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. 2024 May 3;3(6):102016.
doi: 10.1016/j.jscai.2024.102016. eCollection 2024 Jun.

Transcatheter Closure of Postinfarct VSD With the Amplatzer PIVSD Occluder: Results of a US Study

Vijay Iyer  1 , Courtney Weiler  2 , William Merhi  3 , Biswajit Kar  4 , J Curtis Fudge  5 , Puvi Seshiah  6 , Vaikom S Mahadevan  7 , Dan Gutfinger  2 , Jon Resar  8
Affiliations

Transcatheter Closure of Postinfarct VSD With the Amplatzer PIVSD Occluder: Results of a US Study

Vijay Iyer et al. J Soc Cardiovasc Angiogr Interv. .

Abstract

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.

Keywords: acute myocardial infarction; postinfarct ventricular septal defect; transcatheter closure.

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Figures

Central Illustration
Central Illustration
Probability of 6-month (183 days) survival for cohorts 1 and 2. Both cohort 1 and 2 were assessed using the Kaplan-Meier method. Probability of survival was 37.2% and 46.4% at 6 months postprocedure for cohorts 1 and 2, respectively. Cohort 1 included all available patients (N = 99) who underwent a PIVSD Occluder implant attempt under Emergency and Compassionate Use between 2011 and 2016. Cohort 2 patients (N = 32) were enrolled across 16 clinical sites between 2017 and 2021.
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References

    1. Cinq-Mars A., Voisine P., Dagenais F., et al. Risk factors of mortality after surgical correction of ventricular septal defect following myocardial infarction: retrospective analysis and review of the literature. Int J Cardiol. 2016;206:27–36. doi: 10.1016/j.ijcard.2015.12.011. - DOI - PubMed
    1. Crenshaw B.S., Granger C.B., Birnbaum Y., et al. Risk factors, angiographic patterns, and outcomes in patients with ventricular septal defect complicating acute myocardial infarction. GUSTO-I (Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries) trial investigators. Circulation. 2000;101(1):27–32. doi: 10.1161/01.cir.101.1.27. - DOI - PubMed
    1. O'Gara P.T., Kushner F.G., Ascheim D.D., et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127(4):e362–e425. doi: 10.1161/CIR.0b013e3182742cf6. - DOI - PubMed
    1. Lundberg S., Soderstrom J. Perforation of the interventricular septum in myocardial infarction. A study based upon an autopsy material. Acta Med Scand. 1962;172:413–418. doi: 10.1111/j.0954-6820.1962.tb07174.x. - DOI - PubMed
    1. Dimagli A., Guida G., Sinha S., et al. Surgical outcomes of post-infarct ventricular septal defect repair: insights from the UK national adult cardiac surgery audit database. J Card Surg. 2022;37(4):843–852. doi: 10.1111/jocs.16178. - DOI - PubMed

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