scholarly journals Transcatheter mitral valve-in-valve implantation: a 10-year single center experience

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Akodad ◽  
G Sathananthan ◽  
A G Chatfield ◽  
C Trpkov ◽  
Y Lounes ◽  
...  

Abstract Background Transcatheter mitral valve-in-valve (TMVIV) appears a reasonable alternative to surgical redo mitral valve replacement in patients with degenerated mitral prosthesis and high surgical risk with favorable early and mid-terms outcomes. Long-term outcomes are limited by high mortality in a comorbid population. Purpose We aimed to evaluate early prosthesis hemodynamic performance and late clinical outcomes following TMVIV. Methods All patients who underwent TMVIV for degenerated surgical mitral bioprostheses from 2011 to 2020 in our center were included. Prospectively collected demographic, clinical, procedural, and imaging variables were analyzed. Clinical and echocardiographic outcomes were defined according to Mitral Valve Academic Research Consortium (MVARC) definitions and assessed at 30-day and at the latest follow-up available. Results A total of 67 patients were included; mean age 76.9±9.6 years, mean STS score 11.0±6.2%, 53.7% male (n=36). Mechanisms of bioprosthetic failure were mitral stenosis (n=32, 47.8%), mitral regurgitation (n=24, 35.8%), and mixed (n=11, 16.4%). Mean time from mitral valve surgery to TMVIV was 10.2±4.3 years. Access was mostly transapical (n=45; 67.2%), followed by transseptal (n=22; 32.8%). Following the first transseptal procedure in 2016; transseptal access accounted for the majority of procedures (22 of 37 cases, 59.4%). Technical success was achieved in 65 patients (97.0%). Mean hospitalization was 9.2±10.0 days; shorter with the transseptal as opposed to the transapical approach (6.3±8.1 days versus 11.0±10.5 days, p=0.001). At 30-day echographic follow-up, mean mitral valve gradient was 7.3±2.7 and 1 patient (1.9%) had mitral regurgitation >mild. At 30-day follow-up, 3 patients had died (4.5%); due to left ventricular outflow tract obstruction (1), heart failure (1), and stroke (1). New pacemakers were required in 2 patients (3.0%) and pacemaker lead dislodgement occurred in 1 patient (1.5%), 4 patients (6.2%) were hospitalized for heart failure. At a median follow-up of 3.8 years [1.7–5.1], 29 patients had died (43.3%), valve thrombosis was found in 6 (8.9%) and endocarditis in 4 patients (6.2%). Mitral valve reintervention was performed in 4 patients (6.2%); redo TMVIV due to valve migration in 1 (1.9%), surgical valve replacement in 1 (1.9%), and delayed redilation with a non-compliant balloon due to underexpansion in 2 patients (3.8%). Conclusion TMVIV is associated with acceptable 30-day mitral valve hemodynamics. Long-term mortality remains high in this high-surgical risk comorbid group. FUNDunding Acknowledgement Type of funding sources: None.

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
AM Caggegi ◽  
P Capranzano ◽  
S Scandura ◽  
S Mangiafico ◽  
G Castania ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background – Although percutaneous mitral valve repair is an attractive alternative treatment option for patients with severe mitral regurgitation (MR) at high surgical risk, residual MR is commonly observed after the procedure and little is known about its impact on outcomes after MitraClip therapy, expecially in patients with severe left ventricular (LV) impairment. Purpose – The aim of this prospective, observational study was to evaluate the impact of residual MR (MR ≤1+ vs. MR >1+) on long-term outcomes of mitral valve repair with the MitraClip System in high surgical risk patients presenting with moderate-to-severe or severe MR and with severe reduction of LV ejection fraction (EF). Methods – Patients enrolled in the prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) with functional MR and EF ≤30% who were eligible at almost five-year follow-up were included in the present analysis.  The primary endpoint was death at 5-year follow-up.  Also echocardiographic parameters at baseline and 5-year follow-up and rehospitalization rates were assessed. Results – A total of 139 patients were included: 92 (66.2%) with post-procedural residual MR ≤1+ and 47 (33.8%) with residual MR > 1+ (41 patients with residual MR 2+, 5 with residual MR 3+, 1 with residual MR 4+).  Comparable clinical and echocardiographic baseline characteristics were observed between the two groups except for NYHA functional class IV and implanted pace-maker (more frequent in patients with residual MR >1+) and previous myocardial infarction (more frequent  in patients with residual MR ≤1+). At 5-year follow-up, no significant differences were reported in the primary endpoint (49.6% in patients with residual MR ≤ 1+ vs. 65.3% in patients with residual MR > 1+, p 0.203) and in cardiac death (37.8% in patients with residual MR ≤ 1+ vs. 42.6% in patients with residual MR > 1+, p 0.921). Cox regression analysis identified residual MR > 1+ as an independent predictor of re-hospitalization (HR 0.51, 95% CI 0.28-0.92, p =0.026). At 5-year follow-up,  a significant reduction in left ventricular end-systolic volume was  observed in patients with residual MR ≤ 1+. Conclusions – At 5-year follow no significant differences in survival emerged in patients with severe  LV dysfunction undergoing MitraClip therapy regardless residual MR. Nevertheless residual MR > 1+ emerged as an indipendent predictor of re-hospitalization.


Heart ◽  
2018 ◽  
Vol 105 (21) ◽  
pp. 1622-1628 ◽  
Author(s):  
Saibal Kar ◽  
Ted Feldman ◽  
Atif Qasim ◽  
Alfredo Trento ◽  
Samir Kapadia ◽  
...  

ObjectivesThis study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS).MethodsPatients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up.ResultsAt 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (−38.2 mL; 95% CI −55.0 to –21.4; p<0.0001) and LV end-systolic volume (−14.6 mL; 95% CI −27.7 to −1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years.ConclusionsThe EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up.Trial registration numberNCT01940120.


Author(s):  
Nicola Maschietto ◽  
Ashwin Prakash ◽  
Pedro del Nido ◽  
Diego Porras

Background: Despite the improvement of surgical techniques for mitral valve (MV) repair in children, mitral valve replacement (MVR) is sometimes still necessary. MVR and redo-MVR continue to be burdened by early postoperative mortality and long-term morbidity with only about 75% of these patients being alive or transplant-free 10 years after the initial MVR. Although transcatheter MVR (TMVR) is a well-established intervention in high surgical risk adults, only a few pediatric valve-in-valve case reports have been published. The purpose of this study was to describe our initial experience with the off-label use of the Sapien S3 valve for TMVR in a highly selected pediatric patient population. Methods: We conducted a retrospective analysis of pediatric patients who underwent TMVR at Boston Children’s Hospital between October 2018 and July 2020. Results: Eight consecutive high surgical risk pediatric patients (median age, 9 years; range, 8–15) underwent TMVR (7 as valve-in-valve, 1 in a native MV). Each patient previously underwent multiple MV surgeries or MVR (median 4, range 2–5) and was highly symptomatic (Ross functional class 3 or 4). The indication for TMVR was mitral stenosis in 4 patients, regurgitation in 1, and mixed disease in 3. TMVR was successful in each patient, effectively reduced the left atrium and pulmonary hypertension ( P =0.012 and 0.043 respectively), and was carried out without significant complications. Conclusions: TMVR is an attractive alternative to MVR in high surgical risk patients. In this small series, TMVR was acutely effective and safe, with very encouraging early results.


2016 ◽  
Vol 19 (4) ◽  
pp. 160
Author(s):  
Montaser Elsawy Abd elaziz ◽  
Islam Moheb Ibrahim

<strong>Background:</strong> Mitral valve regurgitation leads to deterioration of left ventricular functions if not treated early. We aimed to study the effect of mitral valve replacement on normalization of ejection fraction, remodeling of left ventricular dimensions, and left atrial reduction in patients with chronic mitral regurgitation.<br /><strong>Methods:</strong> Between December 2012 and August 2014, <br />45 patients with chronic mitral regurgitation underwent isolated mitral valve replacement. None of the patients had any other severe valvular or concomitant disease or severe coronary heart  disease. The patients were evaluated by echocardiography (preoperative, 1-week, and 1-year postoperative). The results were statistically analyzed by paired t test.<br /><strong>Results:</strong> Forty-five patients who underwent mitral valve replacement in our hospital were included in  the study. The group comprised 20 men and 25 women; the mean age was 31.8 ± 6.76 years. The mean  left ventricular ejection fraction was 61.09 ± 7.6 and decreased significantly to 59.04 ± 6.65 and 59.67 ± 6.56, 1-week and 1-year postoperative follow up, respectively. The left atrium showed significant reduction in size (4 ± 0.54 cm) at 1-year postoperative follow up, from (4.51 ± 0.57 cm) one-week postoperative, and from (5.55 ± 0.88 cm) preoperatively. The mean left ventricular end systolic diameter significantly decreased from 4.06 ± 0.65 cm preoperatively to 3.4 ± 0.4 cm, 1-week postoperative (P = .01), and also decreased significantly to 3.45 ± 0.51 cm at 1-year follow up postoperatively, but was higher than that at 1-week follow up. Also, the mean left ventricular end diastolic diameter decreased  significantly during periods of follow up (P &lt; .001).<br /><strong>Conclusion:</strong> Reversal of left ventricular functions and reduction of left-sided chamber dimensions are possible if early mitral valve replacement is considered in chronic mitral regurgitation before worsening of the condition.<br /><br />


2019 ◽  
Vol 40 (27) ◽  
pp. 2206-2214 ◽  
Author(s):  
Annelieke H J Petrus ◽  
Olaf M Dekkers ◽  
Laurens F Tops ◽  
Eva Timmer ◽  
Robert J M Klautz ◽  
...  

Abstract Aims Recurrent mitral regurgitation (MR) has been reported after mitral valve repair for functional MR. However, the impact of recurrent MR on long-term survival remains poorly defined. In the present study, mortality-adjusted recurrent MR rates, the clinical impact of recurrent MR and its determinants were studied in patients after mitral valve repair with revascularization for functional MR in the setting of ischaemic heart disease. Methods and results Long-term clinical and echocardiographic outcome was evaluated in 261 consecutive patients after restrictive mitral annuloplasty and revascularization for moderate to severe functional MR, between 2000 and 2014. The cumulative incidence of recurrent MR ≥ Grade 2, assessed by competing risk analysis, was 9.6 ± 1.8% at 1-year, 20.3 ± 2.5% at 5-year, and 27.6 ± 2.9% at 10-year follow-up. Cumulative survival was 85.8% [95% confidence interval (CI) 81.0–90.0] at 1-year, 67.3% (95% CI 61.1–72.6%) at 5-year, and 46.1% (95% CI 39.4–52.6%) at 10-year follow-up. Age, preoperative New York Heart Association Class III or IV, a history of renal failure, and recurrence of MR expressed as a time-dependent variable [HR 3.28 (1.87–5.75), P < 0.001], were independently associated with an increased mortality risk. Female gender, a history of ST-elevation myocardial infarction, a preoperative QRS duration ≥120 ms, a higher preoperative MR grade, and a higher indexed left ventricular end-systolic volume were independently associated with an increased likelihood of recurrent MR. Conclusion Mitral valve repair for functional ischaemic MR resulted in a low incidence of recurrent MR with favourable clinical outcome up to 10 years after surgery. Presence of recurrent MR at any moment after surgery proved to be independently associated with an increased risk for mortality.


Author(s):  
Yuichiro Kitada ◽  
Mamoru Arakawa ◽  
Homare Okamura ◽  
Kei Akiyoshi ◽  
Daijiro Hori ◽  
...  

Background and Aim of the Study: Negative impact of prosthesis-patient mismatch (PPM) on long term survival after valve replacement has been reported. However, the effect of PPM after bioprosthetic mitral valve replacement (MVR) has not yet been well examined. The purpose of this study was to investigate the effect of PPM on late outcomes after bioprosthetic MVR for mitral regurgitation (MR). Methods: A total of 181 patients underwent bioprosthetic MVR between April 2008 and December 2016. After excluding patients with mitral stenosis and those with incomplete data, 128 patients were included in the study. Postoperative transthoracic echocardiography was performed for all patients and the effective orifice area (EOA) was calculated using the pressure half-time method. The effective orifice area index (EOAI) was calculated by the formula: EOA/body surface area (BSA). PPM was defined as a postoperative EOAI ≤ 1.2 cm2/m2. The characteristics and outcomes were compared between the groups. Results: There were 34 patients (26.6%) with PPM and 94 patients (73.4%) without PPM. Although proportion of males and BSA were higher in the PPM group, valve size distributions were similar between the two groups. There were no significant differences in the in-hospital mortality and morbidities. Multivariable analysis showed that PPM was an independent predictor of late mortality (hazard ratio [HR] 3.38; 95% confidence interval [CI] 1.69-6.75; p = .001) and death from heart failure (HR 31.03, 95% CI 4.49-214.40, p < .001). Conclusions: PPM after MVR for MR was associated with long-term mortality and death from heart failure.


Author(s):  
Adeline Fuchs ◽  
Marina Urena ◽  
Caroline Chong-Nguyen ◽  
John Kikoïne ◽  
Eric Brochet ◽  
...  

Background: Transcatheter mitral valve implantation (TMVI) is emerging as an alternative to surgical mitral valve replacement in selected high-risk patients. Delaying definitive mechanical mitral valve replacement and the constraints of anticoagulation thanks to TMVI may be an attractive option in young women contemplating pregnancy and suffering from failure of mitral bioprosthesis or annuloplasty. The aim of the study was to evaluate the possibility, safety, and outcomes of pregnancy after TMVI in this population. Methods: From 2013 to 2019, 12 young women contemplating pregnancy underwent transseptal valve-in-valve or valve-in-ring TMVI using the Edwards SAPIEN XT/3 valves and were prospectively followed up at 1 month, 6 months, 1 year, and yearly thereafter. Results: Mean age of the patients was 30±6 years. Bioprosthesis degeneration was observed in 7 cases and annuloplasty failure in 5. Three valve-in-ring patients required the implantation of a second valve, which led to an overall procedural success rate of 75%. One delayed left ventricular outflow tract obstruction required elective surgical mitral valve replacement. At 6 months/1 year, 83% of the patients were in New York Heart Association classes I/II. Mitral regurgitation was ≤2+ in all the cases and mean gradient was 7±2 mm Hg. Four patients could complete 6 full-term pregnancies. One symptomatic thrombosis occurred and resolved under aspirin and anticoagulation therapy. All others pregnancies were uneventful. Predelivery mean gradient was 11 mm Hg, and systolic pulmonary artery pressure was 32 mm Hg. There were 4 vaginal deliveries and 2 cesarians. Newborns were alive and healthy. At last follow-up, there was no death, and 3 patients required elective surgical mitral valve replacement at 6- to 54-month follow-up. Conclusions: Our study suggests that, in young women, transseptal TMVI to treat failing bioprostheses may result in good short-term outcomes that allow uneventful pregnancies. The results are less favorable in women with failed annuloplasty rings.


2020 ◽  
Vol 59 (1) ◽  
pp. 180-186
Author(s):  
Bettina Pfannmueller ◽  
Martin Misfeld ◽  
Alexander Verevkin ◽  
Jens Garbade ◽  
David M Holzhey ◽  
...  

Abstract OBJECTIVES Non-leaflet resection techniques including loop chordal replacement are being used with increasing frequency, but the long-term results of these techniques are still unknown. The aim of this study was to compare the long-term results of loop neochord replacement with leaflet resection techniques in patients undergoing minimally invasive mitral valve (MV) repair for MV prolapse. METHODS Between 1999 and 2014, 2134 consecutive MV prolapse patients underwent minimally invasive MV repair with isolated loop (n = 1751; 82.1%) or resection techniques (n = 383, 17.9%) at our institution. Follow-up data were available for 86% of patients with a mean follow-up time of 6.1 ± 4.3 years. RESULTS The 30-day mortality was 0.8% for all patients (loop: 0.7%, resection: 1.6%; P = 0.09). Leaflet resection was associated with more moderate or more mitral regurgitation on predischarge echocardiography (P = 0.003). The 1-, 5- and 10-year survival rates were 98 ± 1%, 95 ± 1% and 86 ± 2% for the loop technique versus 97 ± 1%, 92 ± 1% and 81 ± 2% for resection patients, respectively (P = 0.003). Significant predictors for late mortality were MV repair technique (P = 0.004), left ventricular ejection fraction (P &lt; 0.001), age (P &lt; 0.001) and myocardial infarction (P &lt; 0.001). Freedom from MV reoperation at 1, 5 and 10 years was 98 ± 1%, 97 ± 1%, 97 ± 1% and 97 ± 1%, 97 ± 1%, 96 ± 1% for patients operated on with the loop technique and leaflet resection (P = 0.4). CONCLUSIONS In our patient cohort, MV repair with loop chordal replacement is associated with less early recurrent mitral regurgitation and very good long-term results when compared to classical leaflet resection techniques for MV prolapse and is therefore an excellent option for such patients.


2021 ◽  
Vol 23 (8) ◽  
Author(s):  
Elias Rawish ◽  
Tobias Schmidt ◽  
Ingo Eitel ◽  
Christian Frerker

Abstract Purpose of review Transcatheter mitral valve replacement (TMVR) has been developed to address the need for an alternative therapeutic option to surgery in patients suffering from severe mitral regurgitation who are at high surgical risk. The present review illustrated the state-of-the-art of catheter-based mitral valve replacement evaluating technical characteristics and early clinical experience of different devices to outline prospects and challenges of TMVR. Recent findings Several devices are currently under clinical assessment. Early experience has demonstrated high procedural success of TMVR. However, TMVR faces several possible hurdles such as left ventricular outflow tract obstruction (LVOTO) after prosthesis deployment, access site complications, and thrombotic risk requiring anticoagulatory therapy. Summary Future studies should assess long-term prosthesis stability, optimal anticoagulation regime, and occurrence of paravalvular leakage. The development of smaller TMVR prostheses suitable for transseptal implantation could overcome bleeding complications. In perspective, TMVR may emerge to a clinically relevant therapeutic approach for patients with severe MR at high surgical risk.


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