Transcatheter Mitral Valve Replacement Research Articles

Transcatheter Mitral Valve Replacement Using Transcatheter Aortic Valve or Dedicated Devices: Current Evidence and Future Prospects

Transcatheter mitral valve replacement (TMVR) is a novel and evolving field dedicated to addressing the therapeutic challenges posed by patients at high surgical risk with mitral valve disease. TMVR can be categorized into two distinct fields based on the type of device and its specific indications: TMVR with transcatheter aortic valves (TAV) and TMVR with dedicated devices. Similar to aortic stenosis, TMVR with TAV requires a rigid support structure to secure the valve in place. As a result, it is indicated for patients with failing bioprothesis or surgical rings or mitral valve disease associated with severe mitral annular calcification (MAC), which furnishes the necessary foundation for valve anchoring. While TMVR with TAV has shown promising outcomes in valve-in-valve procedures, its effectiveness remains more contentious in valve-in-ring or valve-in-MAC procedures. Conversely, TMVR with dedicated devices seeks to address native mitral regurgitation, whether accompanied by MAC or not, providing an alternative to Transcatheter Edge-to-Edge Repair (TEER) when TEER is not feasible or expected to yield unsatisfactory results. This emerging field is gradually surmounting technical challenges, including anchoring a valve in a non-calcified annulus and transitioning from the transapical route to the transeptal approach. Numerous devices are presently undergoing clinical trials. This review aims to furnish an overview of the supporting evidence for TMVR using TAV in each specific indication (valve-in-valve, valve-in-ring, valve-in-MAC). Subsequently, we will discuss the anticipated benefits of TMVR with dedicated devices over TEER, summarize the characteristics and clinical results of TMVR systems currently under investigation, and outline future prospects in this field.

Left ventricle outflow tract obstruction after transcatheter mitral valve replacement with a transatrial approach.

Left ventricle outflow tract obstruction after transcatheter mitral valve replacement with a transatrial approach.

Cardiac Reoperation or Transcatheter Mitral Valve Replacement for Patients With Failed Mitral Prostheses

BackgroundEvidence is limited regarding patient outcomes comparing redo surgical mitral valve replacement (redo SMVR) vs transcatheter mitral valve replacement (TMVR) for failed prostheses. ObjectivesThe goal of this study was to compare the outcomes of redo SMVR vs TMVR in patients with failed prostheses, as well as evaluate the association between case volume and outcomes. MethodsMedicare beneficiaries aged ≥65 years who underwent redo SMVR or TMVR for failed mitral prostheses between 2016 and 2020 were included. The primary endpoint was mid-term (up to 3 years) major adverse cardiovascular events (MACE), including all-cause death, heart failure rehospitalization, stroke, or reintervention. Propensity score–matched analysis was used. ResultsA total of 4,293 patients were included (redo SMVR: 64%; TMVR: 36%). TMVR recipients were older, with a higher comorbidity burden. In matched cohort (n = 1,317 in each group), mid-term risk of MACE was similar (adjusted HR: 0.92; 95% CI: 0.80-1.04; P = 0.2). However, landmark analysis revealed a lower risk of MACE with TMVR in the first 6 months (adjusted HR: 0.75; 95% CI: 0.63-0.88; P < 0.001) albeit with a higher risk beyond 6 months (adjusted HR: 1.28; 95% CI: 1.04-1.58; P = 0.02). Increasing procedural volume was associated with decreased risk of mid-term MACE after redo SMVR (P = 0.001) but not after TMVR (P = 0.3). ConclusionsIn this large cohort of Medicare beneficiaries with failed mitral prostheses, outcomes were similar between redo SMVR and TMVR at 3 years, with TMVR showing a lower initial risk but a higher risk of MACE after 6 months. These findings highlight the importance of striking a balance between surgical risk, anticipated longevity, and hospital expertise when selecting interventions.

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results

BackgroundHigh surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients. ObjectivesThis analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR. MethodsThe Intrepid TMVR Early Feasibility Study is a multicenter, prospective, single-arm study. Clinical events were adjudicated by a clinical events committee; endpoints were defined according to Mitral Valve Academic Research Consortium criteria. ResultsA total of 33 patients, enrolled at 9 U.S. sites between February 2020 and August 2022, were included. The median age was 80 years, 63.6% of patients were men, and mean Society of Thoracic Surgeons Predicted Risk of Mortality for mitral valve replacement was 5.3%. Thirty-one (93.9%) patients were successfully implanted. Median postprocedural hospitalization length of stay was 5 days, and 87.9% of patients were discharged to home. At 30 days, there were no deaths or strokes, 8 (24.2%) patients had major vascular complications and none required surgical intervention, there were 4 cases of venous thromboembolism all successfully treated without sequelae, and 1 patient had mitral valve reintervention for severe left ventricular outflow tract obstruction. At 1 year, the Kaplan-Meier all-cause mortality rate was 6.7%, echocardiography showed ≤mild valvular MR, there was no/trace paravalvular leak in all patients, median mitral valve mean gradient was 4.6 mm Hg (Q1-Q3: 3.9-5.3 mm Hg), and 91.7% of survivors were in NYHA functional class I/II with a median 11.4-point improvement in Kansas City Cardiomyopathy Questionnaire overall summary scores. ConclusionsThe early benefits of the Intrepid transfemoral transseptal TMVR system were maintained up to 1 year with low mortality, low reintervention, and near complete elimination of MR, demonstrating a favorable safety profile and durable valve function.

Preemptive alcohol septal ablation prior to transcatheter mitral valve replacement.

Alcohol septal ablation (ASA) has been shown to increase the neo-left ventricular outflow tract (LVOT) area before transcatheter mitral valve replacement (TMVR) but there is little literature on its success and use with dedicated devices. To describe our experience with preemptive ASA to increase the predicted neo-LVOT area and its utility with both dedicated TMVR devices and balloon-expandable valves. All patients who underwent ASA for TMVR candidacy in our center between May 2018 and October 2022 and had computed tomography(CT) scans done before and after ASA were included. Each CT was assessed for the minimum predicted neo-LVOT area at end-systole, using a virtual valve of the desired TMVR device for each patient. The primary outcome was an increase in the predicted neo-LVOT area after ASA that was deemed sufficient for safe implantation of the desired TMVR device. The secondary outcome was the absence of acute LVOT obstruction after TMVR. A total of 12 patients underwent ASA and all but 1 (n = 11, 91.6%) achieved the primary outcome of having sufficient predicted neo-LVOT area to proceed with TMVR. The mean increase in neo-LVOT area after ASA was 126 ± 64 mm2 (median 119.5, interquartile range: 65.0-163.5 mm2 ). Two patients (16.7%) required a permanent pacemaker after ASA. Nine patients went on and underwent TMVR with their respective devices and none had LVOT obstruction after the procedure. Among the remaining three patients, one had insufficient neo-LVOT clearance after ASA, one had unrelated mortality before TMVR, and one had advanced heart failure before TMVR. In appropriately selected patients and at centers experienced with ASA, preemptive ASA can achieve sufficient neo-LVOT clearance for TMVR with a variety of devices in approximately 90% of patients.

Transcatheter Mitral Valve Replacement: Endocarditis Surgically Treated

Transcatheter Mitral Valve Replacement: Endocarditis Surgically Treated

Optimizing transcatheter mitral valve replacement with direct, continuous transvalvular haemodynamic evaluation: first-in-man.

Optimizing transcatheter mitral valve replacement with direct, continuous transvalvular haemodynamic evaluation: first-in-man.

National trends in utilization of transatrial transcatheter mitral valve replacement and postoperative outcomes

ObjectiveTransatrial transcatheter mitral valve replacement reduces complexity during mitral valve replacements involving high-risk patients with mitral annular calcification. This study examines trends in transatrial transcatheter mitral valve replacement use and outcomes. MethodsPatients in the Society of Thoracic Surgeons database from 2014 to 2021 with mitral annular calcification undergoing transatrial transcatheter mitral valve replacement were included. Exclusion criteria were hypertrophic cardiomyopathy, congenital mitral valve disease, ventricular assist device placement, or prior mitral valve surgery. Primary outcomes were operative mortality and major adverse cardiac events compared between the Early (2014-2017, N = 71) and Recent (2018-2021, N = 151) eras. Parsimonious multivariable regression assessed select possible confounders for trends in major adverse cardiac events. ResultsOverall, 222 transatrial transcatheter mitral valve replacements at 104 hospitals were identified. Annual volume increased from 6 in 2014 to 43 in 2021. Median hospital volume was 1, maximum hospital volume was 17, and 10 or more replacements were performed at 4 hospitals. Mortality and major adverse cardiac events occurred in 10.4% and 22.5% of patients, respectively. Compared with the Early era patients, Recent era patients were more often elective (79.5% vs 64.8%) and were approached via sternotomy (90.1% vs 80.3%, all P < .05). Despite similar predicted risk of mortality (9.6% ± 11.1% vs 11.0% ± 6.0%; P = .61), Recent patients had reduced mortality (3.3% vs 25.4%, P < .001) and major adverse cardiac events (18.5% vs 31.0%; P = .057). On univariate and multivariable analyses, the Recent surgical era was significantly associated with lower mortality (0.10 [0.04-0.29]; P < .001) and lower major adverse cardiac events (0.48 [0.25-0.94]; P = .032), respectively. There were no preoperative characteristics that were significant confounders for the difference in major adverse cardiac events. ConclusionsMortality and major adverse cardiac events after transatrial transcatheter mitral valve replacement have decreased significantly in the contemporary era independent of changes in major patient and operative characteristics. Transatrial transcatheter mitral valve replacement will have a future role in patients with mitral annular calcification.

TCT-632 3-Dimensional Echocardiographic Analysis for Device Sizing and Risk Assessment of Left Ventricular Outflow Tract Obstruction in Transcatheter Mitral Valve Replacement

TCT-632 3-Dimensional Echocardiographic Analysis for Device Sizing and Risk Assessment of Left Ventricular Outflow Tract Obstruction in Transcatheter Mitral Valve Replacement

TCT-246 Nationally Representative Outcomes of Redo Surgical and Transcatheter Mitral Valve Replacement in Failed Mitral Bioprostheses

TCT-246 Nationally Representative Outcomes of Redo Surgical and Transcatheter Mitral Valve Replacement in Failed Mitral Bioprostheses

TCT-738 Impact of COVID-19 on In-Hospital Outcomes of Transcatheter Aortic and Mitral Valve Replacement

TCT-738 Impact of COVID-19 on In-Hospital Outcomes of Transcatheter Aortic and Mitral Valve Replacement

TCT-297 Transcatheter Mitral Valve Replacement: What Are the Outcomes of Uneligible Patients?

TCT-297 Transcatheter Mitral Valve Replacement: What Are the Outcomes of Uneligible Patients?

Characterization of Left Atrial Appendage Closure Device Protrusion and Implications for Transcatheter Mitral Valve Replacement

Characterization of Left Atrial Appendage Closure Device Protrusion and Implications for Transcatheter Mitral Valve Replacement

Outcomes After Transcatheter Mitral Valve Replacement According to Regurgitation Etiology

BackgroundWhether transcatheter mitral valve replacement (TMVR) devices perform similarly with respect to the underlying mitral regurgitation (MR) etiology remains unknown. The aim of the present analysis was to assess outcomes of TMVR according to the MR underlying etiology among the CHoice of OptImal transCatheter trEatment for Mitral Insufficiency (CHOICE-MI) registry. MethodsOf 746 patients, 229 patients (30.7%) underwent TMVR. The study population was subdivided according to primary, secondary, or mixed MR. Patients with mitral annular calcification were excluded. The primary study endpoint was a composite endpoint of all-cause mortality or hospitalization for heart failure at 1 year. Secondary study endpoints were all-cause and cardiovascular mortality at 1 year, New York Heart Association functional class, and residual MR, both at discharge and 1 year. ResultsThe predominant MR etiology was secondary MR (58.4%), followed by primary MR (28.7%) and mixed MR (12.9%). Technical success and procedural mortality were similar according to MR etiology. Discharge echocardiography revealed residual MR 2+ in 11.3%, 3.7%, and 5.3% of patients with primary, secondary, and mixed MR, respectively (P = .1). MR elimination was similar in all groups up to the 1-year follow-up. There was no difference in terms of primary combined outcome occurrence according to MR etiology. One-year all-cause mortality was reported in 28.8%, 24.2%, and 32.1% of patients with primary, secondary, and mixed MR, respectively (P = .07). ConclusionsIn our study we did not find differences in short-term and 1-year outcomes after TMVR according to MR etiology.

5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results

BackgroundThe MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective trial to evaluate the safety and feasibility of balloon-expandable aortic transcatheter heart valves in patients with failed surgical bioprostheses or annuloplasty rings and severe mitral annular calcification treated with mitral valve-in-valve (MViV), valve-in-ring (MViR), or valve–in–mitral annular calcification (ViMAC). ObjectivesThe aim of this study was to evaluate 5-year outcomes among these patients. MethodsA multicenter prospective study was conducted among patients at high surgical risk at 13 U.S. sites. Patients underwent MViV (n = 30), MViR (n = 30), or ViMAC (n = 31) and were followed annually for 5 years. Kansas City Cardiomyopathy Questionnaire scores were obtained at baseline and follow-up visits. Echocardiograms were analyzed at independent core laboratories. ResultsA total of 91 patients underwent transcatheter mitral valve replacement (February 2015 to December 2017). The mean age was 74.3 ± 8.9 years. At 5-year follow-up, the lowest all-cause mortality was observed in the MViV group (21.4%), 94.7% of patients were in NYHA functional class I or II, and the mean mitral gradient was 6.6 ± 2.5 mm Hg. The MViR and ViMAC groups had higher all-cause mortality (65.5% and 67.9%), most survivors were in NYHA functional classes I and II (50% and 55.6%), and mean mitral gradients remained stable (5.8 ± 0.1 and 6.7 ± 2.5 mm Hg). Significant improvements in Kansas City Cardiomyopathy Questionnaire scores were observed when all 3 arms were pooled. ConclusionsMViV, MViR, and ViMAC procedures were associated with sustained improvement of heart failure symptoms and quality of life among survivors at 5 years. Transcatheter heart valve function remained stable in all 3 groups. Patients treated with MViV had excellent survival at 5 years, whereas survival was lower in the MViR and ViMAC groups, consistent with underlying disease severity. Patients with more residual mitral regurgitation had higher mortality.

Innovalve transcatheter mitral valve replacement system: Short-term pre-clinical study in pigs

Innovalve is a transcatheter mitral valve replacement (TMVR) system with a unique fixation system that aims to grasp the chordae in a rotational maneuver. ObjectivesThis study will examine the safety and efficacy of the transapical mitral implantation of Innovalve bioprosthesis in the porcine model. MethodsInnovalve MV bioprosthesis was implanted in the porcine model (5 pigs) for a duration of 30 days. ResultsThe Innovalve bioprosthesis was successfully implanted in all of the animals with accurate positioning, anchoring and good paravalvular sealing. At 30 days after implantation, all animals exhibited normal clinical status without evidence of cardiac impairment. The prosthetic valve seemed adequately adhered to the mitral annulus with fibrous tissue. ConclusionWe have demonstrated that the implantation of the Innovalve in healthy porcine subjects is feasible and safe and that the valve function and interaction with normal biological tissue is favorable and predictable.

Valve-in-Valve Transcatheter Mitral Valve Replacement: A Large First-in-Human 13-Year Experience

BackgroundFavourable early outcomes have been reported following valve-in-valve transcatheter mitral valve replacement (TMVR). However, reports of long-term outcomes are lacking. We aimed to evaluate early and late outcomes in a large first-in-human valve-in-valve TMVR 13-year experience. MethodsAll patients undergoing valve-in-valve TMVR in our centre from 2008 to 2021 were included. Clinical and echocardiographic outcomes, defined according to the Mitral Valve Academic Research Consortium, were reported. ResultsA total of 119 patients were analysed: mean age 76.8 ± 10.2 years, mean Society of Thoracic Surgeons score 10.7 ± 6.8%, 55.4% female, 63.9% transapical access. Thirty-day mortality was 2.5% for the total population and 0.0% after transseptal TMVR. Maximum follow-up was 13.1 years. During a median follow-up of 3.4 years (interquartile range 1.8-5.3 years), 55 patients (46.2%) died, mainly from noncardiovascular causes. Valve hemodynamics were acceptable at 5 years, with 2.5% structural dysfunction. Patients treated from 2016 on (n = 68; 57.1%), following the advent of routine use of the Sapien 3 valve, CT screening, and transseptal access, were compared with those treated before 2016 (n = 51; 42.9%). Patients from 2016 on had a higher technical success rate (100.0% vs 94.1%; P = 0.04), shorter hospitalisation (P < 0.001), trending lower 30-day mortality (1.5% vs 3.9%; P = 0.4) and better 5-year survival (74.7% vs 41.1%; P = 0.03). ConclusionsValve-in-valve TMVR can be performed with little morbidity and low mortality. Mid- to long-term survival remains limited owing to advanced age and comorbidities. Structural bioprosthetic valve dysfunction was rare and redo TMVR feasible in selected patients. Outcomes continue to improve, but the role for valve-in-valve TMVR in lower surgical risk patients remains unclear.

Transapical electrosurgical laceration and stabilization of mitral clips followed by transcatheter mitral valve replacement—A one-stop shop

ObjectiveElectrosurgical laceration and stabilization of mitral clips (ELASTA-CLIP) is a bail-out technique to recreate a single-orifice mitral valve after transcatheter edge-to-edge repair (TEER) with subsequent transcatheter mitral valve replacement (TMVR). This technique is a novel option for patients with significant residual mitral regurgitation after TEER with high risk for conventional surgery. The original ELASTA CLIP procedure features a transseptal approach, whereas the TMVR with the Tendyne bioprosthesis has a transapical access. Hereby we tested the hypothesis that a modified transapical ELASTA CLIP technique can be safely applied transapically allowing a straightforward one-stop shop access strategy. MethodsWe developed the procedural steps in a porcine passive-beating heart model and applied the modified technique with subsequent TMVR in 2 consecutive patients with severe mitral regurgitation after previous TEER. Patients were followed up to 30 days. ResultsThe modified transapical ELASTA CLIP procedure was successful in both patients. The mean total procedure time was 118 minutes, and the mean fluoroscopy duration 22 minutes. At 30 days’ follow-up, both patients were alive without bleeding complications, reintervention, or prosthetic valve dysfunction. ConclusionsThe modified transapical ELASTA CLIP procedure is technically feasible and safe at 30 days. Procedure times are lower compared with previous reports of the original transseptal approach.

Outcomes of Percutaneous Atrial Septal Defect Closure With Mitral Transcatheter Edge-to-Edge Repair and Transseptal Mitral Valve Replacement (2015 to 2020)

Patients who underwent transcatheter edge-to-edge repair (TEER) or transcatheter mitral valve replacement (TMVR) have a transeptal access created by an iatrogenic atrial septal defect (ASD) which leads to significant complications requiring closure. Given limited data, we used the National Inpatient Sample between 2015 and 2020 to evaluate the clinical outcomes of percutaneous closure of ASD (PC-ASD) in TEER/TMVR hospitalizations. A total of 44,065 eligible weighted hospitalizations with either TEER (n=39,625, 89.9%) or TMVR (n=4,440, 10.1%) with a higher rate of PC-ASD in the TMVR group (10.7% vs 2.0%, p<0.01). The TEER with PC-ASD group were more likely to experience acute heart failure and right ventricular failure and had longer hospital stays but there was no difference in in-hospital mortality compared with the no PC-ASD group. In the TMVR group, there was no difference in the odds of acute heart failure, right ventricular failure, cardiogenic shock, or acute hypoxic respiratory failure, but the odds of mechanical circulatory support, in-hospital mortality, and length of stay were significantly higher in patients with PC-ASD in the TMVR group. In conclusion, rates of percutaneous closure of ASD after TEER were lower than after TMVR and associated with worse in-hospital mortality in TMVR but not in TEER. Further prospective clinical trials are needed to identify patients who would benefit from the closure of iatrogenic ASD.

An analytical, mathematical annuloplasty ring curvature model for planning of valve-in-ring transcatheter mitral valve replacement.

An increasing number of high-risk patients with previous mitral valve annuloplasty require transcatheter mitral valve replacement due to recurrent regurgitation. Annulus dilation with a transcatheter balloon is often performed before valve-in-ring transcatheter mitral valve replacement, which is believed to reduce misalignment and paravalvular leakage, yet little evidence exists to support this practice. Our objective was to generate intuitive annuloplasty ring analyses for improved valve-in-ring transcatheter mitral valve replacement planning. We generated a mathematical model that calculates image-tracked differential ring curvature to build quantifications for improved planning for valve-in-ring procedures. Carpentier-Edwards Physio M24 and M30 (n=2 each), Physio II M24 and M26 (n=3 each), LivaNova AnnuloFlex M26 (n=2), and Edwards Geoform M28 (n=2) rings were tested with a 30-mm Toray Inoue balloon inflated to maximum rated pressures. Curvature variance reduces with larger ring sizes, indicating that larger rings are initially more circular than smaller ones. Evaluated semi-rigid and rigid rings showed little to no difference between pre- and post-dilation states. Annuloflex rings (flexible band) showed a postdilation variance reduction of 32.83% (P<.001) followed by an increase after 10minutes of relaxation that was still reduced by 19.62% relative to the initial state (P<.001). We discovered that balloon dilation does not significantly deform evaluated semi-rigid or rigid rings at maximum rated balloon pressures. This may mean that dilation for these conditions before valve-in-ring transcatheter mitral valve replacement is unnecessary. Our mathematical approach creates a foundation for extended classification of this practice, providing meaningful quantification of ring geometry.