This article is more than 5 years old. Information may no longer be current.
PARACHUTE III: Percutaneous ventricular restoration device safe in patients with ischemic dilated HF
Click Here to Manage Email Alerts
LAS VEGAS — Patients implanted with a percutaneous ventricular restoration device with heart failure after a remote MI experienced hemodynamic and functional improvements, with adverse event rates similar to that of other structural heart disease interventions, according to results from the European postmarket PARACHUTE III trial.
The trial was designed to evaluate the safety and efficacy of the Parachute percutaneous ventricular restoration device (CardioKinetix) for the treatment of patients with anteroapical MI. The device is implanted at the site of an anteroapical wall motion abnormality and is designed to restore an elliptical shape to the heart, recreate a conical apex and replace wall motion in the apical region.
The single-arm, multicenter, international trial included 100 consecutive patients with symptomatic ischemic dilated HF; 97 patients had device successfully implanted. All patients had NYHA class III or IV HF, a left ventricular ejection fraction of 15% to 40% and had received stable doses of standard HF therapy for at least 3 months.
William T. Abraham
During 1 year of follow-up, nine deaths, one transplantation, one device removal and two missed visits were recorded, resulting in 84 patients with completed follow-up data. Fourteen percent of patients experienced complications and 11% experienced major complications, according to results presented by William T. Abraham, MD, director of the division of cardiovascular medicine at The Ohio State University Wexner Medical Center, at the Heart Failure Society of America Annual Scientific Meeting. Abraham noted that these rates are comparable to those observed for other structural heart interventions, and that the rate of major complications was about 7 to 8% in the ongoing, randomized PARACHUTE IV trial in the United States.
The primary endpoint was procedural and/or device-related major adverse cardiac and cerebrovascular events (MACCE) at 1 year, and then annually for up to 5 years. According to Abraham, the overall MACCE rate was 7%. All events occurred during or soon after implantation, he said.
The secondary composite endpoint of mortality, MI, stroke and HF-related hospitalization occurred in 32.3% of patients, over 1 year. When examined separately, HF hospitalization occurred in 24.1%, mortality in 9.5% and stroke in 3.2% of patients.
All-cause mortality or HF-related hospitalization occurred in 26% of patients. According to Abraham, these rates are consistent with those projected for PARACHUTE IV and less than what has historically been observed in this population.
Left ventricular volume was decreased at 1 year (P<.0001), whereas contractility index was increased (P<.001). Eighty percent of patients improved or maintained their NYHA class at follow-up. Three-quarters of patients improved or maintained their performance in the 6-minute walk test, with an average improvement from baseline of 25 m (P<.01).
Abraham said the 7% rate of MACCE, when compared with other structural heart disease approaches and trials, “might be considered an acceptable postmarket result.” He also noted that the combined mortality/HF hospitalization rate “supports the assumptions made for the US pivotal randomized controlled trial design.” – by Adam Taliercio
For more information:
Abraham WT. Late-Breaking Clinical Trials. Presented at: the Heart Failure Society of American Annual Scientific Meeting; Sept. 14-17, 2014; Las Vegas.
Disclosure: Abraham reports serving as a consultant for CardioKinetix, and is the national principal investigator of the PARACHUTE IV trial.