Human Fitting Studies of Cleveland Clinic Continuous-Flow Total Artificial Heart

Abstract

Implantation of mechanical circulatory support devices is challenging, especially in patients with a small chest cavity. We evaluated how well the Cleveland Clinic continuous-flow total artificial heart (CFTAH) fit the anatomy of patients about to receive a heart transplant. A mock pump model of the CFTAH was rapid-prototyped using biocompatible materials. The model was brought to the operative table, and the direction, length, and angulation of the inflow/outflow ports and outflow conduits were evaluated after the recipient's ventricles had been resected. Thoracic cavity measurements were based on preoperative computed tomographic data. The CFTAH fit well in all five patients (height, 170 ± 9 cm; weight, 75 ± 24 kg). Body surface area was 1.9 ± 0.3 m2 (range, 1.6-2.1 m2). The required inflow and outflow port orientation of both the left and right housings appeared consistent with the current version of the CFTAH implanted in calves. The left outflow conduit remained straight, but the right outflow direction necessitated a 73 ± 22 degree angulation to prevent potential kinking when crossing over the connected left outflow. These data support the fact that our design achieves the proper anatomical relationship of the CFTAH to a patient's native vessels.

Evaluation of the novel total artificial heart Realheart in a pilot human fitting study

“…Their internal sagittal distance was within CARMAT TAH’s range of 154‐179 mm (Figure B). Their thoracic circumference was 106‐141 cm, larger than in CCFTAH’s anatomical study of 84.6‐118.7 cm . Smaller patients will be evaluated in the future.…”

Virtual implantations to transition from porcine to bovine animal models for a total artificial heart

“…To our knowledge, this is the first‐time virtual implantations have been used in an animal model. Other TAH developers have used virtual implantation methods for adjusting the design to fit the human patient, and to estimate the number of patients who will be within the target size . However, the shape of the thorax differs between species.…”

“…Other TAH developers have used virtual implantation methods for adjusting the design to fit the human patient, and to estimate the number of patients who will be within the target size. 11,18,19 However, the shape of the thorax differs between species. Humans have elliptical, flattened chests, whereas intermediate-sized mammals have narrower, slightly pointed chests, and large mammals, have round to downward-pointing ovular chests.…”

Previous challenges and current progress–the use of total artificial hearts in patients with end-stage heart failure

“…Human fitting studies have also been conducted [14]. BiVACOR chronic studies in calves have involved nine implantations, with greater than 30-day survival in three calves.…”