Meeting Summaries - News & Events

cVAD Registry Pursues Best Practices for Cardiogenic Shock

ProtectedPCI
November 1, 2016

Although percutaneous circulatory support has seen exponential growth over the last decade, there is a need for real-world data on complex patients to develop best practices, aid research and improve outcomes.

But large randomized clinical trials involving cardiogenic shock patients are difficult to conduct, so the global cVAD registry was created, said Brij Maini, MD, FACC, the regional medical director of transcatheter therapies for Tenet Healthcare Corp.

“Well-designed and conducted clinical registries are critical in providing clinical evidence, especially in the setting of diseases where randomized clinical trials are not feasible,” Dr. Maini said during a presentation at TCT 2016.

Begun in 2009, the registry collects data by reviewing existing medical records and conducting periodic patient follow-up interviews by telephone after the implant of Impella, a percutaneous ventricular assist device (PVAD). To participate in the registry, medical centers had to agree on data elements and definitions, such as how to define “cardiogenic shock.”

The hope is that the cVAD registry will generate best practices to improve outcomes in AMI and cardiogenic shock, among other diseases.

At this point, the registry includes only Impella devices, the family of PVADs made by Abiomed Inc., which provides financial backing for the registry, Dr. Maini said.

“Eventually, we want to include all PVADs,” he added.

He said he also would like to see broader industry support, as well as support from such organizations as the American College of Cardiology and the American Heart Association.

Impella® Device — Indication & Safety Information

INDICATIONS FOR USE

Protected PCI

The Impella 2.5® and Impella CP® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and Impella CP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Cardiogenic Shock

The Impella 2.5®, Impella CP®, Impella 5.0®, and Impella LD® Catheters, in conjunction with the Automated Impella Controller (collectively, “Impella® System Therapy”), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5 and Impella CP, and ≤ 6 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.

Important Risk Information for Impella devices

CONTRAINDICATIONS

The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*

* This condition is a contraindication for the cardiogenic shock indication only.

POTENTIAL ADVERSE EVENTS

Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more.