of a patient with post-TAVR intraventricular conduction abnormalities who presented with intermittent advanced atrioventricular block and BBR VT and discuss the potential risks, diagnosis, and management of BBR after TAVR.

Long-Term Outcomes of Coronary Stenting With and Without Use of Intravascular Ultrasound.

OBJECTIVES: This study sought to explore if intravascular ultrasound (IVUS) use in real-world patients is associated with improved long-term outcomes of percutaneous coronary intervention (PCI). BACKGROUND: The benefit of IVUS use with PCI in real world is uncertain. METHODS: We identified Medicare patients who underwent PCI from 2009 to 2017 and evaluated the association of IVUS use with long-term risk of mortality, myocardial infarction (MI), and repeat revascularization. We used propensity score matching and inverse probability weighting to adjust for baseline characteristics. To account for hospital effects, patients undergoing IVUS-guided PCI were matched to non-IVUS patients in the same hospital and year. Sensitivity analyses comparing outcomes with and without IVUS in stable coronary artery disease and acute coronary syndrome, PCI with bare-metal stents and drug-eluting stents, complex and noncomplex PCI, and facilities with 1% to 5%, 5% to 10%, and >10% IVUS use were performed. RESULTS: Overall, IVUS was used in 5.6% of all PCI patients (105,787 out of 1,877,177 patients). Patients with IVUS-guided PCI had a higher prevalence of most comorbidities. In the propensity matched analysis, IVUS-guided PCI was associated with lower 1-year mortality (11.5% vs. 12.3%), MI (4.9% vs. 5.2%), and repeat revascularization (6.1% vs. 6.7%) (p < 0.001 for all). In inverse probability weighting analysis with a median follow-up of 3.7 years (interquartile range: 1.7 to 6.4 years), IVUS-guided PCI was associated with a lower risk of mortality (adjusted hazard ratio [aHR]: 0.903; 95% confidence interval [CI]: 0.885 to 0.922), MI (aHR: 0.899; 95% CI: 0.893 to 0.904), and repeat revascularization (aHR: 0.893; 95% CI: 0.887 to 0.898) (p < 0.001 for all). These findings were consistent in all subgroups in sensitivity analyses. CONCLUSIONS: In this contemporary U.S. Medicare cohort, the use of IVUS guidance in PCI remains low. Use of IVUS is associated with lower long-term mortality, MI, and repeat revascularization.

Management of Aortic Stenosis in Patients With End-Stage Renal Disease on Hemodialysis.

BACKGROUND: Patients with end-stage renal disease on hemodialysis (ESRD-HD) and aortic stenosis have poor prognosis. The role of transcatheter aortic valve replacement (TAVR) in this high-risk population is debated. METHODS: We compared the outcomes among ESRD-HD Medicare beneficiaries who were managed with TAVR, surgical AVR (SAVR), or conservative management for aortic stenosis between 2015 and 2017, using overlap propensity score weighting analysis to control for differences in treatment assignment. The primary outcome was all-cause mortality and was compared between treatment groups as well as to age-sex matched mortality for ESRD-HD in the US population. Secondary outcomes included trend of heart failure hospitalizations. RESULTS: A total of 8107 ESRD-HD patients with aortic stenosis were included, 4130 (50%) underwent TAVR, 2565 (31.6%) underwent SAVR, and 1412 (17.4%) were managed conservatively. TAVR patients had more comorbidities and higher frailty compared with the other 2 groups. Thirty-day mortality was lower with TAVR compared with SAVR (4.6% versus 12.8%, P<0.01). After a median follow-up of 465 days (interquartile range, 261-759), on overlap propensity score weighting analysis, there was no difference in mortality between TAVR and SAVR (adjusted hazard ratio, 1.02 [95% CI, 0.91-1.15], P=0.7), and mortality was lower with TAVR compared with conservative management (adjusted hazard ratio, 0.53 [95% CI, 0.47-0.60], P<0.001). Standardized mortality ratios with TAVR, SAVR, and conservative management compared with age-sex matched ESRD-HD US population were 1.24, 1.27, and 1.83, respectively. The rate of heart failure admissions declined after TAVR (incidence rate ratio, 0.55 [95% CI, 0.48-0.62], P<0.001) and SAVR (incidence rate ratio, 0.76 [95% CI, 0.65-0.88], P<0.001). CONCLUSIONS: In ESRD-HD patients with aortic stenosis, mortality was lower in the short-term with TAVR compared with SAVR but comparable in the mid-term. AVR is associated with an improvement in survival and reduction in heart failure hospitalizations compared with conservative management.

Incidence, Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States.

OBJECTIVES: This study sought to evaluate the incidence and outcomes of endocarditis after transcatheter aortic valve replacement (TAVR). BACKGROUND: Data about endocarditis after TAVR are limited. METHODS: The study investigated Medicare patients who underwent TAVR from 2012 to 2017 and identified patients admitted with endocarditis during follow-up using a validated algorithm. The main study outcome was all-cause mortality. RESULTS: Of 134,717 patients who underwent TAVR, 1868 patients developed endocarditis during follow-up (incidence 0.87%/year), with majority of infections (65.0%) occurring within 1 year. Incidence of endocarditis declined in recent years. The most common organisms were Staphylococcus (22.0%), Streptococcus (20.0%), and Enterococcus (15.5%). Important predictors for endocarditis were younger age at TAVR, male sex, prior endocarditis, end-stage renal disease, repeat TAVR procedures, liver and lung disease, and post-TAVR acute kidney injury. Thirty-day and 1-year mortality were 18.5% and 45.6%, respectively. After adjusting for comorbidities and procedural complications, endocarditis after TAVR was associated with 3-fold higher risk of mortality (44.9 vs. 16.2 deaths per 100 person-years; adjusted hazard ratio [aHR]: 2.94; 95% confidence interval [CI]: 2.77 to 3.12; p < 0.0001). End-stage renal disease (aHR: 2.12; 95% CI: 1.72 to 2.60), endocarditis complicated by cardiogenic shock (aHR: 2.50, 95% CI: 1.56 to 4.02), ischemic stroke (aHR: 1.56; 95% CI: 1.07 to 2.28), intracerebral hemorrhage (aHR: 1.67; 95% CI: 1.01 to 2.76), acute kidney injury (aHR: 1.44; 95% CI: 1.27 to 1.63), blood transfusion (aHR: 1.28; 95% CI: 1.09 to 1.50), staphylococcal (aHR: 1.71; 95% CI: 1.49 to 1.97), and fungal endocarditis (aHR: 1.72; 95% CI: 1.23 to 2.39) (p < 0.05 for all) portended higher mortality following endocarditis. CONCLUSIONS: The incidence of endocarditis after TAVR is low and declining. However, it is associated with poor prognosis with one-half the patients dying within 1 year.

Incidence and Outcomes of Acute Coronary Syndrome After Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to address a knowledge gap by examining the incidence, timing, and predictors of acute coronary syndrome (ACS) after transcatheter aortic valve replacement (TAVR) in Medicare beneficiaries. BACKGROUND: Evidence about incidence and outcomes of ACS after TAVR is scarce. METHODS: We identified Medicare patients who underwent TAVR from 2012 to 2017 and were admitted with ACS during follow-up. We compared outcomes based on the type of ACS: ST-segment elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), and unstable angina. In patients with non-ST-segment elevation ACS, we compared outcomes based on the treatment strategy (invasive vs. conservative) using inverse probability weighting analysis. RESULTS: Out of 142,845 patients with TAVR, 6,741 patients (4.7%) were admitted with ACS after a median time of 297 days (interquartile range: 85 to 662 days), with 48% of admissions occurring within 6 months. The most common presentation was NSTEMI. Predictors of ACS were history of coronary artery disease, prior revascularization, diabetes, valve-in-TAVR, and acute kidney injury. STEMI was associated with higher 30-day and 1-year mortality compared with NSTEMI (31.4% vs. 15.5% and 51.2% vs. 41.3%, respectively; p < 0.01). Overall, 30.3% of patients with non-ST-segment elevation ACS were treated with invasive approach. On inverse probability weighting analysis, invasive approach was associated with lower adjusted long-term mortality (adjusted hazard ratio: 0.69; 95% confidence interval: 0.66 to 0.73; p < 0.01) and higher risk of repeat revascularization (adjusted hazard ratio: 1.29; 95% confidence interval: 1.16 to 1.43; p < 0.001). CONCLUSIONS: After TAVR, ACS is infrequent (<5%), and the most common presentation is NSTEMI. Occurrence of STEMI after TAVR is associated with a high mortality with nearly one-third of patients dying within 30 days. Optimization of care is needed for post-TAVR ACS patients and if feasible, invasive approach should be considered in these high-risk patients.

Transcatheter Repair of Anterior Mitral Leaflet Perforation: Deploy, Retrieve, Redeploy.

We describe a case of anterior mitral leaflet perforation successfully treated with the Amplatzer Cribriform device, with resultant hemolytic anemia. The device was retrieved, and perforation occluded with the GORE CARDIOFORM device with resolution of hemolysis. (Level of Difficulty: Advanced.).

Impact of Pre-Existing and New-Onset Atrial Fibrillation on Outcomes After Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to evaluate impact of new-onset and pre-existing atrial fibrillation (AF) on transcatheter aortic valve replacement (TAVR) long-term outcomes compared with patients without AF. BACKGROUND: Pre-existing and new-onset AF in patients undergoing TAVR are associated with poor outcomes. METHODS: The study identified 72,660 patients ≥65 years of age who underwent nonapical TAVR between 2014 and 2016 using Medicare inpatient claims. History of AF was defined by diagnoses on claims during the 3 years preceding the TAVR, and new-onset AF was defined as occurrence of AF during the TAVR admission or within 30 days after TAVR in a patient without prior history of AF. Outcomes included all-cause mortality, and readmission for bleeding, stroke, and heart failure (HF). RESULTS: Overall, 40.7% had pre-existing AF (n = 29,563) and 6.8% experienced new-onset AF (n = 2,948) after TAVR. Mean age was 81.3, 82.4, and 83.8 years in patients with no AF, pre-existing, and new-onset AF, respectively. Pre-existing AF patients had the highest burden of comorbidities. After follow-up of 73,732 person-years, mortality was higher with new-onset AF compared with pre-existing and no AF (29.7, 22.6, and 12.8 per 100 person-years, respectively; p < 0.001). After adjusting for patient characteristics and hospital TAVR volume, new-onset AF remained associated with higher mortality compared with no AF (adjusted hazard ratio: 2.068, 95% confidence interval [CI]: 1.92 to 2.20; p < 0.01) and pre-existing AF (adjusted hazard ratio: 1.35; 95% CI: 1.26 to 1.45; p < 0.01). In competing risk analysis, new-onset AF was associated with higher risk of bleeding (subdistribution hazard ratio [sHR]: 1.66; 95% CI: 1.48 to 1.86; p < 0.01), stroke (sHR: 1.92; 95% CI: 1.63 to 2.26; p < 0.01), and HF (sHR: 1.98; 95% CI: 1.81 to 2.16; p < 0.01) compared with pre-existing AF. CONCLUSIONS: In patients undergoing TAVR, new-onset AF is associated with increased risk of mortality and bleeding, stroke, and HF hospitalizations compared with pre-existing AF or no AF.