The feasibility and safety of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy: Initial first in man clinical results

Randall J. Lee, Andy Hinson, Robert Bauernschmitt, Klaus Matschke, Qi Fang, Douglas L. Mann, Robert Dowling, Nelson Schiller, Hani N. Sabbah

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Background A tissue engineering approach to augment the left ventricular wall has been suggested as a means to treat patients with advanced heart failure. This study evaluated the safety and feasibility of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy undergoing open-heart surgery. Methods and results Eleven male patients (aged 44 to 74 years) with advanced heart failure (NYHA class 3 or 4), a left ventricular ejection fraction (LVEF) of < 40% and requiring conventional heart surgery received Algisyl-LVR delivered into the LV myocardial free wall. Serial echocardiography, assessment of NYHA class, Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24-hour Holter monitoring were obtained at baseline, days 3 and 8 (for echocardiography and Holter monitoring), and at 3, 6, 12, 18 and 24 months. A total of 9 (81.8%) patients completed 24 months of follow-up. Two patients withdrew consent after day 8 and at the 3 month visit. Operative mortality was 0% (n = 10 with 30 day follow-up). There were no adverse events attributed to Algisyl-LVR. Mean LVEF improved from 27.1 (± 7.3) % at screening to a mean LVEF of 34.8 (± 18.6) % 24 months post-discharge. Improvements of NYHA class were corroborated with improvements in KCCQ summary scores. Holter monitor data showed a significant decrease in the episodes of nonsustained ventricular tachycardia following administration of Algisyl-LVR. Conclusions Administration of Algisyl-LVR to patients with advanced HF at the time of cardiac surgery is feasible and safe; warranting continued development of Algisyl-LVR as a potential therapy in patients with advanced HF.

Original languageEnglish (US)
Pages (from-to)18-24
Number of pages7
JournalInternational Journal of Cardiology
Volume199
DOIs
StatePublished - Sep 15 2015

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Dilated Cardiomyopathy
Safety
Stroke Volume
Thoracic Surgery
Ambulatory Electrocardiography
Cardiomyopathies
Echocardiography
Heart Failure
Tissue Engineering
Ventricular Tachycardia
Mortality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Lee, Randall J. ; Hinson, Andy ; Bauernschmitt, Robert ; Matschke, Klaus ; Fang, Qi ; Mann, Douglas L. ; Dowling, Robert ; Schiller, Nelson ; Sabbah, Hani N. / The feasibility and safety of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy : Initial first in man clinical results. In: International Journal of Cardiology. 2015 ; Vol. 199. pp. 18-24.
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title = "The feasibility and safety of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy: Initial first in man clinical results",
abstract = "Background A tissue engineering approach to augment the left ventricular wall has been suggested as a means to treat patients with advanced heart failure. This study evaluated the safety and feasibility of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy undergoing open-heart surgery. Methods and results Eleven male patients (aged 44 to 74 years) with advanced heart failure (NYHA class 3 or 4), a left ventricular ejection fraction (LVEF) of < 40{\%} and requiring conventional heart surgery received Algisyl-LVR delivered into the LV myocardial free wall. Serial echocardiography, assessment of NYHA class, Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24-hour Holter monitoring were obtained at baseline, days 3 and 8 (for echocardiography and Holter monitoring), and at 3, 6, 12, 18 and 24 months. A total of 9 (81.8{\%}) patients completed 24 months of follow-up. Two patients withdrew consent after day 8 and at the 3 month visit. Operative mortality was 0{\%} (n = 10 with 30 day follow-up). There were no adverse events attributed to Algisyl-LVR. Mean LVEF improved from 27.1 (± 7.3) {\%} at screening to a mean LVEF of 34.8 (± 18.6) {\%} 24 months post-discharge. Improvements of NYHA class were corroborated with improvements in KCCQ summary scores. Holter monitor data showed a significant decrease in the episodes of nonsustained ventricular tachycardia following administration of Algisyl-LVR. Conclusions Administration of Algisyl-LVR to patients with advanced HF at the time of cardiac surgery is feasible and safe; warranting continued development of Algisyl-LVR as a potential therapy in patients with advanced HF.",
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The feasibility and safety of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy : Initial first in man clinical results. / Lee, Randall J.; Hinson, Andy; Bauernschmitt, Robert; Matschke, Klaus; Fang, Qi; Mann, Douglas L.; Dowling, Robert; Schiller, Nelson; Sabbah, Hani N.

In: International Journal of Cardiology, Vol. 199, 15.09.2015, p. 18-24.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The feasibility and safety of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy

T2 - Initial first in man clinical results

AU - Lee, Randall J.

AU - Hinson, Andy

AU - Bauernschmitt, Robert

AU - Matschke, Klaus

AU - Fang, Qi

AU - Mann, Douglas L.

AU - Dowling, Robert

AU - Schiller, Nelson

AU - Sabbah, Hani N.

PY - 2015/9/15

Y1 - 2015/9/15

N2 - Background A tissue engineering approach to augment the left ventricular wall has been suggested as a means to treat patients with advanced heart failure. This study evaluated the safety and feasibility of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy undergoing open-heart surgery. Methods and results Eleven male patients (aged 44 to 74 years) with advanced heart failure (NYHA class 3 or 4), a left ventricular ejection fraction (LVEF) of < 40% and requiring conventional heart surgery received Algisyl-LVR delivered into the LV myocardial free wall. Serial echocardiography, assessment of NYHA class, Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24-hour Holter monitoring were obtained at baseline, days 3 and 8 (for echocardiography and Holter monitoring), and at 3, 6, 12, 18 and 24 months. A total of 9 (81.8%) patients completed 24 months of follow-up. Two patients withdrew consent after day 8 and at the 3 month visit. Operative mortality was 0% (n = 10 with 30 day follow-up). There were no adverse events attributed to Algisyl-LVR. Mean LVEF improved from 27.1 (± 7.3) % at screening to a mean LVEF of 34.8 (± 18.6) % 24 months post-discharge. Improvements of NYHA class were corroborated with improvements in KCCQ summary scores. Holter monitor data showed a significant decrease in the episodes of nonsustained ventricular tachycardia following administration of Algisyl-LVR. Conclusions Administration of Algisyl-LVR to patients with advanced HF at the time of cardiac surgery is feasible and safe; warranting continued development of Algisyl-LVR as a potential therapy in patients with advanced HF.

AB - Background A tissue engineering approach to augment the left ventricular wall has been suggested as a means to treat patients with advanced heart failure. This study evaluated the safety and feasibility of Algisyl-LVR™ as a method of left ventricular augmentation in patients with dilated cardiomyopathy undergoing open-heart surgery. Methods and results Eleven male patients (aged 44 to 74 years) with advanced heart failure (NYHA class 3 or 4), a left ventricular ejection fraction (LVEF) of < 40% and requiring conventional heart surgery received Algisyl-LVR delivered into the LV myocardial free wall. Serial echocardiography, assessment of NYHA class, Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24-hour Holter monitoring were obtained at baseline, days 3 and 8 (for echocardiography and Holter monitoring), and at 3, 6, 12, 18 and 24 months. A total of 9 (81.8%) patients completed 24 months of follow-up. Two patients withdrew consent after day 8 and at the 3 month visit. Operative mortality was 0% (n = 10 with 30 day follow-up). There were no adverse events attributed to Algisyl-LVR. Mean LVEF improved from 27.1 (± 7.3) % at screening to a mean LVEF of 34.8 (± 18.6) % 24 months post-discharge. Improvements of NYHA class were corroborated with improvements in KCCQ summary scores. Holter monitor data showed a significant decrease in the episodes of nonsustained ventricular tachycardia following administration of Algisyl-LVR. Conclusions Administration of Algisyl-LVR to patients with advanced HF at the time of cardiac surgery is feasible and safe; warranting continued development of Algisyl-LVR as a potential therapy in patients with advanced HF.

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