Search

Background Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching. Methods Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n = 1846) or Evolut R (n = 302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events. Results Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p = 0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R. Conclusion In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1 year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning. [ABSTRACT FROM AUTHOR]

Background Percutaneous mitral valve repair (PMVR) is a new option for high risk patients with functional mitral regurgitation (FMR) and severely depressed left ventricular (LV) function who are not responding to optimal medical therapy. However patients with end stage heart failure have a high mortality rate despite MitraClip implantation. We sought to identify right ventricular (RV) echocardiographic predictors of outcome in a large cohort of patients with severe FMR and advanced heart failure in order to select the most appropriate candidate who could benefit from this treatment. Methods 169 consecutive high surgical risk patients affected by severe FMR underwent PMVR with the MitraClip System. The primary end-point was cardiovascular mortality at the longest available follow-up. Results The survival free from cardiac death was 97.6% at 30 days, 86.7% at 1 year, 71.5% at 2 years and 61.6% at 3 years. Patients who died were significantly older and had more severe comorbidities and signs of more advance heart failure. Independent predictors of cardiovascular mortality were severely impaired renal function [glomerular filtration rate (GFR) < 30 ml/min; OR = 5.46, 95%CI = 1.43–20.84, ( p = 0.01)] and RV systolic dysfunction [peak systolic velocity tissue Doppler imaging (PSV tdi ) < 9.5 cm/s; OR = 0.57, 95%CI = 0.39–0.82, ( p = 0.003)]. Conclusion Our study shows the importance of RV systolic function evaluation for the risk stratification of patients with FMR and advanced heart failure undergoing PMVR. Severe right ventricular failure identifies patients with an increased risk for cardiovascular mortality despite MitraClip treatment. RV PSV tdi is the best independent predictor of outcome in these end-stage patients for a threshold value of 9.5 cm/s. [ABSTRACT FROM AUTHOR]

Percutaneous mitral valve repair (PMVR) using the MitraClip System is feasible and entails clinical improvement even in patients with high surgical risk and severe functional mitral regurgitation (MR). The aim of this study was to assess survival rates and clinical outcome of patients with severe, functional MR treated with optimal medical therapy (OMT) compared with those who received MitraClip device. Sixty patients treated with OMT were compared with a propensity-matched cohort of 60 patients who underwent PMVR. Baseline demographics and echocardiographic variables were similar between the 2 groups. The mean age of patients was 75 years, and 67% were men. The median logistic EuroSCORE and EuroSCORE II were 17% and 6%, respectively, because of the presence of several co-morbidities. The mechanism of MR was functional in all cases with an ischemic etiology in 52% of patients. Median left ventricle ejection fraction was 34%. All the patients were symptomatic for dyspnea with 63% and 12% in the New York Heart Association class III and IV, respectively. In PMVR group, the procedure was associated with safety and very low incidence of procedural complications with no occurrence of procedural and inhospital mortality. After a median follow-up of 515 days (248 to 828 days), patients treated with PMVR demonstrated overall survival, survival freedom from cardiac death and survival free of readmission due to cardiac disease curves higher than patients treated conservatively (log-rank test p = 0.007, p = 0.002, and p = 0.04, respectively). In conclusion, PMVR offers a valid option for selected patients with high surgical risk and severe, functional MR and entails better survival outcomes compared with OMT. [ABSTRACT FROM AUTHOR]

Aims: Degenerative aortic valve stenosis with preserved ejection fraction (ASpEF) and heart failure with preserved ejection fraction (HFpEF) display intriguing similarities. This study aimed to provide a non‐invasive, comparative analysis of ASpEF versus HFpEF at rest and during exercise. Methods and results: We prospectively enrolled 148 patients with HFpEF and 150 patients with degenerative moderate‐to‐severe ASpEF, together with 66 age‐ and sex‐matched healthy controls. All subjects received a comprehensive evaluation at rest and 351/364 (96%) performed a combined cardiopulmonary exercise stress echocardiography test. Patients with ASpEF eligible for transcatheter aortic valve replacement (n = 125) also performed cardiac computed tomography (CT). HFpEF and ASpEF patients showed similar demographic distribution and biohumoral profiles. Most patients with ASpEF (134/150, 89%) had severe high‐gradient aortic stenosis; 6/150 (4%) had normal‐flow, low‐gradient ASpEF, while 10/150 (7%) had low‐flow, low‐gradient ASpEF. Both patient groups displayed significantly lower peak oxygen consumption (VO2), peak cardiac output, and peak arteriovenous oxygen difference compared to controls (all p < 0.01). ASpEF patients showed several extravalvular abnormalities at rest and during exercise, similar to HFpEF (all p < 0.01 vs. controls). Epicardial adipose tissue (EAT) thickness was significantly greater in ASpEF than HFpEF and was inversely correlated with peak VO2 in all groups. In ASpEF, EAT was directly related to echocardiography‐derived disease severity and CT‐derived aortic valve calcium burden. Conclusion: Functional capacity is similarly impaired in ASpEF and HFpEF due to both peripheral and central components. Further investigation is warranted to determine whether extravalvular alterations may affect disease progression and prognosis in ASpEF even after valve intervention, which could support the concept of ASpEF as a specific sub‐phenotype of HFpEF. [ABSTRACT FROM AUTHOR]

Aims: To explore whether left ventricular reverse remodelling (LVRR) is a predictor of outcomes in patients with functional mitral regurgitation (FMR) undergoing MitraClip procedure.Methods and Results: We analysed 184 consecutive patients with FMR who underwent successful MitraClip procedure. LVRR was defined as a reduction in left ventricular end-systolic volume ≥ 10% from baseline to 6 months. LVRR was observed in 79 (42.9%) patients. Compared with non-LVRR, LVRR patients were more likely to be females, less likely to have an ischaemic aetiology of mitral regurgitation or a prior (<6 months) heart failure (HF) hospitalization, and had smaller left ventricular dimensions. New York Heart Association class improved from baseline up to 1-year follow-up in both groups. Higher rates of overall survival (87.3% vs. 75.2%, P = 0.039), freedom from HF hospitalization (77.2% vs. 60%, P = 0.020), and freedom from the composite endpoint (cardiovascular mortality or HF hospitalization) (74.7% vs. 55.2%; P = 0.012) were observed in LVRR vs. non-LVRR patients at 2-year follow-up. LVRR was associated with a significant reduction of the adjusted relative risk of mortality, HF hospitalization and composite endpoint [hazard ratio (HR) 0.44; 95% confidence interval (CI) 0.20-0.96, P = 0.040; HR 0.55; 95% CI 0.32-0.97, P = 0.038; and HR 0.54; 95% CI 0.32-0.92, P = 0.023, respectively]. Female gender, absence of diabetes, freedom from prior HF hospitalization, non-ischaemic aetiology of mitral regurgitation, and left ventricular end-diastolic diameter < 75 mm were found to be independent predictors of LVRR.Conclusions: Left ventricular reverse remodelling is associated with better long-term outcomes in patients with FMR successfully treated with MitraClip. A careful patient selection may be useful as specific baseline features predict favourable left ventricular remodelling. [Correction added on 17 January 2019, after online publication: the preceding sentence has been changed.]. [ABSTRACT FROM AUTHOR]

Aims: This study aimed to compare outcomes after transcatheter mitral valve replacement (TMVR) and mitral valve transcatheter edge‐to‐edge repair (M‐TEER) for the treatment of secondary mitral regurgitation (SMR). Methods and results: The CHOICE‐MI registry included 262 patients with SMR treated with TMVR between 2014 and 2022. The EuroSMR registry included 1065 patients with SMR treated with M‐TEER between 2014 and 2019. Propensity score (PS) matching was performed for 12 demographic, clinical and echocardiographic parameters. Echocardiographic, functional and clinical outcomes out to 1 year were compared in the matched cohorts. After PS matching, 235 TMVR patients (75.5 years [70.0, 80.0], 60.2% male, EuroSCORE II 6.3% [interquartile range 3.8, 12.4]) were compared to 411 M‐TEER patients (76.7 years [70.1, 80.5], 59.0% male, EuroSCORE II 6.7% [3.9, 12.4]). All‐cause mortality was 6.8% after TMVR and 3.8% after M‐TEER at 30 days (p = 0.11), and 25.8% after TMVR and 18.9% after M‐TEER at 1 year (p = 0.056). No differences in mortality after 1 year were found between both groups in a 30‐day landmark analysis (TMVR: 20.4%, M‐TEER: 15.8%, p = 0.21). Compared to M‐TEER, TMVR resulted in more effective mitral regurgitation (MR) reduction (residual MR ≤1+ at discharge for TMVR vs. M‐TEER: 95.8% vs. 68.8%, p < 0.001), and superior symptomatic improvement (New York Heart Association class ≤II at 1 year: 77.8% vs. 64.3%, p = 0.015). Conclusion: In this PS‐matched comparison between TMVR and M‐TEER in patients with severe SMR, TMVR was associated with superior reduction of MR and superior symptomatic improvement. While post‐procedural mortality tended to be higher after TMVR, no significant differences in mortality were found beyond 30 days. [ABSTRACT FROM AUTHOR]

Body surface area (BSA) has been reported to be the stronger predictor for prognosis than body mass index in heart failure (HF) patients. The sex-specific association of BSA with mortality has been unclear. EuroSMR, a European multicenter registry, included patients who underwent edge-to-edge repair (TEER) for secondary mitral regurgitation (SMR). The outcome was two-year all-cause mortality. The present cohort included 1594 HF patients (age, 74 ± 10 years; male, 66%). Association of calculated BSA with two-year all-cause mortality was evaluated. Patients were classified into three BSA groups: the lowest 10% (S), the highest 10% (L), and intermediate between S and L (M). Mean BSA was 1.87 ± 0.21 m2 (male, 1.94 ± 0.18 m2; female, 1.73 ± 0.18 m2). The association of BSA with the endpoint in females showed a U-shaped curve, indicating worse prognosis for both S and L. The association in males followed a linear regression, demonstrating better prognosis for L. Hazard ratio (HR) of L to S in males was 0.43 (95% confidence interval [CI], 0.25–0.74; p = 0.002), whereas HR of L to M in females was 1.76 (95% CI, 1.11–2.78; p = 0.016) (p for interaction = 0.003). Sex-specific association patterns demonstrate the complex influence of anthropomorphic factors in HF patients scheduled for TEER. Further investigation beyond simple evaluation of weight and height is needed for better comprehension of the obesity paradox and better prediction of the results of transcatheter therapy in HF patients. • BSA was a strong predictor for 2-year mortality after mitral TEER. • Such relationship demonstrated a pattern of linear regression in males. • The association of BSA with mortality indicated a U-shaped pattern in females. • In both sexes, low BSA was an independent predictor for mortality. [ABSTRACT FROM AUTHOR]

Aim: To evaluate short‐term changes in tricuspid regurgitation (TR) after transcatheter edge‐to‐edge mitral valve repair (M‐TEER) in secondary mitral regurgitation (SMR), their predictors and impact on mortality. Methods and results: This is a retrospective analysis of SMR patients undergoing successful M‐TEER (post‐procedural mitral regurgitation ≤2+) at 13 European centres. Among 503 patients evaluated 79 (interquartile range [IQR] 40–152) days after M‐TEER, 173 (35%) showed ≥1 degree of TR improvement, 97 (19%) had worsening of TR, and 233 (46%) remained unchanged. Smaller baseline left atrial diameter and residual mitral regurgitation 0/1+ were independent predictors of TR ≤2+ after M‐TEER. There was a significant association between TR changes and New York Heart Association class and pulmonary artery systolic pressure decrease at echocardiographic re‐assessment. At a median follow‐up of 590 (IQR 209–1103) days from short‐term echocardiographic re‐assessment, all‐cause mortality was lower in patients with improved compared to those with unchanged/worsened TR (29.6% vs. 42.3% at 3 years; log‐rank p = 0.034). Baseline TR severity was not associated with mortality, whereas TR 0/1+ and 2+ at short‐term follow‐up was associated with lower all‐cause mortality compared to TR 3/4+ (30.6% and 35.6% vs. 55.6% at 3 years; p < 0.001). A TR ≤2+ after M‐TEER was independently associated with a 42% decreased risk of mortality (p = 0.011). Conclusion: More than one third of patients with SMR undergoing successful M‐TEER experienced an improvement in TR. Pre‐procedural TR was not associated with outcome, but a TR ≤2+ at short‐term follow‐up was independently associated with long‐term mortality. Optimal M‐TEER result and a small left atrium were associated with a higher likelihood of TR ≤2+ after M‐TEER. [ABSTRACT FROM AUTHOR]

Aims: Guideline‐directed medical therapy (GDMT), based on the combination of beta‐blockers (BB), renin–angiotensin system inhibitors (RASI), and mineralocorticoid receptor antagonists (MRA), is known to have a major impact on the outcome of patients with heart failure with reduced ejection fraction (HFrEF). Although GDMT is recommended prior to mitral valve transcatheter edge‐to‐edge repair (M‐TEER), not all patients tolerate it. We studied the association of GDMT prescription with survival in HFrEF patients undergoing M‐TEER for secondary mitral regurgitation (SMR). Methods and results: EuroSMR, a European multicentre registry, included SMR patients with left ventricular ejection fraction <50%. The outcome was 2‐year all‐cause mortality. Of 1344 patients, BB, RASI, and MRA were prescribed in 1169 (87%), 1012 (75%), and 765 (57%) patients at the time of M‐TEER, respectively. Triple GDMT prescription was associated with a lower 2‐year all‐cause mortality compared to non‐triple GDMT (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.60–0.91). The association persisted in patients with glomerular filtration rate <30 ml/min, ischaemic aetiology, or right ventricular dysfunction. Further, a positive impact of triple GDMT prescription on survival was observed in patients with residual mitral regurgitation of ≥2+ (HR 0.62; 95% CI 0.44–0.86), but not in patients with residual mitral regurgitation of ≤1+ (HR 0.83; 95% CI 0.64–1.08). Conclusion: Triple GDMT prescription is associated with higher 2‐year survival after M‐TEER in HFrEF patients with SMR. This association was consistent also in patients with major comorbidities or non‐optimal results after M‐TEER. [ABSTRACT FROM AUTHOR]

The aims of this study were: i) to report the prevalence of low-risk patients with degenerative mitral regurgitation (DMR) undergoing mitral transcatheter edge-to-edge repair (M-TEER) in a real-world setting; ii) to evaluate the prognostic significance of EuroSCORE II; iii) to determine whether an optimal M-TEER provides a mortality benefit regardless of EuroSCORE-II. We analyzed data from the GIOTTO registry that enrolled patients undergoing M-TEER in Italy. We included only patients with DMR. Two groups were defined: patients with EuroSCORE<4% and with EuroSCORE≥4%. A further stratification according to variables included in the EuroSCORE-II was made. Interaction between EuroSCORE-II and optimal procedural success was evaluated. Outcome of interest was all-cause death at 2-year. Among 1659 patients prospectively enrolled in the GIOTTO registry, 657 had DMR, 364 with an EuroSCORE<4% (53%) and 311 with an EuroSCORE≥4% (47%). Patients with lower EuroSCORE were older with less comorbidities. All-cause mortality was higher in patients with EuroSCORE≥ vs <4%. EuroSCORE II ≥ 4% was independently associated with an increased risk of mortality (HR 2.36, 95%CI 1.28–4.38, p = 0.007). Among variables included in the EuroSCORE-II, Left Ventricular Ejection Fraction<35% and systolic Pulmonary Artery Pressure ≥ 50mmhg were independent predictors of clinical outcome. Two-year all-cause death was higher in patients without optimal MR reduction regardless of the calculated surgical risk (p for interaction 0.3). More than half of patients with DMR undergoing M-TEER had a Euroscore<4% with a median age of 81. An optimally successful M-TEER was associated with a lower mortality regardless of EuroSCORE. • Percutaneous option for primary mitral regurgitation is limited to high-surgical risk. • In the real-word most of patients treated were at intermediate or low-surgical risk. • Optimal reduction of mitral regurgitation was associated with lower mortality. • Percutaneous choice for primary mitral regurgitation could be an option for elderly. [ABSTRACT FROM AUTHOR]

Aims: To investigate the role of left atrial volume index (LAVi) in patients with secondary mitral regurgitation (SMR) undergoing transcatheter edge‐to‐edge mitral valve repair (TEER). Methods and results: Outcomes were evaluated in SMR patients of a European multicentre registry according to baseline LAVi. Main analysis was performed for all‐cause mortality; residual mitral regurgitation (MR) and New York Heart Association (NYHA) class improvement were analysed for patients available. A total of 1074 patients were included with a median LAVi (interquartile range) of 58 ml/m2 (46–73). Postprocedural reduction of MR grade to ≤2+ was similar across LAVi quintiles, ranging 91%–96% (p = 0.26). Symptomatic benefit (≥1 NYHA class improvement) also did not differ by LAVi quintiles (61%–68% of patients) (p = 0.66). The risk of mortality increased by 23%–42% in the four upper quintiles compared to the bottom quintile (LAVi <42 ml/m2). The hazard ratio (HR) of mortality was 1.35 (95% confidence interval [CI] 1.02–1.78, p = 0.035) associated with a LAVi >42 ml/m2, which was attenuated after multivariable adjustment (HR 1.18, 95% CI 0.83–1.67, p = 0.36). A significant interaction was found for MR severity and pulmonary hypertension, with an increased risk of death associated with enlarged LAVi in patients with inframedian effective regurgitant orifice area (HR 1.99, 95% CI 1.06–3.74, p = 0.032) and in patients with systolic pulmonary pressure ≤50 mmHg (HR 1.67, 95% CI 1.02–2.75, p = 0.042) in multivariable analysis. Conclusion: Procedural success and symptomatic benefit were high throughout the whole range of LAVi. The prognostic impact of left atrial enlargement was relevant in patients with less severe SMR and without pulmonary hypertension, reinforcing the need to identify patients in the early course of backward congestion to achieve good long‐term outcome after TEER. [ABSTRACT FROM AUTHOR]

Aims: Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real‐world data have not yet been reported. This study aimed to assess procedural and 30‐day outcomes of TMVI in a real‐world patient cohort. Method and results: All consecutive patients undergoing implantation of a transapically delivered self‐expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high‐risk patients included (43% female, mean age 75 ± 7 years, mean STS‐PROM 7.2 ± 5.3%), 25% was treated for an off‐label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30‐day all‐cause mortality was 12%. At early clinical follow‐up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off‐label indication (74% vs. 81% for off‐ vs. on‐label, p = 0.41). Conclusion: In a real‐world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement. [ABSTRACT FROM AUTHOR]

Background: Although mitral valve transcatheter edge-to-edge repair (M-TEER) achieves symptomatic benefit for a broad spectrum of patients with relevant secondary mitral regurgitation, conflicting data exist on its prognostic impact.Objectives: Adapted enrollment criteria approaching those used in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) and MITRA-FR (Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation) trials were retrospectively applied to a European real-world registry to evaluate the influence of the respective criteria on outcomes.Methods: A total of 1,022 patients included in the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) registry and treated with M-TEER (November 2008 to September 2019) were stratified into COAPT-eligible (n = 353 [34.5%]) and COAPT-ineligible (n = 669 [65.5%]) as well as MITRA-FR-eligible (n = 408 [48.3%]) and MITRA-FR-ineligible (n = 437 [51.7%]) groups.Results: Although the stratification of patients according to adapted MITRA-FR criteria led to comparable outcomes regarding all-cause mortality (P = 0.19), the application of adapted COAPT enrollment criteria demonstrated lower mortality rates in COAPT-eligible compared with COAPT-ineligible patients (P < 0.001). Multivariable Cox regression analysis identified New York Heart Association functional class IV (hazard ratio [HR]: 2.29; 95% confidence interval [CI]: 1.53-3.42; P < 0.001), logarithmic N-terminal pro-brain natriuretic peptide (HR: 1.47; 95% CI: 1.24-1.75; P < 0.001), and right ventricular-to-pulmonary arterial coupling (HR: 0.10; 95% CI: 0.02-0.57; P = 0.009) as independent predictors of outcome. Yet improvement of functional outcome was demonstrated in a subset of patients irrespective of COAPT eligibility status.Conclusions: In this real-world cohort of patients with secondary mitral regurgitation undergoing M-TEER, the retrospective application of adapted COAPT enrollment criteria successfully identified a specific phenotype demonstrating lower mortality rates. On the contrary, stratification according to adapted MITRA-FR criteria resulted in comparable outcomes. [ABSTRACT FROM AUTHOR]

Aims: The Italian Society of Interventional Cardiology (GIse) registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) was conceived in order to assess the safety and efficacy of MitraClip therapy in Italy. The aim of this study was to assess procedural and mid‐term outcomes, and clinical and echocardiographic predictors of mid‐term mortality after MitraClip therapy, stratifying the results according to the diagnosis of functional and degenerative mitral regurgitation (FMR vs. DMR). Methods and results: Between January 2016 and March 2020, 1659 patients were prospectively included in the GIOTTO registry (FMR 59.4% vs. DMR 40.6%). Acute Mitral Valve Academic Research Consortium (MVARC) technical success was achieved in 97.2% of patients, without differences between FMR and DMR and with sustained results at 30 days. In the study population, all‐cause mortality was 4.0%, 17.5% and 34.6% at 30 days, 1 year and 2 years, respectively. Cardiovascular death was the most frequent cause of mortality. Overall hospitalization rates were 6.3%, 23.4% and 31.7% at 30 days, 1 year and 2 years, respectively. The most frequent cause of hospitalization was heart failure, particularly in the first 30 days. FMR and MVARC structural and functional failure were strongly associated with 1‐year mortality. Residual mitral regurgitation 1+ (rMR) was independently related to a reduced risk of 1‐year mortality (hazard ratio 0.62; P = 0.005). Coherently, at 2‐year follow up, FMR was associated with worse outcomes than DMR, and Kaplan–Meier all‐cause mortality was related to rMR. Conclusions: Functional mitral regurgitation aetiology affects 1‐year mortality after MitraClip implantation, and differences in mortality and hospitalization rates between FMR and DMR can be observed within 2 years. Optimal rMR 1+ was correlated to a more favourable mid‐term outcome, particularly in FMR. [ABSTRACT FROM AUTHOR]

Background: Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs).Objectives: The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures.Methods: Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs.Results: A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups).Conclusions: In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up. [ABSTRACT FROM AUTHOR]

Patients awaiting heart transplantation (HTx) often need bridging therapies to reduce worsening and progression of underlying disease. Limited data are available regarding the use of the MitraClip procedure in secondary mitral regurgitation for this clinical condition. We evaluated an international, multicenter (17 centers) registry including 119 patients (median age: 58 years) with moderate-to-severe or severe secondary mitral regurgitation and advanced heart failure (HF) (median left ventricular ejection fraction: 26%) treated with MitraClip as a bridge strategy according to 1 of the following criteria: (1) patients active on HTx list (in list group) (n = 31); (2) patients suitable for HTx but awaiting clinical decision (bridge to decision group) (n = 54); or (3) patients not yet suitable for HTx because of potentially reversible relative contraindications (bridge to candidacy group) (n = 34). Procedural success was achieved in 87.5% of cases, and 30-day survival was 100%. At 1 year, Kaplan–Meier estimates of freedom from the composite primary end-point (death, urgent HTx or left ventricular assist device implantation, first rehospitalization for HF) was 64%. At the time of last available follow-up (median: 532 days), 15% of patients underwent elective transplant, 15.5% remained or could be included in the HTx waiting list, and 23.5% had no more indication to HTx because of clinical improvement. MitraClip procedure as a bridge strategy to HTx in patients with advanced HF with significant mitral regurgitation was safe, and two thirds of patients remained free from adverse events at 1 year. These findings should be considered exploratory and hypothesis-generating to guide further study for percutaneous intervention in high-risk patients with advanced HF. [ABSTRACT FROM AUTHOR]

Background: Available scientific evidence of transcatheter mitral valve repair with the MitraClip comes from randomized controlled trials, which showed controversial results that hardly translate into real-world practice, and from registries of relatively small sample size.Aim: To collect real-world data in a multicenter, prospective, country-level registry.Methods and Result: The Italian Society of Interventional Cardiology (GIse) Registry Of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) is an ongoing single-arm, multicenter, prospective registry that started enrollment in February 2016. Clinical end points were defined according to the Mitral Valve Academic Research Consortium (MVARC) criteria. From February 2016 to December 2018, 1189 patients (mean age 76 ± 9.1 years) were enrolled. The main MR etiology was functional (64.9%). MVARC technical success was 96.6%. At 30-day follow-up (n = 1131), MVARC device and procedural success were 92.5% and 87% respectively, and all-cause death was 3%. The majority of patients who died at 30-day had functional MR (69.7%). Mixed etiology (OR 0.94, 95% CI 0.02-0.61) and prolonged length of stay in ICU (OR 0.97, 95% CI 0.95-0.99) were found to be negative independent predictors of device success at 30-day. The EuroSCORE II (OR 0.96, 95% CI 0.93-0.99), LVEDV-I (OR 0.99, 95% CI 0.98-0.99) and prolonged length of stay in ICU (OR 0.98, 95% CI 0.97-0.99) were negative independent factors of MVARC procedural success at 30-day.Conclusions: The GIOTTO registry is one of the largest prospective registries available on MitraClip and shows favorable acute and 30-day safety and efficacy. [ABSTRACT FROM AUTHOR]

In the first report from the MitraBridge registry, MitraClip as a bridge to heart transplantation (HTx) proved to be at 1-year an effective treatment strategy for 119 patients with advanced heart failure (HF) who were potential candidates for HTx. We aimed to determine if benefits of MitraClip procedure as a bridge-to-transplant persist up to 2-years. By the end of the enrollment period, a total of 153 advanced HF patients (median age 59 years, left ventricular ejection fraction 26.9 ± 7.7%) with significant secondary mitral regurgitation, who were potential candidates for HTx and were treated with MitraClip as a bridge-to-transplant strategy, were included in the MitraBridge registry. The primary endpoint was the 2-year composite adverse events rate of all-cause death, first hospitalization for HF, urgent HTx or LVAD implantation. Procedural success was achieved in 89.5% of cases. Thirty-day mortality was 0%. At 2-year, Kaplan-Meier estimates of freedom from primary endpoint was 47%. Through 24 months, the annualized rate of HF rehospitalization per patient-year was 44%. After an overall median follow-up time of 26 (9–52) months, elective HTx was successfully performed in 30 cases (21%), 19 patients (13.5%) maintained or obtained the eligibility for transplant, and 32 patients (22.5%) no longer had an indication for HTx because of significant clinical improvement. After 2-years of follow-up, the use of MitraClip as a bridge-to-transplant was confirmed as an effective strategy, allowing elective HTx or eligibility for transplant in one third of patients, and no more need for transplantation in 22.5% of cases. • Advanced heart failure patients often need bridging therapies to heart transplant. • Secondary mitral regurgitation negatively affects their prognosis. • MitraClip used as a bridge to heart transplant strategy. • MitraClip is a safe and effective procedure in this advanced scenario. • It could guarantee safe access to or eligibility for transplant. [ABSTRACT FROM AUTHOR]

Background: Transcatheter aortic valve replacement (TAVR) is a well-established treatment option for severe aortic stenosis (AS). AS and coronary artery disease frequently coincide, and therefore some patients may require coronary angiography (CAG) and/or intervention (PCI) post-TAVR. Due to valve stent design, most self-expanding prostheses always cover the coronary ostium, and therefore may hinder future access. The objective of this research was to evaluate the incidence, safety and feasibility of CAG/PCI in patients with prior self-expanding TAVR valves.Methods: Among 2170 patients (age 82 ± 6 years, 43% male) who underwent TAVR with Corevalve or Evolut prostheses, as part of the Italian CoreValve ClinicalService® framework (data from 13 Italian centers), the occurrence of CAG/PCI following TAVR and periprocedural characteristics were examined.Results: During median follow-up of 379 days, 41 patients (1.9%) required CAG and/or PCI (total 46; 16 CAG, 14 PCI, 16 both PCI/CAG). 56.5% of the procedures were performed under emergency/urgency settings. Left system coronary angiography was successfully performed in most cases (28/32, 87.5%), while right coronary angiography was successful only in 50.0% (16/32). PCI procedures (20 for left system, 3 for right system, 4 for graft) were successfully performed in 93.3% (28/30) of the procedures. No CAG/PCI procedure-related complications including prosthesis dislodgment or coronary ostium dissection occurred.Conclusions: CAG and PCI procedures following CoreValve TAVR is safe and mostly feasible, although the success rate of selective right coronary angiography was relatively low when compared to the left system. Further investigations are required to explore this issue. [ABSTRACT FROM AUTHOR]

Introduction Little is known about the early and late performance of the 31 mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31 mm CRS with other valve sizes. Methods Consecutive patients undergoing transcatheter aortic valve implantation (TAVI) with CRS in nine Italian centers were prospectively included and dichotomized according to prosthesis size in two different groups, as follows: 31 mm and other valve sizes (i.e., 23, 26, and 29 mm combined). End points were defined according to Valve Academic Research Consortium definitions. Propensity score matching was performed. Results In total, 2069 patients (n = 169 [8%] in the 31 mm group and n = 1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31 mm valve was associated with lower rates of procedural- (91.3% vs. 98.1%, p = 0.030) and device-success (88.5% vs. 97.1%, p = 0.016), longer procedural time (120 [80–180] min. vs. 90 [60–120] min., p < 0.001), and higher rates of implantation of a second valve (10.6% vs. 2.9%, respectively, p = 0.027). The rates of permanent pacemaker implantation in the 31 mm group were higher but not statistically different from other valve sizes (41.7% vs. 30.9%, respectively, p = 0.149). Significant improvement, without between-group differences, was observed in NYHA functional class. Cardiovascular death was lower in the 31 mm valve group through 2-years (3.8% vs. 13.5%, respectively, p = 0.014). Conclusions The acute performance of the 31 mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes. [ABSTRACT FROM AUTHOR]

Objectives Assessment of the prognostic role of left ventricular stiffness ( LVS) in patients with aortic stenosis ( AS) undergoing transcatheter aortic valve implantation ( TAVI). Methods We performed a complete two-dimensional transthoracic echocardiographic study before and after TAVI in patients with severe AS at high surgical risk. In order to assess LVS, we measured LV end-diastolic pressure ( EDP) invasively during TAVI and LV end-diastolic volume ( EDV) by means of echocardiography. We defined LVS as the EDV indexed by body surface area at an EDP of 20 mm Hg ( EDVI20). Our aim was to assess the impact of LVS on one-year all-cause mortality after TAVI. Results One hundred sixty-six patients undergoing TAVI (64% female; mean age 82.7 ± 5.1 years) were enrolled. Seven patients died within the first 30 days after TAVI and 21 within 1 year. Overall follow-up duration was 580 ± 478 days. At multivariate analysis, independent predictors of 1-year all-cause mortality were moderate-to-severe paravalvular leak ( PVL; HR 4.7, 95% confidence interval [ CI] 1.9-11, P=.0003), female gender ( HR 3.5, 95% CI 1.0-12, P=.045), and EDVI20 ( HR 0.94, 95% CI 0.90-0.98, P=.015). In particular, patients with higher LVS ( EDVI20≤48 mL/m2) had a 1-year mortality of 26.9% vs 7.4% in patients with lower LVS ( EDVI20>48 mL/m2; HR 4.2, 95% CI 1.6-10.6, P=.0007). Patients with higher LVS who developed moderate-to-severe PVL had the worst outcome (incremental chi-square test, P=.014). Conclusion In patients with AS, an increased LVS has a negative prognostic impact. Development of significant PVL in patients with higher LVS had an incremental adverse effect. [ABSTRACT FROM AUTHOR]

This paper explores the added value of micro-chemical and microscopic approaches to gather scientific evidence that can technically explain the pictorial quality of an egg-tempera painting, and underpin assessments that otherwise would be based on naked eye observations only. Demonstration is here provided via the interdisciplinary investigation of the original technique used by Giovanni del Biondo in the polyptych Annunciation and Saints (1385 ca), Galleria dell'Accademia, Florence, Italy. The exquisite surface appearance makes this panel painting remarkable compared to artworks by coeval artists. Imaging techniques (UV, IR and IR false color), non-invasive single spot techniques (XRF and FORS spectrometry) and analytical investigations on eight selected micro-samples (ATR-FTIR, GC/MS and Py/GC–MS, ESEM-EDS) were combined to retrieve the palette and identify organic binding media and a superficial coating layer. Stratigraphic and micro-chemical data confirmed the use of a relatively simple egg-tempera technique applied on a ground made of gypsum mixed with animal glue, without complex stratigraphic superimposition of preparation and pictorial layers. Various pigments were identified, among which is the precious lapis lazuli. While Py/GC–MS highlight that the coating is made of dammar resin and honey mixed with animal glue, the results allow us to state that the painting was not intentionally varnished by Giovanni del Biondo. These outcomes shed a new light on the technical knowledge of this polyptych, and prove how challenging is the attempt to categorize egg-tempera recipes used by ancient painters at the turn of the 14th century. [ABSTRACT FROM AUTHOR]

Although transcatheter aortic valve implantation (TAVI) is still currently guided by transesophageal echocardiography (TEE) in a considerable number of hospitals, exclusive angiographic (Angio) guidance seems a reasonable approach in this setting. To date, however, no studies have directly compared the outcomes of TAVI according to the imaging modality used for procedural guidance. We, therefore, used data from a large multicenter data repository to compare the outcomes of TAVI guided exclusively by Angio and ATEE. All consecutive patients with severe aortic stenosis who underwent TAVI with the CoreValve Revalving System (CRS) in 9 Italian centers from September 2007 to March 2014, dichotomized according to the imaging support used to guide the procedure (ATEE and Angio), were included. Thirty-day and 12-month clinical outcomes were evaluated. Propensity matching analysis was performed to adjust for baseline differences. A total of 625 patients were included (256 and 369 patients were included in the ATEE and Angio groups, respectively). Patients from the ATEE more frequently underwent TAVI under general anesthesia compared with Angio group (37.9% vs 22.8%, respectively, p <0.001). Importantly, ~80% of the patients experienced mild or even less aortic regurgitation as assessed by angiography after the procedure, without between-group differences. Postdilation and valve-in-valve rates were equivalent (24.7% vs 25%, p = 0.934 and 5.5% vs 3.4%, respectively, p = 0.217). No differences were revealed in the rates of death, cardiovascular death, and stroke or transient ischemic attack at 12-month follow-up. These results were sustained after propensity matching analysis. In conclusion, as long as a comprehensive procedural planning is performed, TAVI with CRS may be performed exclusively under angiographic guidance without the need for associated TEE. [ABSTRACT FROM AUTHOR]

Midterm outcomes for patients presenting with heart failure and functional mitral regurgitation (MR) treated with Mitraclip remain unclear. Pubmed, Medline, and Google Scholar were systematically searched for studies enrolling patients with severe-moderate MR who underwent Mitraclip implantation. All events after at least 6 months were the primary safety end point (including death, rehospitalization for heart failure, and reinterventions), whereas change in the ejection fraction, left ventricular volumes, arterial pulmonary pressure, and left atrial diameters were considered as secondary end points. Meta-regression analysis was performed to evaluate the effect of baseline clinical and echocardiographic parameters on efficacy outcomes: 875 patients were included in 9 studies; 1.48 clips (1.3 to 1.7) for patients were implanted, and after a median follow-up of 9 months (6 to 12), 409 patients (78% [75% to 83%]) were in class New York Heart Association I/II and 57 (11% [8% to 14%]) still had moderate-to-severe MR. Overall adverse events occurred in 137 (26% [20% to 31%]) of the patients and 78 (15% [1% to 17%]) of them died; 6-minute walk test improved by 100 m (83 to 111), whereas a significant reduction in left ventricular volumes and systolic pulmonary pressure was reported. At meta-regression analysis, an increase in left ventricle systolic volumes positively affected reduction of volumes after Mitraclip, whereas atrial fibrillation reduced the positive effect of the valve implantation on ejection fraction on end-diastolic and -systolic volumes. In conclusion, Mitraclip represents an efficacious strategy for patients with heart failure and severe MR. It offers a significant improvement in functional class and in cardiac remodeling, in patients with severely dilated hearts as well, although its efficacy remains limited in the presence of atrial fibrillation. [ABSTRACT FROM AUTHOR]

The aim of this study was to explore the adaptability of 3 contemporary surgical scores (Logistic EuroSCORE [LES], EuroSCORE II [ESII], and Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM]) for prediction of mortality after percutaneous mitral valve repair with the MitraClip system. A total of 304 patients from the multicenter Getting Reduction of mitrAl inSufficiency by Percutaneous clip implantation in ITaly registry (GRASP-IT) were stratified based on LES, ESII, and STS-PROM tertiles and analyzed by different measurements of discrimination, calibration, and global accuracy with focus on 30-day and 1-, 2-, and 3-year mortality. A statistically significant gradient in the distribution of mortality was observed at all time points with ESII, at 2 years with LES, and at 2 and 3 years with STS-PROM. ESII had the best discrimination at 30 days (C-statistic 0.80), which remained acceptable at later follow-up, being significantly superior to that of LES at each time point (p = 0.003 at 30 days, p = 0.005 at 1 year, p = 0.011 at 2 years, and p = 0.029 at 3 years). Compared with STS-PROM, ESII showed better discrimination at 30 days (C-statistic 0.80 vs 0.62, p = 0.023). All scores overpredicted the risk of mortality at 30 days and were miscalibrated at 2 and 3 years. At 1 year, there was a good agreement between the observed and predicted probabilities for ESII and STS-PROM, whereas LES remained overpredictive. ESII showed the best global accuracy at 30 days and 1 year, whereas no notable differences were noted versus LES and STS-PROM at 2 and 3 years. In conclusion, lacking specific tools for risk stratification of patients undergoing MitraClip implantation, ESII holds favorable prognostic characteristics, which makes it a valid surrogate. [ABSTRACT FROM AUTHOR]

Background In recent years, right ventricular ( RV) function has acquired greater relevance as a clinical and prognostic marker in many physiopathological conditions. The study aims to point out the value of real time three-dimensional echocardiography ( RT3 DE) and tissue Doppler imaging ( TDI) in the evaluation of patients affected by pulmonary hypertension ( PH), compared with conventional two-dimensional (2D) echocardiography. Methods We enrolled 44 subjects affected by PH who underwent 2D and Doppler echocardiography, RT 3D Echocardiography and TDI evaluation of the RV, and a healthy control group. PH itself can induce severe functional and structural abnormalities of the RV, such as RV hypertrophy, RV dilation, and RV systolic and diastolic dysfunction. Results In this study, RV FAC, and TAPSE showed marked alterations in patients with PH compared to the control group (C): ( RVFAC: [ PH] 0.29 ± 0.07 vs. [C] 0.49 ± 0.05%, P < 0.0001; TAPSE: [ PH] 15.3 ± 3.2 vs. [C] 21.1 ± 2.6 mm, P > 0.0001). The 3D RV end-diastolic volume was significantly higher in PH than in C ( PH) (138.7 ± 25.3 vs. [C] 82.8 ± 12.5 mL, P < 0.0001] as well as 3D RV end-systolic volume ( PH) (97.6 ± 21.5 vs. [C] 39.3 ± 9.5 mL, P < 0.0001). The 3D RV ejection fraction ( EF) was significantly lower in the pulmonary hypertension group than in healthy subjects (31.8 ± 6.8 vs. [C] 52.5 ± 4.7%, P < 0.0001). Conclusions In patients with PH, evaluation of the RV diastolic and systolic volume and EF by RT3 DE has shown a higher discriminating power in comparison, respectively, with 2 DRV diastolic area and the relative fractional area changes. [ABSTRACT FROM AUTHOR]

Background: In the last recent years a new percutaneous procedure, the MitraClip, has been validated for the treatment of mitral regurgitation. MitraClip procedure is a promising alternative for patients unsuitable for surgery as it reduces the risk of death related to surgery ensuring a similar result. Few data are present in literature about the variation of hemodynamic parameters and ventricular coupling after Mitraclip implantation. Methods: Hemodynamic data of 18 patients enrolled for MitraClip procedure were retrospectively reviewed and analyzed. Echocardiographic measurements were obtained the day before the procedure (T0) and 21 ± 3 days after the procedure (T1), including evaluation of Ejection Fraction, mitral valve regurgitation severity and mechanism, forward Stroke Volume, left atrial volume, estimated systolic pulmonary pressure, non invasive echocardiographic estimation of single beat ventricular elastance (Es(sb)), arterial elastance (Ea) measured as systolic pressure • 0.9/ Stroke Volume, ventricular arterial coupling (Ea/Es(sb) ratio). Data were expressed as median and interquartile range. Measures obtained before and after the procedure were compared using Wilcoxon non parametric test for paired samples. Results: Mitraclip procedure was effective in reducing regurgitation. We observed an amelioration of echocardiographic parameters with a reduction of estimated systolic pulmonary pressure (45 to 37,5 p = 0,0002) and left atrial volume (110 to 93 p = 0,0001). Despite a few cases decreasing in ejection fraction (37 to 35 p = 0,035), the maintained ventricular arterial coupling after the procedure (P = 0,67) was associated with an increasing in forward stroke volume (60,3 to 78 p = 0,05). Conclusion: MitraClip is effective in reducing mitral valve regurgitation and determines an amelioration of hemodynamic parameters with preservation of ventricular arterial coupling. [ABSTRACT FROM AUTHOR]

Objectives: The goal of this study was to assess the procedural and 2-year results of the subclavian approach for transcatheter aortic valve implantation (TAVI) compared with those of the femoral approach by using propensity-matched analysis. Background: The subclavian approach with the CoreValve prosthesis (Medtronic, Inc., Minneapolis, Minnesota) represents an interesting opportunity when the femoral access is unfeasible. Methods: All consecutive patients enrolled in the Italian CoreValve Registry who underwent TAVI with the subclavian approach were included. Propensity score analysis was used to identify a matching group of patients undergoing femoral TAVI. Results: Subclavian approach was used in 141 patients (61% men; median age 83 years; median logistic European System for Cardiac Operative Risk Evaluation score 23.7%). The femoral group of 141 patients was matched for baseline clinical characteristics, except for peripheral artery disease. The 2 groups showed similar procedural success (97.9% vs. 96.5%; p = 0.47), major vascular complications (5.0% vs. 7.8%; p = 0.33), life-threatening bleeding events (7.8% vs. 5.7%; p = 0.48), and combined safety endpoint (19.9% vs. 25.5%; p = 0.26). The subclavian group showed lower rates of acute kidney injury/stage 3 (4.3% vs. 9.9%; p = 0.02), of minor vascular complications at the 18-F sheath insertion site (2.1% vs. 11.3%; p = 0.003), and of all types of bleeding events related to vascular complications. Survival at 2 years was 74.0 ± 4.0% in the subclavian group compared with 73.7 ± 3.9% in the femoral group (p = 0.78). The 2-year freedom from cardiovascular death was 87.2 ± 3.1% versus 88.7 ± 2.8% in the subclavian versus femoral group, respectively (p = 0.84). Conclusions: The subclavian approach for TAVI is safe and feasible, with procedural and medium-term results similar to the femoral approach. Subclavian access should be considered a valid option not only when the femoral approach is impossible but also when it is difficult, albeit feasible. [Copyright &y& Elsevier]

OBJECTIVES Redo surgery after failed mitral valve repair may be high risk, or contraindicated in patients with comorbidities. Because of this high risk, other interventional possibilities like transcatheter valve implantation might be of benefit. We report our experience with transcatheter mitral valve-in-ring implantation (TVIR) in high-risk patients after failure of surgical ring annuloplasty. METHODS From January 2010 to February 2012, following a multidisciplinary discussion, 17 high-risk patients underwent TVIR using Edwards SAPIEN XT prostheses, via either a transvenous transseptal (n = 8), or a transapical approach (n = 9). RESULTS Patients were aged 70 ± 16 years, in New York Association classes III/IV. Their mean logistic EuroSCORE was 36 ± 17% and mean Society of Thoracic Surgeons risk score 13 ± 9%. The mean time interval between surgery and repair failure was 7 ± 3 years. Annuloplasty rings were semi-rigid in 14 cases, flexible in 2, and rigid in 1. Manufacturers ring diameters were 26 mm in 4 patients, 27 mm in 1, 28 mm in 9, 30 mm, 31 mm and 34 mm in 1. The predominant failure mode was regurgitation in 12 cases and stenosis in 5. SAPIEN XT diameters were 26 mm in 15 patients, 23 mm and 29 mm in 1. Procedural success rate was 88% (15/17). Emergency surgery was needed in 1 patient due to acute dislodgement of the ring. The degree of mitral regurgitation was reduced to none or mild in all but 2 patients; final mean gradient was 7 ± 3 mmHg. Thirty-day survival was 82% (14/17 patients). At last follow-up (13 ± 5 months), survival rate was 71% (12/17). CONCLUSIONS These preliminary results suggest that TVIR is feasible, with low operative risk, and may provide short-term clinical and haemodynamic improvement in selected high-risk patients with failure of mitral ring annuloplasty. [ABSTRACT FROM PUBLISHER]

Background: In the last recent years a new percutaneous procedure, the MitraClip, has been validated for the treatment of mitral regurgitation. MitraClip procedure is a promising alternative for patients unsuitable for surgery as it reduces the risk of death related to surgery ensuring a similar result. Few data are present in literature about the variation of hemodynamic parameters and ventricular coupling after Mitraclip implantation.Methods: Hemodynamic data of 18 patients enrolled for MitraClip procedure were retrospectively reviewed and analyzed. Echocardiographic measurements were obtained the day before the procedure (T0) and 21 ± 3 days after the procedure (T1), including evaluation of Ejection Fraction, mitral valve regurgitation severity and mechanism, forward Stroke Volume, left atrial volume, estimated systolic pulmonary pressure, non invasive echocardiographic estimation of single beat ventricular elastance (Es(sb)), arterial elastance (Ea) measured as systolic pressure • 0.9/ Stroke Volume, ventricular arterial coupling (Ea/Es(sb) ratio). Data were expressed as median and interquartile range. Measures obtained before and after the procedure were compared using Wilcoxon non parametric test for paired samples.Results: Mitraclip procedure was effective in reducing regurgitation. We observed an amelioration of echocardiographic parameters with a reduction of estimated systolic pulmonary pressure (45 to 37,5 p = 0,0002) and left atrial volume (110 to 93 p = 0,0001). Despite a few cases decreasing in ejection fraction (37 to 35 p = 0,035), the maintained ventricular arterial coupling after the procedure (P = 0,67) was associated with an increasing in forward stroke volume (60,3 to 78 p = 0,05).Conclusion: MitraClip is effective in reducing mitral valve regurgitation and determines an amelioration of hemodynamic parameters with preservation of ventricular arterial coupling. [ABSTRACT FROM AUTHOR]