Transvalvular Pressure Gradients and All-Cause Mortality Following TAVR: A Multicenter Echocardiographic and Invasive Registry.

BACKGROUND: Low ejection fraction (EF) and low flow as determined by an echocardiographic stroke volume index (SVi) <35 mL/m2 are associated with low transvalvular gradients and increased mortality in both severe aortic stenosis (AS) and post-transcatheter aortic valve replacement (TAVR). Absence of an elevated echocardiographic transaortic gradient post-TAVR is considered a marker of procedural success despite the absence of data on its impact on mortality. OBJECTIVES: The authors sought to examine the association of invasive and echocardiographic gradients post-TAVR with all-cause mortality in relation to flow and EF. METHODS: In a multicenter retrospective registry of patients undergoing TAVR, Cox models with regression splines explored the relationship between invasive and echocardiographic gradients post-TAVR with 2-year mortality. An invasive gradient <5 mm Hg was considered low, between ≥5 and <10 mm Hg was considered intermediate, and ≥10 mm Hg was considered high. An echocardiographic gradient <10 mm Hg was considered low, ≥10 and <20 mm Hg was considered intermediate, and ≥20 mm Hg was considered high. RESULTS: Higher mortality occurred in low echocardiographic gradients at discharge relative to intermediate gradients (P < 0.001), and low gradient was associated with lower EF and echocardiographic SVi (P < 0.001 and P < 0.008, respectively). Lower mortality occurred in low invasive gradients relative to intermediate gradients (P = 0.012) with no difference in EF and echocardiographic SVi between groups (P = 0.089 and P = 0.947, respectively). There were insufficient observations to determine the impact of high echocardiographic and invasive gradients on mortality. CONCLUSIONS: In this large retrospective analysis, the impact of transaortic gradients on mortality after TAVR was not linear and complex, showing opposite results among echocardiographic and invasive measurements in low-gradient patients.

Ejection Fraction Improvement Following Contemporary High-Risk Percutaneous Coronary Intervention: RESTORE EF Study Results.

Background: Despite many reports of clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (HRPCI) with hemodynamic support, little is known about whether this approach improves left ventricular ejection fraction (LVEF). The purpose of the present observational study was to examine, in an ideal patient population with Impella-supported HRPCI, whether there is an impact on left ventricular function at midterm follow-up. Methods: RESTORE EF is a multicenter, retrospective analysis of a prospectively collected observational data set that aimed to assess 90-day LVEF in patients undergoing Impella-supported nonemergent HRPCI (NCT04648306), who survived with no intervening cardiac procedures prior to the primary endpoint follow-up window (90-day LVEF assessment). Secondary endpoints included change in New York Heart Association Functional Classification and Canadian Cardiovascular Society Angina Grade at the last follow-up. Results: From August 2019 to May 2021, 406 patients were enrolled at 22 US sites. Age was 70.2 â€‹â€‹± â€‹â€‹11.4 â€‹â€‹years; 26% were female. In paired assessment at 90-day follow-up, baseline LVEF improved from 35 â€‹â€‹± â€‹â€‹15% to 45 â€‹â€‹± â€‹â€‹14% (N = 251, P < .0001), with significantly greater improvement in patients with residual SYNTAX score I of 0. Percentage classified as New York Heart Association class III/IV decreased from 62% at baseline to 15% at last follow-up (P < .001), and percentage with Canadian Cardiovascular Society grade III/IV symptoms decreased from 72% to 2% (P < .0001). Conclusions: In an ideal cohort of HRPCI patients, there is a signal that hemodynamically supported HRPCI affords significant improvement in 90-day LVEF, with complete revascularization associated with greater LVEF improvement. These hypothesis-generating findings merit further assessment in large, all-comer studies and randomized trials.