Seyed Hossein Aalaei-Andabili1, Thomas M Beaver2, Anthony A Bavry3, John W Petersen4, Ashkan Karimi4, Siddharth Wayangankar4, George Arnaoutakis2, R David Anderson5. 1. Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, FL, USA; Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL, USA. 2. Division of Thoracic and Cardiovascular Surgery, Department of Surgery, University of Florida, Gainesville, FL, USA. 3. Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL, USA; North Florida/South Georgia Veterans Health System, Gainesville, FL, USA. 4. Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL, USA. 5. Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL, USA. Electronic address: david.anderson@medicine.ufl.edu.
Abstract
PURPOSE: We investigated the outcomes of patients who underwent Transcatheter Aortic Valve Replacement (TAVR) with and without Balloon Aortic Valvuloplasty (BAV) using the SAPIEN 3 (S3) valve. METHODS: All patients who underwent TAVR using S3 valve were included. The primary outcomes were the incidence of stroke and significant paravalvular leak (PVL). Secondary outcomes were the incidence of mortality, balloon post dilation, and need for permanent pacemaker. RESULTS: From July-2014 to April-2018, 34 (9%) patients underwent BAV prior to TAVR and 344 (91%) patients underwent direct TAVR without BAV using the S3 valve. The Society of Thoracic Surgeons (STS) risk score was similar between two groups; 5.8 ± 3.5 in no BAV group and 5.4 ± 3.3 in BAV group, p = 0.53. After TAVR, 6 (1.7%) patients in no BAV group but no patient in BAV group developed stroke (p = 1.0). No patient had severe PVL and only 5 patients (1.3%) had moderate PVL at 30-day; 4 (1.2%) in no BAV group and 1 (2.9%) in BAV group (p = 0.38). Forty-six patients (13.4%) in the no BAV group and 4 (11.8%) patients in the BAV group needed balloon post dilation (p = 1.0). Six (1.6%) patients died during hospitalization, all in the no BAV group (p = 1.0). Forty-five (11.9%) patients needed new pacemaker implantation; 44 (12.8%) patients in no BAV group and 1 (2.9%) patient in BAV group (p = 0.1). Two-year survival rate was 85% in no BAV group and 84% in BAV group (p = 0.46). CONCLUSIONS: TAVR using S3 valves is associated with very low rates of post-TAVR stroke and significant PVL. Outcomes of direct TAVR are similar to the outcomes of TAVR with BAV, without an increased rate of stroke, significant PVL, or balloon post dilation.
PURPOSE: We investigated the outcomes of patients who underwent Transcatheter Aortic Valve Replacement (TAVR) with and without Balloon Aortic Valvuloplasty (BAV) using the SAPIEN 3 (S3) valve. METHODS: All patients who underwent TAVR using S3 valve were included. The primary outcomes were the incidence of stroke and significant paravalvular leak (PVL). Secondary outcomes were the incidence of mortality, balloon post dilation, and need for permanent pacemaker. RESULTS: From July-2014 to April-2018, 34 (9%) patients underwent BAV prior to TAVR and 344 (91%) patients underwent direct TAVR without BAV using the S3 valve. The Society of Thoracic Surgeons (STS) risk score was similar between two groups; 5.8 ± 3.5 in no BAV group and 5.4 ± 3.3 in BAV group, p = 0.53. After TAVR, 6 (1.7%) patients in no BAV group but no patient in BAV group developed stroke (p = 1.0). No patient had severe PVL and only 5 patients (1.3%) had moderate PVL at 30-day; 4 (1.2%) in no BAV group and 1 (2.9%) in BAV group (p = 0.38). Forty-six patients (13.4%) in the no BAV group and 4 (11.8%) patients in the BAV group needed balloon post dilation (p = 1.0). Six (1.6%) patientsdied during hospitalization, all in the no BAV group (p = 1.0). Forty-five (11.9%) patients needed new pacemaker implantation; 44 (12.8%) patients in no BAV group and 1 (2.9%) patient in BAV group (p = 0.1). Two-year survival rate was 85% in no BAV group and 84% in BAV group (p = 0.46). CONCLUSIONS: TAVR using S3 valves is associated with very low rates of post-TAVR stroke and significant PVL. Outcomes of direct TAVR are similar to the outcomes of TAVR with BAV, without an increased rate of stroke, significant PVL, or balloon post dilation.
Authors: Gerhard Schymik; Tanja Rudolph; Claudius Jacobshagen; Jürgen Rothe; Hendrik Treede; Sebastian Kerber; Derk Frank; Lenka Sykorova; Maki Okamoto; Martin Thoenes; Cornelia Deutsch; Peter Bramlage; Christian Butter Journal: Open Heart Date: 2019-10-03