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The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited.The aim of this multinational registry is to present a real-world overview of TMVR use in Europe.The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data.A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation).This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms.

Objectives The aim of this study was to compare the acute performance of the PLLA ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) with second-generation metal drug-eluting stents (DES) in complex coronary artery lesions. Background Thick polymer-based BVS have different mechanical properties than thin second-generation DES. Data on the acute performance of BVS are limited to simple coronary lesions treated in trials with strict inclusion criteria. Methods Fifty complex coronary lesions (all type American College of Cardiology/American Heart Association B2-C) treated with a BVS undergoing a final optical coherence tomography (OCT) examination were compared with an equal number of matched lesions treated with second-generation DES. The following stent performance indexes were assessed with OCT: mean and minimal area, residual area stenosis (RAS), incomplete strut apposition (ISA), tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. Results One hundred lesions from 73 patients were analyzed. A higher balloon diameter/reference vessel diameter ratio was used for predilation in the BVS group (p < 0.01). Most of the BVS and DES were post-dilated with short noncompliant (NC) balloons of similar diameter. OCT showed in the BVS group a higher tissue prolapse area (p = 0.08) and greater incidence of ISA at the proximal edge (p = 0.04) with no difference in the overall ISA. The RAS was 20.2% in the BVS group and 21.7% in the DES group (p = 0.32). There was no difference in the eccentricity index. The minimal and mean lumen areas were similar in the 2 groups. Two cases of strut fractures occurred after the BVS, whereas none was observed in the DES. Conclusions Based on OCT, the BVS showed similar post-procedure area stenosis, minimal lumen area, and eccentricity index as second-generation DES. The different approach for lesion preparation and routine use of OCT guidance during BVS expansion may have contributed to these results. © 2014 by the American College of Cardiology Foundation.

AIMS Our aim was to assess one-year outcomes of patients enrolled in the pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation (TAVI). METHODS AND RESULTS One-year outcomes of 4,571 patients (81.4±7.2 years, 2,291 [50.1%] male) receiving TAVI with the SAPIEN XT (57.3%) or CoreValve prosthesis at 137 European centres were analysed using Kaplan-Meier and Cox proportional hazards regression techniques. At one year, 3,341 patients were alive, 821 had died, and 409 were lost to follow-up. Of 2,125 patients who underwent functional assessment, 1,916 (90%) were in New York Heart Association (NYHA) Class I/II at one year, with functional improvement from baseline noted in 1,682 patients (88%). One-year survival based on 4,564 patients was estimated at 79.1%. Independent baseline predictors of mortality were increasing age and logistic EuroSCORE, the presence of NYHA III/IV, chronic obstructive pulmonary disease, and atrial fibrillation. Female gender was associated with a 4% survival benefit at one year. Vascular access routes other than transfemoral were associated with poorer survival. Procedural failure and major periprocedural complications had an adverse impact on survival. CONCLUSIONS Contemporary European experience attests to the effectiveness of routine TAVI in unselected elderly patients.

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Objectives: To assess safety and effectiveness of balloon aortic valvuloplasty (BAV) in patients with symptomatic severe aortic stenosis (AS) and significant aortic regurgitation. Background: BAV is a palliative procedure that has possibly been underused in patients with symptomatic AS not suitable for surgical aortic valve replacement or transcatheter aortic valve implantation. Significant aortic regurgitation is commonly perceived as a contraindication to BAV. Methods: Among 416 consecutive patients undergoing BAV at our Institution, 73 patients showed moderate or severe AR before the procedure. Demographics and baseline characteristics, as well as in-hospital clinical outcome, have been prospectively collected in a dedicated database. Transthoracic echocardiography was regularly performed in all patients undergoing BAV before the procedure and at hospital discharge. Results: Patients had a high-risk profile, confirmed by advanced age (77.2 ± 11.8 years) and important comorbidity (logistic Euroscore 26.5 ± 16.3%). Advanced heart failure was present in 73.9%. Indication to BAV was cardiogenic shock in 9.6%, palliation in 31.5%, bridge in 58.9% of the patients. BAV was performed with standard retrograde approach. Aortic valve area increased from 0.62 ± 0.15 cm2 at baseline to 0.83 ± 0.17 cm2 before discharge (P < 0.001). The degree of AR was improved or unchanged in 65 patients (89%). In-hospital mortality was 6.9%, mainly limited to terminal patients. Symptomatic status at discharge was improved in all surviving patients. Acute AR occurred in seven patients; in five of them it was successfully resolved in the catheterization laboratory. Conclusions: When clinically indicated, BAV can be safely performed in patients with combined aortic stenosis and significant aortic regurgitation. © 2011 Wiley Periodicals, Inc.

Aims Many inoperable patients with severe aortic stenosis (AS) are not immediately eligible for transcatheter aortic valve implantation (TAVI). We evaluated the role of percutaneous balloon aortic valvuloplasty (BAV) in this setting. Methods and results Among 210 consecutive patients referred to our institution for BAV, we identified three groups: immediately eligible for TAVI (n=65, 31%), excluded from TAVI (n=67, 32%), BAV as a bridge to TAVI (n=78, 37%). This last group comprised patients with low left ventricular ejection fraction, frailty or enfeebled status, symptoms of uncertain origin, critical conditions, moderate-to-severe mitral valve regurgitation, need of major non-cardiac surgery. Outpatient clinic visit and echocardiography were performed around one month after BAV to decide the final therapeutic strategy. Mean age was 81±8 years and the vast majority of patients had comorbidities and high-risk features. The incidence of periprocedural adverse events was 6.4%: 5.1% death (four patients: one procedural complication, three, natural disease progression), 1.3% minor stroke. After BAV, 46% of these patients were deemed eligible for TAVI, and 28% for cardiac surgery. Patients who underwent TAVI after bridge BAV showed 94% 30-day survival. Conclusions BAV is a safe and effective tool to bridge selected patients to TAVI when indications are not obvious.

Objective We sought to assess what proportion of patients with severe symptomatic aortic stenosis who are excluded from cardiac surgery are eligible for transcatheter aortic valve implantation (TAVI). Methods Between July 2007 and December 2008, 98 patients with severe symptomatic aortic stenosis judged inoperable were referred to our institution for percutaneous aortic balloon valvuloplasty (PABV). They entered a screening for TAVI with the CoreValve Revalving System or the Edwards-Sapien valve, comprising general clinical evaluation, echocardiogram, coronary angiography, angiography and angio-CT scan of thoracic aorta and ilio-femoral axes. Results Mean patients' age was 82 +/- 7 years; the vast majority presented relevant comorbidities. Mortality risk predicted by the logistic European System for Cardiac Operative Risk Evaluation was on average 25.3 +/- 14.5%. Overall, 45 (45.9%) patients met the criteria for TAVI: 29.6% for percutaneous transfemoral access, 6.1% for trans-subclavian and 10.2% for transapical approaches. Reason for exclusion was severe noncardiac comorbidity in around half of the cases. PABV allowed re-classification of several patients with very poor left ejection fraction and severe mitral regurgitation. Among the 39 patients undergoing TAVI after the screening, in-hospital mortality was 3.7% for transfemoral and 0 for trans-subclavian and transapical approaches. Conclusions TAVI represents a viable therapeutic option for elderly patients with severe symptomatic aortic stenosis who are not candidates for surgical aortic valve replacement. However, presently less than half of them actually fulfil the criteria for these procedures.

Aims To evaluate the clinical impact of early administration of glycoprotein IIb/IIIa agents (IIb/IIIa agents) in the context of a dedicated hub and spoke network allowing very prompt pharmacological/mechanical interventions. Methods and results Using a prospective database, we conducted a cohort study of ST-elevation myocardial infarction (STEMI) patients ( n = 1124) undergoing primary percutaneous coronary interventions (PPCIs) and IIb/IIIa agents administration (period, 2003–2006). Comparisons were planned between patients receiving early IIb/IIIa agents administration (in hub/spoke centre emergency departments or during ambulance transfer; early group, n = 380) or delayed administration (in the catheterization laboratory; late group, n = 744). The primary outcome measure was long-term overall mortality/re-infarction. Baseline characteristics of the two groups were largely comparable. Angiographically, early group patients more often achieved pre-PPCI TIMI Grade 2–3 and TIMI Grade 3 flow. Clinically, the early administration group experienced lower 2-year risk of unadjusted mortality/re-infarction (17 vs. 23%; P = 0.01). After adjustment for potential confounders, early administration was associated with favourable outcome in the overall population (HR = 0.71, P = 0.03) and in high-risk subgroups (TIMI risk index >25, HR = 0.64, P = 0.02; Killip class >1, HR = 0.54, P = 0.01). Conclusion In patients treated by PPCI within a STEMI network setting, early administration of IIb/IIIa agents may provide long-term clinical benefits. Notably, these results appeared magnified in high-risk patients.

OBJECTIVE: To evaluate strut coverage after biolimus-A9 eluting stent (BES) implantation for unprotected left main artery (ULMA) stenosis during follow-up and identify features associated with the length of uncovered stent segment, as assessed by frequency domain-optical coherence tomography (FD-OCT). BACKGROUND: Incomplete stent strut coverage is a risk factor for late stent thrombosis. Long-term interaction between vessel wall and BES in the context of ULMA stenting has not been investigated in depth. METHODS: We prospectively enrolled 32 patients with ULMA stenosis treated with BES. FD-OCT was performed at 9-month follow-up. Both malapposed and uncovered segment length were indexed for the segment between the distal and proximal cross-sections in which stent struts were circumferentially visible. Patients were divided into two groups according to the median value of maximal indexed uncovered segment length. Study endpoints were the rate of strut coverage and predictors of high uncovered segment length. RESULTS: We analyzed 3622 struts. The rate of covered struts was 87%. A high correlation was found between malapposed and uncovered segment length (r ≤ 0.82; P

Background: There is great variability for the type of anaesthesia used during TAVI, with no clear consensus coming from comparative studies or guidelines. We sought to detect regional differences in the anaesthetic management of patients undergoing transcatheter aortic valve implantation (TAVI) in Europe and to evaluate the relationship between type of anaesthesia and in-hospital and 1 year outcome. Methods: Between January 2011 and May 2012 the Sentinel European TAVI Pilot Registry enrolled 2807 patients treated via a transfemoral approach using either local (LA-group, 1095 patients, 39%) or general anaesthesia (GA-group, 1712 patients, 61%). Results: A wide variation in LA use was evident amongst the 10 participating countries. The use of LA has increased over time (from a mean of 37.5% of procedures in the first year, to 57% in last 6 months, p < 0.01). MI, major stroke aswell as in-hospital death rate (7.0% LAvs 5.3% GA, p = 0.053) had a similar incidence between groups, confirmed in multivariate regression analysis after adjusting for confounders. Dividing our population in tertiles according to the Log-EuroSCORE we found similar mortality under LA, whilst mortality was higher in the highest risk tertile under GA. Survival at 1 year, compared by Kaplan-Meier analysis, was similar between groups (log-rank: p = 0.1505). Conclusions: Selection of anaesthesia appears to be more influenced by national practice and operator preference than patient characteristics. In the absence of an observed difference in outcomes for either approach, there is no compelling argument to suggest that operators and centres should change their anaesthetic practice. (C) 2014 Elsevier Ireland Ltd. All rights reserved.

Several prospective studies have shown that high on-clopidogrel platelet reactivity (HPR) in patients undergoing percutaneous coronary intervention (PCI) is a risk factor for ischemic events. All studies were insufficiently powered to detect differences in stroke between patients with HPR and those without. Therefore, we performed a systematic review and meta-analysis of available publications aimed at determining whether patients undergoing PCI with HPR are also at increased risk of stroke. We searched for prospective studies enrolling patients undergoing PCI and treated with aspirin and clopidogrel that reported on clinical relevance of HPR to adenosine diphosphate. Study end point was the rate of stroke. We also investigated whether there was an interaction on the relative risk of stroke between HPR, clinical presentation, duration of follow-up, or laboratory methods. Fourteen studies including 11,959 patients were deemed eligible. On pooled analysis, the risk of stroke was higher in patients with HPR compared with patients with no HPR (1.2% vs 0.7%, relative risk on fixed effect 1.84, 95% confidence interval 1.21 to 2.80). There was no heterogeneity among the studies (I2 = 0%, p = 0.5). Clinical presentation (p = 0.39 for interaction), duration of follow-up (p = 0.87 for interaction), and laboratory method for detection of HPR (p = 0.99 for interaction) did not affect the relative increase in the risk of stroke in patients with HPR compared with patients with no HPR. In conclusion, in patients with coronary artery disease undergoing PCI, the presence of HPR to adenosine diphosphate is a risk factor for stroke. © 2014 Elsevier Inc. All rights reserved.

AIMS: Non-ST segment elevation acute coronary syndrome (NSTE-ACS) is a heterogeneous syndrome in terms of patho-physiological mechanisms and prognosis. We sought to investigate the clinical features associated with complicated athero-thrombotic (CAT) coronary lesions and their prognostic relevance in NSTE-ACS. METHODS: We enrolled 701 consecutive NSTE-ACS patients without previous coronary bypass undergoing coronary angiography. The study population was divided into two groups according to the presence/absence of angiographic signs of endoluminal thrombi and/or plaque rupture, defined as CAT lesions. Multivariable analyses were used to identify predictors of CAT lesions. Their relation to composite endpoint of death, re-myocardial infarction, and re-unstable angina was investigated with the use of multivariable logistic regression. RESULTS: Patients with CAT lesions (n = 279, 40%) had a higher incidence of the combined endpoint (11.5 vs. 4.3%; P

Background: Limited data exist on renal complications of transcatheter aortic valve implantation (TAVI)within a comprehensive program using different valves with transfemoral, transapical, and trans-subclavian approach. Methods: Prospective single-center registry of 102 consecutive patients undergoing TAVI using both approved bioprostheses and different access routes. The main objective was to assess the incidence, predictors and the clinical impact of acute kidney injury (AKI). AKI was defined according to the valve academic research consortium (VARC) indications. Results: Mean age was 83.7±5.3 years, logistic EuroSCORE 22.6±12.4%, and STS score 8.2±4.1%. Chronic kidney disease at baseline was present in 87.3%. Periprocedural AKI developed in 42 patients (41.7%): 32.4% stage 1, 4.9% stage 2 and 3.9% stage 3. The incidence of AKI was 66.7% in transapical, 30.3% in transfemoral, and 50% in trans-subclavian procedures. The only independent predictor of AKI was transapical access, with a hazard ratio (HR) between 4.57 and 5.18 based on the model used. Cumulative 1-year survival was 88.2%. At Cox regression analysis, the only independent predictor of 30-day mortality was diabetes mellitus (HR 7.05, 95% CI 1.07-46.32; p=0.042), whilst the independent predictors of 1-year death were baseline glomerular filtration rateb30 mL/min (HR 5.74, 95% CI 1.42-23.26; p=0.014) and post-procedural AKI 3 (HR 8.59, 95% CI 1.61-45.86, p=0.012). Conclusions: TAVI is associated with a high incidence of AKI. Although in the majority of the cases AKI is of mild entity and reversible, AKI 3 holds a strong negative impact on 1-year survival. The incidence of AKI is higher with transapical access.