Defect size as noted below is presented as a percentage of the aortic annulus diameter.
If left untreated, VSD can lead to pulmonary hypertension and/or congestive heart failure.2 Additionally, with unrepaired VSD, there is also an increased risk of infective endocarditis.4
Medical therapy may be used to treat symptoms associated with muscular VSD but does not address the underlying pathology. Additionally, both transcatheter and surgical closure are options for patients with moderate-to-large VSDs.
Treatment for post-myocardial infarction (MI) muscular VSD is critical.5 However, medical therapy may be insufficient and surgical closure may not be an option for high risk patients.1,6,7
A post-myocardial infarction muscular VSD is a life-threatening complication that often leads to cardiogenic shock.5 Medical treatment alone is associated with a poor prognosis of a 94% mortality rate at 30 days.6
Abbott offers two transcatheter devices for VSD closure, the Amplatzer™ Muscular VSD Occluder and the Amplatzer™ P.I. Muscular VSD Occluder. Providing a solution for:7,8
1. Dakkak, W., Oliver, TI., (2019). Ventricular Septal Defect. StatPearls Publishing 2020, https:// www.ncbi.nlm.nih.gov/pubmed/29261884 - Accessed September 2022.
2. Taylor MD. Ventricular Septal Defect, Muscular Clinical Presentation. Medscape Reference. http://emedicine.medscape.com/article/899873-clinical. Accessed September 2022.
3. Australian Institute of Health and Welfare 2019. Congenital heart disease in Australia. Cat. no. CDK 14. Canberra: AIHW.
4. Stout, KK, 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;139:e698–e800.
5. Schlotter F, et al. Interventional post-myocardial infarction ventricular septal defect closure: a systematic review of current evidence. EuroIntervention. 2016;12:94-102.
6. Crenshaw BS, et al. Risk factors, angiographic patterns, and outcomes in patients with ventricular septal defect complicating acute myocardial infarction. Circulation. 2000;101(1):27-32.
7. Amplatzer™ Muscular VSD Occluder Instructions for Use.
8. Amplatzer™ Post-infarct Muscular VSD Occluder Instructions for Use.
Abbott’s Amplatzer™ portfolio is a pioneer in the treatment of structural heart defects and has retained its leadership position in structural heart innovation and treatment worldwide.1
Specifically designed to close complex VSDs in patients considered to be high risk for surgical repair.2-3
Occluder devices centre and fill the defect using materials that promote occlusion and tissue in-growth.2-3
For femoral or arterial delivery. Devices are designed to be recapturable and redeployable for precise placement.
The Amplatzer™ Muscular VSD Occluder designed for muscular VSD closure in patients considered to be high risk for standard surgical repair
The Amplatzer™ P.I. Muscular VSD Occluder designed for the damaged muscular tissue in the septal wall of patients who have had a myocardial infarction
1. Data on file at Abbott.
2. Dakkak, W., Oliver, TI., (2019). Ventricular Septal Defect. StatPearls Publishing 2020, https://www.ncbi.nlm.nih.gov/pubmed/29261884 - Accessed September 2022.
3. Amplatzer™ Muscular VSD Occluder Instructions for Use.
The Amplatzer™ VSD Occluder was evaluated in a prospective, non-randomised, multi-centre clinical study in 38 patients considered to be high risk for standard surgical repair of muscular VSD.2
*Patients who had a shunt ≤ 2 mm at follow-up interval as assessed by investigator.
The safety and effectiveness of the Amplatzer™ P.I. Muscular VSD Occluder were evaluated in 44 post-myocardial infarction VSD patients.3
*Patients in which device placement was attempted and a device was successfully deployed in a defect during a catheterisation at some point during the study.
†Successful closure of the defect was defined as ≤ 2-mm residual shunt, but may include shunts up to 2.9 mm. Rate is per patients seen.
‡Successful closure of the defect was defined as ≤ 2-mm residual shunt. Rate is per patients seen.
§Major adverse events were reported between Days 0 and 84. 1/3 of major adverse events occurred within 24 hours of implant (at Day 0).
1. Data on file at Abbott.
2. Amplatzer™ Muscular VSD Occluder Instructions for Use
3. Amplatzer™ P.I. Muscular VSD Occluder Instructions for Use.
The Amplatzer™ App helps physicians determine which Amplatzer™ Structural Intervention device to use by suggesting applicable devices based on respective Instructions for Use.
Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions