Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation.

AIMS: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone. METHODS AND RESULTS: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03). CONCLUSION: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.

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.

Diagnosis and staging of cardiac masses: additional value of CMR with 18F-FDG-PET compared to CMR with CECT.

PURPOSE: Characterization of malignant cardiac masses is usually performed with cardiac magnetic resonance (CMR) and staging with whole-body contrast-enhanced computed tomography (CECT). In this study, our objective was to evaluate the role of 18Fluor-fluorodeoxyglucose positron emission tomography (18F-FDG-PET) with CMR for both characterization and staging of cardiac masses. METHODS: Patients with cardiac masses who underwent CMR, CECT, and 18F-FDG-PET were retrospectively identified. For the characterization of cardiac masses, we calculated the respective performances of CMR alone, 18F-FDG-PET alone, and the combination of 18F-FDG-PET and CMR. For staging, we compared head-to-head the respective performances of 18F-FDG-PET and CECT. Histology served as gold standard for malignancy, and response to anticoagulation for thrombus. RESULTS: In a total of 28 patients (median age 60.5 years, 60.7% women), CMR accurately distinguished malignant from benign masses with sensitivity (Se) of 86.7%, specificity (Sp) of 100%, positive predictive value (PPV) of 100%, negative predictive value (NPV) of 86.7%, and accuracy of 92.9%. 18F-FDG-PET demonstrated 93.3% Se, 84.6% Sp, 87.5% PPV, 91.7% NPV, and 89.3% accuracy. Combining CMR with 18F-FDG-PET allowed to benefit from the high sensitivity of 18F-FDG-PET (92.9%) and the excellent specificity of CMR (100%) for malignant diseases. For staging, 18F-FDG-PET outperformed CECT on per-patient (66.7% vs 55.6% correct diagnosis, respectively), per-organ (10 vs 7 organs, respectively), and per-lesion basis (> 29 vs > 25 lesions, respectively). CONCLUSION: Combining 18F-FDG-PET with CMR improved the characterization of cardiac masses compared to each modality alone. Additionally, the diagnostic performance of 18F-FDG-PET was better than CECT for staging. This study suggests that the combination of CMR and 18F-FDG-PET is the most effective for the characterization of cardiac masses and the staging of these lesions.

Causes and predictors of mortality after transcatheter mitral valve implantation in patients with severe mitral annulus calcification.

OBJECTIVES: To evaluate the causes and predictors of mortality after valve-in-mitral annulus calcification (MAC) transcatheter mitral valve implantation (TMVI). BACKGROUND: Conventional surgical mitral valve replacement is associated with a high risk in patients with mitral valve disease associated with severe MAC. In this population, TMVI may be an attractive alternative option. However, its prognostic factors are poorly understood. METHODS: All patients undergoing valve-in-MAC TMVI from 2013 to 2018 in our center were included. Indication for TMVI relied on the judgment of the local heart team. Patients were followed at 30 days and 1 year. RESULTS: A total of 34 patients underwent valve-in-MAC TMVI. The mean age was 79 ± 11 years and 73% of patients were women. Their mean EuroSCORE 2 was 8 ± 7%. The transseptal approach was used in 79% of patients and a hybrid transatrial in 29%. Balloon expandable transcatheter heart valves were used in all the patients. Technical success was achieved in 76% of the patients. Thirty-day and 1-year all-cause mortality rates were 14.7% and 32.4%, respectively. The main two causes of 1-year mortality were congestive heart failure (8.8%) and infective endocarditis (5.9%). In multivariate analysis, the only predictor of 1-year mortality was the presence of periprothetic mitral regurgitation grade 2 (HR, 5.69; 95%CI, 1.59-27.88, p = 0.032). CONCLUSION: Early and mid-term mortality remains high after valve-in-MAC TMVI and seems to be associated with the presence of paravalvular mitral regurgitation. However, whether the latter is a prognostic factor or marker remains to be determined to improve clinical outcomes in this high-risk population.

Clinical and haemodynamic outcomes of balloon-expandable transcatheter mitral valve implantation: a 7-year experience.

Aims: We analysed the early and long-term clinical and haemodynamic outcomes of balloon-expandable transcatheter mitral valve implantation (TMVI) in an experienced centre. Methods and results: All patients undergoing TMVI from July 2010 to July 2017 in our centre were prospectively included. Indication for TMVI relied on the judgement of the local heart team. Patients were followed at 1 month, 1 year, and yearly thereafter. A total of 91 patients underwent TMVI. The median age was 73 (57-81) years and 70% of patients were women. Patients were at high risk for surgery with a median EuroSCORE II of 9.6 (4.0-14.6) %. Indication for TMVI was bioprosthesis failure (valve-in-valve) in 37.3%, annuloplasty failure (valve-in-ring) in 33.0%, and severe mitral annulus calcification (MAC) in 29.7%. The transseptal approach was used in 92.3% of patients and balloon-expandable valves were used in all patients. Technical success was achieved in 84.6% of patients, one patient died during the procedure and haemodynamically significant left ventricular outflow tract obstruction occurred in three patients (3.3%). At 30 days, 7.7% of patients had died, without significant differences between groups, and a major stroke occurred in 2.2% of patients. The cumulative rates of all-cause mortality at 1-year and 2-year follow-up were 21.0% [95% confidence interval (CI) 9.9-38.8] and 35.7% (95% CI 19.2-56.5), respectively, with a higher late mortality in patients with MAC. The 2-year rates of re-intervention and valve thrombosis were 8.8% and 14.4%, respectively. At 6 months to 1 year, 68.9% of patients were in New York Heart Association Class I or II, and 90.7% of patients had mild or less mitral regurgitation. The mean transmitral gradient decreased from 9.3 ± 3.9 mmHg at baseline to 6.0 ± 2.3 mmHg at discharge (P < 0.001) without changes at 6-month to 1-year follow-up. Conclusion: Transcatheter mitral valve implantation using balloon-expandable valves in selected patients with bioprosthesis or annuloplasty failure or severe MAC was associated with a low rate of peri-procedural complications and acceptable long-term outcomes.

Feasibility of percutaneous mitral commissurotomy in patients with commissural mitral valve calcification.

AIMS: Whether a percutaneous mitral commissurotomy (PMC) should be attempted in patients with mitral stenosis (MS) and valvular calcification, especially located at the commissural level remained debated. We sought to evaluate the impact of the degree and location of mitral valve calcifications on PMC results. METHODS AND RESULTS: Over a 3-year period, we enrolled 464 consecutive patients who underwent a PMC at our institution. According to the location (within the body valve leaflets' or at the commissural level) and the degree of calcification, patients were divided into three groups: 261 patients were in Group 1 (no leaflets' or commissural calcification), 141 in Group 2 (leaflets' calcification with no significant commissural calcification), and 62 in Group 3 (at least one commissure significantly calcified). Final valve area (1.83 ± 0.26, 1.71 ± 0.25, and 1.60 ± 0.24 cm(2), P < 0.00001) and the rate of complete opening of at least one commissure (92, 94, and 84%, P = 0.05) were significantly different. However, the rate of post-PMC mitral regurgitation (MR) of grade ≥ 3 (10, 10, and 8%, P = 0.90) was not different among the groups and if the rate of good immediate result, defined as valve area ≥ 1.5 cm(2) with no MR >2/4 was different among the three groups (88, 78, and 73%, P = 0.004), an overallprocedural success could be achieved in most patients with calcified commissures. CONCLUSION: In this large contemporary series of patients with MS, a procedural success was obtained less frequently in patients with calcified commissure but a successful PMC could still be safely achieved in a large proportion of patients. Our results support the use of PMC as a first-line treatment of patients with severe MS even in the presence of significant commissural calcifications with otherwise favourable clinical characteristics.

Reinterventions after percutaneous mitral commissurotomy during long-term follow-up, up to 20 years: the role of repeat percutaneous mitral commissurotomy.

AIMS: We analysed reinterventions performed during long-term follow-up after percutaneous mitral commissurotomy (PMC) with a particular focus on freedom from mitral surgery and late results of repeat PMC. METHODS AND RESULTS: In 912 patients who had good immediate results of PMC (valve area ≥1.5 cm² with mitral regurgitation ≤2/4), we analysed survival without reintervention (surgery or repeat PMC) and survival without surgery alone, with a follow-up up to 20 years. The median age was 48 years, and 251 patients (27%) had calcified valves. During a median follow-up of 12 years, 351 patients (38%) underwent a reintervention: surgery was performed in 266 (76%) patients and repeat PMC in 85 (24%). Cardiovascular survival without reintervention (surgery or repeat PMC) was 38 ± 2% at 20 years. When analysing cardiovascular survival without surgery, this rate increased to 46 ± 2% at 20 years. In the 504 patients aged <50 years at the time of their initial PMC, 20-year rates were 45 ± 3% for cardiovascular survival without reintervention and 57 ± 3% for cardiovascular survival without surgery. Of the 85 patients who underwent repeat PMC, cardiovascular survival without surgery was 60 ± 7% at 10 years. CONCLUSION: After successful PMC, reintervention is frequently needed. However, almost half of the patients remained free from surgery at 20 years. Repeat PMC was performed in one out of four cases of reintervention in this study, thereby allowing for postponement of surgery in a substantial number of patients.

Comparison of Direct Oral Anticoagulants vs Vitamin K Antagonists After Transcatheter Mitral Valve Replacement.

BACKGROUND: There is currently no established recommendation for antithrombotic treatment following transcatheter mitral valve replacement (TMVR). However, based on the analogy with surgical mitral bioprosthesis, vitamin K antagonists (VKAs) are predominantly used. OBJECTIVES: The purpose of this study was to compare bleeding and thrombotic events associated with direct oral anticoagulants (DOACs) or VKAs in a prospective cohort of TMVR patients. METHODS: We enrolled consecutive patients who underwent transseptal TMVR using a SAPIEN family prosthesis at our center between 2011 and 2023. The primary outcome was the occurrence of bleeding. VKAs were administered to patients until October 2019, after which DOACs were prescribed. The median follow-up was 4.7 months (Q1-Q3: 2.6-6.7 months). RESULTS: A total of 156 patients were included. The mean age was 65 ± 18.5 years, and 103 patients (66%) were women. The median EuroSCORE II was 7.48% (Q1-Q3: 3.80%-12.97%). Of the participants, 20.5% received DOACs and 79.5% were treated with VKAs. The primary outcome was observed in 50 (40%) patients in the VKA group and 3 (9%) patients in the DOAC group (adjusted HR: 0.21; 95% CI: 0.06-0.74; P = 0.02). Treatment with DOAC was associated with a shorter length of hospital stay. No significant differences were found in terms of thrombotic events, major vascular complications, stroke, or death. CONCLUSIONS: The use of DOACs after TMVR, compared with VKAs, appears to reduce the risk of bleeding complications and decrease the length of hospital stay for patients, without a significant increase in the risk of thrombotic events.

Late results of percutaneous mitral commissurotomy up to 20 years: development and validation of a risk score predicting late functional results from a series of 912 patients.

BACKGROUND: Long-term follow-up after percutaneous mitral commissurotomy enables predictive factors of late results to be identified. METHODS AND RESULTS: Late results of percutaneous mitral commissurotomy were assessed in 1024 consecutive patients. Good immediate results, defined as valve area ≥1.5 cm(2) without mitral regurgitation >2/4, were obtained in 912 patients (89%). These 912 patients were randomly split into 2 cohorts comprising 609 and 303 patients that were used to develop and validate, respectively, a scoring system predicting late functional results. The 20-year rate of good functional results (survival without cardiovascular death, mitral surgery, or repeat percutaneous mitral commissurotomy and in New York Heart Association class I or II) was 30.2 ± 2.0%. A multivariable Cox model identified 7 predictive factors of poor late functional results: higher final mean gradient (P<0.0001), interaction between age and final mitral valve area (P<0.0001) showing that the impact of valve area decreases with age, interaction between sex and valve calcification (P<0.0001) showing that the impact of valve anatomy is stronger in men, and interaction between rhythm and New York Heart Association class showing an impact of New York Heart Association class only in patients in atrial fibrillation (P<0.0001). A 13-point score enabled 3 risk groups to be defined, corresponding to predicted good functional results of 55.1%, 29.1%, and 10.5% at 20 years in the validation cohort. CONCLUSIONS: Twenty years after percutaneous mitral commissurotomy in a population of patients with varied characteristics, 30% still had good functional results. Prediction of late functional results is multifactorial and strongly determined by age and the quality of immediate results. A simple validated scoring system is useful for estimating individual patient outcome.

Determinants of cerebral lesions in endocarditis on systematic cerebral magnetic resonance imaging: a prospective study.

BACKGROUND AND PURPOSE: Cerebral lesions are frequent complications of infective endocarditis (IE) and have a prognostic impact. Cerebral MRI identifies lesions in a high number of patients. However, their determinants have not been identified. The aim of the study was to define the determinants of cerebral lesions in patients with IE undergoing systematic cerebral MRI. METHODS: Determinants of ischemic lesions and of microbleeds were prospectively analyzed in 120 patients with left-sided IE, using systematic cerebral MRI. RESULTS: Median age was 60 years (interquartile range 51-72); IE occurred on a prosthetic valve in 37 patients (30.8%) and was due to Streptococci in 47 patients and Staphylococci in 36; 15 (12.5%) had neurological symptoms. MRI detected ischemic lesions in 64 patients (53.3%; territorial lesions in 32 and small lesions in 57) and microbleeds in 72 (60.0%). In multivariate analysis, ischemic lesions were associated with vegetation length (odds ratio 1.10/mm; 95% confidence interval 1.03-1.16; P=0.003) and Staphylococcus aureus IE (odds ratio 2.65; 95% confidence interval 1.01-6.96; P=0.05). A vegetation length >4 mm identified ischemic lesions with a sensitivity of 74.6% and a specificity of 51.5%. Microbleeds were associated with prosthetic IE (odds ratio 8.01; 95% confidence interval 2.58-24.90; P=0.0003) and not with prior anticoagulant therapy (P=0.67). CONCLUSIONS: Systematic cerebral MRI frequently detects ischemic lesions and microbleeds during acute IE. The high sensitivity of MRI shows that each millimeter increase in vegetation length is associated with a 10% increase in the rate of ischemic lesions. Conversely, microbleeds are associated only with prosthetic IE in this study. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00144885.

Emergent transcatheter mitral valve implantation: Early and mid-term outcomes.

BACKGROUND: Transcatheter mitral valve implantation (TMVI) may be attractive to treat high-risk patients with mitral bioprosthesis or annuloplasty ring failure or severe mitral annular calcification. AIM: To report the outcomes of patients after valve-in-valve/ring/mitral annular calcification TMVI using balloon expandable transcatheter aortic valves, according to the degree of urgency of the procedure. METHODS: All patients who underwent TMVI in our centre from 2010 to 2021 were classified into three groups: elective, urgent or emergent/salvage TMVI. RESULTS: A total of 157 patients were included: 129 (82.2%) had elective, 21 (13.4%) urgent and 7 (4.4%) had emergent/salvage TMVI. Patients with emergent/salvage TMVI had a higher EuroSCORE II: elective, 7.3%; urgent, 9.7%; emergent/salvage, 54.5% (P<0.0001). The indication for TMVI was bioprosthesis failure in all of the emergent/salvage group, in 13 of the urgent group (61.9%) and in 62 of the elective group (48.1%). Overall, the technical success rate of TMVI was 86%, and was similar in the three groups (elective, 86.1%; urgent, 95.2%; emergent/salvage, 71.4%). The cumulative survival rate at 2-year follow-up was lower in the emergent/salvage group than in the elective or urgent group (42.9% vs 71.2% for the elective group; 76.2% for the urgent group; log-rank test, P=0.012). The excess mortality in the emergent/salvage group occurred during the first month postprocedure. Thereafter, the 30-day landmark analysis did not show any more statistical difference between the three groups (log-rank test, P=0.94). CONCLUSIONS: Emergent/salvage TMVI was associated with high early mortality, but 1-month survivors had similar outcomes to patients with elective/urgent TMVI. The degree of urgency of the procedure should not prevent TMVI in high-risk patients.

Transcatheter aortic valve implantation using the SAPIEN 3 valve to treat aortic regurgitation: The French multicentre S3AR study.

BACKGROUND: Transcatheter aortic valve implantation now has a major role in the treatment of patients with severe aortic stenosis. However, evidence is scarce on its feasibility and safety to treat patients with pure aortic regurgitation. AIMS: We sought to evaluate the results of transcatheter aortic valve implantation using the balloon-expandable SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) in patients with pure aortic regurgitation on native non-calcified valves. METHODS: We conducted a retrospective and prospective French multicentre observational study. We included all patients with symptomatic severe pure aortic regurgitation on native non-calcified valves, contraindicated to or at high risk for surgical valve replacement, who underwent transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve. RESULTS: A total of 37 patients (male sex, 73%) with a median age of 81years (interquartile range 69-85years) were screened using transthoracic echocardiography and computed tomography and were included at eight French centres. At baseline, 83.8% of patients (n=31) had dyspnoea New York Heart Association class≥III. The device success rate was 94.6% (n=35). At 30days, the all-cause mortality rate was 8.1% (n=3) and valve migration occurred in 10.8% of cases (n=4). Dyspnoea New York Heart Association class≤II was seen in 86.5% of patients (n=32), and all survivors had aortic regurgitation grade≤1. At 1-year follow-up, all-cause mortality was 16.2% (n=6), 89.7% (n=26/29) of survivors were in New York Heart Association class≤II and all had aortic regurgitation grade≤2. CONCLUSION: Transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve seems promising to treat selected high-risk patients with pure aortic regurgitation on non-calcified native valves, contraindicated to surgical aortic valve replacement.

Multimodality imaging for patient selection, procedural guidance, and follow-up of transcatheter interventions for structural heart disease: a consensus document of the EACVI Task Force on Interventional Cardiovascular Imaging: part 1: access routes, transcatheter aortic valve implantation, and transcatheter mitral valve interventions.

Transcatheter therapies for the treatment of structural heart diseases (SHD) have expanded dramatically over the last years, thanks to the developments and improvements of devices and imaging techniques, along with the increasing expertise of operators. Imaging, in particular echocardiography, is pivotal during patient selection, procedural monitoring, and follow-up. The imaging assessment of patients undergoing transcatheter interventions places demands on imagers that differ from those of the routine evaluation of patients with SHD, and there is a need for specific expertise for those working in the cath lab. In the context of the current rapid developments and growing use of SHD therapies, this document intends to update the previous consensus document and address new advancements in interventional imaging for access routes and treatment of patients with aortic stenosis and regurgitation, and mitral stenosis and regurgitation.

Prognostic Value of Tricuspid Valve Gradient After Transcatheter Edge-to-Edge Repair: Insights From the TriValve Registry.

BACKGROUND: Data regarding the impact of the tricuspid valve gradient (TVG) after tricuspid transcatheter edge-to-edge repair (TEER) are scarce. OBJECTIVES: This study sought to evaluate the association between the mean TVG and clinical outcomes among patients who underwent tricuspid TEER for significant tricuspid regurgitation. METHODS: Patients with significant tricuspid regurgitation who underwent tricuspid TEER within the TriValve (International Multisite Transcatheter Tricuspid Valve Therapies) registry were divided into quartiles based on the mean TVG at discharge. The primary endpoint was the composite of all-cause mortality and heart failure hospitalization. Outcomes were assessed up to the 1-year follow-up. RESULTS: A total of 308 patients were included from 24 centers. Patients were divided into quartiles of the mean TVG as follows: quartile 1 (n = 77), 0.9 ± 0.3 mm Hg; quartile 2 (n = 115), 1.8 ± 0.3 mm Hg; quartile 3 (n = 65), 2.8 ± 0.3 mm Hg; and quartile 4 (n = 51), 4.7 ± 2.0 mm Hg. The baseline TVG and the number of implanted clips were associated with a higher post-TEER TVG. There was no significant difference across TVG quartiles in the 1-year composite endpoint (quartiles 1-4: 35%, 30%, 40%, and 34%, respectively; P = 0.60) or the proportion of patients in New York Heart Association class III to IV at the last follow-up (P = 0.63). The results were similar after adjustment for clinical and echocardiographic characteristics (composite endpoint quartile 4 vs quartile 1-quartile 3 adjusted HR: 1.05; 95% CI: 0.52-2.12; P = 0.88) or exploring post-TEER TVG as a continuous variable. CONCLUSIONS: In this retrospective analysis of the TriValve registry, an increased discharge TVG was not significantly associated with adverse outcomes after tricuspid TEER. These findings apply for the explored TVG range and up to the 1-year follow-up. Further investigations on higher gradients and longer follow-up are needed to better guide the intraprocedural decision-making process.

Predictors of Clinical Success After Transcatheter Paravalvular Leak Closure: An International Prospective Multicenter Registry.

BACKGROUND: Transcatheter closure of a symptomatic prosthetic paravalvular leak (PVL) is feasible, but there is presently no conclusive evidence to show consistent efficacy. We aimed to identify predictors of clinical success after transcatheter PVL closure. METHODS: Consecutive patients referred to 24 European centers for transcatheter PVL closure in 2017 to 2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP). Clinical success was absence of any of the following within 1 month: re-admission for heart failure, blood transfusion, open-heart valvular surgery, and death. RESULTS: We included 216 symptomatic patients, who underwent 238 percutaneous PVL closure procedures on the mitral (64.3%), aortic (34.0%), or tricuspid (1.7%) valve. Symptoms were heart failure, hemolytic anemia, or both in 48.9%, 7.8%, and 43.3% of patients, respectively. One, 2, and 3 leaks were treated during the same procedure in 69.6%, 26.6%, and 3.8% of patients, respectively. The PVL was pinpoint or involved 1/8 or 1/4 of the valve circumference in 18.6%, 52.4%, and 28.1% of cases, respectively. The most frequently used devices were the Vascular Plug 3, Ventricular Septal Defect Occluder, Vascular Plug 2, and Paravalvular Leak Device (45.0%, 16.6%, 14.2%, and 13.6% of cases, respectively). Successful device(s) implantation with leak reduction to ≤grade 2 was obtained in 85.0% of mitral and 91.4% of aortic procedures, respectively (P=0.164); with major periprocedural adverse event rates of 3.3% and 1.2%, respectively (P=0.371); and clinical success rates of 70.3% and 88.0%, respectively (P=0.004). By multivariate analysis, technical failure, mechanical valve, and hemolytic anemia were independently associated with absence of clinical success (odds ratios [95% CIs], 7.7 [2.0-25.0]; P=0.002; 3.6 [1.1-11.1]; P=0.036; and 3.7 [1.2-11.9]; P=0.025; respectively). CONCLUSIONS: Transcatheter PVL closure is efficient and safe in symptomatic patients but is associated with a lower clinical success rate in patients with hemolysis and/or a mechanical valve. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifiers: NCT05089136.

Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty: Insight From an International Registry.

OBJECTIVES: This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization. BACKGROUND: Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure. METHODS: Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. RESULTS: A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death. CONCLUSIONS: MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up.

Right Ventricular-Pulmonary Arterial Coupling and Afterload Reserve in Patients Undergoing Transcatheter Tricuspid Valve Repair.

BACKGROUND: The right ventricular (RV)-pulmonary arterial (PA) coupling ratio relates the efficiency with which RV stroke work is transferred into the PA. Lower ratios indicate an inadequate RV contractile response to increased afterload. OBJECTIVES: This study sought to evaluate the prognostic significance of RV-PA coupling in patients with tricuspid regurgitation (TR) who were undergoing transcatheter tricuspid valve repair or replacement (TTVR). METHODS: The study investigators calculated RV-PA coupling ratios for patients enrolled in the global TriValve registry by dividing the tricuspid annular plane systolic excursion (TAPSE) by the PA systolic pressure (PASP) from transthoracic echocardiograms performed before the procedure and 30 days after the procedure. The primary endpoint was all-cause mortality at 1-year follow-up. RESULTS: Among 444 patients analyzed, their mean age was 76.9 ± 9.1 years, and 53.8% of the patients were female. The median TAPSE/PASP ratio was 0.406 mm/mm Hg (interquartile range: 0.308-0.567 mm/mm Hg). Sixty-three patients died within 1 year of TTVR, 21 with a TAPSE/PASP ratio >0.406 and 42 with a TAPSE/PASP ratio ≤0.406. In multivariable Cox regression analysis, a TAPSE/PASP ratio >0.406 vs ≤0.406 was associated with a decreased risk of all-cause mortality (HR: 0.57; 95% CI: 0.35-0.93; P = 0.023). In 234 (52.7%) patients with echocardiograms 30 days after TTVR, a decline in RV-PA coupling was independently associated with reduced odds of all-cause mortality (odds ratio [OR]: 0.42; 95% CI: 0.19-0.93; P = 0.032). The magnitude of TR reduction after TTVR (≥1+ vs <1+; OR: 2.53; 95% CI: 1.06-6.03; P = 0.037) was independently associated with a reduction in post-TTVR RV-PA coupling. CONCLUSIONS: RV-PA coupling is a powerful, independent predictor of all-cause mortality in patients with TR undergoing TTVR. These data suggest that the TAPSE/PASP ratio can inform patient selection and prognostication following TTVR.

Real-time 3D transoesophageal measurement of the mitral valve area in patients with mitral stenosis.

AIMS: Planimetry measured by two-dimensional transthoracic echocardiography (TTE, MVA2D) is the reference method for the evaluation of the severity of mitral stenosis (MS) but requires experienced operators and good echocardiographic windows. Real-time three-dimensional transoesophageal echocardiography (3D-TEE, MVA3D) may overcome these limitations but its accuracy has never been evaluated. METHODS AND RESULTS: We prospectively enrolled 80 patients (58±15 years, 86% female) referred for MS evaluation who underwent, within 1 week, a clinically indicated TTE and TEE. MVA2D was measured by experienced operators (Level III), MVA3D by one experienced and one non-experienced (Level I) operators blinded of any clinical or TTE information. MVA3D measured by the experienced operator [1.11±0.32 cm2; median, 1.1 cm2; range (0.45-2.20)] did not differ from and correlated well with MVA2D [1.10±0.34 cm2; median, 1.05 cm2; range (0.45-2.30)], P=0.87; r=0.79, P<0.0001; ICC=0.79) and mean difference between methods was small (+0.004±0.21 cm2). MVA3D measured by the non-experienced operator [1.08±0.34 cm2; median 1.02 cm2; range (0.45-2.23)] also did not differ from and correlated well with MVA2D measured by experienced operators (P=0.25; r=0.86, P<0.0001; mean difference -0.02±0.18 cm2; ICC=0.86). Intra and interobserver variability were 0.02±0.25 and 0.01±0.33 cm2. CONCLUSION: 3D-TEE provides accurate and reproducible MVA measurements similar to 2D planimetry performed by experienced operators. Thus, 3D-TEE could be considered as a second-line alternative tool for the evaluation of MS severity in patients with poor echocardiographic windows or for team less accustomed to evaluate MS patients.

Echocardiographic right ventricular function assessment before and after successful percutaneous mitral commissurotomy.

BACKGROUND AND AIM OF THE STUDY: In patients with mitral stenosis (MS), previous studies have shown discordant results with regards to improvements in right ventricular (RV) function immediately after percutaneous mitral commissurotomy (PMC). Hence, the study aim was to evaluate the impact of PMC on RV function, by using Doppler-echocardiography. METHODS: A total of 41 patients with severe symptomatic MS, in sinus rhythm, who had been referred to the authors' institution for PMC, was prospectively enrolled. A group of 25 healthy age- and gender-matched subjects served as controls. Transthoracic echocardiography (TTE) was performed on the day before and at 24/48 h after PMC. The RV function was evaluated using the Tricuspid Annular Plane Excursion (TAPSE), the RV Tei index, and systolic myocardial velocities by Doppler tissue imaging peak isovolumic contraction (DTI(IVC)) and peak systolic (DTI(S)) at the lateral tricuspid annulus). RESULTS: All patients but three underwent a successful PMC. The mitral valve area (MVA) was significantly increased (1.8 +/- 0.3 versus 1.1 +/- 0.2 cm2, p <0.0001), while the mean gradient (5 +/- 2 versus 10 +/- 7 mmHg, p <0.0001) and systolic pulmonary artery pressure (40 +/- 10 versus 54 +/- 21 mmHg, p = 0.0002) were decreased. Compared to healthy controls, the RV dysfunction in MS patients was authenticated by the DTI(IVC) and the Tei index (8.4 +/- 3.0 versus 11.1 +/- 2.1 cm/s, p = 0.0002 and 0.33 +/- 0.10 versus 0.18 +/- 0.10 respectively, p <0.0001), but not by DTI(S) (12.9 +/- 3 versus 12.3 +/- 1.5 cm/s, p = 0.35) or TAPSE (24 +/- 5 versus 23 +/- 3 mm, p = 0.50). After PMC, no significant change regarding RV function was observed (TAPSE: 24 +/- 5 versus 24 +/- 5 mm, p = 0.54; Tei Index: 0.33 +/- 0.10 versus 0.36 +/- 0.12, p = 0.20; DTI(IVC): 8.4 +/- 3.0 versus 9.2 +/- 3.4 cm/s, p = 0.08 and DTI(S): 12.9 +/- 3.0 versus 13.0 +/- 3.4 cm/s, p = 0.54). CONCLUSION: The DTI(IVC) and Tei index appear to serve as the more sensitive indices of RV dysfunction in patients with MS. Immediately after a successful PMC, no significant change in Doppler echocardiographic parameters of RV function was observed. Whether late improvement in RV function can be observed, and the prognostic value of these parameters realized, deserve further investigation.

Anesthesia and perioperative management of patients who undergo transfemoral transcatheter aortic valve implantation: an observational study of general versus local/regional anesthesia in 125 consecutive patients.

OBJECTIVE: To describe differences in intra- and postoperative care between general (GA) and local/regional anesthesia (LRA) in consecutive high-risk patients with aortic stenosis who underwent transfemoral transcatheter aortic valve implantation (TAVI). DESIGN: A retrospective review of data collected in an institutional registry. SETTING: An academic hospital. PARTICIPANTS: One hundred twenty-five consecutive patients with severe aortic stenosis who underwent transfemoral TAVI. INTERVENTIONS: GA versus LRA followed by postoperative care. Complications were defined by pre-established criteria. MATERIAL AND METHODS: Consecutive patients referred for transfemoral TAVI between October 2006 and October 2010 initially underwent GA (n = 91) followed by LRA after March 2010 (n= 34). Results are presented as mean ± standard deviation or median (25-75 percentiles) as appropriate. GA and LRA TAVI patients had similar preoperative characteristics. LRA was associated with a significantly shorter procedure duration (LRA: 80 [67-102]; GA: 120 [90-140 minutes]; p < 0.001), hospital stay (LRA: 8.5 [7-14.5]; GA: 15.5 [10-24] days; p < 0.001), intraoperative requirements of catecholamines (LRA 23%; GA: 90% of patients; p < 0.001), and volume expansion (LRA: 11 [8-16]; GA: 22 [15-36] mL/kg; p < 0.001). There were significant differences in delta creatinine (day 1, preoperative creatinine values; LRA: 0 [-12 to 9]; GA: -15 (-25 to 2.9) µmol, p < 0.004). The frequency of any postoperative complications was 38% (LRA) and 77% (GA) (p = 0.11). Thirty-day mortality was 7% (GA) and 9% (LRA) (p = 0.9). CONCLUSIONS: This observational study suggests that LRA was associated with less intraoperative hemodynamic instability and significant shortening of the procedure and hospital stay. Changes in the anesthetic technique adapted to changes in TAVI interventional techniques and did not increase the rate of postoperative complications.