Clinical and haemodynamic outcomes of balloon-expandable transcatheter mitral valve implantation: a 7-year experience (original) (raw)
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JACC. Cardiovascular interventions, 2017
Transcatheter mitral valve replacement (TMVR) using balloon-expandable valves has become an alternative therapy for selected patients with mitral valve disease. Up to now, the transapical approach has been the preferred route, but the transseptal approach is becoming increasingly popular due to its reduced invasiveness and increased safety. However, transseptal TMVR procedures are technically challenging, and little is known about the screening process required before this therapy. The authors provide operators with a step-by-step approach from the screening process to follow-up care for transseptal TMVR procedures.
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.
2022
The Valve-in-Valve (ViV) technique is an emerging alternative for the treatment of bioprosthetic structural valve deterioration (SVD) in the mitral position. We report on intermediate-term outcomes of patients with symptomatic SVD in the mitral position who were treated by transcatheter mitral valve-in-valve (TM-ViV) implantation during the years 2010–2019 in our center. Three main outcomes were examined during the follow-up period: NYHA functional class, TM-ViV hemodynamic data per echocardiography, and mortality. Our cohort consisted of 49 patients (mean age 77.4 ± 10.5 years, 65.3% female). The indications for TM-ViV were mainly for regurgitant pathology (77.6%). All 49 patients were treated with a balloon-expandable device. The procedure was performed via transapical access in 17 cases (34.7%) and transfemoral vein/trans-atrial septal puncture in 32 cases (65.3%). Mean follow-up was 4.4 ± 2.0 years. 98% and 91% of patients were in NYHA I/II at 1 and 5 years, respectively. Mitral...
Transcatheter mitral valve implantation via transapical approach: an early experience†
European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2015
As many as 50% of patients with severe symptomatic mitral valve regurgitation are denied surgical valve replacement or repair due to high operative risk. We describe an early series of cases of transcatheter implantation with a CardiAQ™ mitral valve via a transapical approach. Three consecutive patients with an Society of Thoracic Surgeons (STS) mortality score of >22% were selected for transcatheter mitral valve implantation (TMVI) on compassionate grounds. All patients were elderly, had severe mitral regurgitation (MR), were in Class IV heart failure and deemed unsuitable for the MitraClip. Two of the patients had functional MR in the setting of ischaemic cardiomyopathy with left ventricular ejection fraction (LVEF) <40%, deemed while the remaining patient had chordal rupture with extensive anterior leaflet flail (preserved LVEF). Comorbidities included previous coronary artery bypass surgery (n = 2), severe pulmonary hypertension (n = 1) and moderate to severe chronic renal...
Journal of the American College of Cardiology, 2017
Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower techn...
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.
European heart journal, 2018
We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC a...
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.