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Over the last two decades there has been a significant shift towards the use of bioprostheses in the context of surgical aortic valve replacement, despite the well-known process of structural valve deterioration (SVD). This process has been extensively evaluated even though with many different definitions and methods, thus, the true long-term durability of surgical bioprostheses is not yet fully elucidated. Following the increasing implementation of the transcatheter aortic valve implantation (TAVI) technology, a better understanding of the long-term durability of transcatheter bioprostheses has become increasingly important as well, despite the limited availability of such data compared to the surgical experience. This lack of knowledge is a major barrier to the use of TAVI platforms to treat relatively younger patients. We thus aimed at providing an overview on long-term actual data concerning the durability of bioprostheses focusing on definition, incidence, and subsequent management of SVD of both surgical and transcatheter bioprosthetic aortic valves.

BACKGROUND Mitral valve (MV) repair with MitraClip system is a safe treatment option for high-risk patients with significant mitral regurgitation (MR). We aimed to characterize, by three-dimensional echocardiography (3D-E), changes occurring in MV after implantation of third generation MitraClip XTR device, with specific reference to the underlying MR mechanism (functional vs degenerative, FMR vs DMR). METHODS We prospectively enrolled 59 patients, who underwent intra-procedural 3D-E before and after device deployment. Three-D datasets were analyzed off-line, using a dedicated semiautomatic software, to obtain parametric quantification of mitral anatomy. RESULTS Post-procedural MR of mild or lesser degree was achieved in 40 patients (68%), with no differences between FMR and DMR (p 0.9). After MitraClip XTR implantation, the FMR group experienced an immediate annular resizing, with reduction of antero-posterior diameter (p 0.024) and sphericity index (p 0.017), next to a recovery of physiological saddle-shape, defined by lower non-planar angle (p ≤0.001) and higher annulus height to commissural width ratio (p ≤0.001). On the opposite, the DMR group revealed a significant decrease of maximum annular velocity (p 0.027), addressing a mechanic effect of the device deployment. Finally, baseline anterior mitral leaflet angle was found as an independent predictor of acute procedural result (OR 6.7, [CI 1.01-44.33], p 0.049). CONCLUSIONS MitraClip XTR implantation acts in restoring the original mitral geometry, with distinctive effects according to MR mechanism. Three-D parametric quantification of MV sheds new light on changes occurring in the valvular apparatus, and helps identifying possible new predictors of acute procedural success.

To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population.IVL is a relatively new but promising modality for treating coronary calcified lesions, but there is a dearth of long-term outcome data from real-world patients.This was a multicenter, observational study in which we enrolled all patients treated with IVL from November 2018 to February 2021 from eight centers in Europe and the United Kingdom. Procedural success, complications, and clinical outcomes (cardiac death, target vessel myocardial infarction [TVMI], target lesion revascularization [TLR], and MACE [major adverse cardiac events, the composite of cardiac death, TVMI, and TLR]) were assessed.In total, 273 patients with a mean age of 72 ± 9.1 years were treated with IVL. Major comorbidities included diabetes mellitus (n = 110, 40%) and chronic kidney disease (n = 45, 16%). Acute coronary syndrome accounted for 48% (n = 132) of patients, while 52% (n = 141) had stable angina. De novo lesions and in-stent restenosis accounted for 79% and 21% of cases, respectively. Intravascular imaging was used in 33% (n = 90) of patients. An upfront IVL strategy was adopted in 34% (n = 92), while the rest were bailout procedures. Adjuvant rotational atherectomy ("RotaTripsy") was required in 11% (n = 31) of cases. The procedural success was 99%. During a median follow-up of 687 days (interquartile range: 549-787), cardiac death occurred in 5% (n = 14), TVMI in 3% (n = 8), TLR in 6% (n = 16), and MACE rate was 11% (n = 30).This is the largest multicenter registry with a long-term follow-up showing the remarkably high procedural success of IVL use in calcified coronary lesions with low rates of hard endpoints and MACE.

The new iteration of the Portico transcatheter heart valve delivery system, the FlexNav, has been designed to enhance procedural safety and accuracy of the platform. Major technological advancements were the significant reduction of the insertion profile, allowing a transfemoral access down to 5.0 mm vessels, and the addition of a stability layer, improving deployment accuracy and thus potentially reducing implantation depth and permanent pacemaker implantation rate. Published data on patients undergoing Portico transcatheter heart valve implantation with the new FlexNav delivery system confirms excellent procedural and 30-day safety profile.Lay abstract Transcatheter aortic valve replacement, a minimally invasive alternative to surgical aortic valve replacement, has become an established treatment option for patients with severe aortic stenosis approved across the entire spectrum of risk, from patient’s ineligible for surgery to those at low risk. With the rapid spread of transcatheter aortic valve replacement to younger patients, researchers are focusing on reducing procedural adverse events rates, such as pacemaker implantation or access site-related complication, and increase procedural accuracy. The new FlexNav delivery system, employed to implant the Portico transcatheter heart valve, had recently proved its procedural safety and, with its major technological advancements encompassing a reduced insertion profile and an improved device stability during implant, may significantly reduce pacemaker implantation and access site-related complication rate.

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.

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.

Background: Preprocedural right ventricular–to–pulmonary artery (RV-PA) coupling is a major predictor of outcome in patients with secondary mitral regurgitation (SMR) undergoing transcatheter edge-to-edge mitral valve repair (M-TEER). However, clinical significance of changes in RV-PA coupling after M-TEER is unknown. Objectives: The aim of this study was to evaluate changes in RV-PA coupling after M-TEER, their prognostic value, and predictors of improvement. Methods: This was a retrospective observational study, including patients undergoing successful M-TEER (residual mitral regurgitation ≤2+ at discharge) for SMR at 13 European centers and with complete echocardiographic data at baseline and short-term follow-up (30-180 days). RV-PA coupling was assessed with the use of echocardiography as the ratio of tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP). All-cause death was assessed at the longest available follow-up starting from the time of the echocardiographic reassessment. Results: Among 501 patients included, 331 (66%) improved their TAPSE/PASP after M-TEER (responders) at short-term follow-up (median: 89 days; IQR: 43-159 days), whereas 170 (34%) did not (nonresponders). Lack of previous cardiac surgery, low postprocedural mitral mean gradient, low baseline TAPSE, high baseline PASP, and baseline tricuspid regurgitation were independently associated with TAPSE/PASP improvement after M-TEER. Compared with nonresponders, responders had lower New York Heart Association functional class and less heart failure hospitalizations at short-term follow-up. Improvement in TAPSE/PASP was independently associated with reduced risk of mortality at long-term follow-up (584 days; IQR: 191-1,243 days) (HR: 0.65 [95% CI: 0.42-0.92]; P = 0.017). Conclusions: In patients with SMR, improvement in TAPSE/PASP after successful M-TEER is predicted by baseline clinical and echocardiographic variables and postprocedural mitral gradient, and is associated with a better outcome.

Up to half of real-world patients with secondary mitral regurgitation who underwent transcatheter edge-to-edge repair (TEER) do not meet the highly selective COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) criteria. No randomized trials or standardized and validated tools exist to evaluate the risk: benefit ratio of TEER in this specific population. We sought to derive and externally validate a clinical risk score to predict the risk of death or heart failure (HF) hospitalization for COAPT-ineligible patients who underwent TEER (CITE score). The study population consisted of patients with secondary mitral regurgitation having at least 1 exclusion criterion of the COAPT trial. The derivation cohort included 489 patients from the GIOTTO (GIse registry of Transcatheter treatment of Mitral Valve regurgitaTiOn) registry. Cox proportional hazards regression was used to identify predictors of 2-year death/HF hospitalization and develop a numerical risk score. The predictive performance was assessed in the derivation cohort and validated in 268 patients from the MiZüBr (Milan-Zürich-Brescia) registry. The CITE score (hemodynamic instability, left ventricular impairment, New York Heart Association class III/IV, peripheral artery disease, atrial fibrillation, brain natriuretic peptide, and hemoglobin) showed a c-index for 2-year death or HF hospitalization of 0.70 (95% confidence interval [CI] 0.67 to 0.73) in the derivation cohort, and 0.68 (95% CI 0.64 to 0.73) in the validation cohort. A cutoff of12 points was selected to identify patients at lower risk of adverse outcomes, hazard ratio of 0.35 (95% CI 0.26 to 0.46). In conclusion, the CITE score is a simple 7-item tool for the prediction of death or HF hospitalization at 2 years after TEER in COAPT-ineligible patients. The score may support clinical decision-making by identifying those patients who, even if excluded from clinical trials, can still benefit from TEER.

Procedural success after transcatheter edge-to-edge mitral valve repair (TEER) is defined as a reduction of mitral regurgitation (MR) degree tomoderate (2+). However, post-procedural MR 0/1+ was found to be associated with a better outcome and a lower rate of MR recurrence compared to post-procedural MR 2+.To evaluate predictors and prognostic impact of optimal procedural result (MR 0/1+) after TEER.The Italian Society of Interventional Cardiology (GIse) Registry of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) is a large multicenter registry including patients undergoing TEER in 19 Italian centers between January 2016 and March 2020. For the purpose of this analysis, only patients with secondary MR and successful TEER were included.Among 950 patients enrolled, 637 (67%) had an optimal procedural result (MR 0/1+) and 313 (33%) had an acceptable procedural result (MR 2+) after TEER. Moderate-to-severe, rather than severe, MR, left ventricular end-systolic diameter70 mm at baseline, and treatment in centers performing ≥20 procedures/year were independent predictors of the optimal procedural result. Compared to patients with acceptable procedural result, those with optimal result had shorter device time and length of stay and better outcomes with lower rates of all-cause and cardiac deaths (25.7% vs. 40%, p 0.001 and 16.3% vs. 24.8%, p = 0.003, respectively) and HF hospitalizations (24% vs. 30%; p = 0.035) at 2-year follow-up.In patients with secondary MR undergoing TEER, an optimal procedural result is associated with favorable outcomes and can be achieved by selecting patients with moderate-to-severe MR, without severe left ventricular dilatation, and treated in high-volume centers.mitral regurgitation, mitral valve repair, chronic heart failure.

BACKGROUND Risk stratification for transcatheter edge-to-edge mitral valve repair (TEER) is paramount in the decision-making process for treating severe mitral regurgitation (MR). OBJECTIVES This study sought to create and validate a user-friendly score (MitraScore) to predict the risk of mortality in patients undergoing TEER. METHODS The derivation cohort was based on a multicentric international registry that included 1,119 patients referred for TEER between 2012 and 2020. Score discrimination was assessed using Harrell's c-statistic, and the calibration was evaluated with the Gronnesby and Borgan goodness-of -fit test. An external validation was carried out in 725 patients from the GIOTTO registry. RESULTS After multivariate analysis, we identified 8 independent predictors of mortality during the follow-up (2.1 +/- 1.8 years): age $75 years, anemia, glomerular filtrate rate

Randomized controlled trials comparing the use of the MitraClip device in addition to guideline directed medical therapy (GDMT) to GDMT alone in patients with secondary mitral regurgitation (MR) have shown conflicting results. However, if these differences could be due to the underlying MR aetiology is still unknown. Therefore, we aimed to evaluate if the effects of percutaneous edge-to-edge repair with MitraClip implantation could differ in patients with ischaemic (I-MR) and non-ischaemic mitral regurgitation (NI-MR).PubMed, Embase, BioMed Central, and the Cochrane Central Register of Controlled Trials were searched for all studies including patients with secondary MR treated with the MitraClip device. Data were pooled using a random-effects model. Primary endpoint was the composite of all-cause death and heart failure-related hospitalization. Secondary endpoints were the single components of the primary endpoint, New York Heart Association functional Classes III and IV, and mitral valve re-intervention. Seven studies enrolling 2501 patients were included. Patients with I-MR compared with patients with NI-MR had a similar risk of the primary endpoint (odds ratio: 1.17; 95% confidence interval: 0.93 to 1.46; IThe risk of mortality after MitraClip implantation is lower in patients with NI-MR than in those with I-MR. No absolute differences in the risk of heart failure related hospitalization were observed between groups.

To evaluate the prognostic impact of baseline tricuspid annular plane systolic excursion/pulmonary artery systolic pressure (TAPSE/PASP) ratio, as an expression of the right ventricle-pulmonary artery (RV-PA) coupling, in patients with mitral regurgitation (MR) treated with the MitraClip.Impaired RV to PA coupling is considered a marker of RV dysfunction.From February 2016 to February 2020, a total of 165 patients were evaluated and stratified in two groups according to a prespecified value of TAPSE/PASP ratio ≤ 0.36.The median patients' age was 79 (men: 62.4%). Sixty-three patients (38.1%) presented TAPSE/PASP ≤ 0.36 and were then compared with patients with TAPSE/PASP 0.36. Functional MR etiology was more frequent in TAPSE/PASP ≤ 0.36 (71.4%; p = 0.046). Acute technical success was achieved in 92.7% of the population, without any significant difference between the two groups of study and with sustained results at 30-day (device success: 85.5%; procedural success: 84.8%). On multivariate Cox regression analysis, after correction for body mass index, chronic kidney disease and left ventricle ejection fraction ≥30% but50%, TAPSE/PASP ≤ 0.36 remained a sustained predictor of mortality and hospitalization for heart failure at one year after MitraClip (hazard ratio: 3.87; 95% confidence interval: 1.83-8.22; p ≤ 0.001). Kaplan-Meier all-cause mortality and heart failure hospitalization rates at one year were consequently higher in patients with TAPSE/PASP ≤ 0.36 (39.4% vs. 14.8%; log-rank p ≤ 0.001).Baseline TAPSE/PASP ratio seems independently associated with all-cause mortality and heart failure hospitalization after MitraClip both in functional and degenerative MR.

Background 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). Methods 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. Results 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. Conclusions MitraClip resulted to be a safe and effective option to treat A-FMR in elderly patients.

Transcatheter aortic valve implantation (TAVI) has become an established alternative to surgery in patients with calcific aortic stenosis. Broad implementation of devices and increased experience have led operators to explore the feasibility of TAVI in off-label indication such as pure native aortic valve regurgitation. Given the technical issues related to the absence of leaflet calcification and aortic root or ascending aorta dilation, this procedure is typically performed in patients in whom surgical risk is deemed prohibitive. Although recently published data have shown encouraging results in patients treated with new generation prostheses, new iteration of transcatheter valves, specifically designed for the treatment of aortic regurgitation, is needed. Nowadays, with no dedicated system on the horizon and in order to guarantee the best results, efforts should be made to improve patient selection.

Mitral valve (MV) repair with MitraClip system is a safe treatment option for high-risk patients with significant mitral regurgitation (MR). We aimed to characterize, by three-dimensional echocardiography (3D-E), changes occurring in MV after implantation of third generation MitraClip XTWe prospectively enrolled 59 patients, who underwent intra-procedural 3D-E before and after device deployment. Three-D datasets were analyzed off-line, using a dedicated semiautomatic software, to obtain parametric quantification of mitral anatomy.Post-procedural MR of mild or lesser degree was achieved in 40 patients (68%), with no differences between FMR and DMR (p 0.9). After MitraClip XTMitraClip XT

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. (C) 2020 International Society for Heart and Lung Transplantation. All rights reserved.

We conducted a comprehensive and updated overview on complications occurring after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis. Despite remarkable improvements in patient selection, devices, procedures, and ancillary management, complications may still occur in patients undergoing TAVI. On top of most commonly described adverse events such as death, myocardial infarction, stroke, bleeding, vascular complication, renal failure, pacemaker implantation and residual valve regurgitation, other less common but similarly severe complications may still occur. These may include events ranging from acute delirium to valve compression during cardiopulmonary resuscitation. Meticulous care should be applied to all screening and procedural steps for TAVI, and attentive follow-up should be implemented afterwards, especially in suboptimal TAVI candidates or those otherwise at high operative risk. Despite recent remarkable improvements, additional research is warranted in order to further improve early and late outlook of TAVI, identify predictors of complications, and the best way to handle them.

Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. Methods: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Results: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Conclusions: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04500964.

BACKGROUND Patients with diabetes mellitus (DM) represents a challenging subset of population as they experience worse outcomes after percutaneous coronary intervention than patients without diabetes. We evaluated the 2-year efficacy and safety profile of the Abluminus DES+ in patients with diabetes within the population enrolled in the large multicenter en-ABL e-registry. METHODS Multicenter, prospective, all-comers registry performed in 31 centers in India. We analyze patients according to the diagnosis of DM and insulin dependency (ID or Non-ID): non-DM (1641 patients), NIDDM (721 patients), IDDM (138 patients). The primary endpoint was a composite of device-oriented major adverse cardiac events (MACE): cardiac death, target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)/ target vessel revascularization (TVR) at 2-year. Stent thrombosis (ST) at any time point was also recorded. RESULTS The MACE rate at 2-year follow-up was 3.0% in the overall population with DM patients showing a higher rate of primary endpoint compared to non-DM (4.4% vs. 2.4%, P=0.025). Rate of cardiac death was actually low and consistent between the 2 groups (1.7% vs. 0.9%, P=0.100). At 2-year follow-up, the rate of ST was 0.9% in DM patients versus 0.5% in non-DM, P=0.213. CONCLUSIONS At 2-year follow-up, the Abluminus DES+ technology that merges the features of a sirolimus coated balloon with those of a bioresorbable polymer drug eluting stent appears to be safe and effective. This safety/efficacy profile was consistent in patients with or without DM.

AIMS The aim of this proof-of-concept study was to investigate safety and efficacy of a CT-scan based patient-specific algorithm to maximize coronary clearance and secondarily to achieve anatomically correct commissural alignment with the Acurate Neo device. METHOD AND RESULTS A total of 45 consecutive patients undergoing TAVR with the Acurate Neo THV were prospectively enrolled in the study. Mean age was 81.6 ± 5.5 years, mean STS score was 6.1 ± 3.7. Device success rate was 100%. Aim of the technique was to rotationally deploy the TAVR device with a commissure lying on the bisector between the coronary ostia as calculated on the pre-procedural CT-scan. At post-TAVR CT-scan, coronary clearance was achieved in 98% of patients with no cases of severe coronary artery overlap. In 42 out of 45 patients, THV was aligned or, at most, mildly misaligned; there were 2 cases of moderate misalignment without any case of severe misalignment. Post-TAVR selective coronary artery engagement was attempted and succeeded in all patients (100%). CONCLUSION Our CT-scan based patient-specific algorithm is safe and proven to be effective in avoiding coronary artery overlap and providing commissural alignment with Acurate Neo in all treated patients.

BACKGROUND. Mitral valve (MV) repair with MitraClip system is a safe treatment option for high-risk patients with significant mitral regurgitation (MR). We aimed to characterize, by three-dimensional echocardiography (3D-E), changes occurring in MV after implantation of third generation MitraClip XTR device, with specific reference to the underlying MR mechanism (functional vs. degenerative, FMR vs DMR). METHODS. We prospectively enrolled 59 patients, who underwent intra-procedural 3D-E before and after device deployment. Three-D datasets were analysed off-line, using a dedicated semiautomatic software, to obtain parametric quantification of mitral anatomy. RESULTS. Post-procedural MR of mild or lesser degree was achieved in 40 patients (68%), with no differences between FMR and DMR (p 0.9). After MitraClip XTR implantation, the FMR group experienced an immediate annular resizing, with reduction of antero-posterior diameter (p 0.024) and sphericity index (p 0.017), next to a recovery of physiological saddle-shape, defined by lower non-planar angle (p ≤0.001) and higher annulus height to commissural width ratio (p ≤0.001). On the opposite, the DMR group revealed a significant decrease of maximum annular velocity (p 0.027), addressing a mechanic effect of the device deployment. Finally, baseline anterior mitral leaflet angle was found as the strongest independent predictor of acute procedural result (OR 0.91, [CI 0.84-0.99], p = 0.030). CONCLUSIONS. MitraClip XTR implantation acts in restoring the original mitral geometry, with distinctive effects according to MR mechanism. Three-D parametric quantification of MV sheds new light on changes occurring in the valvular apparatus, and helps identifying possible new predictors of acute procedural success.

We aimed at appraising features and outcomes of patients undergoing MitraClip treatment according to their age.We queried the prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) multicenter registry dataset including 19 Italian centers performing MitraClip implantation, distinguishing patients80 vs ≥80 years of age.In total, 1853 patients were included, 751 (40.5%) octogenarians and 1102 (59.5%) non-octogenarians. Several baseline and procedural features were significantly different, including gender, regurgitation etiology, and functional class (all p 0.05). In-hospital outcomes were similarly satisfactory, with death occurring in 18 (2.4%) and 32 (2.9%, p = 0.561), respectively, and improvement in mitral regurgitation in 732 (97.4%) and 1078 (97.8%, p = 0.746), respectively. After a mean follow-up of 15 months, death occurred in 152 (20.2%) and 264 (24.0%), and cardiac death in 85 (11.3%) and 138 (12.5%), respectively (both p 0.05). Rehospitalization for heart failure and the composite of cardiac death or rehospitalization for heart failure were significantly less common in octogenarians: 63 (8.4%) vs 156 (14.2%, p 0.001), and 125 (16.6%) vs 242 (22.0%, p = 0.005), respectively. Multivariable analysis showed that these differences were largely due to confounding features, as after adjustment for baseline, clinical and imaging characteristics no significant difference was found for the above clinical endpoints.Transcatheter mitral valve repair with the MitraClip in carefully selected octogenarians appears feasible and safe, and is associated with favorable clinical outcomes at mid-term follow-up.

Objectives To investigate paravalvular leak (PVL) and devices success rates according to aortic angle (AA) in patients undergoing transcatheter aortic valve implantation (TAVI) with three new-generation self-expanding devices. Background The impact of aortic angle (AA) on TAVI device success and PVL rates is controversial. Methods This retrospective study included 392 patients submitted to TAVI for severe aortic stenosis with Portico, Evolut-R and Acurate-NEO, and available AA measurements at computed tomography (CT) angiography. AA was calculated from the implantation projection and was defined as the angle between the plane of aortic annulus and an ideal horizontal plane. Aorta was defined horizontal if AA>57° (75th percentile). Results In the horizontal group, the rates of moderate/severe PVL was higher in the Evolut-R group (20.8%), which was also characterized by a lower implant compared to that of Acurate-NEO, whereas device success was comparable among the three devices. AA was a significant predictor of moderate/severe PVLs (AUC 0.72, p = .002) only in the Evolut-R population. On multivariate analysis, calcium volume 850HU, bicuspid aortic valve, and implantation depth at the level of left coronary cusp were independent predictors of moderate/severe PVL. On univariate analysis in the horizontal aorta population, implantation depth was confirmed among the most significant predictors of moderate/severe PVL. Conclusions Despite comparable device success rates, horizontal aorta represented a technical challenge only in the Evolut-R subgroup, which showed higher rates of moderate/severe PVL than Portico and Acurate-NEO, and was associated with a low implant.

Aims: In patients with heart failure and reduced ejection fraction (HFrEF) and secondary mitral regurgitation (SMR), impaired right ventricular function (RVF) may negatively influence the prognosis. Percutaneous mitral valve repair (pMVR) can promote the recovery of RVF. We sought to characterize the response of the right ventricle to pMVR in HFrEF with SMR and to assess the association between improved RVF after pMVR and outcomes. Methods and results: Overall, 221 patients with HFrEF and SMR ≥3+ successfully treated with pMVR in four tertiary care centres for heart failure were included. Improved RVF was defined as Δ right ventricular fractional area change (ΔRVFAC) ≥5% at early follow-up (median time 4 months). The primary endpoint was a composite of death/heart transplantation (D/HT). Mean age was 69 ± 11 years, mean left ventricular ejection fraction was 31 ± 8% and mean RVFAC was 34 ± 9%. ΔRVFAC ≥5% occurred in 88 patients (40%) and was independent of the measures of left ventricular reverse remodelling. During a median follow-up of 29 months (interquartile range 12–46), 81 patients (37%) reached the primary endpoint. After adjustment for other significant covariates, ΔRVFAC ≥5% was significantly associated with lower risk of D/HT (hazard ratio 0.52, 95% confidence interval 0.29–0.94, P = 0.030). In the secondary outcome analysis exploring the risk of heart failure hospitalizations, ΔRVFAC ≥5% confirmed the prognostic association with the endpoint. Conclusions: In patients with HFrEF and SMR, about 40% of patients improved RVF after pMVR. RVF improvement was associated with better long-term survival free from HT and lower risk of heart failure hospitalization.

BACKGROUND Transcatheter mitral valve repair (TMVR) with the MitraClip device is an established treatment for mitral regurgitation (MR). More than one MitraClip may be implanted if a single one does not reduce MR adequately. We aimed at appraising the outlook of patients undergoing implantation of one, two or multiple MitraClips for TMVR. METHODS Exploiting the ongoing prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) Study dataset, we compared patients, procedural details and outcomes distinguishing those receiving one, two or multiple MitraClips. The primary endpoint was the composite of 1-year cardiac death or rehospitalization for heart failure. Additional endpoints included all cause death, surgical mitral repair, and functional class. Multivariable adjusted Cox proportional hazard analysis was used for confirmatory purposes. RESULTS As many as 1824 patients were included: 718 (39.4%) treated with a single MitraClip, and 940 (51.5%) receiving two MitraClips, and 166 (9.1%) receiving three or more. Significant differences were found for baseline features, including age, female gender, diabetes mellitus, hypertension, chronic obstructive pulmonary disease, prior myocardial infarction, atrial fibrillation, permanent pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and prior mitral valve repair (all p

OBJECTIVE This study sought to investigate the procedural and mid-term outcomes of transcatheter aortic valve implantation for failed surgical bioprostheses (TAVI-ViV) with Portico device. BACKGROUND Limited evidence coming from early experience on Portico system does not allow to fully assess safety and efficacy of this device in this ViV patients. METHODS From January 2016 up to June 2019, 56 consecutive patients undergoing TAVI-ViV with Portico were prospectively included in our institutional TAVI database. RESULTS The prevalent mechanism of failure was stenosis (58.9%); true internal diameter (ID) was

Nowadays, tricuspid regurgitation (TR) is a widespread condition and this has led to a not-unexpected interest in the "forgotten valve". Medical treatment and/or a surgical approach remain the gold standard for this valve disorder, although these approaches are often limited. In the era of transcatheter therapies, the primary interest for less invasive percutaneous approaches targeted to the treatment of TR can thus find a clear rationale for its evolution. The aim of this review is to explore the different transcatheter techniques for TR that are available or under study, and also to report on preliminary clinical results worldwide.

The pattern and reasons for re-hospitalization (RH) after MitraClip implantation are not well characterized. A total of 322 consecutive MitraClip patients were included, with data stratified by RH status. Multivariate analyses were conducted to identify predictors of early (30-day) and late (30-day to 12-month) RH. Eighty-nine patients (27.6%) were readmitted to hospital during the study period and early RH occurred in 27%. The median time from MitraClip to RH was 99 days. RH was mostly related to cardiovascular causes (66.3%). Anemia and gastrointestinal bleeding were the most frequent noncardiovascular causes. Independent predictors of early RH were length of stay ≥3 days during the index procedure (odds ratio [OR] 4.13, 95% confidence interval [CI] 1.32 to 12.91), reduction of left ventricular ejection fraction ≥5% after MitraClip implantation (OR 4.88, 95% CI 1.36 to 18.91), and severe systolic pulmonary artery pressure ≥60 mm Hg at discharge (OR 3.72, 95% CI 1.23 to 11.26). Conversely, the independent predictors of late RH were device failure (OR 4.02, 95% CI 1.22 to 13.25) and systolic pulmonary artery pressure ≥60 mm Hg at discharge (OR 2.34, 95% CI 1.01 to 5.44). In patients with early RHs, survival was significantly worse at 12 months compared with patients with late RH and no-RH (69.3% vs 82.6% vs 86%, p 0.001). In conclusion, RH is not uncommon after MitraClip implantation and cardiovascular causes represent its most frequent etiology. Clinical and echocardiographic predictors of early and late RH can be identified at discharge. Early RH carries a worse prognosis than late RH.