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 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.
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.
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.
Abstract Background Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV). Objectives ...This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV. Methods We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV. Results A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio OR: 0.19, 95% confidence intervals CI: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03). Conclusions TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.
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.
The aim of this study was to identify predictors of 30-day and midterm mortality after transcatheter aortic valve implantation (TAVI) by means of a systemic review. TAVI was demonstrated to be safe ...and efficacious in patients with severe aortic stenosis. An accurate estimation of procedural risk of these patients represents an actual challenge. The PubMed and Cochrane Collaboration databases were systematically searched for studies reporting on the incidence and independent predictors of 30-day and midterm mortality. Adverse events were pooled with random effect, whereas independent predictors are reported as odds ratios (ORs) with 95% confidence intervals (CIs). A total of 25 studies with 8,874 patients were included (median age 82.5 ± 1.5 years, 54.6% women). At 30 days, 7.5% of patients (n = 663) died. At midterm follow-up (median 365 days, interquartile range 267 to 365 days), the cumulative mortality rate was 21.6% (n = 1,917). Acute kidney injury (AKI) stage ≥2 (OR 18.0, 95% CI 6.3 to 52), preprocedural hospitalization for heart failure (OR 9.4, 95% CI 2.6 to 35), periprocedural acute myocardial infarction (OR 8.5, 95% CI 2.6 to 33.5), and increased pro–brain natriuretic peptide (pro-BNP) levels (OR 5.4, 95% CI 1.7 to 16.5) were the most important independent predictors of 30-day mortality. Increased pro-BNP levels (OR 11, 95% CI 1.5 to 81), AKI stage 3 (OR 6.8, 95% CI 2.6 to 15.7), left ventricular ejection fraction <30% (OR 6.7, 95% CI 3.5 to 12.7), and periprocedural acute myocardial infarction (OR 6.5, 95% CI 2.3 to 18.1) represented the predictors of midterm mortality. In conclusion, in this large meta-analysis of patients undergoing TAVI, we found that high pro-BNP levels and postprocedural AKI were the strongest independent predictors of both 30-day and 1-year mortality. These findings may contribute to a better understanding of the risk assessment process of patients undergoing TAVI.
Objectives The aim of this study was to compare outcomes after transfemoral transcatheter aortic valve implantation with the Medtronic CoreValve (MCV) versus the Edwards SAPIEN/SAPIEN XT ...transcatheter heart valve (ESV) for severe aortic stenosis. Background No large matched comparison study has been conducted so far evaluating both commercially available devices. Methods The data from databases of 4 experienced European centers were pooled and analyzed. Due to differences in baseline clinical characteristics, propensity score matching was performed. Study objectives were Valve Academic Research Consortium outcomes at 30 days and 1 year. Results In total, 793 patients were included: 453 (57.1%) treated with the MCV and 340 (42.9%) with the ESV. After propensity matching, 204 patients were identified in each group. At 30 days, there were no differences in all-cause mortality (MCV, 8.8% vs. ESV, 6.4%; hazard ratio HR: 1.422; 95% confidence interval CI: 0.677 to 2.984; p = 0.352), cardiovascular mortality (MCV, 6.9% vs. ESV, 6.4%; HR: 1.083; 95% CI: 0.496 to 2.364; p = 0.842), myocardial infarction (MCV, 0.5% vs. ESV, 1.5%; HR: 0.330; 95% CI: 0.034 to 3.200; p = 0.339), stroke (MCV, 2.9% vs. ESV, 1.0%; HR: 3.061; 95% CI: 0.610 to 15.346; p = 0.174), or device success (MCV, 95.6% vs. ESV, 96.6%; HR: 0.770; 95% CI: 0.281 to 2.108; p = 0.611). Additionally, there were no differences in major vascular complications (MCV, 9.3% vs. ESV, 12.3%; HR: 0.735; 95% CI: 0.391 to 1.382; p = 0.340) or life-threatening bleeding (MCV, 13.7% vs. ESV, 8.8%; HR: 1.644; 95% CI: 0.878 to 3.077; p = 0.120). MCV was associated with more permanent pacemakers (22.5% vs. 5.9%; HR: 4.634; 95% CI: 2.373 to 9.050; p < 0.001). At 1 year, there were no differences in all-cause (MCV, 16.2% vs. ESV, 12.3%; HR: 1.374; 95% CI: 0.785 to 2.407; p = 0.266) or cardiovascular (MCV, 8.3% vs. ESV, 7.4%; HR: 1.145; 95% CI: 0.556 to 12.361; p = 0.713) mortality. Conclusions No differences between the 2 commercially available transfemoral transcatheter aortic valve implantation devices were observed at the adjusted analysis in Valve Academic Research Consortium outcomes except for the need for permanent pacemakers with the MCV.
Abstract Objectives The study sought to assess the safety and efficacy of a minimally invasive strategy (MIS) (local anesthesia and conscious sedation) compared to general anesthesia (GA) among the ...largest published cohort of patients undergoing transcarotid transcatheter aortic valve replacement (TAVR). Background Transcarotid TAVR has been shown to be feasible and safe. There is, however, no information pertaining to the mode anesthesia in these procedures. Methods Between 2009 and 2014, 174 patients underwent transcarotid TAVR at 2 French centers. All patients were unsuitable for transfemoral TAVR due to severe peripheral vascular disease. An MIS was undertaken in 29.8% (n = 52) and GA in 70.1% (n = 122). One-year clinical outcomes were available in all patients and were described according to the Valve Academic Research Consortium-2 consensus. Results Transcarotid vascular access and transcatheter valve deployment was successful in all cases. Thirty-day mortality was 7.4% (n = 13) and 1-year all-cause and cardiovascular mortality were 12.6% (n = 22) and 8.0% (n = 14), respectively. According to the type of anesthesia, there was no between group difference in 30-day mortality (GA 7.3% vs. MIS 7.6%; p = 0.94), 1-year mortality (GA 13.9% vs. MIS 9.6%; p = 0.43), 1-month clinical efficacy (GA 85.2% vs. MIS 94.2%; p = 0.09), and early safety (GA 77.8% vs. MIS 86.5%; p = 0.18). There were 10 (5.7%) periprocedural cerebrovascular events: 4 strokes (2.2%) and 6 transient ischemic attacks (3.4%) among those treated with GA. There was neither stroke nor transient ischemic attack in the MIS group (p < 0.001). Conclusions The transcarotid approach for TAVR is feasible using general or local anesthesia. A higher rate of perioperative strokes was observed with GA.
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