P926Comparative safety and effectiveness of vitamin K antagonist and direct oral anticoagulants in patients with atrial fibrillation undergoing transcatheter aortic valve implantation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J H Butt ◽  
O De Backer ◽  
J B Olesen ◽  
E Havers-Borgersen ◽  
G H Gislason ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background Data on the comparative safety and effectiveness of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve implantation (TAVI) are sparse. Purpose To examine the risk of thromboembolism, bleeding, and all-cause mortality in patients treated with DOACs versus VKAs. Methods Danish nationwide registries were used to identify all patients undergoing TAVI (2011–2016) with a history of AF and who were treated with oral anticoagulants. The risk of outcomes in patients treated with DOACs versus VKAs were examined by the Aalen-Johansen estimator and cause-specific Cox regression models. Results The study population comprised 762 patients (median age 82 [interquartile range 77–85], 52.9% men), of whom 216 (28.3%) and 546 (71.7%) patients were treated with DOACs and VKAs, respectively. The DOAC group was characterized by a higher prevalence of previous thromboembolism and a lower prevalence of chronic kidney disease compared with the VKA group. The distribution of age, sex, CHA2DS2-VASc and HAS-BLED score, and concomitant antiplatelet therapy was similar between groups. Compared with VKA, treatment with DOACs was not associated with a significantly different 3-year absolute risk of thromboembolism (9.5% [95% confidence interval [CI], 4.7%-16.2%] versus 7.7% [95% CI, 5.3%-10.8%] in the DOAC and VKA group, respectively), bleeding (5.3% [95% CI, 2.4%-10.0%] versus 6.3% [95% CI, 4.1%-9.0%]), and all-cause mortality (32.6% [95% CI, 21.9%-43.7%] versus 33.3% [95% CI, 28.3%-38.5%]). In adjusted analyses, treatment with DOACs, as compared with VKA treatment, was not associated with a significantly different risk of thromboembolism (hazard ratio [HR], 1.25 [95% CI, 0.61–2.57]), bleeding (HR, 1.22 [95% CI, 0.54–2.75]), and all-cause mortality (HR, 0.90 [95% CI, 0.60–1.35]). Conclusions In patients with atrial fibrillation undergoing TAVI, treatment with DOACs was not associated with a significantly different risk of thromboembolism, bleeding, and all-cause mortality compared with treatment with VKA. Acknowledgement/Funding None

Vitamin K Antagonists versus Direct Oral Anticoagulants After Transcatheter Aortic Valve Implantation in Atrial Fibrillation

2019 ◽  
Author(s):  
Jawad H Butt ◽  
Ole De Backer ◽  
Jonas B Olesen ◽  
Thomas A Gerds ◽  
Eva Havers-Borgersen ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Arterial Thromboembolism ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Aim To examine the risk of arterial thromboembolism, bleeding, and all-cause mortality in AF patients treated with direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) undergoing transcatheter aortic valve implantation (TAVI). Methods and Results In this nationwide observational cohort study, 735 patients undergoing TAVI from January 1, 2012 to June 30, 2017 with a history of AF and who were treated with oral anticoagulants were identified using data from Danish nationwide registries. Of these, 219 (29.8%) and 516 (70.2%) patients were treated with DOACs and VKAs, respectively. The DOAC group was characterized by a higher prevalence of previous arterial thromboembolism and a lower prevalence of chronic kidney disease compared with the VKA group. The distribution of age, sex, CHA2DS2-VASc and HAS-BLED-score, and concomitant antiplatelet therapy was similar between groups. Compared with VKA, treatment with DOACs was not associated with a significantly different 3-year absolute risk of arterial thromboembolism (9.6% [95% confidence interval [CI], 4.7%-16.5%] versus 7.4% [95%CI, 4.9%-10.5%] in the DOAC and VKA group, respectively), bleeding (14.3% [95%CI, 7.6%-22.9%] versus 13.3% [95%CI, 9.9%-17.1%]), or all-cause mortality 32.7% [95%CI, 21.8%-44.0%] versus 32.0% [95%CI, 26.8%-37.3%]). In adjusted analyses, treatment with DOACs, as compared with VKAs, was not associated with a significantly different rate of arterial thromboembolism (hazard ratio [HR], 1.23 [95%CI, 0.58-2.59]), bleeding (HR, 1.14 [95%CI, 0.63-2.06]), or all-cause mortality (HR, 0.93 [95%CI, 0.61-1.40]). Conclusions In patients with AF undergoing TAVI, treatment with DOACs was not associated with a significantly different risk of arterial thromboembolism, bleeding, or all-cause mortality compared with VKA.

scholarly journals The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes

2021 ◽  
Author(s):  
Helge Möllmann ◽  
David M. Holzhey ◽  
Michael Hilker ◽  
Stefan Toggweiler ◽  
Ulrich Schäfer ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Valve Thrombosis ◽  
Aortic Valve Implantation ◽  
And Performance ◽  
Valve Implantation

Abstract Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract

New onset left bundle branch block after transcatheter aortic valve implantation and the effect on long-term survival – a UK wide experience

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S.S Arri ◽  
A Myat ◽  
I Malik ◽  
N Curzen ◽  
A Baumbach ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Left Bundle Branch Block ◽  
Left Ventricular ◽  
Bundle Branch Block ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation ◽  
New Onset

Abstract Introduction New onset left bundle branch block (LBBB) is the most common conduction disturbance associated with transcatheter aortic valve implantation (TAVI). It has been shown to adversely affect cardiac function and increase re-hospitalisation, although its impact on mortality remains contentious. Methods We conducted an observational cohort analysis of all TAVI procedures performed by 13 heart teams in the United Kingdom from inception of their structural programmes until 31st July 2013. The primary outcome was 1-year all-cause mortality. Secondary outcomes included left ventricular ejection fraction (LVEF) at 30 days and need for a post-TAVI permanent pacemaker (PPM). Results 1785 patients were eligible for inclusion to the study. The primary analysis cohort was composed of 1409 patients with complete electrocardiographic (ECG) data pre- and post-TAVI. Pre-existing LBBB was present in 200 (14.2%) patients. New LBBB occurred in 323 (22.9%) patients post TAVI, which resolved in 99 (7%) patients prior to discharge. A balloon-expandable device was implanted in 968 (69%) patients, whilst 421 (30%) patients received a self-expandable valve. New LBBB was observed in 120 (12.4%) and 192 (45.6%) patients receiving a balloon- or self-expandable prosthesis respectively. Overall 1-year all-cause mortality post TAVI was 18.7%. New onset LBBB was not associated with an increase in 1-year all-cause mortality (p=0.416). Factors that were associated with mortality included an increasing logistic EuroScore (p=0.05), history of previous balloon aortic valvuloplasty (p=0.001), renal impairment (p=0.003), previous myocardial infarction with pre-existing LBBB (p=0.028) and atrial fibrillation (p=0.039). Lower baseline peak and mean AV gradients were also associated with greater mortality at 1 year (p=0.001), likely reflecting underlying left ventricular dysfunction. In the majority of patients, LVEF remained unchanged following TAVI. Interestingly, the presence or absence of new onset LBBB did not affect LVEF improvement at 30 days. 10% of patients required a PPM post TAVI. Predictors of PPM included new LBBB (OR 2.6, p&lt;0.001), pre-TAVI left ventricular systolic impairment (OR 1.2, p=0.037), a self-expandable device (p&lt;0.001), and pre-existing RBBB (OR 4.0, p&lt;0.001). Conclusions These findings suggest that new onset LBBB post TAVI does not increase mortality at 1 year or adversely affect LVEF at 30 days. Funding Acknowledgement Type of funding source: None

Abstract 15761: New Onset Atrial Fibrillation After Transcatheter Aortic Valve Implantation: A Pooled Meta-Analysis

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Arun Kanmanthareddy ◽  
Madhu Reddy ◽  
Venkata S Koripalli ◽  
Avanija Buddam ◽  
Nivedita Adabala ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Meta Analysis ◽  
Mortality Data ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation ◽  
The Impact ◽  
New Onset

Introduction: Atrial fibrillation (AF) after cardiac surgery is associated with increased morbidity and mortality. Data comparing the occurrence of AF after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) is unknown. Methods: We identified all studies reporting outcomes after TAVI in all available electronic databases. Meta-analysis of all the studies was performed using random effects model to a) evaluate the incidence of AF and b) compare the incidence of AF between TAVI and SAVR. Results: The incidence of AF was reported in 7 studies, 5 prospective observational studies and 2 randomized controlled studies. The cumulative event rate for new onset AF at 30 days after TAVI was 0.1 (95% CI; 0.06 -0.17). Three studies reported incidence of AF after TAVI and SAVR. The odds ratio (OR) of developing new onset AF with TAVI compared to SAVR was 0.3 (95% CI; 0.10 - 0.88) at 30 days. One year outcome of new onset AF was reported in only two studies. Although, the incidence of AF was lower in the TAVI group, this did not reach statistical significance (OR 0.7, 95% CI; 0.46 -1.07). Conclusion: The incidence of new onset AF after TAVI is 10% within the first 30 days. This risk is 70% lower in patients undergoing TAVI compared to SAVR. The impact of AF after TAVI in terms of stroke, mortality and future recurrences of AF are unknown. Further studies are therefore necessary to study these outcomes.

scholarly journals P1812 The effect of pre-procedural significant mitral regurgitation upon mortality after transcatheter aortic valve implantation

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
S Soulaidopoulos ◽  
M Drakopoulou ◽  
G Oikonomou ◽  
K Stathogiannis ◽  
P Toskas ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Mitral Regurgitation ◽  
Aortic Stenosis ◽  
Transcatheter Aortic Valve Implantation ◽  
Reverse Remodeling ◽  
Cumulative Mortality ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background The presence of concomitant mitral regurgitation (MR) is a common issue in patients with severe aortic stenosis and negatively affects patient outcome. Available data regarding MR reduction due to aortic gradient reduction and left ventricular reverse remodeling after transcatheter aortic valve implantation (TAVI) are contradictory. Purpose To investigate the prognostic impact of both pre- and post-procedural MR in patients undergoing TAVI. Methods Patients with severe and symptomatic aortic stenosis stenosis [effective orifice area (EOA)≤1cm2] referred for TAVI at our institution were consecutively enrolled. Prospectively collected demographic, laboratory and echocardiographic data were retrospectively analyzed. Patients were stratified into two groups according to MR severity : ≤ grade 1 were defined as non-significant and ≥ grade 2 as significant. Change in MR was determined by comparison between baseline and 30-day echocardiogram. Primary clinical endpoint was all-cause mortality, as defined by the criteria proposed by the Valve Academic Research Consortium2. Results 263 consecutive patients (136 men, mean age : 80 ± 7.5 years) were included in the analysis. Significant (grade≥2) MR was present in 65 (24,7%) patients, while 198 (75,3%) patients had mild or no ( ≤ grade 1) MR. Comparing the two groups, patients with significant MR had higher systolic pulmonary pressure (51.3 ± 14.6mmHg versus 42.8 ± 11.2mmHg, p &lt; 0.001), lower ejection fraction (47.4 ± 10.8% versus 51.2 ± 8.2%) and were more dyspnoic (New York Heart Association class IV 18.5% vesrus 2.5%, p &lt; 0.001). The primary clinical end point occurred in 63 (24%) patients during a follow-up period of 26.6 ± 26.8 months. Patients with significant pre-procedural MR displayed greater cumulative mortality (40% versus 18.8%, p = 0.001). Perioperative risk assessed by logistic EuroScore, NYHA class and pre-procedural MR were found to significantly associate to cumulative mortality in a univariate analysis. Performing a multivariable analysis demonstrated that preprocedural MR severity could independently predict cumulative mortality [OR 2.38, B = 0.869 (95% CI 1.2 – 4.6, p = 0.01)] (Figure). Conclusion Significant MR is not infrequent in patients undergoing TAVI and appears to independently associate with high increased all-cause mortality. Abstract P1812 Figure.

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