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Early feasibility testing and engineering development of a sutureless beating heart connector for left ventricular assist devices.

ABSTRACT: APK Advanced Medical Technologies (Atlanta, GA) is developing a sutureless beating heart (SBH) left ventricular assist device (LVAD) connector system consisting of anchoring titanium coil, titanium cannula with integrated silicone hemostatic valve, coring and delivery tool, and LVAD locking mechanism to facilitate LVAD inflow surgical procedures. Feasibility testing was completed in human cadavers (n = 4) under simulated normal and hypertensive conditions using saline to observe seal quality in degraded human tissue and assess anatomic fit; acutely in ischemic heart failure bovine model (n = 2) to investigate short-term performance and ease of use; and chronically for 30 days in healthy calves (n = 2) implanted with HeartWare HVAD to evaluate performance and biocompatibility. Complete hemostasis was achieved in human cadavers and animals at LV pressures up to 170 mm Hg. In animals, off-pump (no cardiopulmonary bypass) anchoring of the connector was accomplished in less than 1 minute with no residual bleeding after full delivery and locking of the LVAD; and implant of connector and LVAD were successfully completed in under 10 minutes with total procedure blood loss less than 100 ml. In chronic animals before necropsy, no signs of leakage or disruption at the attachment site were observed at systolic LV pressures >200 mm Hg.

SUBMITTER: Koenig SC

PROVIDER: S-EPMC4224637 | biostudies-literature | 2014 Nov-Dec

REPOSITORIES: biostudies-literature

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Early feasibility testing and engineering development of a sutureless beating heart connector for left ventricular assist devices.

Koenig Steven C SC Jimenez Jorge H JH West Seth D SD Sobieski Michael A MA Choi Young Y Monreal Gretel G Giridharan Guruprasad A GA Soucy Kevin G KG Slaughter Mark S MS

ASAIO journal (American Society for Artificial Internal Organs : 1992) 20141101 6

APK Advanced Medical Technologies (Atlanta, GA) is developing a sutureless beating heart (SBH) left ventricular assist device (LVAD) connector system consisting of anchoring titanium coil, titanium cannula with integrated silicone hemostatic valve, coring and delivery tool, and LVAD locking mechanism to facilitate LVAD inflow surgical procedures. Feasibility testing was completed in human cadavers (n = 4) under simulated normal and hypertensive conditions using saline to observe seal quality in ...[more]

PMID: 25238500

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Project description:AimsPatients with left ventricular assist device (LVAD) suffer from persistent exercise limitation despite improvement of their heart failure syndrome. Exercise training (ET) programmes to improve aerobic capacity have shown modest efficacy. High-intensity interval training (HIIT), as an alternative to moderate continuous training, has not been systematically tested in this population. We examine the feasibility of a short, personalized HIIT programme in patients with LVAD and describe its effects on aerobic capacity and left ventricular remodelling.Methods and resultsPatients on durable LVAD support were prospectively enrolled in a 15-session, 5 week HIIT programme. Turndown echocardiogram, Kansas City Cardiomyopathy Questionnaire, and cardiopulmonary exercise test were performed before and after HIIT. Training workloads for each subject were based on pretraining peak cardiopulmonary exercise test work rate (W). Percentage of prescribed training workload completed and adverse events were recorded for each subject. Fifteen subjects were enrolled [10 men, age = 51 (29-71) years, HeartMate II = 12, HeartMate 3 = 3, and time on LVAD = 18 (3-64) months]. Twelve completed post-training testing. HIIT was well tolerated, and 90% (inter-quartile range: 78, 99%) of the prescribed workload (W) was completed with no major adverse events. Improvements were seen in aV?O2 at ventilatory threshold [7.1 (6.5, 9.1) to 8.5 (7.7, 9.3) mL/kg/min, P = 0.04], work rate at ventilatory threshold [44 (14, 54) to 55 (21, 66) W, P = 0.05], and left ventricular end-diastolic volume [168 (144, 216) to 159 (124, 212) mL, n = 7, P = 0.02]. HIIT had no effect on maximal oxygen consumption (V?O2peak ) or Kansas City Cardiomyopathy Questionnaire score.ConclusionsCardiopulmonary exercise test-guided HIIT is feasible and can improve submaximal aerobic capacity in stable patients with chronic LVAD support. Further studies are needed on its effects on the myocardium and its potential role in cardiac rehabilitation programmes.

Dataset Information

Early feasibility testing and engineering development of a sutureless beating heart connector for left ventricular assist devices.

Publications

Early feasibility testing and engineering development of a sutureless beating heart connector for left ventricular assist devices.

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