Pushing the Boundaries of Transcatheter Mitral Valve Replacement (original) (raw)
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JACC: Cardiovascular Interventions, 2019
OBJECTIVES This study evaluates outcomes of pre-emptive alcohol septal ablation (ASA) to prevent iatrogenic left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR). BACKGROUND LVOT obstruction is a life-threatening complication of TMVR. Bail-out ASA has been described as a therapeutic option for patients with outflow obstruction during TMVR, but little is known about pre-emptive ASA. METHODS Multicenter registry of patients with severe mitral valve disease who underwent pre-emptive ASA to mitigate LVOT obstruction risk after TMVR. High risk of LVOT obstruction was predicted in all patients by pre-procedural computed tomographic imaging. RESULTS Thirty patients (age 76.1 AE 7.7 years; women 76.7%) with severe mitral valve disease underwent pre-emptive ASA to mitigate TMVR-induced LVOT obstruction risk. Twenty patients underwent mitral valve replacement (14 transseptal, 3 transatrial, 1 transapical, 1 transseptal with percutaneous laceration of anterior mitral leaflet, 1 treated with surgical mitral valve replacement). Eight patients experienced clinical improvement post-ASA. Two patients died before TMVR. Median increase in neo-LVOT surface area post-ASA was 111.2 mm 2 (interquartile range: 71.4 to 193.1 mm 2). Five patients (16.7%) required pacemaker implantation post-ASA. In-hospital and 30-day mortality post-ASA was 6.7% (2/30 patients). After ASA, TMVR was performed successfully in 100% of attempted cases. In-hospital and 30-day mortality post-TMVR was 5.3% (1/19). Mortality of entire cohort was 10% (3/30 patients: 2 post-ASA before TMVR, 1 died 30 days post-TMVR). CONCLUSIONS Pre-emptive ASA is associated with a significant increase in predicted neo-LVOT area before TMVR and may enable safe TMVR in patients usually excluded secondary to prohibitive risk of LVOT obstruction.
Transcatheter mitral valve replacement (TMVR) has been used for "off-label" treatment when annuloplasty band ring for mitral repair fails. However, the complex anatomy and function of the mitral valve may lead to fatal complications as a result of the left ventricular outflow tract (LVOT) obstruction in TMVR. We report the structural and hemodynamic response of LVOT obstruction resulting from TMVR with the Edwards SAPIEN 3 Ultra (S3) device. We modified the original Living Heart Human Model (LHHM) to account for a failed mitral valve with an annuloplasty band ring and simulated the cardiac beating condition in the setting of S3 device implantation. Findings demonstrated a high dynamic behavior of the newly formed LVOT (neoLVOT) as confined by the displaced mitral valve and the interventricular septum. During the cardiac beat, the neoLVOT area oscillated from a maximum of 472.1 mm 2 at early systole to the minimum of 183 mm 2 at end-systole. The profile of both anchoring force and contact pressure revealed that the band ring serves as the anchoring zone while mitral valve is primally displaced by the deployed device. At early systole, computational flow dynamics highlighted hemodynamic disturbances associated with the LVOT obstruction, with a skewed flow towards the septum and a pressured drop of 4.5 mmHg between the left ventricular apex and the neoLVOT region. This study can lead to a more accurate assessment of the risk induced by the LVOT obstruction when stratifying patient anatomic suitability for 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.
The Journal of Thoracic and Cardiovascular Surgery, 2014
Objective: Transcatheter heart valve (THV) procedures are constantly evolving. We report our experience with valve-in-valve, valve-in-ring, and direct-view valve-in-native-ring implantation in the mitral position. Methods: Fourteen patients undergoing THV implantation in the mitral position were included. Clinical and postoperative data, including echocardiography and further follow-up, were analyzed. Results: Ten valve-in-valve and 2 valve-in-ring procedures were successfully performed using the transapical access route. For the third valve-in-ring procedure we used an antegrade left-atrial access via right anterolateral minithoracotomy. In 1 patient surgical mitral valve replacement was planned. Intraoperatively, the annulus appeared severely calcified and regular implantation of a bioprosthesis was not possible. As a last resort, a 29-mm Sapien XT valve (Edwards Lifesciences Inc, Irvine, Calif) was implanted under direct view. The initial result was satisfactory, but on the first postoperative day relevant paravalvular regurgitation occurred. Subsequently, the valve was fixed to an atrial cuff by 1 running suture. In this series 27-, 29-, and 31-mm bioprostheses and 28-and 30-mm annuloplasty rings were treated with 26-or 29-mm Sapien XT valves. Postoperative echocardiography on day 10 and after 6 weeks revealed good prosthesis function in all cases. In 2 valve-in-valve patients who solely received anticoagulation therapy with acetylsalicylic acid, signs of beginning valve thrombosis occurred after 8 weeks and 3 months, respectively. During further course, valve function was normalized using warfarin therapy. Conclusions: Our results demonstrate feasibility of valve-in-valve and valve-in-ring THV procedures in the mitral position. Permanent anticoagulation therapy with warfarin seems to be necessary to prevent valve dysfunction. THV implantation in a calcified native mitral ring for bailout seems not to be reproducible and thus cannot be recommended.
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...