Effect of left ventriculoplasty with Algisyl-LVR device

Introduction: Purpose: To report the modification of geometrical shape, systolic and diastolic left ventricular function parameters after implantation of AlgisylLVR™ device in the first 4 patients from our center, randomized in the surgical group in Augment-HF clinical trial and evaluated aft er 6 months. Augment-HF clinical trial is a randomized, controlled study to evaluate the safety and cardiovascular effects of Algisyl-LVR™ as a method of LV augmentation in patients with chronic HF due to ischemic or non-ischemic dilated cardiomyopathy. Methods: Algisyl-LVR™ is a biopolymer classified as medical device by regulatory authorities implanted in free wall of the left ventricle aiming to alleviate LV dysfunction by reducing the wall stress through the modification of the ratio between LV radius and wall thickness. The technique of implantation is a surgical procedure consisting in a left thoracotomy, afterwards the biopolymer being delivered by the cardiac surgeon through a series of 10 to 19 implants that are placed circumferential at the mid-ventricular level. We report the presently available echo data on 6 months followup for the first 4 patients operated in our center. Results: All patients have advanced chronic HF refractory to optimal medical treatment, being in NYHA III class at randomization. Comparison of ultrasound data recorded preoperatively with the postoperative evolution at eight days, one month, three months and six months showed an improvement in systolic and diastolic sphericity index, ejection fraction and E/E’.The improvement of echo parameters is consistent with the amelioration of clinical status, evaluated by NYHA class, 6-minutes walk test and Kansas City Cardiomyopathy Questionnaire. Conclusion: The implantation of the biopolymer resulted in the improvement of the geometry, systolic and diastolic function of the left ventricle.

ISSN – online: 2734 – 6382
ISSN-L 1220-658X
ISSN – print: 1220-658X
The Romanian Journal of Cardiology is indexed by:
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CODE: 379
CME Credits: 10 (Romanian College of Physicians)