Baylor Scott & White Research Institute was recently selected as one of only seven sites in the nation to participate in the landmark feasibility study of the Carmat Total Artificial Heart (TAH) for transplant-eligible patients in severe, end-stage heart failure. It is also the only site to offer the FDA-approved TAH in the region.
The TAH is a blood pump that eliminates the symptoms and source of end-stage heart failure by replacing both failing heart ventricles and the four heart valves. Baylor Scott & White transplanted its first TAH as a bridge to transplant in 2016.
The latest generation from Carmat, Aeson® TAH, is indicated as a bridge to transplant in patients suffering from end-stage biventricular heart failure who are not responsive to maximal medical therapy or LVAD and are likely to undergo a heart transplant in the 180 days following device implantation. The new version uses highly biocompatible materials, offers a unique self-regulation system and its pulsatile nature is expected to reduce or eliminate the risk of rejection.
In the US, the surgical procedure involving Aeson® TAH may only be performed by those specialists trained and approved by Carmat in the clinical trial setting.
Led by principal site investigator Dan M. Meyer, M.D. for Baylor Scott & White Research Institute (BSWRI), the prospective, multi-center, staged feasibility study is designed to assess the initial evidence of safety and performance of the Carmat TAH in the treatment of severe, end-stage heart failure. Per the study protocol approved by the FDA, ten transplant-eligible patients will be enrolled in the trial. The primary study endpoint is patient survival at 180 days post-implant or successful cardiac transplantation within 180 days post-implant.
As a cardiothoracic surgeon and chief of heart transplant and advanced circulatory support at Baylor University Medical Center, Dr. Dan Meyer has been operating on and transplanting hearts for nearly three decades.
CARMAT represents what could be the first major advance in over two decades for patients requiring biventricular support as a bridge to transplant. The outcomes to date in pre-FDA trials and in the commercial European experience have been shown to decrease stroke and infectious complications compared to the currently available left ventricular assist devices, as well as the available TAH device. We are proud to be among a select few programs in the US taking part in this trial, and to be able to bring this clinical trial option to patients throughout the Baylor Scott and White System.”– Dr. Dan Meyer
Carmat obtained approval from the Centers for Medicare and Medicaid Services to reimburse the device and associated services within the framework of this study in May 2020.
Patient recruitment for Carmat TAH in Texas: BSWRI is Baylor Scott & White Health’s dedicated research and development arm, conducting nearly 2,000 active research protocols. The institute is actively screening patients for Carmat TAH. To be considered for study inclusion, patients must be 18 years of age or older at the time of informed consent and eligible for cardiac transplantation. Additional inclusion criteria include:
- Anatomic compatibility confirmed using 3D imaging (CT-scan).
- Inotrope dependent (with documented attempt to wean) or cardiac Index (CI) < 2.2 L/min/m2 if inotropes are contra-indicated (heart failure due to restrictive or constrictive physiology).
- On Optimal Medical Management as judged by the investigator based on current Heart Failure practice guidelines (ESC/AHA).
- Eligible for biventricular Mechanical Circulatory Support according to ISHLT guidelines for mechanical circulatory support.
- Biventricular failure with at least two of the following hemodynamic/ echocardiographic measurements implying right heart failure: RVEF ≤30%; RVSWI ≤0.25mmHg*L/m2; TAPSE ≤14mm; RV-to-LV end-diastolic diameter ratio >0.72; CVP >15 mmHg; CVP-to-PCWP ratio >0.63; Tricuspid insufficiency grade 4; PAPi<2
- Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.
- Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis / senile or other infiltrative heart disease).