scholarly journals Current Devices in TMVI and Their Limitations: Focus on Tendyne

2020 ◽  
Vol 7 ◽  
Author(s):  
Gry Dahle

Mitral valve regurgitation (MR) has a high incidence in the western world, and mortality is high for untreated severe MR. Catheter based repair was introduced with MitraClip in 2003, and some additional devices later came into the market. To expand the transcatheter treatment options for mitral valve disease, the first transcatheter mitral valve implantation (TMVI) was performed by Søndergaard et al. 2012, only 10 years after the first transcatheter aortic valve implantation (TAVI), however, the development has been much slower for the TMVI than for TAVI. From 2012, studies were started for several devices to prove feasibility and safety. However, there were big challenges in valve design; delivery systems and anchoring in addition to anatomical issues (avoid LVOT obstruction and paravalvular leak, big size of annulus). The main valves in studies were CardiaQ (later bought by Edwards Lifesciences, Irvine, United States), Tiara (Neovasc Inc., Richmond, Canada), Twelve (later Intrepid, Medtronic, MN, United States) and Tendyne™ (Abbott, MN, United States). I will focus on the Tendyne™ valve that is the only CE approved transcatheter mitral valve implant. It is available in a large number of sizes and is repositionable and retrievable. The results for the 100 first patients included in the early feasibility study (EFS) at 1 and 2 years are promising. Initially feasible for MR, but further investigations show promising results also for implant in mitral annular calcification.

Author(s):  
Mustafa Zakkar ◽  
Aiman Alassar ◽  
Manuel Lopez-Perez ◽  
David Roy ◽  
Stephen Brecker ◽  
...  

Objective The impact of transcatheter aortic valve implantation (TAVI) on left ventricular (LV) mass regression is not well defined. We aimed to measure LV mass regression, changes in LV volumes and dimensions, as well as mitral valve function after TAVI. Methods Eighty patients who underwent TAVI between 2008 and 2010 were studied. Echocardiographic findings before procedure and at 6- and 12-month follow-up were analyzed. Results Aortic valve area increased from 0.71 (0.27) cm2 before procedure to 1.89 (0.64) cm2 at 12 months ( P < 0.001), which was associated with reduction in peak [80.79 (23) vs 16.9 (6.5) mm Hg, P < 0.001] and mean [47.65 (14.2) vs 8.77 (3.29) mm Hg, P < 0.001] gradients. At 1 year, there was a change in LV end-systolic volume [46.12 (36.6) to 48.96 (4.05) mL, P = 0.042] and LV mass [202.4 (92.2) to 183.6 (98.2) g, P = 0.04]. Left ventricular mass index regressed from 130.7 (28.9) to 122.1 (28.9) g/m2 ( P = 0.01). Maximum wall thickness decreased from 1.28 (0.18) to 1.25 (0.17) cm ( P < 0.001). There was no significant change in LV ejection fraction, LV end-systolic and end-diastolic diameters, as well as mitral valve regurgitation. Conclusions Transcatheter aortic valve implantation is associated with significant regression of LV hypertrophy at 1 year. However, this regression was not associated with changes in LV systolic and diastolic functions, size, or changes in mitral valve regurgitation.


2020 ◽  
Vol 23 (6) ◽  
pp. E793-E796
Author(s):  
Varghese Panicker ◽  
Renjith Sreekantan ◽  
Sai Suraj Kotera

Background: Mitral valve surgery can be challenging for patients with mitral annular calcification (MAC). The prevalence of MAC in patients who undergo mitral valve replacement is 19.9%. The  treatment options for MAC include complete decalcification and annular reconstruction with valve repair/replacement or performing a surgical valve repair or replacement without decalcification, accepting the risk of paravalvular leak. We describe three cases of mitral valve prolapse with posterior annular calcification, which were repaired using a unique technique that does not require decalcification. Case reports: The mitral annular calcification was heavy and involved most of the posterior annulus just sparing the commissures in all the three cases. Leaflet prolapse was dealt with by using neochordae, closing any clefts, and leaflet plication. Since the MAC ring was not complete and there was chance of further dilatation of the annulus, a partial annuloplasty was done using a PTFE felt (cut as strip). There was trivial to no mitral regurgitation with this technique in the immediate postoperative and five-year follow-up period echocardiography in all the three cases. Conclusion: This technique can benefit the major subset of pure mitral valve regurgitant lesions associated with MAC, which is limited to the posterior annulus.


Author(s):  
Helge Möllmann ◽  
David M. Holzhey ◽  
Michael Hilker ◽  
Stefan Toggweiler ◽  
Ulrich Schäfer ◽  
...  

Abstract Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract


2019 ◽  
Vol 71 (1) ◽  
Author(s):  
Khaled D. Algarni ◽  
Amr A. Arafat

Abstract Background Reoperations are required frequently after the Ross procedure in rheumatic patients. The use of transcatheter aortic valve implantation (TAVI) in those patients could decrease the risk of future open procedure; however, the outcome may be affected by the concomitant mitral valve disease, and subsequent mitral reoperation may distort the implanted aortic valve. Case presentation We present a female patient who had a beating mitral valve replacement after valve-in-valve TAVI in a patient with prior Ross procedure. Weaning from cardiopulmonary bypass was difficult, and the patient needed extra-cardiac membrane oxygenation (ECMO) and intra-aortic balloon pump because of right ventricular dysfunction. The right ventricular dysfunction could be due to the concomitant coronary artery disease or air embolism during the beating mitral valve surgery. Recovery was gradual, and the patient was discharged after 33 days. Pre-discharge echocardiography showed a maximum gradient of 9 mmHg on the aortic valve and mild paravalvular leak. Conclusions Mitral valve replacement in a patient with prior TAVI and the Ross procedure was feasible; it decreased the operative risk and did not distort the implanted aortic valve.


Sign in / Sign up

Export Citation Format

Share Document