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 ).
Objective Statins are powerful lipid-lowering drugs that have been proved effective in the prevention of coronary artery disease, clearly reducing the risk of mortality and cardiovascular events. ...Whether hyperlipidemic patients undergoing coronary artery bypass grafting profit from the lipid-lowering beneficial effects of statins is as yet uncertain. We sought to determine whether preoperative statin therapy may have an effect on outcome among hyperlipidemic patients undergoing coronary artery bypass grafting. Methods From January 2000 through March 2006, prospectively recorded clinical data from 3346 consecutive patients undergoing isolated first-time elective coronary artery bypass grafting were analyzed for major adverse cardiac events and all-cause in-hospital mortality. Of these, 167 patients had preoperative statin-untreated hyperlipidemia (group 1), 2592 had statin-treated hyperlipidemia (group 2), and 587 had statin-untreated normolipidemia (group 3). Results Risk-adjusted multivariate logistic regression analysis revealed statin-treated hyperlipidemia (odds ratio, 0.42; 95% confidence interval, 0.26-0.69; P = .0007) and statin-untreated normolipidemia (odds ratio, 0.42; confidence interval, 0.26-0.69; P = .0007) to be independently associated with reduced in-hospital major adverse cardiac events but not with in-hospital mortality. To further control for selection bias, a computed propensity score matching based on 14 major preoperative risk factors was performed. After propensity matching, conditional logistic regression analysis confirmed statin-treated hyperlipidemia and statin-untreated normolipidemia to be strongly related to reduced in-hospital major adverse cardiac events (odds ratio, 0.41; 95% confidence interval, 0.24–0.71 P = .0013 and odds ratio, 0.23; 95% confidence interval, 0.11–0.48 P = .0001) but not with in-hospital mortality (odds ratio, 1.18; 95% confidence interval, 0.36–3.87 P = .79 and odds ratio, 1.10; 95% confidence interval, 0.32–4.41 P = .80) after coronary artery bypass grafting surgery. Conclusions Hyperlipidemic, but not normolipidemic, patients have an increased risk for in-hospital major adverse cardiac events and therefore clearly benefit from preoperative statin therapy before coronary artery bypass grafting surgery.
Background Treatment of ST-elevation myocardial infarction has undergone great evolution since introduction of percutaneous coronary intervention (PCI). The purpose was therefore to assess the ...outcome of patients with ST-elevation myocardial infarction undergoing surgical revascularization with coronary artery bypass grafting (CABG). Methods A total of 138 consecutive patients with ST-elevation myocardial infarction underwent CABG therapy between January 2000 and January 2007 at our institution. Prospectively recorded preoperative, intraoperative, and postoperative data were retrospectively screened for in-hospital mortality and major adverse cardiac events (MACE). Results The delay between the onset of ST-elevation myocardial infarction symptoms and CABG procedures was within 6 hours in 37 patients, 7 to 24 hours in 21, 1 to 3 days in 15, 4 to 7 days in 24, and 8 to 14 days in 41 patients. Cardiogenic shock (Killip class ≥III) was present in 38 patients (28%), and 37 patients (27%) were referred for CABG after failed PCI. Overall in-hospital mortality was 8.7%, but mortality varied between 10.8% (≤6 hours), 23.8% (7 to 24 hours), 6.7% (1 to 3 days), 4.2% (4 to 7 days), and 2.4% (8 to 14 days), depending on time interval from symptom onset to operation. Overall, more nonsurvivors were women (58% versus 23%; p < 0.01), had higher preoperative cardiac troponin I levels (13.2 ± 9.8 versus 4.5 ± 4.2 ng/ml; p < 0.0001), and were more frequently in cardiogenic shock (83% versus 22%; p < 0.0001). Unadjusted univariable and risk-adjusted multivariable logistic regression analysis revealed age, female sex, preoperative cardiac troponin I levels, and cardiogenic shock to be the most potent predictors of in-hospital death and MACE. Conclusions CABG in ST-elevation myocardial infarction can be performed with acceptable risk by incorporating adequate management strategies. However, female sex, preoperative cardiac troponin I level, preoperative cardiogenic shock, and time to operation are major variables of mortality and morbidity results.
Objectives Do prior percutaneous coronary interventions adversely affect the outcome of subsequent coronary artery bypass grafting? We investigated this effect on a multicenter basis. Methods Eight ...cardiac surgical centers provided outcome data of 37,140 consecutive patients who underwent isolated first-time coronary bypass grafting between January 2000 and December 2005. Twenty-two patient characteristics and outcome variables were retrieved. Three groups of patients were analysed for in-hospital mortality and in-hospital major adverse cardiac events: patients without a previous percutaneous coronary intervention, with 1 previous intervention, and with 2 or more previous percutaneous coronary interventions before bypass grafting. A total of 29,928 patients with complete information for prior percutaneous coronary intervention underwent final analysis. Unadjusted univariate and risk-adjusted multivariate logistic regression analysis as well as computed propensity score matching were performed, based on 14 major risk factors to correct for and minimize selection bias. Results A total of 10.3% of patients had 1 previous percutaneous coronary intervention, and 3.7% of patients had 2 or more previous interventions. Risk-adjusted multivariate logistic regression analysis revealed a significant association of 2 or more previous percutaneous coronary interventions with in-hospital mortality (odds ratio OR, 2.0; confidence interval CI, 1.4–3.0; P = .0005) and major adverse cardiac events (OR, 1.5; CI, 1.2–1.9; P = .0013). After propensity score matching, conditional logistic regression analysis confirmed the results of adjusted analysis. A history of 2 or more previous percutaneous coronary interventions was significantly associated with in-hospital mortality (OR, 1.9; CI, 1.3–2.7; P = .0016) and major adverse cardiac events (OR, 1.5; CI, 1.2–1.9; P = .0019). Conclusions Multicenter analysis confirms that a history of multiple previous percutaneous coronary interventions increases in-hospital mortality and the incidence of major adverse cardiac events after subsequent coronary artery bypass grafting. Critical discussion of the treatment strategy in these patients is warranted.
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 Liver transplantation has become one of the best treatment options for early hepatocellular carcinoma in cirrhosis. The purpose of this study was to correlate pathologic findings with ...outcomes after liver transplantation for hepatocellular carcinoma and to evaluate associations between various tumor characteristics and patient outcomes. Study Design One hundred patients with hepatocellular carcinoma underwent liver transplantation at our center during an 8-year period. Fifty-five patients received deceased donor livers and the remaining 45 received live donor grafts. A systematic literature search was performed. Using the truncated product method and Tippet’s method p values from the literature were combined with our own results, for a total of 3,107 patients. Results For survival, significant associations were found for tumor grading in our series. Tumor recurrence was significantly associated with α-fetoprotein levels, tumor grading, vascular invasion, Milan and University of California San Francisco criteria in univariate analysis, and with tumor grading and University of California San Francisco criteria by multivariable analysis. Meta-analysis showed significant associations for all variables evaluated (α-fetoprotein, tumor number, tumor size, lobar distribution, vascular invasion, tumor differentiation, Milan criteria, and University of California San Francisco criteria) both for survival and recurrence in the performed univariate truncated product method analyses. Interestingly, metaanalysis of the available multivariable studies showed no significant associations between Milan/University of California San Francisco criteria and survival or tumor recurrence. Conclusions Although results of this study add some corroborative evidence in this special field of transplantation for malignancy, they also open the discussion about the prognostic power of the current listing criteria.
Objectives The Trifecta valve (St Jude Medical, St Paul, Minn) is a new bioprosthetic heart valve designed for supra-annular aortic valve replacement. We compared the hemodynamic performance of the ...Trifecta against the Perimount-Magna and Magna-Ease valve prostheses (Edwards Lifesciences, Irvine, Calif) in a nonrandomized, observational, single-center study. Methods A total of 346 consecutive patients with aortic valve disease underwent aortic valve replacement between January 2003 and November 2011, with implantation of the Trifecta (group 1, n = 121), the Perimount-Magna (group 2, n = 126), or the Magna Ease bioprosthesis (group 3, n = 99). Clinical and hemodynamic data were prospectively recorded and compared. Hemodynamic performance was evaluated by transthoracic echocardiography, including mean pressure gradient (MPG) and aortic valve area (AVA) at baseline, discharge, and 6-month follow-up. A multivariate model of covariance analysis was constructed to further compare the primary study end points of MPG and AVA at 6-month follow-up. Results For all valve sizes, unadjusted MPGs did not differ ( P = .08), but AVAs differed ( P < .001) between groups at 6-month follow-up. After final adjustment by a multivariate model of covariance analysis, neither the MPGs ( P = .16) nor the AVAs ( P = .92) at 6 months postoperatively were influenced by the type of prosthesis used. Conclusions The present observational study is the first to compare the new Trifecta valve with well-established supra-annular aortic valve bioprostheses from a hemodynamic perspective. Although mean pressure gradients and aortic valve areas seem to be advantageous at 6-month follow-up with the new Trifecta valve, after multivariate covariance analysis, no influence of prosthesis type on mean pressure gradient or aortic valve area could be demonstrated.
Summary Background Remote ischaemic preconditioning has been associated with reduced risk of myocardial injury after coronary artery bypass graft (CABG) surgery. We investigated the safety and ...efficacy of this procedure. Methods Eligible patients were those scheduled to undergo elective isolated first-time CABG surgery under cold crystalloid cardioplegia and cardiopulmonary bypass at the West-German Heart Centre, Essen, Germany, between April, 2008, and October, 2012. Patients were prospectively randomised to receive remote ischaemic preconditioning (three cycles of 5 min ischaemia and 5 min reperfusion in the left upper arm after induction of anaesthesia) or no ischaemic preconditioning (control). The primary endpoint was myocardial injury, as reflected by the geometric mean area under the curve (AUC) for perioperative concentrations of cardiac troponin I (cTnI) in serum in the first 72 h after CABG. Mortality was the main safety endpoint. Analysis was done in intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov , number NCT01406678. Findings 329 patients were enrolled. Baseline characteristics and perioperative data did not differ between groups. cTnI AUC was 266 ng/mL over 72 h (95% CI 237–298) in the remote ischaemic preconditioning group and 321 ng/mL (287–360) in the control group. In the intention-to-treat population, the ratio of remote ischaemic preconditioning to control for cTnI AUC was 0·83 (95% CI 0·70–0·97, p=0·022). cTnI release remained lower in the per-protocol analysis (0·79, 0·66–0·94, p=0·001). All-cause mortality was assessed over 1·54 (SD 1·22) years and was lower with remote ischaemic preconditioning than without (ratio 0·27, 95% CI 0·08–0·98, p=0·046). Interpretation Remote ischaemic preconditioning provided perioperative myocardial protection and improved the prognosis of patients undergoing elective CABG surgery. Funding German Research Foundation.
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