Última generación de prótesis percutáneas expandibles con balón y autoexpandibles en la estenosis aórtica bicúspide: estudio TRITON / Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study

Introducción y objetivos: La última generación de válvulas cardiacas expandibles con balón y autoexpandibles para implante percutáneo no se han comparado en valvulopatía aórtica bicúspide (VAB).Métodos: Registro multicéntrico de pacientes consecutivos con VAB y estenosis grave tratados con las válvulas cardiacas expandibles con balón (Myval y SAPIEN 3 Ultra [S3U]) o autoexpandible Evolut PRO+(EP+). Se realizó un análisis de tripletes mediante el software TriMatch para minimizar el impacto de las diferencias basales. El objetivo primario del estudio fue evaluar la tasa de éxito del dispositivo a 30 días y los objetivos secundarios, el objetivo combinado de seguridad y sus componentes individuales a 30 días.Resultados: Se incluyó a 360 pacientes (media de edad, 76,6±7,6 años; el 71,9% varones); 122 con Myval (33,9%), 129 con S3U (35,8%) y 109 con EP+(30,3%). La media de puntuación STS fue de 3,6±1,9%. No hubo ningún caso de oclusión coronaria, rotura de anillo, disección aórtica o mortalidad periprocedimiento. El evento primario de éxito del dispositivo a 30-días fue significativamente superior en el grupo que recibió Myval (Myval, 100%; S3U, 87,5%, y EP+, 81,3%), fundamentalmente a expensas de mayor gradiente residual con S3U y mayor tasa de insuficiencia aórtica al menos moderada con EP+. La tasa no ajustada de implante de marcapasos no presentó diferencias significativas.Conclusiones: En la VAB con estenosis grave y cirugía contraindicada, Myval, S3U y EP+tuvieron una seguridad comparable, aunque Myval presentó mejor gradiente residual que S3U y ambos dispositivos expandibles con balón resultaron en menos fuga perivalvular residual que EP+. Por lo tanto, ajustándose a los riesgos específicos de cada paciente, se puede seleccionar cualquiera de los 3 dispositivos con resultados óptimos.(AU)

Introduction and objectives: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis.Methods: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days.Results: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation.Conclusions: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.(AU)

Current Status and Future Prospects of Transcatheter Mitral Valve Replacement: JACC State-of-the-Art Review.

Mitral regurgitation (MR) is the most prevalent valvular heart disease and, when left untreated, it confers a poorer prognosis. Catheter-based repair therapies face some limitations like their applicability on challenging anatomies and the potential recurrence of significant MR over time. Transcatheter mitral valve replacement (TMVR) has emerged as a less invasive approach potentially overcoming some of the current limitations associated with transcatheter mitral valve repair. Several devices are under clinical investigation, and a growing number of systems allow for a fully percutaneous transfemoral approach. In this review, the authors aimed to delineate the main challenges faced by the TMVR field, to highlight the key aspects for procedural planning, and to describe the clinical results of the TMVR systems under clinical investigation. Finally, they also discuss what the future perspectives are for this emerging field.

Early commercial experience with a newly designed balloon-expandable transcatheter heart valve: 30-day outcomes and implications of preprocedural computed tomography.

OBJECTIVES: We herein report a single-centre experience with the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve implantation (TAVI) system. METHODS: Between March 2019 and January 2020, a total of 79 consecutive patients received transfemoral TAVI using the SAPIEN 3 Ultra device. Data were retrospectively analysed according to updated Valve Academic Research Consortium-2 definitions. Detailed analysis of multislice computed tomography data was conducted to identify potential predictors for permanent pacemaker (PPM) implantation and residual paravalvular leakage (PVL) post TAVI. RESULTS: Device success and early safety were 97.5% (77/79) and 94.9% (75/79) with resulting transvalvular peak/mean pressure gradients of 21.1 ± 8.2/10.9 ± 4.4 and PVL >mild in 0/79 patients (0%). Mild PVL was seen in 18.9% (15/79) of cases. Thirty-day mortality was 2.5% (2/79). The Valve Academic Research Consortium-2 adjudicated clinical end points disabling stroke, acute kidney injury and myocardial infarction occurred in 1.3% (1/79), 5.1% (4/79) and 0% (0/79) of patients. Postprocedural PPM implantation was necessary in 7.6% (6/79) of patients. Multislice computed tomography analysis revealed significantly higher calcium amounts of the right coronary cusp in patients in need for postprocedural PPM implantation and a higher eccentricity index in patients with postinterventional mild PVL. CONCLUSIONS: First experience with this newly designed balloon-expandable-transcatheter heart valve demonstrates adequate 30-day outcomes and haemodynamic results with low mortality, low rates of PPM implantation and no residual PVL >mild. The herein-presented multislice computed tomography values with an elevated risk for PPM implantation and residual mild PVL may help to further improve outcomes with this particular transcatheter heart valve in TAVI procedures.

Recent Progress Toward Clinical Translation of Tissue-Engineered Heart Valves.

Surgical replacement remains the primary option to treat the rapidly growing number of patients with severe valvular heart disease. Although current valve replacements-mechanical, bioprosthetic, and cryopreserved homograft valves-enhance survival and quality of life for many patients, the ideal prosthetic heart valve that is abundantly available, immunocompatible, and capable of growth, self-repair, and life-long performance has yet to be developed. These features are essential for pediatric patients with congenital defects, children and young adult patients with rheumatic fever, and active adult patients with valve disease. Heart valve tissue engineering promises to address these needs by providing living valve replacements that function similarly to their native counterparts. This is best evidenced by the long-term clinical success of decellularised pulmonary and aortic homografts, but the supply of homografts cannot meet the demand for replacement valves. A more abundant and consistent source of replacement valves may come from cellularised valves grown in vitro or acellular off-the-shelf biomaterial/tissue constructs that recellularise in situ, but neither tissue engineering approach has yet achieved long-term success in preclinical testing. Beyond the technical challenges, heart valve tissue engineering faces logistical, economic, and regulatory challenges. In this review, we summarise recent progress in heart valve tissue engineering, highlight important outcomes from preclinical and clinical testing, and discuss challenges and future directions toward clinical translation.

Current Indications for Transcatheter Mitral Valve Replacement Using Transcatheter Aortic Valves: Valve-in-Valve, Valve-in-Ring, and Valve-in-Mitral Annulus Calcification.

Use of transcatheter mitral valve replacement (TMVR) using transcatheter aortic valves in clinical practice is limited to patients with failing bioprostheses and rings or mitral valve disease associated with severe mitral annulus calcification. Whereas the use of valve-in-valve TMVR appears to be a reasonable alternative to surgery in patients at high surgical risk, much less evidence supports valve-in-ring and valve-in-mitral annulus calcification interventions. Data on the results of TMVR in these settings are derived from small case series or voluntary registries. This review summarizes the current evidence on TMVR using transcatheter aortic valves in clinical practice from the characteristics of the TMVR candidates, screening process, performance of the procedure, and description of current results and future perspectives. TMVR using dedicated devices in native noncalcified mitral valve diseases is beyond the scope of the article.

Incidence, Risk Factors, and Outcomes of Coronary Obstruction Following Valve-in-Valve Transcatheter Aortic Valve Replacement.

There is scant information about the incidence, risk factors, and outcomes of coronary obstruction (CO) following valve-in-valve transcatheter aortic valve replacement (VIV-TAVR). A meta-analysis of the published studies from January 2000 to April 2020 was conducted, and the endpoint was CO. A total of 2858 patients were enrolled in this study. The mean age was 77.7 ± 9.8, and 39.9% of them were female. The Society of Thoracic Surgeons (STS) score, European System for Cardiac Operative Risk Evaluation (EuroSCORE), and Logistic EuroSCORE were 8.9 ± 7.8, 16.0 ± 10.9, and 26.3 ± 16.3, respectively. The overall incidence of CO was 2.58%. CO incidence between patients with prior stented and stentless valves were significantly different (1.67% versus 7.17%), with an odds ratio (OR) of 0.25 and a 95% confidence interval (CI) of 0.14-0.44 (P < 0.00001). The first-generation valves were significantly associated with higher CO incidence compared with the second-generation valves (7.09% versus 2.03%; OR, 2.44; 95%CI, 1.06-5.62; P = 0.04), while no statistical difference was found between self-expandable valves and balloon-expandable valves (2.45% versus 2.60%; OR, 0.99; 95%CI, 0.55-1.79; P = 0.98). Virtual transcatheter to coronary ostia (VTC) distance (3.3 ± 2.1 mm, n = 29 versus 5.8 ± 2.4 mm, n = 169; mean difference, -2.70; 95%CI, -3.46 to -1.95; P < 0.00001) and the sinus of Valsalva (SOV) diameter (27.5 ± 3.8 mm, n = 23 versus 32.3 ± 4.0 mm, n = 101; mean difference, -3.80; 95%CI, -6.55 to -1.05; P = 0.007) were enormously shorter in patients with CO. The 24-hour, in-hospital, and 30-day mortality of patients with CO were 10.5%, 30.8%, and 37.1%, respectively. In conclusion, device selections, VTC distances, and SOV diameters may be important factors in assessing the CO risk in VIV-TAVR.

Trends in MitraClip, mitral valve repair, and mitral valve replacement from 2000 to 2016.

OBJECTIVE: The dissemination of mitral valve repair as the first-line treatment and the introduction of MitraClip for patients who have a prohibitive risk for surgery have changed the landscape of mitral valve intervention. The aim of this study is to provide current and generalizable data regarding the trend of mitral valve interventions and outcomes from 2000 to 2016. METHODS: Patients ≥18 years of age who underwent mitral-valve interventions were identified using the National Inpatient Sample database. National estimates were generated by means of discharge weights; comorbid conditions were identified using Elixhauser methods. All trends were analyzed with JoinPoint software. RESULTS: A total of 656,030 mitral valve interventions (298,102 mitral valve replacement, 349,053 mitral valve repair, and 8875 MitraClip) were assessed. No changes in rate of procedures (per 100,000 people in the United States) were observed over this period (annual percent change, -0.4; 95% confidence limit, -1.1 to 0.3; P = .3). From 2000 to 2010, the number of replacements decreased by 5.6% per year (P < .001), whereas repair increased by 8.4% per year from 2000 to 2006 (P < .001). MitraClip procedures increased by 84.4% annually from 2013 to 2016 (P < .001). The burden of comorbidities increased throughout the study for all groups, with the greatest score for MitraClip recipients. Overall, length of stay has decreased for all interventions, most significantly for MitraClip. In-hospital mortality decreased from 8.5% to 3.7% for all interventions, with MitraClip having the most substantial decrease from 3.6% to 1.5%. CONCLUSIONS: Over a 17-year period, mitral-valve interventions were associated with improved outcomes despite being applied to an increasingly sicker population.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial.

BACKGROUND: It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD. OBJECTIVES: This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry. METHODS: In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years. RESULTS: Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 ± 0.24% vs. 0.63 ± 0.16%), SVD-related BVF (0.58 ± 0.14% vs. 0.12 ± 0.07%), and all-cause (structural or nonstructural) BVF (0.81 ± 0.16% vs. 0.27 ± 0.10%) (p ≤ 0.01 for all). The 5-year rates of SVD (0.68 ± 0.18% vs. 0.60 ± 0.17%; p = 0.71), SVD-related BVF (0.29 ± 0.12% vs. 0.14 ± 0.08%; p = 0.25), and all-cause BVF (0.60 ± 0.15% vs. 0.32 ± 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts. CONCLUSIONS: Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A [PARTNERII A]; NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - PARTNER II - PARTNERII - S3 Intermediate [PARTNERII S3i]; NCT03222128).

Similarity measures and attribute selection for case-based reasoning in transcatheter aortic valve implantation.

In a clinical decision support system, the purpose of case-based reasoning is to help clinicians make convenient decisions for diagnoses or interventional gestures. Past experience, which is represented by a case-base of previous patients, is exploited to solve similar current problems using four steps-retrieve, reuse, revise, and retain. The proposed case-based reasoning has been focused on transcatheter aortic valve implantation to respond to clinical issues pertaining vascular access and prosthesis choices. The computation of a relevant similarity measure is an essential processing step employed to obtain a set of retrieved cases from a case-base. A hierarchical similarity measure that is based on a clinical decision tree is proposed to better integrate the clinical knowledge, especially in terms of case representation, case selection and attributes weighting. A case-base of 138 patients is used to evaluate the case-based reasoning performance, and retrieve- and reuse-based criteria have been considered. The sensitivity for the vascular access and the prosthesis choice is found to 0.88 and 0.94, respectively, with the use of the hierarchical similarity measure as opposed to 0.53 and 0.79 for the standard similarity measure. Ninety percent of the suggested solutions are correctly classified for the proposed metric when four cases are retrieved. Using a dedicated similarity measure, with relevant and weighted attributes selected through a clinical decision tree, the set of retrieved cases, and consequently, the decision suggested by the case-based reasoning are substantially improved over state-of-the-art similarity measures.

Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies.

Aim of the present analysis was to collect and pool all available data currently in the literature regarding outcomes and complications of all approved TAVR prosthesis and to assess the transition from first to next generation TAVR devices by directly comparing both in regard of procedure related complications. Transcatheter aortic valve replacement is a well established treatment modality in patients with severe aortic stenosis deemed to be inoperable or at unacceptable risk for open heart surgery. First generation prostheses were associated with a high rate of peri-procedural complications like paravalvular regurgitation, valve malpositioning, vascular complications and conduction disorders. Refinement of the available devices incorporate features to address the limitations of the first-generation devices. A PRISMA checklist-guided systematic review and meta-analysis of prospective observational studies, national and device specific registries or randomized clinical trials was conducted. Studies were identified by searching PUBMED, SCOPUS, Cochrane Central Register of Controlled Trials and LILACs from January 2000 to October 2017. We extracted and pooled data on both mortality and complications from 273 studies for twelve different valves prostheses in a total of 68,193 patients. In second generation prostheses as compared to first generation devices, we observed a significant decrease in mortality (1.47 ± 1.73% vs. 5.41 ± 4.35%; p < 0.001), paravalvular regurgitation (1.75 ± 2.43vs. 12.39 ± 9.38, p < 0.001) and MACE. TAVR with contemporary next generation devices has led to an impressive improvement in TAVR safety driven by refined case selection, improved procedural techniques and increased site experience.

Contemporary trends in mitral valve surgery in East China: a 10-year experience.

BACKGROUND: Contemporary nationwide data from mainland China on trends in mitral valve surgery are scarce. The purpose of the present study was to review a single-center experience with mitral valve surgery over a 10-year period in East China. METHODS: Between July 2009 and June 2019, 3238 consecutive patients who underwent mitral valve surgery in our center were retrospectively reviewed. The patients were evenly divided into three periods: July 2009 to October 2012 (period I), November 2012 to February 2016 (period II), March 2016 to June 2019 (period III). RESULTS: The 3238 patients included 536 (16.6%) who had mitral valve repair and 2702 (83.4%) who had mitral valve replacement. Early mortalities for mitral valve repair and mitral valve replacement were 0.2% and 0.9%, respectively. There were trends towards a higher proportion of degenerative valve lesions (24.6%, 35.8%, 54.7% in periods I, II, and III, respectively) and a lower proportion of rheumatic valve lesions (71.0%, 62.6%, 38.0%) in more recent years. The proportions of minimally invasive surgery (0.7%, 2.1%, 30.2%), mitral valve repair (8.3%, 15.4%, 27.5%), use of a bioprosthesis (10.1%, 17.0%, 23.1%), and concomitant tricuspid valve procedures (13.2%, 28.5%, 46.0%) increased dramatically, while early mortality remained constant during the 10-year period (1.0%, 0.3%, 0.9%). CONCLUSIONS: In the past 10 years, the spectrum of mitral valve disease experienced a trend towards more degenerative valve lesions and less rheumatic valve lesions in East China. Mitral valve repair, bioprostheses, tricuspid valve repair, and minimally invasive surgery have been more often applied in recent years.

Impact of Transcatheter Aortic Valve Replacement on Risk Profiles of Surgical Aortic Valve Replacement Patients.

BACKGROUND: The advent of transcatheter aortic valve replacement (TAVR) has changed which patients undergo surgical aortic valve replacement (SAVR). We sought to understand the impact of TAVR on the characteristics of SAVR patients in the United States. METHODS: A cohort of 2959 patients who underwent isolated SAVR at 11 US hospitals that perform both TAVR and SAVR from 2013 through 2017 were grouped by the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database version (v)2.73 (2011-2014), v2.81 (2014-2017), and v2.9 (2017) to assess temporal trends in patient characteristics. RESULTS: Over time, SAVR patients were younger with fewer preoperative comorbidities. There was a significant decrease in median STS predicted risk of mortality (PROM) score (2.0 vs. 1.8 vs. 1.3, p < 0.001, in v2.73 vs. v2.81 vs. v2.9). Specifically, there were fewer high-risk (STS PROM > 8%: 4.3% vs. 4.7% vs. 1.2%, p = 0.03) and intermediate-risk (STS PROM 4% to 8%: 16.3% vs. 11.7% vs. 4.3%, p < 0.001) patients. The proportion of patients with bicuspid aortic valve disease increased significantly (11.2% vs. 26.9% vs. 36.6%, p < 0.001). There were no differences in operative mortality (1.9% vs. 2.1% vs. 1.4%, p = 0.75). CONCLUSIONS: The introduction of TAVR has already impacted the demographics, clinical characteristics and risk profiles of patients undergoing SAVR in the US. Now that TAVR is approved for low-risk patients, SAVR is likely to be reserved for younger patients who are willing to receive a mechanical valve and for patients with aortopathy, coronary artery disease, or concomitant mitral or tricuspid pathology.

Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study.

BACKGROUND: Subclinical leaflet thrombosis has been reported after bioprosthetic aortic valve replacement, characterized using 4-dimensional computed tomographic imaging by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM). The incidence and clinical implications of these findings remain unclear. OBJECTIVES: The aim of this study was to determine the frequency, predictors, and hemodynamic and clinical correlates of HALT and RLM after aortic bioprosthetic replacement. METHODS: A prospective subset of patients not on oral anticoagulation enrolled in the Evolut Low Risk randomized trial underwent computed tomographic imaging 30 days and 1 year after transcatheter aortic valve replacement (TAVR) or surgery. The primary endpoint was the frequency of HALT at 30 days and 1 year, analyzed by an independent core laboratory using standardized definitions. Secondary endpoints included RLM, mean aortic gradient, and clinical events at 30 days and 1 year. RESULTS: At 30 days, the frequency of HALT was 31 of 179 (17.3%) for TAVR and 23 of 139 (16.5%) for surgery; the frequency of RLM was 23 of 157 (14.6%) for TAVR and 19 of 133 (14.3%) for surgery. At 1 year, the frequency of HALT was 47 of 152 (30.9%) for TAVR and 33 of 116 (28.4%) for surgery; the frequency of RLM was 45 of 145 (31.0%) for TAVR and 30 of 111 (27.0%) for surgery. Aortic valve hemodynamic status was not influenced by the presence or severity of HALT or RLM at either time point. The rates of HALT and RLM were similar after the implantation of supra-annular, self-expanding transcatheter, or surgical bioprostheses. CONCLUSIONS: The presence of computed tomographic imaging abnormalities of aortic bioprostheses were frequent but dynamic in the first year after self-expanding transcatheter and surgical aortic valve replacement, but these findings did not correlate with aortic valve hemodynamic status after aortic valve replacement in patients at low risk for surgery. (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).

Contemporary Outcomes of Surgical Aortic Valve Replacement in Japan.

BACKGROUND: Given the rapid expansion in the use of transcatheter aortic valve implantation (TAVI), recent outcomes of surgical aortic valve replacement (SAVR) should be re-evaluated.Methods and Results:Using the data from the Japan Cardiovascular Surgery Database of 160 enrolled hospitals, trends in elective isolated SAVR were evaluated until the introduction of TAVI in Japan. Trend analyses were performed over 4 periods: period 1, 2008-2009 (4,415 cases); period 2, 2010-2011 (4,861 cases); period 3, 2012-2013 (5,674 cases); and period 4, 2014-2015 (5,563 cases). Baseline risk, evaluated on JapanSCORE, increased significantly over the 4 periods, from a median of 1.56 (IQR, 0.99-2.61) in period 1 to 2.08 (IQR, 1.33-3.96) in period 4 (P<0.001, trend test). Despite the increased risk, the composite major complication and operative mortality rate decreased significantly (10.7% in period 1 to 9.2% in period 4, P=0.01). Using a risk-adjusted model, the OR of operative mortality was 1.61 (95% CI: 1.29-2.02) in period 1 (P<0.0001) compared with period 4. An increase in the use of bioprostheses was also observed, from 60.4% to 76.8% (P<0.001) over the 4 periods. CONCLUSIONS: Even in a short 8-year period, SAVR outcomes improved in Japan. This should be taken into account when discussing the indications for aortic valve intervention.

Gender-related differences in patients undergoing transcatheter mitral valve interventions in clinical practice: 1-year results from the German TRAMI registry.

OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population. METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates. CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.