Alessandro Beneduce

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in all-comers population. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry)

BACKGROUNDnThis study was designed to confirm in a large population of unselected patients the promising results of Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) already shown in previous trial.nnnMETHODSnULISSE is an observational, multicenter, national registry evaluating all patients undergoing PCI with the Ultimaster® BP-SES. Incidence of 1-year TLF (cardiac death or target vessel MI or clinically indicated TLR) was the primary endpoint. Pre-specified subgroup analysis was performed for diabetic patients and for those with lesion longer than 25u202fmm, bifurcation and CTO lesions.nnnRESULTSn1660 patients were enrolled in 9 Italian cardiology centers, 82% were males, mean age of 68u202f±u202f10u202fyears, and 29% were diabetics. Overall 2422 lesions were treated, 65% type B2/C lesions, 7% CTOs, 17% bifurcations and 38% long lesions. The incidence of 1-year TLF was 5%, with 3.2% of clinically indicated TLR. TLF occurred in 8% of the patients with diabetes mellitus, and 7% in bifurcation, 6.7% in CTO and 6.2% in long lesions. Definite overall ST was 0.9%, and 1.2% in patients treated for type B2/C lesions. Multivariate logistic regression analysis identified stenting on unprotected LMT (ORu202f=u202f4.80), stenting on ISR lesion (ORu202f=u202f3.19) and need for rotational atherectomy (ORu202f=u202f6.24) as the strongest independent predictors of TLF.nnnCONCLUSIONSnThe results of this national all-comers registry show that the Ultimaster® BP-SES real-world performance was comparable with that observed in the clinical trial, with low rate of primary endpoint and TLR. Long term follow-up will be necessary to prove the theoretical advantage of the BP-SES over time.

Two-year cardiac mortality after MitraClip treatment of functional mitral regurgitation in ischemic and non-ischemic dilated cardiomyopathy

BACKGROUNDnMitraClip implantation has evolved as a new tool for treatment of inoperable or high-risk patients with severe functional mitral regurgitation (FMR) due to dilated cardiomyopathy (DCM). Limited data are available regarding MitraClip outcomes comparing patients with ischemic and non-ischemic DCM.nnnMETHODSnFrom 2008 to 2016, 314 patients received MitraClip for FMR at four institutions: Brescia, Zurich and Milan. Patients were stratified according to MR aetiology in non-ischemic FMR (nu202f=u202f99) and ischemic FMR (nu202f=u202f215). Preoperative risk factors, operative variables and outcomes up to 2-year were evaluated. A multivariable Cox Proportional Hazards survival model with covariate adjustments was used to assess the relationship between FMR aetiology and 2-year cardiac mortality.nnnRESULTSnAs expected, patients with ischemic FMR had significantly more risk factors and comorbidities. Overall procedural success rate was 80% and in-hospital cardiac mortality was 3% without significant differences between aetiology. Two-year overall (25% vs. 19%, pu202f=u202f0.574) and cardiac (18% vs. 16%, pu202f=u202f0.990) mortality rates were comparable. No differences were detected in terms of re-hospitalization rates (32%), LVAD implantation (4.5%) and mitral valve surgery (1%). LVEFu202f≤u202f25%, LVEDVu202f>u202f216u202fml, NT-proBNPu202f≥u202f10.000u202fpg/ml and AF were the strongest baseline predictors of 2-year cardiac mortality. Greater improvements of 6MWT and NYHA functional class were observed in patients with non-ischemic FMR.nnnCONCLUSIONSnThe ischemic or non-ischemic aetiology of DCM did not affect in-hospital and 2-year cardiac mortality after MitraClip in patients with FMR. In case of unfavorable baseline clinical condition, the indication for MitraClip should be carefully weighed in favour of conservative medical therapy alone or left ventricular assist device.

Subclinical Leaflet Thrombosis After Transcatheter Mitral Valve-in-Ring Implantation

A 66-year-old man with a history of ischemic cardiomyopathy (ejection fraction 35%) and severe functional mitral regurgitation underwent coronary artery bypass grafting and mitral valve repair by quadrangular resection of the posterior leaflet and 30-mm Carpentier-Edwards annuloplasty ring (Edwards

Incidence of contrast-induced acute kidney injury in a large cohort of all-comers undergoing percutaneous coronary intervention: Comparison of five contrast media

BACKGROUNDnThere is controversy as to whether iso-osmolar contrast media (IOCM) are associated with lower risk of contrast-induced acute kidney injury (CI-AKI), compared with low-osmolar contrast media (LOCM). We aimed to evaluate if a differential risk of CI-AKI exists after percutaneous coronary intervention (PCI) according to different contrast media (CM) types.nnnMETHODSnWe performed a single-center retrospective study in a cohort of all-comers undergoing PCI between January 2012 and December 2016. CI-AKI was defined as an increase in serum creatinine ≥0.3u202fmg/dl or ≥50% within 72u202fh from PCI. IOCM were represented by iodixanol, whereas four different LOCM were utilized (ioversol, iopromide, iomeprol, iobitridol). Multiple-treatment inverse probability of treatment weighting (IPTW)-adjusted logistic regression analysis was performed to identify whether CM type was an independent predictor of CI-AKI.nnnRESULTSnWe included 2648 subjects (ioversol, nu202f=u202f272; iopromide, nu202f=u202f818; iomeprol, nu202f=u202f611; iobitridol, nu202f=u202f460; iodixanol, nu202f=u202f487). CI-AKI occurred in 300 patients (11.7%) overall, with no differences across CM groups (ioversol 13.0%, iopromide 11.5%, iomeprol 10.2%, iobitridol 13.9%, iodixanol 11.3%; pu202f=u202f0.42). CI-AKI requiring dialysis was observed in 8 patients (0.3%) overall (pu202f=u202f0.50). On IPTW-adjusted analysis, none of the LOCM was associated with a significantly different risk of CI-AKI compared with iodixanol: ioversol OR 0.986 (95% confidence interval [CI] 0.611-1.591), iopromide OR 0.870 (95% CI 0.606-1.250), iomeprol OR 0.904 (95% CI 0.619-1.319), iobitridol OR 1.258 (95% CI 0.850-1.861).nnnCONCLUSIONSnIn a large cohort of all-comers undergoing PCI, there were no differences in the adjusted risk of CI-AKI across 4 LOCM, compared with iodixanol.

Contrast-Induced Nephropathy After Percutaneous Coronary Intervention for Chronic Total Occlusion Versus Non-Occlusive Coronary Artery Disease

Contrast volume is associated with the incidence of contrast-induced nephropathy (CIN), and CIN risk could be particularly high in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Our aim was to evaluate the incidence of CIN in patients who underwent CTO versus non-CTO PCI. All PCIs performed at our institution from January 2012 to December 2016 were included in this study. CIN was defined as an increase of ≥0.3 mg/dl or ≥50% from baseline within 72 hours. Multivariable logistic regression analysis was performed to identify independent predictors of CIN. A total of 2,580 patients were included (nu202f=u202f309 CTO PCI and nu202f=u202f2271 non-CTO PCI). Estimated glomerular filtration rate was lower in the non-CTO group (73.9 ± 27.3 vs 77.1 ± 24.7 ml/min/1.73/m2, pu202f=u202f0.05). Patients in the non-CTO PCI group presented more often with acute coronary syndrome (47% vs 15%, p < 0.001). Contrast volume (347 ± 159 vs 215 ± 107 ml, p < 0.001) and contrast-volume-to-creatinine-clearance ratio (4.7 ± 2.1 vs 3.2 ± 1.8, p < 0.001) were higher in the CTO group. There was no difference in CIN rates between CTO and non-CTO groups (9.4% vs 12.1%, pu202f=u202f0.17). This was confirmed in a sensitivity analysis including only patients who underwent PCI in a stable clinical setting (7.7% vs 8.5%, pu202f=u202f0.66). On multivariate analysis hypotension during/before PCI (odds ratio [OR] 2.86), acute coronary syndrome (OR 1.86), age (OR 1.54), female sex (OR 1.51), left ventricular ejection fraction (OR 0.64), diabetes mellitus (OR 1.49), and contrast volume (OR 1.17) were independent predictors of CIN, while CTO PCI was not. In conclusion, CTO PCI is associated with similar rates of CIN, compared with non-CTO PCI. These findings persisted on sensitivity and multivariable analyses.