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Objectives: The aims of this study were to assess the epidemiology of atrial fibrillation (AF) in patients treated with transcatheter aortic valve replacement (TAVR) and included in the large prospective SOURCE XT (SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) study and to evaluate their outcomes according to the presence of pre-existing or new-onset AF (NOAF) (defined as AF occurring within 30 days after TAVR)., Background: Data on the epidemiology and clinical impact of AF in patients undergoing TAVR are scant and limited to small retrospective studies., Methods: The SOURCE XT study is a multicenter, prospective registry of consecutive patients treated with the SAPIEN XT valve at 99 sites in 17 countries. Follow-up was scheduled at discharge, 1 month, 1 year, and yearly thereafter. Patients (n = 2,706) were categorized according to the presence of pre-existing or NOAF., Results: The prevalence of pre-existing AF was 35.6%, whereas NOAF occurred in 7.2% of patients. Both pre-existing AF and NOAF correlated with worse clinical outcomes compared with patients in sinus rhythm, including all-cause death, cardiac death, and bleeding events. NOAF was associated with higher rates of stroke at 2 years compared with sinus rhythm. Independent predictors of NOAF were age (hazard ratio: 1.1), New York Heart Association class III or IV (hazard ratio: 1.9), nontransfemoral access route (hazard ratio: 3), and balloon post-dilation (odds ratio: 1.6). No interaction was observed between any degree of post-implantation paravalvular leak and NOAF., Conclusions: In the large dataset of the SOURCE XT registry, the presence of either pre-existing or NOAF increased all-cause and cardiac mortality and bleeding events. NOAF was associated with increased stroke rates at long-term follow-up., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: There is limited evidence to support decision making on antiplatelet therapy following transcatheter aortic valve implantation (TAVI). Our aim was to assess the efficacy and safety of aspirin-only (ASA) versus dual antiplatelet therapy (DAPT) following TAVI., Methods: We performed a systematic review and pooled analysis of individual patient data from 672 participants comparing single versus DAPT following TAVI. Primary endpoint was defined as the composite of net adverse clinical and cerebral events (NACE) at 1 month, including all-cause mortality, acute coronary syndrome (ACS), stroke, life-threatening and major bleeding., Results: At 30 days a NACE rate of 13% was observed in the ASA-only and in 15% of the DAPT group (OR 0.83, 95% CI 0.48 to 1.43, p=0.50). A tendency towards less life-threatening and major bleeding was observed in patients treated with ASA (OR 0.56, 95% CI 0.28 to 1.11, p=0.09). Also, ASA was not associated with an increased all-cause mortality (OR 0.91, 95% CI 0.36 to 2.27, p=0.83), ACS (OR 0.5, 95% CI 0.05 to 5.51, p=0.57) or stroke (OR 1.21; 95% CI 0.36 to 4.03, p=0.75)., Conclusions: No difference in 30-day NACE rate was observed between ASA-only or DAPT following TAVI. Moreover, a trend towards less life-threatening and major bleeding was observed in favour of ASA. Consequently the additive value of clopidogrel warrants further investigation., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objectives: The SOURCE XT Registry (Edwards SAPIEN XT Aortic Bioprosthesis Multi-Region Outcome Registry) assessed the use and clinical outcomes with the SAPIEN XT (Edwards Lifesciences, Irvine, California) valve in the real-world setting., Background: Transcatheter aortic valve replacement is an established treatment for high-risk/inoperable patients with severe aortic stenosis. The SAPIEN XT is a balloon-expandable valve with enhanced features allowing delivery via a lower profile sheath., Methods: The SOURCE XT Registry is a prospective, multicenter, post-approval study. Data from 2,688 patients at 99 sites were analyzed. The main outcome measures were all-cause mortality, stroke, major vascular complications, bleeding, and pacemaker implantations at 30-days and 1 year post-procedure., Results: The mean age was 81.4 ± 6.6 years, 42.3% were male, and the mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 20.4 ± 12.4%. Patients had a high burden of coronary disease (44.2%), diabetes (29.4%), renal insufficiency (28.9%), atrial fibrillation (25.6%), and peripheral vascular disease (21.2%). Survival was 93.7% at 30 days and 80.6% at 1 year. At 30-day follow-up, the stroke rate was 3.6%, the rate of major vascular complications was 6.5%, the rate of life-threatening bleeding was 5.5%, the rate of new pacemakers was 9.5%, and the rate of moderate/severe paravalvular leak was 5.5%. Multivariable analysis identified nontransfemoral approach (hazard ratio [HR]: 1.84; p < 0.0001), renal insufficiency (HR: 1.53; p < 0.0001), liver disease (HR: 1.67; p = 0.0453), moderate/severe tricuspid regurgitation (HR: 1.47; p = 0.0019), porcelain aorta (HR: 1.47; p = 0.0352), and atrial fibrillation (HR: 1.41; p = 0.0014), with the highest HRs for 1-year mortality. Major vascular complications and major/life-threatening bleeding were the most frequently seen complications associated with a significant increase in 1-year mortality., Conclusions: The SOURCE XT Registry demonstrated appropriate use of the SAPIEN XT THV in the first year post-commercialization in Europe. The safety profile is sustained, and clinical benefits have been established in the real-world setting. (SOURCE XT Registry; NCT01238497)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Common clinical practice recommends dual antiplatelet therapy (DAPT) for transcatheter aortic valve implantation (TAVI). The aim of the study was to evaluate, in a double blind randomized study, the safety of TAVI, with adjunctive pharmacotherapy consisting of single antiplatelet therapy., Methods and Results: From April 2010 to April 2011, 120 consecutive patients, undergoing TAVI, have been enrolled in the study. Patients were randomly assigned to DAPT group (aspirin and clopidogrel 75 mg/qd or ticlopidine 500 mg/bid) or ASA group (aspirin only). TAVI device was the Sapien XT-Novaflex Delivery System (Edwards Lifesciences, Inc.). All patients were followed up to 6 months. Device success was achieved in 100% of patients. No difference in the VARC combined 30 day safety endpoint, all cause and cardiovascular mortality was observed. At 30 days vascular complications were reduced in the ASA group (p<0.05). No differences in the clinical status were detected between the groups up to 6 months., Conclusions: This study suggests that TAVI procedures can be performed without DAPT without increasing the morbidity and mortality. These findings, if confirmed in a larger multicenter randomized trial, will no longer support the use of DAPT for TAVI., (Copyright © 2014. Published by Elsevier Ireland Ltd.)

Objectives: Transapical (TA) aortic valve implantation using the Edwards SAPIEN bioprosthesis was commercially introduced in Europe in January 2008. Limited data on the mid-term results are available., Methods: Using data from the SOURCE-Registry (largest consecutive cohort treated using Edwards SAPIEN bioprosthesis in Europe), we report on the mid-term results (≥30 days-2 years) of TA patients., Results: Between November 2007 and December 2009, a total of 1387 patients from 38 European centres underwent TA aortic valve implantation. The mean follow-up is 14.9 months, with 1004 patients who completed 1 year and 464 patients who completed the 2-year follow-up. The mean age of patients was 80.6 ± 7.1 years with a logistic-EuroSCORE of 27.6%. The main co-morbidities were coronary artery disease (55.8%), previous bypass grafting (25.5%), porcelain aorta (10.2%), previous stroke (6.5%) and peripheral vascular disease (26.4%). A total of 840 patients (60.6%) received a 26 mm and 535 (38.6%) a 23 mm Edwards SAPIEN bioprosthesis. Survivals at 30 days, 1 year and 2 years were 88.7, 73.8 and 65.1%, respectively. Causes of the 276 deaths observed between >30 days and 2-year follow-up were cardiac in 86 patients (31.2%), non-cardiac in 142 (51.4%) and unknown in 48 (17.4%). Cardiac causes of death included heart failure (33.7%), sudden cardiac death (33.7%), myocardial infarct (8.1%), endocarditis (5.8%) and others (18.6%). Non-cardiac deaths were related to pulmonary disease (21.1%), cancer (12.7%), renal failure (11.3%), stroke (10.6%), gastrointestinal disease (7.7%) and others (36.6%). Using univariable and multivariable analyses, logistic EuroSCORE, renal insufficiency and liver diseases were identified as independent predictors of 2-year mortality., Conclusions: These results demonstrate that in elderly patients with severe co-morbidities, TA aortic valve implantation results in excellent mid-term results. Causes of death during the mid-term follow-up are mainly non-cardiac and related to co-morbidities.

Objective: The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) versus patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve stenosis., Methods: We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SU-AVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2 groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex, body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease, chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection fraction., Results: Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in the TA-TAVI and SU-AVR groups, respectively (P = .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%, P = 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the TA-TAVI group (P = 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P = .001), but there were no differences in terms of mean transprosthetic gradient (10.3 ± 5 mm Hg vs 11 ± 3.7 mm Hg, P = .59)., Conclusions: This preliminary experience showed that, in patients at high risk for conventional surgery, SU-AVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular leak., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: Redo cardiac surgery has an increased risk of morbidity and mortality when compared with the initial operation. The aim of this study was to assess the impact of previous cardiac operations on patients undergoing transapical aortic valve implantation (TA-TAVI)., Methods: We analysed data from 566 patients included in the Italian Registry of Transapical Aortic Valve Implantation who underwent TA-TAVI implantation with the Sapien valve (Edwards Lifesciences, Irvine, CA, USA) from April 2008 through May 2011. Of these, 110 patients (19.4%) had already undergone at least one previous cardiac operation with opening of the pericardium (group R) while for 456 patients (80.6%) TA-TAVI was the first cardiac procedure (group F). Data were prospectively collected at each of the 20 participating centres and then sent to a central database for storage and analysis., Results: Preoperative logistic EuroSCORE was higher in group R (35 ± 18.6 vs. 23.5 ± 11.9%; P < 0.001). Hospital mortality occurred in eight (7.2%) and 36 (7.9%) patients in groups R and F, respectively (P = 0.8). Mean follow-up was 10.4 ± 7.9 months (range: 1-34). Overall 2-year Kaplan-Meier survival was 64.2 ± 9.8 and 75.4 ± 3.5% in groups R and F, respectively (P = 0.69). Incidence of operative complications, postoperative bleeding, pacemaker implantation, myocardial infarction and stroke did not show statistically significant differences between groups. The univariate analysis showed that arterial hypertension, logistic EuroSCORE, porcelain aorta, left ventricular ejection fraction and previous percutaneous coronary interventions were significantly associated with 30-day mortality in group R., Conclusions: According to our data, patients undergoing TAVI with previous cardiac operations have a higher preoperative risk profile but have similar outcomes when compared with patients undergoing a first operation. In these subset of patients, TAVI is a promising therapeutic option.

Objective: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)., Methods: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, < 20 cases) and learning curve (first 50% cases vs second 50% cases of each center)., Results: All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm(2). These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P < .001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases., Conclusions: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival., (Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement., Methods and Results: The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P=0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality., Conclusion: The SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured.

Objective: Trans-apical aortic valve implantation (TA-AVI) has been shown to be a reproducible technique. Early results from the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry identified major access complications associated with high 30-day mortality. Using the SOURCE Registry, we analyze the learning curve for TA-AVI over the first 2 years after commercialization., Methods: The SOURCE Registry gathered data for 2 consecutive years at European centers following commercialization of the Edwards SAPIEN bioprosthesis, totaling 2339 patients (1038 in COHORT 1 and 1301 in COHORT 2). Only data from centers that provided all of their consecutively treated patients were included in this study. We compared the 30-day results of TA-AVI from COHORT 1 (C-1: January/2008-January/2009) with the 30-day results of COHORT 2 (C-2: February/2009-January/2010)., Results: This analysis is based on a total number of 575 TA-AVIs in C-1 and 819 TA-AVIs in C-2. Mean age (C-1: 80.7 years, C-2: 80.5 years) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (C-1: 29.1%, C-2 27.3%) were not significantly different. Valve malposition (C-1: 1.6%, C-2: 1.2%), valve migration/embolization (C-1: 0.5%, C-2: 1.0%), and major access complications (C-1: 2.1%, C-2: 1.8%) were in total less frequent, but not statistically significant lower in C-2. However, the reduction of aortic regurgitation >2+ immediately following the procedure (C-1: 4.52%, C-2: 2.1%, p=0.011) and conversion rate to open surgery (C-1: 3.7%, C-2: 1.5%, p=0.0315) reached statistical significance. Postoperative complications included dialysis (C-1: 7.0%, C-2: 5.7%, p=ns), pacemaker implantation (C-2: 7.7%, C-2: 6.7%, p=ns), stroke (C-1: 2.4%, C-2: 2.6%, p=ns), and myocardial infarct (C-1: 0.7%, C-2: 0.4%, p=ns). The total 30-day mortality was 10.8% and not significantly different between the two groups (C-1: 10.8%, C-2: 10.7%, p=ns)., Conclusions: Although the incidence of technical intra procedural complications has trended downward, reflecting the learning curve for TA-AVI, 30-day mortality was unchanged, likely due to patient co-morbidities not captured by preoperative risk variables., (Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.)

Aims: Transcatheter aortic valve implantation (TAVI) is becoming a safe and effective technique for treating symptomatic aortic valvular stenosis (AVS) as an alternative to surgery in very high-risk patients. A possible consequence of valve implantation is the obstruction of coronary ostia., Methods and Results: Here we report five cases of angiographically confirmed left main (LM) obstruction, occurred immediately after balloon expandable aortic valve implantations at our institution. In four of these cases, LM obstruction was resolved with an emergency percutaneous coronary intervention (PCI). In the remaining case, obstruction transiently occurred only at the time of balloon valvuloplasty and did not required treatment. During this type of intervention, performing an aortography at the time of balloon valvuloplasty could help to identify patients at risk for coronary obstructions., Conclusions: These cases illustrate that obstruction of the coronary ostia following TAVI is a possible complication. As the use of TAVI becomes widespread, the operators should be aware of this dangerous complication in their case preparation should it arise.

Transcatheter aortic valve replacement is an emerging therapeutic alternative for patients with severe aortic valve stenosis and high surgical risk. The inability to reposition the current prosthesis is a limiting feature of these devices. Here we report on a case of a 74-year-old woman, in which a balloon expandable aortic valve malpositioning was treated with a second transapical transcatheter aortic valve implant., (Copyright (c) 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Abstract: Objective: Trans-catheter aortic valve implantation is an alternative treatment option for patients facing high risk for aortic valve replacement. Currently, the results of trans-apical trans-catheter procedures performed outside controlled trials are unknown. Methods: The Edwards SAPIEN™ Aortic Bioprosthesis European Outcome (SOURCE) Registry collects data of patients treated at European centres during the first year following commercialisation of the Edwards SAPIEN™ bioprosthesis. Only data from centres that could provide 100% of their consecutively treated patients (n =32) were included in the study population. This article provides the 30-day outcome data involving the trans-apical patients, including univariate and multivariate risk analyses for postoperative 30-day mortality. Results: The interim results are based on a total number of 575 procedures performed between January 2008 and 31 January 2009. Mean age at implant was 80.7 years, and patients had a mean logistic EuroSCORE of 29.1%. Baseline characteristics included coronary artery disease 56%, prior coronary intervention 27.1%, prior coronary bypass grafting 26.9%, concomitant mitral valve disease 32.8%, porcelain aorta 11.5%, peripheral vascular disease 27.5%, prior stroke 6.3% and pulmonary disease 29.4%. Successful valve deployment was observed in 92.7% with a 3.5% conversion rate to open surgery, incidence of coronary obstruction of 0.7% and valve embolisation of 0.5%. The incidence of aortic regurgitation in excess of 2+ was 2.3% immediately following the procedure. The incidence of major postoperative complications included bleeding requiring re-operation 2.1%, dialysis 7.1%, pacemaker implantation 7.3%, stroke 2.6%, major vascular complications 2.4% and myocardial infarction 0.7%. The total 30-day mortality was 10.3%. Logistic EuroSCORE ≥30% and missing ejection fraction were found to be the only independent predictors for 30-day mortality. Conclusions: These results demonstrate that although trans-apical trans-catheter aortic valve implantation is a complex surgical technique, the learning curve can be minimised by appropriate training programmes. Very high logistic EuroSCOREs predict inferior survival and make it likely that in this subgroup of patients there may be some who, despite having had a successful trans-catheter aortic valve implantation procedure, do not benefit in the midterm. [Copyright &y& Elsevier]