Elsevier

American Heart Journal

Volume 163, Issue 5, May 2012, Pages 812-820.e1
American Heart Journal

Clinical Investigation
Congestive Heart Failure
Percutaneous left ventricular partitioning in patients with chronic heart failure and a prior anterior myocardial infarction: Results of the PercutAneous Ventricular RestorAtion in Chronic Heart failUre PaTiEnts Trial

https://doi.org/10.1016/j.ahj.2012.02.013Get rights and content

Objectives

The aim of this study was to assess the feasibility, safety, and preliminary efficacy of a novel percutaneous left ventricular partitioning device (VPD) in patients with chronic heart failure (HF) and a prior anterior myocardial infarction.

Background

Anterior myocardial infarction is frequently followed by left ventricular remodeling, HF, and increased long-term morbidity and mortality.

Methods

Thirty-nine patients were enrolled in a multinational, nonrandomized, longitudinal investigation. The primary end point was an assessment of safety, defined as the successful delivery and deployment of the VPD and absence of device-related major adverse cardiac events over 6 months. Secondary (exploratory) efficacy end points included changes in hemodynamics and functional status and were assessed serially throughout the study.

Results

Ventricular partitioning device placement was not attempted in 5 (13%) of 39 subjects. The device was safely and successfully implanted in 31 (91%) of the remaining 34 patients or 79% of all enrolled patients. The 6-month rate of device-related major adverse cardiac event occurred in 5 (13%) of 39 enrolled subjects and 5 (15%) of 34 treated subjects, with 1 additional event occurring between 6 and 12 months. For patients discharged with the device to 12 months (n = 28), New York Heart Association class (2.5 ± 0.6 to 1.3 ± 0.6, P < .001) and quality-of-life scores (38.6 ± 6.1 to 28.4 ± 4.4, P < .002) improved significantly; however, the 6-minute hall walk distance (358.5 ± 20.4 m to 374.7 ± 25.6 m, P nonsignificant) only trended toward improvement.

Conclusions

The left VPD appears to be relatively safe and potentially effective in the treatment for patients with HF and a prior anterior myocardial infarction. However, these limited results suggest the need for further evaluation in a larger randomized controlled trial.

Section snippets

Study population

Between October 2005 and June 2009, 39 patients were enrolled at 12 sites in the United States and Europe. In the protocol, patients were defined as enrolled if they had signed a consent form, undergone baseline evaluation, and progressed as far as having a 14F or 16F sheath placed in the femoral artery for final in-laboratory assessment of eligibility. Participants were required to be at least 18 years old, have anterio-apical akinesis (or dyskinesis) due to myocardial infarction (MI), and an

VPD implant procedure data

Ventricular partitioning device placement was not attempted in 5 (13%) of the 39 patients primarily due to LV anatomical considerations that were identified during the diagnostic portion of the implant procedure. Of these 5 “non-attempts,” 4 occurred in the European portion of the trial before a change in protocol requiring cardiac computed tomographic (CT) scans before enrollment. In 1 European patient, the device was not implanted because the delivery system was too short. The system was

Discussion

The results of this study demonstrate the feasibility and preliminary safety and efficacy of percutaneous LV partitioning in patients with HF with a prior anterior MI. The VPD was safely and successfully implanted in 31 (91%) of the 34 patients who were anatomically suitable for implantation and in 79% of all enrolled patients. Improved preimplantation anatomical screening, a wider variety of VPD sizes, the development of a second generation delivery device, and the continued experience of the

Disclosures

CardioKinetix, Inc (Menlo Park, CA) supported this study. Drs Mazzaferri, Jr; Abraham; Gradinac; and Sievert served as consultants for Cardiokinetix, Inc. Dr Nikolic is an employee of CardioKinetix, Inc.

Acknowledgements

We thank DSMB voting members: Teresa De Marco, MD; Chris O'Connor, MD; Richard Daily, MD; David Moliterno, MD; Jan Tijssen; Mark Groh, MD; David Lee, MD; Wade Smith, MD. We thank the additional physician investigators of the PARACHUTE trial: William Abernethy, MD; Alex Auseon, MD; Keith Benzuly, MD; Peter Berger, MD; Charles Davidson, MD; Reynolds Delgado, MD; Henry Fesniak, MD; Igor Gregoric, MD; Biswajit Kar, MD; Robert Kipperman, MD; Pranav Loyalka, MD; Veselin Mitrovic, MD; Lowell Satler,

References (19)

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On behalf of the PARACHUTE Study Group.

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