Contemporary 1-Year Outcomes of Mitral Valve-in-Ring With Balloon-Expandable Aortic Transcatheter Valves in the U.S.

BACKGROUND: Adequate valve performance after surgical mitral valve repair with an annuloplasty ring is not always sustained over time. The risk of repeat mitral valve surgery may be high in these patients. Transcatheter mitral valve-in-ring (MViR) is emerging as an alternative for high-risk patients. OBJECTIVES: The authors sought to assess contemporary outcomes of MViR using third-generation balloon-expandable aortic transcatheter heart valves. METHODS: Patients who underwent MViR and were enrolled in the STDS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between August 2015 and December 2022 were analyzed. RESULTS: A total of 820 patients underwent MViR at 236 sites, mean age was 72.2 ± 10.4 years, 50.9% were female, mean STS score was 8.2% ± 6.9%, and most (78%) were in NYHA functional class III to IV. Mean left ventricular ejection fraction was 47.8% ± 14.2%, mean mitral gradient was 8.9 ± 7.0 mm Hg, and 75.5% had ≥ moderate mitral regurgitation. Access was transseptal in 93.9% with 88% technical success. All-cause mortality at 30 days was 8.3%, and at 1 year, 22.4%, with a reintervention rate of 9.1%. At 1-year follow-up, 75.6% were NYHA functional class I to II, Kansas City Cardiomyopathy Questionnaire score increased by 25.9 ± 29.1 points, mean mitral valve gradient was 8.4 ± 3.4 mm Hg, and 91.7% had ≤ mild mitral regurgitation. CONCLUSIONS: MViR with third-generation balloon-expandable aortic transcatheter heart valves is associated with a significant reduction in mitral regurgitation and improvement in symptoms at 1 year, but with elevated valvular gradients and a high reintervention rate. MViR is a reasonable alternative for high-risk patients unable undergo surgery who have appropriate anatomy for the procedure. (STS/ACC TVT Registry Mitral Module [TMVR]; NCT02245763).

Preprocedural Computed Tomography Planning for Surgical Aortic Valve Replacement.

BACKGROUND: Selection of transcatheter valve size using preprocedural computed tomography (CT) is standardized and well established. However, valve sizing for surgical aortic valve replacement (SAVR) is currently performed intraoperatively by using sizers, which may result in variation among operators and risk for prosthesis-patient mismatch. This study evaluated the usefulness of CT annulus measurement for SAVR valve sizing. METHODS: This study included patients who underwent SAVR using Inspiris or Magna Ease and received preoperative electrocardiogram-gated CT imaging. Starting from June 2022, study investigators applied a CT sizing algorithm using CT-derived annulus size to guide minimum SAVR label size. The final decision of valve selection was left to the operating surgeon during SAVR. The study compared the appropriateness of valve selection (comparing implanted size with CT-predicted size) and prosthesis-patient mismatch rates without aortic root enlargement between 2 cohorts: 102 cases since June 2022 (CT sizing cohort) and 180 cases from 2020 to 2021 (conventional sizing cohort). RESULTS: Implanted size smaller than CT predicted size and severe prosthesis-patient mismatch were significantly lower by CT sizing than by conventional sizing (12% vs 31% [P = .001] and 0% vs 6% [P = .039], respectively). Interoperator variability was a factor associated with implanted size smaller than CT predicted with conventional sizing, whereas it became nonsignificant with CT sizing. CONCLUSIONS: Applying CT sizing to SAVR led to improved valve size selection, less prosthesis-patient mismatch, and less interoperator variability. CT sizing for SAVR could also be used to predict prosthesis-patient mismatch before SAVR and identify patients who need aortic root enlargement.

Impact of transcatheter heart valve type on outcomes of surgical explantation after failed transcatheter aortic valve replacement: the EXPLANT-TAVR international registry.

BACKGROUND: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure. AIMS: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV). METHODS: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV. RESULTS: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69). CONCLUSIONS: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.

Tricuspid Regurgitation: From Imaging to Clinical Trials to Resolving the Unmet Need for Treatment.

Tricuspid regurgitation (TR) is a highly prevalent and heterogeneous valvular disease, independently associated with excess mortality and high morbidity in all clinical contexts. TR is profoundly undertreated by surgery and is often discovered late in patients presenting with right-sided heart failure. To address the issue of undertreatment and poor clinical outcomes without intervention, numerous structural tricuspid interventional devices have been and are in development, a challenging process due to the unique anatomic and physiological characteristics of the tricuspid valve, and warranting well-designed clinical trials. The path from routine practice TR detection to appropriate TR evaluation, to conduction of clinical trials, to enriched therapeutic possibilities for improving TR access to treatment and outcomes in routine practice is complex. Therefore, this paper summarizes the key points and methods crucial to TR detection, quantitation, categorization, risk-scoring, intervention-monitoring, and outcomes evaluation, particularly of right-sided function, and to clinical trial development and conduct, for both interventional and surgical groups.

Surgical Explantation of Failed Transcatheter Aortic Valve Replacement.

BACKGROUND: Recent reports have demonstrated worse than expected outcomes of surgical explantation after transcatheter aortic valve replacement (TAVR). However in-depth analysis of the short- and mid-term risk of concomitant cardiac surgery at the time of TAVR explant is lacking. METHODS: Data from the multicenter EXPLANT-TAVR registry of patients undergoing TAVR-explant between November 2009 and September 2020 were retrospectively analyzed. Patients undergoing concomitant procedures were included, but explants performed during the same admission as the initial TAVR or concomitant procedures performed on the aortic root, ascending aorta, or arch were excluded. Outcomes were evaluated between the isolated surgical aortic valve replacement (SAVR) and concomitant SAVR groups. Median follow-up was 6.6 months. RESULTS: Among 199 patients, concomitant SAVR was performed in 94 patients (47.2%), primarily with mitral valve surgery (n = 45) followed by coronary artery bypass grafting (n = 23). Despite similar mean ages between groups (72.8 vs 73.4 years), concomitant SAVR had a higher median Society of Thoracic Surgeons Predicted Risk of Mortality score at the index TAVR (5.9% vs 3.7%, P = .001). There were no differences in median time-to-explant between groups (12.9 vs 8.7 months, P = .78). However concomitant SAVR had longer mean cardiopulmonary bypass (166 vs 114 minutes, P = .001) and cross-clamp times (123 vs 81 minutes, P = .001). Both 30-day (16.7% vs 9.9%) and 1-year mortality (36.1% vs 22.1%) were higher with concomitant SAVR but did not reach statistical significance (both P > .05). On Kaplan-Meier analysis, actuarial estimates of cumulative survival were significantly lower with concomitant SAVR at 3 years (56.8% vs 81.1%, P = .020). CONCLUSIONS: For surgical explantation after TAVR failure, concomitant SAVR is associated with increased mortality. Further studies with longer follow-up are warranted to examine the benefit from earlier intervention before concomitant disease develops.

Impact of Mitral Regurgitation Etiology on Mitral Surgery After Transcatheter Edge-to-Edge Repair: From the CUTTING-EDGE Registry.

BACKGROUND: Although >150,000 mitral TEER procedures have been performed worldwide, the impact of MR etiology on MV surgery after TEER remains unknown. OBJECTIVES: The authors sought to compare outcomes of mitral valve (MV) surgery after failed transcatheter edge-to-edge repair (TEER) stratified by mitral regurgitation (MR) etiology. METHODS: Data from the CUTTING-EDGE registry were retrospectively analyzed. Surgeries were stratified by MR etiology: primary (PMR) and secondary (SMR). MVARC (Mitral Valve Academic Research Consortium) outcomes at 30 days and 1 year were evaluated. Median follow-up was 9.1 months (IQR: 1.1-25.8 months) after surgery. RESULTS: From July 2009 to July 2020, 330 patients underwent MV surgery after TEER, of which 47% had PMR and 53.0% had SMR. Mean age was 73.8 ± 10.1 years, median STS risk at initial TEER was 4.0% (IQR: 2.2%-7.3%). Compared with PMR, SMR had a higher EuroSCORE, more comorbidities, lower LVEF pre-TEER and presurgery (all P < 0.05). SMR patients had more aborted TEER (25.7% vs 16.3%; P = 0.043), more surgery for mitral stenosis after TEER (19.4% vs 9.0%; P = 0.008), and fewer MV repairs (4.0% vs 11.0%; P = 0.019). Thirty-day mortality was numerically higher in SMR (20.4% vs 12.7%; P = 0.072), with an observed-to-expected ratio of 3.6 (95% CI: 1.9-5.3) overall, 2.6 (95% CI: 1.2-4.0) in PMR, and 4.6 (95% CI: 2.6-6.6) in SMR. SMR had significantly higher 1-year mortality (38.3% vs 23.2%; P = 0.019). On Kaplan-Meier analysis, the actuarial estimates of cumulative survival were significantly lower in SMR at 1 and 3 years. CONCLUSIONS: The risk of MV surgery after TEER is nontrivial, with higher mortality after surgery, especially in SMR patients. These findings provide valuable data for further research to improve these outcomes.

Contemporary Anatomic Criteria and Clinical Outcomes With Transcatheter Mitral Repair.

BACKGROUND: Consensus-driven criteria have recently been proposed for prediction of mitral transcatheter edge-to-edge repair outcomes, yet validation for response to therapy is needed. We examined the relation between contemporary criteria and outcomes with mitral transcatheter edge-to-edge repair therapy. METHODS: Mitral transcatheter edge-to-edge repair patients were classified according to anatomic and clinical criteria (1) Heart Valve Collaboratory criteria for nonsuitability; (2) commercial indications (suitable); and (3) neither (ie, intermediate). Analyses for Mitral Valve Academic Research Consortium-defined outcomes of reduction in mitral regurgitation and survival were performed. RESULTS: Among 386 patients (median age, 82 years; 48% women), the most common classification was intermediate (46%), with 138 patients (36%) and 70 patients (18%) in the suitable and nonsuitable categories, respectively. Nonsuitable classification was related to prior valve surgery, smaller mitral valve area, type IIIa morphology, larger coaptation depth, and shorter posterior leaflet. Nonsuitable classification was associated with less technical success (P<0.001) and survival free of mortality, heart failure hospitalization, and mitral surgery (P<0.001). Among the nonsuitable patients, technical failure or any 30-day major adverse cardiac event occurred in 25.7%. Nevertheless, in these patients, acceptable mitral regurgitation reduction without adverse events still occurred in 69%, and their 1-year survival with mild or no symptoms was 52%. CONCLUSIONS: Contemporary classification criteria identify patients less suitable for mitral transcatheter edge-to-edge repair with respect to acute procedural success and survival, though patients most commonly fit an intermediate category. In experienced centers, sufficient mitral regurgitation reduction can be achieved safely in the selected patients even with challenging anatomy.

Aortic valve versus root surgery after failed transcatheter aortic valve replacement.

OBJECTIVE: We sought to determine outcomes of aortic valve replacement (AVR) versus root replacement after transcatheter AVR (TAVR) explantation because they remain unknown. METHODS: From November 2009 to September 2020, data from the EXPLANT-TAVR International Registry of patients who underwent TAVR explant were retrospectively reviewed, divided by AVR versus root replacement. After excluding explants performed during the same admission as the initial TAVR and concomitant procedures involving the other valves, 168 AVR cases were compared with 28 root replacements, and outcomes were reported at 30 days and 1 year. RESULTS: Among 196 patients (mean age, 73.5 ± 9.9 years) who had primary aortic valve intervention at TAVR explant, the median time from TAVR to surgical explant was 11.2 months (interquartile range, 4.4-32.9 months). Indications for explant were similar between the 2 groups. Compared with AVR, patients requiring root replacement had fewer comorbidities but more unfavorable anatomy for redo TAVR (52.6% vs 26.4%; P = .032), fewer urgent/emergency cases (32.1% vs 58.3%; P = .013), longer median interval from index TAVR to TAVR explant (17.6 vs 9.9 months; P = .047), and more concomitant ascending aortic replacement (58.8% vs 14.0%; P < .001). Median follow-up was 6.9 months (interquartile range, 1.4-21.6 months) after TAVR explant and 97.4% complete. Overall survival at follow-up was 81.2% with no differences between groups (log rank P = .54). In-hospital, 30-day, and 1-year mortality rates and stroke rates were not different between the 2 groups. CONCLUSIONS: In the EXPLANT-TAVR Registry, AVR and root replacement groups had different clinical characteristics, but no differences in short-term mortality and morbidities. Further investigations are necessary to identify patients at risk of root replacement in TAVR explant.

Impact of Tricuspid Regurgitation on Outcomes of Mitral Valve Surgery after Transcatheter Edge-to-Edge Repair.

Tricuspid regurgitation (TR) severity after mitral transcatheter edge-to-edge repair (TEER) has been shown to impact outcomes but unknown in patients requiring mitral valve (MV) surgery after TEER. We sought to determine the impact of preoperative TR severity and right ventricular (RV) dysfunction on MV surgery after TEER. From 7/2009 to 7/2020, 260/332 patients in the CUTTING-EDGE registry who underwent MV surgery after TEER had paired echocardiographic evaluation on TR severity, and ≥moderate (2+) vs <2+ TR at the time of index TEER were compared. Median follow-up post-MV surgery was 9.1 months, 96.5% complete at 30 days and 81.9% complete at 1 year. Mean age was 73.8 ± 10.3; with primary/mixed and secondary MR present in 65.6% and 32.0%, respectively. Proportion of ≥2+ TR increased from TEER to MV surgery (40% vs 57%, P < 0.001). Compared to <2+ TR group, ≥2+ pre-TEER TR patients were older, had higher STS risk score at TEER, higher RVSP, more RV dysfunction, more MR post-TEER, and a shorter median interval from TEER to MV surgery (1.9 vs 4.9 months, P = 0.023). Mortality was higher in the ≥2+ pre-TEER TR group at 30 days(24.2% vs 13.8%, P = 0.043) and 1 year (45.3% vs 22.3%, P = 0.003). On Kaplan-Meier analysis, cumulative mortality was 23.8% at 1 year and 31.6% at 3 years after MV surgery overall, and was associated with preoperative RV dysfunction (P = 0.023), ≥2+ TR at pre-TEER (P = 0.001) and presurgery (P = 0.004), but not concomitant tricuspid surgery. Moderate or greater pre-TEER TR was associated with worse outcomes, and pre-TEER TR worsened significantly at MV surgery. Concomitant tricuspid surgery did not increase overall mortality.

Coaptation Reserve Predicts Optimal Reduction in Mitral Regurgitation and Long-Term Survival With Transcatheter Edge-to-Edge Repair.

BACKGROUND: Although transcatheter edge-to-edge repair (TEER) is effective and safe, there is a need for better prediction of optimal outcomes. We aimed to determine predictors of optimal reduction in mitral regurgitation (MR) and survival with TEER. METHODS: We examined mitral anatomy and its change with TEER on outcomes in 183 patients (age, 82 [77-87] years; 53% women). Coaptation reserve was measured as the distance of continuous apposition of the A2 and P2 leaflet segments in 2-dimensional apical long-axis imaging at the site of the predominant jet of MR. Augmentation in coaptation was measured as the total amount of leaflet insertion. Addressable coaptation area was calculated using the physical boundaries of the TEER device. RESULTS: Coaptation reserve, its augmentation, and addressable coaptation area were strong predictors of MR reduction (all P<0.001), as well as heart failure hospitalization and death. For patients with either mild or no residual MR, median values for coaptation reserve, its augmentation, and addressable coaptation area were 3.7 (2.8-4.5) mm, 7.3 (5.2-9.5) mm, and 59.0 (48.0-71.8) mm2, respectively. Receiver operating characteristic analyses determined the best values for optimal MR reduction as a coaptation reserve of >3.0 mm (P<0.001), addressable coaptation area of ≥52 mm2 (P<0.001), and coaptation augmentation of ≥4.7 mm (P<0.001). These values were associated with greater 2-year survival free of all-cause mortality and persisting even in analyses restricted to those with mild or no residual MR after TEER. CONCLUSIONS: Coaptation reserve and its augmentation are simple, independent parameters that predict optimal MR reduction and better survival in patients undergoing TEER. These findings may have implications for patient selection and expanded use of the therapy.

Clinical Outcomes of Mitral Valve Disease With Mitral Annular Calcification.

The prevalence of mitral valve disease with mitral annular calcification (MAC) and its clinical outcomes remain uncertain. This study sought to evaluate the prevalence of significant mitral disease due to MAC, and the impact of intervention on the clinical outcomes in these patients. All patients who underwent transthoracic echocardiography (TTE) between January 2014 and December 2015 in our health care system were reviewed and identified for having MAC with significant mitral valve disease (i.e., either≥moderate mitral regurgitation (MR) or mitral stenosis (MS)). The primary endpoints of the study were all-cause mortality and a composite outcome of mortality or heart failure hospitalization at 3-year follow-up. Of 41,136 patients who underwent TTE, MAC was identified in 2,855 (6.9%) patients, including 434 (1.1% of total) patients who had significant MR and/or MS (median age [IQR], 80 [73 to 87] years; 63% women). MAC predominately involved the posterior annulus (95%), with the majority having calcification of both trigones (55%), the leaflets (71%), and circumferential involvement (67%). During 3-year follow-up, 59 (14%) patients underwent surgical or transcatheter MV intervention. Patients who did not undergo mitral intervention had higher all-cause mortality (HR 2.80, 95% CI 1.60 to 4.92; p <0.001) and a greater risk of the composite outcome (HR 1.43, 1.00 to 2.04; p = 0.05) than those treated. Survival at 3-year follow-up was markedly greater in those with mitral intervention (78% vs 50%; p <0.001). This survival benefit remained after multivariable adjustment. In conclusion, MAC affects approximately % of patients who undergo echocardiography. Those with significant mitral valve disease due to any degree of MAC have poor survival, which may be ameliorated with transcatheter or surgical intervention.

Current state of transcatheter mitral valve implantation in bioprosthetic mitral valve and in mitral ring as a treatment approach for failed mitral prosthesis.

With heightened awareness of mitral valve disease and improvement in surgical techniques, the use of mitral valve bioprostheses has increased. There is a large aging population with prior surgical valvular interventions. Limited durability of the prosthesis due to valvular degeneration over time may necessitate the need for repair or replacement of the prior prosthesis in the future. This usually entails another surgical intervention in this population with elevated risk for a reoperation. There is an ongoing clinical need for newer, less invasive options that are feasible and carry a lower complication rate. The advent of transcatheter heart valve (THV) therapies has opened up a wide range of therapeutic options for treatment of a failed bioprosthesis. Their safety and feasibility are now well established. This article serves as a review of the currently available THVs for implantation in the mitral position, the pre-procedural assessment, the challenges associated with implantation, as well as outcomes associated with a mitral valve-in-valve (VIV) and a mitral valve-in-ring (VIR) procedure.

Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry.

OBJECTIVES: The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). BACKGROUND: Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking. METHODS: Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year. RESULTS: From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery. CONCLUSIONS: In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only <10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes.

Saphenous Vein Graft Failure: From Pathophysiology to Prevention and Treatment Strategies.

Saphenous vein grafts (SVGs) remain the most frequently used conduits in coronary artery bypass graft surgery (CABG). Despite advances in surgical techniques and pharmacotherapy, SVG failure rates remain high, often leading to repeat coronary revascularization. The no-touch SVG harvesting technique (minimal graft manipulation with preservation of vasa vasorum and nerves) reduces the risk of SVG failure, whereas the effect of the off-pump technique on SVG patency remains unclear. Use of buffered storage solutions, intraoperative graft flow measurement, careful selection of the target vessels, and physiological assessment of the native coronary circulation before CABG may also reduce the incidence of SVG failure. Perioperative aspirin and high-intensity statin administration are the cornerstones of secondary prevention after CABG. Dual antiplatelet therapy is recommended for off-pump CABG and in patients with a recent acute coronary syndrome. Intermediate (30%-60%) SVG stenoses often progress rapidly. Stenting of intermediate SVG stenoses failed to improve outcomes; hence, treatment focuses on strict control of coronary artery disease risk factors. Redo CABG is associated with higher perioperative mortality compared with percutaneous coronary intervention (PCI); hence, the latter is preferred for most patients requiring repeat revascularization after CABG. SVG PCI is limited by high rates of no-reflow and a high incidence of restenosis during follow-up. Drug-eluting and bare metal stents provide similar long-term outcomes in SVG PCI. Embolic protection devices reduce no-reflow and should be used when feasible. PCI of the corresponding native coronary artery is associated with better short- and long-term outcomes and is preferred over SVG PCI, if technically feasible.

Prospective Study of TMVR Using Balloon-Expandable Aortic Transcatheter Valves in MAC: MITRAL Trial 1-Year Outcomes.

OBJECTIVES: The aim of this study was to evaluate 1-year outcomes of valve-in-mitral annular calcification (ViMAC) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial. BACKGROUND: The MITRAL trial is the first prospective study evaluating the feasibility of ViMAC using balloon-expandable aortic transcatheter heart valves. METHODS: A multicenter prospective study was conducted, enrolling high-risk surgical patients with severe mitral annular calcification and symptomatic severe mitral valve dysfunction at 13 U.S. sites. RESULTS: Between February 2015 and December 2017, 31 patients were enrolled (median age 74.5 years [interquartile range (IQR): 71.3 to 81.0 years], 71% women, median Society of Thoracic Surgeons score 6.3% [IQR: 5.0% to 8.8%], 87.1% in New York Heart Association functional class III or IV). Access was transatrial (48.4%), transseptal (48.4%), or transapical (3.2%). Technical success was 74.2%. Left ventricular outflow tract obstruction (LVOTO) with hemodynamic compromise occurred in 3 patients (transatrial, n = 1; transseptal, n = 1; transapical, n = 1). After LVOTO occurred in the first 2 patients, pre-emptive alcohol septal ablation was implemented to decrease risk in high-risk patients. No intraprocedural deaths or conversions to open heart surgery occurred during the index procedures. All-cause mortality at 30 days was 16.7% (transatrial, 21.4%; transseptal, 6.7%; transapical, 100% [n = 1]; p = 0.33) and at 1 year was 34.5% (transatrial, 38.5%; transseptal, 26.7%; p = 0.69). At 1-year follow-up, 83.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.1 mm Hg (IQR: 5.6 to 7.1 mm Hg), and all patients had ≤1+ mitral regurgitation. CONCLUSIONS: At 1 year, ViMAC was associated with symptom improvement and stable transcatheter heart valve performance. Pre-emptive alcohol septal ablation may prevent transcatheter mitral valve replacement-induced LVOTO in patients at risk. Thirty-day mortality of patients treated via transseptal access was lower than predicted by the Society of Thoracic Surgeons score. Further studies are needed to evaluate safety and efficacy of ViMAC.

Reoperative Mitral Surgery Versus Transcatheter Mitral Valve Replacement: A Systematic Review.

Bioprosthetic mitral structural valve degeneration and failed mitral valve repair (MVr) have traditionally been treated with reoperative mitral valve surgery. Transcatheter mitral valve-in-valve (MVIV) and valve-in-ring (MVIR) replacement are now feasible, but data comparing these approaches are lacking. We sought to compare the outcomes of (1) reoperative mitral valve replacement (redo-MVR) and MVIV for structural valve degeneration, and (2) reoperative mitral valve repair (redo-MVr) or MVR and MVIR for failed MVr. A literature search of PubMed, Embase, and the Cochrane Library was conducted up to July 31, 2020. Thirty-two studies involving 25 832 patients were included. Redo-MVR was required in ≈35% of patients after index surgery at 10 years, with 5% to 15% 30-day mortality. MVIV resulted in >95% procedural success with 30-day and 1-year mortality of 0% to 8% and 11% to 16%, respectively. Recognized complications included left ventricular outflow tract obstruction (0%-6%), valve migration (0%-9%), and residual regurgitation (0%-6%). Comparisons of redo-MVR and MVIV showed no statistically significant differences in mortality (11.3% versus 11.9% at 1 year, P=0.92), albeit higher rates of major bleeding and arrhythmias with redo-MVR. MVIR resulted in 0% to 34% mortality at 1 year, whereas both redo-MVr and MVR for failed repairs were performed with minimal mortality and durable long-term results. MVIV is therefore a viable alternative to redo-MVR for structural valve degeneration, whereas redo-MVr or redo-MVR is preferred for failed MVr given the suboptimal results with MVIR. However, not all patients will be candidates for MVIV/MVIR because anatomical restrictions may preclude transcatheter options from adequately addressing the underlying pathology.

Surgical and Transcatheter Mitral Valve Replacement in Mitral Annular Calcification: A Systematic Review.

Mitral annular calcification with mitral valve disease is a challenging problem that could necessitate surgical mitral valve replacement (SMVR). Transcatheter mitral valve replacement (TMVR) is emerging as a feasible alternative in high-risk patients with appropriate anatomy. PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched from inception to December 25, 2019 for studies discussing SMVR or TMVR in patients with mitral annular calcification; 27 of 1539 articles were selected for final review. TMVR was used in 15 studies. Relevant data were available on 82 patients who underwent hybrid transatrial TMVR, and 354 patients who underwent transapical or transseptal TMVR. Outcomes on SMVR were generally reported as small case series (447 patients from 11 studies); however, 1 large study recently reported outcomes in 9551 patients. Patients who underwent TMVR had a shorter median follow-up of 9 to 12 months (range, in-hospital‒19 months) compared with patients with SMVR (54 months; range, in-hospital‒120 months). Overall, those undergoing TMVR were older and had higher Society of Thoracic Surgeons risk scores. SMVR showed a wide range of early (0%-27%; median 6.3%) and long-term mortality (0%-65%; median at 1 year, 15.8%; 5 years, 38.8%, 10 years, 62.4%). The median in-hospital, 30-day, and 1-year mortality rates were 16.7%, 22.7%, and 43%, respectively, for transseptal/transapical TMVR, and 9.5%, 20.0%, and 40%, respectively, for transatrial TMVR. Mitral annular calcification is a complex disease and TMVR, with a versatile option of transatrial approach in patients with challenging anatomy, offers a promising alternative to SMVR in high-risk patients. However, further studies are needed to improve technology, patient selection, operative expertise, and long-term outcomes.