2024 Scientific Sessions

OR13-4
Transcatheter Closure of Post-Infarct VSDs with the Amplatzer™ PIVSD Occluder: Results of a U.S. Study

Presenter

Vijay S. Iyer, M.D., Ph.D., FSCAI, Great Lakes Cardiovascular, East Amherst, NY
Vijay S. Iyer, M.D., Ph.D., FSCAI, Great Lakes Cardiovascular, East Amherst, NY, Courtney Weiler, Abbott Cardiovascular, Minneapolis, MN, William Merhi, D.O., Spectrum Health/Michigan State University, Grand Rapids, MI, Biswajit Kar, M.D., McGovern Medical School, Houston, TX, James Fudge, MD, -, Gainesville, FL, Puvi Seshiah, TriHealth Bethesda North Hospital, Cincinnati, OH, Vaikom S. Mahadevan, M.D., FSCAI, University of Massachusetts Medical School, Worcester, MA, Dan Gutfinger, MD, -, Agoura Hills, CA and Jon Rodney Resar, M.D., FSCAI, The Johns Hopkins Hospital, Stevenson, MD

Keywords: Cardiogenic Shock, Occlusion Devices, Structural Heart Disease (SHD) and Ventricular Septal Defect (VSD)

Background:

A post-infarct ventricular septal defect (PIVSD) is associated with a high mortality and morbidity particularly in patients with hemodynamic instability who are not suitable candidates for surgical repair. The Amplatzer™ PIVSD Occluder (Abbott, Plymouth, MN, USA) is indicated for transcatheter PIVSD closure in patients who are not satisfactory candidates for surgical repair. The objective of this study was to evaluate associated clinical outcomes.

Methods


A total of 131 patients underwent transcatheter PIVSD closure using the Amplatzer PIVSD Occluder between 2011 and 2021 as part of a post-approval multi-center, retrospective, observational study. The patients were analyzed in two cohorts. Cohort 1 included 99 patients (age 68.6±11.9 years) implanted from 2011 to 2016 and evaluated technical success, procedure survival, and 6-month survival. Cohort 2 included 32 patients (age 66.4±10.9 years) implanted from 2012 to 2021 with post-procedure echocardiograms and evaluated 24-hour closure, 6-month closure, and 6-month survival.

Results


Technical success was achieved in 76.8% (76/99), procedure survival in 84.3% (75/89), and 6-month survival was observed in 37.2% of Cohort 1 patients. 24-hour and 6-month closure was achieved in 53.1% (17/32) and 66.7% (4/6) of Cohort 2 patients, respectively. Six-month survival was 46.4% of Cohort 2 patients. Of the 16 deaths in cohort 2, 11 were cardiac-related, 4 were non-cardiac-related, and 1 was of unknown etiology.

Conclusions


This study demonstrates high morbidity of patients undergoing PIVSD closure using the Amplatzer PIVSD Occluder and that the device continues to be a safe alternative to medical therapy in patients who are not satisfactory candidates for surgical repair of a PIVSD.