Long-term prognosis analysis of PARACHUTE device implantation in patients with ischemic heart failure: a single-center experience of Chinese patients

Jianghua Li, Huadong Liu, Qiyun Liu, Cheng Liu, Wei Xiong, Wei Ma, Baowei Zhang, Shaohong Dong, Tangzhiming Li, Jianghua Li, Huadong Liu, Qiyun Liu, Cheng Liu, Wei Xiong, Wei Ma, Baowei Zhang, Shaohong Dong, Tangzhiming Li

Abstract

Background: Heart 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.

Methods: From 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.

Results: Device 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.

Conclusion: The PARACHUTE device is an alternative therapy for patients with severe LV maladaptive remodeling. However, the device seems to increase the HF ratio.

Trial registration: NCT02240940.

Keywords: Heart failure; Left ventricular systolic function; Mortality; Myocardial infarction.

Conflict of interest statement

Not applicable.

Figures

Fig. 1
Fig. 1
Disposition of subjects enrolled. Six post-myocardial infarction eligible subjects with aneurysm received the PARACHUTE device
Fig. 2
Fig. 2
Sequence of the PARACHUTE device implantation in the left ventricle. The operation was performed through the femoral artery (a). LV angiography was executed to observe the systolic (b) and diastolic (c) LV geometry. The device was placed in contact within the LV apical wall (d). After balloon inflation to facilitate device expansion, the LV geometric reconfiguration was evaluated in the systolic (e) and diastolic (f) phases. The white dotted line indicates the outline of the chamber morphological characteristics before the device implantation. The white arrow indicates the implanted PARACHUTE device
Fig. 3
Fig. 3
Cumulative incidence of cardiovascular events in PARACHUTE-implanted patients. a Cumulative event rates for the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or heart failure end-point. b, c, and d Cumulative myocardial infarction, hospitalization, and mortality, respectively. e Changes in functional capacity according to NYHA. MACEs, major adverse cardiovascular events; MI, myocardial infarction; HFH, hospitalization for heart failure. NYHA, New York Heart Association class
Fig. 4
Fig. 4
Transthoracic echocardiograph-based cardiac function assessment. Transthoracic echocardiography (TTE)-based cardiac function evaluation was performed at baseline (the first time for MI treatment); before the PARACHUTE device procedure; and at 1 week, 6 months, 1 year, 2 years, and 3 years after device implantation. a, c, and e Comparison of each time point for the left ventricular ejection fraction, left ventricular end-diastolic diameter, and estimated pulmonary artery pressure assessment, respectively. b, d, and f Changes in the TTE-based parameter measurement mentioned above. ***: P < 0.001, compared with baseline; ##: P < 0.01, compared with the PARACHUTE procedure; NS: not significant. mm: millimeter
Fig. 5
Fig. 5
Case with left ventricular thrombus after device implantation by contrast echocardiography. a CT scan right after the PARACHUTE implantation to check potential device-related migration or embolization. b Latest follow-up detected by contrast-enhanced CT. The filling defect appeared in the apical left ventricle. c and d 3D-TTE and 2D-TEE were applied to exclude device migration, respectively. The white arrow indicates the implanted device. e and f Left ventricular thrombus confirmed by LVO and MCE, respectively. The white arrow points to the filling defect-implied LV apical thrombus

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