Abstract Background The SAPIEN 3 (Edwards Lifesciences Inc., Irvine, California) transcatheter valve incorporates features designed to address the well-known deficiencies of transcatheter aortic ...valve replacement (TAVR). An ultra–low-profile delivery system facilitates safe, controlled, and accurate implantation and an external seal minimizes paravalvular regurgitation. Objectives The study evaluated whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis. Methods The prospective study enrolled 150 patients at 16 sites in Europe and Canada. Clinical and echocardiographic outcomes were assessed at baseline, post-procedure, and 30 days. New sizing recommendations were developed during the course of the study. Results Patients were 83.6 ± 5.0 years of age, with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 ± 4.5% and logistic EuroSCORE of 21.6 ± 12.3%. A transfemoral approach was chosen in 64.0% and alternative access (transapical/direct aortic) in the remainder. At 30 days, paravalvular regurgitation was none to mild in 96.4% and moderate in 3.5%. No patient had severe regurgitation. Transfemoral implantation was associated with low mortality (2.1%), no disabling stroke (0.0%), and fully percutaneous access and closure in 95.8%. Nontransfemoral alternative access was associated with higher rates of mortality (11.6%) and stroke (5.6%). Conclusions This third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients. (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve SAPIEN3; NCT01808287 )
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.
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.
Objective Remote ischemic preconditioning protects the myocardium from ischemia/reperfusion injury. We recently identified protection by remote ischemic preconditioning to be associated with the ...activation of signal transducer and activator of transcription 5 in left ventricular biopsy specimens of patients undergoing coronary artery bypass grafting during isoflurane anesthesia. Because remote ischemic preconditioning did not protect the heart during propofol anesthesia, we hypothesized that propofol anesthesia interferes with signal transducer and activator of transcription 5 activation. Methods In a randomized, single-blind, placebo-controlled, prospective study, we analyzed an array of established cardioprotective proteins during propofol anesthesia with or without remote ischemic preconditioning in 24 nondiabetic patients with 3-vessel coronary artery disease. Results Remote ischemic preconditioning (n = 12) compared with no remote ischemic preconditioning (n = 12) failed to decrease the area under the troponin I time curve (273 ± 184 ng/mL × 72 hours vs 365 ± 301 ng/mL × 72 hours; P = .374). Although phosphorylation of several protein kinases was increased from baseline to reperfusion, signal transducer and activator of transcription 5 phosphorylation was not increased and was not different between the remote ischemic preconditioning and no remote ischemic preconditioning groups. Conclusions Remote ischemic preconditioning during propofol anesthesia did not evoke either signal transducer and activator of transcription 5 activation or cardioprotection, implying interaction of propofol with cardioprotective signaling upstream of signal transducer and activator of transcription 5.
Background Major scores for the evaluation of procedural risk in cardiac surgery are the European system for cardiac operative risk evaluation score (EuroSCORE), the Society of Thoracic Surgeons ...(STS) score, and the Parsonnet score. The aim of our study was to analyze the predictive value of these scores in “high risk” patients undergoing isolated aortic valve replacement (AVR). Methods Six hundred and fifty-two patients underwent isolated AVR from January 1999 through June 2007. Emergency and redo operations were included; acute endocarditis was excluded. Evaluation was performed by logistic regression analysis. Data collection was prospective. Results The mean logistic EuroSCORE of all patients was 8.5 ± 7.9%, the mean STS score was 4.4 ± 3.9%, and the mean logistic Parsonnet score was 9.8 ± 8.5%. In-hospital mortality was 2.5% (n = 16). Freedom from all-cause death was 93.4% at 1 year, 90.2% at 2 years, and 75.8% at 5 years, respectively. A total of 182 patients had a logistic EuroSCORE greater than 10. For the group of patients with a EuroSCORE between 10% and 20% (n = 130) the mean EuroSCORE was 13.9 ± 2.8% and the STS score was 6.5 ± 3.8%. Observed mortality was 4.6% in this group. For the 52 patients with a logistic EuroSCORE of at least 20 (mean 28.5 ± 10.3%, STS score 10.1 ± 7.3%) the observed mortality was 3.9% (n = 2). By stepwise logistic regression, none of the EuroSCORE variables could be identified as an independent predictor in the “high- risk” group. Conclusions The logistic EuroSCORE was primarily created to allow patient grouping for the total spectrum of cardiac surgery. In patients undergoing isolated AVR, the EuroSCORE highly overestimates mortality, whereas the STS score seems to be actually more suitable in assessing perioperative mortality for these patients.
Valve-in-Valve Transcatheter Aortic Valve Implantation for Degenerated Bioprosthetic Heart Valves Holger Eggebrecht, Ulrich Schäfer, Hendrik Treede, Peter Boekstegers, Jörg Babin-Ebell, Markus ...Ferrari, Helge Möllmann, Helmut Baumgartner, Thierry Carrel, Philipp Kahlert, Philipp Lange, Thomas Walther, Raimund Erbel, Rajendra H. Mehta, Matthias Thielmann Multicenter data from 47 patients aged 64 to 97 years undergoing transfemoral (n = 25) or transapical (n = 22) valve-in-valve (viv) transcatheter aortic valve implantation (TAVI) for degenerated surgically implanted bioprosthetic heart valves were analyzed. Procedural success was obtained in all patients. Vascular access complications occurred in 6 (13%). Five (11%) patients required new pacemaker implantation. Valvular function was excellent with respect to valve competence, but increased transvalvular gradients ≥20 mm Hg were noted in 44%. Mortality at 30 days was 17% (1 procedural and 7 post-procedural deaths). Valve-in-valve TAVI can be performed with high technical success rates, acceptable post-procedural valvular function, and excellent functional improvement.
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 Heart-type fatty acid binding protein ( h FABP) and ischemia-modified albumin (IMA) have been put forward as novel biomarkers to detect myocardial injury shortly after onset of ischemia. ...We compared h FABP and IMA with cardiac troponin I (cTnI) for speed and reliability in the diagnosis of perioperative myocardial infarction (PMI) after coronary artery bypass graft surgery (CABG). Methods In all, 210 consecutive patients undergoing isolated CABG with cardiopulmonary bypass were enrolled in a prospective study. Blood samples were taken perioperatively and throughout the first 72 hours after surgery; clinical data and events were recorded. In cohort A, serum concentrations of h FABP and cTnI were measured using a combined quantitative bedside assay. In cohort B, IMA and cTnI serum concentrations were measured using an albumin cobalt binding test. Perioperative myocardial infarction was defined using a cTnI cutoff of greater than 10.5 ng/mL occurring within 24 hours of CABG or new electrocardiographic changes. Results In cohort A, 14 patients were identified with PMI (group 1), whereas 94 had no PMI and served as controls (group 2). Both h FABP and cTnI were increased in group 1 as compared with group 2 ( p < 0.001). Although cTnI did not differ before 12 hours, h FABP diverged much earlier, at 1 hour postoperatively ( p < 0.001). An h FABP concentration of 20 μg/mL at 1 hour detected PMI with an area under the curve of 77.1%. In cohort B, 18 patients were identified with PMI (group 3), and 84 patients served as controls (group 4). No difference in cTnI values could be observed between the groups until 12 hours postoperatively. Ischemia-modified albumin failed to differentiate at any postoperative time point; the low discriminative power of IMA was confirmed with an area under the curve of 53.3% at 1 hour, 48.5% at 6 hours, and 39.3% at 12 hours postoperatively. Conclusions Heart-type fatty acid binding protein is a sensitive and rapid biomarker that detected PMI reliably at 1 hour after CABG, much earlier than cTnI. The diagnostic value of IMA for detection of PMI appears to be very limited in this setting.
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.
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