Transcatheter Mitral Valve Replacement Research Articles

Percutaneous balloon mitral valvuloplasty with shockwave lithotripsy for the treatment of calcific mitral valve stenosis.

Calcific mitral stenosis (calcific MS) presents a challenge for surgical treatment and is a contraindication for most contemporary transcatheter mitral valve replacement devices (TMVR), rendering patients with very limited therapeutic options. This study aims to assess the clinical and hemodynamic follow-up after mitral valve lithotripsy (MVL). All consecutive patients who underwent MVL to treat symptomatic calcific MS at St Michael's Hospital, Toronto, Canada, were included. Patients were deemed unsuitable for mitral surgery or TMVR after heart team assessment. Patients with rheumatic MS or ≥moderate mitral regurgitation (MR) were excluded. The primary endpoint was a reduction in the invasive mitral gradient by ≥50% without significant (≥moderate) MR. Fifteen patients underwent MVL between 2021 and 2023 with a mean age of 74 ± 9 years; 53% were female, with a mean STS score of 10% ± 0.1%. Following MVL, there was a reduction in the invasively measured mean trans-mitral gradient compared to baseline (14 mmHg vs. 6 mmHg; p < 0.05). The primary endpoint was achieved in 8 patients (53%) with no major procedural complications. At follow-up (median 90 days, IQR 58-115 days), 14 (93%) patients reported improved symptoms from New York Heart Association (NYHA) Class III-IV to NYHA Class I-II (p < 0.01) with stable echo-derived mean gradient (7.7 mmHg ± 2 mmHg vs. 8.4 mmHg ± 2.9 mmHg (p = 0.7). In selected patients with symptomatic inoperable calcific MS, MVL was safe and associated with significant short-term clinical and hemodynamic improvement. MVL may represent a new compassionate therapy for this challenging cohort. Further studies are needed to determine the long-term outcomes and help define the role of IVL technology in treating calcific valvular conditions.

B-60 | Impact of Pulmonary Hypertension on Long-Term Outcome After Transcatheter Mitral Valve Replacement: A Meta- Analysis

B-60 | Impact of Pulmonary Hypertension on Long-Term Outcome After Transcatheter Mitral Valve Replacement: A Meta- Analysis

B-51 | Prevalence, mortality, cost, and disparities in transcatheter mitral valve repair and replacement in cancer patients: Artificial intelligence and propensity score national 5-year analysis of 7,495 procedures

B-51 | Prevalence, mortality, cost, and disparities in transcatheter mitral valve repair and replacement in cancer patients: Artificial intelligence and propensity score national 5-year analysis of 7,495 procedures

Simultaneous transapical transcatheter aortic and mitral valve replacement in patients with severe valve dysfunction: initial experience.

Simultaneous transcatheter mitral valve in valve (VIV) replacement and aortic valve replacement experience is limited. We report our initial experience with simultaneous transapical transcatheter aortic and mitral valve replacement in patients with severe valve dysfunction. A total of 8 patients had simultaneous transcatheter heart valve implants for severe mitral bioprosthesis failure (VIV), with a second valve procedure that included native aortic regurgitation (n = 3) or degenerated bioprostheses in the aortic position (n = 5). All patients were treated with a self-expandable J-valve transcatheter valve, using the transapical approach. The mean age of the patients was 73.1 ± 6.2years. The mean Society of Thoracic Surgeons score was 13.8 ± 6.3%. Device success was 100% according to Valve Academic Research Consortium-2 criteria. No other procedure-associated complications occurred, including left ventricular outflow tract obstruction and valve migration. The mean hospital lengths of stay after the procedure were 11.5 ± 8.0days. No deaths occurred at 30days. At a median follow-up period of 28.7 ± 22.3months, no patients died. All patients were in New York Heart Association functional classes I-II. Echocardiographic parameters at follow-up showed a normofunctioning J valve in the mitral position and a mean max mitral flow velocity of 2.0 ± 0.5m/s; the J valve in the aortic position was also normofunctioning, and the mean max aortic flow velocity was 2.3 ± 0.5m/s. Simultaneous transapical transcatheter aortic and mitral valve replacement using the self-expandable J valve appears to be a feasible and effective alternative to redo surgery.

Clinical characteristics and outcomes of alcohol septal ablation in the era of transcatheter valve interventions.

The clinical efficacy and safety of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) have been well-established; however, less is known about outcomes in patients undergoing preemptive ASA before transcatheter mitral valve replacement (TMVR). The goal of this study is to characterize the procedural characteristics and examine the clinical outcomes of ASA in both HCM and pre-TMVR. This retrospective study compared procedural characteristics and outcomes in patient who underwent ASA for HCM and TMVR. In total, 137 patients were included, 86 in the HCM group and 51 in the TMVR group. The intraventricular septal thickness (mean 1.8 vs. 1.2 cm; p < 0.0001) and the pre-ASA LVOT gradient (73.6 vs. 33.8 mmHg; p ≤ 0.001) were higher in the HCM group vs the TMVR group. The mean volume of ethanol injected was higher (mean 2.4 vs. 1.7 cc; p < 0.0001). The average neo-left ventricular outflow tract area increased significantly after ASA in the patients undergoing TMVR (99.2 ± 83.37 mm2 vs. 196.5 ± 114.55 mm2; p = <0.0001). The HCM group had a greater reduction in the LVOT gradient after ASA vs the TMVR group (49.3 vs. 18 mmHg; p = 0.0040). The primary composite endpoint was higher in the TMVR group versus the HCM group (50.9% vs. 25.6%; p = 0.0404) and had a higher incidence of new permanent pacemaker (PPM) (25.5% vs. 18.6%; p = 0.3402). The TMVR group had a higher rate of all-cause mortality (9.8% vs. 1.2%; p = 0.0268). Preemptive ASA before TMVR was performed in patients with higher degree of clinical comorbidities, and correspondingly is associated with worse short-term clinical outcomes in comparison to ASA for HCM patients. ASA before TMVR enabled percutaneous mitral interventions in a small but significant minority of patients that would have otherwise been excluded. The degree of LVOT and neoLVOT area increase is significant and predictable.

Prevalence, mortality, cost, and disparities in transcatheter mitral valve repair and replacement in cancer patients: Artificial intelligence and propensity score national 5-year analysis of 7495 procedures

IntroductionWe conducted the first comprehensive evaluation of the therapeutic value and safety profile of transcatheter mitral edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) in individuals concurrently afflicted with cancer. MethodsUtilizing the National Inpatient Sample (NIS) dataset, we analyzed all adult hospitalizations between 2016 and 2020 (n = 148,755,036). The inclusion criteria for this retrospectively analyzed prospective cohort study were all adult hospitalizations (age 18 years and older). Regression and machine learning analyses in addition to model optimization were conducted using ML-PSr (Machine Learning-augmented Propensity Score adjusted multivariable regression) and BAyesian Machine learning-augmented Propensity Score (BAM-PS) multivariable regression. ResultsOf all adult hospitalizations, there were 5790 (0.004%) TMVRs and 1705 (0.001%) TEERs. Of the total TMVRs, 160 (2.76%) were done in active cancer. Of the total TEERs, 30 (1.76%) were done in active cancer. After the comparable rates of TEER/TMVR in active cancer in 2016, the prevalence of TEER/TMVR was significantly less in active cancer from 2017 to 2020 (2.61% versus 7.28% p < 0.001). From 2017 to 2020, active cancer significantly decreased the odds of receiving TEER or TMVR (OR 0.28, 95%CI 0.13–0.68, p = 0.008). In patients with active cancer who underwent TMVR/TEER, there were no significant differences in socio-economic disparities, mortality or total hospitalization costs. ConclusionThe presence of malignancy does not contribute to increased mortality, length of stay or procedural costs in TMVR or TEER. Whereas the prevalence of TMVR has increased in patients with active cancer, the utilization of TEER in the context of active cancer is declining despite a growing patient population.

Impact of Tricuspid Regurgitation on Outcomes After Transcatheter Mitral Valve Replacement

Development of functional tricuspid regurgitation (TR) due to chronic mitral disease and subsequent heart failure is common. However, the effect of TR on clinical outcomes following transcatheter mitral valve replacement (TMVR) remains unclear. We aimed to evaluate the impact of baseline TR on outcomes after TMVR. This was a single-center retrospective analysis of patients who received valve-in-valve or valve-in-ring TMVR between 2012 and 2022. Patients were categorized into none/mild TR and moderate/severe TR based on baseline echocardiography. Primary outcome was 3-years all-cause death and secondary outcomes were in-hospital events. Among the 135 patients who underwent TMVR, 64 (47%) exhibited none/mild TR at baseline, while 71 (53%) demonstrated moderate/severe TR. There were no significant differences in in-hospital events among the groups. At 3-years, the moderate/severe TR group exhibited a significantly elevated risk of all-cause death (adjusted HR 3.37, 95% CI 1.35-8.41, p = 0.009). When patients with baseline moderate/severe TR were stratified by echocardiography at 30 days into improved (36%) and non-improved (64%) TR groups, although limited by small sample size, there was no significant difference in 3-year all-cause mortality (p = 0.48). In conclusion, this study investigating the impact of baseline TR on clinical outcomes revealed that moderate/severe TR is prevalent among those undergoing TMVR, and was an independent predictor of 3-years all-cause mortality. Earlier mitral valve intervention, prior to the development of significant TR, may play a pivotal role in improving outcomes following TMVR.

2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System.

Thirty-day outcomes with the investigational Intrepid transapical (TA) transcatheter mitral valve replacement (TMVR) system have previously demonstrated good technical success, but longer-term outcomes in larger cohorts need to be evaluated. The authors sought to evaluate the 2-year safety and performance of the Intrepid TA-TMVR system in patients with symptomatic,≥moderate-severe mitral regurgitation (MR) and high surgical risk. Patient eligibility was determined by local heart teams and approved by a central screening committee. Clinical events were adjudicated by an independent clinical events committee. Echocardiography was evaluated by an independent core laboratory. The cohort included 252 patients that were enrolled at 58 international sites before February 2021 as part of the global Pilot Study (n=95) or APOLLO trial (primary cohort noneligible+ TA roll-ins, n=157). Mean age was 74.2years, mean STS-PROM was 6.3%, 60.3% were male, and 80.6% were in NYHA functional class III/IV. Most presented with secondary MR (70.1%), and nearly all had≥moderate-severe MR (98.4%). All-cause mortality was 13.1% (30-day), 27.3% (1-year), and 36.2% (2-year). The 30-day≥major bleeding event rate was 22.3%. Heart failure rehospitalization was 9.6% (30-day) and 36.2% (2-year). At 2 years, >50% of patients were alive with improvement in NYHA functional class (82.1%, class I/II), and all patients with available echocardiograms had≤mild MR. This analysis represents the largest reported TA-TMVR experience with the longest follow-up in high-risk≥moderate-severe MR patients. Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years.

ALCOHOL SEPTAL ABLATION FOR TRANSCATHETER MITRAL VALVE REPLACEMENT RELATED LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION

ALCOHOL SEPTAL ABLATION FOR TRANSCATHETER MITRAL VALVE REPLACEMENT RELATED LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION

Transcatheter Myotomy to Reduce Left Ventricular Outflow Obstruction

BackgroundLeft ventricular outflow tract (LVOT) obstruction is a source of morbidity in hypertrophic cardiomyopathy (HCM) and a life-threatening complication of transcatheter mitral valve replacement (TMVR) and transcatheter aortic valve replacement (TAVR). Available surgical and transcatheter approaches are limited by high surgical risk, unsuitable septal perforators, and heart block requiring permanent pacemakers. ObjectivesThe authors report the initial experience of a novel transcatheter electrosurgical procedure developed to mimic surgical myotomy. MethodsWe used septal scoring along midline endocardium (SESAME) to treat patients, on a compassionate basis, with symptomatic LVOT obstruction or to create space to facilitate TMVR or TAVR. ResultsIn this single-center retrospective study between 2021 and 2023, 76 patients underwent SESAME. In total, 11 (14%) had classic HCM, and the remainder underwent SESAME to facilitate TMVR or TAVR. All had technically successful SESAME myocardial laceration. Measures to predict post-TMVR LVOT significantly improved (neo-LVOT 42 mm2 [Q1-Q3: 7-117 mm2] to 170 mm2 [Q1-Q3: 95-265 mm2]; P < 0.001; skirt-neo-LVOT 169 mm2 [Q1-Q3: 153-193 mm2] to 214 mm2 [Q1-Q3: 180-262 mm2]; P < 0.001). Among patients with HCM, SESAME significantly decreased invasive LVOT gradients (resting: 54 mm Hg [Q1-Q3: 40-70 mm Hg] to 29 mm Hg [Q1-Q3: 12-36 mm Hg]; P = 0.023; provoked 146 mm Hg [Q1-Q3: 100-180 mm Hg] to 85 mm Hg [Q1-Q3: 40-120 mm Hg]; P = 0.076). A total of 74 (97.4%) survived the procedure. Five experienced 3 of 76 (3.9%) iatrogenic ventricular septal defects that did not require repair and 3 of 76 (3.9%) ventricular free wall perforations. Neither occurred in patients treated for HCM. Permanent pacemakers were required in 4 of 76 (5.3%), including 2 after concomitant TAVR. Lacerations were stable and did not propagate after SESAME (remaining septum: 5.9 ± 3.3 mm to 6.1 ± 3.2 mm; P = 0.8). ConclusionsWith further experience, SESAME may benefit patients requiring septal reduction therapy for obstructive hypertrophic cardiomyopathy as well as those with LVOT obstruction after heart valve replacement, and/or can help facilitate transcatheter valve implantation.

Etiologies and Impact of Exclusion Rates for Transcatheter Mitral and Tricuspid Valve Structural Heart Clinical Trials at a High-Volume Quaternary Care Hospital

There are various devices under clinical investigation for transcatheter mitral valve intervention (TMVI) and tricuspid valve intervention (TTVI), but exclusion rates remain high. We aim to investigate exclusion rates for transcatheter mitral valve repair (TMVr), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid valve repair (TTVr) and transcatheter tricuspid valve replacement (TTVR). There were a total of 129 patients who were referred to St. Francis Hospital & Heart Center valve clinic and completed screening between January 2021 and July 2022. Causes for exclusion were classified into 4 categories: patient withdrawal, anatomic unsuitability, clinical criteria and medical futility. Among 129 patients, the exclusion rates for TMVr, TMVR, TTVr and TTVR were 81%, 85%, 91% and 87%, respectively. Patient withdrawal and medical futility were leading etiologies for exclusion, followed by anatomical unsuitability. TMVr had the highest rate of patient withdrawal (64%), the lowest anatomic unsuitability (5%) due to short posterior leaflet length. Replacement interventions have higher anatomic unsuitability (33%) compared to repair interventions (17%) (p=0.04). Most exclusions of anatomic unsuitability was due to mitral stenosis or small annulus size for TMVR and large annulus size for TTVR. Fifty percent of exclusions from TTVr were due to presence of pacemaker/defibrillator leads. Among patients excluded from their respective trials, patients being referred for TMVr had the highest recurrent hospitalization and repair group had a higher mortality (p<0.01 and p=0.01, respectively). In conclusion, exclusion rates for TMVI and TTVI trials remain high due to various reasons, limiting patients’ enrollment and treatment. This supports the need for further device improvement or exploring alternative means of therapy.

Standardization and validation of neoLVOT assessment using three-dimensional trans-esophageal echocardiography before trans-catheter mitral valve replacement.

Trans-catheter mitral valve replacement (TMVR) procedures had emerged as an alternative solution for patients who are at high risk for mitral valve surgery. Although cardiac computed tomography (CT) remains the standard method for procedural planning, there is no full agreement on the best systolic phase for quantitation of the neoLVOT. Furthermore, a new three-dimensional trans-esophageal echocardiography (3DTEE) based software was developed to serve as filter and or an alternative for patients who cannot have CT due to any contraindication. To determine the systolic phase of the cardiac cycle that shows the narrowest NeoLVOT area in order to standardize the way of using these software and then to validate the 3DTEE-based software against the CT-based one as a gold standard, in mitral valve annulus (MA) and NeoLVOT assessment. A single center, observational, retrospective study. Initially, a sample of 20 patients (age 62±4 years, 70% men) had CT-based analysis at mid-diastole (80%), early-systole (10%), mid-systole (20%), late-systole (30%-40%), in order to detect the best systolic phase at which the neoLVOT area is the narrowest after TMVR. Then, the end systolic phase was standardized for the analysis of 49 patients (age 57±6 years, 60% men), using both the commercially available CT-based software and the newly available 3DTEE-based software (3mensio Structural Heart, Pie Medical Imaging, The Netherlands). The 3DTEE derived parameters were compared with the gold standard CT-based measurements. The neoLVOT area was significantly narrower at end-systole (224±62 mm2), compared to early-systole (299±70 mm2) and mid-systole (261±75 mm2), (p=.005). Excellent correlation was found between 3DTEE and CT measurements for MA AP diameter (r=.96), IC diameter (r=.92), MA area (r=.96), MA perimeter (r=.94) and NeoLVOT area (r=.96), (all p-values<.0001). Virtual valve sizing was based on annulus measurement and was identical between CT and 3DTEE. Interobserver and intraobserver agreements were excellent for all the measurements with ICCs>.80. End-systole is the phase that shows the narrowest neoLVOT and hence should be the standard phase used during the analysis. The 3DTEE based analysis using this new software is reliable compared to the CT-based analysis and can be serve as an alternative analysis tool in patients who cannot have CT for any clinical contraindication or as a screening test and/or filter for all patients before proceeding to a detailed CT scan.

Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry

BackgroundEarly studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. ObjectivesThe authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. MethodsAll patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. ResultsAmong 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had “real-world” indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and “real-world” indications up to 1 year. ConclusionsThis large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and “real-world” indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335)

Transcatheter mitral valve replacement at an inflection point: lessons learned and the path forward.

Transcatheter mitral valve replacement at an inflection point: lessons learned and the path forward.

Optimal antithrombotic strategy following valve-in-valve transcatheter aortic and mitral valve replacement.

The treatment of aortic and mitral valve disease requiring replacement has shifted to an increasing use of bioprosthetic heart valves. Due to their limited durability, there is a growing need for reintervention in the setting of failing bioprosthesis. Even though the gold standard for the treatment of failed bioprosthesis remains surgical repair or replacement, valve-in-valve (ViV) transcatheter aortic and mitral valve replacement have emerged as safe and effective alternatives for patients who are at high or prohibitive risk for surgery. Both procedures are associated with a substantial risk of postprocedural thromboembolic events and valvular thrombosis that is often higher than transcatheter replacement of native valves. With guidelines lacking specific protocols and a limited number of available studies, the optimal postprocedural antithrombotic therapy remains to be clarified. Multiple factors including valvular hemodynamics, the characteristics of the failing surgical valve, and the choice of the new transcatheter heart valve (THV) must be considered. Additionally, patients are often at an advanced age with multiple comorbidities and may require oral anticoagulation (OAC) due to other indications such as atrial fibrillation. Although the recommended antithrombotic strategy for native transcatheter aortic valve replacement (TAVR) is antiplatelet monotherapy with aspirin or a P2Y12 inhibitor in the absence of another anticoagulation indication, the use of oral anticoagulants including vitamin K antagonists (VKAs) and direct thrombin inhibitors has been shown to be effective in reducing valvular thrombosis and are commonly used after ViV procedures. Prospective studies investigating these results specifically for ViV transcatheter aortic and mitral valve replacement are needed to identify the optimal antithrombotic therapy.

Procedural performance and healing response of a novel lowprofile transseptal transcatheter mitral valve replacement system.

Procedural performance and healing response of a novel lowprofile transseptal transcatheter mitral valve replacement system.

Management strategies and prognosis of patients ineligible for transcatheter mitral valve replacement

BackgroundTranscatheter mitral valve replacement (TMVR) faces anatomical challenges, currently limiting widespread adoption. ObjectivesTo describe the natural history and prognosis of patients ineligible for various TMVR devices. MethodsDuring a 4-year period (2019–2023) 3 TMVR devices (SAPIEN M3, Intrepid and Alta Valve) became available at a single institution (The Christ Hospital, Cincinnati, OH) in the setting of pivotal clinical trials or early feasibility study. Consenting patients who were deemed ineligible ≥1 of these trials were prospectively studied to capture anatomical reasons for ineligibility, cross-over to alternative mitral valve therapies (surgery or high-risk mitral transcatheter edge to edge repair [M-TEER]), and clinical events. ResultsA total of 61 patients (out of 71 consenting patients or 85.9 %) were deemed ineligible for TMVR during the study period. The mean age was 79.2 ± 8.8 years, 65.6 % were female, with elevated surgical risk (median STS 4.3, IQR: 2.7–7.3). The 2 most common anatomical reasons for ineligibility were increased risk of left ventricular outflow tract obstruction (LVOTO) (n = 24, 39.3 %) and annular size (n = 29, 47.5 %).During follow-up (median 277 [162–555] days) there were 7 deaths (11.5 %) and 12 (19.7 %) hospitalizations for heart failure. Management strategies included high-risk M-TEER in 11 patients (1 death [9.0 %], 0 HF hospitalizations [0 %]), surgery in 9 patients (0 deaths, 1 HF hospitalizations [11.1 %]), and medical management in 41 patients (6 deaths [14.6 %], 11 HF hospitalizations [26.8 %]) (p = 0.715 for mortality and p = 0.093 for HF hospitalizations). Residual MR ≥ moderate was 0 %, 50 %, and 100 % for surgery, M-TEER and medical treatment, respectively (p < 0.001). ConclusionsOne third of patients deemed ineligible for TMVR are candidates for high-risk M-TEER or surgery with acceptable morbidity and mortality. Our results have practical implications for patient management.

Transcatheter Paravalvular Leak Closure With Covered Stent Tract and Vascular Plug: Tootsie Roll Technique

BackgroundTranscatheter closure of transcatheter heart valve (THV)–related paravalvular leak (PVL) is associated with a high failure rate with available devices due to the complex interaction of THV and aortic/mitral annulus. ObjectivesThis study reports on novel transcatheter techniques to treat PVL after THV. MethodsThe authors describe consecutive patients who underwent PVL closure after transcatheter aortic valve replacement (TAVR) or transcatheter mitral valve replacement (TMVR). A covered self-expanding stent (Viabahn) was deployed in the defect to create a seal between the THV and annulus. A vascular plug (Amplatzer Vascular Plug 2 [AVP2] or AVP4) was then deployed inside the covered stent to obliterate PVL. ResultsEight patients with THV-related PVL were treated using this method (aortic [3 SAPIEN, 1 Evolut], mitral [2 SAPIEN-in-MAC (mitral annular calcification), 2 M3 TMVR). Various combinations of stents and plugs were used (5 mm × 2.5 cm Viabahn + 6 mm AVP4 [n = 2], 8 mm × 2.5 cm Viabahn + 10 mm AVP2 [n = 5], and 10 mm × 5.0 cm Viabahn + 12 mm AVP2 [n = 1]). All had technical success with immediate elimination of target PVL, without in-hospital complications. None had signs of postprocedure hemolysis. All patients were discharged alive (median 3.5 days [Q1-Q3: 1.0-4.8 days]). No residual PVL was seen at discharge, except for 1 patient with mild regurgitation due to another untreated PVL location. One patient died before 30 days due to complication of valve-in-MAC TMVR. In remaining patients, none had recurrence of PVL at 30 days. Symptoms decreased to NYHA functional class I/II in 6 patients. NYHA functional class III symptoms remained in 1 patient with mitral regurgitation awaiting subsequent valve replacement procedure. ConclusionsThe technique of sequential deployment of a covered stent and vascular plug may effectively treat THV-related PVL.

Economic Burden of Inpatient Care for Mitral Regurgitation in Maryland.

Mitral regurgitation (MR) is the most common valvular disease in the United States and increases the risk of death and hospitalization. The economic burden of MR in the United States is not known. We analyzed inpatient hospitalization data from the 1 221 173 Maryland residents who had any in-state admissions from October 1, 2015, to September 30, 2019. We assessed the total charges for patients without MR and for patients with MR who underwent medical management, transcatheter mitral valve repair or replacement, or surgical mitral valve repair or replacement. During the study period, 26 076 inpatients had a diagnosis of MR. Compared with patients without MR, these patients had more comorbidities and higher inpatient mortality. Patients with medically managed MR incurred average total charges of $23 575 per year; MR was associated with $10 559 more in charges per year and an incremental 3.1 more inpatient days per year as compared with patients without MR. Both surgical mitral valve repair or replacement and transcatheter mitral valve repair or replacement were associated with higher charges as compared with medical management during the year of intervention ($47 943 for surgical mitral valve repair or replacement and $63 108 for transcatheter mitral valve repair or replacement). Annual charges for both groups were significantly lower as compared with medical management in the second and third years postintervention. MR is associated with higher mortality and inpatient charges. Patients who undergo surgical or transcatheter intervention incur lower charges compared with medically managed MR patients in the years after the procedure.

First-in-Human Percutaneous Excision of a Failed MitraClip Followed by Transcatheter Mitral Valve Replacement

First-in-Human Percutaneous Excision of a Failed MitraClip Followed by Transcatheter Mitral Valve Replacement