SICI-GISE commuNity CAmpania survey doNna TAVI (INCANTA): Outcome perioperatorio e a breve termine della procedura di impianto transcatetere di valvola aortica nelle donne

Background. Nowadays the prognostic role of gender as a relevant factor after transcatheter aortic valve implantation (TAVI) is still unfair, since available data in the literature are few and uneven. The aim of this survey was to collect acute and 30-day safety and efficacy clinical data in high-and intermediate-risk women, who underwent TAVI with new-generation devices, in the Campania Region.Methods. All medium and high-volume TAVI centers in Campania have been invited to fulfill an online, ad-hoc questionnaire, collecting pre-, peri-and post-procedural data concerning female patients, treated between January and December 2016.Results. 331 women (representing the 61% of the overall population treated; mean age 83 +/- 7 years) underwent TAVI in the participating Campania centers. Age >80 years (72%), high surgical risk score (63%) and frailty (55%) were found to be the top three reasons for the TAVI choice. Overall, 95% of the procedures were performed by transfemoral approach with local anesthesia; the remaining 5% (16 cases) were conducted via transapical (14, 4%) and transaortic (2, 1%) accesses, under general anesthesia. Edwards Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Medtronic Evolut R (Medtronic Inc., Minneapolis, MN, USA) were the most frequently implanted valves (146, 44% and 132, 43%, respectively). The questioned Centers reported a mean length of hospital stay of 5.5 +/- 1.1 days, 1.6 +/- 0.37 of which in a cardiac care unit. The most prevalent in-hospital complication was pacemaker implantation (15%), followed by life-threatening vascular complications (3%). The 30-day VARC-2 composite endpoint occurred in 7% of cases, all-cause death in 4%, and stroke in 1%.Conclusions. This survey, the first representative of women undergoing TAVI in Campania, appears to confirm the good safety and efficacy profile of this procedure, also in the high-and intermediate-risk settings, probably favored by a prevalent use of new-generation devices and a low rate prevalence of significant patient comorbidities.Background. Nowadays the prognostic role of gender as a relevant factor after transcatheter aortic valve implantation (TAVI) is still unfair, since available data in the literature are few and uneven. The aim of this survey was to collect acute and 30-day safety and efficacy clinical data in high- and intermediate-risk women, who underwent TAVI with new-generation devices, in the Campania Region. Methods. All medium and high-volume TAVI centers in Campania have been invited to fulfill an online, ad-hoc questionnaire, collecting pre-, peri- and post-procedural data concerning female patients, treated between January and December 2016. Results. 331 women (representing the 61[%] of the overall population treated; mean age 83 ± 7 years) underwent TAVI in the participating Campania centers. Age >80 years (72[%]), high surgical risk score (63[%]) and frailty (55[%]) were found to be the top three reasons for the TAVI choice. Overall, 95[%] of the procedures were performed by transfemoral approach with local anesthesia; the remaining 5[%] (16 cases) were conducted via transapical (14, 4[%]) and transaortic (2, 1[%]) accesses, under general anesthesia. Edwards Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Medtronic Evolut R (Medtronic Inc., Minneapolis, MN, USA) were the most frequently implanted valves (146, 44[%] and 132, 43[%], respectively). The questioned Centers reported a mean length of hospital stay of 5.5 ± 1.1 days, 1.6 ± 0.37 of which in a cardiac care unit. The most prevalent in-hospital complication was pacemaker implantation (15[%]), followed by life-threatening vascular complications (3[%]). The 30-day VARC-2 composite endpoint occurred in 7[%] of cases, all-cause death in 4[%], and stroke in 1[%]. Conclusions. This survey, the first representative of women undergoing TAVI in Campania, appears to confirm the good safety and efficacy profile of this procedure, also in the high- and intermediate-risk settings, probably favored by a prevalent use of new-generation devices and a low rate prevalence of significant patient comorbidities

Clinical outcomes and predictors in patients with previous cardiac surgery undergoing mitral valve transcatheter edge-to-edge repair

Mitral-valve transcatheter edge-to-edge repair (MV-TEER) is recommended in patients with severe functional mitral regurgitation (FMR) and in those with degenerative mitral regurgitation (DMR) not eligible to traditional surgery. Patients with a history of previous cardiac surgery are considered at high risk for surgical reintervention, but data are lacking regarding procedural and clinical outcomes

Italian Society of Interventional Cardiology (GIse) registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO): impact of valve disease aetiology and residual mitral regurgitation after MitraClip implantation

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 30days. In the study population, all-cause mortality was 4.0%, 17.5% and 34.6% at 30days, 1year and 2years, respectively. Cardiovascular death was the most frequent cause of mortality. Overall hospitalization rates were 6.3%, 23.4% and 31.7% at 30days, 1year and 2years, respectively. The most frequent cause of hospitalization was heart failure, particularly in the first 30days. 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 2years. Optimal rMR 1+ was correlated to a more favourable mid-term outcome, particularly in FMR

Characteristics and outcomes of MitraClip in octogenarians: Evidence from 1853 patients in the GIOTTO registry

Background: We aimed at appraising features and outcomes of patients undergoing MitraClip treatment according to their age.Methods: We queried the prospective GIse registry Of Transcatheter treatment of mitral valve regurgitaTiOn (GIOTTO) multicenter registry dataset including 19 Italian centers performing MitraClip implantation, dis-tinguishing patients <80 vs >= 80 years of age.Results: 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.Conclusions: 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

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

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 = 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. Conclusions 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. Classifications mitral regurgitation, mitral valve repair, chronic heart failur

Implantation of one, two or multiple MitraClips for transcatheter mitral valve repair: insights from a 1824-patient multicenter study

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