Clinical InvestigationCongestive Heart FailurePercutaneous 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
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,
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Reverse Left Ventricular Remodeling With Transcatheter Interventions in Chronic Heart Failure Syndromes: An Updated Appraisal of the Device Landscape
2023, Journal of the Society for Cardiovascular Angiography and InterventionsPercutaneous Ventricular Restoration Prevents Left Ventricular Remodeling Post Myocardial Infarction: One-Year Evaluation of the Heartech First-in-man Study
2022, Journal of Cardiac FailureCitation Excerpt :Nearly one-half of the patients in the current study were excluded after the initial enrollment owing to nonideal LV structure or thrombosis, evaluated by the imaging core laboratory. Because, theoretically, LVPD implantation can block mechanical remodeling, we selected early stage patients who have not developed excessively large LV volumes, as was observed in prior Parachute studies.19–21,23,31 Our aim was to identify the role of PVR in blocking mechanical ventricular remodeling.
A novel inflatable left ventricular partitioning device
2020, Medical HypothesesDevice-based treatment of heart failure
2020, Nanomedicine for Ischemic Cardiomyopathy: Progress, Opportunities, and ChallengesInterventional Heart Failure and Hemodynamic Monitoring
2018, Heart Failure ClinicsCitation Excerpt :The aim is to exclude infarcted and akinetic or dyskinetic regions, partly restore the internal LV geometry, and reduce LV volume and wall stress. Early clinical results were favorable among patients with LV ejection fraction less than 35%, NYHA functional class III or greater symptoms, and a prior infarction in the left anterior descending artery territory with associated anteroapical aneurysm.14 However, the randomized PARACHUTE IV trial was terminated early and the company had closed.15
Interventional Therapies for Heart Failure in Older Adults
2017, Heart Failure ClinicsCitation Excerpt :Device implantation was attempted in 34 patients and was successful in 31 (91%). The primary safety end point, defined as the successful delivery and deployment of the Parachute device and 6-month follow-up without the occurrence of major adverse cardiovascular events related to the investigational device was met in 29 of 34 patients (85.3%).134 Improvements in LV volume indices and NYHA class were sustained through 1-year and 3-year follow-ups.134,135
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On behalf of the PARACHUTE Study Group.