Longest available real-world follow-up data for Tendyne valve support use of device in select patients

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Alicja Zientara

The longest available real-world follow-up data of transcatheter mitral valve implantation (TMVI) using the first-generation Tendyne (Abbott) has shown symptomatic improvements in patients, with low periprocedural complication rates. These were the findings presented at the European Society of Cardio-Thoracic Surgery annual meeting (EACTS 2021; 13–16 October; Barcelona, Spain and virtual) by Alicja Zientara (Royal Brompton Hospital, London, UK) who detailed single-centre experience and a review of echocardiographic parameters following implantation of the Tendyne device. 

The first-in-man implantation of the Tendyne valve was performed in 2014 at the Royal Brompton Hospital followed by successful treatment with the device in a further 30 patients. The Tendyne programme at the Royal Brompton is coordinated by cardiologist Alison Duncan and cardiac surgeon Cesare Quarto, who are both leading and performing all Tendyne implantations in the hybrid theatre.

Tendyne TMVI is the first and only commercially available transcatheter mitral valve device, having received the CE mark in January 2020 for the management of patients with mitral regurgitation (MR) who are not suitable for mitral valve surgery or percutaneous edge-to-edge repair.

Zientara presented clinical experience involving the use of Tendyne in the first 26 consecutive patients at the Royal Brompton Hospital, with endpoints including 30-day mortality, mid-term survival, and New York Heart Association (NYHA) Functional Classification at six months.

Patients were treated with Tendyne between 2014‒2020, five on compassionate use, 19 as part of the early feasibility study (EFS) of the device, and two patients who received the device post-CE mark. Anatomical patient selection necessitated three-dimensional transesophageal echocardiography (TOE) and full-phase multislice computer tomography (MSCT), Zientara detailed, with inclusion criteria consisting of an ejection fraction (EF) >30%, reversable pulmonary hypertension, and cardiac index over 2l/min/m2, according to the EFS entry criteria.

Of the 26 patients undergoing Tendyne, 34.6% were female with an average age of 74 years. A total of 17 (65.4%) patients had received previous cardiac operations (15 coronary artery bypass graft (CABG—of which two had two previous CABG intervention), one pulmonary embolectomy, one mitral valve repair), and one had previous transcatheter aortic valve implantation (TAVI). A total of 18 patients (69.2%) had a previous heart attack, with nine patients (34.6%) experiencing previous percutaneous coronary intervention (PCI).  Left ventricular ejection fraction (LVEF) was ≥50% in 10 patients, 35-49% in 13, and ≤34% in 3 patients. Eighteen patients (69.2%) were in NYHA Class III, and 5 patients (19.3%) were in NYHA Class IV.

Outlining the postoperative outcomes of the Tendyne procedures, Zientara reported the intraoperative success for full transvalvular MR elimination was 100%, with only one patient experiencing a mild paravalvular leak immediately following the operation which spontaneously resolved. Two patients required short-term peri-procedural support with intra-aortic balloon pump, and one patient developed peri-procedural left ventricular outflow tract (LVOT) obstruction, which was successfully treated, and four pacemaker implantations. No patient experienced myocardial infarction, and one patient suffered a stroke on day 59 post-procedure. At six-month follow-up, echocardiography demonstrated complete resolution of mitral regurgitation without leaks in 22 patients and significant reduction in systolic pulmonary arterial pressure (sPAP) (from 50mmHg to 37mmHg). LV cavity size did not change, but NYHA status improved significantly after six months.

The findings demonstrated a low periprocedural complication rate with convincing mid-term results of no residual MR and decreased sPAP, Zientara relayed. Symptomatic improvement in patients was apparent at six-month follow-up. The results led to the conclusion that the Tendyne implantation is a safe and reproducible procedure without the need of cardiopulmonary bypass or rapid pacing Tendyne is a good alternative for high-risk patients unsuitable for surgery or TEER, Zientara’s presentation concluded.


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