BACKGROUND: Operator experience is a key determinant of outcomes after transcatheter aortic valve replacement (TAVR). However, whether early-career operators achieve comparable results to more experienced peers is unknown. Herein, we evaluate case volumes, patient risk profiles, and 30-day outcomes of early-career versus non–early-career operators performing TAVR in the United States. METHODS: Using the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry, we identified isolated TAVR procedures from October 2011 through March 2024. Early-career status was defined as ≤5 years in independent practice (based on board certification or first TAVR date); non–early-career status was >5 years. Multivariable hierarchical models adjusted for patient-, procedural-, operator-, and site-level factors, including annualized institutional TAVR volume, while accounting for clustering of procedures within operators and operators within sites. Primary outcomes were 30-day mortality and a composite of death, stroke, major bleeding, stage III acute kidney injury, or moderate-to-severe paravalvular leak. RESULTS: A total of 634 723 TAVR procedures were performed by 3126 operators across 847 sites, including 90 376 (14.2%) by early-career operators. Median annualized lifetime volume was lower for early-career operators (13 [interquartile range, 5–31] versus 19 [interquartile range, 7–42] cases per year; P <0.001). After adjustment, 30-day mortality was similar between early-career and non–early-career operators (2.38% versus 2.44%; risk ratio, 0.97 [95% CI, 0.92–1.01]; P =0.293), whereas the composite end point was lower among early-career operators (11.19% versus 11.77%; risk ratio, 0.95 [95% CI, 0.93–0.98]; P <0.001). CONCLUSIONS: In a national TAVR registry, early-career operators performed fewer cases but achieved similar 30-day mortality and a modestly lower adjusted composite event rate relative to more experienced peers. These findings suggest that within the structured, team-based environment of contemporary TAVR programs, early-career status alone is not associated with inferior procedural outcomes and should not be viewed as a barrier to independent practice.
BACKGROUND: Transcatheter mitral cerclage ventriculoplasty places a circumferential tensioning loop around the base of the left ventricle to reduce mitral annular dimensions and reshape ventricular geometry in patients with functional mitral regurgitation and heart failure. Early experience demonstrated reductions in mitral regurgitation and improvements in heart failure symptoms. METHODS: The National Heart, Lung, and Blood Institute Division of Intramural Research Transcatheter Mitral Cerclage Ventriculoplasty Early Feasibility Study was an investigator-initiated, prospective, multicenter study. Between 1 and 5 years, vital status, serious adverse events, routine clinical documentation, and site-reported transthoracic echocardiography findings were collected. RESULTS: Nineteen procedures were attempted in 18 participants (63% heart failure with reduced ejection fraction, 37% heart failure with preserved ejection fraction). Median age was 73 years, and 63% were female. Kaplan-Meier estimated 5-year survival was 57%. One participant underwent left ventricular assist device implantation after 2 years, and 1 participant underwent mitral transcatheter edge-to-edge repair after 3 years; none underwent heart transplantation. The study was suspended after complete heart block developed in 6 participants, including 4 requiring new cardiac implantable electronic devices. Among participants with available follow-up echocardiography, site-reported imaging demonstrated mitral regurgitation reduction and improved left ventricular ejection fraction through 5 years. Symptomatic improvement was most apparent during the first year and attenuated thereafter. CONCLUSIONS: Cerclage ventriculoplasty was associated with mitral regurgitation reduction and improved ventricular function among participants with available long-term follow-up. Symptomatic benefit was greatest during the first year and diminished thereafter, suggesting that favorable remodeling may not fully offset progression of the underlying cardiomyopathy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03929913.
Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) provides organ support in cardiogenic shock but increases left ventricular (LV) afterload, potentially impairing cardiac recovery. LV unloading with an intra-aortic balloon pump (IABP) or micro-axial flow pump (mAFP) may mitigate this effect. HERACLES compared their effects on myocardial oxygen supply and demand. Methods: Patients receiving VA-ECMO for cardiogenic shock were randomized to LV unloading with IABP or mAFP, stratified by ischemic/non-ischemic etiology. Distal coronary, aortic and LV pressures and coronary flow (inverse mean transit time, Tmn) were measured with and without unloading. Myocardial oxygen demand was estimated as the area under the LV pressure curve in systole (TTI) x heart rate (HR). The primary endpoint was the change in myocardial oxygen supply-demand ratio calculated as [(Tmn * TTI*HR)off / (Tmn * TTI *HR)unload]. Secondary endpoints included changes in coronary flow [device flow ratio (DFR) =(Tmn)off/ (Tmn)unload], oxygen demand per beat (DTTI), contractility (DdP/dtmax) and filling pressure (DLVEDP). Results: Twenty-four patients were enrolled (age 51 [46-57]; 46% male; 96% SCAI D/E; 38% ischemic). At randomization, lactate was 4.3 mmol/L [IQR 2.5 to 8.4], LV ejection fraction 10% [10 to 17], LVEDP 18 mmHg [14 to 24]. The myocardial oxygen supply-demand ratio improved with IABP but not mAFP (1.48 [1.23 to 2.10] vs 0.97 [0.92 to 1.39]; P=0.036), driven predominantly by differential reduction of TTI. Coronary pressure increased but flow was unchanged with mAFP (DFR 1.00 [0.86 to 1.13]). Coronary flow increased marginally with IABP (DFR 1.16 [1.00 to 1.51]). LV pressures decreased with both devices and contractility with IABP only, with no between-group differences. Thirty-day mortality was similar (38% vs 45%, p=0.84). Conclusions: In VA-ECMO supported SCAI D/E cardiogenic shock, IABP improved myocardial oxygen supply-demand balance, whereas mAFP did not. Further research is needed to determine whether these mechanistic differences translate to clinical outcomes.
BACKGROUND: The BRIGHT-4 trial (Bivalirudin With Prolonged Full-Dose Infusion During Primary PCI Versus Heparin Trial-4) demonstrated that procedural anticoagulation with bivalirudin plus a high-dose postprocedure infusion reduced the 30-day composite end point of all-cause death or Bleeding Academic Research Consortium types 3 to 5 bleeding compared with heparin monotherapy in patients with ST-segment–elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI) with radial artery access. We now report the 12-month follow-up results to evaluate the long-term outcomes of primary PCI with these 2 anticoagulation regimens. METHODS: In this multicenter, open-label, randomized controlled trial, 6016 patients with ST-segment–elevation myocardial infarction undergoing primary PCI with radial artery access were randomly assigned (1:1) to receive bivalirudin with a high-dose post-PCI infusion for 2 to 4 hours (n=3009) or heparin monotherapy (n=3007). The primary outcome of interest was the composite of all-cause death or Bleeding Academic Research Consortium types 3 to 5 bleeding at 12 months. RESULTS: At 12 months, the primary outcome occurred in 124 (4.1%) patients in the bivalirudin group and 169 (5.6%) patients in the heparin group (hazard ratio, 0.73 [95% CI, 0.58–0.92]; P =0.007). Bivalirudin resulted in lower 12-month rates of Bleeding Academic Research Consortium types 3 to 5 bleeding (0.6% versus 1.2%; hazard ratio, 0.49 [95% CI, 0.28–0.87]; P =0.01) and stent thrombosis (0.8% versus 1.3%; hazard ratio, 0.60 [95% CI, 0.36–0.99]; P =0.045), with nonsignificant differences in all-cause death (3.8% versus 4.8%; hazard ratio, 0.80 [95% CI, 0.63–1.02]; P =0.08), cardiovascular death, reinfarction, ischemia-driven target vessel revascularization, and stroke between the 2 groups. CONCLUSIONS: Among patients with ST-segment–elevation myocardial infarction undergoing primary PCI with radial artery access, the benefits of bivalirudin with a high-dose post-PCI infusion in reducing the composite end point of all-cause death or Bleeding Academic Research Consortium types 3 to 5 bleeding at 30 days compared with heparin monotherapy are maintained through 12-month follow-up. These findings support the use of bivalirudin with a post-PCI high-dose infusion as an alternative to heparin to reduce mortality and major bleeding in patients with ST-segment–elevation myocardial infarction. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03822975.
