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. 2022 Apr 22;17(18):1523-1531.
doi: 10.4244/EIJ-D-21-00745.

Early outcomes of transcatheter mitral valve replacement with the Tendyne system in severe mitral annular calcification

Mario Gössl  1 , Vinod Thourani  2 , Vasilis Babaliaros  3 , Lenard Conradi  4 , Bassem Chehab  5 , Nicolas Dumonteil  6 , Vinay Badhwar  7 , David Rizik  8 , Benjamin Sun  1 , Richard Bae  1 , Robert Guyton  3 , Michael Chuang  9 , Philipp Blanke  10 , Paul Sorajja  1
Affiliations

Early outcomes of transcatheter mitral valve replacement with the Tendyne system in severe mitral annular calcification

Mario Gössl et al. EuroIntervention. .

Abstract

Background: Treatment of mitral regurgitation (MR) associated with severe mitral annular calcification (MAC) is challenging due to the high risk of fatal atrioventricular groove disruption and significant paravalvular leak.

Aims: The aim of this study was to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) with the Tendyne valve (Abbott Structural) in patients with MR and MAC.

Methods: Twenty patients (mean age 78 years; 11 women) who were treated with the Tendyne valve, either compassionate use (CU; closed) or as part of The Feasibility Study of Tendyne in MAC (NCT03539458), had reported outcomes in a median follow-up duration of 368 days.

Results: In all patients, a valve was implanted with no procedural mortality and successful hospital discharge. Two embolic events occurred, including one with mesenteric ischaemia and one non-disabling stroke. At 30 days and one year, all-cause mortality occurred in one (5%) and eight patients (40%), respectively. At one year, six patients had been hospitalised for heart failure (30%). There was no prosthetic dysfunction, and MR remained absent in all patients at one year. Clinical improvement, measured by New York Heart Association Functional Class, occurred in 11 of 12 patients who were alive at one year. Among seven survivors with Kansas City Cardiomyopathy Questionnaire (KCCQ) data, mean increase in KCCQ score was 29.9±26.3 at one year with improvement of ≥10 points in five (71.4%) patients.

Conclusions: In patients with MR and severe MAC, TMVR with the Tendyne valve was associated with encouraging acute outcomes, midterm durability, and clinical improvement. Dedicated TMVR therapy may have a future role in these anatomically challenging, high-risk patients.

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Conflict of interest statement

M. Gössl reports consulting for Abbott Vascular, and is Chair of the Subject Eligibility Committee for the SUMMIT trial. V. Thourani reports consulting and research for Abbott Vascular. V. Babaliaros reports consulting for Abbott (less than $5,000), and Edwards Lifesciences. L. Conradi reports being a member of the advisory board for Abbott Vascular, and being a consultant for Boston Scientific, Edwards Lifesciences, and Medtronic. B. Chehab reports being a member of the advisory board and a consultant for Abbott Structural, Edwards Lifesciences, and Medtronic. N. Dumonteil reports consulting and proctoring fees for Abbott Vascular, Ancora Heart, Boston Scientific, Edwards Lifesciences and Medtronic. V. Badhwar reports institutional research support from and being a consultant (non-remunerative) for Abbott. D. Rizik reports being on the Medical Advisory Board of Abbott Vascular, and being on the Executive Physician Council of Boston Scientific. B. Sun reports being a consultant and clinical proctor for Abbott Vascular and being a selection committee member for the Tendyne Device (Summit Clinical Trial). R. Bae reports consulting for Abbott Vascular - Speakers Bureau. R. Guyton reports being a consultant for Edwards Lifesciences (no consultation or compensation in last 12 months). M. Chuang is an employee of the Beth Israel Deaconess Medical Center Cardiovascular Imaging Core Laboratory which received funds from the study sponsor to perform image analyses. He also reports Echo Core Laboratory services for Abbott Vascular. P. Blanke reports being a consultant for Edwards Lifesciences and W.L. Gore, CT Core Laboratory services for Abbott Vascular, institutional core laboratory services for Abbott Laboratories, related to this manuscript, with no direct personal compensation, and institutional core laboratory services not related to this manuscript for Medtronic, Edwards Lifesciences, Boston Scientific, and Neovasc without direct personal compensation. P. Sorajja reports consulting or advisory board participation for Abbott Structural, Anteris, Boston Scientific, Medtronic, NeoVasc, TriFlo, VDyne, and W.L. Gore.

Figures

Figure 1
Figure 1. Adjudication of imaging and adverse events.
CT: computed tomography; eCRF: electronic case report form; MAC: mitral annular calcification; TEE: transoesophageal echocardiogram; TTE: transthoracic echocardiogram
Figure 2
Figure 2. Representative patterns of severe MAC in patients treated with the Tendyne.
ECG-gated, contrast-enhanced cardiac computed tomography images from patients treated in this study. Panels A, B, and C are from unique patients; panels C and D are from the same patient. Spicules invading the myocardium were evident in several patients (B and D, arrows). Ao: aorta; ECG: electrocardiogram; LA: left atrium, LV: left atrium; MAC: mitral annular calcification; MV: mitral valve
Figure 3
Figure 3. Post-implantation images of patients with severe MAC treated with the Tendyne.
ECG-gated, contrast-enhanced cardiac computed tomography images from two representative patients 30 days after implantation. (A and B) and (C and D) correspond to the same patient. The asterisk indicates severe mitral annular calcification. Arrows indicate the prosthesis. ECG: electrocardiogram; MAC: mitral annular calcification
Figure 4
Figure 4. New York Heart Association Functional Class at baseline, one-month and one-year follow-up.
The arrows indicate the absolute and proportion of patients moving between classes within follow-up time points. A wider arrow size suggests the majority of that subgroup moving to a different class. NYHA: New York Heart Association
Figure 5
Figure 5. Survival after TMVR with the Tendyne for severe MAC.
Follow-up time for the 20 patients with patients listed on the y-axis in descending order of treatment. The x-axis indicates duration of last follow-up. Dotted line indicates time mark at one-year follow-up. MAC: mitral annular calcification; TMVR: transcatheter mitral valve replacement
Central Illustration
Central Illustration. One-year outcomes of Tendyne in MAC.
Our study included 20 patients with severe MAC and high surgical risk undergoing Tendyne in MAC (two representative cross-sectional and longitudinal contrast-enhanced cardiac computed tomography images of a Tendyne prosthesis in MAC are depicted). All-cause death at one year occurred in eight (40%), cardiac death, however, occurred in only four of the 20 patients (20%). MAC: mitral annular calcification; TMVR: transcatheter mitral valve replacement
See this image and copyright information in PMC

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