Application of the Academic Research Consortium High Bleeding Risk criteria in patients treated with coronary bioresorbable polymer everolimus-eluting stents: Insights from the POEM trial.

BACKGROUND: Previous studies have investigated a 1 to 6-month short dual antiplatelet therapy (S-DAPT) after percutaneous coronary intervention (PCI) with modern drug eluting-stents to reduce bleeding events. OBJECTIVES: To investigate cardiovascular outcomes in patients at high bleeding risk (HBR) according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria after PCI with the Synergy bioresorbable-polymer everolimus-eluting stents (EES). METHODS: We applied ARC-HBR criteria in the population of the prospective, single-arm, multicenter POEM (Performance of Bioresorbable Polymer-Coated Everolimus-Eluting Synergy Stent in Patients at HBR Undergoing Percutaneous Coronary Revascularization Followed by 1-Month Dual Antiplatelet Therapy) trial. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite or probable stent thrombosis at 12 months. RESULTS: The original POEM cohort included 356 patients (80.4 %) fulfilling ARC-HBR criteria. Oral anticoagulant (OAC) usage and age ≥75 years were the most frequent major and minor ARC-HBR criteria, respectively. The ARC-HBR group was mainly represented by men (71.1 %), with 74.4 ± 9.3 years and a high burden of cardiovascular risk factors. DAPT was prescribed in 79.3 %, and single antiplatelet (SAPT) with OAC in 18.7 %. 12-month follow-up was completed in 96.2 %. The primary endpoint occurred in 5.2 % (95 % CI 3.29-8.10) of patients, whereas bleeding Academic Research Consortium type 3-5 occurred in 2.7 % (95 % CI, 1.39 %-5.05 %). CONCLUSION: Previous results of the POEM trial showed positive outcomes regarding ischemic and bleeding events with an S-DAPT regimen after Synergy EES. These results are also confirmed in sub-group analysis when ARC-HBR criteria are applied.

Impact of extra-mitral valve cardiac involvement in patients with primary mitral regurgitation undergoing transcatheter edge-to-edge repair.

BACKGROUND: In the context of primary mitral regurgitation (PMR), the selection of patients for transcatheter edge-to-edge repair (TEER) does not include a systematic assessment of PMR-associated cardiac remodelling. AIMS: We aimed to investigate the epidemiology and prognostic significance of different phenotypes of extra-mitral valve (MV) cardiac involvement in a large series of patients with PMR referred for TEER. METHODS: The study included 654 patients from the multicentre Italian GIOTTO registry, stratified into groups according to extra-mitral valve (MV) cardiac involvement. The primary endpoint was all-cause death at 2-year follow-up. RESULTS: Patients with no cardiac involvement (NI; n=58), left heart involvement (LHI; n=343) and right heart involvement (RHI; n=253) were analysed. Acute technical success was achieved in 98% of patients. Kaplan-Meier curve analysis revealed significantly worse survival in patients with LHI and RHI (p=0.041). On multivariate Cox regression analysis, extra-MV cardiac involvement, haemoglobin level and technical success were independent predictors of the primary endpoint occurrence. CONCLUSIONS: Grading cardiac involvement may help refine risk stratification, since at least 1 group of extra-MV cardiac involvement represents in itself a negative predictor of midterm outcome.

A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial.

Background: Third generation drug-eluting stents (DES) potentially offer better technical performance and reduced neointimal proliferation than previous generation DES. The XLIMIT non-inferiority trial evaluated the performance of the Xlimus (a novel sirolimus-eluting coronary stent system) in terms of endothelialization and tissue healing compared to the bioresorbable polymer Synergy DES. Methods: A total of 177 patients undergoing percutaneous coronary intervention (PCI) were randomized in a 2:1 ratio (2 Xlimus: 1 Synergy). The primary endpoints, defined as the in-stent neointimal volume weighted by the sum of the lengths of the implanted stent (ISNV) and the in-stent neointimal percent volume obstruction (%VO) were evaluated at 6-9 months by means of optical coherence tomography (OCT). Additional OCT parameters as well as clinical endpoints were also collected. Results: Most of the patients were males (77.4%), and the mean age was 64 years. One third of the population had stable angina/silent ischemia. A total of 300 stents (237 lesions) were analyzed: 198 (152 lesions) were in the Xlimus group, and 102 (85 lesions) in the Synergy group. The ISNV in the Xlimus group was 30.7 ± 24.5 mm3 while in the Synergy group it was 26.5 ± 26.7 mm3: the difference between the two means was 0.08 (-0, 04-0, 45), p = 0.018, thus meeting the non-inferiority hypothesis. The %VO was 16.3% ± 10.4% and 13.3% ± 10.8% in the Xlimus and Synergy groups, respectively: the difference between the two means was 3.0 (-0, 06-4, 2), (p = 0.01), thus meeting the non-inferiority hypothesis. No difference was found with respect to the secondary OCT endpoints as well as for clinical endpoints. Conclusions: The study results confirm that the biological interaction of the Xlimus and Synergy DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters at follow-up: as such, the Xlimus is non-inferior to the Synergy. Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT03745053).

Prognostic Significance of Flail Mitral Leaflet in Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation.

Despite the growing experience with MitraClip in the broad spectrum of mitral regurgitation (MR), limited data are available regarding the independent prognostic role on survival of different mitral regurgitation etiology subtypes. We sought to evaluate the impact of flail leaflet etiology in a large series of patients with primary MR (PMR) who underwent MitraClip treatment. The study included 588 patients with significant PMR from the multicenter GIOTTO (Italian Society of Interventional Cardiology [GIse] registry Of Transcatheter treatment of mitral valve regurgitaTiOn), stratified into 2 groups according to MR etiology: flail+ (n = 300) and flail- (n = 288). The primary end point was a composite of cardiac death and first rehospitalization for heart failure (HF). To account for the baseline differences, patients were propensity score-matched 1:1. Flail leaflet etiology was present in about a half of the patients. Acute technical success was achieved in 98% of the overall cohort, with no significant differences between the study groups (p = 0.789). At the 2-year Kaplan-Meier analysis, the primary end point occurred in 13% of flail+ patients compared with 23% in flail- (p = 0.009). The flail+ group presented lower rates of both cardiac death and rehospitalization for HF, whereas a similar overall death rate was observed between the groups. A multivariate Cox regression analysis identified flail leaflet etiology as an independent predictor of favorable outcome in terms of the primary end point (hazard ratio 0.141, 95% confidence interval 0.049 to 0.401, p <0.001). After propensity score matching, flail+ patients had confirmed lower rates of cardiac mortality and rehospitalization for HF but similar rates of overall death. In conclusion, flail leaflet-related etiology was common in patients with PMR who underwent MitraClip treatment and was an independent predictor of midterm favorable clinical outcomes.

Impact of coronary artery disease on outcome after transcatheter edge-to-edge mitral valve repair with the MitraClip system.

BACKGROUND: The clinical impact of coronary artery disease (CAD) on the prognosis of patients undergoing MitraClip implantation is still unclear. METHODS: One thousand nine hundred fifty-three patients undergoing MitraClip implantation included in the multicenter GIOTTO Registry were stratified according to CAD. Endpoints were all-cause death, cardiac death, and re-hospitalization for heart failure at follow-up (median 15.8 months). RESULTS: Although younger, CAD patients were more symptomatic, had worse cardiovascular risk profile, higher burden of comorbidities, more frequently affected by functional MR, with higher left ventricle (LV) diameters and lower ejection fraction (EF). At follow-up, CAD patients showed higher rates of all-cause death (25.4% vs. 19.6%; P=0.002), cardiovascular death (14.0% vs. 10.1%; P=0.007) and re-hospitalization for heart failure (13.9% vs. 10.2%; P=0.011). Dividing the population according to mitral regurgitation (MR) etiology (functional vs. non-functional MR), no differences were observed between CAD and no-CAD patients. At multivariate logistic regression, NYHA III/IV class, prior heart failure hospitalization, severe chronic kidney disease, atrial fibrillation, LV end-diastolic diameter and LVEF<30% but not CAD resulted independent predictors of all-cause death. The same finding was confirmed even after propensity score adjustment. CONCLUSIONS: CAD did not show a relevant impact on mid-term prognosis per se, but seemed to identify a more complex and diseased cohort of patients with worse clinical and functional status.

Postprocedural trans-mitral gradient in patients with degenerative mitral regurgitation undergoing mitral valve transcatheter edge-to-edge repair.

BACKGROUND: The relationship between high postprocedural mean gradient (ppMG) and clinical events following mitral valve transcatheter edge-to-edge repair (MV-TEER) in patients with degenerative mitral regurgitation (DMR) is still debated. AIM: The purpose of this study was to evaluate the effect of elevated ppMG after MV-TEER on clinical events in patients with DMR at 1-year follow-up. METHODS: The study included 371 patients with DMR treated with MV-TEER enrolled in the "Multi-center Italian Society of Interventional Cardiology (GISE) registry of trans-catheter treatment of mitral valve regurgitation" (GIOTTO) registry. Patients were stratified in tertiles according to ppMG. Primary endpoint was a composite of all-cause death and hospitalization due to heart failure at 1-year follow-up. RESULTS: Patients were stratified as follows: 187 with a ppMG ≤ 3 mmHg, 77 with a ppMG > 3/=4 mmHg, and 107 with a ppMG > 4 mmHg. Clinical follow-up was available in all subjects. At multivariate analysis, neither a ppMG > 4 mmHg nor a ppMG ≥ 5 mmHg were independently associated with the outcome. Notably, the risk of elevated residual MR (rMR > 2+) was significantly higher in patients belonging to the highest tertile of ppMG (p = 0.009). The association of ppMG > 4 mmHg and rMR ≥ 2+ was strongly and independently associated with adverse events (hazard ratio: 1.98; 95% confidence interval: [1.10-3.58]). CONCLUSIONS: In a real-world cohort of patients suffering DMR and treated with MV-TEER, isolated ppMG was not associated with the outcome at 1-year follow-up. A high proportion of patients showed both elevated ppMG and rMR and their combination appeared to be a strong predictor of adverse events.

Safety and performance parameters of the Myval transcatheter aortic valve bioprosthesis: The SAPPHIRE prospective registry.

BACKGROUND: TAVR is an established treatment for patients with severe symptomatic aortic stenosis. Different THV platforms are nowadays available, each of them with its inherent limitations and others are under development aiming at overcoming such limitations. We thus sought to investigate the performance and 1-year clinical outcome of a new generation, balloon expandable, THV: the Myval™ (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India). METHODS: This registry included the first 100 consecutive patients (mean age 80.7 ± 7.7; STS 4.3 ± 3.3 %), who underwent transcatheter aortic valve implantation for severe stenosis of the native aortic valve from May 2020 to December 2020, in two Italian Centers. Clinical and procedural outcomes were defined according to VARC-3 criteria. RESULTS: Transfemoral Myval THV was successfully implanted in all patients, with no intra-hospital mortality (technical success 100 %): vascular access complications were all "minor" (16 %), and managed by compression/balloon inflation; no cases of annular rupture or coronary obstruction occurred; 5 % of patients required an in-hospital pacemaker implantation (PM). Device success was 99 %. Overall and cardiovascular mortality were 6 % (CI 5 %-7 %) and 4 % (CI 2 %-5 %) at 1- year, while 12 % (CI 9 %-14 %) and 7 % (6-9 %) at 2 years. A total of 9 % of the patients required a PM within 12 months, and no further PM implantation occurred afterwards. No cerebrovascular events, renal failure and myocardial infarction occurred between discharge and 2-year follow-up. No events of structural valve deterioration but a sustained improvement of echocardiographic parameters were observed. CONCLUSION: The Myval THV has a promising safety/efficacy profile at 2 year follow up. This performance should be further evaluated in the context of randomized trials to better elucidate its potential.

Changes in Right Ventricular-to-Pulmonary Artery Coupling After Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation.

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.

Evolution of tricuspid regurgitation after transcatheter edge-to-edge mitral valve repair for secondary mitral regurgitation and its impact on mortality.

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.

Long-term outcomes following intravascular lithotripsy (IVL) for calcified coronary lesions: A Real-World Multicenter European Study.

OBJECTIVES: To explore the long-term clinical outcomes following intravascular lithotripsy (IVL) in calcified coronary lesions from a real-world population. BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Durability of Surgical and Transcatheter Aortic Bioprostheses: A Review of the Literature.

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.

Predictors of optimal procedural result after transcatheter edge-to-edge mitral valve repair in secondary mitral regurgitation.

BACKGROUND: Procedural success after transcatheter edge-to-edge mitral valve repair (TEER) is defined as a reduction of mitral regurgitation (MR) degree to

Transcatheter edge-to-edge mitral valve repair in atrial functional mitral regurgitation: insights from the multi-center MITRA-TUNE registry.

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.

Prognostic significance of right ventricle to pulmonary artery coupling in patients with mitral regurgitation treated with the MitraClip system.

OBJECTIVES: 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. BACKGROUND: Impaired RV to PA coupling is considered a marker of RV dysfunction. METHODS: 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. RESULTS: 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% but <50%, 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). CONCLUSION: Baseline TAPSE/PASP ratio seems independently associated with all-cause mortality and heart failure hospitalization after MitraClip both in functional and degenerative MR.

Patent foramen ovale occlusion with the Cocoon PFO Occluder. The PROS-IT collaborative project.

Background: The Cocoon patent foramen ovale (PFO) Occluder is a new generation nitinol alloy double-disk device coated with nanoplatinum, likely useful in patients with nickel hypersensitivity. Early results and mid-term outcomes of this device in percutaneous PFO closure are missing. Aims: To assess the preliminary efficacy and safety profile of PFO closure with Cocoon device in an Italian multi-center registry. Methods: This is a prospective registry of 189 consecutive adult patients treated with the Cocoon PFO Occluder at 15 Italian centers from May 2017 till May 2020. Patients were followed up for 2 years. Results: Closure of the PFO with Cocoon Occluder was carried out successfully in all patients, with complete closure without residual shunt in 94.7% of the patients and minimal shunt in 5.3%. Except from a case of paroxysmal supraventricular tachycardia and a major vascular bleeding, no procedural and in-hospital device-related complications occurred. No patient developed cardiac erosions, allergic reactions to nickel, or any other major complications during the follow-up. During the follow-up period, 2 cases of new-onset atrial fibrillation occurred within thirty-day. Conclusions: Percutaneous closure of PFO with Cocoon Occluder provided satisfactory procedural and mid-term clinical follow-up results in a real-world registry.

Acute changes in mitral valve geometry after percutaneous valve repair with MitraClip XTR by three-dimensional echocardiography.

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.

[Transcatheter aortic valve implantation for pure aortic regurgitation]. / Impianto transcatetere di valvola aortica per il trattamento dell'insufficienza valvolare aortica pura.

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.

Bailout From Sinus Jailing: In-Series TAVR-in-TAVR to Avoid Coronary Flow Obstruction.

Redo transcatheter aortic valve replacement (TAVR) may pose the risk of coronary flow obstruction. We report 2 cases of severe TAVR regurgitation due to different physiopathological mechanisms in which TAVR-in-TAVR could be at high risk for sinus sequestration. Both cases were successfully treated by in-series implantation of a second transcatheter heart valve, thus avoiding sinus sequestration. (Level of Difficulty: Intermediate.).

Impact on clinical outcomes of right ventricular response to percutaneous correction of secondary mitral regurgitation.

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.