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Background: Few randomized trials have compared bioprostheses for transcatheter aortic valve replacement, and no trials have compared bioprostheses with supra-annular design. The SCOPE 2 trial (Safety and Efficacy Comparison of Two TAVI Systems in a Prospective Randomized Evaluation 2) was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut bioprostheses for transcatheter aortic valve replacement.Methods: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years old with an indication for transfemoral transcatheter aortic valve replacement as agreed by the heart team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary end point, powered for noninferiority of the ACURATE neo bioprosthesis, was all-cause death or stroke at 1 year. The key secondary end point, powered for superiority of the ACURATE neo bioprosthesis, was new permanent pacemaker implantation at 30 days.Results: Among 796 randomized patients (mean age, 83.2±4.3 years; mean Society of Thoracic Surgeons Predicted Risk of Mortality score, 4.6±2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary end point occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%, upper 1-sided 95% confidence limit, 6.1%; P=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5% [95% CI, -12.4 to -2.60]; P=0.0027). No significant differences were observed in the components of the primary end point. Cardiac death at 30 days (2.8% versus 0.8%; P=0.03) and 1 year (8.4% versus 3.9%; P=0.01), and moderate or severe aortic regurgitation at 30 days (10% versus 3%; P=0.002) were significantly increased in the ACURATE neo group.Conclusions: Transfemoral transcatheter aortic valve replacement with the self-expanding ACURATE neo did not meet noninferiority compared with the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and it was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03192813. [ABSTRACT FROM AUTHOR]

Background: There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting.Objectives: This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR.Methods: The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year.Results: The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year.Conclusions: The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials. [ABSTRACT FROM AUTHOR]

Background There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. Objectives This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. Methods The OBSERVANT (Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. Results The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. Conclusions The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials. [ABSTRACT FROM AUTHOR]

Abstract: The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) score is a useful tool to guide decision-making in patients undergoing three-vessel disease and left main percutaneous coronary intervention. However, someone perceives the SYNTAX score as a labor-intensive surrogate with no added utility over clinical judgment and technical experience. We aimed at reviewing the current limitations of the SYNTAX score and provided practical considerations on how and when this angiographic tool should be used with the goal in mind to maximize its usefulness in the catheterization laboratory. [Copyright &y& Elsevier]

Comparisons of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis remain sparse or limited by a short follow-up. We sought to evaluate early and midterm outcomes of consecutive patients (n = 618) undergoing successful TAVI (n = 218) or isolated SAVR (n = 400) at 2 centers. The primary end point was incidence of Valvular Academic Research Consortium–defined major adverse cerebrovascular and cardiac events (MACCEs) up to 1 year. Control of potential confounders was attempted with extensive statistical adjustment by covariates and/or propensity score. In-hospital MACCEs occurred in 73 patients (11.8%) and was more frequent in patients treated with SAVR compared to those treated with TAVI (7.8% vs 14.0%, p = 0.022). After addressing potential confounders using 3 methods of statistical adjustment, SAVR was consistently associated with a higher risk of MACCEs than TAVI, with estimates of relative risk ranging from 2.2 to 2.6 at 30 days, 2.3 to 2.5 at 6 months, and 2.0 to 2.2 at 12 months. This difference was driven by an adjusted increased risk of life-threatening bleeding at 6 and 12 months and stroke at 12 months with SAVR. Conversely, no differences in adjusted risk of death, stroke and myocardial infarction were noted between TAVI and SAVR at each time point. In conclusion, in a large observational registry with admitted potential for selection bias and residual confounding, TAVI was not associated with a higher risk of 1-year MACCEs compared to SAVR. [Copyright &y& Elsevier]

Abstract: Background: Current guidelines recommend coronary artery bypass grafting (CABG) as the first choice of revascularization in patients with unprotected left main coronary artery (ULMCA) disease. We tested the hypothesis that a non guideline-driven approach to ULMCA revascularization which uses percutaneous coronary intervention (PCI) by default and CABG in selected patients may be as safe as the traditional guideline-driven approach. Methods: Between March 2002 and December 2008, PCI has been used as a default strategy for ULMCA revascularization in Center 1 (non guideline-driven [NGD] group), whereas CABG has been used as a default strategy in Center 2 (guideline-driven [GD] group). Results: A total of 838 patients with ULMCA disease were included. Of these 67.1% and 32.9% were treated in the NGD and GD groups, respectively. A significant higher risk of major adverse cardiac events (MACE) (hazard ratio [HR] 1.60, 95% confidence interval [CI] 1.10–2.33, p =0.014) and target vessel revascularization (HR 2.44, 95% CI 1.26–4.72, p =0.008) occurred at 24months in the NGD group as compared with GD Group. Adjustment by means of propensity score did not result in substantial changes with regard to the subcomponent safety and efficacy endpoints. Conversely, the composite of MACE was no longer significant according to all types of statistical adjustment. Conclusions: In a large registry of patients with ULMCA disease undergoing revascularization in current clinical practice, an approach based on PCI and the selective use of CABG gives results which are not inferior to those of a traditional approach guided by the current guidelines. [Copyright &y& Elsevier]

The aim of this study was to compare long term clinical outcome after left main stenting in a large real world population of patients treated with drug-eluting stents (DES) or bare-metal stents (BMS) in the setting of acute coronary syndromes. The advent of DES decreased the risk of unprotected left main coronary artery restenosis as compared with BMS, but safety concerns still exist, especially when high-risk patients presenting with acute coronary syndromes are considered. The Gruppo Italiano Studi Emodinamici-Societa'' Italiana di Cardiologia Invasiva (GISE-SICI) registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent percutaneous coronary intervention on unprotected left main coronary artery between January 2002 and December 2006. From the registry, a total of 849 consecutive patients presenting with unstable angina or non–ST-segment elevation myocardial infarction who underwent DES (n = 611) or BMS (n = 238) implantation were analyzed with extensive multivariable and propensity-score adjustments. At 3-year follow-up, the adjusted hazard ratio for the risk of mortality after DES implantation relative to BMS implantation was 0.90 (95% confidence intervals [CI] 0.59 to 1.38, p = 0.617), and the adjusted hazard ratio for the risk of cardiac mortality was 0.75 (95% CI 0.45 to 1.27, p = 0.287). DES were associated with significant reduction of myocardial infarction (hazard ratio 0.37, 95% CI 0.17 to 0.81, p = 0.009) and target lesion revascularization rates (hazard ratio 0.38, 95% CI 0.21 to 0.69, p = 0.001). Younger age, low ejection fraction, an increase in the cardiac biomarkers, absence of diabetes, and bifurcations showed a significant interaction with assigned treatment regarding myocardial infarction. The treatment effects on target lesion revascularization were consistent across multiple subgroups, with the possible exception of patients with nonbifurcational lesions. In conclusion, in a large population of patients with acute coronary syndromes and unprotected left main coronary artery disease DES were more effective than BMS in reducing myocardial infarction and target lesion revascularization. There was no evidence of a significant reduction in mortality with DES versus BMS. [Copyright &y& Elsevier]

Stent thrombosis (ST) is an infrequent (0.5% to 1.5%) complication of intracoronary stenting, with severe clinical consequences. This multicenter, randomized study evaluated the clinical outcome in 479 patients (598 lesions treated) who underwent elective coronary stenting with a Carbofilm-coated stent (CarboStent) who met prespecified eligibility criteria and were randomly assigned to receive aspirin alone (n = 235) or aspirin plus a thienopyridine antiplatelet regimen (n = 244). Clinical, angiographic, and procedural characteristics were similar between groups. The primary end point was the incidence of 30-day ST; secondary end points included major vascular or bleeding complications within 30 days and death, acute myocardial infarction, and target vessel revascularization at 6 months. ST occurred in 4 patients (1.4%) in the aspirin-only group and in 1 patient (0.3%) in the aspirin-plus-thienopyridine group (relative risk 0.23, 95% confidence interval 0.03 to 2.08, p = NS). After careful review of cases, 89 patients (19%) with protocol deviations were identified. When they were excluded from the analysis, no ST was observed in either group. Secondary end points were reached by 4% of the aspirin-alone group and 8% of the aspirin-plus-thienopyridine group (relative risk 2.35, 95% confidence interval 0.94 to 5.85, p = NS). In conclusion, after optimal intracoronary implantation of the CarboStent, antiplatelet therapy with aspirin alone was safe and provided efficacy comparable to aspirin plus a thienopyridine in the prevention of ST. [Copyright &y& Elsevier]

Abstract: The Evaluation of Xience Prime or Xience V versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a multicenter, ongoing trial conducted in patients with left main disease and SYNTAX score≤32 to establish the presumptive advantage of percutaneous coronary intervention (PCI) versus bypass surgery in patients with less complex coronary artery disease than those enrolled in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial. In this article, we aimed at critically discussing key features and issues relevant to design and clinical interpretation of this new contemporary trial of left main PCI. [Copyright &y& Elsevier]

This study aimed to compare the peri-procedural success and complication rate within a large registry of intra-cardiac echocardiography (ICE)- vs. transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) procedures with a Watchmann FLX device. Data from 772 LAAO procedures, performed at 26 Italian centers, were reviewed. Technical success was considered as the final implant of a Watchmann FLX device in LAA; the absence of pericardial tamponade, peri-procedural stroke and/or systemic embolism, major bleeding and device embolization during the procedure was defined as a procedural success. One-year stroke and major bleeding rates were evaluated as outcome. ICE-guided LAA occlusion was performed in 149 patients, while TEE was used in 623 patients. Baseline characteristics were similar between the ICE and TEE groups. The technical success was 100% in both groups. Procedural success was also extremely high (98.5%), and was comparable between ICE (98.7%) and TEE (98.5%). ICE was associated with a slightly longer procedural time (73 ± 31 vs. 61.9 ± 36 min, p = 0.042) and shorter hospital stay (5.3 ± 4 vs. 5.8 ± 6 days, p = 0.028) compared to the TEE group. At one year, stroke and major bleeding rates did not differ between the ICE and TEE groups. A Watchmann FLX device showed high technical and procedural success rate, and ICE guidance does not appear inferior to TEE. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Transcatheter or surgical aortic-valve replacement in intermediate-risk patients" by M. B. Leon, and colleagues in the 2016 issue.

The authors comment on the study "Valvular heart disease: What is the impact of providing a transcatheter aortic valve implantation service on conventional aortic valve surgical activity: patient risk factors and outcomes in the first 2 years," by S. W. Grant and colleagues, published within the issue. They briefly cite the prevalence of aortic stenosis. The risk of aortic valve replacement (AVR) in elderly patients is highlighted. The advent of stent-based biological prostheses is also traced.

Background: Concomitant mitral transcatheter edge-to-edge repair (M-TEER) and left atrial appendage closure (LAAC) showed to be a feasible approach to optimize the treatment of patients eligible for both procedures, but mid-term outcomes are unclear. Methods: We retrospectively analyzed consecutive patients undergoing M-TEER and enrolled in the local prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) registry. We compared patients undergoing isolated M-TEER (n = 58, 58.5%) with those undergoing concomitant M-TEER and LAAC (n = 41, 41.5%) from January 2018 to December 2022. The primary endpoint was a composite of all-cause death, stroke or systemic embolism, hospitalization for heart failure, and bleeding at 1 year. The co-primary endpoint was procedural success. Results: The primary endpoint was similar between patients undergoing concomitant M-TEER+LAAC or isolated M-TEER (Kaplan Meier (KM) estimates 36.6% vs. 44.8%; plog-rank = 0.75). Procedural success was also similar (92.7% vs. 94.8%; p = 0.69). At 1- year, minor bleeds were lower in patients undergoing concomitant M-TEER and LAAC (KM estimates 0.0% vs. 18.9%; plog-rank < 0.01). Conclusion: In patients with concomitant MR and AF and eligible for M-TEER and LAAC treatment, a combined approach of M-TEER and LAAC was as safe as an M-TEER-alone strategy and associated with lower minor bleeding at 1 year. [ABSTRACT FROM AUTHOR]

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]

Introduction: Current guidelines recommend three-dimensional echocardiography (3DE) as the reference technique to assess left ventricular (LV) volumes and ejection fraction (EF). We performed a metaanalysis to identify normative reference values by real time 3DE in healthy subjects. Methods: We searched MEDLINE and the Cochrane Library databases using the key search terms three-dimensional echocardiography, volumes, and healthy. Data were pooled using random-effects meta-analysis, and source of variation was investigated using meta-regression. After selection, 13 articles were included (2806 subjects). Four studies were conducted in children and young adolescents; one study provided data in an independent pediatric subgroup. Results: In adults, pooled mean value for LV EDV was 98.4 mL (95%CI, 87-110 mL), while LV ESV mean value was 37.0 mL (95%CI, 32-42 mL). LV EF mean value was 62.9% (95%CI 61.7-64.2%). Male subjects showed a significant increase in both LV EDV index (mean difference 5.3 mL/m²; P < 0.001) and LV ESV index (mean difference 3.3 mL/m²; P < 0.001). LV EF was significantly higher in female subjects (P = 0.003). In pediatric studies, LV EDV pooled mean value was 53.1 mL (95%CI, 38.1-68 mL), while for LV ESV, it was 19.8 mL (95%CI, 14.8-24.8 mL); LV EF mean value was 63.3% (95%CI, 61.6-65%). Significant heterogeneity and inconsistency were noted among studies. Age, systolic blood pressure, and heart rate were identified as a source of between-studies variation for LV volumes. Body surface area was a predictor of nonindexed LV volumes. Conclusions: Data from available studies of normative values for 3DE were summarized. Our findings may increase the genera liza bility of LV normative data by 3DE. [ABSTRACT FROM AUTHOR]

Objective: To compare vascular complications in patients undergoing percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) using ultrasound guidance (USG) versus fluoroscopy guidance (FSG) for femoral access.Background: In patients undergoing PCI, using the arterial femoral access increases the risk of vascular complications compared using the radial access. USG reduces time to access, number of attempts, and vascular complications compared with FSG, but the efficacy of USG has never been tested in the setting of CTO-PCI.Methods: A total of 197 patients undergoing CTO-PCI using at least a femoral vascular access from November 2015 to September 2020 were screened. The primary outcome was a composite of local hematoma, pseudoaneurysm, retroperitoneal hemorrhage, arteriovenous fistula or hemoglobin drop ≥3 g/dL during hospitalization. The independent association between USG and the primary outcome of interest was explored.Results: The primary outcome occurred in 17.3% of patients. Patients in the USG group had a significantly lower incidence of vascular complications compared with patients in the FSG group (8.5% vs. 21.0%, p = 0.039), driven by a reduction of localized hematomas (3.4% vs 13.0%, p = 0.042). After adjustment for type of CTO approach and heparin dose, USG was significantly associated with a reduced relative risk of the composite primary outcome (adjusted odds ratio 0.16, 95% confidence interval 0.05 to 0.51; p = 0.002).Conclusion: USG in CTO-PCI is associated with a decreased risk of vascular complications, primarily driven by a reduction in local hematomas, especially in complex CTO-PCI where the larger use of heparin increases the risk of vascular complications. [ABSTRACT FROM AUTHOR]

The coronavirus 2019 (COVID-19) pandemic upset healthcare systems and their logistics worldwide. We sought to assess safety and effectiveness of an optimized logistics for transcatheter aortic valve implantation (TAVI) pathway developed during the COVID-19 pandemic. This is a retrospective analysis. An optimized TAVI logistics based on performing TAVI work-up and procedure during the same hospitalization was used during the COVID-19 pandemic. In-hospital and 30-day outcomes of patients treated during the pandemic were compared with an historical cohort of patients undergoing TAVI with staged work-up before the pandemic within an homogeneous timeframe. Of 536 patients, 227 (42.4%) underwent TAVI during the COVID-19 pandemic with a reduction of 26.5% compared to the pre-pandemic period (n = 309). The median age was 81 (77–85) years and STS score was 3.4 (2.2–5.6)%. Lower rates of in-hospital major vascular complications (2.2% vs. 8.7%; p < 0.01) and life-threatening bleeding (0.4% vs. 4.2%; p = 0.01) were reported in the COVID-19 period, whereas no difference in acute kidney injury (7.0% vs. 7.4%, p = 0.85) rate was reported between COVID-19 and pre-COVID-19 periods. No difference in 30-day rates of all-cause death (4.0 vs. 4.5, p = 0.75) and of major adverse cardiovascular events (4.0 vs. 6.1, p = 0.26) were reported between COVID-19 and pre-COVID-19 periods. The use of optimized single-hospitalization logistics for TAVI workup and procedure developed during the COVID-19 pandemic, showed to be as safe and effective as the two-stage TAVI pathway previously adopted, allowing the minimization of potential exposure to COVID-19 infection and shortening times to treatment for severely symptomatic patients. [Display omitted] • The COVID-19 pandemic has caused the treatment deferral of a large portion of high-risk AS patients • Pre TAVI work-up is costly and requires a significant use of resources and hospital admissions • This study evaluated a novel TAVI care pathway aimed at optimizing the use of hospital resources • This novel TAVI care pathway could be adopted also after the pandemic period. [ABSTRACT FROM AUTHOR]

A-FMR is considered a specific sub-type of secondary MR in patients with atrial fibrillation (AF) and preserved left ventricle ejection fraction (LVEF). Aim of the study was to investigate the acute and mid-term outcomes of transcatheter edge-to-edge mitral valve repair (TMVr) with the MitraClip in atrial functional mitral regurgitation (A-FMR). The study included patients with A-FMR and concomitant AF who underwent to the MitraClip at 7 Italian Centers. Aim of the study was to assess the safety, efficacy and mid-term cardiovascular outcomes. After reviewing 1153 patients with FMR treated with TMVr from 2009 to 2021, 87 patients (median age 81 years, 61% female) with A-FMR were identified. Technical success was achieved in 97%, 30-day device success in 83% and 30-day procedural success in 80%. All-cause death at 30-day was 5%. Estimated two-year freedom from all-cause death and cardiac death was 60% and 77%, respectively, whereas freedom from all-cause death/heart failure hospitalization was 55%. Residual MR ≤ 2+ was encountered in 89% (n = 47/53) and improvement in NYHA class I/II in 79% (n = 48/61). Post-procedural MR ≥ 2+ (HR 5.400, CI 1.371–21.268) and inter-commissural annular diameter ≥ 35 mm (HR 4.159, CI 1.057–16.363) were independent predictors of all-cause death/heart failure hospitalization during the follow-up. Positive reverse remodeling of left atrium and mitral annular dimensions occurred after TMVr during the follow-up. MitraClip resulted to be a safe and effective option to treat A-FMR in elderly patients. The MITRA-TUNE registry: A-FMR characteristics and changes in MR and NYHA class during the follow-up after MitraClip (A) Compared to baseline (34.5% MR 3+ and 65.5% MR 4+), a statistically significant improvement was observed at discharge (70% MR 1+, 28% MR 2+, 2% MR ≥3+, p ≤ 0.001) and at the follow-up (43% MR 1+, 46% MR 2+, 11% MR 3+, p ≤ 0.001). Median echocardiographic follow-up was 371 days [IQR 158–1067 days]. (B) Compared to baseline (17% NYHA II, 71% NYHA III and 12% NYHA IV), a statistically significant improvement was observed at the follow-up (4% NYHA I, 75% NYHA II, 18% NYHA III, 3% NYHA IV, p ≤ 0.001). Median clinical follow-up was 489 days [IQR 242–1033 days]. LVEF = left ventricle ejection fraction; LVEDD = left ventricle end-diastolic diameter; LV = left ventricle; MR = mitral regurgitation; FMR = functional mitral regurgitation; TMVr = transcatheter mitral valve repair; A-FMR = atrial functional mitral regurgitation; MVARC = Mitral Valve Academic Research Consortium; NYHA = New York Heart Association. [Display omitted] • Up to 1135 patients with FMR treated in Italy with the MitraClip, 87 (7.6%) fulfilled criteria for A-FMR • The MitraClip in A-FMR presented a technical success of 97%, 30-day device success of 83% and procedural success of 80%. • Estimated two-year freedom from all-cause death and cardiac death was 60% and 77%. • Positive reverse remodeling of LA and mitral annular dimensions occurred after the MitraClip during the follow-up. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV). BEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area < 400 mm2 or perimeter <72 mm), medium-annulus (area ≥ 400 and < 575 mm2, perimeter ≥72 mm and< 85 mm), large-annulus (area ≥ 575 mm2 or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success. 45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, younger, with higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, p = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, p < 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type. TAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs. • TAVR can be successfully performed in severe bicuspid aortic stenosis. • However, interaction between annular size and THV type is still unclear. • We compared BEV and SEV hemodynamics by aortic annulus size in BAV patients. • In large annuli a higher rate of PVLs was observed SEVs compared to BEVs. • No differences in clinical outcomes were observed according to annular size nor THV. [ABSTRACT FROM AUTHOR]

Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate <45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction <40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system. [ABSTRACT FROM AUTHOR]

BACKGROUND: Very few data exist on the clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation. The objective of this study was to assess the impact of PPI after transcatheter aortic valve implantation on late outcomes in a large cohort of patients. METHODS AND RESULTS: A total of 1556 consecutive patients without prior PPI undergoing transcatheter aortic valve implantation were included. Of them, 239 patients (15.4%) required a PPI within the first 30 days after transcatheter aortic valve implantation. At a mean follow-up of 22±17 months, no association was observed between the need for 30-day PPI and all-cause mortality (hazard ratio, 0.98; 95% confidence interval, 0.74-1.30; P=0.871), cardiovascular mortality (hazard ratio, 0.81; 95% confidence interval, 0.56-1.17; P=0.270), and all-cause mortality or rehospitalization for heart failure (hazard ratio, 1.00; 95% confidence interval, 0.77-1.30; P=0.980). A lower rate of unexpected (sudden or unknown) death was observed in patients with PPI (hazard ratio, 0.31; 95% confidence interval, 0.11-0.85; P=0.023). Patients with new PPI showed a poorer evolution of left ventricular ejection fraction over time (P=0.017), and new PPI was an independent predictor of left ventricular ejection fraction decrease at the 6- to 12-month follow-up (estimated coefficient, -2.26; 95% confidence interval, -4.07 to -0.44; P=0.013; R(2)=0.121). CONCLUSIONS: The need for PPI was a frequent complication of transcatheter aortic valve implantation, but it was not associated with any increase in overall or cardiovascular death or rehospitalization for heart failure after a mean follow-up of ~=2 years. Indeed, 30-day PPI was a protective factor for the occurrence of unexpected (sudden or unknown) death. However, new PPI did have a negative effect on left ventricular function over time. [ABSTRACT FROM AUTHOR]

Background--Very few data exist on the clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation. The objective of this study was to assess the impact of PPI after transcatheter aortic valve implantation on late outcomes in a large cohort of patients. Methods and Results--A total of 1556 consecutive patients without prior PPI undergoing transcatheter aortic valve implantation were included. Of them, 239 patients (15.4%) required a PPI within the first 30 days after transcatheter aortic valve implantation. At a mean follow-up of 22 ± 17 months, no association was observed between the need for 30-day PPI and all-cause mortality (hazard ratio, 0.98; 95% confidence interval, 0.74-1.30; P=0.871), cardiovascular mortality (hazard ratio, 0.81; 95% confidence interval, 0.56-1.17; P=0.270), and all-cause mortality or rehospitalization for heart failure (hazard ratio, 1.00; 95% confidence interval, 0.77-1.30; P=0.980). A lower rate of unexpected (sudden or unknown) death was observed in patients with PPI (hazard ratio, 0.31; 95% confidence interval, 0.11-0.85; P=0.023). Patients with new PPI showed a poorer evolution of left ventricular ejection fraction over time (P=0.017), and new PPI was an independent predictor of left ventricular ejection fraction decrease at the 6- to 12-month follow-up (estimated coefficient, -2.26; 95% confidence interval, -4.07 to -0.44; P=0.013; R² = 0.121). Conclusions--The need for PPI was a frequent complication of transcatheter aortic valve implantation, but it was not associated with any increase in overall or cardiovascular death or rehospitalization for heart failure after a mean follow-up of ≈2 years. Indeed, 30-day PPI was a protective factor for the occurrence of unexpected (sudden or unknown) death. However, new PPI did have a negative effect on left ventricular function over time. [ABSTRACT FROM AUTHOR]

The ability of optical coherence tomography (OCT) to recognize intraplaque macrophage infiltration is now well acknowledged. This post-hoc analysis of the CLIMA study aimed to address the clinical impact of the circumferential extension of OCT-defined macrophages and their location at one year follow-up. The multicentre CLIMA study enrolled 1003 patients undergoing OCT evaluation of the untreated proximal left anterior descending (LAD) coronary artery. Measurements of circumferential extension of macrophages and measurements of the distance from intima-lumen contour to macrophages string were performed at the plaque cross-section judged as containing the greatest amount of macrophages. The main study endpoint was a composite of cardiac death, myocardial infarction (MI) and/or target vessel revascularization (TVR). Patients with large macrophage arc (p = 0.001) and superficial macrophage arc (p < 0.001) showed a higher one-year incidence of the main one-year composite endpoint. Consistently hypertension (p = 0.018), family history of CAD (p = 0.046), diabetes mellitus (p = 0.036), lower ejection fraction (p = 0.009) and chronic kidney disease (p = 0.019) were more frequently found in patients experiencing the main composite endpoint. At multivariate Cox regression analysis, fibrous cap thickness < 75 μm (HR 2.51, 95% 1.46–4.32), presence of large (HR 1.97, 95%CI 1.16–3.35, p = 0.012) and superficial (HR 1.72, 95%CI 1.02–2.90; p = 0.040) macrophage arc remained independent predictors of the main composite endpoint. Large macrophage arc was associated with target LAD related MI. The present post-hoc analysis of the CLIMA showed that the circumferential extension of macrophages and their location are related to a composite endpoint of cardiac death, MI and/or TVR. • Patients with intraplaque macrophages have higher risk of 1-year cardiac mortality. • Patients with large/superficial macrophage arc suffer more from 1-year cardiac events. • Large macrophage infiltration is associated with 1-year target LAD related MI. [ABSTRACT FROM AUTHOR]

Although transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is becoming an established technique, the effect of gender-related differences is poorly described. We performed a gender-based comparison of high-risk patients undergoing TAVI with the self-expandable CoreValve Revalving System for severe aortic stenosis to evaluate early and mid-term clinical outcomes. From the Italian prospective CoreValve registry, 659 consecutive patients (55.8% women) who underwent TAVI were included in the present study. We analyzed the gender-based differences in terms of clinical, angiographic, and procedural features and the differences in the rate of early and mid-term major adverse cardiac and cerebrovascular events. The men were younger, presented more often with severe left ventricular dysfunction, and had a greater rate of previous myocardial infarction, coronary revascularization, peripheral artery disease, renal failure, and heart conduction disorders than the women. The logistic European System for Cardiac Operative Risk Evaluation score did not differ between the 2 groups. The overall unadjusted and adjusted analyses failed to show significant differences between genders in terms of major adverse cardiac and cerebrovascular events at a median follow-up of 13 months (range 8 to 18). At late follow-up (landmark analysis >12 months), a survival benefit was observed in women (hazard ratio 0.27, 95% confidence interval 0.09 to 0.84, p=0.02). In conclusion, in this multicenter registry, the gender-based comparison of TAVI patients showed that men, despite the younger age, had more extensive atherosclerotic burden compared to women. Overall, the early and mid-term outcomes were similar between genders, although women might have a survival benefit with longer follow-up. [ABSTRACT FROM AUTHOR]

Abstract: A distal location of the atherosclerotic plaque is one of the most powerful predictors of adverse events after left main angioplasty. However, bifurcations are not alike and may differ with regards to a number of variables, including the angle of the bifurcation, the presence of a ramus, the burden of downstream coronary artery disease, the involvement of stemming arteries and their mismatch. For these reasons, research is seeking to identify new specific predictors that are relevant to this patient population. Simple variables, including stenting strategy, SYNTAX (SYNergy between percutaneous coronary interventions with TAXus and cardiac surgery) score, angles and plaque distribution carry a prognostic value and may be useful to drive decisions in distal left main disease. We reviewed the evidences to date that specifically address the treatment of left main bifurcations, with emphasis on emerging prognostic determinants in this challenging scenario. [Copyright &y& Elsevier]

The functional status of ischemic heart disease (IHD) is currently assessed using the Seattle Angina Questionnaire (SAQ), a tool for monitoring and predicting the patient’s prognosis. Illness perceptions (IP) are associated with IHD behavioral risk factors. The aim of the study was to find whether different IP, as evaluated by the IP Questionnaire (IPQr), can predict any of the features of the SAQ, i.e., to determine whether the SAQ is influenced and/or biased by illness perceptions. Moreover, whether New York Heart Association class and Ejection Fraction (EF%) are predictors of IHD severity measured as need of subsequent stenting procedures was also assessed. Eighty IHD patients eligible for percutaneous coronary intervention (PCI) and drug-eluting stent implant were asked to complete the IPQr and the SAQ. Laboratory analyses, echocardiography, and coronary diagnostic and interventional procedures were performed concurrently. Physical limitations of the SAQ are predicted by IPQr emotional representation. Ischemic heart disease functional status is regulated by illness perceptions and beliefs. Thus, some of the inferences drawn from the SAQ regarding IHD prognosis and even interventional indications may be biased and compromise the prognostic reliability of the SAQ information on physical function. This can also have consequences for therapeutic indications. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to investigate whether there is a temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery (ULMCA) stenosis treated with percutaneous coronary intervention (PCI). Background: Identifying which periods during follow-up of patients with ULMCA stenosis treated with PCI are associated with higher risk of clinical events might help to improve therapeutic strategies. Methods: We analyzed data from 15 centers involved in an observational study conducted by the Italian Society of Invasive Cardiology on patients with ULMCA stenosis treated with PCI. Eight hundred ninety-four patients were enrolled. Results: At 30-day follow-up, the rate of cardiac mortality and myocardial infarction (MI) was 5.4%. In patients still taking dual antiplatelet therapy, the adjusted incidence rate ratio/10,000 patient-days of the combination of cardiac mortality and MI in the 31- to 180-day interval compared with the 181- to 360-day interval after PCI was 3.64 (p = 0.035). This risk was particularly high in patients with acute coronary syndromes. After stopping clopidogrel, the adjusted incidence rate ratio of cardiac mortality and MI in the 0- to 90-day interval compared with the 91- to 180-day interval was 4.20 (p = 0.009). Conclusions: In patients with ULMCA stenosis taking dual antiplatelet therapy there is an increased hazard of cardiac mortality and MI between 31 and 180 days compared with 181 to 360 days. Furthermore, there is an increased hazard of cardiac mortality and MI in the first 90 days after stopping clopidogrel. [Copyright &y& Elsevier]

Data are limited about the relative efficacy of drug-eluting stents (DESs) versus bare-metal stents (BMSs) for the treatment of unprotected left main coronary artery (ULMCA) stenosis. The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centers of patients with ULMCA stenosis treated using percutaneous coronary intervention (PCI). From January 2002 to December 2006, of 1,453 patients identified with ULMCA stenosis treated with PCI, 1,111 were treated with DESs and 342 were treated with BMSs. During a 2-year follow-up, risk-adjusted survival free from cardiac death was significantly higher in patients treated with DESs than in those treated with BMSs. The propensity-adjusted hazard ratio for risk of 2-year cardiac mortality after DES versus BMS implantation was 0.49 (95% confidence interval 0.32 to 0.77). The benefit of DESs in reducing cardiac mortality was obtained in the period from 3 to 6 months and maintained up to 2 years. In conclusion, for patients with ULMCA stenosis undergoing PCI, DES implantation was associated with higher adjusted rates of 2-year survival free from cardiac death. The benefit of DESs in reducing cardiac mortality was obtained in the period in which clinical manifestations of restenosis usually peak. [Copyright &y& Elsevier]

Current medication adherence telemonitoring systems have several limitations prompting the need for simpler, low-cost and widely applicable tools. To meet these needs, we propose a novel method consisting in sending a digital feedback of medication intake by just reading a pre-defined Quick Response (QR) code attached on the pills box. To assess the potential clinical applicability of the proposed QR code-based task, its feasibility was tested among elderly with heart diseases. The primary endpoint was the learning success defined as a correct execution of all QR code-based digital task steps within 10 min. Study outcomes were compared between patients 65–75 years old (younger cohort) and those aged >75 years (older cohort) admitted to the Cardiology ward of a tertiary center. A total of 262 patients were included: 128 (48.9%) were younger and 134 (51.1%) older. Despite a baseline low smartphone use in the overall population (41.2%), patients learning success of the digital task was as high as 75.6%, with lower rates among older vs. younger (67.9% vs. 83.6%, p = 0.005). After adjustment no significant independent association between age and success in learning the QR code-based task was found. Differently, increasing age was a negative independent predictor of smartphone use. The learning time was overall small, but longer in the older group (126 ± 100 vs. 100 ± 60 s, p = 0.03). The QR code-based digital task was highly feasible for elderly with heart diseases suggesting its potential large-scale clinical application and encouraging the investigation of QR code-based systems for medication adherence telemonitoring. • Implementation of the low-cost and widely available QR code technology may improve medication adherence telemonitoring. • The QR code could be applied to generate real-time feedback of medication intake. • The QR code reading is suitable for elderly with heart diseases, suggesting its potentially high clinical applicability. • Age is an independent predictor of smartphone use, but has no impact on learning the technology. • Clinical rehabilitation programs should be implemented to increase the digital literacy of elderly patients. [ABSTRACT FROM AUTHOR]

OBJECTIVES We sought to develop and validate a novel risk assessment tool for the prediction of 30-day mortality after surgical aortic valve replacement incorporating a patient's frailty. METHODS Overall, 4718 patients from the multicentre study OBSERVANT was divided into derivation (n  = 3539) and validation (n  = 1179) cohorts. A stepwise logistic regression procedure and a criterion based on Akaike information criteria index were used to select variables associated with 30-day mortality. The performance of the regression model was compared with that of European System for Cardiac Operative Risk Evaluation (EuroSCORE) II. RESULTS At 30 days, 90 (2.54%) and 35 (2.97%) patients died in the development and validation data sets, respectively. Age, chronic obstructive pulmonary disease, concomitant coronary revascularization, frailty stratified according to the Geriatric Status Scale, urgent procedure and estimated glomerular filtration rate were independent predictors of 30-day mortality. The estimated OBS AVR score showed higher discrimination (area under curve 0.76 vs 0.70, P  < 0.001) and calibration (Hosmer–Lemeshow P  = 0.847 vs P  = 0.130) than the EuroSCORE II. The higher performances of the OBS AVR score were confirmed by the decision curve, net reclassification index (0.46, P  = 0.011) and integrated discrimination improvement (0.02, P  < 0.001) analyses. Five-year mortality increased significantly along increasing deciles of the OBS AVR score (P  < 0.001). CONCLUSIONS The OBS AVR risk score showed high discrimination and calibration abilities in predicting 30-day mortality after surgical aortic valve replacement. The addition of a simplified frailty assessment into the model seems to contribute to an improved predictive ability over the EuroSCORE II. The OBS AVR risk score showed a significant association with long-term mortality. [ABSTRACT FROM AUTHOR]

RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-μm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions. FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months. A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months. In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up. • First-in-human study evaluating 150 μm FORTITUDE bioresorbable scaffold. • Low levels of target vessel failure and late lumen loss at 9- and 24-months. • FORTITUDE® BRS was shown to be safe and effective upto 36-months follow-up. [ABSTRACT FROM AUTHOR]

Introduction: Data on the early and late outcome following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in obese patients are limited. We investigated whether TAVI may be superior to SAVR in obese patients.Material and Methods: Obese patients (body mass index ≥ 30 kg/m2) who underwent either SAVR or TAVI were identified from the nationwide OBSERVANT registry, and their in-hospital and long-term outcomes were analysed. Propensity score matching was employed to identify two cohorts with similar baseline characteristics.Results: The propensity score matching provided 142 pairs balanced in terms of baseline risk factors. In-hospital and 30-day mortality did not differ between SAVR and TAVI obese patients (4.6% vs. 3.3%, p = 0.56, and 5.2% vs. 3.2%, p = 0.41, respectively). Obese SAVR patients experienced a higher rate of renal failure (12.4% vs. 3.6%, p = 0.0105) and blood transfusion requirement (60.3% vs. 25.7%, p < 0.0001) in comparison with TAVI patients. A higher rate of permanent pacemaker implantation (14.4% vs. 3.6%, p = 0.0018), and major vascular injuries (7.4% vs. 0%, p = 0.0044) occurred in the TAVI group. Five-year survival was higher in the SAVR group compared to the TAVI patient cohort (p = 0.0046), with survival estimates at 1, 3 and 5 years of 88.0%, 80.3%, 71.8% for patients undergoing SAVR, and 85.2%, 69.0%, 52.8% for those subjected to TAVI procedures.Conclusions: In obese patients, both SAVR and TAVI are valid treatment options, although in the long term SAVR exhibited higher survival rates. [ABSTRACT FROM AUTHOR]

Background: The benefit of percutaneous mitral valve repair (PMVR) in patients with secondary MR is still debated. We aimed to compare the outcome of PMVR with optimal medical therapy (OMT) versus OMT alone in patients with secondary mitral regurgitation (MR) and to assess the role of potential effect modifiers.Methods: We performed a systematic review and meta-analysis of 2 randomized clinical trials (RCT) and 7 non-randomized observational studies (nROS). Hazard ratios (HR) and 95% confidence intervals (CI) were pooled through inverse variance random-effects model to compute the summary effect size for all-cause death, cardiovascular death and cardiac-related hospitalization. Subgroup and meta-regression analysis were also performed.Results: An overall population of 3118 individuals (67% men; mean age, 73 years) was included: 1775 PMVR+OMT and 1343 OMT patients, with mean follow-up of 24 ± 15 months. PMVR+OMT was associated with a lower risk of all-cause death (HR: 0.77; 95% CI: 0.68-0.87), cardiovascular death (HR: 0.55; 95% CI: 0.34-0.89) and cardiac-related hospitalization (HR:0.77; 95% CI: 0.64-0.92). Meta-regression analysis showed that larger left ventricular end-diastolic volume index (LVEDVI) portends higher risk of all-cause death, cardiovascular death and cardiac-related hospitalization after PMVR (p < 0.001 for all).Conclusions: This study-level meta-analysis shows that PMVR+OMT is associated with reduced all-cause death, cardiovascular death and cardiac-related hospitalization when compared with OMT alone in secondary MR. LVEDVI is a predictive marker of efficacy, as patients with smaller LVEDVI have been shown to derive the largest benefit from PMVR. [ABSTRACT FROM AUTHOR]

We sought to determine whether the chronic total occlusions (CTO) recanalization results differ between circumflex artery (CX) and other coronary arteries in our center. The study dataset encompassed 428 consecutive procedures. J-CTO score was highest in the right coronary artery (RCA) and lowest in CX lesions. After adjusting for the J-CTO score, age, body mass index, baseline creatinine, diabetes, dyslipidemia and hypertension the odds ratio for procedural success in CX compared to the other arteries was not statistically significant. We found no difference in success rates of recanalizing CTO in CX compared to other coronary arteries. [ABSTRACT FROM AUTHOR]

Guidelines recommend the use of neurohormonal antagonists for all patients with heart failure and mitral regurgitation (MR) as an initial treatment strategy.1,2 Patients with symptoms despite maximally tolerated neurohormonal antagonist treatment, evidence-based therapy (EBT), and moderate-to-severe MR who are surgery-ineligible may undergo transcatheter mitral valve repair with the MitraClip (Abbott Vascular, Abbott Park, IL, USA) system. Patients undergoing the MitraClip procedure for secondary MR with EBT are at lower risk of death compared to patients without EBT. In the era of surgical and transcatheter treatment options, the importance of medications may be neglected when severe MR is present in a patient with heart failure. [Extracted from the article]

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]