Search

Aim The aim of this study is to describe our 9-year experience in transcatheter aortic valve replacement (TAVR) using transthoracic echocardiography (TTE) as a routine intra-procedural imaging modality with trans-oesophageal echocardiography (TEE) as a backup. Methods and results From January 2008 to December 2017, 1218 patients underwent transfemoral TAVR at our Institution. Except the first 20 cases, all procedures have been performed under conscious sedation, with fluoroscopic guidance and TTE imaging monitoring. Once the TTE resulted suboptimal for final result assessment or a complication was either suspected or identified on TTE, TEE evaluation was promptly performed under general anaesthesia. Only 24 (1.9%) cases required a switch to TEE: 6 cases for suboptimal TTE prosthetic valve leak (PVL) quantification; 12 cases for haemodynamic instability; 2 cases for pericardial effusion without haemodynamic instability; 4 cases for urgent TAVR. The 30-days and 1-year all-cause mortality were 2.1% and 10.2%, respectively. Cardiac mortality at 30-days and 1-year follow-up were 0.6% and 4.1%, respectively. Intra-procedural and pre-discharge TT evaluation showed good agreement for PVL quantification (k agreement: 0.827, P  = 0.005). Conclusion TTE monitoring seems a reasonable imaging tool for TAVR intra-procedural monitoring without delay in diagnosis of complications and a reliable paravalvular leak assessment. However, TEE is undoubtedly essential in identifying the exact mechanism in most of the complications. [ABSTRACT FROM AUTHOR]

Aim: The aims of this study were: i) to report the prevalence of low-risk patients with degenerative mitral regurgitation (DMR) undergoing mitral transcatheter edge-to-edge repair (M-TEER) in a real-world setting; ii) to evaluate the prognostic significance of EuroSCORE II; iii) to determine whether an optimal M-TEER provides a mortality benefit regardless of EuroSCORE-II., Methods: We analyzed data from the GIOTTO registry that enrolled patients undergoing M-TEER in Italy. We included only patients with DMR. Two groups were defined: patients with EuroSCORE<4% and with EuroSCORE≥4%. A further stratification according to variables included in the EuroSCORE-II was made. Interaction between EuroSCORE-II and optimal procedural success was evaluated. Outcome of interest was all-cause death at 2-year., Results: Among 1659 patients prospectively enrolled in the GIOTTO registry, 657 had DMR, 364 with an EuroSCORE<4% (53%) and 311 with an EuroSCORE≥4% (47%). Patients with lower EuroSCORE were older with less comorbidities. All-cause mortality was higher in patients with EuroSCORE≥ vs <4%. EuroSCORE II ≥ 4% was independently associated with an increased risk of mortality (HR 2.36, 95%CI 1.28-4.38, p = 0.007). Among variables included in the EuroSCORE-II, Left Ventricular Ejection Fraction<35% and systolic Pulmonary Artery Pressure ≥ 50mmhg were independent predictors of clinical outcome. Two-year all-cause death was higher in patients without optimal MR reduction regardless of the calculated surgical risk (p for interaction 0.3)., Conclusion: More than half of patients with DMR undergoing M-TEER had a Euroscore<4% with a median age of 81. An optimally successful M-TEER was associated with a lower mortality regardless of EuroSCORE., Competing Interests: Declaration of competing interest M.A., M.M., F.B., C.G., A.G., and C.T. received consultation and speaker fees from Abbott Vascular outside the submitted work. All other authors have nothing to disclose., (Copyright © 2024. Published by Elsevier B.V.)

Background: In patients with atrial fibrillation (AF) on vitamin K antagonist (VKA) therapy and therapeutic international normalized ratio (INR) range, the incidence of cardiac thromboembolism is not negligible, and the subgroup of patients who have a mechanical prosthetic mitral valve (PMV) has the highest risk. We aimed to assess the long-term effects of left atrial appendage closure (LAAC) in AF patients with a mechanical PMV who experienced a failure of VKA therapy., Methods: In this retrospective, multicentre study, patients underwent LAAC because of thrombotic events including transient ischemic attack and/or stroke, systemic embolism, and evidence of left atrial appendage thrombosis and/or sludge, despite VKA therapy, were enrolled. Patients with a mechanical PMV were included and compared with those affected by nonvalvular AF. The primary endpoint was the composite of all-cause death, major cardiovascular events, and major bleedings at follow-up. The feasibility and safety of LAAC also were assessed., Results: A total of 55 patients (42% female; mean age, 70 ± 9 years), including 12 with a mechanical PMV, were enrolled. The most-frequent indication to LAAC (71%) was LAA thrombosis or sludge. Procedural success was achieved in 96% of overall cases, and in 100% of patients with a PMV. In 35 patients, a cerebral protection device was used. During a median follow-up of 6.1 ± 4.3 years, 4 patients with a PMV, and 20 patients without a PMV, reported adverse events (hazard ratio 0.73 [95% confidence interval 0.25-2.16, P = 0.564])., Conclusions: LAAC seems to be a valuable alternative in patients with AF who have a mechanical PMV, with failure of VKA therapy. This off-label, real-world clinical practice indication deserves validation in further studies., (Copyright © 2024 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Data deriving from patients who underwent TAVR between 2007 and 2017 in 13 Italian centers were prospectively collected. Patients were stratified in those with normal LVEF and reduced LVEF. The latter was further classified according to ischemic or nonischemic etiology. The primary end point was a composite of all-cause death and rehospitalizations; the secondary end points were the isolated composers of the primary end point and cardiac death. Overall, 2,626 patients were included in the analysis: 68.1% with normal LVEF and 31.9% with reduced LVEF. At 8 years, reduced LVEF was significantly associated with the primary end point (adjusted hazard ratio 1.17, 95% confidence interval 1.06 to 1.29). Consistent findings were evident for the composite end point. No differences in these trends were found at the 30-day landmark analyses. Compared with nonischemic etiology, ischemic reduced LVEF was associated with an increased risk of cardiac death (adjusted hazard ratio 1.43, 95% confidence interval 1.02 to 2.02). In conclusion, patients with reduced LVEF who underwent TAVR are exposed to a progressively increased risk of death and rehospitalizations, even at very long-term follow-up., Competing Interests: Declaration of competing interest CG, MA, and MDC received speaker fees from Medtronic; FB received consultant/proctor fees from Medtronic; MM received consultant fees from Abbott, Boston, Kardia and Medtronic; TP received lectures fees from Medtronic, Edwards and Abbott. The remaining authors have no competing interest to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Minimally invasive mitral valve repair has a favorable risk-benefit profile in patients with significant de novo mitral regurgitation. Its role in patients with prior mitral valve repair is uncertain. We aimed to appraise the outcome of patients undergoing transcatheter edge-to-edge repair (TEER) with prior transcatheter or surgical mitral valve repair (SMVR)., Methods and Results: We queried the Italian multicenter registry on TEER with MitraClip, distinguishing naïve patients from those with prior TEER or (SMVR). Inhospital and long-term clinical/echocardiographic outcomes were appraised. The primary outcome was the occurrence of death or rehospitalization for heart failure. A total of 2238 patients were included, with 2169 (96.9%) who were naïve to any mitral intervention, 29 (1.3%) with prior TEER, and 40 (1.8%) with prior SMVR. Several significant differences were found in baseline clinical and imaging features. Respectively, device success was obtained in 2120 (97.7%), 28 (96.6%), and 38 (95.0%, P =0.261) patients; procedural success in 2080 (95.9%), 25 (86.2%), and 38 (95.0%; P =0.047); and inhospital death in 61 (2.8%), 1 (3.5%), and no ( P =0.558) patients. Clinical follow-up after a mean of 14 months showed similar rates of death, cardiac death, rehospitalization, rehospitalization for heart failure, and their composite (all P >0.05). Propensity score-adjusted analysis confirmed unadjusted analysis, with lower procedural success for the prior TEER group (odds ratio, 0.28 [95% CI, 0.09-0.81]; P =0.019) but similar odds ratios and hazard ratios for all other outcomes in the naïve, TEER, and SMVR groups (all P >0.05)., Conclusions: In carefully selected patients, TEER can be performed using the MitraClip device even after prior TEER or SMVR.

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., (© 2021 European Society of Cardiology.)

Background: Intracranial hemorrhage (ICH) represents the most serious complication of oral anticoagulant therapy (OAT) in patients with atrial fibrillation (AF), and AF patients with previous ICH are a challenge for clinicians. Left atrial appendage (LAA) occlusion has emerged as an alternative option for AF patients not suitable for OAT. Currently, few data are available on long term outcomes after LAA occlusion in this population. We evaluated the safety and efficacy of LAA occlusion in a cohort of patients with AF and previous ICH., Methods: This is a multicenter, observational, retrospective study involving 5 LAA occlusion centers in Italy. It includes all consecutive patients (n = 120) with previous ICH who underwent LAA occlusion for nonvalvular AF and high thromboembolic risk. Procedural outcomes, post-procedural therapies and 12-months follow-up data were analyzed., Results: The device was successfully implanted in 100% of cases, with a 6% of major peri-procedural complications. 59% had a prior ICH during OAT. The sample had a high risk of stroke (5.18%/year) and bleeding (6.62%/year). 30% were discharged on single and 54.2% on dual antiplatelet therapy. The expected annual risk for thromboembolism was 5.1%. Excluding periprocedural ischemic complications, the stroke annual rate was 1.8%. The expected annual risk of bleeding was 6.7%. The observed annual bleeding rate was 5.45%., Conclusions: Percutaneous LAA occlusion is an effective option for AF patients and previous intracranial hemorrhage. After LAA occlusion, a single antiplatelet therapy strategy could be considered for patients with the highest risk of recurrent bleeding., Competing Interests: Declaration of Competing Interest All the authors have read and approved submission of the manuscript and the manuscript has not been published and is not being considered for publication elsewhere in whole or in part in any language. We declare to have no conflicts of interest. This research did not receive any specific grant from funding agencies in the public, commercial, or -for-profit sectors., (Copyright © 2020. Published by Elsevier B.V.)

Aim: To assess the outcome of nonagenarians patients receiving transcatheter aortic valve replacement (TAVR)., Methods: We aimed to stratify the overall population from an Italian, multicenter, observational project including a total of 3792 consecutive patients who underwent TAVR with CoreValve and Evolut R/PRO devices between April 2009 and October 2018, into four groups according to their age class (≥90 vs. 80-89 years vs. 70-79 vs. <70 years) and to compare outcomes up to 4 years after TAVR., Results: At 4 years, survival estimates showed no difference in terms of overall survival [Kaplan-Meier estimates (KM est.) 49.9 vs. 58.1% vs. 57.0 vs. 69.3%; Plogrank = 0.28] among the four groups. After 2 years from the procedure, landmark analysis showed an age-based difference in overall survival (KM est. 63.8 vs. 75.0% vs. 75.1 vs. 88.7%; Plogrank = 0.025) but no difference in terms of survival from cardiovascular death (KM est. 87.8 vs. 87.4% vs. 86.1 vs. 96.1%; Plogrank = 0.43). Finally, age itself was not correlated with overall mortality at 4 years (hazard ratio 1.06, 95% confidence interval 0.86-1.30, P = 0.591)., Conclusion: TAVR with self-expanding CoreValve and Evolut prostheses was demonstrated to have good long-term outcomes, regardless of the patient's age. At 4 years, no difference in overall mortality was reported among age-based groups, while a higher overall mortality was reported in nonagenarians after 2 years from the procedure. TAVR showed good long-term outcomes even in nonagenarian patients, and it could be the therapy of choice for selected elderly patients., (Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.)

The impact of chronic kidney disease (CKD) on clinical outcomes after percutaneous coronary intervention for unprotected left main distal bifurcation lesions in patients with diabetes mellitus (DM) is not fully understood in drug eluting stent era. We identified 512 consecutive DM patients who underwent percutaneous coronary intervention for unprotected left main distal bifurcation lesions at New Tokyo Hospital, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus between January 2005 and December 2015. We analyzed according to estimated glomerular filtration rate (eGFR). Each group was defined as follows; no CKD (60 ≤ eGFR), mild CKD (45 ≤ eGFR < 60), moderate CKD (30 ≤ eGFR < 45), and severe CKD (15 ≤ eGFR < 30). The primary end point was target lesion failure (TLF) at 3 years. TLF was defined as a composite of cardiac death, target lesion revascularization, and myocardial infarction. The rate of TLF was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 3.64, [1.86 to 7.11], p < 0.001). Cardiac mortality was significantly higher in the severe CKD group than that in the other groups (Adjusted HR of severe CKD relative to the others 6.43, [2.19 to 18.9], p = 0.001). Target lesion revascularization rate was comparable in 4 groups (Adjusted HR of severe CKD relative to the others 1.71, [0.60 to 4.82], p = 0.31). In conclusions, in DM patients, those with severe CKD was extremely associated with worse clinical outcomes., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-μm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions., Methods: FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months., Results: A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months., Conclusions: In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up., Competing Interests: Declaration of Competing Interest Alaide Chieffo, MD: Proctorship fees from Amaranth Medical Inc. Juan F. Granada, MD: Scientific advisor and equity shareholder Amaranth Medical Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020. Published by Elsevier B.V.)

Aims: We aim at exploring whether severe chronic kidney disease (CKD) may modify the impact of acute kidney injury (AKI) post-transcatheter aortic valve implantation (TAVI) on early, mid, and long-term mortality., Methods and Results: The analysis included 2,733 TAVI patients from the Italian Clinical Service Project. The population was stratified in four groups according to the presence of baseline severe CKD and postprocedural AKI. All-cause mortality was the primary end point. Postprocedural AKI is associated with an increased risk of early and mid-term mortality after TAVI regardless of baseline severe CKD. Preprocedural severe CKD is associated with an increased risk of long-term mortality after TAVI regardless of postprocedural AKI. No interaction between preprocedural severe CKD and postprocedural AKI was observed in predicting mortality at both 30-day (CKD: hazard ratio [HR] = 2.65, 95% confidence interval [CI] = 1.15-6.12; no-CKD: HR = 3.83, 95% CI = 2.23-6.58; P int = .129) and 1-year (CKD: HR = 2.29, 95% CI = 1.37-3.82; no-CKD: HR = 2.47, 95% CI = 1.75-3.49; P int = .386). Preprocedural severe CKD is an independent predictor of postprocedural AKI (HR = 2.17, 95% CI = 1.56-3.03; p < .001) as well as general anesthesia and access alternative to femoral. Among no-AKI patients, those with severe CKD at admission underwent kidney function recovery after TAVI (serum creatinine at baseline 2.24 ± 1.57 mg/dL and at 48-hr 1.80 ± 1.17 mg/dL; p = .003)., Conclusions: Preprocedural severe CKD did not modify the impact of postprocedural AKI in predicting early and mid-term mortality after TAVI. Closely monitoring of serum creatinine and strategies to prevent AKI post-TAVI are needed also in patients without severe CKD at admission., (© 2020 Wiley Periodicals LLC.)

Background: Limited real-world data are available regarding the outcome of patients treated with inappropriate dose of nonvitamin-K antagonist oral anticoagulants (NOACs)., Objective: To assess the prevalence and factors associated with inappropriate dose prescription of NOACs and to evaluate adverse events that come from this inappropriate prescription., Methods: Single-center multidisciplinary registry including nonvalvular atrial fibrillation patients treated with NOACs. Based on guidelines criteria for dose reduction, two subcohorts were defined as treated with appropriate or inappropriate NOACs dose. Primary efficacy endpoint was 2-year rate of thromboembolic events. Primary safety endpoint was 2-year rate of major bleeding. Event-free survival curves among groups were compared using Cox-Mantel test., Results: A total of 760 nonvalvular atrial fibrillation patients were included; 32% patients were treated with dabigatran, 34% with apixaban, 24% with rivaroxaban and 10% with edoxaban. An inappropriate dose was prescribed in 96 patients (12.6%), and in most cases (68%) it was too low. Rivaroxaban (15%) and apixaban (18.5%) were the most frequently prescribed with an inappropriate dose. Patients treated with an inappropriate dose were elderly people, with low-creatinine clearance value, who had experienced previous bleeding and with a high CHADS2 VASc score. In 2 years, a trend for higher numbers of thromboembolic events (5.2 vs. 3.3%, P = 0.348) and less major bleeding (2.1 vs. 4.2%, P = 0.316) has been observed in patients with inappropriate NOACs prescriptions., Conclusion: Nearly 13% of patients were treated with an inappropriate dose of NOACs, in this single-center study. A trend for higher numbers of thromboembolic events was observed in these patients. The results should be considered as hypothesis generating.

Background: Available scientific evidence of transcatheter mitral valve repair with the MitraClip comes from randomized controlled trials, which showed controversial results that hardly translate into real-world practice, and from registries of relatively small sample size., Aim: To collect real-world data in a multicenter, prospective, country-level registry., Methods and Result: The Italian Society of Interventional Cardiology (GIse) Registry Of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) is an ongoing single-arm, multicenter, prospective registry that started enrollment in February 2016. Clinical end points were defined according to the Mitral Valve Academic Research Consortium (MVARC) criteria. From February 2016 to December 2018, 1189 patients (mean age 76 ± 9.1 years) were enrolled. The main MR etiology was functional (64.9%). MVARC technical success was 96.6%. At 30-day follow-up (n = 1131), MVARC device and procedural success were 92.5% and 87% respectively, and all-cause death was 3%. The majority of patients who died at 30-day had functional MR (69.7%). Mixed etiology (OR 0.94, 95% CI 0.02-0.61) and prolonged length of stay in ICU (OR 0.97, 95% CI 0.95-0.99) were found to be negative independent predictors of device success at 30-day. The EuroSCORE II (OR 0.96, 95% CI 0.93-0.99), LVEDV-I (OR 0.99, 95% CI 0.98-0.99) and prolonged length of stay in ICU (OR 0.98, 95% CI 0.97-0.99) were negative independent factors of MVARC procedural success at 30-day., Conclusions: The GIOTTO registry is one of the largest prospective registries available on MitraClip and shows favorable acute and 30-day safety and efficacy., Competing Interests: Declaration of competing interest Francesco Bedogni, Carmelo Grasso, Paolo Denti, Arturo Giordano, Antonio L. Bartorelli, Anna Sonia Petronio, Corrado Tamburino received fees from Abbott Vascular outside the submitted work. The other authors have no conflicts of interest to declare with the present work., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The ULISSE registry evaluated the real-world performance of the Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) in a multicenter-independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients., Methods: In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP-SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non-DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac-death, target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) at 1-year. Secondary endpoint was TLR at 1-year., Results: At 1-year follow-up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non-DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin-treated DM (ITDM) patients showed higher rate of TLF as compared to non-ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP-SES implantation., Conclusions: This study is the first all-comers evaluation of BP-SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP-SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non-DM patients., (© 2019 Wiley Periodicals, Inc.)

Competing Interests: Declaration of competing interest The authors report no relationships that could be construed as a conflict of interest.

Objective: To evaluate the impact of left ventricular outflow tract calcification (LVOT-CA) localization and extension on permanent pacemaker implantation (PPI) rates after transcatheter aortic valve implantation (TAVI) with second-generation devices., Methods: This single-center retrospective study included all consecutive patients who underwent transfemoral TAVI with second-generation devices at San Raffaele Hospital in Milan, Italy from January 2014 to June 2017. The localization and extension of LVOT-CA were evaluated using computed tomography imaging; LVOT regions were categorized according to the overlying coronary cusps., Results: The study population consisted of 377 patients, of which LVOT-CA was present in 133 patients (35.3%). Patients with LVOT-CA had significantly a higher rate of post-TAVI PPI (32.0% vs 19.2% in patients with no LVOT-CA; P<.01). Multivariable analysis demonstrated LVOT-CA in the non-coronary cusp, as well as preprocedural right bundle-branch block, age, body mass index, and mechanically expanded prosthesis implantation, to be strong independent predictors of PPI., Conclusions: LVOT-CA in the non-coronary cusp is a strong independent predictor of PPI after TAVI with second-generation devices. Further studies are needed to confirm these data in a larger, multicenter population.

Objectives: This study sought to evaluate the feasibility of complete cerebral protection during transcatheter aortic valve replacement (TAVR) with a novel embolic protection device., Background: Evidences and data about new cerebral embolic protection devices are lacking and scarce., Methods: A prospective, nonrandomized, multicenter, first-in-man pilot study designed to evaluate the efficacy and safety of cerebral embolic protection utilizing the Emblok embolic protection system (Innovative Cardiovascular Solutions, Grand Rapids, Michigan) during TAVR. The Emblok is a transfemoral aortic filter that provide full coverage of the epiaortic vessels. Brain diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and 2 to 5 days after TAVR. Primary endpoints were technical success and immediate cerebral embolic burden after TAVR, defined as number and volume of new brain lesions detected with DW-MRI at days 2 to 5 post-TAVR compared with baseline., Results: A total of 20 subjects were enrolled. The Emblok system was successfully positioned in all the cases. At 30-day follow-up, no major adverse cardiovascular and cerebrovascular events occurred. Nineteen (95%) patients had new ischemic defects at post-procedural DW-MRI. The median number of new lesions per patient was 10.00 (interquartile range [IQR]: 4.75 to 15.25). The total new lesion volume was 199.9 mm 3 (IQR: 83.9 to 447.5 mm 3 ) and the mean lesion volume per lesion was 42.5 mm 3 (IQR: 21.5 to 75.6 mm 3 ). Histopathologic analysis showed evidence of significant debris in 18 (90%) filters., Conclusions: The Emblok embolic protection system appears to be feasible and safe during TAVR. The device was successfully placed and retrieved in all cases and no neurological events were observed. Cerebral total new lesion volume was similar to other trials on cerebral protection during TAVR, thus warranting a larger study. (European Study Evaluating the Emblok Embolic Protection System During TAVR; NCT03130491)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The Agent paclitaxel-coated balloon is a new drug-coated balloon (DCB) with few available real-world data. Our study sought to assess the safety and efficacy of the Agent DCB during percutaneous coronary intervention (PCI) in different coronary lesion types in a prospective registry., Methods and Results: All patients undergoing PCI with the Agent DCB at three Italian centers between September 2014 and March 2018 were included in this registry. Major adverse cardiac event (MACE) rate was defined as the composite of cardiac death, recurrent non-fatal myocardial infarction (MI), and target-lesion revascularization (TLR). Procedural success was also evaluated. Among the 354 patients included in the registry (450 lesions treated with 508 DCBs), Agent DCBs were used for the treatment of in-stent restenosis (ISR) in 34%, small-vessel disease (SVD) in 29%, bifurcation lesions in 26%, and "stent-like result" (SLR) lesions obtained after balloon predilation in 11%. The implantation of Agent DCBs was safe and had a high DCB lesion success rate of 92%. One-year MACE rate was 5.7% in the overall population. A higher MACE rate was observed in the ISR group (8.3%) vs the SVD group (3.6%; P=.03), with a trend toward higher event rates vs both BL (3.7%; P=.09) and SLR patients (5.5%; P=.54)., Conclusions: The use of Agent DCBs during PCI appears safe and effective in a large real-world registry. These results were maintained in all subgroups, with a slightly higher trend of events rates in the ISR setting, consistent with the higher-risk nature of this patient subset.

Aims: The aim of this study was to investigate nationwide trends and clinical outcomes of the Impella device for cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI)., Methods and Results: The IMP-IT study was a multicentre observational national registry which enrolled all patients treated with Impella 2.5, Impella CP, Impella 5.0 and Impella RP, both for CS and HR-PCI indications, across 17 Italian centres from 2004 to June 2018. A total of 406 patients were included: 229 had CS (56.4%) and 177 underwent HR-PCI (43.6%). The use of Impella increased significantly during the study period (average annual percent change 39.8%, 95% confidence interval: 30.4 to 49.9; p<0.0001) for both indications. The Impella 2.5 was the most commonly used device (N=242; 59.6%). Rates of in-hospital and one-year all-cause death in patients with CS were 46.9% and 57.0%, respectively; 18.5% underwent left ventricular assist device implantation or heart transplant at one year. Rates of in-hospital and one-year all-cause death in patients who underwent HR-PCI were 5.7% and 15.6%, respectively. Rates of device-related complications were 37.1% and 10.7% in the setting of CS and HR-PCI, respectively., Conclusions: Use of the Impella for CS and HR-PCI is increasing substantially in Italy, despite relatively high rates of device-related complications.

The durability of chronic total occlusion (CTO) percutaneous coronary intervention (PCI) is uncertain. We aimed to compare the long-term outcomes of CTO PCI with those of complex non-CTO PCI. We built a single-center registry including all patients who underwent CTO and complex non-CTO PCI between 2012 and 2017. Complex non-CTO PCI was defined as: 3 vessels treated, ≥3 stents implanted, total stent length >60 mm, saphenous vein graft intervention, 2-stent bifurcation intervention, left main PCI, protected PCI, or rotational/laser atherectomy. The primary endpoint was target-lesion failure, a composite of cardiac death, myocardial infarction, and target-lesion revascularization. A total of 2,396 patients were included (n=609 CTO PCI, n=1,787 complex non-CTO PCI). Patients who underwent CTO PCI were younger and had higher prevalence of cardiovascular comorbidities. CTO PCI patients exhibited worse procedural metrics and success rate (74% vs 98%, p <0.001). They also suffered a higher incidence of coronary perforation (3.5% vs 2.0%, p = 0.04) and cardiac tamponade (0.8% vs 0.1%, p = 0.001). However, there was no difference in the overall incidence of in-hospital major adverse cardiac and cerebrovascular events (4.1% vs 5.0%, p = 0.40). At 36 months, there were no differences in the incidence of target-lesion failure (10.1% vs 9.9%, p = 0.91) or its individual components, between the CTO and complex non-CTO group. This finding was confirmed on multivariable analysis. In conclusion, CTO PCI is associated with lower success rates and higher risk for coronary perforation and tamponade compared with complex non-CTO PCI. The incidence of other in-hospital and long-term adverse events is similar and reasonably low., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI)., Methods: We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR)., Results: Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF., Conclusions: In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aims of this study were to evaluate the long-term clinical outcomes after coronary covered stent (CS) implantation and to compare the results according to the indications., Background: To date, data on the long-term follow-up of coronary CS are limited, and no studies have been conducted to compare outcomes on the basis of specific lesions treated., Methods: A total of 190 consecutive patients (212 lesions) implanted with CS and surviving until discharge between May 1997 and February 2017 were enrolled in this retrospective study. Clinical outcomes were evaluated and compared using the Gehan-Breslow-Wilcoxon test., Results: CS was mainly used for the treatment of a saphenous vein graft (SVG) (51.4%), followed by coronary artery perforation (CAP) (25.0%) and coronary artery aneurysm (CAA) (11.8%). The median follow-up duration was 6.0 (interquartile range: 1.6-13.5) years. Target vessel myocardial infarction (MI), target vessel occlusion, target lesion revascularization, and stent thrombosis, frequently occurred in the early follow-up period (7.3%, 16.6%, 21.5%, and 8.9% at 1 year, respectively) and continued to increase throughout the long-term follow-up (14.8%, 38.6%, 38.7%, and 17.8% at 10 years, respectively). Target vessel occlusion, target vessel MI, and ST were not identified in CAA with superiority to CAP (Gehan-Breslow-Wilcoxon p-value = 0.010, 0.047, and 0.046, respectively). SVG had a higher rate of target vessel occlusion than CAA (p = 0.004)., Conclusions: Clinical events after CS implantation frequently occurred in the early period and steadily increased in the long-term period. CS implantation in CAA was associated with fewer adverse cardiac events and may lead to safe and acceptable outcomes. However, CS implanted in CAP and SVG are associated with a high risk of long-term cardiac events., (© 2019 Wiley Periodicals, Inc.)

Background: Severe aortic stenosis (AS) is often associated with ascending aorta dilation (AAD). AAD is amenable to surgical correction combined with aortic valve replacement. Transcatheter aortic valve implantation (TAVI) might represent a valid therapeutic option in these patients when AAD correction Is not indicated. The aim of the present study is to evaluate the impact of concomitant AAD on early and mid-term outcomes after TAVI for symptomatic severe AS., Methods: This is a single-center observational study including patients undergoing transfemoral TAVI. All patients with previous surgery on the left ventricular outflow tract, aortic valve, or ascending aorta (except coronary artery bypass graft surgery) were excluded from the analysis. Patients undergoing TAVI for congenital aortic valve defects or subjects in whom a computed tomography (CT) scan was not available were excluded from the analysis. Ascending aortas were measured on CT scans using appropriate multiplanar reconstructions. Ascending aortas were qualified as dilated if the measurement was >40 mm. Study outcomes were death from any cause, significant paravalvular leaks (PVLs), and new permanent pacemaker (PPM) implant., Results: The final population consisted of 680 subjects, 61% females, mean age 82 ± 7 years. One hundred subjects (15%) had AAD. No differences in terms of significant PVL or PPM implantation were found between subjects with or without AAD (P>.99 and P=.13, respectively). At a median follow-up of 498 ± 216 days, no significant difference in terms of mortality was found between subjects with or without AAD (P=.78)., Conclusions: AAD does not appear to impact the mid-term outcomes in a cohort of subjects undergoing TAVI.

Background: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity., Methods: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis., Results: 82 patients (5%) were discharged with ≤3-month DAPT (57 ± 27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ± 75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142)., Conclusions: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: The aim of this study is to evaluate the long-term risk of cardiac death and sudden cardiac death (SCD) and/or sustained ventricular arrhythmias (SVAs) in patients with coronary chronic total occlusions (CTO) revascularised versus those with CTO not revascularised by percutaneous coronary intervention (PCI)., Methods: From a cohort of 1357 CTO-PCI patients, 1162 patients who underwent CTO PCI attempt were included in this long-term analysis: 837 patients were revascularised by PCI (CTO-R group) and 325 were not revascularised (CTO-NR group). Primary adverse endpoint was the incidence of cardiac death; secondary endpoint was the cumulative incidence of SCD/SVAs., Results: Up to 12-year follow-up (median 6 year), compared with CTO-R patients, those with CTO-NR had significantly higher rate of cardiac death (13%[43/325]vs6%[48/837]; p<0.001) and SCD/SVAs (7.5%[24/325]vs2.5%[20/837]; p<0.001). The risk of cardiac death and SCD/SVAs was mainly driven by the subgroup of infarct-related artery (IRA) CTO patients and was significantly higher only in IRA CTO-NR patients (18%vs7%, p<0.001, 14%vs5%, p=0.001; IRA CTO-NR vs IRA CTO-R, respectively). At multivariable Cox hazards regression analysis, CTO-NR remains one of the strongest independent predictors of higher risk of cardiac death and of SCD/SVAs in the overall population and in IRA CTO patients., Conclusions: At long-term follow-up, patients with CTO not revascularised by PCI had worse outcomes compared with those with CTO revascularised, with >2-fold risk of cardiac death and threefold risk of SCD/SVAs. The presence of an infarct-related artery (IRA CTO) not revascularised identified the category of patients with the highest rate of adverse events ., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: This study sought to determine predictors of advanced conduction disturbances requiring late (≥48 h) permanent pacemaker replacement (PPM) after transcatheter aortic valve replacement (TAVR)., Methods: Data of consecutive patients were identified by retrospective review of a TAVR database of a single center in Milan, Italy, between October 2007 and July 2015. We defined delta PR (ΔPR) and delta QRS (ΔQRS) interval as the difference between the last PR and QRS length available 48 h after TAVR and the baseline PR and QRS length., Results: Overall population included 740 patients. We excluded 78 patients who already had a PPM and 51 patients who received a PPM <48 h after TAVR. The final analysis included 611 patients. Fifty-four patients (8.8%) developed an advanced conduction disturbance requiring PPM ≥48 h following TAVR. Patients who required a late PPM implant had a wider QRS width (113 ± 25 ms vs. 105 ± 23 ms; p = 0.009) and a higher prevalence of baseline right bundle branch block (12.9% vs. 5.3%; p = 0.026) and were more likely to have a self-expandable valve implanted (51.8% vs. 31.9%; p = 0.003). The ΔPR was 40 ± 51 ms (p = 0.0001) and the ΔQRS was 22 ± 61 ms (p = 0.001). Multivariable analysis revealed that baseline right bundle branch block (odds ratio: 3.56; 95% confidence interval: 1.07 to 11.77; p = 0.037) and ΔPR (odds ratio for each 10-ms increase: 1.31; 95% confidence interval: 1.18 to 1.45; p = 0.0001) are independent predictors of delayed advanced conduction disturbances., Conclusions: This analysis showed that baseline right bundle branch block and the amount of increase of PR length after TAVR are independent predictors of late (≥48 h) advanced conduction disturbances requiring PPM replacement after TAVR in this cohort. A simple ECG analysis could help in detecting potentially lethal advanced conduction disturbances that could occur more than 48 h after TAVR., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)-guided versus transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet devices included in a large Italian registry., Background: TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO., Methods: Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and device embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed., Results: CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high (≥94%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures., Conclusions: ICE-guided LAAO by means of Amplatzer devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina., Background: The coronary sinus Reducer is a novel device to aid in the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization., Methods: Fifty patients with refractory angina and objective evidence of myocardial ischemia who were judged unsuitable for revascularization were treated with coronary sinus Reducer implantation at a single center between March 2015 and August 2016. Safety endpoints were procedural success and the absence of device-related adverse events. Efficacy endpoints, assessed at 4- and 12-month follow-up, were a reduction in Canadian Cardiovascular Society angina class, improvement in quality of life assessed using the Seattle Angina Questionnaire, improvement in exercise tolerance assessed using the 6-min walk test, and reduction in pharmacological antianginal therapy., Results: Procedural success was achieved in all patients, with no device-related adverse effects during the procedure or at follow-up. Regarding the efficacy endpoint, 40 patients (80%) had at least 1 reduction in Canadian Cardiovascular Society class, and 20 patients (40%) had at least 2 class reductions, with a mean class reduction to 1.67 ± 0.83 vs. 2.98 ± 0.52 (p < 0.001) at 4-month follow-up. All Seattle Angina Questionnaire items improved significantly (p < 0.001 for all). A significant increment in 6-min walk distance to 388.6 ± 119.7 m vs. 287.0 ± 138.9 m (p = 0.004) was observed. Sixteen patients (32%) and 3 patients (6%) demonstrated reductions of at least 1 or 2 antianginal drugs, respectively. The benefit of Reducer implantation observed at 4-month follow-up was maintained at 1 year., Conclusions: In this real-world, single-center experience, implantation of the coronary sinus Reducer appeared safe and was associated with reduction in anginal symptoms and improvement in quality of life in patients with refractory angina who were not candidates for further revascularization., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Second generation transcatheter aortic valve implantation (TAVI) devices have been designed to reduce the rate of paravalvular leak (PVL) and other complications. An important technological advancement has been the ability to fully reposition devices to facilitate optimal implantation depth and position to reduce the likelihood of PVL., Objectives: To compare procedural and 30-day outcomes according to the Valve Academic Research Consortium (VARC)-2 criteria following TAVI with the fully repositionable and retrievable Lotus and DFM devices., Methods and Results: 175 patients with severe aortic stenosis underwent transfemoral TAVI with the Lotus (n = 60) and DFM (n = 115) valve. Baseline clinical characteristics did not differ between the two groups. All devices were successfully implanted, with one case of valve embolization in the Lotus group. Device success (95 vs. 98.2%, P = 0.89), VARC-defined combined safety (90 vs. 93%, P = 0.48), and clinical efficacy (86.7 vs. 90.4%, P = 0.65) rates at 30-days were similar between Lotus and DFM groups. There was no severe PVL; one patient in both Lotus and DFM group developed moderate PVL after the procedure. The Lotus valve was associated with a higher rate of new pacemaker implantation (37.3 vs. 11.2%, P < 0.001) and a lower mean aortic gradient (9.4 ± 5 vs. 12.3 ± 5, P < 0.001) at 30-days as compared with the DFM valve., Conclusions: In this single-center, retrospective analysis, both Lotus and DFM devices demonstrated excellent device success, safety and efficacy at 30-day follow-up. The DFM valve was associated with minimally higher transvalvular gradients but lower new pacemaker implantation rates when compared to the Lotus valve., (© 2017 Wiley Periodicals, Inc.)

Objectives: To compare indications and clinical outcomes of two contemporary left atrial appendage (LAA) percutaneous closure systems in a "real-world" population., Background: Percutaneous LAA occlusion is an emerging therapeutic option for stroke prevention in atrial fibrillation. Some questions however remain unanswered, such as the applicability of results of randomized trials to current clinical practice. Moreover, currently available devices have never been directly compared., Methods: We retrospectively analyzed consecutive patients who underwent LAA closure at San Raffaele Hospital, Milan, Italy between 2009 and 2015. Clinical indications and device selection were left to operators' decision; routine clinical and transesophageal echocardiography (TEE) follow-up was performed., Results: One-hundred and sixty-five patients were included in the study, of which 99 were treated with the Amplatzer Cardiac Plug (ACP) and 66 with the Watchman system. During the follow-up period (median 15 months, interquartile range 6-26 months) five patients died. The incidence of ischemic events was low, with one patient suffering a transient ischemic attack and no episodes recorded of definitive strokes. Twenty-six leaks ≥1 mm were detected (23%); leaks were less common with the ACP and with periprocedural three-dimensional TEE evaluation, but were not found to correlate with clinical events. Clinical outcomes were comparable between the two devices., Conclusions: Our data show excellent safety and efficacy of LAA closure, irrespectively of the device utilized, in a population at high ischemic and hemorrhagic risk. The use of ACP and 3D-TEE minimized the incidence of residual leaks; however, the clinical relevance of small peri-device flow warrants further investigation. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Transcatheter aortic valve implantation (TAVI) is now the treatment of choice for patients with symptomatic aortic stenosis who are inoperable or with high surgical risk. Data with regards to contemporary clinical practice and long-term outcomes are sparse. To evaluate temporal changes in TAVI practice and explore procedural and long-term clinical outcomes of patients in a contemporary "real-world" population, outcomes of 829 patients treated from November 2007 to May 2015, at the San Raffaele Scientific Institute, Milan, Italy, were retrospectively analyzed. Median follow-up was 568 days, with the longest follow-up of 2,677 days. Overall inhospital mortality was 3.5%. During the study period, there was a trend toward treating younger, lower risk patients. Overall mortality rates were 3.5% (30 days), 14% (1 year), 22% (2 years), 29% (3 years), 37% (4 years), 47% (5 years), 53% (6 years), and 72% (7 years). The survival probability at 5 years was significantly higher in patients treated through the transfemoral (TF) route compared to other vascular access sites (log rank p <0.001). Non-TF vascular access and residual paravalvular leak ≥2 (after TAVI) were identified as independent predictors for both all-cause and cardiovascular mortality. No patient required further aortic valve intervention for TAVI prosthesis degeneration. In conclusion, there is a trend toward treating younger, lower-risk patients. Non-TF vascular access approach and ≥2 PVL after TAVI were identified as independent predictors for both overall and cardiovascular mortality with no cases of prosthesis degeneration suggesting acceptable durability., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objectives: This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB)., Background: To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR., Methods: Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group)., Results: Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p < 0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p = 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p = 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p = 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p = 0.049) to be independent predictors of TLR., Conclusions: The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to assess the clinical impact of strut width (evaluated by abluminal strut surface area [ASSA]) on periprocedural myocardial infarction (PMI) and clinical outcomes in patients treated with bioresorbable scaffolds (BRS) versus first-generation sirolimus-eluting stents (SES)., Background: To date, there are no reports on the impact of ASSA on PMI and clinical outcomes., Methods: We compared the impact of ASSA on outcomes and PMI in propensity-matched patients treated with BRS and SES. The primary outcome was the incidence of major adverse cardiac events (MACE), defined as the combination of all-cause mortality, follow-up myocardial infarction, and target vessel revascularization, at 30-days and 1-year follow-ups. The secondary endpoint was the incidence of PMI., Results: After propensity-matched analysis, 499 patients (147 BRS patients vs. 352 SES patients) were evaluated. Mean ASSA was higher in patients treated with BRS versus SES (BRS: 132.3 ± 76.7 mm(2) vs. SES: 67.6 ± 48.4 mm(2), p < 0.001). MACE was not significantly different between groups (30-days MACE: BRS: 0% vs. SES: 1.4%, p = 0.16, and 1-year MACE: BRS: 15.7% vs. SES: 11.4%, p = 0.67). The incidence of PMI was significantly higher in the BRS group (BRS: 13.1% vs. SES: 7.5%, p = 0.05). Multivariable analyses indicated that treatment of left anterior descending artery and ASSA were independent predictors of PMI., Conclusions: BRS implantation, compared with SES implantation, was associated with a higher incidence of PMI. MACE at 30 days and 1 year were not significantly different. Left anterior descending artery percutaneous coronary intervention and ASSA were independent predictors of PMI., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To compare the clinical outcomes following unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) of ostial/midshaft lesions between first and new generation drug-eluting stents (DES)., Background: Clinical outcomes after treatment of ostial/midshaft lesions in ULMCA with first generation DES were favorable. However, to date, data regarding treatment for those lesion subsets with new generation DES have not been reported., Methods: A total of 219 patients with ostial/midshaft lesions in ULMCA treated with first (n = 139) or new generation DES (n = 80) were analyzed., Results: There was a higher prevalence of IVUS use (35.2% vs. 50.0%, P = 0.032) and postdilation (70.5% vs. 93.8%, P < 0.001) with larger maximum balloon diameter (3.81 ± 0.45 vs. 4.08 ± 0.44, P < 0.001) in the new generation DES group. At a median follow-up period of 730 days, there were no significant differences in the propensity-score adjusted analyses, for major adverse cardiac events (MACE) defined as composite endpoint of all-cause death, myocardial infarction, and target vessel revascularization (hazard ratio (HR) [new vs. first generation DES]: 1.22; 95% confidence interval (CI): 0.64-2.31; P = 0.549). Of note, target lesion revascularization rates at 2-years were only 0.9% and 2.7%, for first and new generation DES groups, respectively (P = 0.339). On multivariable analysis, SYNTAX score (HR: 1.06; 95% CI: 1.02-1.11, P = 0.006) and European System for Cardiac Operative Risk Evaluation (HR: 1.14; 95% CI: 1.00-1.31, P = 0.051) were independent predictors for MACE., Conclusions: This study suggests that new generation DES for ostial/midshaft lesions in ULMCA are associated with favorable clinical outcomes, similar to those observed with first generation DES., (© 2014 Wiley Periodicals, Inc.)

Objectives: To compare the early clinical outcomes between ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) and cobalt chromium everolimus-eluting stents in real-world patients with mostly complex disease., Background: BVS represents the most interesting development in the drug-eluting stent field over recent years with promising results emerging from clinical trials. Available data however on the use of the ABSORB in real-world patients is limited., Methods: All patients (n = 92) treated with BVS and 1296 patients treated with EES were included in this study. Propensity score matching was performed to adjust for differences in baseline clinical characteristics, yielding 92 patient pairs (BVS = 92 patients with 137 lesions and EES = 92 patients with 124 lesions). Clinical outcomes were examined between the 2 groups at 6-months., Results: In both groups, most lesions were classified as either B2 or C (83.9% vs. 77.4%, P = 0.19). Predilatation (97.8% vs. 75.8%, P < 0.01) as well as postdilation (99.3% vs. 77.4%, P < 0.01) was more common in the BVS group. Clinical outcomes at 6-months were similar between the two groups with respect to both target lesion revascularization (3.3% vs. 5.4%, P = 0.41) and major adverse cardiac events (defined as the composite of target vessel revascularization, follow-up myocardial infraction and all-cause death) (3.3% vs. 7.6%, P = 0.19)., Conclusions: ABSORB BVS for the treatment of complex lesions appears to be associated with good procedural and early clinical outcomes similar to those observed with conventional drug-eluting stents. Larger studies with long-term follow-up are required in order to fully assess the role of BVS in the treatment of such lesions and how this compares with that of conventional stents. © 2014 Wiley Periodicals, Inc., (© 2014 Wiley Periodicals, Inc.)

Data on transcatheter aortic valve implantation (TAVI) for severe bicuspid aortic valve (BAV) stenosis and how this compares to that for tricuspid aortic valve (TAV) stenosis are limited. Twenty-one consecutive patients with BAV were treated with the Edwards or CoreValve bioprosthesis from November 2007 to December 2012 at San Raffaele Scientific Institute and Clinical Institute S. Ambrogio, Milan, Italy. Results were compared with a cohort of patients with TAV (n=447) treated with the same bioprostheses over the same period. Procedural 1- and 12-month outcomes were examined as defined by the Valve Academic Research Consortium criteria. Patients with BAV were younger (76.7±7.1 vs 79.8±7.4 years, p=0.06) and with a larger aortic annulus (25.0±1.8 vs 23.6±2.1 mm, p=0.01). Device success (85.7% vs 94.4%, p=0.10) was lower in patients with BAV. Although the 30-day composite safety end point (23.8% vs 21.0%, p=0.76) was similar between the 2 groups, mortality rate at 30 days was higher (14.2% vs 3.6%, p=0.02) in the BAV group. Cardiovascular mortality at 1 year did not differ significantly between the 2 groups (10.5% vs 7.4%, p=0.62). In conclusion, transcatheter aortic valve implantation in high surgical risk patients with severe BAV stenosis appears to be feasible with mid-term cardiovascular mortality similar to that for patients with TAV. Early survival and device success, however, were lower for patients with BAV demonstrating that further studies are required to identify which subset of patients with BAV is best suited for transcatheter treatment., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Unprotected distal left main trifurcation (ULMT) lesion represents a challenge for interventional cardiologists with the potential for peri-procedural complications and adverse events at follow-up especially when the main branch and the side branches are concomitantly diseased., Methods: A retrospective cohort analysis was performed on consecutive patients with ULMT stenosis who electively underwent percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation in order to assess the technical feasibility and long-term outcomes according to the disease distribution in the trifurcation branches (true vs. non-true ULMT). Primary endpoint of the study was a composite of major adverse cardiovascular events (MACE) defined as cardiac-death, myocardial infarction (MI), and target lesion revascularization (TLR) during follow-up., Results: Eighty-four patients underwent PCI with DES for ULMT disease during the study period (40 true trifurcation and 44 non-true trifurcation). Angiographic and procedural success were obtained in 94% and 92.8% of cases. At 3-years follow-up, the occurrence of MACE was significantly higher in patients with true ULMT than in those with non-true ULMT (HR 2.801 [confidence interval; CI 1.164-7.896], P = 0.025) due to a higher TLR rate (HR 3.032 [CI 1.164-7.896], P = 0.023). No episodes of late and very late definite/probable stent thrombosis (ST) occurred. On multivariable analysis, a true-ULMT lesion was the only independent predictor of MACE (HR 2.344 [C.I. 1.006-5.461], P = 0.049)., Conclusions: PCI with DES for ULMT stenosis is feasible with a high procedural success rate and no definite/probable ST reported at follow-up. A true trifurcation lesion is associated with enhanced risk of MACE mainly driven by TLR., (Copyright © 2013 Wiley Periodicals, Inc.)

Objectives: This study sought to investigate the role of drug-eluting balloons (DEB) alone or in combination with drug-eluting stents (DES) in the treatment of diffuse de novo coronary artery disease (CAD) (>25 mm)., Background: The use of DEB in diffuse CAD, either alone or in combination with DES, offers an alternative to stenting alone. Data regarding DEB in this context are limited., Methods: We retrospectively evaluated all patients treated with DEB for diffuse CAD between June 2009 and October 2012. Endpoints analyzed were major adverse cardiac events, defined as all-cause death, myocardial infarction, and target vessel revascularization (TVR), as well as TVR and target lesion revascularization separately. Results were compared with those obtained from a cohort of patients with similar characteristics treated with DES alone., Results: A total of 69 patients (93 lesions) were treated with DEB ± DES, and 93 patients with DES alone (93 lesions). A high proportion of patients were diabetic (46.4% vs. 44.1%, p = 0.77). Of the DEB-treated lesions, 56.0% were treated with DEB alone, 7.4% with DEB and DES as bail out, and 36.6% with DES and DEB as part of a hybrid approach for very long disease. Outcome rates with DEB ± DES were comparable to those with DES alone at 2-year follow-up (major adverse cardiac events = 20.8% vs. 22.7%, p = 0.74; TVR = 14.8% vs. 11.5%, p = 0.44; target lesion revascularization = 9.6% vs. 9.3%, p = 0.84)., Conclusions: DEB may have a role in the treatment of diffuse de novo CAD, either alone in smaller vessels or in combination with DES in very long disease., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Patients who undergo transcatheter aortic valve implantation are generally discharged on dual-antiplatelet therapy. However, many of these patients also have indications for anticoagulant therapy, and it is unclear what the best antithrombotic strategy is in these cases. Data from 360 patients who underwent transcatheter aortic valve implantation were retrospectively analyzed, of whom 60 (16.7%) had indications for anticoagulant treatment, mainly because of atrial fibrillation. The antithrombotic regimen was decided according to clinical evaluation of thrombotic and hemorrhagic risk; most of these patients (n = 43) were discharged with warfarin plus a single antiplatelet drug. Their outcomes were compared to those in a group with no indications for anticoagulation (n = 300) treated with dual-antiplatelet therapy. During the follow-up period (median 11 months), 53 patients (15%) died; mortality was not associated with antithrombotic regimen. The incidence of cerebral events or intracranial hemorrhage (4.6% and 1.1%, respectively) was low in the study population, and no significant differences were detected between groups; the bleeding rate was also unaffected by antithrombotic therapy. In conclusion, when anticoagulation is indicated after transcatheter aortic valve implantation, many variables must be taken into account. The most frequent scenario in this study was patients in atrial fibrillation, most of whom were discharged with warfarin plus a single antiplatelet medication. When bleeding was a concern, especially in the absence of coronary disease, warfarin alone was prescribed. These results suggest that this approach is safe, but data from larger, randomized studies are needed., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: Few data are available regarding the optimal revascularization strategy for unprotected distal left main coronary artery (UDLM) in-stent restenosis (ISR)., Methods and Results: Between April 2002 and December 2008, UDLM-ISR following drug-eluting stent (DES) implantation occurred in 92 of 474 patients (19.4%). Of these, 8 (8.7%) who underwent a coronary artery bypass graft (CABG) were excluded, and the remaining 84 (91.3%) who underwent percutaneous coronary intervention (PCI) (43 plain old balloon angioplasty [POBA] and 41 DES) were analyzed to assess the feasibility of PCI for UDLM-ISR. The overall cardiac death, myocardial infarction (MI), and major adverse cardiac events during the follow-up period (median, 24 months) occurred in 4, 2, and 31 patients, respectively. Repeat target lesion revascularization (TLR) occurred in 28 patients. The incidence of repeat TLR was higher following PCI with POBA than with DES (hazard ratio [HR], 2.79; 95% CI, 1.23-6.34; P=0.014). On Cox regression analysis, the independent predictors of repeat TLR were treatment with POBA (HR, 3.29; 95% CI, 1.41-7.69; P=0.006) and EuroSCORE (European System for Cardiac Operative Risk Evaluation) >6 (HR, 2.53; 95% CI, 1.02-6.28; P=0.045). More complex lesions requiring a 2-stent strategy were associated with a higher occurrence of TLR for restenosis of the left circumflex coronary artery ostium (LCX-ISR) (HR, 2.51; 95% CI, 1.59-3.97; P=0.001) as well as repeat TLR for recurrent LCX-ISR (HR, 4.32; 95% CI, 0.97-19.20; P=0.05) compared to a 1-stent strategy. No cardiac death at 2 years occurred in patients with LCX-ISR., Conclusions: UDLM restenosis is better treated with DES than with POBA. The rate of recurrent ISR following repeat PCI was high, whereas the rates of MI and death were relatively low. Complex lesions requiring a 2-stent strategy had a higher recurrence rate at the ostial LCX but without an associated increased risk of MI and death.

Objectives: This study aims to report a "real-world" experience of in hospital complications and clinical outcome of a large cohort of consecutive patients who underwent percutaneous coronary intervention (PCI) with intra-aortic balloon pump counterpulsation (IABP) support, from a tertiary care center over a 12-year period., Background: The incidence of vascular complications in patients treated with PCI and IABP is expected to be higher due to simultaneous puncture of femoral arteries, larger IABP sheath size, and longer duration of IABP therapy., Methods: A total of 360 consecutive patients (mean age of 65.9 ± 11.2 years; 80.6% male) who required an IABP support during percutaneous PCI were classified into 3 groups: Urgent: 133 patients (36.9%) admitted with acute coronary syndrome in whom IABP therapy was started before urgent PCI; Emergent: 56 patients (15.6%) in whom emergent IABP insertion was required to manage hypotension during PCI; and Elective: 171 patients (47.5%) with stable angina pectoris in whom IABP was inserted before elective PCI. Overall bleeding was defined according to the newest the Bleeding Academic Research Consortium (BARC) definition criteria., Results: BARC bleeding occurred in 68 patients (19%), with the highest incidence noted in the Urgent group (31.1%), in comparison with the Emergent (26.8%) and Elective (7%) groups, p < 0.0001. Bleeding related to the IABP access site was 7.5%, which accounted for 82% of any access site-related bleeding. It was significantly higher in the Urgent group (12.8%) compared with the Elective (4.1%) and Emergent (5.4%) groups. At multivariate analysis, IABP treatment duration and renal impairment were the only independent predictors of BARC bleeding., Conclusions: Bleeding related to the IABP access site was significantly higher in the Urgent group and accounted for more than two-thirds of overall access site-related bleeding. IABP treatment duration and renal impairment were independent predictors of overall bleeding., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: To assess outcomes after transcatheter aortic valve implantation (TAVI) according to sex, with the two available valves and four recognised delivery approaches., Methods and Results: VARC outcomes are reported according to sex for 305 high-risk patients consecutively treated in our centre, via available access routes utilising the Edwards SAPIEN™/SAPIEN™ XT or the Medtronic CoreValve ReValving System® devices. Three hundred and five patients underwent TAVI: 52.1% male and 47.9% female. Females had a smaller body surface area (1.84±0.16 m² vs. 1.70±0.16 m²; p<0.001) and aortic annulus (24.4±1.6 mm vs. 22.6±1.7 mm; p<0.001) with increased symptoms (NYHA Class III/IV 61.6% vs. 73.6%; p=0.026). Conversely, men had more comorbidities: diabetes mellitus (35.2% vs. 21.9%; p=0.010), chronic kidney disease (41.8% vs. 23.3%; p=0.001), chronic obstructive pulmonary disease (45.3% vs. 30.1%; p=0.006) and previous myocardial infarction (28.3% vs. 14.4%; p=0.003). Thirty-day mortality was 4.7% with no difference between groups. There was a trend for females to develop more major vascular complications (11.9% vs. 19.9%; p=0.058). Notably, females required more blood transfusion (38.4% vs. 50.0%; p=0.041). No differences were observed in device success (92.5%; p=0.667), combined safety endpoint (61.8%; p=0.211) or combined efficacy endpoint (72.0%; p=0.889)., Conclusions: Female sex was a predictor of major vascular complications with females requiring more transfusion. No differences were noted amongst patients undergoing TAVI in composite safety and efficacy endpoints according to sex.

Objectives: The aim of this study was to analyze the short-term outcomes after transcatheter aortic valve implantation with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, California)., Background: The SXT has been recently commercialized in Europe, but there are no studies analyzing the efficacy and safety of SXT, compared with ESV., Methods: All consecutive patients (n = 120) who underwent transcatheter aortic valve implantation in our center via the transfemoral approach with either ESV (n = 66) or SXT (n = 54). Valve Academic Research Consortium endpoints were used., Results: Mean age was 80 ± 8 years, and mean Logistic-European System for Cardiac Operative Risk Evaluation was 24.9 ± 17.0. The ilio-femoral artery minimal lumen diameter was smaller in patients treated with the SXT (7.27 ± 1.09 mm vs. 7.94 ± 1.08 mm, p = 0.002). Device success was high in both groups (96.3% vs. 92.4%, p = 0.45). Major vascular events were 3-fold lower in the SXT group (11.1% vs. 33.3%, relative risk: 0.40, 95% confidence interval: 0.28 to 0.57; p = 0.004). Life-threatening and major bleeding events were not significantly different between groups (18.5% vs. 27.3% and 35.2% vs. 40.9%, respectively). The SXT group had a lower 30-day Valve Academic Research Consortium combined safety endpoint (20.4% vs. 45.5%; relative risk: 0.44, 95% confidence interval: 0.24 to 0.80; p = 0.004). The 30-day mortality was 1.7% (n = 2). At 30 days, mean transaortic gradient was approximately 10 mm Hg in both groups and the aortic regurgitation was mild-to-moderate in 70.2% of SXT and 76.3% of ESV., Conclusions: The new SXT valve has the same short-term performance as the ESV but seems to be associated with a lower risk of major vascular complications and thus has a broader clinical application., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion., Background: Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis., Methods: We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach., Results: A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events., Conclusions: Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes., (Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Prolonged periods of dual antiplatelet therapy (DAT), i.e., aspirin plus a thienopyridine, are currently recommended to prevent late drug-eluting stent (DES) thrombosis. The aim of our study was to determine the risk and predictors of bleeding and compliance associated with such prolongation of DAT. In this observational study we examined 2,355 consecutive patients undergoing successful DES implantation at 4 hospitals in Italy from June 2002 to December 2004. Bleeding events occurring on DAT and warfarin or in the first 30 days after stent implantation were excluded. Median duration of DAT was 209 days (interquartile range 178 to 444) and only 158 patients (6.7%) prematurely discontinued DAT. The overall bleeding rate was 1.9% (45), with major bleeding in 19 (0.8%) and minor bleeding in 26 (1.1%). Independent predictors of bleeding were DAT (hazard ratio 19.8, 95% confidence interval [CI] 3.69 to 106.34, p <0.001) and age >65 years (hazard ratio 2.15, 95% CI 1.16 to 4.00, p = 0.02). In patients on DAT, the incidence rate (30 days to 18 months) of any bleeding event was 2.57 per 100 person-years (95% CI 1.85 to 3.48) and major bleeding was 1.10 per 100 person-years (95% CI 0.65 to 1.74). In conclusion, DAT after DES implantation is well tolerated and associated with a very low risk of major bleeding.

Objectives: This study evaluated clinical outcome after multivessel stenting with sirolimus-eluting stents (SES) in unselected lesions., Background: Safety and effectiveness of multivessel SES implantation is currently unknown., Methods: Major adverse cardiac events (MACE) (death, myocardial infarction [MI], and repeat revascularization) were analyzed at 30 days and at 6 months after multivessel SES implantation., Results: In 155 consecutive patients, 573 SES were implanted in 3.3 +/- 1.3 lesions per patient. At 30 days, the cumulative MACE rate was 10.3%: 7.1% patients developed a non-Q-wave MI, 1.9% developed a Q-wave MI, 0.6% died for non-cardiac reasons, and 0.6% had a repeat revascularization. Clinical follow-up was obtained in all 112 eligible patients treated for 359 lesions at a mean time of 6.5 +/- 2.2 months. The cumulative MACE rate was 22.3%: 3 (2.7%) deaths (1 for cardiac reasons), 4 (3.6%) MIs, target lesion revascularization (TLR) in 16 (14.3%) patients with 24 (6.7%) lesions. Target vessel revascularization was required in 18 (16.1%) patients due to TLR of lesions treated with SES or to disease progression (1.8% of patients). Cox regression analysis revealed total stent length per patient as the most powerful independent predictor of MACE. Overall stent thrombosis occurred in three (1.9%) patients., Conclusions: Multivessel SES implantation can be safely performed on patients with complex coronary artery disease. The need for revascularization increases because of the cumulative effect of TLR on patients with multiple lesions.

Stainless steel (SS) and carbon-coated (CC) stents were randomly compared in 347 patients (520 lesions). No differences were observed in in-hospital major adverse cardiac events: 2.8% in the CC group and 4.5% in the SS group (p = 0.286). The 6-month follow-up showed similar rates of binary restenosis (31.8% in the CC group vs 35.9% in the SS group; p = 0.448) and of cumulative major adverse cardiac events (30.5% in the CC group vs 32.7% in the SS group; p = 0.675). In unselected patients and lesions, carbon coating does not provide significant improvements over SS stents with the same design.

We report a new stenting technique employed in 20 consecutive patients to treat true bifurcation lesions using the Cypher stent (Cordis, Warren, NJ). Both stents are advanced at the site of the bifurcation. The proximal marker of the side-branch stent must be situated in the main branch at a distance of 4-5 mm proximal to the carina of the bifurcation and the main branch stent must cover the bifurcation as well as the protruding segment of the side-branch stent. The side-branch stent is deployed first and balloon and wire are removed. The stent deployed in the main branch completely covers and crushes the protruding segment of the side branch stent against the vessel wall of the main branch. Following main- and side-branch predilatation, stents were successfully deployed in all lesions. Final kissing balloon inflation was performed in seven patients. Two patients had in-hospital myocardial infarction and one patient underwent in-hospital re-PTCA due to a dissection distal to a stent. No other major adverse cardiac events were observed in-hospital and during 1-month clinical follow-up. Treatment of bifurcation lesions using crushing stent technique is feasible with acceptable rate of procedural complications. Angiographic follow-up is necessary to prove the advantage of this specific technique to give complete coverage of the ostium of the side branch with a drug-eluting stent., (Copyright 2003 Wiley-Liss, Inc.)