Percutaneous Ventricular Restoration Prevents Left Ventricular Remodeling Post Myocardial Infarction: One-Year
Zhengbin Zhu1, Jinzhou Zhu1, Jiwei Yu2
1Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine. Shanghai, China; Cardiovascular Research institution, Shanghai Jiao Tong University School of Medicine. Shanghai, China.
Insights
The Heartech left ventricular partitioning device (LVPD) shows promise for treating chronic heart failure (HF) post-myocardial infarction. This novel therapy effectively reduced heart size and improved function in patients, demonstrating safety and efficacy up to 12 months.
Area of Science:
- Cardiology
- Medical Devices
- Regenerative Medicine
Background:
- Chronic heart failure (HF) following myocardial infarction (MI) remains a significant clinical challenge.
- The Heartech left ventricular partitioning device (LVPD) is a novel implantable therapy designed for ventricular restoration.
- This study represents the first human investigation of the Heartech LVPD.
Purpose of the Study:
- To evaluate the safety and efficacy of the Heartech LVPD in patients with chronic HF post-MI.
- To assess the impact of LVPD implantation on left ventricular (LV) volumes, LV ejection fraction (LVEF), and functional status.
- To document major adverse cardiovascular and cerebrovascular events (MACCEs) following the procedure.
Main Methods:
- A prospective, first-in-human study involving 16 patients from three cardiac centers in China.
- Percutaneous implantation of the Heartech LVPD.
- Comprehensive assessments including echocardiography, European Quality of Life-5 Dimensions (EQ-5D) scale, and 6-minute walk test (6MWT) at baseline and 12-month follow-up.
Main Results:
- Successful LVPD implantation in 93.75% of patients.
- Significant reduction in LV end-systolic volume index (LVESVI) and LV end-diastolic volume index (LVEDVI) (P=.001 and P=.002, respectively).
- Significant improvement in LVEF (P=.003), 6MWT distance (P=.01), and EQ-5D scores (P<.001).
- One patient experienced a fatal MI; no other MACCEs were reported at 12 months.
Conclusions:
- The Heartech LVPD is safe and effective for reducing LV volume and improving LV function in patients with chronic HF post-MI.
- The observed benefits in cardiac structure and function were sustained up to the 12-month follow-up.
- The Heartech LVPD represents a promising therapeutic option for managing heart failure after myocardial infarction.
Background:
This is first-in-man investigation of an implantable Heartech left ventricular partitioning device (LVPD) therapy for chronic heart failure (HF) after a myocardial infarction.
Methods And Results:
Initially, 16 patients were chosen from 3 cardiac centers within China. All patients were treated with percutaneous ventricular restoration involving the Heartech LVPD implantation. Major adverse cardiovascular and cerebrovascular events were documented. Functional status, echocardiograph evaluation, European five-dimensional health scale, 6-minute walk test before the procedure and at postoperative follow-ups were recorded. We demonstrated successful implantation and device function with a success rate of 93.75%. One patient suffered a fatal myocardial infarction within the 12 ± 1 month follow-up. However, other patients did not report any major adverse cardiovascular and cerebrovascular events at their 12 ± 1 month follow-ups. After the operation, the average left ventricular end-systolic volume index decreased dramatically (66.00 mL/m2, interquartile range [IQR] 63.00-89.00 mL/m2 vs 48.00 mL/m2, IQR 32.25-68.25 mL/m2, P = .001), along with the left ventricular end-diastolic volume index (105.00 mL/m2, IQR 90.00-130.00 mL/m2 vs 76.50 mL/m2, IQR 57.75-120.25 mL/m2, P = .002). The left ventricular ejection fraction (35.00%, IQR 27.00-38.00% vs 42.50%, IQR 34.75-50.25%, P = .003), 6-minute walk test (383.13 ± 108.70 m vs 491.17 ± 118.44 m, P = .01), and European five-dimensional health scale (65.93 ± 11.25 vs 82.50 ± 5.44, P < .001), in turn, improved significantly.
Conclusions:
In our study, the Heartech LVPD was demonstrated as both safe and effective in reducing LV volume, enhancing LV function after implantation. These results remain constant at least till the 12 month follow-up. (Trial Registration: NCT02938637.).
