Risk of Bleeding after Transcatheter Aortic Valve Replacement: impact of Preoperative Antithrombotic Regimens

Abstract Introduction: Bleeding after transcatheter aortic valve replacement (TAVR) has a negative impact on the outcome of the procedure. Risk factors for bleeding vary widely in the literature, and the impact of preoperative antithrombotic agents has not been fully established. The objectives of our study were to assess bleeding after TAVR as defined by the Valve Academic Research Consortium-2 (VARC-2), identify its risk factors, and correlate with antithrombotic treatment in addition to its effect on procedural mortality. Methods: The study included 374 patients who underwent TAVR from 2009 to 2018. We grouped the patients into four groups according to the VARC-2 definition of bleeding. Group 1 included patients without bleeding (n=265), group 2 with minor bleeding (n=22), group 3 with major bleeding (n=61), and group 4 with life-threatening bleeding (n=26). The median age was 78 (25th-75th percentiles: 71-82), and 226 (60.4%) were male. The median EuroSCORE was 3.4 (2-6.3), and there was no difference among groups (P=0.886). The TAVR approach was transfemoral (90.9%), transapical (5.6%), and trans-subclavian (1.9%). Results: Predictors of bleeding were stroke (OR: 2.465; P=0.024) and kidney failure (OR: 2.060; P=0.046). Preoperative single and dual antiplatelet therapy did not increase the risk of bleeding (P=0.163 and 0.1, respectively). Thirty-day mortality occurred in 14 patients (3.7%), and was significantly higher in patients with life-threatening bleeding (n=8 [30.8%]; P<0.001). Conclusion: Bleeding after TAVR is common and can be predicted based on preprocedural comorbidities. Preprocedural antithrombotic therapy did not affect bleeding after TAVR in our population.

Risk of Bleeding after Transcatheter Aortic Valve Replacement: impact of Preoperative Antithrombotic Regimens.

INTRODUCTION: Bleeding after transcatheter aortic valve replacement (TAVR) has a negative impact on the outcome of the procedure. Risk factors for bleeding vary widely in the literature, and the impact of preoperative antithrombotic agents has not been fully established. The objectives of our study were to assess bleeding after TAVR as defined by the Valve Academic Research Consortium-2 (VARC-2), identify its risk factors, and correlate with antithrombotic treatment in addition to its effect on procedural mortality. METHODS: The study included 374 patients who underwent TAVR from 2009 to 2018. We grouped the patients into four groups according to the VARC-2 definition of bleeding. Group 1 included patients without bleeding (n=265), group 2 with minor bleeding (n=22), group 3 with major bleeding (n=61), and group 4 with life-threatening bleeding (n=26). The median age was 78 (25th-75th percentiles: 71-82), and 226 (60.4%) were male. The median EuroSCORE was 3.4 (2-6.3), and there was no difference among groups (P=0.886). The TAVR approach was transfemoral (90.9%), transapical (5.6%), and trans-subclavian (1.9%). Results: Predictors of bleeding were stroke (OR: 2.465; P=0.024) and kidney failure (OR: 2.060; P=0.046). Preoperative single and dual antiplatelet therapy did not increase the risk of bleeding (P=0.163 and 0.1, respectively). Thirty-day mortality occurred in 14 patients (3.7%), and was significantly higher in patients with life-threatening bleeding (n=8 [30.8%]; P<0.001). Conclusion: Bleeding after TAVR is common and can be predicted based on preprocedural comorbidities. Preprocedural antithrombotic therapy did not affect bleeding after TAVR in our population.

Outcomes After Transcatheter Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Diastolic Dysfunction.

OBJECTIVES: Left ventricular diastolic dysfunction (LVDD) in patients undergoing transcatheter aortic valve replacement (TAVR) is associated with poor outcomes; however, the effect of its severity is controversial. We sought to assess the impact of diastolic dysfunction on hospital outcomes and survival after TAVR and identify prognostic factors. METHODS: We included patients who underwent TAVR for severe aortic stenosis with preexisting LVDD from 2009 to 2018 (n = 325). Patients with prior mitral valve surgery (n = 4), atrial fibrillation (n = 39), missing or poor baseline diastolic dysfunction assessment (n = 36) were excluded. The primary endpoint was all-cause mortality. 246 patients were included in the study. RESULTS: The median age was 80 years (25th and 75th percentiles:75-86.7), 154 (62.6%) were males and the median EuroSCORE II was 4.3 (2.2-8). Patients with severe LVDD had significantly higher EuroSCORE, and lower ejection fraction (p < 0.001). There was no difference in post-TAVR new atrial fibrillation (p = 0.912), pacemaker insertion (p = 0.528), stroke (p = 0.76), or hospital mortality (p = 0.95). Patients with severe LVDD had longer hospital stay (p = 0.036). The grade of LVDD did not affect survival (log-rank = 0.145) nor major adverse cardiovascular events (log-rank = 0.97). Predictors of mortality were; low BMI (HR: 0.95 (0.91-0.99); p = 0.019), low sodium (0.93 (0.82-2.5); p = 0.021), previous PCI (HR: 1.6 (1.022-2.66); p = 0.04), E-peak (HR: 1.01 (1.002-1.019); p = 0.014) and implantation of more than one device (HR: 3.55 (1.22-10.31); p = 0.02). CONCLUSION: Transcatheter aortic valve replacement is feasible in patients with diastolic dysfunction, and the degree of diastolic dysfunction did not negatively affect the outcome. Long-term outcomes in those patients were affected by the preoperative clinical state and procedure-related factors.

Lessons from the SYNTAX trial.

Despite the fact that CABG is the standard of care for patients with multivessel coronary arteries and/or left main stem stenosis, PCI has become a rival to CABG in patients with multivessel coronary artery disease or left main disease. However, the need for repeat revascularization, in-stent stenosis and thrombosis remain the achilis heal of PCI. SYNTAX trial randomized patients with left main disease and/or three-vessel disease to PCI with TAXus stent or CABG with the concept that PCI is not inferior to CABG. At 1 and 2 years follow up, MACCE was significantly increased in PCI patients mainly attributed to increased rate of repeat revascularization; however, stroke was significantly more with CABG. The composite safety endpoint of death/stroke/MI was comparable between the 2 groups. Therefore the criterion for non-inferiority was not met. What we learn from SYNTAX is that multi disciplinary team approach should be the standard of care when recommending treatment in more complex coronary artery disease. SYNTAX makes interventionists and surgeons come together, it may set the benchmark for MVD revascularization. PCI and CABG should be considered complementary rather than competitive revascularization strategies. There is no substitute for sound clinical judgment that takes into account the patient's overall clinical profile, functionality, co-morbidities, as well as the patient's coronary anatomy. The SYNTAX Score should be utilized to decide on treatment of patients with LM/MVD. Patients with low and intermediate score can be treated with PCI or CABG with equal results. Those with high score do better with CABG. SYNTAX trial showed that 66% of patients with 3VD or LMD are still best treated with CABG. In the remaining 1/3 of patients with low syntax score, PCI may be considered as an alternative to surgery. Finally, medical treatment should be optimized in patients going for CABG.