The Amplatzer™ Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD) of significant size to warrant closure—large volume left-to-right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure—in patients who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.
Both transcatheter and surgical closure are options for patients with moderate to large VSDs. In particular, physicians should perform VSD closure when the patient has:2
- Left ventricular (LV) volume overload and hemodynamically significant shunts, with pulmonary-to-systemic blood ﬂow ratio (Qp/Qs) of 1.5 or higher*
- Worsening aortic regurgitation (AR) caused by perimembranous VSD
In patients whose VSD is not repaired, there is an increased risk of infective endocarditis (IE), usually involving the tricuspid and pulmonary valves.
*Assuming that pulmonary artery (PA) systolic pressure is less than 50% systemic and pulmonary vascular resistance is less than one-third systemic.
A post-myocardial infarction muscular VSD is a life-threatening complication that often leads to cardiogenic shock.3 Notably, medical management alone is associated with a grim prognosis of a 94% mortality rate at 30 days.4
The Amplatzer™ Post-infarct Muscular VSD Occluder is a percutaneous transcatheter occlusion device intended for closure of post-myocardial infarction muscular VSD.5
MAT-2008370 v1.0 | Item approved for Global OUS use only.
- Minette MS, Sahn DJ. Ventricular septal defects. Circulation. 2006;114:2190-2197.
- Stout KK, Daniels CJ, Aboulhosn JA, et al. 2018 AHA/ACC Guideline for the Management of Adults with Congenital Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;73(12):e81-e192. doi: 10.1161/CIR.0000000000000603.
- Schlotter F, de Waha S, Eitel I, et al. Interventional post-myocardial infarction ventricular septal defect closure: a systematic review of current evidence. EuroIntervention. 2016;12:94-102.
- Crenshaw BS, Granger CB , Birnbaum Y, et al. Risk factors, angiographic patterns, and outcomes in patients with ventricular septal defect complicating acute myocardial infarction. Circulation. 2000;101(1):27-32.
- AMPLATZER™ Muscular VSD Occluder and P.I. Muscular VSD Occluder Instructions for Use ARTMT600034253 B 2019-02.