The impella recover 2.5 and TandemHeart ventricular assist devices are safe and associated with equivalent clinical outcomes in patients undergoing high-risk percutaneous coronary intervention†

  1. Jason C. Kovacic MD PhD,
  2. Huy T. Nguyen MD,
  3. Rucha Karajgikar MBBS,
  4. Samin K. Sharma MD,
  5. Annapoorna S. Kini MD‡,*

DOI: 10.1002/ccd.22929

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Author Information

  1. Cardiac Catheterization Laboratory, Cardiovascular Institute, Mount Sinai Hospital, New York, NY, USA

  1. ‡

    Ph: +1 212-241-4181; Fax: +1 E212-534-2845

*Mount Sinai Hospital, One Gustave L. Levy Place, Box 1030, New York, NY 10029

  1. †

    Funding sources: No specific funding or grant was used to fund this study.

Publication History

  1. Accepted manuscript online: 13 JAN 2011 11:29AM EST
  2. Manuscript Accepted: 27 NOV 2010
  3. Manuscript Received: 15 OCT 2010

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Keywords:

  • left ventricular assist device;
  • coronary disease;
  • revascularization

Abstract

Objectives:

To compare the practical use, safety and clinical outcomes associated with the TandemHeart (TH) versus Impella Recover 2.5 (IR2.5) devices when used for circulatory support during high-risk percutaneous coronary intervention (PCI).

Background:

Small studies and registries suggest safety and efficacy for the TH and IR2.5 percutaneous-left ventricular assist devices (P-LVADs). However, these P-LVADs differ markedly in their insertion, operation and manner of circulatory augmentation. To date, no study has compared these devices.

Methods:

We identified 68 patients (49 males, 19 females; age 71.1±12.1 years) from our single-center database that underwent ‘high-risk’ PCI with P-LVAD support from 04/2005-06/2010 (32 with TH, 36 with IR2.5). Relevant data were extracted and imputed for analysis.

Results:

Baseline demographics were similar, including low LVEF (overall mean 31.0±13.7%) and elevated STS mortality risk score (4.2±3.7%). Angiographic characteristics were also similar, with a mean of 2.4±1.0 lesions treated per patient, and 29% undergoing left main PCI. PCI success rates were 99% in both groups, with similar in-hospital outcomes and a combined 7% major vascular access site complication rate. A single episode of left atrial perforation occurred during TH use. No patient required emergent CABG and no in-hospital deaths occurred. The 30 day MACE rate (death, myocardial infarction, target lesion revascularization) was 5.8%. There were no differences between the IR2.5 and TH groups with respect to short- or long-term clinical outcomes.

Conclusions:

The IR2.5 and TH assist devices are safe, equally effective, and associated with acceptable short- and long-term clinical outcomes in patients undergoing ‘high-risk’ PCI. © 2011 Wiley-Liss, Inc.

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