Purpose Transcatheter aortic valve implantation (TAVI) results in the dislodgement of debris with risk of cerebral lesions or stroke. The EMBOL-X protection device (Edwards Lifesciences, Irvine, CA) ...is positioned within the ascending aorta to capture such debris. Description Between July 2012 and April 2014 we randomly assigned 30 high-risk patients to undergo transaortic TAVI with the SAPIEN XT prosthesis (Edwards Lifesciences) combined with either the EMBOL-X device (group-1, n = 14) or without (group-2, n = 16). Periprocedural cerebral lesions were assessed by diffusion-weighted magnetic resonance imaging (DW-MRI) at baseline and within 7 days post-procedurally. Evaluation New foci of restricted diffusion on cerebral DW-MRI were found in 69% in group-2 and 50% in group-1. Lesion size was smaller in patients treated with the EMBOL-X device than in those without (88 ± 60 vs 168 ± 217 mm3 , p = 0.27, t = 1.2, degrees of freedom = 10). Transaortic TAVI patients treated with the EMBOL-X device had significantly smaller lesion volumes in the supply region of the middle cerebral artery (33 ± 29 vs 76 ± 67 mm3 , p = 0.04). There were no neurologic events after transaortic TAVI. Conclusions The intraaortic protection device seems to reduce both the incidence and the volume of new cerebral lesions ( ClinicalTrials.gov number, NCT01735513 ).
Background Liver dysfunction increases death and morbidity after cardiac operations. There are currently no data evaluating liver function in patients undergoing transcatheter aortic valve ...replacement (TAVR). We aimed therefore to evaluate our TAVR results in regard to liver function. Methods A total of 640 consecutive TAVR patients were evaluated. Of those, 11 patients presented with chronic liver disease before TAVR. The Model for End-Stage Liver Disease score was used to measure liver function in these patients. The primary study end point was 30-day mortality in patients presenting with liver dysfunction. Secondary study end point was liver enzymes after TAVR. Results The mean Model for End-Stage Liver Disease score in patients with chronic liver disease was 16.8 ± 6.2 (median, 18; range, 7 to 26). The 30-day mortality was 9.1% (57 of 629) in patients presenting without liver disease and 9.1% (1 of 11) in patients with liver disease ( p = 1.00). Patients with chronic liver disease showed significantly higher preoperative levels of γ-glutamyl transpeptidase ( p < 0.001). After TAVR, we observed a significant increase in alanine aminotransferase on postoperative day 3 compared with preoperative values ( p < 0.001), accompanied by a decrease in albumin ( p < 0.001). Conclusions Liver cirrhosis per se is not considered as a contraindication for cardiac operations. In the present study, we did not observe a higher 30-day mortality rate in liver cirrhotic patients undergoing TAVR, suggesting TAVR as a feasible alternative with acceptable outcomes in patients with chronic liver disease. Moreover, the present study is the first to evaluate liver variables in patients undergoing TAVR.
Background Cognitive decline is well recognized early after coronary artery bypass graft surgery (CABG), but controversy exists regarding the degree and duration of these changes. We investigated the ...course of cognitive performance during 3 years after surgery and determined whether ischemic brain injury detected by diffusion-weighted magnetic resonance imaging was related to cognitive decline. Methods Thirty-nine patients undergoing on-pump CABG completed preoperative neuropsychologic examination and were followed up prospectively at discharge, 3 months, and 3 years after surgery. Cognitive performance was assessed with a battery of 11 standardized psychometric tests assessing 7 cognitive domains. Cognitive outcome was analyzed by determining (1) mean changes in within-patient scores over time (identifying cognitive functions with decline), and (2) the incidence of cognitive deficit for each individual (identifying patients with decline). Objective evidence of acute cerebral ischemia was obtained by diffusion-weighted magnetic resonance imaging. Prospectively collected data were used to identify predictors of cognitive deficits. Results From baseline to discharge, cognitive test scores significantly declined in 7 measures. Most tests improved by 3 months. Between 3 months and 3 years, late decline was observed in 2 measures with persistent deterioration in 1 measure (verbal memory) relative to baseline. Postoperative cognitive deficits (drop of ≥1 SD in scores on ≥3 tests) were observed in 56% of patients at discharge, 23% at 3 months and 31% at 3 years. On postoperative diffusion-weighted magnetic resonance imaging, there were new ischemic cerebral lesions in 51% of patients. The presence of cognitive deficit at discharge was a significant univariate predictor of late cognitive decline ( p = 0.025). A relation between the presence of new diffusion-weighted magnetic resonance imaging detected lesions and cognitive decline, however, was not found. Conclusions Longitudinal cognitive performance of patients with CABG showed a two-stage course with early improvement followed by later decline. Long-term cognitive deficit was predicted by early cognitive decline, but not by ischemic brain lesions on magnetic resonance imaging.
Objectives In the current era of stent usage, percutaneous coronary intervention is more frequently performed as the initial revascularization strategy in multivessel disease before patients are ...finally referred to coronary artery bypass grafting. We sought to determine whether previous PCI has a prognostic impact on outcome in patients with diabetes mellitus and triple-vessel disease. Methods Between January 2000 and March 2006, 621 consecutive patients with diabetes mellitus and triple-vessel disease undergoing isolated first-time coronary artery bypass grafting as the primary revascularization procedure (group 1) were evaluated for in-hospital mortality and major adverse cardiac events and compared with 128 patients with diabetes mellitus and triple-vessel disease treated during the same time period with previous percutaneous coronary intervention before coronary artery bypass grafting (group 2). Results All-cause in-hospital mortality was 2.9% in group 1 and 7.8% in group 2 (odds ratio, 2.84; 95% confidence interval, 1.19-6.68; P = .02). In-hospital major adverse cardiac events were identified in 6.1% and 14.1% (odds ratio, 2.51; 95% confidence interval, 1.32-4.73; P < .005), respectively. Risk-adjusted multivariate logistic regression analysis of previous percutaneous coronary intervention significantly correlated with in-hospital mortality (odds ratio, 2.87; 95% confidence interval, 1.29-6.37; P = .03) and major adverse cardiac events (odds ratio, 2.54; 95% confidence interval, 1.39-4.62; P = .01). After computed propensity score matching based on 12 major preoperative risk factors to control selection bias, conditional regression analysis confirmed previous percutaneous coronary intervention to be associated with all-cause in-hospital mortality (odds ratio, 2.97; 95% confidence interval, 1.12-7.86; P = .03) and major adverse cardiac events (odds ratio, 2.46; 95% confidence interval, 1.18-5.15; P = .02) in these patients. Conclusion Previous percutaneous coronary intervention before coronary artery bypass grafting in patients with diabetes mellitus and triple-vessel disease independently increases the risk for in-hospital mortality and major adverse cardiac events.
Background Decline in renal and cognitive function may complicate early recovery after coronary-artery bypass grafting. AT₁-receptor antagonists have been demonstrated to be neuro- and ...renoprotective. Aim of ARTA, a prospective, double-blind, randomised and placebo controlled study, was to detect whether preoperative treatment with candesartan influences postoperative cognitive and renal function. Study protocol One hundred and five patients eligible for coronary artery bypass graft surgery (65-85 years old, all suffering from hypertension and coronary artery disease, with stable kidney function) were randomized to candesartan (8 mg od) or placebo for between 8 and 11 days prior to surgery. Existing ACE-inhibitor/angiotensin receptor antagonist-therapy had to be stopped prior to the study. Validated cognitive function tests (trail making, Horn's perfomance III und VI, divided attention and change of reaction, memory - immediate and delayed recall, digit span) were performed preoperatively, 1 week and 3 months after surgery. Renal function was assessed by creatinine clearance on the day before, 1 week and 3 months after surgery. Results Eighty-seven patients (n = 43 Candesartan, n = 44 placebo) were included in the ITT-population for analysis. Drug treatment had no adverse effect on perioperative blood pressure. Only five patients experienced a period of hypotension during introduction of anaesthesia (Candesartan 1/44, placebo 4/44). One week as well as three months after surgery, there were no differences in relevant cognitive function parameters compared to the status prior to surgery, independent from treatment. Creatinine clearance showed a clear decrease one week after surgery with a minor further reduction observed 3 months after surgery, but there was no difference between Candesartan and placebo treated patients. Between both groups, there were no significant differences in the number of adverse events and number of patients with adverse events nor in the incidence of renal failure with consecutive dialysis and cerebral strokes (candesartan 2, placebo 5) and possibly drug related severe adverse events. Conclusion This randomised placebo-controlled and prospective study in elderly patients does not support previous reports suggesting a substantial impairment of cognitive function after coronary artery bypass graft surgery. Preservation of cognitive and renal function was independent of pre-surgical administration of candesartan.
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