BACKGROUND:The Alterra Adaptive Prestent provides a landing zone for implantation of the 29 mm SAPIEN 3 transcatheter heart valve (THV) in patients with a dysfunctional right ventricular outflow tract (RVOT) to treat pulmonary regurgitation (PR). Here, we report 3-year outcomes from a pooled analysis of patients who underwent Alterra/SAPIEN 3 THV implantation enrolled in the ALTERRA pivotal trial, Continued Access Protocol, and Pulmonic Delivery System Registry. METHODS:This multicenter, prospective trial enrolled patients with moderate or greater PR and RVOT/pulmonary valve anatomy suitable for implantation. The nonhierarchical composite end point of THV dysfunction was examined at 6 months: RVOT/pulmonary valve reintervention, moderate or greater PR, and mean RVOT/pulmonary valve gradient ≥35 mm Hg. Individual components of the composite, as well as additional clinical and echocardiographic outcomes were examined up to 3 years. RESULTS:The Alterra/SAPIEN 3 THV system was implanted in 118 patients at 14 sites. At 6 months, THV dysfunction was 3.5% (4/113). At 3 years, 97.3% of patients in the valve implant population had freedom from reintervention, 100% of patients had a mean RVOT/pulmonary valve gradients <35 mm Hg, and 93.3% of patients had mild or lesser total PR. The Kaplan-Meier estimate of all-cause mortality was 3.5% at 3 years. There were no cases of coronary artery compression, hemopericardium, or endocarditis. CONCLUSIONS:This analysis reports the longest follow-up in the largest cohort of patients from the ALTERRA trials. The Alterra Adaptive Prestent with the SAPIEN 3 THV system has shown excellent procedural outcomes and is effective in reducing PR at 3-year follow-up. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03130777.
OBJECTIVES:The EARLY TAVR trial demonstrated improved clinical outcomes for patients with asymptomatic severe aortic stenosis (aSAS) treated with transcatheter aortic valve replacement (eTAVR) compared with clinical surveillance (CS). The cost-effectiveness of an eTAVR strategy for patients with aSAS in the United States is unknown. METHODS:A Markov model with 30-day cycles was developed from the US healthcare payor perspective to estimate the cost-effectiveness of eTAVR vs CS over a lifetime horizon. Inputs for population characteristics and health outcomes were derived from the EARLY TAVR trial. Costs were derived from US Medicare reimbursement rates. Probabilistic and deterministic sensitivity analyses were performed to evaluate the effect of parameter uncertainty on model output. RESULTS:When compared with CS, eTAVR was associated with 0.21 additional life-years (LY) and 0.24 additional quality-adjusted life-years over a lifetime because of more time spent in the alive and well health state with eTAVR. Lifetime costs were estimated to be $8812 lower, due primarily to reductions in costs associated with the AVR procedure, stroke, and heart failure hospitalizations. Accordingly, eTAVR was projected to be economically dominant over CS. In probabilistic sensitivity analysis, a large majority of iterations (95.9%) produced cost-effective results ($100 000 threshold) for eTAVR versus CS, with most simulations (90.3%) showing dominance, confirming the robustness of the base-case results. These findings were consistent over a variety of scenario analyses. CONCLUSIONS:An eTAVR strategy for the treatment of aSAS may be a cost-saving approach for US healthcare payors, when compared with CS.
BACKGROUND:Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical aortic valve replacement for symptomatic severe aortic stenosis, but long-term, comparative clinical outcomes and echocardiography data are lacking. OBJECTIVES:Our goal was to compare 10-year clinical and echocardiographic outcomes after balloon-expandable TAVR or surgery in intermediate-risk surgical patients in the PARTNER 2A randomized trial. METHODS:Between 2011 and 2013, patients with severe, symptomatic aortic stenosis at intermediate surgical risk were randomized at 57 centers to TAVR with the balloon-expandable SAPIEN XT system (Edwards Lifesciences) or to surgery. Randomization was stratified by anatomical suitability for transfemoral (TF) or transthoracic (transapical/transaortic [TA/TAo]) access. Ten-year outcomes were evaluated in the valve implant population and included all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes. To obtain 10-year data, patient reconsent at 5 years was required, and vital status sweeps were implemented to improve data completeness for all-cause mortality. RESULTS:Among 1,910 randomized patients who received a valve, 974 underwent TAVR (TF: 749/974 [76.9%]) and 936 had surgery. Mean patient age was 81.6 years, 45.4% were women, and the mean Society of Thoracic Surgeons score was 5.8%. At 10 years, vital status was available for 881 of 974 patients (90.5%) and 838 of 936 patients (89.5%). All-cause 10-year mortality with vital status sweeps was 86.1% after TAVR and 82.8% after surgery (HR: 1.13; 95% CI: 1.02-1.25; P = 0.02). When stratified by access route, rates of all-cause mortality for TAVR and surgery in the TF group were similar (83.9% vs 82.1%, respectively; P = 0.27), whereas mortality was higher for TAVR in the TA/TAo group (93.2% vs 85.1%; P < 0.01; P for interaction = 0.03). Cumulative incidence rates of aortic valve reintervention at 10 years were 6.3% for TAVR and 1.6% for surgery (P < 0.001). Of the 24 TAVR and 35 surgical patients with available echocardiographic data at 10 years, mean gradients were 12.6 mm Hg and 12.7 mm Hg, respectively. CONCLUSIONS:At the 10-year follow-up, TAVR in intermediate-risk patients with the SAPIEN XT prosthesis compared with surgery was associated with lower survival rates, with differences predominantly observed in the TA/TAo access cohort. TAVR with the XT valve was also associated with significantly higher rates of aortic valve reintervention. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk [PII A]; NCT01314313).
AIMS:Use of bioprosthetic tissue valves in surgical aortic valve replacement (SAVR) has increased in recent years. The effect of novel bovine pericardial tissue valves on short-term costs and utilization has not been established. We assessed INSPIRIS RESILIA aortic tissue valves (*Edwards Lifesciences, Irvine CA) during SAVR hospitalization and 90 days post-discharge compared to other tissue valves for all ages, and to mechanical valves for patients of shared decision-making age (50-65). MATERIALS AND METHODS:Retrospective observational study using US hospital data. Adults admitted for first-time SAVR 2018-2021 with identifiable tissue or mechanical valves were analyzed. Outcomes were adjusted for demographics, comorbidities, procedure and hospital characteristics using generalized linear modeling. RESULTS:20,125 patients were analyzed; majority were male, with elective procedures in academic hospitals. Compared to other tissue valves, length of stay and ICU stay were shorter with INSPIRIS (p < 0.001). In-hospital mortality was not statistically different. Readmissions at 30 days were 7.1% with INSPIRIS, 9.0% other tissue valves; 10.4% vs. 13.0% at 90 days (both p < 0.001). Reduced cost of readmission (-$1,013 at 90 days) partially offset the difference of $2,429 in initial hospitalization cost. INSPIRIS valves compared to mechanical valves (ages 50-65) showed similar patterns in utilization. In-hospital mortality was lower with INSPIRIS than mechanical valves (2.0% vs. 3.2%, p = 0.009), but did not differ when limited to isolated SAVR only. Initial hospitalization cost was higher for INSPIRIS ($7,079, p < 0.001), with lower 90-day readmissions cost (-$899, p < 0.05). LIMITATIONS:Non-randomized analysis of real-world data. CONCLUSIONS:Patients undergoing SAVR with INSPIRIS valves had shorter length of stay and fewer readmissions compared to other tissue valves and to mechanical valves. Reduced cost of readmissions partially offset higher cost of initial SAVR admission. Further research is warranted to explore this association between valve used and utilization outcomes.
