P3600Safety and feasibility of balloon aortic valvuloplasty in patients with severe aortic stenosis: role of non TAVI centers. The BAV for LIFE experience of CAMPANIA SICI GISE COMMUNITY

Abstract

Background: Many high-risk patients with symptomatic severe aortic stenosis are neither eligible for surgical nor for transcath-eter (TAVI) aortic valve replacement. Although percutaneous balloon aortic valvuloplasty (BAV) is a viable option in these patients, it had been almost abandoned in the majority of centers not performing TAVI. Purpose: To evaluate the safety and the feasibility of BAV in patients at high-risk for SAVR or TAVI in centers not performing TAVI after a 10-sessions, six months practical training in TAVI centers as compared to high-volume TAVI center. Methods: Between June 2016 to June 2017, we consecutively and prospectively collected clinical, echocardiographic and procedural data of all patients undergoing BAV in five participating non-TAVI centers (GROUP A) and in one highvolume TAVI center (GROUP B). All patients underwent clinical follow up in order to evaluate the occurrence of all-cause death and rehospitalization for heart failure (HF). Results: A total of 55 patients (mean age 83.9±7.0, 41.8% males) were enrolled: 25 in the GROUP A, 30 in the GROUP B. The overall population showed a high burden of comorbidities with high prevalence of hypertension (85.4%), diabetes (32.7%), chronic obstructive pulmonary disease (36.4%), coronary artery disease (52.7%), prior myocardial infarction (25.4%) and peripheral arteriopathy (23.6%), with no differences between groups. Only chronic kidney disease at baseline was more prevalent in GROUP B (90% vs 60%, p=0.009). The surgical risk evaluated by Logistic EuroSCORE and STS score was almost similar between groups, while EuroSCORE II was significantly higher in GROUP B [6.1 (4.8-9.3) vs 10.8 (6.7-20.0), p=0.011]. All procedure were performed by using transfemoral approach determining an increase in indexed aortic valve area from 42.8±10.1 to 53.8±18.1 mm2, and a reduction of mean and peak transvalvular aortic gradient from 46.5±15.5 to 28.5±12.4 and from 81.1±28.3 to 52.5±20.2 mmHg respectively, without differences between groups. The mean follow-up time was 293±189 days; two patients were lost. All-cause death occurred in 7 (29.2%) patients of the GROUPS A and in 11 (37.9%) patients of the GROUP B (p=0.502); the rehospitalization for HF occurred in 6 (25.0%) and in 9 (31.0%, p=0.627). The Kaplan- Meier analysis of overall survival showed a substantial overlap of the curves with 6 and 12-months survival estimates of 74.8% vs 72.4% and of 74.8% vs 62.2% in GROUPS A and B respectively (p=0.656) (Figure); the survival free from rehospitalization probability at 6 months and 1 year was 78.1% vs 75.4% and 71.6% vs 59.9% (p=0.665). Conclusions: BAV is a life-saving procedure in patients at prohibitive risk for TAVI or SAVR and should be performed in all catheterization laboratories with an adequate skillness. In our study, although limited by the small population size, BAV shows a good feasibility and safety profile in centers not performing TAVI after a relatively short training period. (Figure Presented).