The sponsor presented data from a patient-level meta-analysis incorporating the results from 2 European randomized trials of the Sentinel device (CLEAN-TAVI5 and MISTRAL-C6) and the results of the ...SENTINEL trial.3 Individual study and treatment groups were considered random and fixed effects, respectively.The panel recognized that availability of normative neurocognitive data is limited in octogenarians and stressed the importance of standardization of neurological testing in future clinical trials using recently published guidelines.7 Although there was no significant change in neurocognitive function between test and control arms in the SENTINEL trial, in post hoc analysis, there was some evidence of benefit in executive function with cerebral protection.1., C.R. Smith, M.B. Leon, M.J. Mack, Transcatheter versus surgical aortic-valve replacement in high-risk patients, N Engl J Med, Vol. 364, 2011, 2187-2198 2., De novo classification process (evaluation of automatic class III designation).Draft guidance for industry and Food and Drug Administration staff 3., S.R. Kapadia, S. Kodali, R. Makkar, Protection against cerebral embolism during transcatheter aortic valve replacement, J Am Coll Cardiol, Vol. 69, 2017, 367-377 4., A.P. Kappetein, S.J. Head, P. Genereux, Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document, J Thorac Cardiovasc Surg, Vol. 145, 2013, 6-23 5., S. Haussig, N. Mangner, M.G. Dwyer, Effect of a cerebral protection device on brain lesions following transcatheter aortic valve implantation in patients with severe aortic stenosis: the CLEAN-TAVI randomized clinical trial, JAMA, Vol. 316, 2016, 592-601 6., N.M. Van Mieghem, L. van Gils, H. Ahmad, Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial, EuroIntervention, Vol. 12, 2016, 499-507 7., A.J. Lansky, S.R. Messe, A.M. Brickman, Proposed standardized neurological endpoints for cardiovascular clinical trials: an Academic Research Consortium initiative, J Am Coll Cardiol, Vol. 69, 2017, 679-691
Abstract Background Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse ...and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent thrombosis. Methods PubMed was systematically searched for eligible studies from the drug-eluting stent (DES) era (1/2002–12/2010). Studies were selected if including ≥ 2000 patients undergoing stenting or reporting on ≥ 25 thromboses. Study features, patient characteristics, and incidence of stent thrombosis were abstracted and pooled, when appropriate, with random-effect methods (point estimate 95% confidence intervals), and consistency of predictors was formally appraised. Results A total of 30 studies were identified (221,066 patients, 4276 thromboses), with DES used in 87%. After a median of 22 months, definite, probable, or possible stent thrombosis had occurred in 2.4% (2.0%; 2.9%), with acute in 0.4% (0.2%; 0.6%), subacute in 1.1% (1.0%; 1.3%), late in 0.5% (0.4%; 0.6%), and very late in 0.6% (0.4%; 0.8%). Similar figures were computed for studies reporting only on DES. From a total of 47 candidate variables, definite/probable stent thrombosis was more commonly and consistently predicted by early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length, with acute coronary syndrome at admission, diabetes, smoking status, and bifurcation/ostial disease also proving frequent predictors, but less consistently. Conclusions Despite numerous possible risk factors, the most common and consistent predictors of stent thrombosis are early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length.
Early- and Long-Term Intravascular Ultrasound and Angiographic Findings After Bioabsorbable Magnesium Stent Implantation in Human Coronary Arteries Ron Waksman, Raimund Erbel, Carlo Di Mario, Jozef ...Bartunek, Bernard de Bruyne, Franz R. Eberli, Paul Erne, Michael Haude, Mark Horrigan, Charles Ilsley, Dirk Böse, Hans Bonnier, Jacques Koolen, Thomas F. Lüscher, Neil J. Weissman, on behalf of the PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting with Absorbable Metal Stents) Investigators This study aimed to evaluate the degradation rate and the long-term vascular responses to the absorbable metal stent (AMS) as seen by series of angiographic and intravascular ultrasound (IVUS) studies. We concluded that IVUS imaging supports the safety profile of AMS with degradation at 4 months and durability of the results without any early or late adverse findings. Slower degradation is warranted to provide sufficient radial force to eliminate early recoil and improve long-term patency rates of the AMS.
Risk assessment for transcatheter aortic valve replacement (TAVR) patients is challenging, and surgical scores do not optimally correlate with outcome. The aim of this study was to assess the ...correlation between serum albumin and survival of patients with symptomatic severe aortic stenosis undergoing TAVR. Patients with severe aortic stenosis who underwent TAVR were categorized into 2 groups according to low and normal preprocedural serum albumin (<3.5 and ≥3.5 g/dl, respectively). The all-cause mortality rates at hospital discharge, at 30-day and 1-year follow-up were compared across the groups. Additionally, a Cox proportional-hazards model was generated to assess the independent effect of serum albumin at 1-year follow-up. Among 567 consecutive patients who underwent TAVR, 476 (84%) had documented preprocedural serum albumin measurements. Of these, 50% had low serum albumin levels, and 50% had normal serum albumin levels. Baseline and procedural characteristics, including age, gender, and transapical access, were similar among the groups. Prevalence of left ventricular ejection fraction <40% was higher in patients with low albumin (29% vs 20%, p = 0.02), and risk assessment according to Society of Thoracic Surgeons score tended to be higher in the low-albumin group (10 ± 4.7 vs 9.4 ± 4.4, p = 0.09). Patients presenting with low albumin had higher in-hospital mortality (11% vs 5%), as well as at 30-day (12% vs 6%, p = 0.01) and 1-year (29% vs 19%, p = 0.02) follow-up. Serum albumin was independently associated with 1-year mortality (adjusted hazard ratio per 0.1 g/dl decrease 1.64, 95% confidence interval 2.50 to 1.75, p = 0.02), along with body mass index <20 kg/m2 (hazard ratio 1.89, 95% confidence interval 3.33 to 1.75, p = 0.03). In conclusion, preprocedural serum albumin level and low body mass index are independently associated with mortality in patients who undergo TAVR. Patients with severe aortic stenosis and low albumin levels should undergo careful evaluation before and after TAVR.
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