Our study objective was to assess the incidence, predictors, and implications of access site complications related to transfemoral transcatheter aortic valve implantation (TAVI). We pooled the ...prospective TAVI databases of 5 experienced centers in Europe enrolling only transfemoral cases for this analysis. Access site complications were defined according to the Valve Academic Research Consortium end-point definitions. The global transfemoral TAVI database contained 986 patients. Percutaneous access and closure was performed in 803 patients (81%) and a surgical strategy in 183 (19%). Incidences of major vascular complications, life-threatening/disabling bleeding, and major bleeding were 14.2%, 11%, and 17.8% respectively. In the patient cohort with a completely percutaneous access strategy, major vascular complications and life-threatening/disabling bleedings were related to closure device failure in 64% and 29%, respectively. Female gender (odds ratio 1.63, 95% confidence interval 1.12 to 2.36) and use of >19Fr system (2.87, 1.68 to 4.91) were independent predictors for major vascular complications. Female gender (odds ratio 2.04, 95% confidence interval 1.31 to 3.17), use of >19Fr system (1.86, 1.02 to 3.38), peripheral arterial disease (2.14, 1.27 to 3.61), learning effect (0.45, 0.27 to 0.73), and percutaneous access strategy (2.39, 1.16 to 4.89) were independently associated with life-threatening/disabling bleedings. In conclusion, transfemoral TAVI is associated with a >10% incidence of major vascular-related complications. A considerable number of these events is related to arteriotomy closure failure. Arterial sheath size and female gender are important determinants of major vascular complications and life-threatening/disabling bleeding.
Background Only limited and conflicting data on the impact of preoperative chronic kidney disease (CKD) on outcomes after transcatheter aortic valve implantation (TAVI) are available. Methods We ...retrospectively analyzed pooled data from the prospective TAVI databases of 4 centers (942 patients). Valve Academic Research Consortium end point definitions were used. The outcomes were compared among patients with normal estimated glomerular filtration rate (≥90 mL/min), mild (60-89 mL/min), moderate (30-59 mL/min), and severe (<30 mL/min) CKD and those on chronic hemodialysis (HD). The primary end point was 1-year survival. Results A total of 109 patients had a normal estimated glomerular filtration rate (11.6%); 329 (34.9%) had mild, 399 (42.5%) moderate, 72 (7.5%) severe CKD, and 33 (3.5%) were on HD. Baseline and procedural characteristics were similar among all groups except for Logistic EuroSCORE. Major stroke, life-threatening bleeding, all-cause 30-day mortality (HD 15.2%, severe CKD 8.3%, moderate CKD 8.3%, mild CKD 6.7%, normal 1.8%, P = .007) and 1-year survival (HD 54.8%, severe CKD 67.2%, moderate CKD 80.0%, mild CKD 85.2%, normal eGFR 91.4%, HD vs severe CKD P = .23, severe CKD vs moderate CKD P = .002, moderate CKD vs mild CKD P = .04, moderate CKD vs normal eGFR P = .03, by log-rank test) differed significantly across groups. Through multivariable analysis, HD and severe CKD were independently associated with an increased risk of 1-year mortality (hazard ratios 5.07 95% CI 1.79-14.35, P = .002 and 4.03 95% CI 1.52-10.69, P = .005, respectively). Conclusions Patients with CKD who undergo TAVI have a higher-risk profile and worse 30-day and 1-year outcomes. Chronic hemodialysis and severe preprocedural CKD are independently associated with an increased risk of 1-year mortality after TAVI.
Background There are no direct comparisons between transapical aortic valve implantation (TA-AVI) and transfemoral aortic valve implantation (TF-AVI). Therefore, the aim of this study was to compare ...the short-term and midterm outcomes of TA-AVI versus TF-AVI. Methods Data from four European centers were pooled and analyzed. To minimize differences between TA-AVI and TF-AVI multivariable analysis was used. Study endpoints were defined according to the Valve Academic Research Consortium-I criteria at 30 days and 1 year. Primary endpoints of this study were 30-day all-cause mortality and mortality during follow-up. Results A total of 882 patients underwent TAVI, of whom 793 (89.9%) underwent TF-AVI and 89 (10.1%) underwent TA-AVI. Patients undergoing TA-AVI had a higher estimated risk of mortality as defined by the logistic European System for Cardiac Operative Risk Evaluation score (median 27.0, interquartile range IQR: 20.2 to 33.8 versus median 20.0, IQR: 12.3 to 27.7; p < 0.001) and The Society of Thoracic Surgeons Score (median 10.2, IQR: 5.3 to 9.9 versus median 6.7, IQR: 3.5 to 9.9; p < 0.001) and had more comorbidities. At 30 days, there was an increased risk of all-cause mortality in the TA-AVI group (odds ratio OR 3.12, 95% confidence interval CI: 1.43 to 6.82; p = 0.004). TF-AVI was associated with a higher frequency of major (OR 0.33, 95% CI: 0.12 to 0.90; p = 0.031) and minor vascular complications (OR 0.17, 95% CI: 0.04 to 0.71; p = 0.0015). In-hospital stay was significantly longer among patients undergoing TA-AVI (OR 2.29, 95% CI: 1.28 to 4.09; p = 0.05). During a median follow-up of 365 days (IQR: 174 to 557), TA-AVI was associated with an increased risk of all-cause mortality (hazard ratio 1.88, 95% CI: 1.23 to 2.87; p = 0.004). Conclusions In institutions performing a low volume of TA-AVI, the technique is associated with an increased risk of all-cause mortality and longer hospital stay but less vascular complications in comparison with TF-AVI. The interaction between experience and type of treatment on outcome requires further investigation before advocating one treatment over the other.
Background Little is known about the impact of bleeding and red blood cells transfusion (RBC) on the outcome post transcatheter aortic valve implantation (TAVI). Methods Between November 2005 and ...August 2011, 943 consecutive patients underwent TAVI. Bleeding was assessed according to the Valve Academic Research Consortium definitions. Patients receiving RBC were compared to those not requiring transfusion. Results Life-threatening and major bleedings occurred respectively in 13.9% and 20.9% of the patients, significantly more frequently in the RBC cohort. Vascular complications occurred in 23.2% of the patients. Major and minor vascular complications were more frequent in the RBC group: 19.3 vs 5.2%, P < .001; 15.3 vs 9%, P = .003, respectively. Thirty-day all-cause mortality was 7.2%. Of the overall cohort, 38.9% required RBC transfusion; those receiving at least 4 U of RBC had higher 30-day all-cause mortality than those receiving 1 to 4 U of RBC and those not requiring transfusion: 14.4%, vs 6.3% vs 6.3%, respectively, P = .008. By multivariate analysis, transfusion of RBC was associated with an increased 30-day and 1-year mortality. Major stroke and all stages of acute kidney injury were significantly more frequent in the RBC cohort. Conclusions Bleeding is frequent after TAVI, mainly driven by vascular complications. RBC transfusion was associated with increased mortality at 1 year and increased risk of major stroke and acute kidney injury. Specific scores are needed to identify the patients at higher risk for TAVI-related bleeding and RBC transfusion.
Better outcomes have been reported after percutaneous cardiac intervention in obese patients (“obesity paradox”). However, limited information is available on the effect of the body mass index on the ...outcomes after transcatheter aortic valve implantation (TAVI). We, therefore, sought to determine the effect of the body mass index on the short- and long-term outcomes in patients who underwent TAVI. The population consisted of 940 patients, of whom 25 (2.7%) were underweight, 384 had a (40.9%) normal weight, 372 (39.6%) were overweight, and 159 (16.9%) were obese. Overall, the obese patients were younger (79.7 ± 6.4 years vs 81.7 ± 7.3 and 80.8 ± 7.0 years, p = 0.008) and had a greater prevalence of preserved left ventricular and renal function. On univariate analysis, obese patients had a greater incidence of minor stroke (1.3% vs 0 and 0.3%, p = 0.03), minor vascular complications (15.7% vs 9.1% and 11.6%, p = 0.028) and acute kidney injury stage I (23.3% vs 10.7% and 16.1%, p <0.001). After adjustment, body mass index, as a continuous variable, was associated with a lower risk of mortality at 30 days (odds ratio 0.93, 95% confidence interval 0.86 to 0.98, p = 0.023) and no effect on survival after discharge (hazard ratio 1.01, 95% confidence interval 0.96 to 1.07, p = 0.73). In conclusion, obesity was associated with a greater incidence of minor, but no major, perioperative complications after TAVI. After adjustment, obesity was associated with a lower risk of 30-day mortality and had no adverse effect on mortality after discharge, underscoring the “obesity paradox” in patients undergoing TAVI.
Background Transfemoral transcatheter aortic valve implantation (TF-TAVI) is a viable and safe treatment strategy for patients with symptomatic severe aortic stenosis and high operative risk and has ...been introduced as such in the recently updated European guidelines on the management of valvular heart disease.Our aim was to assess trends in outcome after TF-TAVI. Methods Propensity score–matched analysis of a multicenter registry of consecutive patients undergoing TF-TAVI subdivided into 3 tertiles based on enrollment date was performed. Three tertiles of 214 propensity score–matched patients were compared. Results With mounting experience and moving from the initial to the last cohort, procedural contrast volume and radiation time decreased. Over time, there were less major vascular complications (15% vs 7.9%, P = .023), life-threatening bleedings (17.8% vs 7.9%, P = .003), and major bleedings (22.4% vs 12.1%, P = .007). Major vascular complications and life-threatening bleedings caused by closure device failure decreased significantly (9.2% vs 3.1% P = .01 and 5.7% vs 1 % P = .01, respectively). The combined safety end point dropped from 31.3% in tertile (T) (T1) to 17.8% in T3 ( P < .001). By multivariable analysis, the last cohort as compared with the initial cohort was associated with significant reductions in 30-day mortality (odds ratio OR 0.35, 95% CI 0.12-0.96), stage 3 AKI (OR 0.12, 95% CI 0.29-0.93), and the combined safety end point (OR 0.52, 95% CI 0.29-0.93). One-year survival improved significantly (T1 79% vs T3 86%, P = .016). Conclusions Over time, TAVI is performed with significant reductions in major vascular complications, life-threatening bleedings, and the combined clinical safety end point and improved 1-year survival.
Results from randomized trials evaluating thrombus aspiration (TA) in patients with ST-elevation myocardial infarction (STEMI) are conflicting. We assessed 1-year survival in STEMI patients ...participating in the French Registry of Acute ST-Elevation and non–ST-Elevation Myocardial Infarction (FAST-MI) 2010 according to the use of TA during primary percutaneous coronary intervention (PCI). FAST-MI 2010 is a nationwide French registry that included 4,169 patients with acute myocardial infarction at the end of 2010 in 213 centers. Of those, 2,087 patients had STEMI, of whom 1,538 had primary PCI, with TA used in 671 (44%). Patients with TA were younger (61 ± 13.5 vs 63 ± 14 years), with a similar risk score of the Global Registry of Acute Coronary Events (140 ± 31 vs 143 ± 34) and a shorter median time from symptom onset (245 vs 285 minutes); location of acute myocardial infarction, history of myocardial infarction, PCI, or coronary artery bypass surgery did not differ significantly. Thirty-day mortality was 2.1% versus 2.1% (adjusted p = 0.18), and the rate of 1-year survival was 95.5% versus 94.8%. Using fully adjusted Cox multivariate analysis, hazard ratio for 1-year death was 1.13 (95% confidence interval 0.66 to 1.94). After propensity score matching (480 patients per group), 1-year survival was also similar with both strategies. In a real-world setting of patients admitted with STEMI, the use of TA during primary PCI was not associated with improved 1-year survival.
Abstract Objectives The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT in aspirin-sensitive patients. Background The ITALIC ...(Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented. Methods In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post–percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component. Results Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6- versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: −1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding. Conclusions Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT.
Summary Background Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease, no data from comparisons with its metallic stent counterpart ...are available. In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent. Here we report secondary clinical and procedural outcomes after 1 year of follow-up. Methods In a single-blind, multicentre, randomised trial, we enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience, Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. The co-primary endpoints of this study are vasomotion (change in mean lumen diameter before and after nitrate administration at 3 years) and difference between minimum lumen diameter (after nitrate administration) after the index procedure and at 3 years. Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound; composite clinical endpoints based on death, myocardial infarction, and coronary revascularisation; device and procedural success; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at 6 and 12 months. Cumulative angina rate based on adverse event reporting was analysed post hoc. This trial is registered at ClinicalTrials.gov , number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the bioresorbable scaffold group (335 patients, 364 lesions) or the metallic stent group (166 patients, 182 lesions). Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group, whereas the acute recoil post implantation was similar (0·19 mm for both, p=0·85). Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography (1·15 mm vs 1·46 mm, p<0·0001) and quantitative intravascular ultrasound (2·85 mm2 vs 3·60 mm2 , p<0·0001), resulting in a smaller lumen diameter or area post procedure. At 1 year, however, cumulative rates of first new or worsening angina from adverse event reporting were lower (72 patients 22% in the bioresorbable scaffold group vs 50 30% in the metallic stent group, p=0·04), whereas performance during maximum exercise and angina status by SAQ were similar. The 1-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups (16 patients 5% vs five patients 3%, p=0·35). Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses (one definite acute, one definite sub-acute, and one probable late), compared with no patients in the metallic stent group. There were 17 (5%) major cardiac adverse events in the bioresorbable scaffold group compared with five (3%) events in the metallic stent group, with the most common adverse events being myocardial infarction (15 cases 4% vs two cases 1%, respectively) and clinically indicated target-lesion revascularisation (four cases 1% vs three cases 2%, respectively). Interpretation The everolimus-eluting bioresorbable scaffold showed similar 1-year composite secondary clinical outcomes to the everolimus-eluting metallic stent. Funding Abbott Vascular.
Abstract Background The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, ...particularly in those with acute coronary syndrome (ACS). Objectives This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. Methods A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting. Results A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: −1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 95% confidence interval: 0.519 to 6.057; p = 0.361). Conclusions Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel ITALICplus; NCT01476020 )
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