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STRUCTURAL INTERVENTIONS

AMPLATZER™ VENTRICULAR SEPTAL DEFECT OCCLUDERS

Ventricular septal defects (VSDs) are the most commonly found congenital heart defect.2 Our Amplatzer™ VSD portfolio includes occluders specifically designed to close complex VSDs in patients considered to be too high risk for standard surgical repair.

THE PIONEER IN VENTRICULAR SEPTAL OCCLUDERS1

Abbott’s Amplatzer line not only pioneered structural heart defect occluders, it also retains a leadership position in structural heart innovation and treatment worldwide.1 Amplatzer™ VSD Occluders have a record of safety and effectiveness for more than 20 years.

A ventricular septal defect (VSD) is a hole in the septum between the ventricles and is the most common type of heart malformation.2 A VSD allows blood from the left ventricle to pass through into the right ventricle, creating extra stress to the right ventricle in order to keep up with the additional blood flow. Patients with a VSD carry an increased risk of infection to the heart walls and valves.
 

Types of VSD

There are 4 types of VSDs:

  • Perimembranous
  • Muscular
  • Conal, or subpulmonary
  • Inlet

Learn more about each type of VSD

Amplatzer options for Ventricular Septal Defect closure

Abbott offers two devices for transcatheter VSD closure, the Amplatzer Muscular VSD Occluder and the Amplatzer Post-MI Muscular VSD Occluder. Like many Amplatzer occluders, these devices:

  • Are self-expandable, double-disc devices
  • Are made of nitinol wire mesh with interwoven polyester substrate to promote occlusion and tissue in-growth
  • Can be recaptured and redeployed if necessary for precise placement
  • Are designed for complete closure
  • Have a symmetrical design that allows for a venous or arterial delivery approach
  • Have a connecting waist that corresponds to the size of the VSD*

*With the condition that the implanter chooses the appropriate device size.

The importance of treating patients with VSD

Josef - Amplatzer VSD

After receiving the Amplatzer™ VSD Occluder Jozef, amazed at his energy and ability to walk long distances again, said:

“I feel joy deep inside me—inside my heart.”

*This testimonial relates an account of an individual’s response to the treatment. This patient’s account is genuine, typical and documented. However, it does not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatment. Responses to the treatment discussed can and do vary and are specific to the individual patient.

 

 

Amplatzer™ Muscular VSD Occluders

The Amplatzer™ Muscular VSD Occluder is indicated for use in patients with a complex 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.

Benefits, ease of transcatheter closure of VSDs

“The benefits of avoiding [cardiopulmonary] bypass are intuitive, and the relative ease of placement makes this procedure ultimately attractive.”3

  • When closure should be performed

    Both transcatheter and surgical closure are options for patients with moderate to large VSDs. In particular, physicians should perform VSD closure when the patient has2: 

    • 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.

  • Treatment for Post-Mi Muscular VSD is critical

    A post-myocardial infarction muscular VSD is a life-threatening complication that often leads to cardiogenic shock.4 Notably, medical management alone is associated with a grim prognosis of a 94% mortality rate at 30 days.5

    The Amplatzer™ Post-infarct Muscular VSD Occluder is a percutaneous transcatheter occlusion device intended for closure of post-myocardial infarction muscular VSDs in patients who are not satisfactory surgical candidates.6

    Josef - Amplatzer VSD

    Amplatzer was “Just the right device” for VSD

    Cardiologist

    Due to his VSD, Jozef developed endocarditis, which in turn led to heart failure and kidney failure. After receiving an Amplatzer VSD Occluder, Jozef, astonished at his symptom improvement, noted “I feel joy deep inside me—inside my heart.”

Choose between two Amplatzer™ devices for
Muscular VSD Closure

Abbott’s 2 muscular VSD occluders allow for either a femoral or an arterial delivery.


Amplatzer™ Muscular VSD Occluder

  • Is designed for muscular VSD closure in patients considered to be high risk for standard surgical repair
  • Has a 7 mm waist length to accommodate the thickness of the muscular septal wall
Amplatzer Muscular VSD Occluder for ventricular septal defects too high-risk for surgical repair


Amplatzer™ P.I. Muscular VSD Occluder

  • Is designed for the damaged muscular tissue in the septal wall of patients who have had a myocardial infarction
  • Has a 10 mm waist length to accommodate the damaged tissue that can occur with septal wall rupture
Amplatzer PI Muscular VSD Occluder for damaged muscular tissue in the septal wall

The Amplatzer Occluder for
membranous VSD closure

Amplatzer™ Membranous VSD Occluder

The Amplatzer Membranous VSD Occluder is intended for occlusion of hemodynamically significant perimembranous VSDs. These VSDs are adjacent to the tricuspid valve’s septal leaflet, or adjacent to the aortic valve. This occluder’s non-concentric design allows for placement while avoiding interference with the aortic or atrioventricular valves. With sizes that increase by 1-mm increments, the Amplatzer Membranous VSD Occluder is available from 4 to 18 mm.

For implantation of this device, hemodynamic significance is defined as:

  • Evidence of left ventricular (LV) and/or left atrial enlargement (for body surface area) or pulmonary-to-systemic flow ratio (Qp/Qs) greater than 1.5, per transthoracic echocardiography
  • Cardiomegaly
  • Increased pulmonary vasculature on chest x-ray
  • Diastolic murmur at apex
Abbott Amplatzer Portfolio App helps physicians determine which structural intervention device to use

NEW VERSION AVAILABLE
GET THE AMPLATZER PORTFOLIO APP

The Amplatzer Portfolio App helps physicians determine which Amplatzer Structural Interventions device to use by suggesting applicable devices based on respective Instructions for Use.
 

App Store
Google Play

MAT-2008370 v3.0 | Item approved for OUS use only.

References
  1. Data on file at Abbott.
  2. 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.
  3. Minette MS, Sahn DJ. Ventricular septal defects. Circulation. 2006;114:2190-2197.
  4. 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.
  5. 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.
  6. Amplatzer Post-infarct Muscular VSD Occluder Instructions for Use.
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