Abstract
BackgroundHeart failure (HF) is one of the leading causes of mortality and morbidity. The PARACHUTE device is designed to partition for left ventricular (LV) apical aneurysm post extensive anterior myocardial infarction (MI). However, the long-term prognosis of the PARACHUTE device post-implantation is unclear.MethodsFrom November 2015 to April 2017, six subjects with New York Heart Association Classes II, III and IV ischemic HF, LV ejection fraction between (LVEF) 15 and 40%; and LV anterior apical aneurysm were enrolled in our center. The cumulative event rates for MI, hospitalization, and mortality were documented. Further assessment of LVEF, LV end-diastolic diameter (LVEDD), and estimated pulmonary artery pressure were determined by echocardiography core laboratory. For quantitative data comparison, paired t-test was employed.ResultsDevice implantation was successful in all six enrolled subjects, and acute device association adverse events were not observed. At 4.6 ± 1.7 years follow-up, major adverse cardiac events (MACEs) were found in 50% patients, and the survival rate was 86.7%. We observed that the LVEF was significantly elevated after deployment (46.00 ± 6.00% vs. 35.83 ± 1.47%, P = 0.009). Besides, the LVEDD elevated after MI (51.17 ± 3.71 vs. 62.83 ± 3.25, P < 0.001) was revealed, but the device sustained preserved LVEDD after implantation.ConclusionThe PARACHUTE device is an alternative therapy for patients with severe LV maladaptive remodeling. However, the device seems to increase the HF ratio.Trial registrationNCT02240940
Highlights
Left ventricle (LV) maladaptive remodeling after acute myocardial infarction (MI) has been well documented in experimental and clinical trials [1, 2]
The following baseline characteristics were summarized using the mean ± standard deviation (SD) for continuous variables and counts and percentages for Patient characteristics From November 2015 to April 2017, 139 patients with post-anterior MI were initially enrolled in our trial (Fig. 1)
A total of 122 of these patients were ineligible, 98 subjects had not developed an aneurysm in the left ventricular (LV), and 24 patients had an LV ejection fraction between (LVEF) less than 15% or over 40%
Summary
Left ventricle (LV) maladaptive remodeling after acute myocardial infarction (MI) has been well documented in experimental and clinical trials [1, 2]. Despite the treatment improvement in MI, the long-term prognosis of MI-related LV remodeling remains unfavorable. Previous clinical trials implied that the PARACHUTE device may reduce cardiac dimensions and end-diastolic wall stress, thereby benefitting patients with LV dilation post-MI. Little is known about the long-term cardiac function, life quality, and major adverse cardiac events (MACEs) of PARACHUTE-implanted patients. The PARACHUTE device is designed to partition for left ventricular (LV) apical aneurysm post extensive anterior myocardial infarction (MI). The long-term prognosis of the PARACHUTE device post-implantation is unclear
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