Francesco Giannini

Comparison of incidence and predictors of left bundle branch block after transcatheter aortic valve implantation using the CoreValve versus the Edwards valve.

Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p <0.001). Persistent new-onset LBBB at discharge was not associated with overall (log-rank p = 0.42) or cardiovascular (log-rank p = 0.46) mortality. New-onset right bundle branch block was documented in 4.6% of patients (n = 11), with no statistically significant differences between the ESV and MCRS. In conclusion, new-onset LBBB is a frequent intraventricular conduction disturbance after TAVI with a higher incidence with the MCRS compared with the ESV. LBBB persists in most patients, but in this cohort, it was not a predictor of overall or cardiovascular mortality or permanent pacemaker implantation.

Comparison of Results of Transcatheter Aortic Valve Implantation in Patients With Severely Stenotic Bicuspid Versus Tricuspid or Nonbicuspid Valves

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.

Comparison of First- and Second-Generation Drug-Eluting Stents in Saphenous Vein Grafts Used as Aorto-Coronary Conduits

Saphenous vein grafts (SVGs) are prone to an aggressive atherosclerotic process, and the efficacy of drug-eluting stents (DES) in treating this is still debated. In recent years, second-generation DES have been increasingly used in SVG intervention. The main objective of this study was to compare midterm clinical outcomes between first- and second-generation DES in SVGs because data regarding the use of second-generation DES in SVG are lacking. Patients treated with first-generation DES (127 patients with 143 lesions) and those treated with second-generation DES (84 patients with 100 lesions) were included in the study. Major adverse cardiac events, defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization, as well as target vessel revascularization and target lesion revascularization separately, were evaluated at 30-day, 12-month, and 18-month follow-up. Baseline characteristics were similar between the 2 groups. Older grafts were treated with second-generation DES (11.6 ± 5.3 vs 14.3 ± 6.0 years, p = 0.001). Stent length was longer in the first-generation group (34.1 ± 25.1 vs 30.5 ± 19.4 mm, p = 0.006), and maximum balloon diameter was smaller in the second-generation group (3.42 ± 0.42 vs 3.30 ± 0.41 mm, p = 0.003). Embolic protection device use was higher in the second-generation DES group (55.2% vs 72.0%, p = 0.012). At 18-month follow-up, rates of major adverse cardiac events, target vessel revascularization, and target lesion revascularization for the first- and second-generation groups were 24.4% versus 20.2% (p = 0.479), 18.1% versus 14.2% (p = 0.465), and 15.0% versus 10.7% (p = 0.373), respectively. In conclusion, second-generation DES are at least comparable with first-generation DES with regard to clinical outcomes at midterm follow-up.

Percutaneous Direct Annuloplasty With Cardioband to Treat Recurrent Mitral Regurgitation After MitraClip Implantation.

A 74-year-old man was referred for worsening symptoms of left-sided heart failure (New York Heart Association functional class III) 1 year after undergoing an edge-to-edge repair with 2 MitraClips (Abbott Vascular, Santa Clara, California) for functional mitral regurgitation (FMR) at another

First- versus second-generation drug-eluting stents for the treatment of coronary bifurcations☆

BACKGROUND Randomized controlled trials have demonstrated that second-generation drug-eluting stents (DESs) for the treatment of obstructive coronary artery disease are associated with comparable, if not improved, clinical outcomes as compared to those of their first-generation counterparts. The aim of this study was to compare the long-term clinical outcomes associated with first- versus second-generation DESs for the treatment of coronary bifurcation lesions. METHODS AND MATERIALS This was a retrospective study of consecutive de novo bifurcation lesions, excluding those at the left main, treated with either second-generation DES (everolimus-eluting or resolute zotarolimus-eluting stents) between October 2006 and October 2011 (199 bifurcation lesions in 192 patients) or first-generation DES (sirolimus-eluting or paclitaxel-eluting stents) between April 2002 and December 2005 (289 bifurcation lesions in 273 patients). RESULTS Second-generation DES use in this setting was associated with less major adverse cardiac events (MACE) (23.1% vs. 14.4%, p=0.02) as well as lower target vessel revascularization (TVR) rates (15.5% vs. 8.3%, p=0.01) at 2-year follow-up. Target lesion revascularization, both per patient (12.6% vs. 7.4%, p=0.02) and per bifurcation (11.8% vs. 7.0%, p=0.03), was also improved with second-generation DES over the same follow-up period. Propensity-score adjusted analysis suggested that second-generation DES was associated with a lower incidence of MACE (HR, 0.53; 95% CI, 0.33-0.85; p=0.01) and TVR (HR, 0.44; 95% CI, 0.24-0.83; p=0.01). CONCLUSIONS Our results suggest that the use of second-generation DES for the treatment of bifurcation lesions is associated with better clinical outcomes as compared to first-generation DES, largely due to a lower need for repeat revascularization.

Two-year outcomes following unprotected left main stenting with first vs. new-generation drug-eluting stents: the FINE registry.

AIMS To assess two-year outcomes following first vs. new-generation drug-eluting stent (DES) implantation in unprotected left main (ULMCA) percutaneous coronary intervention. METHODS AND RESULTS All eligible patients from our two-centre registry treated with first and new-generation DES from October 2006 to November 2010 were analysed. The study objective was major adverse cardiac events (MACE), defined as all-cause mortality, target vessel revascularisation (TVR) and myocardial infarction (MI) at two years. In total, 186 patients were included: 93 (50.0%) treated with first vs. 93 (50.0%) with new-generation DES. No differences were observed in baseline clinical characteristics except for higher EuroSCORE with new-generation DES (3.6±2.5 vs. 4.6±2.7; p=0.007). No significant difference was observed in stenting techniques; two stents were used respectively in 53.8% vs. 44.1% (p=0.187). Notably, intravascular ultrasound guidance was more frequent with new-generation DES (46.2% vs. 61.3%; p=0.040). At 730.0 (interquartile range 365.5-1,224.5) days, there was a trend towards improved MACE with new-generation DES (31.2% vs. 19.6%; p=0.070) and a significant reduction in TVR (23.7% vs. 12.0%; p=0.038) and MI (4.3% vs. 0%; p=0.044). Notably, there were four cases of definite stent thrombosis (ST) with first vs. none with new-generation DES (p=0.044). CONCLUSIONS In our study, new-generation DES had a trend for less MACE and improved results with regard to MI, TVR and definite ST at two-year follow-up.

Usefulness of baseline activated clotting time-guided heparin administration in reducing bleeding events during transfemoral transcatheter aortic valve implantation.

OBJECTIVES This study sought to evaluate the impact of baseline activated clotting time (ACT)-guided heparin administration on major bleeding after transfemoral transcatheter aortic valve implantation (TAVI). BACKGROUND Bleeding after TAVI is frequent and associated with unfavorable prognosis. Proper intraprocedural heparin dose administration may reduce the risk of potential overdosing in this frail study group. METHODS Of the patients who underwent transfemoral TAVI in our center from November 1, 2007 to June 31, 2012, 362 were retrospectively analyzed. Because abnormally high baseline ACT values were noted, heparin was administered at the operators discretion, according to baseline ACT (ACT-guided, n = 174) or patients body weight (non-ACT-guided, n = 188). The primary study objective was 30-day major bleeding as defined by the Valve Academic Research Consortium criteria. Secondary objectives were any life-threatening, and minor bleeding, and other Valve Academic Research Consortium outcomes at 30 days. RESULTS Bleeding occurred in 167 (46.1%) patients; of these, 76 (21.0%) had major bleeding. The ACT-guided group had a significantly lower occurrence of major (7.5% vs. 33.5%, p < 0.001), life-threatening (12.1% vs. 20.2%, p = 0.04), and any bleeding (25.9% vs. 64.9%, p < 0.001). Conversely, no differences were noted in the other study objectives. After adjustment for potential confounders, the protective odds ratio for ACT-guided therapy on major bleeding was 6.4 (95% confidence interval: 2.3 to 17.9; p < 0.001) at 30 days. CONCLUSIONS In our experience, heparin administration according to baseline ACT was correlated with a significantly lower occurrence of major bleeding in transfemoral TAVI. This strategy might be a useful tool in reducing bleeding in this high-risk study group.

Comparison of abluminal biodegradable polymer biolimus-eluting stents and durable polymer everolimus-eluting stents in the treatment of coronary bifurcations.

To compare biodegradable polymer biolimus‐eluting (BES) with abluminal drug elution and durable polymer everolimus‐eluting (EES) stents in the treatment of bifurcation lesions.

Focus on cardiac amyloidosis: a single-center experience with a long-term follow-up.

Aim Amyloidosis is a systemic disease, related to different underlying causes, with frequent cardiac involvement. Clinical evaluation, echocardiography and electrocardiography represent important noninvasive tools in identification of cardiac involvement. The aim of this study was to assess the clinical–laboratory features of a series of patients affected by cardiac amyloidosis in order to evaluate the risk of cardiac mortality. Methods We evaluated 48 patients (men 65%, mean age 63 ± 11 years) with biopsy-proven diagnosis of amyloidosis and heart involvement observed from 1991 to 2009. All patients underwent clinical–laboratory evaluation at baseline and were followed up. Results During a median follow-up of 9.5 months (first to third interquartile: 3–41.5 months), 24 patients (50%) died as a result of a cardiac cause. Survival free from cardiac death was 69, 50, 48 and 41% at 6, 12, 24 and 60 months from diagnosis, respectively. At multivariable Cox regression analysis, the presence of heart failure at enrolment [hazard ratio (HR) 4.67, 95% confidence interval (CI) 1.07–20.27, P = 0.04] and history of recent syncope (HR 3.97, 95% CI 1.28–12.34, P = 0.017) emerged as independent predictors of cardiac death. By using the equation derived from the multivariate analysis, individual survival probability at different times of follow-up was calculated. Conclusion We confirm the particularly poor outcome of cardiac amyloidosis in the short term. A careful clinical evaluation emerges as the most important tool for the prognostic stratification and quantification of risk in patients with cardiac amyloidosis.

The coronary sinus reducer: clinical evidence and technical aspects

ABSTRACT Introduction: Chronic refractory angina is often a disabling condition, predominantly due to severe obstructive coronary artery disease, that is inadequately controlled by optimal medical therapy and not amenable to further percutaneous or surgical revascularization. mortality rates associated with this condition are relatively low in clinically stable patients. however, it is associated with a high hospitalization rate and a reduction in both exercise capacity and quality of life. due to the paucity of available treatment options, there is an unmet need for new therapies for these patients and for a reduction in the associated economic healthcare burden. Areas covered: This review is focusing on the clinical evidence and technical aspects of this new therapeutic modality in refractory angina patients unsuitable for revascularization. Expert commentary: The Coronary Sinus Reducer (Neovasc Inc. Richmond B.C., Canada) is a new percutaneous device designed to achieve a controlled narrowing of the coronary sinus that may alleviate myocardial ischemia, possibly by redistributing blood from the less ischemic sub-epicardium to the more ischemic sub-endocardium, or by neoangiogenesis. Recently, a randomized, double-blind, multi-center clinical trial demonstrated a benefit in improving symptoms in 104 refractory angina patients, when compared to placebo.