Abstract Worldwide, valvular heart disease (VHD) is a common cause of hospitalization for acute heart failure. In acute heart failure caused by VHD, symptoms result from rapid haemodynamic changes and subsequent decline in cardiac function, and if left untreated, leads to acute decompensation and cardiogenic shock. Current evidence remains scarce and recommendations regarding the management of acute heart failure caused by VHD are lacking in most recent international guidelines. Herein, we review the management of acute heart failure caused by VHD with a focus on transcatheter therapies and describe currently available evidence based on a systematic literature search on the following valve pathologies: (i) aortic stenosis, (ii) aortic regurgitation, (iii) mitral regurgitation, and (iv) mitral stenosis. Articles reporting outcomes following urgent or emergent valve intervention in the setting of cardiogenic shock or acute heart failure were considered. After screening a total of 2234 articles, 76 published between 1994 and 2023 were included in subsequent analysis. Based on available evidence, proposed treatment algorithms to guide optimal management of acute heart failure caused by VHD were created. As the number of patients presenting with acute heart failure caused by VHD continues to rise and outcomes following transcatheter valve interventions continue to improve, it is inevitable that minimally invasive options will play an increasingly important role in the acute setting, especially given these patients are at an increased operative risk. This review aims to present an organized approach to the complex management and interventional treatment of patients with acute heart failure caused by VHD.
Contemporary Outcomes of TAVR Using a Balloon-Expandable Valve in Patients With Severe Mitral Stenosis: Insights From the Transcatheter Valve Therapies Registry
Circulation: Cardiovascular Interventions | November 22, 2024 | Volume: 17 | Issue: 12 | Pages: No page available
BACKGROUND: While initial data for transcatheter aortic valve replacement (TAVR) in aortic stenosis patients with mitral stenosis (MS) suggested a poor short-term prognosis, outcomes for contemporary balloon-expandable valves remain unknown. The aim of this retrospective multicenter registry study was to compare the potential impact of MS on TAVR outcomes with balloon-expandable valves. METHODS: Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry and Centers for Medicare & Medicaid Services claims data were used to obtain a cohort of 327 925 patients who underwent TAVR with current balloon-expandable valves (SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra Resilia) between June 2015 and December 2022 across 791 sites. Severe MS (defined as >10 mm Hg mean gradient or <1.5 cm 2 area) was compared with mild or less MS (defined as <5 mm Hg mean gradient and >2 cm 2 area) using propensity matching to minimize confounding variables. RESULTS: Patients with severe MS (n=8500; 2.6%) had a higher number of comorbid conditions, Society of Thoracic Surgeons risk scores, and were more often women than patients with mild or less MS at the time of index TAVR. While patients with severe MS had worse outcomes at 30 days, when propensity-matched, patients exhibited similar 30-day rates of death (3.2% versus 3.0%), stroke (2.4% versus 2.2%), major vascular complications (1.6% versus 1.6%), device implant success (98.9% versus 99.2%), and new dialysis (0.7% versus 0.5%), with higher rates of pacemaker implantation (11.3% versus 9.4%; P <0.001). By 1 year, there was no difference in the change in the KCCQ (Kansas City Cardiomyopathy Questionnaire) overall score from baseline to 1 year (30.7±27.0 versus 31.9±27.0; P =0.07). By 3 years, an increase in the mortality rate (45.1% versus 40.9%; P <0.001) of patients with severe MS was observed. CONCLUSIONS: MS in isolation is not associated with worsened short-term outcomes among patients undergoing contemporary TAVR with balloon-expandable valves.
Racial, ethnic, and sex disparities in the utilization and outcomes of tricuspid valve surgery
European Heart Journal | October 28, 2024 | Volume: 45 | Issue: Supplement_1 | Pages: No page available
Abstract Background Data on racial/ethnic and sex disparities in the utilization and outcomes of tricuspid valve surgery (TVS) in the United States are scarce. Purpose We aimed to evaluate the impact of race/ethnicity and sex on the utilization and outcomes of TVS. Methods We analyzed the National Inpatient Sample database from 2016 to 2020 to identify hospitalizations for tricuspid valve surgery. Racial/ethnic and sex disparities in tricuspid valve surgery outcomes were determined using logistic regression models. Results Between 2016 and 2020, 19,395 hospitalizations for tricuspid valve surgery were identified. The utilization rates (defined as the number of tricuspid valve surgery performed per 100,000 US hospitalizations) were lower in Black and Hispanic patients compared with White patients for surgical tricuspid valve repair (331 versus 493 versus 634, p<0.01) and surgical tricuspid valve replacement (312 versus 601 versus 728, p<0.01). Similarly, the utilization rates were lower for women compared with men for surgical tricuspid valve repair (1,021 versus 1,364, p<0.01) and surgical tricuspid valve replacement (930 versus 1,316, p<0.01). Compared to White men undergoing tricuspid valve surgery, all women had lower odds of acute kidney injury (aOR 0.65, 95% CI 0.55-0.78) and higher odds of blood transfusion (aOR 1.30, 95% CI 1.07-1.59), and Black men had higher odds of blood transfusion (aOR 1.59, 95% CI 1.08-2.35). In-hospital mortality and other surgical complications were similar between all groups (all p>0.05). Conclusions Significant racial/ethnic and sex disparities exist in the utilization of tricuspid valve surgery in the United States. Further studies are needed to understand the reasons for these disparities and to identify effective strategies for their mitigation.
Transcatheter versus surgical aortic valve replacement in patients younger than 65 years: analysis from the national inpatient sample database
European Heart Journal | October 28, 2024 | Volume: 45 | Issue: Supplement_1 | Pages: No page available
Abstract Background Data on the relative utilization and outcomes of transcatheter aortic valve replacement (TAVR) versus surgical AVR (SAVR) in patients <65 years are limited. Purpose To compare the relative utilization and outcomes of TAVR versus SAVR in patients <65 years in the United States. Methods We queried the National Inpatient Sample (2016-2020) to identify patients <65 years hospitalized for isolated AVR. In-hospital outcomes of TAVR versus SAVR were compared using multivariable regression and propensity-matching analyses. Results Of 74,155 patients aged <65 years hospitalized for isolated AVR, 17,300 (23.3%) underwent isolated TAVR, and 56,855 (76.7%) underwent isolated SAVR. From 2016-2020, the use of TAVR increased, while the use of SAVR decreased in patients <65 years (both ptrend<0.01). Factors independently associated with TAVR selection in patients <65 years included female sex, congestive heart failure, pulmonary disease, renal failure, liver disease, cancer, and prior revascularization. Factors independently associated with SAVR selection included bicuspid aortic valve. After adjustment for baseline characteristics, TAVR was associated with lower odds of in-hospital mortality (adjusted odds ratio [aOR] 0.61, 95% confidence interval [CI] 0.38-0.97), stroke (aOR 0.58, 95% CI 0.38-0.90), acute kidney injury (aOR 0.41, 95% CI 0.34-0.49), and major bleeding (aOR 0.62, 95% CI 0.38-0.96), and higher vascular complications compared with SAVR (aOR 2.39, 95% CI 1.75-3.24). Length of stay was shorter and nonhome discharges were lower with TAVR (all p<0.01). Similar findings were observed in the propensity-matched cohort. Conclusions This nationwide observational analysis showed that TAVR is a feasible treatment option for patients <65 years with lower in-hospital mortality and resource utilization compared with SAVR.Central Illustration
Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli
Importance Historically, women with aortic stenosis have experienced worse outcomes and inadequate recognition compared to men, being both underdiagnosed and undertreated, while also facing underrepresentation in clinical trials. Objective To determine whether women with small aortic annuli undergoing transcatheter aortic valve replacement have better clinical and hemodynamic outcomes with a self-expanding valve (SEV) or balloon-expandable valve (BEV). Design, Setting, Participants The Small Annuli Randomized to Evolut or SAPIEN Trial (SMART) was a large-scale randomized clinical trial focusing on patients with small aortic annuli undergoing transcatheter aortic valve replacement, randomized to receive SEVs or BEVs and included 716 patients treated at 83 centers in Canada, Europe, Israel, and the US from April 2021 to October 2022. This prespecified secondary analysis reports clinical and hemodynamic findings for all 621 women enrolled in SMART. Data for this report were analyzed from February to April 2024. Interventions Transcatheter aortic valve replacement with an SEV or a BEV. Main Outcomes and Measures The composite coprimary clinical end point comprised death, disabling stroke, or heart failure–related rehospitalization. The coprimary valve function end point was the incidence of bioprosthetic valve dysfunction, both assessed through 12 months. Secondary end points included the incidence of moderate or severe prosthesis-patient mismatch. Results A total of 621 women (mean [SD] age, 80.2 [6.2] years; 312 randomized to the SEV group and 309 to the BEV group) were included in the present analysis. At 12 months, there were no significant differences in the coprimary clinical end point between the SEV and BEV groups (9.4% vs 11.8%, absolute risk difference −2.3%; 95% CI −7.2 to 2.5, P = .35). However, SEV implantation was associated with less bioprosthetic valve dysfunction (8.4% vs 41.8%; absolute risk difference, −33.4%; 95% CI, −40.4 to −26.4; P &lt; .001). SEV implantation resulted in lower aortic valve gradients and larger effective orifice areas at 30 days and 12 months and less mild or greater aortic regurgitation at 12 months compared to BEV implantation. Prosthesis-patient mismatch was significantly lower with SEVs, regardless of the definition used and adjustment for body mass index. Use of SEVs was associated with better quality of life outcomes as assessed by the Valve Academic Research Consortium-3 ordinal quality of life measure. Conclusions and Relevance Among women with severe symptomatic aortic stenosis and small aortic annuli undergoing transcatheter aortic valve replacement, the use of SEVs, compared to BEVs, resulted in similar clinical outcomes and a markedly reduced incidence of bioprosthetic valve dysfunction through 12 months, including a lower risk of prosthesis-patient mismatch and better 12-month quality of life. Trial Registration ClinicalTrials.gov Identifier: NCT04722250
Transcatheter vs. surgical aortic valve replacement in patients with aortic stenosis and cardiogenic shock
European Heart Journal: Acute Cardiovascular Care | September 13, 2024 | Volume: 13 | Issue: 10 | Pages: 685-698
Abstract Aims Patients with aortic stenosis (AS) and cardiogenic shock (CS) are an extremely high-risk population with a poor prognosis in the absence of definitive therapy. We aimed to compare the outcomes of transcatheter aortic valve replacement (TAVR) with those of surgical aortic valve replacement (SAVR) in patients with AS–CS. Methods and results We queried the Nationwide Readmission Database (2016–21) to identify patients hospitalized for AS–CS who underwent isolated TAVR or SAVR. In-hospital outcomes of TAVR vs. SAVR were compared using multivariable regression and propensity-matching analyses. Ninety-day readmissions were compared using a Cox proportional hazards regression model. A total of 16 161 patients were hospitalized for AS–CS, of whom 6470 (40.0%) underwent isolated TAVR and 9691 (60.0%) underwent isolated SAVR. From 2016 through 2021, the proportion of TAVR increased from 29.5 to 46.5% and the proportion of SAVR correspondingly decreased in AS–CS (Ptrend < 0.01). After adjustment for baseline characteristics, TAVR was associated with lower odds of stroke [adjusted odds ratio (aOR) 0.63, 95% confidence interval (CI) 0.47–0.84], acute kidney injury (aOR 0.80, 95% CI 0.69–0.93), and major bleeding (aOR 0.54, 95% CI 0.40–0.71) and higher odds of vascular complications (aOR 1.56, 95% CI 1.23–1.97) compared with SAVR. In-hospital mortality, myocardial infarction, permanent pacemaker placement, and 90-day all-cause and heart failure readmissions showed similar rates between TAVR and SAVR. However, hospital length of stay was shorter and total costs and non-home discharges were lower with TAVR than with SAVR. Conclusion This nationwide observational analysis showed that TAVR is increasingly performed in patients with AS–CS and is associated with similar rates of in-hospital mortality and 90-day readmissions but lower rates of in-hospital complications and resource utilization compared with SAVR.
Contemporary Outcomes and Trends for the Transseptal Mitral Valve-in-Valve Procedure Using Balloon Expandable Transcatheter Valves in the United States
BACKGROUND: Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement. METHODS: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications. RESULTS: A total of 4243 patients with a mean±SD STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year ( P <0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4–8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital ( P =0.0005), 30-day ( P =0.004), and 1-year mortality rates ( P =0.01). CONCLUSIONS: This multicenter, prospective study reports excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates.
One-Year Outcomes of Transseptal Mitral Valve-in-Valve in Intermediate Surgical Risk Patients
Circulation: Cardiovascular Interventions | July 22, 2024 | Volume: 17 | Issue: 8 | Pages: No page available
BACKGROUND: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03193801.
Transcatheter vs. surgical mitral valve interventions in patients with prior coronary artery bypass grafting
European Heart Journal - Quality of Care and Clinical Outcomes | July 18, 2024 | Volume: 11 | Issue: 5 | Pages: 539-553
Abstract Background A significant proportion of patients requiring mitral valve (MV) intervention have undergone prior coronary artery bypass grafting (CABG). Reoperative heart surgery is associated with increased risk. Aims To evaluate the utilization and outcomes of transcatheter vs. surgical MV interventions in patients with prior CABG. Methods We queried the Nationwide Readmission Database (2016–21) to identify adults with prior CABG hospitalized for transcatheter or surgical MV intervention. In-hospital outcomes were compared using multivariable regression and propensity-matching analyses. Readmissions were compared using Cox proportional hazards regression model. Results Of 305 625 weighted hospitalizations for MV intervention, 23 506 (7.7%) occurred in patients with prior CABG. From 2016Q1–2021Q4, the use of transcatheter MV interventions increased among patients with prior CABG (72 to 191 for repair and 6 to 45 for replacement per 100 000 hospitalizations, both ptrend < 0.001). Compared with surgical MV repair and replacement, transcatheter MV repair and replacement were associated with similar in-hospital mortality (adjusted odds ratio [aOR] 0.44, 95% confidence interval [CI] 0.20–1.03 for repair; aOR 0.61, 95% CI 0.38–1.02 for replacement) and 180-day heart failure (HF) readmissions (adjusted hazard ratio [aHR] 1.56, 95% CI 0.85–2.87 for repair; aHR 1.15, 95% CI 0.63–2.09 for replacement) and lower stroke, acute kidney injury, permanent pacemaker placement, length of stay, and non-home discharges, respectively. Vascular complications were higher with transcatheter vs. surgical MV replacement. Conclusion Transcatheter MV interventions are increasingly used as the preferred modality of MV intervention in patients with prior CABG and are associated with similar in-hospital mortality and 180-day HF readmissions compared with surgical MV interventions.
Racial, ethnic, and sex disparities in the utilization and outcomes of tricuspid valve surgery
Annals of Medicine & Surgery | June 18, 2024 | Volume: 86 | Issue: 8 | Pages: 4368-4376
Background: Data on racial/ethnic and sex disparities in the utilization and outcomes of tricuspid valve surgery (TVS) in the United States are scarce. The authors aimed to evaluate the impact of race/ethnicity and sex on the utilization and outcomes of TVS. Methods: The authors analyzed the National Inpatient Sample database from 2016 to 2020 to identify hospitalizations for TVS. Racial/ethnic and sex disparities in TVS outcomes were determined using logistic regression models. Results: Between 2016 and 2020, 19 395 hospitalizations for TVS were identified. The utilization rate (number of surgeries/100,000 hospitalizations) was lower in Black and Hispanic patients compared with White patients for surgical tricuspid valve repair (STVr) (331 versus 493 versus 634, P<0.01) and surgical tricuspid valve replacement (STVR) (312 versus 601 versus 728, P<0.01). Similarly, the utilization rate was lower for women compared with men for STVr (1021 versus 1364, P<0.01) and STVR (930 versus 1,316, P<0.01). Compared to White men undergoing TVS, all women had lower odds of acute kidney injury [adjusted odds ratio (aOR) 0.65, 95% CI 0.55–0.78] and higher odds of blood transfusion (aOR 1.30, 95% CI 1.07–1.59), and Black men had higher odds of blood transfusion (aOR 1.59, 95% CI 1.08–2.35). In-hospital mortality and other surgical complications were similar between all groups (all P>0.05). Conclusions: Significant racial/ethnic and sex disparities exist in the utilization of TVS in the United States. Further studies are needed to understand the reasons for these disparities and to identify effective strategies for their mitigation.