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Background: Transcarotid transcatheter aortic valve replacement (TAVR) recipients may be exposed to a higher ipsilateral subclinical cerebral ischemic burden compared with the contralateral hemisphere. We sought (1) to compare the cerebral ischemic burden of the 2 hemispheres after transcarotid TAVR, as evaluated by diffusion weighted-magnetic resonance imaging (DW-MRI), and (2) to identify the factors associated with ipsilateral ischemic burden., Methods: This prospective study included 52 patients undergoing transcarotid TAVR, followed by a DW-MRI examination. All DW-MRIs were analyzed offline by a radiologist blinded to the clinical data., Results: TAVR was performed through the left (n = 50) or right (n = 2) carotid artery. Procedural success was achieved in all patients, carotid dissection requiring patch closure occurred in 1 patient, and there were no periprocedural stroke events. At least 1 cerebral ischemic lesion was identified in the ipsilateral and contralateral hemisphere in 84.6% and 63.5% of patients, respectively (P = .005), and the number of ischemic lesions per patient was higher in the ipsilateral vs the contralateral hemisphere (2 [interquartile range, 1-5] vs 1 [interquartile range, 0-3], P = .005). The lesion volume (per lesion) and the average lesion volume (per patient) did not differ between the 2 hemispheres. A larger sheath/catheter size (≥18F vs ≤16F) was associated with a higher ipsilateral ischemic burden (P = .026)., Conclusions: Carotid artery access for TAVR was associated with a higher number of cerebral ischemic lesions in the ipsilateral (vs contralateral) cerebral hemisphere. The use of a larger sheath/delivery system (≥18F) was associated with an increased ipsilateral ischemic burden., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Recent randomized trials including low-risk patients showed positive results for transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR), but patients with non-tricuspid aortic valve (NTAV), severe coronary artery disease (SevCAD), and those requiring concomitant mitral/tricuspid valve (CMTV) or concomitant ascending aorta replacement (CAAR) interventions were excluded., Objectives: This study sought to evaluate the presence and impact of the main clinical variables not evaluated in TAVR versus SAVR trials (NTAV, SevCAD, and CMTV or CAAR intervention) in a large series of consecutive low-risk patients with severe aortic stenosis (SAS) undergoing SAVR., Methods: Single-center study including consecutive patients with SAS and low surgical risk (Society of Thoracic Surgeons score of <4%) undergoing SAVR. Baseline, procedural characteristics, and 30-day outcomes were prospectively collected., Results: Of 6,772 patients with SAS who underwent SAVR between 2000 and 2019, 5,310 (78.4%) exhibited a low surgical risk (mean Society of Thoracic Surgeons score: 1.94 ± 0.87%). Of these, 2,165 patients (40.8%) had at least 1 of the following: NTAV (n = 1,468, 27.6%), SevCAD (n = 307, 5.8%), CMTV (n = 306, 5.8%), and CAAR (n = 560, 10.5%). The 30-day mortality and stroke rates for the overall low-risk SAS cohort were 1.9% and 2.4%, respectively. The mortality rate was similar in the SevCAD (2.6%) and CAAR (2.1%) groups versus the rest of the cohort (odds ratio [OR]: 1.79; 95% confidence interval [CI]: 0.85 to 3.75, and OR: 1.64; 95% CI: 0.88 to 3.05, respectively), lower in the NTAV group (0.9%; OR: 0.42; 95% CI: 0.22 to 0.81), and higher in the CMTV group (5.9%; OR: 2.61; 95% CI: 1.51 to 4.5)., Conclusions: In a real-world setting, close to one-half of the low-risk patients with SAS undergoing SAVR exhibited at least 1 major criterion not evaluated in TAVR versus SAVR randomized trials. Clinical outcomes were better than or similar to those predicted by surgical scores in all groups but those patients requiring CMTV intervention. These results may help determine the impact of implementing the results of TAVR-SAVR trials in real practice and may inform future trials in specific groups., Competing Interests: Author Disclosures Drs. Alperi and Silva were supported by a research grant from Martín Escudero foundation (Madrid, Spain). Dr. Rodés-Cabau holds the Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions; and has received institutional research grants from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Conduction disturbances are the most frequent complication of transcatheter aortic valve replacement (TAVR). However, no data exists regarding the outcomes of intraprocedural high-degree atrioventricular block (HAVB) or complete heart block (CHB) in patients without previous conduction disturbances., Objectives: The aim of this study was to evaluate the outcomes of intraprocedural-HAVB/CHB in patients without previous intraventricular conduction disturbances., Methods: The occurrence of intraprocedural-HAVB/CHB was assessed in 676 consecutive patients undergoing TAVR, and two groups were established according to its duration: persistent-HAVB/CHB (PHAVB/CHB) and transient-HAVB/CHB (THAVB/CHB), not present at the end of the procedure., Results: Intraprocedural-HAVB/CHB occurred in 50 patients (7.4%), being persistent in 32 (64.0%), and transient in 18 (36.0%). The use of Medtronic Corevalve Revalving System (MCRS) and a greater oversizing of the valve increased the risk of intraprocedural-HAVB/CHB (p < 0.001). Permanent pacemaker implantation (PPI) was more frequent in the PHAVB/CHB than in the THAVB/CHB group (96.9% vs. 33.3%; p < 0.001). At 1-month follow-up, the PHAVB/CHB group showed a 98% ventricular pacing rate (VPR) compared to 16% in the THAVB/CHB group (p < 0.001), and similar VPR were observed at 1-year follow-up (98% vs. 37%, p < 0.001). Left ventricular ejection fraction (LVEF) decreased at 1-year follow-up in patients with PHAVB/CHB (-3.9 ± 1.8%, p = 0.003)., Conclusions: In TAVR recipients with no prior intraventricular conduction disturbances, intraprocedural-HAVB/CHB occurred in 7.4% of cases. HAVB/CHB was persistent in most cases and determined a high rate of PPI post-TAVR. Very high VPR at 1- and 12-month follow-up were observed, which in turn was associated with a negative effect on LVEF. These results support early PPI and close follow-up in patients developing intraprocedural-PHAVB/CHB., (© 2019 Wiley Periodicals, Inc.)

No data exist on the optimal duration of antithrombotic therapy (AT) following patent foramen ovale (PFO) closure. We sought to assess the safety of AT discontinuation following PFO closure in patients with a cryptogenic ischemic event. A total of 453 consecutive patients (mean age: 48 ± 13years, men: 51%) who underwent PFO closure due to a cryptogenic ischemic event were included. All patients were on AT following PFO closure (antiplatelet therapy: 92.7%, anticoagulation: 7.3%). Ischemic and bleeding events, and AT were assessed at a median follow-up of 8 (IQR: 4 to 11) years, and follow-up was complete in 96% of patients. Stroke and transient ischemic attack occurred in 4 (0.9%) and 12 (2.6%) patients, respectively, and 27 (6.0%) patients had bleeding events (major in 6 [1.3%] patients, including 4 episodes of intracranial hemorrhage). All major bleeding events occurred under aspirin therapy. A total of 82 patients (18%) stopped the AT at a median of 7 (IQR: 5 to 34) months post-PFO closure (due to a bleeding event or gastrointestinal symptoms: 13 patients, no specific reason: 69 patients), and none of them had any ischemic event after a median time of 7 (IQR 3 to 10) years without any AT. A propensity score matched analysis including 46 patients who discontinued the AT within 1-year post-PFO closure and 120 patients with an ongoing AT showed the lack of differences in ischemic events between groups (0 vs 0.2 stroke/transient ischemic attack per 100 patient-years in the no-AT and AT groups, respectively). In conclusion, in young patients who underwent PFO closure, bleeding events occurred in ∼6% of patients after a median follow-up of 8years. AT was discontinued in about one fifth of patients (most of them within the year following PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up. These results suggest that, in patients without other co-morbidities increasing the risk of stroke, temporary AT following PFO closure may be a reasonable strategy., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Patent foramen ovale (PFO) closure is the gold standard for treating patients with cryptogenic stroke and PFO. However, scarce data exist on the long-term outcomes following PFO closure., Objectives: The purpose of this study was to determine the long-term (>10 years) clinical outcomes (death, ischemic, hemorrhagic events) following transcatheter PFO closure., Methods: We included 201 consecutive patients (mean age: 47 ± 12 years, 51% women) who underwent PFO closure due to a cryptogenic embolism (stroke: 76%, transient ischemic attack [TIA]: 32%, systemic embolism: 1%). Echocardiographic examinations were performed at 1- to 6-month follow-up. Ischemic and bleeding events and antithrombotic medication were collected at a median follow-up of 12 years (range 10 to 17 years), and follow-up was complete in 96% of the patients., Results: The PFO closure device was successfully implanted in all cases, and residual shunt was observed in 3.3% of patients at follow-up echocardiography. A total of 13 patients died at follow-up (all from noncardiovascular causes), and nondisabling stroke and TIA occurred in 2 and 6 patients, respectively (0.08 strokes per 100 patient-years; 0.26 TIAs per 100 patient-years). A history of thrombophilia (present in 15% of patients) tended to associate with a higher rate of ischemic events at follow-up (p = 0.067). Bleeding events occurred in 13 patients and were major (intracranial bleeding) in 4 patients (all of them under aspirin therapy at the time of the event). A total of 42 patients stopped the antithrombotic treatment at a median of 6 months (interquartile range 6 to 14 months) post-PFO closure, and none of them had any ischemic or bleeding episode after a mean of 10 ± 4 years following treatment cessation., Conclusions: PFO closure was associated with a low rate of ischemic events (stroke, 1%) at >10 years of follow-up. Major bleeding events occurred in 2% of the patients (all of them in patients on antiplatelet therapy). One-fifth of patients stopped the antithrombotic therapy during the follow-up period (the majority within the first-year post-PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors sought to assess the incidence, predictors, management, and prognosis of acute coronary syndrome (ACS) following TAVR., Background: About one-half of the patients undergoing transcatheter aortic valve replacement (TAVR) have concurrent coronary artery disease (CAD). However, the occurrence and clinical impact of coronary events following TAVR remain largely unknown., Methods: Consecutive patients undergoing TAVR in our institution between May 2007 and November 2017 were included. Patients were followed at 1, 6, and 12 months, and yearly thereafter. ACS was diagnosed and classified according to the Third Universal Definition of Myocardial Infarction., Results: A total of 779 patients (mean age 79 ± 9 years, 52% male, mean STS: 6.8 ± 5.1%) were included, 68% of which had a history of CAD. At a median follow-up of 25 (interquartile range: 10 to 44) months, 78 patients (10%) presented at least 1 episode of ACS, with one-half of the events occurring within the year following TAVR. Clinical presentation was type 2 non-ST-segment elevation myocardial infarction (35.9%), unstable angina (34.6%), type 1 non-ST-segment elevation myocardial infarction (28.2%), and ST-segment elevation myocardial infarction (1.3%). Male sex (hazard ratio [HR]: 2.19; 95% confidence interval [CI]: 1.36 to 3.54; p = 0.001), prior CAD (HR: 2.78; 95% CI: 1.50 to 5.18; p = 0.001), and nontransfemoral approach (HR: 1.71; 95% CI: 1.04 to 2.75; p = 0.035) were independently associated with ACS. Coronary angiography was performed in 53 (67.9%) patients with ACS, and 30 of them (56.6%) underwent percutaneous coronary intervention. In-hospital death rate at the time of the ACS episode was 3.8%. At a median follow-up of 21 (interquartile range: 8 to 34) months post-ACS, all-cause and cardiovascular death rates were 37.3% and 25.3%, respectively., Conclusions: Approximately one-tenth of patients undergoing TAVR were readmitted for an ACS after a median follow-up of 25 months. Male sex, prior CAD, and nontransfemoral approach were independent predictors of ACS. ACS was associated with high midterm mortality., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Paclitaxel-coated balloon (PCB) coronary angioplasty is an alternative treatment for de-novo coronary lesions in small vessels. This study with the new Essential PCB aimed to evaluate early and mid-term clinical outcomes following angioplasty with the Essential PCB in the treatment of de-novo lesions in small vessels., Patients and Methods: We included all patients who underwent PCB angioplasty for treating de-novo coronary lesions in small vessels (reference diameter <2.5 mm) between October 2015 and June 2016 in 2 centres. The primary endpoint was the 12-month target lesion failure (TLF) rate: a composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization. The secondary endpoints were rates of target vessel failure and global major adverse cardiac events (MACE)., Results: A total of 71 patients (comprising 71 lesions) were included, with a mean age of 66±11 years. A 56% were diabetic and 70% had an acute coronary syndrome as an indication for coronary revascularization. The mean vessel diameter and lesion length were 2.21±0.41 and 20.7±9.2 mm, respectively. Predilatation was performed in 85.9% of patients. The median diameter, length, and inflation pressure of the Essential balloon were 2.0 [interquartile range (IQR): 2.0-2.5] mm, 20 (IQR: 15-30) mm, and 12±2 atmospheres, respectively. Angiographic success was achieved in 97.2% of cases, and bail-out stenting was required in nine (12.7%) cases. The incidence of TLF at the 12-month follow-up was 4.2%, with a target lesion revascularization rate of 4.2%. Target vessel failure and global MACE rates were 4.2 and 9.9%, respectively., Conclusion: Use of the Essential PCB for treating de-novo coronary lesions in small vessels was safe, with low TLF and MACE rates at the 12-month follow-up.

Objectives: This study sought to evaluate the long-term clinical impact of permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR)., Background: Conduction disturbances leading to PPI are common following TAVR. However, no data exist regarding the impact of PPI on long-term outcomes post-TAVR., Methods: This was a multicenter study including a total of 1,629 patients without prior PPI undergoing TAVR (balloon- and self-expandable valves in 45% and 55% of patients, respectively). Follow-up clinical, echocardiographic, and pacing data were obtained at a median of 4 years (interquartile range: 3 to 5 years) post-TAVR., Results: PPI was required in 322 (19.8%) patients within 30 days post-TAVR (26.9% and 10.9% in patients receiving self- and balloon-expandable CoreValve and Edwards systems, respectively). Up to 86% of patients with PPI exhibited pacing >1% of the time during follow-up (>40% pacing in 51% of patients). There were no differences between patients with and without PPI in total mortality (48.5% vs. 42.9%; adjusted hazard ratio [HR]: 1.15; 95% confidence interval [CI]: 0.95 to 1.39; p = 0.15) and cardiovascular mortality (14.9% vs. 15.5%, adjusted HR: 0.93; 95% CI: 0.66 to 1.30; p = 0.66) at follow-up. However, patients with PPI had higher rates of rehospitalization due to heart failure (22.4% vs. 16.1%; adjusted HR: 1.42; 95% CI: 1.06 to 1.89; p = 0.019), and the combined endpoint of mortality or heart failure rehospitalization (59.6% vs. 51.9%; adjusted HR: 1.25; 95% CI: 1.05 to 1.48; p = 0.011). PPI was associated with lesser improvement in LVEF over time (p = 0.051 for changes in LVEF between groups), particularly in patients with reduced LVEF before TAVR (p = 0.005 for changes in LVEF between groups)., Conclusions: The need for PPI post-TAVR was frequent and associated with an increased risk of heart failure rehospitalization and lack of LVEF improvement, but not mortality, after a median follow-up of 4 years. Most patients with new PPI post-TAVR exhibited some degree of pacing activity at follow-up., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine the incidence, causes, and predictors of unplanned hospital readmissions after transcatheter aortic valve replacement (TAVR)., Background: Data regarding unplanned hospital readmissions after TAVR in a real-world all-comers population are scarce., Methods: A total of 720 consecutive patients undergoing TAVR at 2 centers who survived the procedure, were included. Median follow-up was 23 months (interquartile range [IQR]: 12 to 39 months), available in 99.9% of the initial population. The occurrence, timing, and causes of hospital readmission within the first year post-TAVR were obtained in all cases. Early and late readmissions were defined as those occurring ≤30 days and >30 days to 1 year post-TAVR, respectively., Results: There were 506 unplanned readmissions in 316 patients (43.9%) within the first year post-TAVR (median time: 63 days; IQR: 19 to 158 days post-discharge). Of these, early readmission occurred in 105 patients (14.6%), and 118 patients (16.4%) had multiple (≥2) readmissions. Readmissions were due to noncardiac and cardiac causes in 59% and 41% of cases, respectively. Noncardiac readmissions included, in order of decreasing frequency, respiratory, infection, and bleeding events as the main causes, whereas heart failure and arrhythmias accounted for most cardiac readmissions. The predictors of early readmission were periprocedural major bleeding complications (p = 0.001), anemia (p = 0.019), lower left ventricular ejection fraction (p = 0.042), and the combined presence of antiplatelet and anticoagulation therapy at hospital discharge (p = 0.014). The predictors of late readmission were chronic obstructive pulmonary disease (p = 0.001), peripheral vascular disease (p = 0.023), chronic renal failure (p = 0.013), and atrial fibrillation (p = 0.012). Early readmission was an independent predictor of mortality during the follow-up period (hazard ratio: 1.56, 95% confidence interval: 1.02 to 2.39, p = 0.043)., Conclusions: The readmission burden after TAVR in an all-comers population was high. Nearly one-fifth of the patients were readmitted early after hospital discharge, increasing the risk of mortality at follow-up. Reasons for readmission were split between noncardiac and cardiac causes, with respiratory causes and heart failure as the main diagnoses in each group, respectively. Whereas early readmissions were mainly related to periprocedural bleeding events, most late readmissions were secondary to baseline patient comorbidities. These results underscore the importance of and provide the basis for implementing specific preventive measures to reduce readmission rates after TAVR., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The release of cardiac biomarkers of myocardial injury after transcatheter aortic valve replacement (TAVR) is common, but no data exist on patients undergoing TAVR through a transaortic approach. We aimed to evaluate the incidence and prognostic significance of the increase in cardiac biomarkers in nontransfemoral TAVR candidates, comparing transaortic and transapical approaches., Methods: After excluding patients deemed suitable for transfemoral TAVR, 251 consecutive patients (transaortic, 45; transapical, 206) were prospectively evaluated. Creatine kinase-myocardial band and cardiac troponin T levels were measured at baseline and at 6, 12, 24, 48, and 72 hours after TAVR. Baseline and 6- to 12-month echocardiographic and clinical follow-up were performed., Results: After TAVR, cardiac troponin T increased above the upper normal values in all patients (peak value 0.64 μg/L [IQR, 0.39 to 1.03 μg/L]), whereas creatine kinase-myocardial band levels increased in 88% of patients (transaortic 51%, transapical 96%, p < 0.001; peak value 20.1 μg/L [interquartile range, 14.3 to 31.6 μg/L]). Compared with the transaortic approach, the transapical approach was associated with a greater rise in both cardiac biomarkers (p < 0.001 for both), and a lesser improvement in left ventricular ejection fraction (p = 0.058) and global longitudinal strain (p = 0.039) at 6- to 12-month follow-up. Greater increases of cardiac troponin T levels were independently associated with 30-day and 1-year overall and cardiovascular mortality (p < 0.001 for all). A 15-fold rise in cardiac troponin T levels was the optimal threshold for determining poorer outcomes (p < 0.001)., Conclusions: Periprocedural TAVR-related myocardial injury in nontransfemoral candidates was demonstrated in all patients, but the transapical approach was associated with significantly greater myocardial injury compared with the transaortic approach. A higher degree of myocardial injury translated into reduced left ventricular function improvement and lower early and midterm survival rates., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The objectives of this study were to determine the causes and impact of anemia and hemoglobin level on functional status, physical performance, and quality of life in the preprocedural evaluation and follow-up of transcatheter aortic valve replacement (TAVR) candidates. A total of 438 patients who underwent TAVR were included. Anemia was defined as a hemoglobin level <12 g/dl in women and <13 g/dl in men. Before TAVR, anemia was encountered in 282 patients (64.4%). A potential treatable cause of anemia was detected in 90.4% of patients and was attributed to iron deficiency in 53% of them. The occurrence of anemia was an independent predictor of poorer performance in the 6-minute walk test (6MWT), a lower Duke Activity Status Index score, and Kansas City Cardiomyopathy Questionnaires overall, clinical, and social limitation scores (p <0.05 for all). A lower hemoglobin level was associated with a higher prevalence of New York Heart Association class III to IV (p <0.001) and correlated negatively with the results of all functional tests (p <0.02 for all). At follow-up, anemia was found in 62% of patients and was associated with poorer performance in the 6MWT (p = 0.023). A lower hemoglobin level after TAVR was a predictor of poorer New York Heart Association class (p = 0.020) and correlated negatively with the distance walked in the 6MWT (r = -0.191, p = 0.004) and Duke Activity Status Index score (r = -0.158, p = 0.011) at 6-month follow-up. In conclusion, anemia was very common in TAVR candidates and was attributed to iron deficiency in more than half of them. The presence of anemia and lower hemoglobin levels determined poorer functional status before and after the TAVR procedure. These results highlight the importance of implementing appropriate measures for the diagnosis and treatment of this frequent co-morbidity to improve both the accuracy of preprocedural evaluation and outcomes of TAVR candidates., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: To determine the prevalence of a concurrent CTO in men and women and to examine its impact on mortality., Background: The impact of chronic total occlusion (CTO) in patients with ST-elevation myocardial infarction (STEMI) according to gender has not been assessed., Methods: Patients referred with STEMI were categorized into single vessel disease (SVD), multivessel disease (MVD) without, with 1 or > 1 CTO. The primary end-point was the 1-year mortality., Results: Among the 2020 STEMI patients included between 2006 and 2011, 24% were female. Women were older, had more hypertension and renal failure (P < 0.0001 for all). The prevalence of 1 or > 1 concurrent CTO was similar in both sexes, 7 and 1%, respectively. Early and late mortality was significantly higher in women compared with men (P < 0.0001). In women, the mortality was significantly worse in patients with > 1 CTO (100%) and with 1 CTO (36.4%) compared with those with MVD without CTO (18.4%) or with SVD (10.4%) (P < 0.0001). MVD with and without concurrent CTO were both independent predictors of 1-year mortality in women (HR 3.58; 95 % CI 1.69-7.18 and HR 2.76; 95 % CI 1.33-5.51) whereas only MVD with CTO was predictive in men (HR 2.19; 95% CI 1.20-3.97)., Conclusions: Among unselected STEMI patients, the prevalence of CTO was equal in both sexes whereas early and late mortality remained significantly higher in women. Other factors than the presence of a concurrent CTO must be explored to explain differences in survival after STEMI between women and men., (Copyright © 2013 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to demonstrate the first-in-human feasibility and short-term clinical outcomes with a new balloon-expandable transcatheter heart valve (THV)., Background: The SAPIEN 3 (S3) THV incorporates a paravalvular sealing system, an active 3-dimensional coaxial positioning catheter, and is compatible with a 14-F expandable sheath., Methods: The S3 THV was implanted in 15 patients with symptomatic severe aortic stenosis via femoral arterial access. Multidetector computed tomography before and after valve implantation allowed assessment of a novel annular area sizing algorithm. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days., Results: All 15 device implants were successful. Multidetector computed tomography estimated an aortic annular area of 4.9 ± 0.4 cm(2), predicting 9.7 ± 6.9% THV oversizing. Post-transcatheter aortic valve replacement multidetector computed tomography showed consistently symmetrical and circular THVs. Aortic valve area increased from 0.7 ± 0.2 cm(2) to 1.5 ± 0.2 cm(2) (p < 0.001), and mean transaortic gradient decreased from 42.2 ± 10.3 mm Hg to 11.9 ± 5.3 mm Hg (p < 0.001). No patient had more than mild paravalvular aortic regurgitation. Hospital discharge occurred at a median of 3 (range 2 to 12) hospital days. At 30 days there were no deaths, strokes, vascular complications, bleeds, or transfusions, although 1 patient (6.7%) required a new pacemaker. All patients were in New York Heart Association functional class I or II., Conclusions: The S3 THV and delivery system might facilitate fully percutaneous implantation in a broader range of patients with the potential for more accurate positioning and less paravalvular regurgitation., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To investigate the predictors and impact on long-term survival of one chronic total occlusion (CTO) or multiple CTOs in patients presenting with ST-elevation myocardial infarction (STEMI)., Design: Single-centre retrospective observational study., Setting: University-based tertiary referral centre., Patients: Between 2006 and 2011, a total of 2020 consecutive patients referred with STEMI were categorised into single vessel disease, multivessel disease (MVD) without CTO, with one CTO or with multiple CTOs., Intervention: Primary percutaneous coronary intervention., Main Outcome Measure: The primary end-point was the 1-year mortality., Results: The prevalence of single vessel disease, MVD without CTO, with one CTO or with multiple CTOs was 70%, 22%, 7.2% and 0.8%, respectively. Independent clinical predictors for the presence of CTO were cardiogenic shock (OR 5.05; 95% CI 3.29 to 7.64), prior myocardial infarction (OR 2.06; 95% CI 1.35 to 3.09), age >65 years (OR 1.94; 95% CI 1.40 to 2.71) and history of angina (OR 1.94; 95% CI 1.29 to 2.87). Mortality was worse in patients with multiple CTOs (76.5%) compared with those with one CTO (28.1%) or without CTO (7.3%) (p<0.0001). After adjustment for left ventricular ejection fraction and renal function, MVD was an independent predictor for 1-year mortality (HR: 1.81; 95% CI 1.18 to 2.77, p=0.007), but CTO was not (HR: 1.07; 95% CI 0.66 to 1.73, p=0.78)., Conclusions: Simple clinical factors are associated with the presence of CTO in non-infarct-related artery in patients presenting with STEMI. In these patients, long-term survival was independently associated with MVD, left ventricular ejection fraction and renal function, but not with CTO per se.

Objectives: This study sought to evaluate the predictive factors, effects, and safety of balloon post-dilation (BPD) for the treatment of significant paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI)., Background: Very few data exist on BPD after TAVI with a balloon-expandable valve., Methods: A total of 211 patients who underwent TAVI with a balloon-expandable valve were included. BPD was performed after TAVI if paravalvular AR ≥ 2 was identified by transesophageal echocardiography. Clinical events and echocardiographic data were prospectively recorded, and median follow-up was 12 (6 to 24) months., Results: BPD was performed in 59 patients (28%), leading to a reduction in at least 1 degree of AR in 71% of patients, with residual AR <2 in 54% of the patients. The predictors of the need for BPD were the degree of valve calcification and transfemoral approach, with valve calcification volume >2,200 and >3,800 mm(3) best determining the need for and a poor response to BPD, respectively. Patients who underwent BPD had a higher incidence of cerebrovascular events at 30 days (11.9% vs. 2.0%, p = 0.006), with most (83%) events within the 24 h after the procedure occurring in patients who had BPD. No significant changes in valve area or AR degree were observed at follow-up in BPD and no-BPD groups., Conclusions: BPD was needed in about one-fourth of the patients undergoing TAVI with a balloon-expandable valve and was successful in about one-half of them. A higher degree of valve calcification and transfemoral approach predicted the need for BPD. BPD was not associated with any deleterious effect on valve function at mid-term follow-up, but a higher rate of cerebrovascular events was observed in patients who had BPD., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to evaluate the incidence, predictive factors, and prognostic value of new-onset atrial fibrillation (NOAF) following transcatheter aortic valve implantation (TAVI)., Background: Very few data exist on the occurrence of NOAF following TAVI., Methods: A total of 138 consecutive patients with no prior history of atrial fibrillation (AF) underwent TAVI with a balloon-expandable valve. Patients were on continuous electrocardiogram monitoring until hospital discharge, and NOAF was defined as any episode of AF lasting >30 s. All clinical, echocardiographic, procedural, and follow-up data were prospectively collected., Results: NOAF occurred in 44 patients (31.9%) at a median time of 48 h (interquartile range: 0 to 72 h) following TAVI. The predictive factors of NOAF were left atrial (LA) size (odds ratio [OR]: 1.21 for each increase in 1 mm/m(2), 95% confidence interval [CI]: 1.09 to 1.34, p < 0.0001) and transapical approach (OR: 4.08, 95% CI: 1.35 to 12.31, p = 0.019). At 30-day follow-up, NOAF was associated with a higher rate of stroke/systemic embolism (13.6% vs. 3.2%, p = 0.021, p = 0.047 after adjustment for baseline differences between groups), with no differences in mortality rate between groups (NOAF: 9.1%, no-NOAF: 6.4%, p = 0.57). At a median follow-up of 12 months (interquartile range: 5 to 20 months), a total of 27 patients (19.6%) had died, with no differences between the NOAF (15.9%) and no-NOAF (21.3%) groups, p = 0.58. The cumulative rate of stroke and stroke/systemic embolism at follow-up were 13.6% and 15.9%, respectively, in the NOAF group versus 3.2% in the no-NOAF group (p = 0.039, adjusted p = 0.037 for stroke; p = 0.020, adjusted p = 0.023 for stroke/systemic embolism)., Conclusions: NOAF occurred in about one-third of the patients with no prior history of AF undergoing TAVI and its incidence was increased in patients with larger LA size and those undergoing transapical TAVI. NOAF was associated with a higher rate of stroke/systemic embolism, but not a higher mortality, at 30 days and at 1-year follow-up., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To assess the incidence of conduction disturbances leading to permanent pacemaker implantation (PPI) following isolated aortic valve replacement (AVR) in a large cohort of elderly patients with severe symptomatic aortic stenosis, and to determine the predictive factors and prognostic value of PPI following AVR in such patients., Methods: A total of 780 consecutive elderly patients (age 77 ± 4 years, logistic EuroSCORE 10.4 ± 8.5%, STS score 3.5 ± 1.5%) with severe aortic stenosis and no previous pacemaker were analysed., Main Outcome Measures: The incidence, clinical indications, timing and predictive factors of PPI within 30 days after AVR and their prognostic value were evaluated., Results: Baseline ECG showed the presence of conduction abnormalities in 37.1% of the patients. Twenty-five patients (3.2%) needed PPI during the index hospitalisation due to the occurrence of complete atrioventricular block (2.6%) or severe bradycardia (0.6%). The presence of preprocedural left bundle branch block (OR 4.65, 95% CI 1.62 to 13.36, p = 0.004) or right bundle branch block (OR 4.21, 95% CI 1.47 to 12.03, p = 0.007) predicted the need for PPI after AVR. The need for PPI was associated with a longer hospital stay (p<0.0001). Thirty-day mortality rates were similar between patients with and without PPI (4% vs 3.2%, p = 0.56). Survival rate at 5-year follow-up was 75%, with no differences between patients with and without PPI (p = 0.12)., Conclusions: The need for PPI following isolated AVR in elderly patients with severe symptomatic aortic stenosis was low. Pre-existing bundle branch block predicted the need for PPI. PPI determined a longer hospital stay, but had no effect on acute and long-term mortality.

Objectives: The objectives were to compare different Doppler echocardiographic methods for the measurement of prosthetic valve effective orifice area (EOA) following transcatheter aortic valve implantation (TAVI) and to determine the factors influencing the EOA of transcatheter balloon expandable valves., Background: Previous studies have used different methods for the measurement of the valve EOA following TAVI. Factors influencing the EOA of transcatheter valves are unknown., Methods: A total of 122 patients underwent TAVI with the use of the Edwards-SAPIEN valve (Edwards Lifesciences, Irvine, California). The EOA was measured by transthoracic echocardiography at hospital discharge, 6 months and 1 year after TAVI with the use of 2 methods as described in previous studies. In Method #1 (EOA(1)), LVOT diameter (LVOTd) entered in the continuity equation was measured at the base of prosthesis cusps whereas, in Method #2 (EOA(2)), LVOTd was measured immediately proximal to the prosthesis stent., Results: The average EOA(2) (1.57 ± 0.41 cm(2)) was larger (p < 0.01) than the EOA(1) (1.21 ± 0.38 cm(2)). Accordingly, incidence of severe PPM (indexed EOA ≤0.65 cm(2)/m(2)) was 3-fold lower with the use of EOA(2) than with EOA(1) (9% vs. 33%; p < 0.001). Mean transprosthetic gradient correlated better (p = 0.03) with indexed EOA(2) (r = -0.70, p < 0.0001) than with indexed EOA(1) (r = -0.58, p < 0.0001). Intraobserver and interobserver variability were lower for EOA(2) compared to EOA(1) (intra: 5% vs. 7%, p = 0.06; inter: 6% vs. 14%; p < 0.001). Aortic annulus size was the sole independent determinant (p = 0.01) of prosthetic valve EOA(2). The average EOA varied from 1.37 ± 0.23 cm(2) for aortic annulus size <19 mm up to 1.90 ± 0.17 cm(2) for size >23 mm., Conclusions: When estimating the EOA of Edwards-SAPIEN valves by Doppler-echocardiography, it is recommended to use the LVOT diameter and velocity measured immediately proximal to the stent. The main determinant of the EOA of transcatheter valves is the patient's annulus size and these valves provide excellent hemodynamics even in patients with a small aortic annulus., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The use of routine aspiration thrombectomy in primary percutaneous coronary intervention (PCI) remains controversial., Methods: Patients in the EArly Discharge after Transradial Stenting of CoronarY Arteries in Acute Myocardial Infarction (n = 105) study were treated with aspirin, clopidogrel, and abciximab within 6 hr of symptoms onset. Operators were allowed to use 6 Fr Export aspiration catheter at their discretion. In this observational analysis, we compared acute and late results in patients treated with and without thrombectomy using cardiac biomarkers, angiographic, cardiovascular magnetic resonance (CMR), and clinical parameters., Results: Patients in the thrombectomy group (n = 44) had longer symptoms to balloon time (196 ± 86 min vs. 164 ± 62, P = 0.039) and higher incidence of preprocedural TIMI flow grade 0 or 1 (84% vs. 64%, P = 0.028). Following PCI, both groups had similar incidence of TIMI flow grade 3 (93 vs. 92%, P = 0.73) and myocardial blush grade 2 or 3 (80 vs. 77%, P = 0.86), respectively. Patients in thrombectomy group had significantly higher post-PCI maximum values of creatine kinase-MB (P = 0.0007) and troponin T (P = 0.0010). Accordingly, post-PCI myocardial necrosis by CMR was higher (P = 0.0030) in patients in the thrombectomy group. At 6-month follow-up, necrosis size remained higher (20.7% ± 13.3% vs. 13.5% ± 11.1%, P = 0.012) in the thrombectomy group. Ejection fraction at 6 months was 65% ± 9% in patients in thrombectomy group compared to 70% ± 11% in patients without (P = 0.070). Results were not affected by initial TIMI flow or symptoms to balloon time. Clinical events remained comparable in both groups at 12 months follow-up., Conclusion: In patients with ST-segment elevation myocardial infarction presenting within 6 hr of symptoms and undergoing primary angioplasty with maximal antiplatelet therapy, acute and late results did not suggest significant benefit for additional aspiration thrombectomy, irrespective of initial TIMI flow or total ischemic time., (Copyright © 2010 Wiley-Liss, Inc.)

Objectives: The aim of this study was to: 1) determine the usefulness of transesophageal echocardiography (TEE) as the primary technique to guide transapical (TA) transcatheter aortic valve implantation (TAVI); and 2) to compare TEE with angiography as the primary imaging modality for TA-TAVI guidance., Background: TEE has been routinely used as an adjunct to angiography during TA-TAVI procedures, but very few data exist on the use of TEE as the primary imaging technique guiding TA-TAVI., Methods: One hundred consecutive high-risk patients (mean age 79 ± 9 years, mean logistic EuroSCORE: 25.8 ± 17.6%) who underwent TA-TAVI in our center were included. The Edwards valve was used in all cases, and all procedures were performed in an operating room without hybrid facilities. The TA-TAVI was primarily guided by angiography in the first 25 patients (A-TAVI group) and by TEE in the last 75 patients (TEE-TAVI group). Procedural, 30-day, and follow-up results were evaluated., Results: No differences were observed between groups at baseline except for a higher (p = 0.001) prevalence of moderate or severe mitral regurgitation in the TEE-TAVI group. The procedure was successful in 97.3% and 100% of the patients in the TEE-TAVI and A-TAVI groups, respectively (p = 1.0), and a lower contrast volume was used in the TEE-TAVI group (12 [5 to 20] ml vs. 40 [20 to 50] ml, p < 0.0001). There were no differences between groups in the occurrence of valve malposition needing a second valve (TEE-TAVI: 5.3%; A-TAVI: 4%; p = 1.0) or valve embolization (TEE-TAVI: 1.3%; A-TAVI: 4%; p = 0.44). The results regarding post-procedural valve hemodynamic status and aortic regurgitation were similar between groups. The survival rates at 30-day and 1-year follow-up were 87% and 75% in the TEE-group and 88% and 84% in the A-TAVI group, respectively (log-rank = 0.49)., Conclusions: TEE-TAVI was associated with similar acute and midterm results as A-TAVI and significantly reduced contrast media use during the procedures. These results suggest the feasibility and safety of performing TA-TAVI procedures in an operating room without hybrid facilities, but larger studies are needed to confirm these findings., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The objective of this study was to compare the incidence of cerebral embolism (CE) as evaluated by diffusion-weighted magnetic resonance imaging (DW-MRI) following transapical (TA) transcatheter aortic valve implantation (TAVI) versus transfemoral (TF) TAVI., Background: The TA-TAVI approach avoids both the manipulation of large catheters in the aortic arch/ascending aorta and the retrograde crossing of the aortic valve, and this avoidance might lead to a lower rate of CE., Methods: This was a prospective multicenter study including 60 patients who underwent cerebral DW-MRI the day before and within the 6 days following TAVI (TF approach: 29 patients; TA approach: 31 patients). Neurologic and cognitive function assessments were performed at DW-MRI time points., Results: The TAVI procedure was performed with the Edwards valve and was successful in all cases but one (98%). A total of 41 patients (68%) had 251 new cerebral ischemic lesions at the DW-MRI performed 4 ± 1 days after the procedure, 19 patients in the TF group (66%) and 22 patients in the TA group (71%; p = 0.78). Most patients (76%) with new ischemic lesions had multiple lesions (median number of lesions per patient: 3, range 1 to 31). There were no differences in lesion number and size between the TF and TA groups. No baseline or procedural factors were found to be predictors of new ischemic lesions. The occurrence of CE was not associated with a measurable impairment in cognitive function, but 2 patients (3.3%) had a clinically apparent stroke within the 24 h following the procedure (1 patient in each group)., Conclusions: TAVI is associated with a high rate of silent cerebral ischemic lesions as evaluated by DW-MRI, with no differences between the TF and TA approaches. These results provide important novel insight into the mechanisms of CE associated with TAVI and support the need for further research to both reduce the incidence of CE during these procedures and better determine their clinical relevance., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Late-presenting ST-elevation myocardial infarction (STEMI) patients possess larger, more organized coronary thrombus leading to greater ventricular remodeling and arrhythmia despite angioplasty and pharmacological therapies. We hypothesized that myocardial injury would be reduced in late STEMI by proximal embolic protection (PEP)., Methods: 31 patients with first STEMI 12-24 hr after pain onset and TIMI 0-1 flow were treated with or without PEP (cohort design matched for age, gender, and infarct-related artery). Contrast-enhanced magnetic resonance determined myocardial function, area at risk, necrosis, salvaged myocardium, and arrythmogenic peri-infarct region. Clinical follow-up was performed., Results: Pain to balloon time was 18 hr (95% CI 15.5-21.2 h), and Q waves were present in 87%. Angioplasty was performed with PEP in 15 and without in 16. Left ventricular (LV) volumes and ejection fraction were similar (EF 46.9% vs. 49.0% without PEP, P = 0.9). Although myocardial necrosis was similar (32.5 vs. 37.3% of LV, P = 0.3), PEP improved microvascular obstruction (8.7 vs. 11.2% of LV, P = 0.02) salvaged myocardium (39.6% vs. 29.6% of area at risk, P = 0.001), and the peri-infarct region (20.9 vs. 29.6% of infarct, P < 0.0001). On multivariate analysis, the use of PEP was an independent predictor of decreased arrythmogenic peri-infarct region and greater myocardial salvage., Conclusion: In this pilot study, PEP improved myocardial salvage and the arrythmogenic peri-infarct region in late-presentation STEMI. Randomized trials are required to assess the clinical impact of improving salvaged myocardium and the peri-infarct region with PEP., (© 2010 Wiley-Liss, Inc.)

Background: Female gender has been associated with poorer outcomes after percutaneous coronary intervention (PCI) and femoral approach. However, no data are available on the impact of gender and transradial PCI with maximal antiplatelet therapy on bleeding and ischemic outcomes., Methods: In the EArly discharge after Stenting of coronarY arteries (EASY) trial, 1,348 patients with acute coronary syndrome underwent transradial PCI. All patients were pretreated with aspirin and clopidogrel. After sheath insertion, 70 U/kg heparin was administered and a bolus of abciximab was given before first balloon inflation. Major adverse cardiac events including death, myocardial infarction, and target vessel revascularization; major bleeding; and local hematomas were evaluated at 30 days, 6 months, and 12 months., Results: Women (n = 298, 22%) were older, had more hypertension, more family history, and less previous PCI than men. Weight, baseline hemoglobin, and creatinine clearance were significantly lower in women. The number of dilated sites, complex lesions, and procedure duration was similar, but 5F sheath size was more frequent in women. Major adverse cardiac events remained similar at 30 days (3.4% vs 3.9%, P = .86), at 6 months (11.5% vs 7.8%, P = .06), and at 1 year (14.1% vs 12.6%) in both groups. There was no significant difference in the incidence of major bleeding between the 2 groups, but female gender was the only independent predictor of hematomas (odds ratio 4.40, 95% confidence interval 2.49-7.81, P < .0001)., Conclusion: Despite more comorbidities, female gender was not a predictor of adverse clinical outcomes after transradial PCI with maximal antiplatelet therapy. Still, female gender remained associated with a higher risk of local hematomas. Efforts should continue to identify modifiable factors to reduce procedural bleeding in women, regardless of the access site.

Background: Current guidelines for ST elevation myocardial infarction (STEMI) recommend performing primary percutaneous coronary intervention (PCI) within 90 min of hospital arrival. However, recent data suggest that in a real-world setting, median door-to-balloon (DTB) time is closer to 180 min for transfer patients, with less than 5% of patients being treated within 90 min. A retrospective observational study was conducted to assess time to treatment in patients undergoing primary PCI at the Quebec Heart and Lung Institute (QHLI)., Methods: Consecutive lytic-eligible patients undergoing primary PCI at the QHLI for STEMI between April 2004 and March 2005 were included in the present analysis. The primary evaluation was DTB time measured from arrival at the first hospital to first balloon inflation. Clinical outcomes were in-hospital death, reinfarction and bleeding. DTB times and hospital outcomes of patients transferred from referring hospitals were compared with those of patients presenting directly to the QHLI., Results: During the study period, 203 lytic-eligible patients were treated with primary PCI. Sixty-nine patients presented directly to the QHLI and 134 were transferred from other hospitals. Six transfer patients were excluded because of missing time variables. The median DTB time was 114 min in transfer patients, compared with 87 min in patients presenting directly to the QHLI (P<0.001). DTB time was less than 90 min in 24% of the transfer population compared with 55% of patients presenting directly to the QHLI (P<0.001). In patients referred from hospitals within a radius of 30 km from the QHLI (n=100), median DTB time was 106 min with 30% receiving PCI within 90 min. In these patients, estimated PCI-related delay was 74 min. For patients presenting to hospitals beyond 30 km (n=28), median DTB time was 142 min with 4% receiving reperfusion within 90 min. In these patients, estimated PCI-related delay was 110 min. Median DTB time for patients presenting during off hours at the QHLI was 92 min compared with 79 min for patients presenting during regular business hours (P=0.02). In patients transferred from other hospitals, median DTB time was 118 min during off hours and 108 min during normal business hours (P=0.07)., Conclusions: A DTB time of less than 90 min can be achieved in the majority of patients presenting directly to a primary PCI centre. However, for patients presenting to community hospitals, transfer for primary PCI is often associated with delayed revascularization. The present study highlights the need for careful patient selection when deciding between on-site thrombolytic therapy and transfer for primary PCI for STEMI patients presenting to hospitals without PCI facilities.

Background: The objectives of this study were to compare, in the current era, the immediate results, complications, and midterm outcomes obtained by surgical repair versus transcatheter treatment of coarctation of the aorta (CoA)., Methods: The study was of retrospective nature and included 80 consecutive patients > or = 1 year old (mean age 12 +/- 10 years) treated for an isolated CoA in 4 university centers in Quebec between 1998 and 2004. Fifty patients underwent aortic angioplasty, with stent implantation in 19, and 30 had surgical repair. Immediate results, procedural complications, clinical events, and the incidence of aortic aneurysm at follow-up were compared between groups., Results: There were no differences between the 2 groups in clinical baseline characteristics. Percentage reduction in peak systolic pressure gradient across the coarctation was similar between the 2 groups (angioplasty 72% +/- 23% vs surgery 75% +/- 18%, P = .55). Procedure-related complications occurred more frequently after surgical repair compared with angioplasty (50% vs 18%, P = .005), and median hospitalization time was longer in the surgical than in the angioplasty group (7 vs 1 day, P < .001). At 38 +/- 21 months' follow-up, no patient in the surgical group and 16 patients in the angioplasty group had at least 1 aortic reintervention (0% vs 32%, P < .0001). The presence of an aortic aneurysm was diagnosed more frequently in the angioplasty group compared with the surgical group (24% vs 0%, P = .01)., Conclusion: Aortic angioplasty provided comparable immediate hemodynamic results to surgery, with reduced morbidity and hospitalization length for the treatment of CoA in patients > or = 1 year old. However, angioplasty was associated with a higher rate of reintervention and aneurysm formation at a mean follow-up of 3 years.