Mitral Valve Transcatheter Edge-to-Edge Repair Volumes and Trends.

Background: Despite an association between operator volumes and procedural success, there remains an incomplete understanding of the contemporary utilization and procedural volumes for mitral valve transcatheter edge-to-edge repair (MTEER). We aimed to identify annual operator procedural volumes, temporal trends, and geographic variability for MTEER among Medicare patients in the United States (US). Methods: We queried the National Medicare Provider Utilization and Payment Database for a CPT code (33418) specific for MitraClip device from 2015 through 2019. We analyzed annual operator procedural volumes and incidence and identified longitudinal and geographic trends in MTEER utilization. Results: From 2015 through 2019, a total of 27,034 MTEER procedures were performed among Medicare patients in the US. The nationwide incidence increased from 6.2 per 100,000 patients in 2015 to 23.8 per 100,000 patients in 2019, a 283% increase over the study period (Ptrend < 0.001). The incidence of MTEER by state varied by nearly 900% (range 5.5 to 54.9 per 100,000 person-years). In 2019, the mean annual MTEER operator annual volume was 9.1 MTEER procedures and had grown from 6.2 per year in 2015. Conclusions: In this nationwide study of Medicare beneficiaries in the United States, we identified a significant and sustained increase in the utilization of MTEER devices and operators and growth in annual procedural volumes from 2015 through 2019 with considerable variability in utilization by state. Further studies are needed to understand the clinical impact of variability in utilization and the optimal procedural volumes to ensure high efficacy outcomes and maintain critical access to MTEER therapies.

Clinical Predictors of Mortality and Heart Failure Hospitalization in Patients With Severe Tricuspid Regurgitation.

Background: There is an incomplete understanding of the predictors of morbidity and mortality in patients with severe tricuspid regurgitation (TR). This study sought to identify key risk factors for all-cause mortality and heart failure (HF) hospitalization among patients with severe TR. Methods: Patients with severe TR were identified from 2 centers, Oregon Health & Science University and Abrazo Health, from January 01, 2016 to December 31, 2018. Patients with any concomitant severe valvular diseases or prior valvular intervention were excluded. Multivariable regression was utilized to identify demographic, clinical, and echocardiographic variables independently associated with all-cause mortality or HF hospitalization. Results: 435 patients with severe TR were followed for a median of 2.8 years. The mean age of the population was 66.9 ± 18.5 years and 58% were female. All-cause mortality was identified in 20.5% of the population. Of the cohort, 35.4% of patients were hospitalized for HF. Isolated tricuspid valve intervention was performed in 2.5% of patients. Independent predictors of all-cause mortality included history of solid tumor (odds ratio [OR] 6.6, 95% confidence interval [CI] 2.1-19.1, p = 0.001), history of peripheral artery disease (OR 3.5, 95% CI 1.2-9.4, p = 0.013), and elevated international normalized ratio in the absence of anticoagulation (OR 1.9, 95% CI 1.2-3.2, p = 0.008). Predictors of HF hospitalization included history of diabetes mellitus (OR 2.2, 95% CI 1.1-4.0, p = 0.014) and history of reduced left ventricular ejection fraction (OR 5.7, 95% CI 2.9-11.7, p < 0.0001). Conclusions: Severe untreated TR is associated with high mortality and frequent HF hospitalizations. Understanding predictors of these outcomes is important to identify patients who may benefit from early tricuspid valve intervention to help improve outcomes in this patient population.

Incidence and outcomes of cardiogenic shock among women with spontaneous coronary artery dissection.

BACKGROUND: There is a paucity of data on cardiogenic shock (CS) incidence and outcomes among patients with spontaneous coronary artery dissection (SCAD). METHODS: Women admitted to the hospital for acute myocardial infarction (AMI) with and without SCAD were identified from the United States National Readmission Database from October 1, 2015 to December 31, 2018. We calculated the incidence of CS among women with AMI with and without SCAD and odds for developing CS after adjusting for baseline characteristics. In addition, we report the utilization of percutaneous coronary intervention, mechanical circulatory support, severe disability surrogates, and 30-day readmission rates. RESULTS: A total of 664,292 patients admitted for AMI were eligible for analysis, including 6643 patients with SCAD and 657,649 without SCAD. Patients with SCAD were younger (57 years [interquartile range, IQR 48-68] vs. 71 years [IQR 60-81], p < 0.01) and had fewer comorbidities yet had a higher incidence of CS as compared to patients without SCAD (9% vs. 5%, p < 0.01) and remained at elevated risk after adjusting for baseline comorbidities (adjusted odds ratio 1.5 [95% confidence interval, CI 1.2-1.7]). Among patients who developed CS, those with SCAD had lower in-hospital mortality than non-SCAD (31% vs. 39%, p < 0.01), and were more likely to receive mechanical circulatory support. CONCLUSIONS: In a nationally representative sample of women admitted for AMI, we found that patients with SCAD had a higher risk of developing CS and required more frequent use of mechanical circulatory support but were more likely to survive to discharge than women suffering AMI from causes other than SCAD.

TAVR operator volumes, trends, and geographic variations amongst Medicare beneficiaries in the United States.

OBJECTIVES: To evaluate transcatheter aortic valve replacement (TAVR) operator procedural volumes, and describe temporal and geographic trends. BACKGROUND: TAVR is the standard of care for most patients with severe symptomatic aortic stenosis. Despite an association between operator procedural volume and outcomes, nationwide TAVR operator volumes have been incompletely described. METHODS: We queried the National Medicare Provider Utilization and Payment Database for transfemoral TAVRs from 2014 to 2018. Annual operator volume, state and regional volumes, and longitudinal trends were extracted and analyzed using descriptive statistics. RESULTS: In 2018, the mean annual operator volume was 23.6 TAVRs. The highest 1% of operators by volume performed 7.6% of total TAVR procedures in the United States, while 35.7% of operators performed 10 or fewer TAVRs per year. From 2014 to 2018, there was a 53.9% annualized increase in TAVRs, and the mean annual volume per operator grew from 12.5 to 23.6. There was more than five-fold variability in the density of operators (range 0.35-1.79 operators per 100,000 population) and mean operator volume by state (range 14.2-52.4 TAVRs per operator). CONCLUSIONS: In this nationally representative study of operators performing transfemoral TAVRs among Medicare patients, we found the mean annual volume of TAVR in 2018 to be 23.6 and has increased since 2014. There was considerable variability in operator density and procedural volumes, with a significant proportion of operators performing 10 or fewer TAVRs per year. Ambiguity remains in regard to the optimal balance of procedural requirements to sustain high efficacy outcomes and ensure critical access to TAVR therapies.

Clinical Predictors of Mortality in Patients with Moderate to Severe Mitral Regurgitation.

BACKGROUND: Mitral regurgitation is the most common form of valvular heart disease worldwide, however, there is an incomplete understanding of predictors of mortality in this population. This study sought to identify risk factors of mortality in a real-world population with mitral regurgitation. METHODS: All patients with moderate or severe mitral regurgitation were identified at a single center from January 1, 2016 to August 31, 2017. Multivariate regression was performed to evaluate variables independently associated with all-cause mortality. RESULTS: A total of 490 patients with moderate (76.3%) or severe (23.7%) mitral regurgitation due to primary (20.8%) or secondary (79.2%) etiology were identified. The mean age was 66.7 years; 50% were male. At a median follow-up of 3.1 years, the incidence of all-cause mortality was 30.1%, heart failure hospitalization 23.1%, and mitral valve intervention 11.6%. Of 117 variables, multivariate analysis demonstrated 5 that were independently predictive of mortality: baseline creatinine (hazard ratio [HR] 1.2; 95% CI, 1.0-1.3; P = .02), right atrial pressure by echocardiogram (HR 1.3; 95% CI, 1.07-1.55; P = .008), hemoglobin (HR 0.65; 95% CI, 0.52-0.83; P = .001), hospitalization for heart failure (HR 1.6; 95% CI, 1.1-2.4; P = .015), and mitral valve intervention (HR 0.40; 95% CI, 0.16-0.83; P = .049). CONCLUSION: In this retrospective, pragmatic analysis of patients with moderate or severe mitral regurgitation, admission for heart failure exacerbation, elevated right atrial pressure, renal dysfunction, anemia, and lack of mitral valve intervention were independently associated with increased risk of all-cause mortality. Whether these risk factors may better identify select patients who may benefit from more intensive monitoring or earlier intervention should be considered in future studies.

Pericardial Tamponade and Other Cardiac Complications in POEMS Syndrome.

Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) is a multiorgan syndrome with rare and heterogenous cardiac manifestations. We present the case of a man with pericardial effusion complicated by cardiac tamponade, new onset atrial fibrillation, and high-degree atrioventricular block leading to a diagnosis of POEMS syndrome. (Level of Difficulty: Advanced.).

Imaging-guided cardiac resynchronization therapy: A meta-analysis of randomized controlled trials.

BACKGROUND: Among patients with heart failure and left ventricular (LV) dysfunction despite guideline directed medical therapy, cardiac resynchronization (CRT) is an effective technology to reverse LV remodeling. Given that a large portion of patients are non-responders, alternatives to traditional LV-lead placement have been explored. A promising alternative is image targeted placement of an LV-lead to latest mechanically activated segment without scar. METHODS: Electronic database search for randomized controlled trials (RCTs) that evaluated the imaging-guided LV-lead placement on clinical, echocardiographic, and functional outcomes. The primary outcome was a composite of mortality and heart failure hospitalization. The secondary outcomes included CRT responders, New York Heart Association (NYHA), 6-minute walk test, Minnesota Living with Heart Failure Questionnaire (MLHFQ), and ejection fraction (EF) changes. RESULTS: Analysis included 4 RCTs of 691 patients with an average follow-up of 2 years (age 69.5 ± 10.3 years, 76% males, 54% ischemic cardiomyopathy, 81% with NYHA classes III/IV, and EF of 24.4% ± 8). The most common site for LV-lead paced segment was the anterolateral segment (45%) and at mid-LV (49%). Compared with the control, imaging-guided LV-lead placement was associated with a significant reduction of the primary outcome (hazard ratio [HR] = 0.60; 95% CI = 0.40-0.88; p = .01), higher CRT responders (odd ratio [OR] = 2.10; p < .01), more NYHA improvements by ≥1 (OR = 1.89; p = .01), increased 6MWT (mean difference [MD] = 25.78 feet; p < .01), and lower MLHFQ (MD = -4.04; p = .04), without significant differences in the LVEF (p = .08). CONCLUSIONS: In patients undergoing CRT, imaging-guided LV-lead placement was associated with improved clinical, echocardiographic, and functional status.

Familial hypercholesterolemia related admission for acute coronary syndrome in the United States: Incidence, predictors, and outcomes.

BACKGROUND: Individuals with Familial Hypercholesterolemia (FH) are at high risk for atherosclerotic cardiovascular disease (ASCVD) events. OBJECTIVES: The purpose of this study was to evaluate the incidence, predictors, and outcomes of admissions for acute coronary syndromes (ACS) in this high-risk group. METHODS: Utilizing the National Readmission Databases, we identified individuals with or without FH admitted to participating hospitals for ACS. The primary outcome was admission for recurrent ACS at 11 month follow-up. RESULTS: There were a total of 1,697,513 ACS admissions from 10/2016 to 12/2017 (non-FH=1,696,979 and FH=534). Individuals with FH admitted for ACS were younger (median age 57 vs 69 y), had fewer comorbidities (hypertension 74.7% vs 79.6%; diabetes mellitus 30.5% vs 39.0%;p<0.01), were more likely to present with ST-elevation-myocardial infarction (32.8% vs 22.6%;p<0.01) and more likely to undergo multivessel percutaneous coronary intervention (11.4% vs 7.6%;p<0.01) than patients without FH. After propensity-score matching, FH patients more commonly experienced in-hospital VT arrest (11.8% vs 8.0%;p<0.01) and required more mechanical circulatory support (8.6% vs 3.3%; p<0.01). The 30-day readmission in those with FH was more frequently for cardiovascular disease (81.5% vs 46.5%; =p<0.01). At 11-month follow-up, FH patients were more likely to be readmitted with recurrent ACS compared to those without FH (hazard ratio=2.34; 95% confidence interval=1.30-4.23; p<0.01). CONCLUSIONS: Individuals with FH admitted for ACS are younger, have fewer comorbidities, and more frequently present with STEMIs compared to those without FH. FH patients were more likely to suffer in-hospital cardiac complications and have a higher incidence of recurrent ACS.

Bioprosthetic valve oversizing is associated with increased risk of valve thrombosis following TAVR.

BACKGROUND: Hypoattenuating leaflet thickening (HALT), the radiographic manifestation of transcatheter heart valve thrombosis, is commonly identified following transcatheter aortic valve replacement (TAVR) and associated with increased risk of stroke and structural valve deterioration. While anticoagulation effectively resolves HALT, routine use remains controversial. We aimed to identify hemodynamic, anatomic, and comorbid predictors of HALT. METHODS: We evaluated consecutive patients with severe aortic stenosis who underwent TAVR with Edwards SAPIEN 3 bioprosthesis at a single center between June 1, 2018 and October 30, 2019. Patients on anticoagulation and those receiving valve-in-valve were excluded. Clinically driven computed tomography (CT) imaging was performed to assess for HALT at the discretion of the treating valve team. RESULTS: A total of 78 patients with a mean age of 78 ± 10 years and STS risk score 5.5 ± 3.3% were analyzed. HALT was identified in 11 (14.1%) patients. Compared to controls, those with HALT had smaller annular areas, 435 ± 57 mm2 vs. 489 ± 79 mm2 (p = .032), but received comparable size valves. In multivariate regression, valve oversizing by more than 20% was associated with increased risk of HALT, OR 23.5, 95% CI 2.5-223, (p = .006). After initiation of anticoagulation, patients with HALT had similar rates of stroke, major bleeding, and all-cause mortality out to an average of 243 days. CONCLUSIONS: In this pragmatic study of patients undergoing TAVR with SAPIEN 3 valves, we report the novel finding that oversizing by more than 20% was independently associated with increased risk of HALT. These findings warrant confirmation in larger and prospective trials.

Meta-analysis of catheter ablation in patients with post-infarct cardiomyopathy undergoing defibrillator implantation.

BACKGROUND: Patients with post-infarct cardiomyopathy and ventricular arrhythmias (VT) necessitating implantable cardioverter defibrillators (ICD) are at risk of recurrent shocks with increased morbidity. METHODS: A comprehensive search of electronic databases for all randomized clinical trials that evaluated the role of catheter ablation as a preventive strategy at the time of secondary prevention ICD implantation was performed. We calculated hazard ratios (HR) and 95% confidence intervals (CI) using random-effects model. RESULTS: Four trials were identified with a total of 505 patients (average age 66.4 ± 9.0 years; 87.7% were male). Preventive ablation was associated with a significant reduction in appropriate device therapies (shocks and/or anti-tachycardia therapy) (HR = 0.62; 95% CI = 0.46-0.82; P < .01), sustained VT (HR = 0.74; 95% CI = 0.55-0.99; P = .04) compared to control. There were no differences in inappropriate device shocks (HR = 0.80; 95% CI = 0.38-1.71), all-cause death (HR = 0.93; 95% CI = 0.53-1.64), cardiac death (HR = 0.63; 95% CI = 0.29-1.36), arrhythmic death (HR = 0.26; 95% CI = 0.05-1.31), or cardiac hospitalization (HR = 0.79; 95% CI = 0.57-1.11) between strategies. Preventive ablation was associated with improved SF-36 physical component (mean difference = 2.81; 95% CI-0.53-5.10; P = .02), but not the mental component (mean difference = 1.30; 95% CI = -2.06-4.66). CONCLUSION: Among patients with post-infarct cardiomyopathy and VT, preventive catheter ablation at the time of ICD implantation is associated with a significant reduction of appropriate ICD therapy and sustained VT, and improvement in the physical component of quality-of-life, but no reduction in mortality.

Safety and efficacy of short-term (1 to 3 months) dual antiplatelet therapy in patients undergoing percutaneous coronary interventions: a meta-analysis of randomized controlled trials.

Among patients who have undergone percutaneous coronary intervention (PCI), the use of dual antiplatelet therapy (DAPT) is associated with increased risk of bleeding, but decreased stent thrombosis and myocardial infarction unrelated to the stent. As PCI techniques and devices have progressed, the optimal duration of DAPT has come into question. We identified all randomized controlled trials (RCTs) of patients undergoing PCI, who received one or more drug eluting stents (DES) for stable coronary artery disease (CAD) or acute coronary syndrome (ACS), and randomized to short (1-3 months) versus standard duration DAPT. The prespecified primary outcome was major adverse cardiovascular events (MACE). Important secondary outcomes were net adverse clinical events (NACE) defined as MACE and major bleeding; any bleeding; major bleeding; all-cause death; cardiovascular death. We calculated hazard ratios (HR) and 95% confidence intervals (CI) using random-effects model. Analysis included 7 RCTs, comprising 35,857 patients and 53,321 patient-years of follow-up. The mean (SD) age of patients was 64.4 (10.6) years, 49.6% of patients presented with ACS, and 25.5% were female. There was no difference between short and standard-length DAPT in regards to MACE (HR = 0.93; 95% CI 0.84-1.03; p = 0.19), NACE (HR = 0.93; 95% CI 0.85-1.02; p = 0.12), all-cause death (HR = 0.92; 95% CI 0.80-1.05; p = 0.21), or cardiovascular death (HR = 0.85; 95% CI 0.64-1.13; p = 0.26). However, short-term DAPT was associated with significantly reduced major bleeding events (HR = 0.67; 95% CI 0.47-0.95; p = 0.03) and any bleeding event (HR = 0.63; 95% CI 0.44-0.90; p = 0.01) compared with standard-length DAPT. Among patients undergoing PCI for CAD, the use of short-term DAPT (1-3 months) followed by single antiplatelet therapy was associated with a lower incidence of clinically relevant bleeding events, but with similar risk of MACE, all-cause death, and cardiovascular death compared with standard duration DAPT.

Sodium-Glucose Cotransporter-2 Inhibitors in Heart Failure: A Meta-Analysis of Randomized Clinical Trials.

BACKGROUND: We aimed to conduct this study with the goal of further clarifying the role of sodium-glucose cotransporter-2 inhibitors (SGLT2i) in patients with preexisting heart failure with reduced ejection fraction with or without diabetes and to leverage increased sample size and power to evaluate clinically important secondary safety and efficacy outcomes. METHODS: This meta-analysis was completed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The primary outcome was a composite of cardiovascular death or heart failure hospitalization. Secondary outcomes included the individual components of the primary outcome; major adverse cardiovascular events (defined as a composite of cardiovascular death, myocardial infarction, stroke), any death, myocardial infarction, or stroke, along with adverse events such as volume depletion, acute kidney injury, adverse events leading to drug discontinuation, amputation, and severe hypoglycemia. Other outcomes included the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score and changes in N-terminal pro-hormone BNP (NT-proBNP). Pooled hazard ratios (HRs) and 95% confidence intervals (CIs) for dichotomous variables and weighted difference (MD) and 95% CI for continuous variables. RESULTS: Compared with placebo, SGLT2i use was associated with a significant reduction of cardiovascular death or heart failure hospitalization (HR = 0.74; 95% CI = 0.66-0.82; P <0.01), heart failure hospitalization (HR = 0.69; 95% CI = 0.57-0.84; P <0.01), cardiovascular death (HR = 0.79; 95% CI = 0.68-0.92; P <0.01), and any death (HR = 0.80; 95% CI = 0.70-0.92; P <0.01). CONCLUSIONS: SGLT2i was associated with a decreased risk of clinically relevant cardiovascular death, heart failure hospitalization, and heart failure symptoms with similar rates of adverse events.