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Background: High (≥20 mmHg) postprocedural mean transvalvular gradients are relatively common among valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) recipients, but its clinical impact remains controversial., Methods: Observational study including 190 consecutive ViV-TAVR recipients. Patients were classified according to the presence of high (≥20 mmHg) or low (<20 mmHg) residual mean transvalvular gradient on post-procedural echocardiography. Functional status (NYHA class, DASI), exercise capacity (6MWT), and quality of life (KCCQ) were evaluated at baseline and at 1-year follow-up., Results: 73 (38.4%) and 117 (61.6%) patients exhibited high (HG) and low (LG) postprocedural gradients, respectively. Baseline characteristics were well balanced between groups except for a lower rate of large (>23 mm) surgical valves, atrial fibrillation, and aortic regurgitation as mechanism of valve failure in the HG group (p < 0.05 for all). After a median follow-up of 3 (1-5) years, there were no differences between HG and LG groups in HF hospitalization (HRadj: 1.38, 95%CI 0.44-4.22, p = 0.57), cardiac death (HRadj: 0.50; 95%CI 0.11-2.41, p = 0.39), all-cause mortality (HRajd: 0.71; 95%CI 0.35-1.46, p = 0.36), or the composite endpoint of heart failure/all-cause mortality (HRadj:1.00; 95%CI 0.52-1.94, p = 0.98). At 1-year follow-up, functional status (ΔDASI score, HG: 9.9 ± 10.9, LG: 9.9 ± 12.5, padj = 0.41), exercise capacity (Δ6MWT, HG: 111 ± 67 m, LG: 103 ± 124 m, padj = 0.14), and quality of life parameters (ΔKCCQ, HG: 27 ± 18, LG: 17 ± 21, padj = 0.12) improved similarly in both groups., Conclusions: HG as evaluated by echocardiography following ViV-TAVR were not associated with a negative effect on clinical outcomes including major adverse events, functional status, exercise capacity and quality of life parameters., Competing Interests: Declaration of Competing Interest Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences and Medtronic. The rest of authors do not disclose any conflict of interest with respect to the content of this article., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Para-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases)., Methods: Patients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation., Results: Core-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV., Conclusions: This study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Transcarotid (TC) is a common alternative access for transcatheter aortic valve replacement (TAVR) when the transfemoral route is not suitable. However, scarce data exist on systematic ultrasound (US) follow-up of these patients. This study aims to evaluate the safety of TC-TAVR using pre-and post-procedure carotid artery US assessment., Methods: We performed an observational prospective study including 50 consecutive patients who underwent TC-TAVR that had a follow-up at our institution between September 2016 and July 2020., Results: All patients had a carotid US examination at a median time of 13 months (IQR: 5-17) following the procedure. Thirty-six (71%) patients also had a US examination prior to the procedure. Mean pre-procedural access route common carotid artery (AR-CCA) peak systolic velocity (PSV) was 62.9 cm/s (SD:16.8) vs. 69.0 cm/s (SD: 53.4) in the contralateral CCA (CL-CCA), p = 0.562). There was a significant increase in post-procedural PSV values in the AR-CCA (30.3 cm/s (SD: 36.3), p < 0.001) but not in the CL-CCA (5.8 cm/s (SD: 51.7), p = 0.503). Two new carotid stenoses (4%) were diagnosed after the procedure. No baseline or procedural variables were associated with a higher increase in carotid flow velocities at follow-up. There were no cerebrovascular events related to these findings after a median follow-up of 29 months (IQR:13-33)., Conclusions: TC-TAVR was associated with a mild but significant increase in carotid flow velocities, with new significant (>50%) carotid stenosis diagnosed in 4% of patients. These findings were not associated with clinical events after a median follow-up of 2 years. Further studies are warranted., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: No data exist about cranial nerve injury (CNI) as a potential complication of transcarotid (TC) transcatheter valve replacement (TAVR)., Methods: This monocentric study included 318 consecutive patients undergoing TC-TAVR from May 2015 to August 2021., Results: CNI occurred in 7 (2.2%) TAVR-TC patients. Five out of the 7 patients (71.4%) had an injury of the laryngeal branch of the vagus nerve, and 2 patients (28.6%) had an injury of the facial nerve. The majority of patients were male (85.7%), with high body mass index (35.6 (IQR: 30.1-37.3) kg/m2). The induced disabilities were clinically important especially for patients with dysphonia., Conclusions: CNI is a potential complication of TC-TAVR likely avoidable by a meticulous surgical technique. Structural heart teams must be aware of this serious setback., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background: Biological data suggest that short-term anticoagulation would be more effective than dual antiplatelet therapy (DAPT) to reduce the thrombotic risk following left atrial appendage closure (LAAC). This study sought to assess the safety and efficacy of direct oral anticoagulation (DOAC) versus DAPT immediately post-LAAC., Methods: Multicenter study including 592 consecutive patients with relative contraindication to chronic anticoagulation who underwent LAAC and received either DAPT or DOAC for 1-3 months. Each patient receiving DOAC was matched with 2 patients on DAPT based on propensity-score (propensity-matched population of 285 patients). Outcomes recorded were death, stroke, non-procedural related severe bleeding, serious adverse event (SAE: composite of death, stroke, bleeding) and early (within 3 months post-LAAC) device-related thrombosis (DRT)., Results: Early outcomes (within 3-month post-LAAC) did not significantly differ between groups, but a numerically higher rate of early death (3.7% vs. 1.1%), non-procedural related severe bleeding (7.4% vs. 3.2%), and SAE (11.1% vs. 5.3%) were observed in patients receiving DAPT. After a median follow-up of 22 (8-38) months, similar outcomes were observed in DAPT and DOAC groups regarding death (HR: 1.18; 95% CI: 0.58-2.37; p = 0.652), stroke (HR: 1.01; 95% CI: 0.22-5.45; p = 0.908), non-procedural related severe bleeding (HR: 1.68; 95% CI: 0.69-4.12; p = 0.257), and SAE (HR: 1.28; 95% CI: 0.73-2.24; p = 0.383). DRT was identified in 4 patients (2.6%) receiving DAPT versus 0 patient receiving DOAC (p = 0.162)., Conclusions: Short-term DOAC following LAAC in patients with contraindications to chronic anticoagulation was safe and tended to associate with a lower rate of SAE and DRT compared to DAPT., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Scarce data exist on transcatheter heart valve (THV) performance evaluated by cardiac magnetic resonance (CMR) in newer generation THV patients. Furthermore, it has been suggested that echocardiographic evaluation after TAVR may inaccurately assess residual AR in some patients. This study aimed to determine the incidence and severity of aortic regurgitation (AR) assessed by CMR in patients undergoing TAVR with the SAPIEN 3 valve, and evaluate the agreement between CMR and transthoracic echocardiography (TTE) on the assessment of AR severity in such patients., Methods: This multicentric observational study included 146 SAPIEN 3 patients with TTE and CMR within the month following their procedure. According to the CMR regurgitation fraction (RF), AR was considered mild and moderate-severe if the RF was 15-<30% and ≥ 30%, respectively. TTE exams followed VARC-2 recommendations., Results: By CMR, SAPIEN 3 recipients displayed a mean RF of 5.0 ± 6.1%, and mild and moderate-severe AR rates of 3.4% and 0.7%, respectively. The agreement between CMR-TTE was modest (weighted κ = 0.2640, p<0.001), due to an overestimation of AR severity by TTE. A historical cohort of 139 SAPIEN XT patients with a post-procedure CMR, displayed a mean RF of 9.6 ± 10.7% and mild and moderate-severe AR rates of 18.7% and 3.6%, respectively (p < .001 vs. SAPIEN 3 group)., Conclusions: SAPIEN 3 recipients exhibited very low rates of residual AR by CMR, suggesting a surgical-like performance regarding AR with this newer generation THV. TTE tended to overestimate the severity of AR, particularly among mild AR patients., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Few and controversial data exist on the outcomes of patients with paradoxical low-flow, low-gradient aortic stenosis (PLFLG-AS) following transcatheter aortic valve replacement (TAVR). This study aims to better characterize clinical outcomes and predictors of treatment futility in PLFLG-AS patients undergoing TAVR., Methods: In this multicenter study, 318 patients with PLFLG-AS undergoing TAVR were categorized according to treatment futility, defined as all-cause mortality, poor functional status (NYHA class III-IV) or deterioration in functional class at 1-year follow-up. Clinical outcomes and the factors associated with treatment futility were assessed., Results: The mean age of the patients was 81.0 ± 8.3 years and 50.3% were women. At 1-year follow-up, 17.6% died and 12.9% had heart failure hospitalization. Residual impaired functional capacity (NYHA ≥ II) was present in 54.4% of patients who were alive at 1-year, and 9.8% remained in NYHA III/IV. The primary endpoint was observed in 103 (32.4%) patients, of which 54% died and 46% had a poor or worsening functional class. Factors independently associated with treatment futility were the presence of atrial fibrillation (AF) (OR:1.79, 95%CI, 1.04-3.10), chronic obstructive pulmonary disease (COPD) (OR:2.66, 95%CI, 1.50-4.74) and a lower SVi (OR per each decrease in 10 ml/m 2 :1.89, 95%CI, 1.06-3.45). The risk of treatment futility of patients with AF, COPD and a SVi < 30 ml/m 2 was 66.38% (95%CI, 54.29%-78.48%)., Conclusion: Close to one-third of patients with PLFLG-AS failed to derive a benefit from TAVR. The presence of AF, COPD and a low SVi were predictors of treatment futility. Being able to identify patients less likely to improve after the procedure may help to guide management and improve outcomes in patients with PLFLG-AS., Competing Interests: Declaration of competing interest Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciencies, Medtronic and Boston Scientific. Dr. Pibarot reports having Core Lab contracts with Edwards Lifesciences for which he receives no direct compensation, and receiving grants from Edwards Lifesciences and Medtronic during the conduct of the study. The rest of authors do not report any potential conflict of interest with respect to the content of this study., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Aortic valve calcification severity has been associated with higher rates of aortic regurgitation (AR) following TAVR, but scarce data exist on its impact with the use of newer generation transcatheter heart valves., Methods: This was a multicenter study including 626 patients with severe aortic stenosis who underwent TAVR with the SAPIEN 3 valve. Patients were divided in 2 groups according to the median index calcium score (iCS) for each sex: high CS (HCS, iCS ≥ median), and low iCS (LCS, iCS < median). Another analysis was performed in those patients with extreme iCS (ECS, iCS >75th percentile for each sex). Clinical and echocardiographic data were collected prospectively in a dedicated database., Results: The mean CS was 3758 ± 1417 AU and 1616 ± 691 AU in the HCS and LCS groups, respectively (p < 0.001). There were no differences between groups in 30-day mortality (HCS:2.6%, LCS:1.0%, p = 0.13) and stroke (HCS:2.6%,LCS:2.6%, p = 1.0) rates, but all cases (n = 5) of annulus rupture occurred in the HCS group (1.6% vs. 0%, p = 0.061). The incidence of moderate-severe AR post-TAVR was low in both groups (HCS:1.6%,LCS:1.6%, p = 1.0), and valve gradient and area were similar between groups. The results remained similar in the ECS group (mean CS:4607 ± 1424 AU), but a mildly increased mean transvalvular gradient post-TAVR was observed in ECS patients (12.1 ± 5.6 vs 11.0 ± 4.3 mmHg; p = 0.015)., Conclusion: Aortic valve calcification severity failed to impact mortality/stroke rates following TAVR with the SAPIEN 3 valve. Low rates of significant AR were observed irrespective of CS, and a mild increase in transvalvular gradient was observed in ECS patients., Competing Interests: Declaration of competing interest Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciences. The other authors have not reported any potential conflict of interest with respect to the content of this paper., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objective: In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR), the impact of concomitant mitral stenosis (MS) remains unknown. The aim of this study was to determine the incidence and impact of moderate to severe MS in patients undergoing TAVR., Methods: The study included 2113 consecutive patients (mean age: 80 ± 9 years, mean STS: 6.4 ± 5.2%) who underwent TAVR in 2 centers. The presence of MS was defined as a mean transmitral gradient ≥ 5 mm Hg on baseline echocardiography in the absence of severe mitral regurgitation. Clinical events were prospectively collected in a dedicated TAVR database., Results: A total of 157 patients (7.4%) had moderate to severe MS (mean gradient: 7.2 ± 2.8 mm Hg; degenerative origin in 88%). Patients with MS were younger, more frequently women, had a higher left ventricular ejection fraction and an increased rate of severe pulmonary hypertension (p < 0.02 for all). Thirty-day mortality was similar in both groups (MS: 3.8%; no MS: 5.5%, adjusted p = 0.34). At a mean follow-up of 3 ± 2 years, there were no differences between groups in mortality (MS: 35%, no MS: 36.2%, adjusted HR: 1.14, 95% CI: 0.86-1.51), or heart failure rehospitalization (MS: 21%, no MS: 21.7%; adjusted HR: 1.16, 95% CI: 0.81-1.67). Patients with MS exhibited a similar functional status at follow-up compared to those with no MS (NYHA I-II in 85% and 88% of patients, respectively, adjusted p = 0.20)., Conclusions: About 7% of patients undergoing TAVR had concomitant moderate to severe MS. The presence of MS had no negative impact on early and mid-term clinical outcomes post-TAVR. These results suggest that TAVR is a valid alternative for treating patients with aortic stenosis in the presence of moderate to severe MS., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking., Methods and Results: We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years., Conclusions: The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. CLINICALTRIALS., Gov Identifier: NCT02302131., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Objective: The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices., Methods: A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses., Results: A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n=5423, 45.9%), Lotus Valve (n=3007, %), Portico (n=130, 1.1%), JenaValve (n=345, 2.9%), Symetis Acurate (n=1314, 11,1%), and Evolut R (n=1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3)., Conclusions: Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with <2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Secundum atrial septal defects (ASDs) are treated by surgical closure (SC) or transcatheter device closure (TCC). Due to a scarcity of data directly comparing these approaches, it remains unclear which is superior. This meta-analysis compares the clinical outcomes of the two treatment options., Methods: A literature search was performed in MEDLINE, Embase, PubMed, Google Search, and Cochrane databases for studies directly comparing SC and TCC of ASDs. Outcomes studied were major and minor acute complications, all-cause mortality, residual shunt, reinterventions, and length of stay (LOS). Relative risk (RR), difference in mean (DM) and 95% confidence intervals (CI) were calculated using the Mantel-Haenszel method with a fixed effect model. In cases of heterogeneity (defined as I 2 >25%), random effect models were used. Sensitivity and meta-regression analyses were performed for each outcome., Results: Of the 1742 manuscripts screened, 26 observational studies fulfilled the inclusion criteria (total n=14,559 patients). TCC was superior to SC for the following outcomes: all-cause mortality (RR, 0.66; 95% CI 0.64-0.99), total complications (RR, 0.48; 95% CI 0.35-0.65), major complications (RR, 0.57; 95% CI 0.40-0.81), minor complications (RR, 0.35; 95% CI 0.23-0.53), and LOS (DM, -2.92; 95% CI -3.25 to (-2.58)). Residual shunts were more common with TCC (RR, 3.35; 95% CI 1.72-6.51). No difference was observed regarding the need of reintervention (RR, 1.45; 95% CI 0.60-3.51). Meta-regression analysis showed that older age increases the risk of death and complications in patients undergoing TCC., Conclusions: Though both approaches are effective, TCC is associated with lower mortality, complications, and LOS while SC has a lower rate of residual shunting., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Tricuspid valve (TV) repair at the time of left-sided valve surgery is indicated in patients with either severe functional tricuspid regurgitation (TR) or mild-to-moderate TR with coexistent tricuspid annular dilation or right heart failure. We assessed the benefits of a concomitant TV repair strategy during left-sided surgical valve interventions, focusing on mortality and echocardiographic TR-related outcomes., Methods: A meta-analysis was performed of studies reporting outcomes of patients who underwent left-sided (mitral and/or aortic) valve surgery with or without concomitant TV repair. Primary endpoints were all-cause and cardiac-related mortality; secondary endpoints were the presence of more-than-moderate TR, TR progression, and TR severity grade. All endpoints were evaluated at the longest available follow-up., Results: Fifteen studies were included for a total of 2840 patients. TV repair at the time of left-sided valve surgery was associated with a significantly lower risk of cardiac-related mortality (odds ratio [OR] 0.38; 95% confidence interval [CI]: 0.25-0.58; p<0.001), with a trend towards a lower risk of all-cause mortality (OR 0.57; 95% CI: 0.32-1.05; p=0.07) at a mean weighted follow-up of 6years. The presence of more-than-moderate TR (OR 0.19; 95% CI: 0.12-0.30; p<0.001), TR progression (OR 0.03; 95% CI: 0.01-0.05; p<0.001), and TR grade (standardized mean difference -1.11; 95% CI: -1.57 to -0.65; p<0.001) were significantly lower in the TV repair group at a mean weighted follow-up of 4.7years., Conclusions: A concomitant TV repair strategy during left-sided valve surgery is associated with a reduction in cardiac-related mortality and improved echocardiographic TR outcomes at follow-up., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) has emerged as an alternative to surgical aortic-valve replacement (SAVR) for patients with severe symptomatic aortic stenosis (AS) who are at high operative risk. We sought to determine the long-term (≥1year follow-up) safety and efficacy TAVR compared with SAVR in patients with severe AS., Methods: A comprehensive search of PubMed, EMBASE, Cochrane Central Register of Controlled Trials, conference proceedings, and relevant Web sites from inception through 10 April 2016., Results: Fifty studies enrolling 44,247 patients met the inclusion criteria. The mean duration follow-up was 21.4months. No difference was found in long-term all-cause mortality (risk ratios (RR), 1.06; 95% confidence interval (CI) 0.91-1.22). There was a significant difference favoring TAVR in the incidence of stroke (RR, 0.82; 95% CI 0.71-0.94), atrial fibrillation (RR, 0.43; 95% CI 0.33-0.54), acute kidney injury (RR, 0.70; 95% CI 0.53-0.92), and major bleeding (RR, 0.57; 95% CI 0.40-0.81). TAVR had significant higher incidence of vascular complications (RR, 2.90; 95% CI 1.87-4.49), aortic regurgitation (RR, 7.00; 95% CI 5.27-9.30), and pacemaker implantation (PPM) (RR, 2.02; 95% CI 1.51-2.68). TAVR demonstrated significantly lower stroke risk compared to SAVR in high-risk patients (RR, 1.49; 95% CI 1.06-2.10); no differences in PPM implantation were observed in intermediate-risk patients (RR, 1.68; 95% CI 0.94-3.00). In a meta-regression analysis, the effect of TAVR baseline clinical features did not affect the long-term all-cause mortality outcome., Conclusion: TAVR and SAVR showed similar long-term survival in patients with severe AS; with important differences in treatment-associated morbidity., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Objective: We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV)., Background: BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients., Methodology: We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint--a composite of 30 day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30 days and 1 year., Results: A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%)--mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1 year mortality rates were 8.3% and 16.9% respectively with AR ≥ 3+ occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30 day or 1 year mortality--Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants., Conclusion: In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: In the EASY trial, we have shown the clinical equivalence between abciximab bolus-only and abciximab bolus followed by 12-h infusion in a wide spectrum of patients after percutaneous coronary intervention (PCI). Some reports have suggested better outcomes following intracoronary (IC) abciximab administration compared to intravenous (IV) delivery. We sought to compare cardiac biomarkers release and early and late clinical outcomes after IC or IV abciximab bolus delivery., Methods: From 1005 patients randomized in the EASY trial and undergoing transradial coronary stent implantation, 208 received IC abciximab bolus and 797 received IV abciximab bolus. Route of administration was left to operators' discretion. Creatine Kinase-MB, and Troponin-T (Tn-T) were obtained immediately prior to angiography, 4-6 h after PCI and the next day. MACE (death, MI, TVR) rate was evaluated at 30 days, 6 months and 12 months., Results: There were more patients with acute coronary syndrome (75% vs 64%, P=0.004) and previous MI (53% vs 42%, P=0.005) in the IC group and more patients with >or=3 dilated sites in the IV group (2% IC vs 7% IV, P=0.03). After PCI, the extent of Tn-T and CK-MB release remained comparable in both groups. The MACE rate was 2% in both groups at 30 days, 9% in IC bolus vs 5% in IV bolus (P=0.04) at 6 months and 10% in IC bolus vs 9% in IV bolus (P=0.50) at 12 months. By multivariate analysis, IC abciximab bolus was not associated with better outcomes at 12 months compared to IV bolus (HR 1.07, 95% CI 0.82-1.35, P=0.62)., Conclusion: Compared to IV abciximab administration, IC abciximab was not associated with less cardiac biomarkers release or better clinical outcomes after uncomplicated transradial PCI. Further studies are required in clinical scenarios including patients with higher thrombotic burden and/or occluded vessels as in primary and rescue PCI.

Introduction: Few data exist regarding the potential benefits of continuous echocardiographic guidance during balloon aortic valvuloplasty (BAV) for the treatment of congenital aortic stenosis (AS). The objectives of this study were 1) to prospectively evaluate, in a series of consecutive patients with severe AS, the efficacy of BAV guided by Doppler echocardiography (DE) in relieving AS while preventing the appearance of significant aortic regurgitation (AR), and 2) to compare the results obtained by BAV-DE with those obtained in a historical series of patients who underwent BAV without echocardiographic guidance (BAV guided by angiography, BAV-A)., Methods: From 1995 to 2006 a total of 36 consecutive patients with AS (median age 6 years, range, 1 day to 26 years) underwent BAV in our center, with systematic application of continuous DE guidance since 2003. BAV-DE consisted of measuring the aortic annulus, choosing balloon diameters and evaluating the results of each balloon dilation on the basis of DE., Results: Seventeen patients underwent BAV-DE (transthoracic and transesophageal DE in 3 and 14 patients, respectively) with successful transaortic gradient relief in 88% of them. None of the patients complicated with moderate or severe AR. At 17+/-13 months follow-up there had been 3 cardiac events (18%), all of them related to aortic restenosis. BAV-A was associated with longer fluoroscopic times (35 min vs 16 min, p=0.005 after adjusting for age and weight differences between groups) and a higher degree of AR following BAV (>or=2 degrees increase in AR, 32% vs 0%, p=0.045 after adjusting for age and weight). Angiographic measurements of the aortic annulus were higher than those obtained by DE (mean overestimation+2.5+/-1.8 mm, range 0 to +6 mm, p<0.0001)., Conclusion: BAV-DE provides successful gradient relief of severe AS with lower fluoroscopy time and a lower degree of AR compared to BAV-A. Overestimation of aortic annulus diameters by angiographic measurements might partially explain the high rate of significant AR associated with BAV in the absence of echocardiographic guidance.

Background: Aspirin has been routinely prescribed following transcatheter closure of secundum atrial septal defects (ASDs) but its rationale has not been clinically or biologically evaluated; and despite aspirin, thrombotic complications occur following transcatheter ASD closure. We therefore evaluated the presence, degree and timing of the activation of the coagulation and platelet systems following transcatheter closure of ASDs., Methods and Results: Fourteen consecutive patients (9 females, mean age 41+/-22 years) who underwent successful transcatheter closure of an ASD defect with the Amplatzer septal occluder were prospectively studied. Measurements of the prothrombin fragment 1+2 (F1+2) levels and the percentage of activated platelets (determined by P-selectin expression detected by flow cytometry) were taken at baseline just before the procedure, and at 1, 7, 30 and 90 days following device implantation. F1+2 levels increased from 0.85+/-0.29 nmol/l at baseline to a maximal value of 1.20+/-0.52 nmol/l at 7 days, gradually returning to the baseline levels at 90 days (0.79+/-0.54 nmol/l) (p<0.001). F1+2 levels at 7 days were also significantly higher than those obtained in a control group of 20 healthy subjects (p=0.016). A greater increase in coagulation activation was observed in cases of residual shunt following ASD closure (r=0.53, p=0.050). No significant variations in the percentage of platelets expressing P-selectin were detected at any time., Conclusions: Transcatheter closure of ASDs with the Amplatzer septal occluder was associated with a significant increase in F1+2 levels during the first week after device implantation, but there was no detectable effect on platelet system activation. These findings raise the question whether the optimal prophylactic approach following transcatheter ASD closure should be anticoagulant instead of antiplatelet therapy.