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Transcatheter Closure of Postinfarct VSD With the Amplatzer PIVSD Occluder: Results of a US Study
Vijay Iyer1, Courtney Weiler2, William Merhi3
1Buffalo General Hospital, Buffalo, New York.
Insights
Transcatheter closure of postinfarct ventricular septal defects (PIVSD) using the Amplatzer PIVSD Occluder offers a safe alternative for high-risk patients. While morbidity is high, the procedure provides a viable option when surgical repair is not feasible.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Postinfarct ventricular septal defect (PIVSD) presents significant mortality and morbidity risks, especially in hemodynamically unstable patients unsuitable for surgery.
- The Amplatzer PIVSD Occluder is indicated for transcatheter closure in patients who are not surgical candidates.
Purpose of the Study:
- To evaluate the clinical outcomes of transcatheter PIVSD closure using the Amplatzer PIVSD Occluder.
Main Methods:
- A retrospective, observational study involving 131 patients undergoing transcatheter PIVSD closure between 2011 and 2021.
- Patients were analyzed in two cohorts: Cohort 1 (n=99) for technical success and survival, and Cohort 2 (n=32) for closure rates and survival.
Main Results:
- Technical success was 76.8% in Cohort 1, with 6-month survival at 37.2%.
- In Cohort 2, 24-hour closure was 53.1%, 6-month closure was 66.7%, and 6-month survival was 46.4%.
- Cardiac-related deaths accounted for 11 of 16 deaths in Cohort 2.
Conclusions:
- Transcatheter PIVSD closure with the Amplatzer PIVSD Occluder demonstrates high patient morbidity.
- The device remains a safe alternative to medical management for patients ineligible for surgical PIVSD repair.
Background:
A postinfarct ventricular septal defect (PIVSD) is associated with high mortality and morbidity, particularly in patients with hemodynamic instability who are not suitable candidates for surgical repair. The Amplatzer PIVSD Occluder (Abbott) 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 postapproval, multicenter, retrospective, observational study. The patients were analyzed in 2 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 postprocedure 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. Twenty-four-hour closure and 6-month closure were 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 noncardiac-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.
