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March 4, 2020

Study Shows Benefits of PVADs Versus IABPs for PCI in High-Risk Patients

March 4, 2020—Abiomed, Inc. announced the publication of a study of 21,848 nonemergent, high-risk patients who underwent percutaneous coronary intervention (PCI) with either a percutaneous ventricular assist device (PVAD), including the company’s Impella heart pumps, or an intra-aortic balloon pump (IABP). The study demonstrated that the PVAD patients had a lower rate of mortality and complications than patients who underwent PCI with IABP.

Yasser Al-khadra, MD, et al, published the findings in Catheterization & Cardiovascular Interventions (2020;95:503–512). The investigators obtained the data from the National Inpatient Sampling database.

According to Abiomed, the PVAD cohort was significantly sicker than the IABP cohort. PVAD patients were older and had higher rates of hypertension, diabetes, hyperlipidemia, previous PCI, previous coronary artery bypass graft surgery, anemia, chronic lung disease, liver disease, renal failure, and peripheral vascular disease. Despite these higher rates of comorbidities, PVAD patients had more favorable outcomes.

Using multivariate logistic regression (n = 21,848), PVAD patients versus IABP patients were associated with:

  • Lower in-hospital mortality (6.1% vs 8.8%; P < .001)
  • Lower vascular complications (4.3% vs 7.5%; P = .046)
  • Lower cardiac complications (5.6% vs 14.5%; P < .001)
  • Lower respiratory complications (3.8% vs 9.8%; P < .001)
  • A similar rate of bleeding (2.7% vs 2.8%; P = .581)

Propensity score matching (n = 1,926) demonstrated that PVAD patients versus IABP patients were associated with:

  • Lower in-hospital mortality (3.5% vs 6.4%; P < .012)
  • Lower vascular complications (3.4% vs 6%; P = .017)
  • Lower cardiac complications (3.4% vs 12.2%; P < .001)
  • Lower respiratory complications (2.6% vs 6.1%; P = .001)
  • A similar rate of bleeding (2.6% vs 2.4%; P = .795)

The investigators further noted that PVAD patients had a shorter length of stay (4 days vs 5 days; P < .001), which is consistent with the PROTECT II randomized controlled trial and other peer-reviewed studies, including Maini et al.

In Abiomed’s press release, study investigator Perwaiz Merah, MD, commented, “This analysis is another example of real-world data demonstrating improved outcomes for patients and reduced length of stay when PVADs are used. The use of best practices, techniques, and technologies can enable safer, more complete revascularization that improves patient outcomes and quality of life.” Dr. Meraj is Director of Interventional Cardiology at Zucker School of Medicine at Hofstra/Northwell, Northwell Health in Manhasset, New York.

Investigator Cindy Grines, MD, added, “High-risk PCI patients often pose a challenge to the interventionalist due to patient comorbidities, which drive worse outcomes. This publication demonstrates the rationale for PVAD use during high-risk PCI. Left ventricular support maintains coronary perfusion during periods of transient hypotension during long or repeated inflations necessary to achieve complete revascularization.” Dr. Grines is an interventional cardiologist and Chief Scientific Officer at Northside Hospital Cardiovascular Institute in Atlanta, Georgia.

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