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.
Real world outcomes using 20 mm balloon expandable SAPIEN 3/ultra valves compared to larger valves (23, 26, and 29 mm)–a propensity matched analysis
AbstractObjective/BackgroundSmall balloon expandable valves have higher echocardiographic transvalvular gradients and rates of prosthesis‐patient mismatch (PPM) compared to larger valves. However, the impact of these echocardiographic findings on clinical outcomes is unknown. We sought to determine the clinical outcomes of 20 mm SAPIEN 3 (S3 BEV) compared to larger S3 BEV in relation to echocardiographic hemodynamics.MethodsUsing the STS/ACC transcatheter valve registry, we performed a propensity‐matched comparison of patients undergoing treatment of native aortic valve stenosis using transfemoral, balloon‐expandable implantation of 20 mm and ≥ 23 mm S3 BEVs. Baseline and procedure characteristics, echocardiographic variables and survival were analyzed. Multivariable logistic regression was used to identify predictors of 1‐year mortality.ResultsAfter propensity matching of the 20 mm and ≥ 23 mm SAPIEN 3 valves, 3,931 pairs with comparable baseline characteristics were identified. Small valves were associated with significantly higher echocardiographic gradients at discharge (15.7 ± 7.1 mmHg vs. 11.7 ± 5.5 mmHg, p < 0.0001) and severe PPM rates (21.5% vs. 9.7%, p < 0.0001). There was no significant difference in 1‐year all‐cause mortality (20 mm: 13.0% vs. ≥23 mm: 12.7%, p = 0.72) or other major adverse event rates and outcomes between the two cohorts. Based on a multivariable analysis, elevated discharge mean gradient (>20 mmHg), severe PPM and the use of 20 mm versus ≥23 mm were not independent predictors of 1‐year mortality.ConclusionSAPIEN 3 20 mm valves were associated with higher echocardiographic gradients, and severe PPM rates compared to larger valves but these factors were not associated with significant differences in 1‐year all‐cause mortality or rehospitalization.
Angiotensin-converting enzyme 2 and COVID-19: patients, comorbidities, and therapies
On March 11, 2020, the World Health Organization declared coronavirus disease 2019 (COVID-19) a pandemic, and the reality of the situation has finally caught up to the widespread reach of the disease. The presentation of the disease is highly variable, ranging from asymptomatic carriers to critical COVID-19. The availability of angiotensin-converting enzyme 2 (ACE2) receptors may reportedly increase the susceptibility and/or disease progression of COVID-19. Comorbidities and risk factors have also been noted to increase COVID-19 susceptibility. In this paper, we hereby review the evidence pertaining to ACE2’s relationship to common comorbidities, risk factors, and therapies associated with the susceptibility and severity of COVID-19. We also highlight gaps of knowledge that require further investigation. The primary comorbidities of respiratory disease, cardiovascular disease, renal disease, diabetes, obesity, and hypertension had strong evidence. The secondary risk factors of age, sex, and race/genetics had limited-to-moderate evidence. The tertiary factors of ACE inhibitors and angiotensin II receptor blockers had limited-to-moderate evidence. Ibuprofen and thiazolidinediones had limited evidence.
A novel echocardiographic hemodynamic classification of heart failure based on stroke volume index and left atrial pressure
Background and AimDividing patients with heart failure (HF) based solely on ejection fraction (EF) may over simplify the hemodynamic states of these patients. We describe a novel echo‐derived hemodynamic HF model based on flow (stroke volume index [SVI]) and left atrial pressure (E:E′) correlates.MethodsA retrospective analysis of patients admitted with HF with both reduced (HFrEF) and preserved EF (HFpEF). Patients were subdivided into four hemodynamic groups based on echocardiographic SVI (< or ≥35 mL/m2) and E/E′ (≥ or <15). Group A: normal flow and normal filling pressure, Group B: normal flow but high filling pressure, Group C: low flow and low filling pressure, and Group D: low flow and high filling pressure.ResultsA total of 176 patients were enrolled, 123 patients had HFrEF and 53 patients had HFpEF. Baseline characteristics were not statistically significant in both groups. In HFrEF, most patients were in group D compared to a heterogeneous distribution in HFpEF (P<.0001). In HFrEF, there was a trend toward an increase in B‐type natriuretic peptide levels with a decrease in SVI and increase in E/E′ (P=.05) but not in HFpEF. There was no difference in death, major adverse cardiac events, but a higher readmissions rate in the HFpEF group at 30 days and 18 months.ConclusionsHemodynamic subgroups differ between HFrEF and HFpEF. There is no difference in major adverse cardiovascular events between both groups with increased readmissions in HPpEF patients. Larger studies may help assess the impact of echo‐derived hemodynamic state on clinical outcome.
The Role of Jet Eccentricity in Generating Disproportionately Elevated Transaortic Pressure Gradients in Patients with Aortic Stenosis
In patients with aortic stenosis (AS) and eccentric transaortic flow, greater pressure loss occurs as the jet collides with the aortic wall together with delayed and diminished pressure recovery. This leads to the elevated transaortic valve pressure gradients noted on both Doppler and cardiac catheterization. Such situations may present a diagnostic dilemma where traditional measures of stenosis severity indicate severe AS, while imaging modalities of the aortic valve geometric aortic valve area (GOA) suggest less than severe stenosis. In this study, we present a series of cases exemplifying this clinical dilemma and demonstrate how color M‐mode, 2D and 3D transthoracic (TTE) and transesophageal (TEE) echocardiography, cardiac computed tomography angiography (CTA), and magnetic resonance imaging (MRI), may be used to resolve such discrepancies.
Aortic Valve Stenosis: To the Gradient and Beyond—The Mismatch Between Area and Gradient Severity
ObjectivesThe clinical severity of aortic stenosis (AS) is based largely on symptoms. However, AS severity is primarily determined by estimating the aortic valve area (AVA) and pressure gradients (ΔP). Conditions may arise in which there is a mismatch in severity between AVA and ΔP determinations secondary to errors in measurement and/or assumption, alterations of flow, or variations in the magnitude of pressure recovery. The cause of discrepancy between area and gradient determinations must be deciphered so as to best counsel patients on the most ideal treatment strategy. (J Interven Cardiol 2013;26:183–194)