Guerrero, Mayra E

Background Transcatheter edge‐to‐edge repair (TEER) and replacement (TTVR) have emerged as new modalities to treat patients with symptomatic significant tricuspid regurgitation. This study aimed to compare invasive hemodynamic and right ventricular (RV) changes and symptom improvement over 1 year. Methods Patients who underwent TEER/TTVR at Mayo Clinic (Rochester, MN, 2017–2024) were included. Hemodynamic profiles were described before and immediately after intervention, in addition to RV enlargement/dysfunction ≥moderate at 30 days and change in symptoms over time. Results Of 100 patients included (50 per group, median age 81 versus 80 years and female 62% versus 42%, in TTVR and TEER, respectively), all had ≥ moderate–severe symptomatic tricuspid regurgitation. Post intervention, mean right atrial pressure decreased in TEER (16 to 14 mm Hg, P <0.001), V wave decreased in both groups (to 16 mm Hg, P <0.001). RV enlargement was less prevalent in both cohorts at 30 days (60%–40% in TEER, P =0.01, and 72 to 58% in TTVR, P =0.07), yet prevalence of RV dysfunction decreased only in TEER (26 to 15%, P =0.17) as opposed to TTVR (31 to 44%, P =0.13). TTVR resulted in a higher stroke volume index and more complete tricuspid regurgitation elimination at 30 days. Both groups resulted in similar improvements in New York Heart Association class, with overall similar survival. Conclusions TEER was associated with a greater reduction in right atrial pressure and more favorable RV remodeling at 30 days, as opposed to TTVR, which achieved more complete and sustained elimination of tricuspid regurgitation with higher forward stroke volume.

BACKGROUND: The EARLY TAVR trial (Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) in asymptomatic severe aortic stenosis. The relative impact of early TAVR versus CS strategy by age is unknown. METHODS: The study population of the EARLY TAVR trial was stratified into 4 age groups: 65 to 69 years (n=141), 70 to 74 years (n=263), 75 to 79 years (n=250), and ≥80 years (n=247). Associations between age and the trial primary end point of death, stroke, or unplanned cardiovascular hospitalization; the composite end point of death, stroke, or heart failure hospitalization; and its individual components were examined. Interaction tests evaluated whether the treatment effect of early TAVR versus CS differed by age. RESULTS: No interaction was detected between age and the treatment effect of early TAVR versus CS for the composites or individual outcomes. We observed lower stroke rates with early TAVR compared with CS in the youngest (65–69 years, absolute risk reduction, 13%; P =0.008) and oldest (≥80 years; absolute risk reduction, 12.3%; P =0.029) age groups. The absolute difference in heart failure hospitalization rates between the early TAVR and CS arms at 2 years was greatest in the oldest patients (≥80 years, 9.1%; 75–79 years, 5.9%; 70–74 years, 5.1%; 65–69 years, 4.4%). In the CS group, time to conversion to AVR was similar across all age groups (median, 11 months; P =0.73). Approximately one-third of younger patients (65–69 years) in the CS arm presented with acute valve syndrome at the time of conversion, the frequency of which tended to increase with age ( P =0.06). CONCLUSIONS: In the EARLY TAVR trial, the relative benefit of early TAVR over CS was consistent among all age groups. The greatest absolute reduction in stroke rate with early TAVR compared with CS appeared in the youngest and oldest groups, whereas reduction in heart failure hospitalization was most pronounced in the oldest patients. These data suggest that early TAVR should be considered in all age groups above 65 years. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03042104.

BACKGROUND: Transcatheter mitral valve-in-valve replacement is an established therapy for intermediate and high-risk patients with degenerated bioprostheses, but restricted transcatheter valve (THV) expansion within rigid surgical frames and elevated gradients have raised durability concerns. This study aimed to evaluate midterm outcomes of mitral valve-in-valve patients according to THV expansion and sizing strategy. METHODS: Patients who underwent mitral valve-in-valve with balloon-expandable valves at Mayo Clinic Rochester between 2014 and 2023 were retrospectively analyzed. THV expansion (inflow, waist, outflow) was measured from procedural fluoroscopy and indexed to nominal size, with zero indicating expansion to nominal dimensions. Median index values were used as subgroup cutoffs to compare the incidence of the primary composite outcome of all-cause mortality, heart failure readmission, and valve reintervention. RESULTS: The analysis included 80 patients with a median follow-up of 2.5 years. A total of 53 (66%) valves were underexpanded across all 3 sizes, with median inflow, waist, and outflow expansion indices of −10.2, −16.2, and −3.2, respectively. Across all indices, THV expansion closer to nominal size was associated with lower rates of the primary outcome ( P <0.05). Greater expansion correlated with a larger mitral valve area and lower transvalvular mean gradient. Oversized THVs were significantly less expanded and had a higher incidence of the primary composite outcome compared with recommended-size THVs ( P =0.02). CONCLUSIONS: THV underexpansion in degenerated mitral bioprostheses is common and associated with elevated gradients and worse midterm outcomes. Further research is warranted to define THV expansion targets and improve outcomes following mitral valve-in-valve intervention.

BACKGROUND: While initial data for transcatheter aortic valve replacement (TAVR) in aortic stenosis patients with mitral stenosis (MS) suggested a poor short-term prognosis, outcomes for contemporary balloon-expandable valves remain unknown. The aim of this retrospective multicenter registry study was to compare the potential impact of MS on TAVR outcomes with balloon-expandable valves. METHODS: Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry and Centers for Medicare & Medicaid Services claims data were used to obtain a cohort of 327 925 patients who underwent TAVR with current balloon-expandable valves (SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra Resilia) between June 2015 and December 2022 across 791 sites. Severe MS (defined as >10 mm Hg mean gradient or <1.5 cm 2 area) was compared with mild or less MS (defined as <5 mm Hg mean gradient and >2 cm 2 area) using propensity matching to minimize confounding variables. RESULTS: Patients with severe MS (n=8500; 2.6%) had a higher number of comorbid conditions, Society of Thoracic Surgeons risk scores, and were more often women than patients with mild or less MS at the time of index TAVR. While patients with severe MS had worse outcomes at 30 days, when propensity-matched, patients exhibited similar 30-day rates of death (3.2% versus 3.0%), stroke (2.4% versus 2.2%), major vascular complications (1.6% versus 1.6%), device implant success (98.9% versus 99.2%), and new dialysis (0.7% versus 0.5%), with higher rates of pacemaker implantation (11.3% versus 9.4%; P <0.001). By 1 year, there was no difference in the change in the KCCQ (Kansas City Cardiomyopathy Questionnaire) overall score from baseline to 1 year (30.7±27.0 versus 31.9±27.0; P =0.07). By 3 years, an increase in the mortality rate (45.1% versus 40.9%; P <0.001) of patients with severe MS was observed. CONCLUSIONS: MS in isolation is not associated with worsened short-term outcomes among patients undergoing contemporary TAVR with balloon-expandable valves.

BACKGROUND: Previous transcatheter valve therapy registry analyses of transcatheter mitral valve in valve (MViV) replacement of degenerated bioprosthesis reported early experience in the United States. Given recent increases in transseptal MViV volumes and introduction of the SAPIEN 3 Ultra valve, it is important to determine contemporary outcomes for patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV replacement. METHODS: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry was used to extract data for all patients undergoing transseptal SAPIEN 3/SAPIEN 3 Ultra MViV from 2015 to September 2022. Primary efficacy outcome was 1-year all-cause mortality. Secondary end points included 30-day mortality, functional class, quality of life, and mitral valve performance. Primary safety outcomes were device success and in-hospital complications. RESULTS: A total of 4243 patients with a mean±SD STS score of 9.2±7.7 underwent transseptal MViV at 455 sites. The rate of Mitral Valve Academic Research Consortium technical (96.6%) success was high, and procedural complications were low. All-cause in-hospital, 30-day, and 1-year mortality rates were 3.2%, 4.3%, and 13.4%, respectively. Significant improvements in New York Heart Association class (New York Heart Association I/II, 18% to 87%) and quality of life (Kansas City Cardiomyopathy Questionnaire score, 38 to 78) were noted at 1 year ( P <0.0001 for both) after MViV. Upon stratifying by STS scores, it was observed that the low-risk group (STS<4) had a significantly lower in-hospital mortality rate of 0.4%, whereas the intermediate-risk group (STS, 4–8) had an in-hospital mortality rate of 1.9%. From 2015 to 2022, the number of transseptal MViV cases/year increased significantly, whereas procedure times, length of stay, and intensive care unit hours shortened significantly. At the same time, there was a significant trend toward reduced in-hospital ( P =0.0005), 30-day ( P =0.004), and 1-year mortality rates ( P =0.01). CONCLUSIONS: This multicenter, prospective study reports excellent procedural outcomes, acceptable 1-year mortality rates, and a significant improvement in quality of life for patients undergoing transseptal MViV in the contemporary era. Patients in the low-risk and intermediate-risk STS score categories had significantly better outcomes compared with those in the high-risk category. MViV is a reasonable therapy for the majority of patients with degenerated bioprosthetic mitral valves, who are anatomical candidates.

BACKGROUND: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03193801.

Background Previous studies have shown that women with hypertrophic obstructive cardiomyopathy (HCM) have worse long‐term outcomes irrespective of intervention. However, the outcomes of patients undergoing alcohol septal ablation (ASA) based on sex have not been described. Hence, this study aimed to evaluate pressure changes and long‐term mortality in patients with HCM undergoing ASA based on sex. Methods and Results This is a single‐center retrospective study evaluating hemodynamic changes and long‐term mortality in patients with HCM treated with ASA according to sex. A total of 259 patients were included (aged 68.4±11.9 years, 62.2% women). Women had higher age and baseline pressures at the time of ASA, with a greater percent reduction in mean left atrial pressure (men versus women: 2.2% versus 15.9%, respectively; P =0.02). Women had better survival (median survival rate of men versus women: 8.6 versus 12.5 years, respectively; P =0.011). On Cox multivariable regression, predictors of mortality were age (per group change <60 years, 61–70 years, 71–80 years, and >80 years; hazard ratio [HR], 1.45 [95% CI, 1.10–1.91], P =0.008), female sex (HR, 0.59 [95% CI, 0.35–0.99], P =0.048), chronic kidney disease (HR, 1.88 [95% CI, 1.06–3.33], P =0.031), and left ventricular outflow tract gradient reduction ≤86% (HR, 1.91 [95% CI, 1.14–3.19], P =0.014). Conclusions Women with HCM undergoing ASA are older and have higher left‐sided baseline pressures compared with men yet have better survival. Further studies exploring the mechanisms of differential outcomes according to sex in patients with HCM undergoing ASA are needed.

Background Aortic valve calcium score is associated with hemodynamic severity of aortic stenosis. Whether this association is present in calcific mitral stenosis remains unknown. Methods and Results This study was a retrospective analysis of consecutive patients with mitral stenosis secondary to mitral annular calcification (MAC) undergoing transseptal catheterization. All patients underwent invasive mitral valve assessment via direct left atrial and left ventricular pressure measurement. Computed tomography within 1 year of cardiac catheterization and with adequate visualization of the mitral annulus was included. MAC calcium score quantification by Agatston method was obtained offline using dedicated software (Aquarius, TeraRecon, V.4). Median patient age was 66.9±11.2 years, 47% of patients were women, 50% had coronary artery disease, 40% had atrial fibrillation, 47% had prior cardiac surgery, and 33% had prior chest radiation. Median diastolic mitral valve gradient was 9.4±3.4 mm Hg on echocardiography and 8.5±4 mm Hg invasively. Invasive median mitral valve area using the Gorlin formula was 1.87±0.9 cm 2 . Median MAC calcium score for the cohort was 7280±7937 Hounsfield units. MAC calcium score correlated with the presence of atrial fibrillation ( P =0.02) but was not associated with other comorbidities. There was no correlation between MAC calcium score and mitral valve area ( r =0.07; P =0.6) or mitral valve gradient ( r =−0.03; P =0.8). Conclusions MAC calcium score did not correlate with invasively measured mitral valve gradient and mitral valve area in patients with MAC‐related mitral stenosis, suggesting that calcium score should not be used as a surrogate for invasive hemodynamic parameters.

Background Racial and ethnic disparities in outcomes exist following many cardiac procedures. Transcatheter mitral valve replacement (TMVR) has grown as an alternative to mitral valve surgery for patients at high surgical risk. The outcomes of TMVR by race and ethnicity are unknown. We aimed to evaluate racial and ethnic disparities in the outcomes of TMVR. Methods and Results We analyzed the National Inpatient Sample database from 2016 to 2020 to identify hospitalizations for TMVR. Racial and ethnic disparities in TMVR outcomes were determined using logistic regression models. Between 2016 and 2020, 5005 hospitalizations for TMVR were identified, composed of 3840 (76.7%) White race, 505 (10.1%) Black race, 315 (6.3%) Hispanic ethnicity, and 345 (6.9%) from other races (Asian, Pacific Islander, American Indian or Alaska Native, Other). Compared with other racial and ethnic groups, Black patients were significantly younger and more likely to be women (both P <0.01). There were no significant differences between White, Black, and Hispanic patients in in‐hospital mortality (5.2% versus 5.0% versus <3.5%; P =0.89) and procedural complications, including heart block ( P =0.91), permanent pacemaker ( P =0.49), prosthetic valve dysfunction ( P =0.45), stroke ( P =0.37), acute kidney injury ( P =0.32), major bleeding ( P =0.23), and blood transfusion ( P =0.92), even after adjustment for baseline characteristics. Adjusted vascular complications were higher in Black compared with White patients ( P =0.03). Trend analysis revealed a significant increase in TMVR in all racial and ethnic groups from 2016 to 2020 ( P trend <0.05). Conclusions Between 2016 and 2020, Black and Hispanic patients undergoing TMVR had similar in‐hospital outcomes compared with White patients, except for higher vascular complications in Black patients. Further comparative studies of TMVR in clinically similar White patients and other racial and ethnic groups are warranted to confirm our findings.

Background: Left ventricular outflow tract obstruction may occur following transcatheter mitral valve replacement in the setting of mitral annular calcification. Methods: We present a case series whereby preemptive septal radiofrequency ablation (RADIO-TMVR) was used to augment the left ventricular outflow tract for transcatheter mitral valve replacement in 4 patients at risk for left ventricular outflow tract obstruction despite alcohol septal ablation. Results: All patients were female, average age of 74.9 (68.8–80.4) years. Baseline ejection fraction was 71% (63%–75%). Mean mitral valve area was 1.28 (range, 1.0–1.59) cm 2 . Mean mitral valve gradient at rest was 9.5 (range, 7–11) mm Hg. New York Heart Association symptoms were III to IV at baseline. Patients underwent preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement a range between 69 and 154 days after alcohol septal ablation. Procedural time was 384 (337–424) minutes with a fluoroscopic time of 31 (14–71) minutes. Radiofrequency ablation time was 132 (100–175) minutes. As anticipated, 3 patients developed complete heart block and underwent pacemaker implantation, whereas 1 had a preexisting pacemaker. One patient developed groin hematoma and heart failure exacerbation. There were no peri-procedural deaths. Preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement resulted in septal end-diastolic wall thickness reduction compared with baseline (28.6%, 30.4%, 30.3%, and 11.1%) and following alcohol septal ablation (23.1%, 12%, 8.5%). Valve replacement in the setting of mitral annular calcification was performed in all patients 89 (range, 38–45) days after preemptive septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement. Two patients had concomitant laceration of the anterior mitral leaflet to further augment the neo-left ventricular outflow tract. Postprocedure, New York Heart Association symptoms improved to class I (3 patients) and class II (1 patient). Conclusions: In at-risk individuals, preemptive septal radiofrequency ablation may be an effective strategy at preventing left ventricular outflow tract obstruction with transcatheter mitral valve replacement.