Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI) (original) (raw)
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Catheterization and Cardiovascular Interventions, 2015
Objective: To assess midterm (3 years) clinical outcomes of transcatheter aortic valve implantation (TAVI) in Belgium using the Edwards SAPIEN valve or the Medtronic Core-Valve transcatheter heart valve (THV). Background: Medium and long term follow-up data of both THVs are still relatively scarce, although of great clinical relevance for a relatively new but rapidly expanding treatment modality. Therefore, reporting mid-and long term clinical outcome data, coming from large "real world" national registries, remains contributive. Methods: Between December 2007 and March 2012, 861 "real world" patients who were not candidates for surgical aortic valve replacement as decided by the local heart teams, underwent TAVI at 23 sites. Eleven sites exclusively used SAPIEN THV (n 5 460), while 12 exclusively used CoreValve THV (n 5 401). Differences in clinical outcomes by valve system were assessed, according to access route and baseline EuroSCORE risk profile (<10%: low, 10-20%: intermediate and >20%: high risk). Results: Overall cumulative survival at 3 years was 51% for SAPIEN vs. 60% for CoreValve (P 5 0.021). In transfemorally treated patients, SAPIEN and CoreValve had similar survival at 3 years for each of the baseline EuroSCORE cohorts (low risk: 72% vs. 76%, P 5 0.45; intermediate risk: 62% vs. 59%, P 5 0.94; high risk: 48% vs. 53%, P 5 0.65). Conclusion: Cumulative midterm 3 year survival after transfemoral TAVI in "real world" patients refused for surgery with similar baseline EuroSCORE risk profile is not different between SAPIEN or CoreValve. V
The American Journal of Cardiology, 2015
Many patients have ilio-femoral vessel anatomy unsuitable for conventional transfemoral (TF) trans-catheter aortic valve implantation (TAVI). Safe and practical alternatives to the TF approach are therefore needed. This study compared outcomes of alternative non-femoral routes, trans-apical (TA), direct aortic (DA) and subclavian (SC), with standard femoral access. In this retrospective study, data from 3,962 patients in the UK TAVI registry were analysed. All patients who received TAVI via a femoral, subclavian, transapical or direct aortic approach were eligible for inclusion. The primary outcome measure was survival up to two years. Median Logistic EuroSCORE was similar for SC, DA, and TA, but significantly lower in the TF cohort (22.1% vs 20.3% vs 21.2% vs 17.0% respectively, p<0.0001). Estimated oneyear survival was similar for TF (84.6±0.7%) and SC (80.5±3%, p=0.27), but significantly worse for TA (74.7±1.6%, p<0.001) and DA (75.2±3.3%, p<0.001). A Cox proportional hazard model was used to analyse survival up to 2-years. Survival in the SC group was not significantly different to the TF group (HR 1.22, 95% CI 0.88-1.70, p=0.24). In contrast, survival in the TA (HR 1.74, 95% CI 1.43-2.11;p<0.001) and DA (HR 1.55, 95% CI 1.13-2.14; p<0.01) cohorts was significantly reduced compared to TF. In conclusion, trans-apical and direct aortic TAVI were associated with similar survival, both significantly worse than with the trans-femoral route. In contrast, subclavian access was not significantly different to trans-femoral, and may represent the safest non-femoral access route for TAVI.
Transapical Versus Transfemoral Aortic Valve Implantation: A Comparison of Survival and Safety
The Annals of Thoracic Surgery, 2011
Background. Transcatheter aortic valve implantation (TAVI) is a therapeutic option for high-risk patients with aortic stenosis. Procedural mortality remains high in comparison with conventional aortic valve replacement (AVR) because patients determined for TAVI are commonly denied conventional surgery. We aimed to evaluate access-related complications between the transfemoral (TF) and the transapical (TA) approach and to compare survival between TAVI and conventional AVR in propensity-score-matched patients.
Journal of Interventional Cardiology, 2014
Objectives: To determine whether outcomes from transcatheter aortic valve implantation (TAVI) vary according to access route and valve type in a real-world population. Background: Registry and uncontrolled trial data have found that patients undergoing nonfemoral TAVI have higher early and late mortality. It is not clear whether worse outcomes relate directly to access route. There have been no direct comparisons of outcomes according to valve type. Methods: Data were collected prospectively on 1,620 patients undergoing TAVI in the UK and compared in 4 groups: SAPIEN transfemoral (TF); SAPIEN transapical (TA); CoreValve TF, CoreValve subclavian. Univariable and multivariable regression analysis was performed to identify independent predictors of mortality. Results: Mortality in patients undergoing SAPIEN TAVI via a TA approach was higher than with TF at 30 days (11.2% vs. 4.4%, P < 0.01), 1 year (28.7% vs. 18.1%, P ¼ 0.01), and 2 years (56.0% vs. 43.5%, P ¼ 0.01). Logistic EuroSCORE was higher in TA patients (22.5 AE 12.9% vs. 17.7 AE 11.1%, P < 0.0001). After multivariable analysis TA access was associated with increased mortality at 30 days (OR 2.56, 95% CI 1.46-4.48, P < 0.01) and 2 years (OR 1.75, 1.08-2.74, P ¼ 0.02). There was no significant difference in mortality at any time-point between patients treated with SAPIEN (n ¼ 812) and CoreValve (n ¼ 808) prostheses. CoreValve-treated patients had a higher rate of permanent pacemaker implantation (23.1% vs. 7.2%, P < 0.0001), and grade !2 aortic regurgitation on postprocedure echocardiography (13.0% vs. 7.3%, P < 0.01). Conclusions: Patients undergoing TA TAVI experienced increased early and late mortality compared to a TF approach. Survival was not influenced by valve type. (J Interven Cardiol 2014;27:86-95)
The American Journal of Cardiology, 2015
Patients with previous coronary artery bypass grafting (CABG) are considered to be at increased perioperative risk for a redo cardiac operation. In the era of transcatheter aortic valve implantation (TAVI), these patients constitute a considerable portion of those with severe aortic stenosis referred for TAVI. We evaluated the impact of previous CABG on transfemoral TAVI outcomes. Patients with severe symptomatic aortic stenosis (n [ 515) who underwent transfemoral TAVI were divided according to the presence of history of CABG. Patients with previous valvular surgery were excluded (n [ 12). TAVI clinical end points and adverse events were considered according to the Valve Academic Research Consortium 2 definitions. Survival was estimated using Cox regression models at the enter mode with the dependent variable defined as all-cause mortality. Of the total 503 patients who underwent TAVI, 91 (18.1%) had previous CABG. At baseline, patients with previous CABG were younger (80.8 vs 83.1 years, p <0.001), mostly men (85% vs 35%, p <0.001), had more cardiac and vascular co-morbidities, higher mean logistic EuroSCORE (32.8 vs 22; p <0.001), lower ejection fraction (53% vs 56%, p <0.001), and lower AV gradients and larger valve area. At a mean follow-up of 636 days, the overall Valve Academic Research Consortium 2eadjudicated end points did not differ. No differences in mortality were observed at 30 days, 6 months, and 1 year after TAVI (hazard ratio 1.34, p [ 0.55, Cox regression). We conclude that patients with previous CABG who underwent TAVI do not have increased risk of periprocedural complications or mortality, although having distinct clinical features compared with the total TAVI population.
EuroIntervention, 2014
Aims: To evaluate short-term clinical outcomes following transcatheter aortic valve implantation (TAVI) using CE-mark approved devices in Switzerland. Methods and results: The Swiss TAVI registry is a national, prospective, multicentre, monitored cohort study evaluating clinical outcomes in consecutive patients undergoing TAVI at cardiovascular centres in Switzerland. From February 2011 to March 2013, a total of 697 patients underwent TAVI for native aortic valve stenosis (98.1%), degenerative aortic bioprosthesis (1.6%) or severe aortic regurgitation (0.3%). Patients were elderly (82.4±6 years), 52% were females, and the majority highly symptomatic (73.1% NYHA III/IV). Patients with severe aortic stenosis (mean gradient 44.8±17 mmHg, aortic valve area 0.7±0.3 cm 2) were either deemed inoperable or at high risk for conventional surgery (STS 8.2%±7). The transfemoral access was the most frequently used (79.1%), followed by transapical (18.1%), direct aortic (1.7%) and subclavian access (1.1%). At 30 days, rates of all-cause mortality, cerebrovascular events and myocardial infarction were 4.8%, 3.3% and 0.4%, respectively. The most frequently observed adverse events were access-related complications (11.8%), permanent pacemaker implantation (20.5%) and bleeding complications (16.6%). The Swiss TAVI registry is registered at ClinicalTrials.gov (NCT01368250). Conclusions: The Swiss TAVI registry is a national cohort study evaluating consecutive TAVI procedures in Switzerland. This first outcome report provides favourable short-term clinical outcomes in unselected TAVI patients.
Incidence and prognosis of vascular complications after transcatheter aortic valve implantation
Journal of Vascular Surgery, 2013
Objective: Transcatheter aortic valve implantation (TAVI) has gained increasing global popularity as a minimally invasive option for high-risk cardiac patients. However, this operation is not without risk, particularly of significant vascular complications that increase the morbidity, mortality, and overall cost of the procedure. We aim to present our experience of TAVI-related vascular complications, including the morbidity and cost impacts of these events. Methods: A case-series study was performed for all patients undergoing TAVI at our center. Vascular complications were defined according to the 2011 Valve Academic Research Consortium standardized end points. The data were prospectively collected from February 2009 to April 2012, and the outcomes were entered into a database and cross-checked with the hospital notes. Results: TAVI was performed on 100 patients in our center during the study period, and the 30-day mortality was 6%. Access approaches included 81 transfemoral, 18 transapical, and one trans-subclavian access. The average patient age was 84.9 years, and 65% of the patients were male. Among the transfemoral procedures, there were 16 vascular access-related complications (VAC), including nine major and seven minor complications. The major complications included aortic dissection, iliac arterial rupture, femoral dissection, false aneurysms, and distal embolization, all of which required surgical or endovascular repair. An apical false aneurysm and an apical tear were major VAC of the transapical group, with the latter resulting in death. Patients with VAC had higher blood transfusion requirements (4.1 6 4.5 units vs 0.9 6 2.2 units; P [ .004), greater length of hospital stay (16.4 6 10.7 days vs 6.5 6 5.1 days; P [ .001), and increased cost (A$93,448 6 21,435 vs A$69,932 6 15,007; P [ .002) compared with the non-VAC group. The predictors of vascular complications using multivariate analysis included European System for Cardiac Operative Risk Evaluation (odds ratio, 1.06; 95% confidence interval, 1.02-1.10; P [ .001) and diabetes mellitus (odds ratio, 5.07; 95% confidence interval, 1.17-21.88; P [ .03). Occurrence of major VAC did not affect in-hospital or 30-day mortality rates and was not associated with poorer survival. Conclusions: Vascular complications affect perioperative management and outcomes following TAVI. Our findings show that these complications often require urgent surgical or endovascular repair and result in increased blood transfusions, greater length of hospital stay, and significantly increased costs. Diabetes mellitus and logistic European System for Cardiac Operative Risk Evaluation may be predictive of VAC and should be considered during TAVI patient selection.