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OBJECTIVES Percutaneous coronary intervention (PCI) is often favoured over coronary artery bypass grafting (CABG) surgery for revascularization in patients with chronic obstructive pulmonary disease (COPD). We studied whether COPD affected clinical outcomes according to revascularization in the Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial, in which PCI with everolimus-eluting stents was non-inferior to CABG for the treatment of patients with left main coronary artery disease and low or intermediate SYNTAX scores. METHODS Patients with a history of COPD were propensity score matched to those without COPD. Outcomes at 30 days and 3 years in both groups were compared in patients randomized to PCI versus CABG. RESULTS COPD status was available for 1901 of 1905 randomized patients (99.8%), 148 of whom had COPD (7.8%). Propensity score matching yielded 135 patients with COPD and 675 patients without COPD. Patients with COPD had higher 3-year rates of the primary composite end point of death, myocardial infarction or stroke (31.7% vs 14.5%, P

Observational data suggest that the use of a single internal thoracic artery (SITA) may result in inferior outcomes compared with bilateral internal thoracic artery (BITA) use for coronary artery bypass grafting (CABG)-a finding not yet supported by randomized trial outcomes. However, the optimal number of internal thoracic artery grafts in patients with left main coronary artery disease has not been investigated.The EXCEL trial randomized 1905 patients with left main coronary artery disease to percutaneous coronary intervention with everolimus-eluting stents versus CABG. Among the 905 patients undergoing CABG, 688 (76.0%) received SITA and 217 (24.0%) received BITA. Differences in clinical event rates were estimated using the Kaplan-Meier method and compared with the log-rank test. Multivariable Cox regression was used to adjust for differences in baseline covariates.Compared to SITA, patients treated with BITA were younger (66.1 ± 9.5 vs 64.5 ± 9.3 years, P = 0.020), were less likely female (24.3% vs 14.3%, P = 0.002) and diabetic (28.8% vs 15.2%, P 0.001), and had a lower prevalence of peripheral vessel disease (10.2% vs 5.5%, P = 0.040). The unadjusted 3-year composite primary endpoint of death, stroke or myocardial infarction (MI) occurred in 15.6% of SITA vs 11.6% of BITA patients (P = 0.17). The SITA group tended to have a higher 3-year rate of all-cause death compared with the BITA group (6.7% vs 3.3%; P = 0.070). Stroke, MI and ischaemia-driven revascularization outcomes were not significantly different between groups. After adjusting for baseline differences, neither the composite of death, stroke or MI [hazard ratio (HR) 1.12, 95% confidence interval (CI) 0.71-1.78; P = 0.62] nor mortality (HR 1.36, 95% CI 0.60-3.12; P = 0.46) was significantly higher with SITA. The rehospitalization rate after 3 years was higher in the SITA group (35.8% vs 26.0%, P = 0.008), a difference which was no longer present after multivariable adjustment (HR 1.27, 95% CI 0.93-1.74; P = 0.13). Sternal wound dehiscence within 30 days did not occur more often in the BITA group compared to the SITA group (1.8% vs 2.2%, P 0.99).In the EXCEL trial, there were no clinical differences at 3 years between SITA or BITA revascularization in patients with left main coronary artery disease.

Short-term mechanical circulatory support (MCS) is increasingly used as a bridge to decision in patients with refractory cardiogenic shock. Subsequently, these patients might be bridged to durable MCS either as a bridge to candidacy/transplantation, or as destination therapy. The aim of this study was to review support duration and clinical outcome of short-term MCS in cardiogenic shock, and to analyse application of this technology as a bridge to long-term cardiac support (left ventricular assist device, LVAD) from 2006 till June 2016. Using Cochrane Register of Trials, Embase and Medline, a systematic review was performed on patients with cardiogenic shock from acute myocardial infarction, end-stage cardiomyopathy, or acute myocarditis, receiving short-term MCS. Studies on periprocedural, post-cardiotomy and cardiopulmonary resuscitation support were excluded. Thirty-nine studies, mainly registries of heterogeneous patient populations (n = 4151 patients), were identified. Depending on the device used (intra-aortic balloon pump, TandemHeart, Impella 2.5, Impella 5.0, CentriMag and peripheral veno-arterial extracorporeal membrane oxygenation), mean support duration was (range) 1.6-25 days and the mean proportion of short-term MCS patients discharged was (range) 45-66%. The mean proportion of bridge to durable LVAD was (range) 3-30%. Bridge to durable LVAD was most frequently performed in patients with end-stage cardiomyopathy (22 [12-35]%). We conclude that temporary MCS can be used to bridge patients with cardiogenic shock towards durable LVAD. Clinicians are encouraged to share their results in a large multicentre registry in order to investigate optimal device selection and best duration of support.

OBJECTIVES: This prespecified subgroup analysis examined the effect of diabetes on left main coronary disease (LM) and/or three-vessel disease (3VD) in patients treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the SYNTAX trial. METHODS: Patients (n = 1800) with LM and/or 3VD were randomized to receive either PCI with TAXUS Express paclitaxel-eluting stents or CABG. Five-year outcomes in subgroups with (n = 452) or without (n = 1348) diabetes were examined: major adverse cardiac or cerebrovascular events (MACCE), the composite safety end-point of all-cause death/stroke/myocardial infarction (MI) and individual MACCE components death, stroke, MI and repeat revascularization. Event rates were estimated with Kaplan-Meier analyses. RESULTS: In diabetic patients, 5-year rates were significantly higher for PCI vs CABG for MACCE (PCI: 46.5% vs CABG: 29.0%; P < 0.001) and repeat revascularization (PCI: 35.3% vs CABG: 14.6%; P < 0.001). There was no difference in the composite of all-cause death/stroke/MI (PCI: 23.9% vs CABG: 19.1%; P = 0.26) or individual components all-cause death (PCI: 19.5% vs CABG: 12.9%; P = 0.065), stroke (PCI: 3.0% vs CABG: 4.7%; P = 0.34) or MI (PCI: 9.0% vs CABG: 5.4%; P = 0.20). In non-diabetic patients, rates with PCI were also higher for MACCE (PCI: 34.1% vs CABG: 26.3%; P = 0.002) and repeat revascularization (PCI: 22.8% vs CABG: 13.4%; P < 0.001), but not for the composite end-point of all-cause death/stroke/MI (PCI: 19.8% vs CABG: 15.9%; P = 0.069). There were no differences in all-cause death (PCI: 12.0% vs CABG: 10.9%; P = 0.48) or stroke (PCI: 2.2% vs CABG: 3.5%; P = 0.15), but rates of MI (PCI: 9.9% vs CABG: 3.4%; P < 0.001) were significantly increased in the PCI arm in non-diabetic patients. CONCLUSIONS: In both diabetic and non-diabetic patients, PCI resulted in higher rates of MACCE and repeat revascularization at 5 years. Although PCI is a potential treatment option in patients with less-complex lesions, CABG should be the revascularization option of choice for patients with more-complex anatomic disease, especially with concurrent diabetes.

Objective Surgery is the first choice of treatment for localised non small cell lung cancer (NSCLC) When making decisions regarding resection, physicians must balance the potential long term benefits of surgery with the risk of surgery related death particularly among elderly patients with multiple co morbid conditions In 2005, a predictive model with a preoperative and a postoperative mode to predict survival of an individual patient after NSCLC surgery was created This model combines the patient, tumour and treatment characteristics and can be used to assist in clinical decision making Till present, this model has not been validated The purpose of this study was to validate this model in patients operated on for primary NSCLC Methods A total of 126 patients underwent surgery for primary NSCLC between January 2002 and December 2006 Required model variables were collected for all patients and inserted into the model To evaluate the performance of the two models, we assessed these models in terms of both discrimination (resolution) and calibration (reliability) The discriminative ability was measured using the c index and calibration was evaluated by the Hosmer-Lemeshow goodness of fit test Results The median follow up time was 3 4 years Hospital mortality was 2 4% One, 2 and 3 year survival was 86% 75% and 72% respectively The discriminative ability of the preoperative mode showed a c statistic for 1 year survival of 0 68, for 2 year of 0 68 and for 3 year of 0 66 The postoperative model showed a discriminative ability for 1 year survival of 0 72, for 2 year of 0 76 and for 3 year of 0 77 Calibration was adequate for the first 2 years The preoperative mode showed a p value of 0 62 for 1 year survival and 0 14 for 2 year survival Calibration was poor for 3 year survival (p = 0 0027) For the postoperative mode, calibration was quite similar with p values of 0 4 for 1 year survival 0 14 for 2 year survival and 0 003 for 3 year survival Conclusions The model adequately estimates the 1 and 2 year survival Discrimination was good for 3 year survival Inclusion of more factors with additional prognostic value could potentially further improve the accuracy of the model (C) 2010 European Association for Cardio Thoracic Surgery Published by Elsevier B V All rights reserved

Background: Severe peripheral arterial disease may pose a limitation to the applicability of trans-arterial aortic valve implantation in patients who are otherwise candidates. For this reason, transapical aortic valve implantation has been proposed as a possible alternative. Objective: To evaluate the acute safety and performance of a specially designed delivery system, the CoreValve Tranzap (TM) delivery catheter, for the transapical implantation of a self-expandable aortic valve prosthesis in a porcine animal model. Methods: Thirteen pigs were implanted with a self-expandable aortic valve bioprosthesis using a 21 F catheter delivery system through a transapical. approach. The delivery system was evaluated for: (1) the ability to access the implantation site; (2) the ability to precisely position the delivery catheter; (3) control of the delivery of the prosthesis; (4) safe retrieval of the delivery catheter; and (5) the ability to close the apical access site of the heart. Results: Successful implantation was achieved in 100% of the cases. The following points were achieved in all animals: (1) passage of the delivery catheter through an incision in the left ventricular apex; (2) positioning of the delivery catheter on the implantation site; (3) controlled deployment of the aortic valve prosthesis; (4) the safe retrieval of the delivery catheter system; and (5) the adequate closure of the apex of the heart. Conclusion: This study demonstrates the acute safety and feasibility of the CoreValve Tranzap (TM) delivery system for the transapical implantation of the CoreValve self expanding aortic valve bioprosthesis in a porcine animal model. (C) 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Objective: Symptomatic severe aortic stenosis is an indication for aortic valve replacement. Some patients are denied intervention. This study provides insight into the proportion of conservatively treated patients and into the reasons why conservative treatment is chosen. Methods: Of a patient cohort presenting with severe aortic stenosis between 2004 and 2007, medical records were retrospectively analyzed. Only symptomatic patients (n = 179) were included. We studied their characteristics, treatment decisions, and survival. Results: Mean age was 71 years, 50% were mate. During follow-up (mean 17 months, 99% complete) 76 (42%) patients were scheduled for surgical treatment (63 conventional valve replacement, 10 transcatheter, 1 heart transplantation, 2 waiting list) versus 101 (56%) who received medical treatment. Reasons for medical treatment were: perceived high operative risk (34%), symptoms regarded mild (19%), stenosis perceived non-severe (14%), and patient preference (9%). In 5% the decision was pending at the time of the analysis and in 20% the reason was other/unclear. Mean age of the surgical group was 68 years versus 73 years for medically treated patients (p = 0.004). Predicted mortality (EuroSCORE) was 7.8% versus 11.3% (p = 0.006). During follow-up 12 patients died in the surgical group (no 30-day operative mortality), versus 28 in the medical group. Two-year survival was 90% versus 69%. Conclusions: A large proportion (56%) of symptomatic patients does not undergo aortic valve replacement. Often operative risk is estimated (too) high or hemodynamic severity and symptomatic status are misclassified. Interdisciplinary team discussions between cardiologists and surgeons should be encouraged to optimize patient selection for surgery. (C) 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Objectives: To characterize the current patient population regarding extent and pattern of coronary artery disease (CAD) in a routine cardiac catheterization practice with special focus on de-novo three-vessel coronary artery and/or left main disease (3-VD/LM) during enrolment in the SYNTAX study (synergy between PCI with Taxus drug-eluting stent and cardiac surgery) comparing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and coronary artery bypass grafting (CABG) in 3-VD/LM. Methods: During a 4-month study enrolment period, a total of 3319 consecutive adult patients undergoing coronary angiography were prospectively recorded. Patients with de-novo 3-VD/LM were screened in the daily heart team conference by interventional cardiologists and cardiac surgeons concerning suitability for Study enrolment. Complexity of CAD was quantified by the SYNTAX score. Results: A total of 694 patients (20.9%) presented with 3-VD/LM, of which 271 had previous CABG and 232 previous PCI treatment. Of the 191 patients with de-novo 3-VD/LM, SYNTAX study exclusion criteria were present in 87 patients consisting mostly of acute myocardial infarction (n = 47) or concomitant indications for additional heart Surgery (n = 35). A total of 104 patients (54.4% of all screened) were potentially suitable for study enrolment. Of these, 13 patients refused study participation, 10 presented with uncertain protocol adherence and 6 were already participating in other cardiovascular trials. A total of 67 patients were therefore enrolled in the SYNTAX study, representing 9.7% of 3-VD/LM and 35.1% of all, screened patients. Twenty-four patients were not amenable for PCI and were therefore assigned to the CABG registry. Compared to the randomized cohort, these patients had more complex CAD (SYNTAX score 34 vs 26, p = 0.003) with significantly more chronic coronary vessel occlusion (70.8% vs 22.5%, p, = 0.04). In the randomized cohort, CABG and PCI patients were comparable in age (PCI 69.7 years vs CABG 67.2 years), additive EuroSCORE (4.8 vs 4.4), EF (57.8% vs 52.4%), number of coronary lesions (4.5 vs 4.6), left main disease (42.9% vs 52.6%) and coronary vessel occlusion. Conclusions: Patients with de-novo 3-VD/LM represented a small proportion of patients undergoing coronary angiography at our center. However, SYNTAX study inclusion and randomization rates of these screened patients were high. Chronic vessel occlusion and high SYNTAX scores were more common in CABG registry patients compared to randomized patients. (C) 2008 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Objective: Whether allografts are the biological valve of choice for AVR in non-elderly patients remains a topic of debate. In this light we analyzed our ongoing prospective allograft AVR cohort and compared allograft durability with other biological aortic valve substitutes. Methods: Between April 1987 and October 2005, 336 patients underwent 346 allograft AVRs (95 subcoronary, 251 root replacement). Patient and perioperative characteristics, cumulative survival, freedom from reoperation, and valve-related events were analyzed. Using microsimulation, for adult patients, age-matched actual freedom from allograft reoperation was compared to porcine and pericardial bioprostheses. Results: Mean age was 45 years (range 1 month to 83 years); 72% were males. Etiology was mainly endocarditis 32% (active 22%), congenital 31%, degenerative 9%, and aneurysm/dissection 12%. Twenty-seven percent underwent prior cardiac surgery. Hospital mortality was 5.5% (N = 19). During follow-up (mean 7.4 years, maximum 18.5 years, 98% complete), 54 patients died; there were 57 valve-related reoperations (3 early technical, 11 non-structural, 39 structural valve deterioration (SVD), 4 endocarditis), 5 cerebrovascular accidents, 1 fatal bleeding, 8 endocarditis. Twelve-year cumulative survival was 71% (SE 3), freedom from reoperation for SVD 77% (SE 4); younger patient age was associated with increased SVD rates. Actual risk of allograft reoperation was comparable to porcine and pericardial bioprostheses in a simulated age-matched population. Conclusions: The use of allografts for AVR is associated with low occurrence rates of most valve-related events, but over time the risk of SVD increases, comparable to stented xenografts. It remains in our institute the preferred valve substitute only for patients with active aortic root endocarditis and for patients in whom anticoagulation should be avoided.

Objective: To validate the influence of the Charlson comorbidity index (CCI) in patients with operated primary non-small cell lung cancer. Methods: From January 1996 to December 2001, 205 consecutive resections for non-small cell lung cancer were performed at the Erasmus Medical Center Rotterdam. The patients ranged in age from 29 to 82 years, with a mean age of 64 years. In a retrospective study, each patient was scaled according to the CCI and the complications of surgery were determined. Results: The hospital mortality was 2.4% (5/205). Of the 205 patients 167 (32.7%) experienced minor complications and 32 (15.6%) major complications. In univariate analysis, gender, grades 3–4 of the CCI, any prior tumor treated in the last 5 years and chronic pulmonary disease were significant predictors of adverse outcome. Multivariate analysis showed that only grades 3–4 of the CCI was predictive (odds ratio ¼ 9.8; 95% confidence interval ¼ 2.1–45.9). Although only comorbidity grades 3–4 was a significant predictor, for every increase of the comorbidity grade the relative risk of adverse outcome showed a slight increase. Conclusion: The CCI is strongly correlated with higher risk of surgery in primary non-small cell lung cancer patients and is a better predictor than individual risk factors. q 2002 Elsevier Science B.V. All rights reserved.

Objective: Valvotomy and the autograft procedure are the most common surgical treatment options for children with valvular aortic stenosis. We evaluated the results of these surgical procedures in our institution. Methods: Retrospective analysis was done of all patients presenting with aortic stenosis and operated upon before the age of 18. In 11 patients a valvotomy was performed and in 36 an autograft procedure. Results: There was no hospital mortality. Mean follow-up in the valvotomy group was 4.8 years (SD 3.3), in the autograft group 4.5 years (SD 3.3). During follow-up one patient died suddenly 2 months after valvotomy. Two patients in the autograft group died (not valve-related). After valvotomy three patients underwent a balloon valvotomy, in one followed by an autograft procedure and one patient had a repeat valvotomy. In the autograft group one patient was reoperated for severe aortic regurgitation and moderate pulmonary stenosis. At last echocardiography after valvotomy (eight remaining patients) in only two patients (25%) no aortic stenosis or regurgitation was present. In the remaining six patients aortic stenosis is mild in two and moderate in three, including one with moderate aortic regurgitation. In one patient without stenosis, moderate aortic regurgitation was seen. No pulmonary stenosis or regurgitation is present. Echocardiography after autografting (33 remaining patients) showed no aortic stenosis. Aortic regurgitation was mild in seven patients, moderate in two, severe in one. Pulmonary stenosis was present in two patients (16%). Pulmonary regurgitation was mild in three patients and moderate in one. Conclusions: In selected patients with valvular aortic stenosis who are beyond infancy, valvotomy may be adequate and may postpone further surgery for a significant length of time. After valvotomy the main problem is residual aortic stenosis while after autografting a shift occurs to aortic regurgitation and problems related to the pulmonary valve. Careful clinical and echocardiographic follow-up is therefore warranted in young patients after the autograft procedure. q 2001 Elsevier Science B.V. All rights reserved.