2-Year Follow-Up After Transseptal Transcatheter Mitral Valve Replacement With the Cardiovalve

Abstract Aims Transcatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices. Methods and results A total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%. Conclusions TMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement. Graphic abstract

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Erratum to: Percutaneous transfemoral transcatheter mitral valve replacement of a degenerated mitral bioprosthesis: initial experience in Southeast Asia with nine-month follow-up

Singapore Medical Journal ◽

10.11622/smedj.2020136 ◽

2020 ◽

Vol 61 (9) ◽

pp. 500-500

Keyword(s):

Mitral Valve ◽

Southeast Asia ◽

Valve Replacement ◽

Mitral Valve Replacement ◽

Initial Experience ◽

Transcatheter Mitral Valve Replacement ◽

Mitral Bioprosthesis

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Transseptal transcatheter mitral valve replacement

Russian Journal of Cardiology ◽

10.15829/1560-4071-2020-3842 ◽

2020 ◽

Vol 25 (8) ◽

pp. 3842

Author(s):

V. I. Ganyukov ◽

R. S. Tarasov ◽

I. V. Ganyukov

Keyword(s):

Case Report ◽

Mitral Valve ◽

Valve Replacement ◽

Mitral Valve Replacement ◽

Mitral Valve Disease ◽

Current Data ◽

Valve Disease ◽

Less Invasive ◽

Transcatheter Mitral Valve Replacement

The review presents current data transseptal transcatheter mitral valve replacement, which is becoming an alternative method of managing mitral valve disease. Despite the fact that the transapical transcatheter approach is technically simpler, the transseptal method is less invasive. It has confirmed effectiveness and is predicted to be the most promising. The review describes the relevance, indications, methodology for selecting the required endoprosthesis, stages of procedure, complications, and the postoperative follow-up of patients. The results of publications on transseptal transcatheter mitral valve replacement are analyzed. A case report is given.

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Percutaneous transfemoral transcatheter mitral valve replacement of a degenerated mitral bioprosthesis: initial experience in Southeast Asia with nine-month follow-up

Singapore Medical Journal ◽

10.11622/smedj.2020019 ◽

2020 ◽

Vol 61 (8) ◽

pp. 445-446

Author(s):

PT Chiam ◽

YT Lim ◽

CP Lim ◽

C Sivathasan

Keyword(s):

Mitral Valve ◽

Southeast Asia ◽

Valve Replacement ◽

Mitral Valve Replacement ◽

Initial Experience ◽

Transcatheter Mitral Valve Replacement ◽

Mitral Bioprosthesis

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Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Mid-Term Evaluation of Valve-in-Valve and Valve-in-Ring Implantation from the VIVID Registry

Circulation ◽

10.1161/circulationaha.120.049088 ◽

2020 ◽

Author(s):

Matheus Simonato ◽

Brian Whisenant ◽

Henrique Barbosa Ribeiro ◽

John G. Webb ◽

Ran Kornowski ◽

...

Keyword(s):

Mitral Valve ◽

Valve Replacement ◽

Mitral Valve Replacement ◽

Large Scale ◽

Academic Research ◽

Internal Diameter ◽

Clinical Endpoints ◽

Transcatheter Mitral Valve Replacement ◽

Valve In Valve

Background: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining mid-term outcomes after mitral ViV and ViR. Methods: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mmHg and significant residual mitral regurgitation (MR) as ≥ moderate. Results: A total of 1,079 patients (857 ViV, 222 ViR; mean age 73.5 years ± 12.5; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days [IQR 76 - 996 days]; median echocardiographic follow-up for patients that survived 1 year 772.5 days [IQR 510 - 1211.75 days]. Four-year Kaplan-Meier survival rate was 62.5% in ViV vs. 49.5% for ViR (p<0.001). Mean gradient across the mitral valve post-procedure was 5.7 ± 2.8 mmHg (≥5mmHg, 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (p=0.09). Significant residual MR was more common in ViR patients (16.6% vs. 3.1%; p<0.001) and was associated with lower survival at 4 years (35.1% vs. 61.6%; p=0.02). The rates of MVARC-defined device success were low for both procedures (39.4% total; 32.0% ViR vs. 41.3% ViV; p=0.01), mostly related to having post-procedural mean gradient ≥5mmHg. Correlates for residual MS were smaller true internal diameter, younger age and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (SHR 4.67; 95% CI 1.74 - 12.56; p=0.002) and significant residual MR (SHR 7.88; 95% CI 2.88 - 21.53; p<0.001) were both independently associated with repeat mitral valve replacement. Conclusions: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve post-procedural hemodynamics in mitral ViV and ViR should be further explored.

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TCT-463 Transcatheter Mitral Valve Replacement in a Series of 10 Compassionate-Use Cases With Mid-Term Follow-Up

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2019.08.554 ◽

2019 ◽

Vol 74 (13) ◽

pp. B458

Author(s):

Sebastian Ludwig ◽

Florian Deuschl ◽

Daniel Kalbacher ◽

Niklas Schofer ◽

Oliver Bhadra ◽

...

Keyword(s):

Mitral Valve ◽

Valve Replacement ◽

Mitral Valve Replacement ◽

Use Cases ◽

Compassionate Use ◽

Transcatheter Mitral Valve Replacement

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Transcatheter mitral valve replacement: tissue in-growth after 4 weeks

Interactive CardioVascular and Thoracic Surgery ◽

10.1093/icvts/ivaa225 ◽

2020 ◽

Vol 32 (1) ◽

pp. 1-8

Author(s):

Georg Lutter ◽

Lennart Bax ◽

Yazhou Liu ◽

Jan-Hinnerk Hansen ◽

Derk Frank ◽

...

Keyword(s):

Mitral Valve ◽

Valve Replacement ◽

Histological Examination ◽

Mitral Valve Replacement ◽

Mitral Annulus ◽

Tissue Reaction ◽

Off Pump ◽

Mitral Position ◽

Transcatheter Mitral Valve Replacement

Abstract OBJECTIVES Tissue reaction to transcatheter mitral valve replacement in the mitral annulus remains to be elucidated. METHODS Trileaflet porcine pericardial valves were sewn onto self-expanding d-shaped nitinol stents, which were delivered transapically and in an off-pump fashion into the mitral position of 10 pigs. After at least 4 weeks of follow-up, gross pathological assessment and histological examination were performed. The specimens were stained with Movat’s pentachrome, Elastica-van-Gieson and von Kossa staining. The leucocytes, B cells, T cells or macrophages were detected by specific immunohistochemical staining. RESULTS Proper stent positioning in the mitral annulus was achieved in 9/10 animals. Nine of 10 animals survived the desired observation period. In all but one, the mitral valve stent was well integrated into the left atrium and perpendicularly embedded into the annulus by 85 ± 24%. One animal had minor fractures in the nitinol struts and another animal showed tearing of 1 of 4 tethers. Histological examination demonstrated no major tissue reaction with the nitninol struts but well-preserved overall structures around the mitral annulus in 8/9 cases. CONCLUSIONS This is the first report demonstrating good in-growth of transcatheter-delivered anatomically shaped mitral valve stents after at least 4 weeks of follow-up. Histological examination demonstrated progressive healing and neointimalization.

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