Transcatheter trans-septal mitral valve-in-valve implantation (original) (raw)
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Kardiologia Polska, 2023
Background: Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI) is an emerging treatment alternative to reoperation in high-surgical risk patients with failed mitral bioprostheses. Aim: We aimed to describe the characteristics of ViV-TMVI and evaluate its 30-day outcomes in the Polish population. Methods: A nationwide registry was initiated to collect data on all patients with failed mitral bioprosthesis undergoing ViV-TMVI in Poland. This study presents the results of a 30-day clinical and echocardiographic follow-up. Results: Overall, 27 ViV-TMVI procedures were performed in 8 centers up to May 2022 (85% from 2020 onwards). The mean (standard deviation [SD]) age was 73 (11.6) years with the median (interquartile range [IQR]) Society of Thoracic Surgeons score of 5.3% (4.3%-14.3%). Mean (SD) time between surgical implantation and ViV-TMVI was 8.2 (3.2) years. Failed Hancock II (29%) and Perimount Magna (22%) bioprostheses were most frequently treated. Mechanisms of failure were equally often pure mitral regurgitation or stenosis (both 37%) with mixed etiology in 26%. Balloon-expandable Sapien 3/Ultra valves were used in all but 1 patient. Technical success was 96.3% (1 patient required additional prosthesis). Mean (SD) transvalvular mitral gradient reached 6.7 (2.2) mm Hg and mitral valve area was 1.8 (0.4) cm 2. None of the patients had moderate or severe mitral regurgitation with only 14.8% graded as mild. We achieved device success in 92.6% of patients (2 patients had mean gradient ≥10 mm Hg) and procedural success in 85.6%. There were no deaths, cerebrovascular events, or need for mitral valve surgery during the 30-day follow-up. Conclusions: In short-term follow-up, ViV-TMVI is a safe and effective alternative for patients with failed mitral bioprosthesis at high surgical risk of re-operation. Longer observations on larger samples are warranted.
General Thoracic and Cardiovascular Surgery, 2019
Objective The mitral valve-in-valve procedure has been performed in the world. However, the early clinical outcomes in Japan remain unclear. Hence, we investigated the feasibility, safety, and efficacy in high-risk Japanese patients. Methods In May 2017, we launched the present clinical study of the mitral valve-in-valve procedure (MITRAL VIV study). The study enrolled four patients (three women; age range 69-85 years) with severe mitral regurgitation due to a degenerated mitral bioprosthesis. The median Society of Thoracic Surgeons score was 8.8 (range 8.4-9.8)%. Results In all patients, the mitral valve-in-valve procedure was successfully performed via a transapical approach at the initial attempt. The median grade of mitral insufficiency improved from grade 4 (range 3-4) to grade 1 (range 0-1) at days 7 and 30. The mean mitral pressure gradient of the median value changed from 7.0 (range 5.0-8.0) mmHg to 5.0 (range 5.0-9.5) mmHg at 7 days and 6.2 (range 4.0-11.0) mmHg at 30 days. The median New York Heart Association functional class improved from 2 (range 2-3) to 1 (range 1-3) at day 7 and to 1 (range 1-2) at day 30. We performed a bit deep implantation intentionally to avoid left ventricular outflow tract obstruction in one patient with a small aorto-mitral-annular angle. Neither mortality nor severe complications were observed at the last follow-up (range 207-513 days). Conclusions In our experience, the safe mitral valve-in-valve procedure was feasible with cautious procedures.
Annals of Cardiothoracic Surgery
Background: Transcatheter mitral valve-in-valve (TMVIV) procedure, either transapical (TA) or trans-septal (TS) has become a valuable alternative to conventional redo surgery in case of failing mitral bioprosthesis with good clinical outcomes. Here we present our fourteen-year institutional experience. Methods: All consecutive patients treated with TMVIV with either TA or TS access at our centre between July 2007 and July 2020 were included. Periprocedural and 30-day follow-up (FU) results are reported and TA and TS data are compared. Results: Eighty-two patients were included, of those 60 (73.2%) were TA while 22 (26.8%) were TS. Men represented 51.2% of the population with a mean age of 77.3±9.0 years. STS score and EuroSCORE II were 11.4%±6.2% and 11.5%±6.5% respectively. Baseline characteristics of TA and TS groups were comparable. TMVIV was performed at a median time of 9.3 years [interquartile range (IQR), 7.9-12.0 days] from the initial mitral valve surgery. Balloon expandable transcatheter heart valve (THV) prostheses (Edwards LifeSciences Corp., Irvine, CA, USA) were used exclusively. Technical success was 97.6% (96.7% and 100.0% for TA and TS respectively) with two (2.4%) periprocedural death, both in the TA group (P=0.533). We observed four (4.9%) left ventricular outflow tract (LVOT) obstructions with one being hemodynamically significant. Six (7.3%) major bleeding occurred in the TA group, not significantly different from TS group (P=0.279). The median length of stay was 6 days (IQR, 4-12 days, 1.5 vs. 7.0 days for TS and TA groups respectively, P=0.001). The overall 30-day mortality rate was 3.7%. We also observed three (3.7%) structural valve deteriorations and in one (1.2%) case the patient required redo mitral surgery at two months. Eighty-seven-point-eight percent of patients were I-II New York Heart Association (NYHA) class. At 30day FU mean transmitral valve gradient was 7.3±2.7 mmHg and one patient (1.2%) had mitral regurgitation greater than mild. TA and TS groups were comparable. Conclusions: Our 14-year single-center experience with TMVIV confirms procedural safety and is an effective alternative to redo surgery with comparable results with both TA and TS. With device, technical improvements and increasing operators' experience, TS is the preferred option for TMVIV. However, in some highly selected patient, TA may still play an important role.
2020
This study is a report of clinical and echocardiographic outcomes of experience with transapical mitral valve-in-valve (VIV) replacement. Methods: Eleven patients with a mean age of 63.7±13.0 years who underwent transapical mitral VIV implantation for a failed bioprosthesis at a single institution were enrolled. All of the patients were considered high-risk for surgical intervention, with a Society of Thoracic Surgery predicted risk of mortality of 14.2±17.6%, and a mean European System for Cardiac Operative Risk Evaluation (EuroSCORE II) of 10.5±6.1%. Results: Transapical mitral VIV implantation was successful in all of the patients. Edwards, Sapien XT and Sapien 3 valves (Edwards Lifesciences Corp., Irvine, CA, USA) were used in 8 (73%), 2 (18%), and 1 (9%) patients, respectively. Size 26 valves were used in 6 (55%) patients while size 29 valves were used in 5 (45%) patients. All of the patients (11, 100%) had no or only trace mitral regurgitation at the end of the procedure. The mean length of hospital stay was 19±8.0 days. The survival was 100% at 14 days, and 90% at 30 days and at 4 years. One patient died as a result of multiorgan failure on day 16 of intensive care unit stay. The mean mitral valve gradient across the percutaneous valve was 2.26±1.047 mmHg, and the mean valve area was 2.20±0.14 cm 2. Through the 4 years follow up, the New York Heart Association class of the 10 patients remaining improved to class II with no readmission for heart failure. All of the patients were on coumadin with a target international normalized ratio of 2-3. Conclusion: In high-risk patients, transapical mitral VIV implantation can be performed with a high success rate and considerable improvement in clinical status.
A step-by-step guide to trans septal valve-in-valve transcatheter mitral valve replacement
ASVIDE
With the recent success of transcatheter aortic valve replacement (TAVR), transcatheter options for the management of mitral valve pathology have also gained considerable attention. Valve-in-valve (ViV) transcatheter mitral valve replacement (TMVR) is one such technique that has emerged as a safe and effective therapeutic option for patients with degenerated mitral valve bioprostheses at high-risk for repeat surgical mitral valve replacement. Several access strategies, including trans-apical, transseptal, trans-jugular, and trans-atrial access have been described for ViV-TMVR. Initial experiences were performed primarily via a trans-apical approach through a left mini-thoracotomy because it offers direct access and coaxial device alignment. With the advancements in TMVR technology, such as the development of smaller delivery catheters with high flexure capabilities, the transseptal approach via the femoral vein has emerged as the preferred option. This technique offers the advantages of a totally percutaneous approach, avoids the need to enter the thoracic cavity or pericardial space, and provides superior outcomes compared to a trans-apical approach. In this review, we outline key aspects of patient selection, imaging, procedural techniques, and examine contemporary clinical outcomes of transseptal ViV-TMVR.
The assessment of the neo-left ventricular outflow tract (neo-LVOT) area is an essential metric for pre-procedural imaging when screening patients for transcatheter mitral valve replacement (TMVR) eligibility. Indeed, the implantation of transcatheter heart valves for treating failed annuloplasty band ring (ViR), bioprosthesis (ViV) and mitral valve calcification (ViMAC) can lead to a permanent obstruction of the implanted device (namely, LVOT obstruction). In this study, in silico computational modeling and 3D printing were used to quantify the neo-LVOT area and the resulting hemodynamic outcomes of TMVR. We first simulated the deployment of the SAPIEN 3 Ultra device (Edwards Lifesciences, Irvine, CA) and then evaluated the pressure drop near the LVOT obstruction using computational fluid dynamics. The neo-LVOT area was largest in patients with ViR (453.4 ± 58.1 mm 2) compared to patients with ViV (246.6 ± 109.5 mm 2) and ViMAC (155.6 ± 46.1 mm 2). The pressure drop near the LVOT obstruction differed among patients with TMVRs and significantly correlated with the magnitude of the neo-LVOT area (R = − 0.761 and P-value = 0.047). The present study highlights the potential of in silico and 3D printed models for planning TMVR procedures and for carrying out a risk evaluation of the device protrusion into the left heart when treating failed mitral valves.