Michela Facchin

Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve.

AIMS Early data on the Edwards SAPIEN 3 valve (S3-THV) have shown low rates of paravalvular leaks and vascular complications but relatively high 30-day permanent pacemaker implantation (PPMI) rates. No direct comparisons on clinical outcomes including PPMI rates are available for the S3-THV and the Edwards SAPIEN XT (XT-THV). We aimed to compare the 30-day PPMI rates in patients treated with the two prostheses and to assess the interplay among valve type, depth of implantation and PPMI rate. METHODS AND RESULTS Two hundred and nine patients treated by TAVI were considered. The S3-THV was associated with higher PPMI rates compared to the XT-THV, both overall and in subgroups matched for several predictors of PPMI. However, in the S3-THV group, 30-day PPMI was strictly associated with deep valve implantation, and PPMI risk of high-implanted S3-THVs was similar to that of the overall XT-THV matched group. No cases of significant paravalvular leak were observed in the S3-THV group. CONCLUSIONS The S3-THV was associated with a higher incidence of PPMI compared to the XT-THV. In the S3-THV group, pacemaker implantation was strictly associated with deep valve implantation. An implantation technique involving higher initial placement of the central marker (from 0 to 3 mm above the base of the aortic cusps) and, as a consequence, higher final valve depth might help in preventing post-TAVI PPMI with the S3-THV, without affecting the risk of paravalvular leak.

Outcomes in Patients With Transcatheter Aortic Valve Replacement and Left Main Stenting : The TAVR-LM Registry

BACKGROUND A percutaneous approach with transcatheter aortic valve replacement (TAVR) and percutaneous coronary intervention (PCI) of the left main coronary artery (LM) is frequently used in high-risk patients with coexisting aortic stenosis and LM disease. Outcomes of TAVR plus LM PCI have not been previously reported. OBJECTIVES The primary objective of the TAVR-LM registry is to evaluate clinical outcomes in patients undergoing TAVR plus LM PCI. METHODS Clinical, echocardiographic, computed tomographic, and angiographic characteristics were retrospectively collected in 204 patients undergoing TAVR plus LM PCI. In total, 128 matched patient pairs were generated by performing 1:1 case-control matching between 167 patients with pre-existing LM stents undergoing TAVR and 1,188 control patients undergoing TAVR without LM revascularization. RESULTS One-year mortality (9.4% vs. 10.2%, p = 0.83) was similar between the TAVR plus LM PCI cohort and matched controls. One-year mortality after TAVR plus LM PCI was not different in patients with unprotected compared with protected LMs (7.8% vs. 8.1%, p = 0.88), those undergoing LM PCI within 3 months compared with those with LM PCI greater than 3 months before TAVR (7.4% vs. 8.6%, p = 0.61), and those with ostial versus nonostial LM stents (10.3% vs. 15.6%, p = 0.20). Unplanned LM PCI performed because of TAVR-related coronary complication, compared with planned LM PCI performed for pre-existing LM disease, resulted in increased 30-day (15.8% vs. 3.4%, p = 0.013) and 1-year (21.1% vs. 8.0%, p = 0.071) mortality. CONCLUSIONS Despite the anatomic proximity of the aortic annulus to the LM, TAVR plus LM PCI is safe and technically feasible, with short- and intermediate-term clinical outcomes comparable with those in patients undergoing TAVR alone. These results suggest that TAVR plus LM PCI is a reasonable option for patients who are at high risk for surgery.

Causes and timing of death during long-term follow-up after transcatheter aortic valve replacement.

BACKGROUND Transcatheter aortic valve replacement (TAVR) is an effective therapeutic option for patients with severe aortic stenosis at high risk for surgery. Identification of causes of death after TAVR may help improve patient selection and outcome. METHODS We enrolled 874 consecutive patients who underwent TAVR at 3 centers using all approved bioprostheses and different access routes. Clinical outcomes during follow-up were defined according to the Valve Academic Research Consortium 2 definitions. Causes of deaths were carefully investigated. RESULTS Mean logistic European System for Cardiac Operative Risk Evaluation was 23.5% ± 15.3%; Society of Thoracic Surgery score, 9.0% ± 8.2%. The Corevalve (Medtronic, Minneapolis, MN) was used in 41.3%; the Edwards Sapien (Edwards Lifesciences Inc., Irvine, CA) in 57.3%. Vascular access was transfemoral in 75.7%. In-hospital mortality was 5.0%. Cumulative mortality rates at 1 to 3 years were 12.4%, 23.4%, and 31.5%, respectively. Landmark analysis showed a significantly higher incidence of cardiovascular (CV) death in the first 6 months of follow-up and a significantly higher incidence of non-CV death thereafter. At Cox regression analysis, the independent predictors of in-hospital mortality were acute kidney injury grades 2 to 3 (hazard ratio [HR] 3.41) life-threatening bleeding (HR 4.26), major bleeding (HR 4.61), and myocardial infarction (HR 3.89). The independent predictors of postdischarge mortality were chronic obstructive pulmonary disease (HR 1.48), left ventricular ejection fraction at discharge (HR 0.98), and glomerular filtration rate <30 mL/min per 1.73 m(2) (HR 1.64). CONCLUSIONS Around a third of patients treated with TAVR in daily practice die within the first 3 years of follow-up. Early mortality is predominantly CV, whereas late mortality is mainly non-CV, and it is often due to preexisting comorbidity.

Paclitaxel versus sirolimus eluting stents in diabetic patients: Does stent type and/or stent diameter matter?: Long-term clinical outcome of 2,429-patient multicenter registry†

Drug‐eluting stents (DES) are more effective in reducing restenosis than bare‐metal stents. Less certain is the relative performance of the two widely used DES—sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES)—in diabetic patients undergoing percutaneous coronary intervention (PCI).

Intermediate Clinical and Hemodynamic Outcomes After Transcatheter Aortic Valve Implantation

BACKGROUND Concerns still exist regarding long-term results and freedom from valve-related adverse events in transcatheter aortic valve implantation (TAVI). The aim of this single-center retrospective study was to assess intermediate-term (up to 5-year) clinical and hemodynamic outcomes in patients undergoing TAVI. METHODS From 2007 through 2013, 338 consecutive patients underwent TAVI at our institution. Preoperative variables were defined according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) definitions, and outcomes were reported according to the Valve Academic Research Consortium (VARC)-2 definitions. Multivariate logistic regression analysis was performed to identify independent predictors of mortality at follow-up. RESULTS transfemoral (TF) and transapical (TA) TAVI were performed in 233 (69%) and 105 (31%) patients, respectively. All-cause 30-day mortality was 4.4%, with no differences between TA and TF procedures. Thirty-day cardiovascular death, stroke, and myocardial infarction were not different between groups. The acute kidney injury (AKI) rate was higher in the TA group (30.5% versus 11.2%; p < 0.001). Access-related complications were more frequent in the TF group (36.1% versus 11.4%; p < 0.001). Mean follow-up was 22.3 ± 17.8 months (range, 1-74 months). Overall survival rates at 1, 3, and 5 years were 85.5% ± 2.1%, 69.9% ± 3.2%, and 61% ± 4.3%, respectively. Independent predictors of all-cause mortality at follow-up were previous myocardial infarction (odds ratio [OR], 2.7), any grade of paravalvular leak (PVL) (OR, 2.5), and AKI (OR, 3.1). Mean gradient and effective orifice area at follow-up were 10.7 ± 12.0 mm Hg and 1.1 ± 0.9 cm(2)/m(2), respectively. CONCLUSIONS Our data show that TAVI has good early and intermediate-term clinical and hemodynamic outcomes in high-risk or inoperable patients with severe symptomatic aortic valve stenosis. PVL of any grade has a significant impact on survival.

Gender-related differences of diabetic patients undergoing percutaneous coronary intervention with drug-eluting stents: a real-life multicenter experience.

BACKGROUND Gender-based differences in diabetic patients are understudied in the field of percutaneous coronary intervention (PCI) with drug-eluting stents. METHODS Data were obtained from a multicenter registry of 2420 consecutive patients with diabetes mellitus (DM) who underwent PCI with paclitaxel- or sirolimus-eluting stents between 2003 and 2009. Among them, 679 (28.1%) women were compared to 1741 (71.9%) men in terms of clinical aspects and major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR). Target vessel revascularization (TVR) and any revascularization were also reported. RESULTS Women were less numerous, older, used more insulin and showed more tortuous coronary arteries, while men were more frequently smokers and received larger stents. At the median follow-up of 24.3 months (interquartile range 12.3-39.7), MACE, TVR and any revascularization did not significantly differ between females and males (19.9% vs 18.7%, 12.2% vs 13.4%, 14.1% vs 15.1%, respectively). At multivariable analysis of the overall cohort, female gender was not a predictor of MACE (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.92-2.36, p=0.11), death (HR 1.04, 95% CI 0.84-1.24, p=0.86), MI (HR 1.48, 95% CI 0.92-2.36, p=0.11), and TLR (HR 1.14, 95% CI 0.85-1.52, p=0.38). CONCLUSION In this registry of diabetic patients treated by drug-eluting stents, women were less represented, older and needed more insulin compared to men who, on the other hand, received larger stents. Gender-related outcomes were similar and female sex did not predict MACE.

Paclitaxel- and sirolimus-eluting stents in older patients with diabetes mellitus: results of a real-life multicenter registry.

Older patients and diabetes mellitus (DM) are rapidly increasing in Western world populations. The treatment of coronary artery disease in these patients is challenging because they are complex and at high risk. Performance of the two widely used drug‐eluting stents (DES), i.e. sirolimus‐ (SES) and paclitaxel‐eluting stent (PES), is understudied in this subset.

Comparison of Impact of Mortality Risk on the Survival Benefit of Primary Percutaneous Coronary Intervention Versus Facilitated Percutaneous Coronary Intervention

Available data suggest that thrombolytic therapy facilitated percutaneous coronary intervention (FPCI) is not beneficial, and recent analyses have shown a correlation between mortality risk and outcomes of patients with ST elevation myocardial infarctions treated with FPCI. The aim of this study was to analyze the impact of the mortality risk on the survival benefit of primary percutaneous coronary intervention (PPCI) compared to FPCI. A total of 13 trials enrolling 5,789 patients were pooled for analyses. PPCI survival benefit was calculated as the 30-day mortality after FPCI minus the 30-day mortality after PPCI, and the mortality rate of FPCI was interpreted as a proxy for mortality risk. A weighted metaregression was used to test the relation between mortality risk and explanatory variables. A fixed-effect linear regression analysis modeling the log odds ratio (PPCI/FPCI) as a linear function of the log odds of FPCI mortality was used to estimate the mortality risk that nullified the 30-day survival benefit of PPCI over FPCI. Across all studies, the absolute survival benefit ranged from -5.6 (favoring FPCI) to +7.2 (favoring PPCI). According to the slope of the regression line (-0.7, x-axis intercept -2.1) for the patients with baseline mortality risk > 4.2%, it is unlikely to obtain a survival benefit by FPCI compared to PPCI. In conclusion, the higher the mortality risk of patients with ST elevation myocardial infarctions, the higher the likelihood of a survival advantage of PPCI over FPCI.

Coronary vasospasm complicated by ventricular fibrillation: arrhythmogenic morphological substrates detected in vivo by cardiac magnetic resonance.

© 2017 Italian Federation of C The prognosis of vasospastic angina (VSA) is generally favorable when treated with calcium channel blockers, with or without nitrates. However, VSA may trigger lethal ventricular arrhythmias leading to cardiopulmonary arrest. Furthermore, patients with symptoms despite optimal medical therapy should be considered for implantable cardioverter defibrillator (ICD) implantation. To note, the arrhythmogenic mechanisms underlying ventricular tachycardia or ventricular fibrillation related to VSA still remain to be elucidated in vivo,

Subclinical Atherosclerosis and Primary Prevention

During the past four decades, there has been a dramatic decline in the age-adjusted rate of death from cardiac disease in the United States and many other developed countries [1, 2, 3]. This reduction is attributed in large part to primary and secondary prevention strategies that target modifiable risk factors [2, 4]. Despite these advances, cardiovascular disease remains the leading cause of death in developed countries as well as in most developing countries, [1, 3, 5] and there is concern that the growing prevalence of obesity and type 2 diabetes will reverse the gains of the past 40 years. Therefore, prevention of atherosclerotic cardiovascular events (myocardial infarction, sudden death, and stroke) remains a major imperative for health care professionals. The process of atherosclerosis, now considered to be a chronic immunoinflammatory disease of medium- and large-sized arteries, often begins in childhood and adolescence and frequently remains clinically dormant until plaque rupture or plaque erosion leads to abrupt thrombosis triggering acute clinical events [6].