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Background: Limited data are available on transcatheter heart valves (THVs) durability in bicuspid aortic valve (BAV) stenosis., Aims: To evaluate evaluating 4-year clinical and echocardiographic outcomes of patients with BAV undergoing transcatheter aortic valve implantation (TAVI)., Methods: The bicuSpid TAvi duraBILITY (STABILITY) registry is an Italian multicentre registry including all consecutive patients with BAV and severe aortic stenosis (AS), treated by means of TAVI between January 2011 and December 2017. Outcomes of interest were all-cause death at 4-year, over time changes in echocardiographic measurements, and THV durability according to the valve aortic research consortium (VARC)-3 update definitions., Results: Study population included 109 patients (50% females; mean age 78 ± 7.5 years) with a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 5.1 ± 4.3%. Median follow-up (FU) duration was 4.1 years [interquartile range: 2.8-5.1]. The overall cumulative incidence of all-cause death by Kaplan-Meier estimates at 4 years was 32%. Compared to baseline, a significant decrease in transprosthetic mean gradient was obtained after TAVI (54 ± 16 vs. 10 ± 5 mmHg; p < 0.001), whereas a significant increase was observed at 4-year (13 ± 6.4 mmHg, p = 0.03). Cumulative incidence of hemodynamic valve dysfunction (HVD) was 4%. Six patients met HVD criteria: three moderate and three severe HVD. All three cases of severe HVD were clinically relevant (bioprosthetic valve failure [BVF]) with two patients receiving a reintervention (TAVI in TAVI), and one patient experiencing a valve-related death due to endocarditis., Conclusions: The STABILITY registry suggests that in patients with severe AS and BAV undergoing TAVI, postprocedural clinical benefits might last, over time, up to 4-year FU. The low rates of severe HVD and BVF may support the hypothesis of good THV durability also in BAV recipient., (© 2023 Wiley Periodicals LLC.)

Objectives: The objective of this study is to investigate the use of cutting balloon (CB) inflated at high pressure compared with noncompliant balloon (NCB) for the treatment of calcified coronary lesions., Background: No data are available regarding the safety and efficacy of CB inflated at high pressure in coronary artery calcifications., Methods: Patients with calcified lesions (more than 100° of calcium demonstrated at baseline intravascular ultrasound) were randomized. Primary endpoint of the study was the final minimal stent area (MSA) and stent symmetry in the calcific segment. Secondary endpoints included rate of device failure and the 1-year rate of target lesion revascularization, target vessel revascularization, and major adverse cardiovascular events., Results: From September 2019 to June 2021, a total of 100 patients were included and randomized; 13 patients were excluded for major protocol deviations. Lesions were complex (type B2/C n = 61 [71.2%]) with a mean arch of calcium of 266 ± 84°, a calcium length of 12 ± 6.6 mm. CB was inflated at comparable atmospheres when compared with NCB (18.3 ± 5 vs. 19 ± 4.5, p = 0.46). In the per-protocol population, the final MSA at the level of the calcium site was significantly higher in the CB group (8.1 ± 2 vs. 7.3 ± 2.1, p = 0.035) with a higher eccentricity index achieved in the CB group (0.84 ± 0.07 vs. 0.8 ± 0.08, p = 0.013). Three device failure occurred in the CB group. One-year follow-up outcomes were comparable., Conclusions: Treatment of calcified lesions with high-pressure CB has a good safety profile and is associated with a larger MSA and higher eccentricity of the stent at the level of the calcium site compared with NCB., (© 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Objectives: We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population., Background: Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry., Methods: Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria., Results: Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6 ± 6.3 years, 51.6% females. Mean STS score for mortality was 8.3 ± 5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR., Conclusions: RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Objectives: Assess clinical consequences of acute stent malapposition (ASM) in the context of the multicenter Centro per la Lotta Contro l'Infarto-Optimization of Percutaneous Coronary Intervention (CLI-OPCI) registry., Background: ASM as important determinant of stent thrombosis (ST) risk remains controversial., Methods: From 2009 to 2013, we retrospectively analyzed postprocedural optical coherence tomography (OCT) findings in 864 patients undergoing percutaneous coronary intervention, assessing prevalence and magnitude of ASM and exploring correlation with outcome, especially ST., Results: Postprocedural OCT revealed a variable grade of ASM in 72.3% of stents without correlation between maximal strut-vessel distance and longitudinal extension (R = 0.164, P < 0.01). At a median follow up of 302 (IQ 127-567) days, ASM did not affect risk of following major cardiac adverse events (MACE); residual ASM was comparable in terms of thickness (median [quartiles] 0.21[IQ 0.1-0.4] vs. 0.20[IQ 0.0-0.3], P = 0.397) and length (2.0[IQ 0.5-4.1] vs. 2.2[IQ 0.0-5.2], P = 0.640) in patients with versus without MACE. The predictive accuracy for outcome was low (C-statistic 0.52, CI 95% 0.47-0.58, P = 0.394) as well for target lesion revascularization (HR 0.80, CI 95% 0.5-1.4) and ST (HR 0.71, CI 95% 0.3-1.5). Likewise, timing to MACE was not influenced by presence of such an ASM with similar rate of acute-subacute (HR 1.09, CI 95% 0.6-1.9), late (HR 0.91, CI 95% 0.5-1.8), and very late (HR 1.23, CI 95% 0.5-2.9) events., Conclusions: Limited ASM was a common finding after stent implantation, but was not associated to increased risk of stent failure or ST during mid-term follow-up. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Objectives: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease., Background: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care., Methods: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization., Results: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis., Conclusions: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Background: Carotid endarterectomy (CEA) is the standard revascularization therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) could be considered a potential alternative in patients at high surgical risk. Recent clinical trials have challenged this concept due a relatively high incidence of post-CAS adverse events, which occurred in low volume centers. The aim of this study was to evaluate the outcomes associated with neuroprotected CAS in selected high volume centers., Methods: From January 2007 to December 2007, 1,611 patients underwent neuroprotected CAS in eight European Centers. For each patients, clinical, procedural, and one month follow-up data from all patients have been collected. An independent clinical events committee adjudicated the events., Results: Overall in hospital death was 0.06% (one patient), whereas in-hospital stroke was 0.49% (eight patients). Between hospital discharge and 30 days three additional patients died (0.18%) and 10 patients experienced a stroke (0.67%). Overall 30 days mortality was 0.24% (four patients) and stroke incidence 1.12% (18 patients). The 30 day stroke/death rate was 1.36%., Conclusions: CAS is a reasonable alternative to CEA to treat carotid artery atherosclerosis in well-experienced high volume centers. These data suggest that future prospective trials comparing CAS and CEA outcomes should include only centers highly experienced in both treatment modalities., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: Carotid stenting (CAS) has been proposed as an alternative to carotid endoarterectomy also in elderly patients with discrepant results. However, the use of proximal neuroprotection devices have not been evaluated in octogenarians., Purpose: The aim of this multicenter prospective registry was to demonstrate that CAS in octogenarians is safe and effective if performed in high-volume centers by experienced operators., Methods: From July 2005 to May 2009, a total of 198 octogenarians patients, in three different institutions, were included in this registry. All patients underwent CAS using proximal endovascular occlusion device (Mo.Ma. device Invatec, Roncadelle, Italy). An independent neurologist evaluated all patients. The primary endpoint was death and stroke rate at 30 days., Results: 198 octogenarians (135 men; mean age: 83.2 years) were included in the registry. 39.4% of the patients were symptomatic. Procedural success was 100%. In-hospital complications: Two minor and two major strokes (2.02%) occurred. No device-related complications and no serious access site complication were noted. Between discharge and 30-day follow-up, one patient died due to a cardiac arrest. The overall 30-day combined stroke/death rate was 2.52%, resulting in 1.61% event incidence in asymptomatic and 3.9% in symptomatic patients (P = ns). Logistic regression did not identify independent predictor of neurological events, except in the female gender., Conclusion: This multicenter prospective registry shows that CAS performed with proximal flow blockage is safe and feasible also in octogenarians. Thirty days death/stroke rates are similar to those of the overall population and within the International guidelines., ((c) 2010 Wiley-Liss, Inc.)