Kappetein, A.P.

The SYNTAX score and its clinical implications (Article)

2013-03-28T00:00:00Z

Analysis of Stroke Occurring in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) Trial Comparing Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention in the Treatment of Complex Coronary Artery Disease (Article)

2013-03-21T00:00:00Z

Objectives: This study sought to analyze stroke rates in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial's randomized and registry cohorts of patients being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for treatment of complex coronary artery disease. Background: The SYNTAX trial compared PCI to CABG in patients with de novo 3-vessel and/or left main coronary disease. Methods: The SYNTAX randomized trial was conducted at 85 U.S. and European sites (n = 1,800). All strokes (up to 4 years) were independently adjudicated by a clinical events committee that included a neurologist. An additional 1,077 (of which 644 were followed for 5 years) and 198 patients were included in the CABG and PCI registries, respectively. Results: In the randomized cohort, 31 CABG and 19 PCI patients experienced 33 and 20 strokes post-randomization at 4-year follow-up, respectively (p = 0.062). Three strokes occurred pre-procedurally but following randomization in CABG-treated patients. After CABG, a large proportion of strokes occurred acutely (0 to 30 days: 9 of 33), whereas in the PCI arm, most strokes occurred >30 days after the procedure (18 of 20). Stroke resulted in death in 3 patients in both the PCI and CABG groups. Of the patients who developed stroke, 68% (21 of 31) in the CABG group had residual deficits at discharge; in the PCI group, 47% (9 of 19) had residual deficits. In a multivariate analysis, treatment with CABG was not significantly associated with increased stroke rates (odds ratio: 1.67, 95% confidence interval: 0.93 to 3.01, p = 0.089). The incidence and outcomes of stroke were similar in the randomized trial and registries. Conclusions: There is a higher risk of periprocedural stroke in patients undergoing CABG versus PCI; however, the risk converges over the first 4 years of follow-up. (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery [SYNTAX]; NCT00114972).

Appropriate Coronary Artery Bypass Grafting Use in the Percutaneous Coronary Intervention Era: Are We Finally Making Progress? (Article)

2012-12-01T00:00:00Z

Appropriate use criteria integrate guidelines, clinical trial evidence, and expert opinion in order to determine the most appropriate care for a range of distinct clinical scenarios. Inappropriate use estimates cannot be neglected. Approximately 12%-14% of all percutaneous coronary interventions and 1%-2% of all coronary artery bypass grafting procedures in patients with stable angina are deemed inappropriate. Several reasons for this difference are identified. Continuous improvement of the criteria, multidisciplinary discussions, and the correct financial incentives will be essential in reducing the number of inappropriate procedures, improve patient outcomes, and contain costs.

Updated standardized endpoint definitions for transcatheter aortic valve implantation: The valve academic research consortium-2 consensus document (varc-2) (Article)

2012-11-01T00:00:00Z

Objectives: The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. BACKGROUND: A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. METHODS AND Results: Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. Conclusions: This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavours of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Published on behalf of the European Association for Cardio-Thoracic Surgery. The article has been co-published in the European Heart Journal, EuroIntervention, Journal of the American College of Cardiology, and Journal of Thoracic and Cardiovascular Surgery. All rights reserved. © The Author 2012.

Current concepts on coronary revascularization in diabetic patients (Article)

2011-11-01T00:00:00Z

Diabetic mellitus (DM) patients with coronary artery disease (CAD) are at higher risk of cardiovascular events compared with non-DM individuals. While aggressive cardiovascular prevention and adequate blood glucose control remain cornerstones of therapy, the decision when and how to proceed to coronary revascularization in an individual DM patient should be based on the extent of CAD, ischaemic burden, ventricular function, as well as comorbidities. While in patients with stable symptoms, moderate CAD on coronary angiography and preserved left ventricular function a conservative strategy may be a valuable initial strategy, in patients with acute coronary syndromes (ACS) an early invasive approach should be favoured. The revascularization strategy for DM patients with complex multivessel CAD should be discussed within a heart team consisting of cardiologists, cardiac surgeons, and anaesthesiologists. In general, the threshold for coronary artery bypass surgery (CABG) should be lower for DM than for non-DM individuals. In patients undergoing percutaneous coronary intervention, the use of drug-eluting stents (DES) andin the setting of ACSof potent platelet inhibitors, such as prasugrel or ticagrelor, should be favoured. In the near future, multiple strategies may further favourably impact the prognosis of DM patients undergoing coronary revascularization. These include alternative antiplatelet agents such as thromboxane receptor inhibitors, the broad use of second generation DES, and possibly the implantation of bioresorbable stents. Coronary artery bypass surgery outcomes may also further improve by wide implementation of arterial revascularization, reduction in perioperative stroke by avoiding clamping of the aorta, reduction in wound infection by minimally invasive techniques, and optimization of post-operative medical management.

Comparison of coronary bypass surgery with drug-eluting stenting for the treatment of left main and/or three-vessel disease: 3-year follow-up of the SYNTAX trial (Article)

2011-09-01T00:00:00Z

Aims Long-term randomized comparisons of percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in left main coronary (LM) disease and/or three-vessel disease (3VD) patients have been limited. This analysis compares 3-year outcomes in LM and/or 3VD patients treated with CABG or PCI with TAXUS Express stents. Methods and resultsSYNTAX is an 85-centre randomized clinical trial (n 1800). Prospectively screened, consecutive LM and/or 3VD patients were randomized if amenable to equivalent revascularization using either technique; if not, they were entered into a registry. Patients in the randomized cohort will continue to be followed for 5 years. At 3 years, major adverse cardiac and cerebrovascular events [MACCE: death, stroke, myocardial infarction (MI), and repeat revascularization; CABG 20.2 vs. PCI 28.0, P< 0.001], repeat revascularization (10.7 vs. 19.7, P< 0.001), and MI (3.6 vs. 7.1, P 0.002) were elevated in the PCI arm. Rates of the composite safety endpoint (death/stroke/MI 12.0 vs. 14.1, P 0.21) and stroke alone (3.4 vs. 2.0, P 0.07) were not significantly different between treatment groups. Major adverse cardiac and cerebrovascular event rates were not significantly different between arms in the LM subgroup (22.3 vs. 26.8, P 0.20) but were higher with PCI in the 3VD subgroup (18.8 vs. 28.8, P< 0.001). Conclusion sAt 3 years, MACCE was significantly higher in PCI-compared with CABG-treated patients. In patients with less complex disease (low SYNTAX scores for 3VD or low/intermediate terciles for LM patients), PCI is an acceptable revascularization, although longer follow-up is needed to evaluate these two revascularization strategies.

Effect of experience on results of transcatheter aortic valve implantation using a medtronic CoreValve system (Article)

2011-06-15T00:00:00Z

Outcome after transcatheter aortic valve implantation (TAVI) depends on the patient risk profile, operator experience, progress in technology, and technique. We sought to compare the results of TAVI during the initiation phase and after certification to perform TAVI with the Medtronic CoreValve System without proctoring. A total of 165 consecutive patients was categorized into a first cohort of 33 patients treated before certification (November 2005 to December 2007) and a second cohort of 132 patients treated after certification (January 2008 to October 2010). The study end points were selected and defined according to the Valve Academic Research Consortium recommendations. Compared to cohort 2, the patients in cohort 1 more frequently had New York Heart Association class IIIIV (100% vs 71%, p <0.001), hypertension (67% vs 39%, p = 0.004), and aortic regurgitation grade IIIIV (46% vs 22%, p = 0.006) before TAVI. Over time, the patients in cohort 2 more frequently underwent a truly percutaneous approach (98% vs 82%, p = 0.002) without circulatory support (96% vs 67%, p <0.001) but with more concomitant percutaneous coronary intervention (11% vs 0%, p = 0.042) than the patients in cohort 1. They also more often received a 29-mm prosthesis (72% vs 24%, p <0.001), required less postimplantation balloon dilation (10% vs 27%, p = 0.008), and had less aortic regurgitation grade IIIIV after TAVI (12% vs 30%, p = 0.010). The clinical outcome showed a nonsignificant reduction in the combined safety end point (30% to 17%) but a significant reduction in cerebrovascular events (21% to 7%, p = 0.020) and life-threatening bleeding (15% to 5%, p = 0.044) in cohort 2. However, the reduction in overall bleeding and vascular complications (25% and 14%, respectively) was not significant. In conclusion, TAVI became significantly less complex and was associated with better results over time but remained associated with a high frequency of periprocedural major cardiovascular complications. Crown Copyright

Nonrandomized data on drug-eluting stents compared with coronary bypass surgery: Caution with interpretation (Article)

2011-06-14T00:00:00Z

Details in a meta-analysis comparing mitral valve repair to replacement for ischemic regurgitation (Article)

2011-06-02T00:00:00Z

A crucial factor in shared decision making: The team approach (Article)

2011-05-28T00:00:00Z

In-hospital complications after transcatheter aortic valve implantation revisited according to the valve academic research consortium definitions (Article)

2011-05-13T00:00:00Z

Objectives: To determine the occurrence of in-hospital complications after transcatheter aortic valve implantation (TAVI) according to the Valve Academic Research Consortium (VARC) criteria in addition to the length of stay (LOS). Background: The absence of uniformity in endpoint definitions challenges the comparison between previously reported major adverse cerebro- and cardiovascular event rates after TAVI. To address this, in 2009, the VARC was established aiming to provide standardized endpoint definitions for TAVI clinical trials. Methods: Between November 2005 and September 2010, we prospectively enrolled 150 consecutive patients who underwent TAVI with the Medtronic CoreValve System in our institution. Complications, prosthetic valve associated endpoints, and therapy-specific endpoints were defined according to the definitions provided by the VARC. Results: The mean age (±SD) was 81 (±7) years and 55% were female. Thirty-day or in-hospital mortality was 11%, and the 30-day combined safety endpoint was 22%. Seventy-six patients (51%) had ≥1 cardiovascular and/or noncardiovascular complication of whom 16 also underwent a new permanent pacemaker implantation (PPI). In the 74 patients with uneventful TAVI, 12 patients (8%) underwent PPI. TAVI was truly uneventful in 62 patients (41%). Bleeding complications were observed most frequently (31%), followed by acute kidney injury (18%), vascular complications (16%), and stroke/TIA (11%). The median LOS in patients with a complicated and a truly uncomplicated TAVI was 14.0 (8.0-20.5) and 8.0 (7.0-10.8) days, respectively (P < 0.001). Conclusion: TAVI was associated with ≥1 cardiovascular and/or noncardiovascular event in 51% of the patients; new PPI was needed in another 8%, and TAVI was truly uncomplicated in 41%. Complications and need for new PPI significantly prolonged LOS.

Quality of life after PCI with drug-eluting stents or coronary-artery bypass surgery (Article)

2011-03-17T00:00:00Z

BACKGROUND: Previous studies have shown that among patients undergoing multivessel revascularization, coronary-artery bypass grafting (CABG), as compared with percutaneous coronary intervention (PCI) either by means of balloon angioplasty or with the use of bare-metal stents, results in greater relief from angina and improved quality of life. The effect of PCI with the use of drug-eluting stents on these outcomes is unknown. METHODS: In a large, randomized trial, we assigned 1800 patients with three-vessel or left main coronary artery disease to undergo either CABG (897 patients) or PCI with paclitaxeleluting stents (903 patients). Health-related quality of life was assessed at baseline and at 1, 6, and 12 months with the use of the Seattle Angina Questionnaire (SAQ) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The primary end point was the score on the angina-frequency subscale of the SAQ (on which scores range from 0 to 100, with higher scores indicating better health status). RESULTS: The scores on each of the SAQ and SF-36 subscales were significantly higher at 6 and 12 months than at baseline in both groups. The score on the angina-frequency subscale of the SAQ increased to a greater extent with CABG than with PCI at both 6 and 12 months (P = 0.04 and P = 0.03, respectively), but the between-group differences were small (mean treatment effect of 1.7 points at both time points). The proportion of patients who were free from angina was similar in the two groups at 1 month and 6 months and was higher in the CABG group than in the PCI group at 12 months (76.3% vs. 71.6%, P = 0.05). Scores on all the other SAQ and SF-36 subscales were either higher in the PCI group (mainly at 1 month) or were similar in the two groups throughout the follow-up period. CONCLUSIONS: Among patients with three-vessel or left main coronary artery disease, there was greater relief from angina after CABG than after PCI at 6 and 12 months, although the extent of the benefit was small. (Funded by Boston Scientific; ClinicalTrials.gov number, NCT00114972.). Copyright

Carriage of reduced-function cyp2c19 allele among patients treated with clopidogrel (Article)

2011-02-02T00:00:00Z

One year follow-up of the multi-centre European PARTNER transcatheter heart valve study (Article)

2011-01-01T00:00:00Z

BackgroundTranscatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis.AimsPARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach.Methods and resultsPrimary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7, P <0.0005) and more peripheral disease (49.3 vs. 16.4, P< 0.0001). Procedures were aborted in four TA (5.8) and six TF cases (9.8). Valve implantation was successful in the remaining patients in 95.4 and 96.4, respectively. Thirty days and 6 months survival were 81.2 and 58.0 (TA) and 91.8 and 90.2 (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8 of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7 had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively.ConclusionThis first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes.

The evolution of advanced techniques for the management of symptomatic aortic stenosis in the elderly population: Conventional surgical management vs transcatheter valve implantation (Article)

2010-12-01T00:00:00Z

The shifting age demographic of the adult population has affected every area of contemporary medical and surgical practice. Many more people are living well, not just into their 70s but into their 80s and beyond. Their expectations of treatment for every illness have shifted markedly upwards at the same time. Despite the decline in cases of rheumatic fever in Westernised populations in recent times, the ageing population has led to no decline in the prevalence of valvular aortic stenosis. This is now realised to be an active pro-inflammatory disease, rather than a degenerative process. Thus the condition has remained in the mainstream and continues to be responsible for considerable morbidity, hospitalisation and mortality among the elderly and very elderly. Management has always been based on the triage of cases for direct intervention to the valve by surgery. Just as expectations have risen from patients, the techniques, application and monitoring of cardiac surgery have also made huge strides forward to meet this aspiration. More and more, surgeons are routinely asked to consider procedures in frailer, more elderly patients with more severe disease and co-morbidity. Managing the stenosis is rarely the only issue confronting the operating surgeon. Attempts to provide alternatives to open valve replacement surgery on cardiopulmonary bypass have now emerged. These are based around the transcutaneous placement of a valve prosthesis. While these technologies were initially highly selective in their application, they have now reached a stage to be compared with contemporary standards of cardiac surgical practice. In this debate we have invited two international experts from the fields of cardiac surgery (Professor Jahangiri) and interventional cardiology (Professor Kappetein and colleagues) to take deliberately opposing positions on the evolving management of valvular aortic stenosis in the very elderly. We have asked them to try to consider the strengths of each route. Both approaches provide options for patients who only a few years ago might have been regarded as essentially untreatable.

Validation of a prognostic model to predict survival after non-small-cell lung cancer surgery (Article)

2010-11-01T00:00:00Z

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.

Bilateral mammary artery vs. single mammary artery grafting: Promising early results: But will the match finish with enough players? (Article)

2010-10-01T00:00:00Z

Editorial comment. Is there enough evidence that proves clinical equipoise between stenting and coronary surgery for patients with left main coronary artery disease? (Article)

2010-10-01T00:00:00Z

Long term follow up after surgery in congenitally corrected transposition of the great arteries with a right ventricle in the systemic circulation (Article)

2010-09-28T00:00:00Z

Aim of the study: To investigate the long-term outcome of surgical treatment for congenitally corrected transposition of the great arteries (CCTGA), in patients with biventricular repair with the right ventricle as systemic ventricle.Methods: A total of 32 patients with CCTGA were operated between January 1972 and October 2008. These operations comprised 18 patients with a repair with a normal left ventricular outflow tract, 11 patients with a Rastelli repair of the left ventricle to the pulmonary artery and 3 patients with a cardiac transplantation.Results: Excluding the cardiac transplantation patients, mean age at operation was 16 years (sd 15 years, range 1 week - 49 years). Median follow-up was 12 years (sd 10 years, range 7 days - 32 years). Survival obtained from Kaplan-Meier analysis at 20 years after surgery was 63% (CI 53-73%). For the non-Rastelli group these data at 20 years were 62% (CI 48-76%) and for the Rastelli group 67% (CI 51-83%). Freedom of reoperation at 20 years was 32% (CI 19-45%) in the overall group. In the non-Rastelli group the data at 20 years were 47% (CI 11-83%) and for the Rastelli group 21% (CI 0-54%) after almost 19 years.Conclusions: Long term follow up confirms that surgery in CCTGA with the right ventricle as systemic ventricle has a suboptimal survival and limited freedom of reoperation. Death occurred mostly as a result of cardiac failure.

Clinical and angiographic risk assessment in patients with left main stem lesions (Article)

2010-09-01T00:00:00Z

Percutaneous coronary intervention of unprotected left main stem lesions has been shown to be a suitable alternative to cardiac surgery in selected patients, emphasizing the need for appropriate risk stratification prior to selection of revascularization modality. Several risk models based on clinical and angiographic variables have been developed to guide patient selection, each of which has significant limitations. This paper reviews contemporary and newly proposed risk models for patients undergoing left main stem revascularization.

Prosthesis-patient mismatch after transcatheter aortic valve implantation with the medtronic corevalve system in patients with aortic stenosis (Article)

2010-07-15T00:00:00Z

A prosthesispatient mismatch (PPM) is present when the prosthetic valve is too small in relation to the patient's body size. The purpose of the present study was to investigate the frequency of PPM after the implantation of the Medtronic CoreValve System, and its relation to the clinical outcome. The indexed effective orifice area (EOA) was measured in 74 patients with symptomatic severe aortic stenosis, who had undergone successful transcatheter aortic valve implantation with the Medtronic CoreValve System, at baseline and discharge. PPM was defined as severe (indexed EOA <0.65 cm2/m 2) or moderate (indexed EOA 0.65 to 0.85 cm2/m 2). The indexed EOA increased from 0.35 ± 0.13 to 0.97 ± 0.34 cm2/m2 after transcatheter aortic valve implantation (p <0.001) and was accompanied by significant clinical improvement. Severe and moderate PPMs were found in 16% and 23% of patients, respectively. Patients with severe PPM were more symptomatic and had a smaller indexed EOA at baseline than those with moderate or no PPM (0.28 ± 0.09 vs 0.36 ± 0.12 cm2/m2, p <0.05). Functional status and mortality at 30 days and 6 months was not significantly different between the patients with severe PPM and those with moderate or no PPM. In conclusion, the indexed EOA increased significantly after transcatheter aortic valve implantation. Severe PPM was observed in 16% of the patients and was not associated with the clinical outcome.

Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial (Article)

2010-06-22T00:00:00Z

BACKGROUND-: The prospective, multinational, randomized Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial was designed to assess the optimal revascularization strategy between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), for patients with left main (LM) and/or 3-vessel coronary disease. METHODS AND RESULTS-: This observational hypothesis-generating analysis reports the results of a prespecified powered subgroup of 705 randomized patients who had LM disease among the 1800 patients with de novo 3-vessel disease and/or LM disease randomized to PCI with paclitaxel-eluting stents or CABG in the SYNTAX trial. Major adverse cardiac and cerebrovascular event rates at 1 year in LM patients were similar for CABG and PCI (13.7% versus 15.8%; Δ2.1% [95% confidence interval-3.2% to 7.4%]; P=0.44). At 1 year, stroke was significantly higher in the CABG arm (2.7% versus 0.3%; Δ-2.4% [95% confidence interval-4.2% to-0.1%]; P=0.009]), whereas repeat revascularization was significantly higher in the PCI arm (6.5% versus 11.8%; Δ5.3% [95% confidence interval 1.0% to 9.6%]; P=0.02); there was no observed difference between groups for other end points. When patients were scored for anatomic complexity, those with higher baseline SYNTAX scores had significantly worse outcomes with PCI than did patients with low or intermediate SYNTAX scores; outcomes for patients with CABG did not correlate with baseline SYNTAX score, but baseline EuroSCORE significantly predicted outcomes for both treatments. CONCLUSIONS-: Patients with LM disease who had revascularization with PCI had safety and efficacy outcomes comparable to CABG at 1 year; longer follow-up is required to determine whether these 2 revascularization strategies offer comparable medium-term outcomes in this group of complex patients.

Diabetic and Nondiabetic Patients With Left Main and/or 3-Vessel Coronary Artery Disease. Comparison of Outcomes With Cardiac Surgery and Paclitaxel-Eluting Stents (Article)

2010-03-16T00:00:00Z

Objectives: This study was designed to compare contemporary surgical revascularization (coronary artery bypass graft surgery [CABG]) versus TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stents (PES) in diabetic and nondiabetic patients with left main and/or 3-vessel disease. Background: Although the prevalence of diabetes mellitus is increasing, the optimal coronary revascularization strategy in diabetic patients with complex multivessel disease remains controversial. Methods: The SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) study randomly assigned 1,800 patients (452 with medically treated diabetes) to receive PES or CABG. Results: The overall 1-year major adverse cardiac and cerebrovascular event rate was higher among diabetic patients treated with PES compared with CABG, but the revascularization method did not impact the death/stroke/myocardial infarction rate for nondiabetic patients (6.8% CABG vs. 6.8% PES, p = 0.97) or for diabetic patients (10.3% CABG vs. 10.1% PES, p = 0.96). The presence of diabetes was associated with significantly increased mortality after either revascularization treatment. The incidence of stroke was higher among nondiabetic patients after CABG (2.2% vs. PES 0.5%, p = 0.006). Compared with CABG, mortality was higher after PES use for diabetic patients with highly complex lesions (4.1% vs. 13.5%, p = 0.04). Revascularization with PES resulted in higher repeat revascularization for nondiabetic patients (5.7% vs. 11.1%, p < 0.001) and diabetic patients (6.4% vs. 20.3%, p < 0.001). Conclusions: Subgroup analyses suggest that the 1-year major adverse cardiac and cerebrovascular event rate is higher among diabetic patients with left main and/or 3-vessel disease treated with PES compared with CABG, driven by an increase in repeat revascularization. However, the composite safety end point (death/stroke/myocardial infarction) is comparable between the 2 treatment options for diabetic and nondiabetic patients. Although further study is needed, these exploratory results may extend the evidence for PES use in selected patients with less complex left main and/or 3-vessel lesions. (SYNergy Between PCI With TAXus and Cardiac Surgery [SYNTAX]; NCT00114972).

Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving System-A Bern-Rotterdam Study (Article)

2010-02-01T00:00:00Z

Background: Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or "inoperable" patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. Objective: The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. Methods: All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. Results: Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% ± 13.9% vs STS 6.7% ± 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES ≥15%, 16% had an STS ≥10%, and 40% had an LES ≥20% or STS ≥10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. Conclusions: Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.

Surgical Treatment of Active Native Aortic Valve Endocarditis With Allografts and Mechanical Prostheses (Article)

2009-12-01T00:00:00Z

Background: Surgical intervention for persistent active native aortic valve endocarditis (NVE) remains challenging. We analyzed our combined experience with allografts and mechanical prostheses (MP) in NVE operations. Methods: Between 1980 and 2002, 138 patients (81% males) underwent aortic valve replacement for NVE in 2 centers (106 allografts; 32 MPs). Perioperative characteristics and early and late morbidity and mortality were analyzed. Results: Mean age was 47 years (range, 14 to 76 years), and 34% required emergency surgery. Abscess rate was 38% for allografts vs 18% for MPs. Concomitant mitral valve replacement was required in 38% MP patients and in 5% allograft patients. Hospital mortality was 8% (n = 11; p = 0.25): 10 allograft patients (9%) and 1 MP patient (3%). During a mean 8-year follow-up (range, 0 to 25 years) 33 patients died: 22 allograft (24%) and 11 MP patients (21%; p = 0.14). Survival at 15 years was 59% ± 6% for allograft patients and 66% ± 9% for MP patients (p = 0.68). Late recurrent endocarditis developed in 6 allograft patients and 1 MP patient (p = 0.29). Overall 15-year freedom from reoperation was 76% ± 9% for allografts and 93% ± 6% for MPs (p = 0.02). Conclusions: Mechanical prostheses have comparable rates of midterm survival and freedom from recurrent infection. However, this is in combination with extensive excision of destructive tissue in a specific patient subset. Allograft reoperation rates increase with time. The importance of the mechanical prosthesis in NVE might be established in the coming years.

How to assess risks of valve surgery: Quality, implementation and future of risk models (Article)

2009-12-01T00:00:00Z

Transapical implantation of a self-expanding aortic valve bioprosthesis - animal feasibility study (Article)

2009-11-01T00:00:00Z

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™ 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 21F 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™ delivery system for the transapical implantation of the CoreValve self-expanding aortic valve bioprosthesis in a porcine animal model.

Four-Year Outcome of OPCAB No-Touch With Total Arterial Y-Graft: Making the Best Treatment a Daily Practice (Article)

2009-09-01T00:00:00Z

Background: A retrospective, single-center 4-year clinical study of the off-pump coronary artery bypass grafting no-touch technique with arterial conduits (Y-graft) was compared with the Syntax trial. Methods: Four hundred consecutive patients ("all-comers") who underwent coronary surgery between 2004 and 2008 at the Thorax Center Twente (TCT) formed the study group. The primary end point was in-hospital and 12-month major cardiovascular or cerebrovascular event (MACCE). Event rates of MACCE were based on life tables, and overall MACCE was determined by Kaplan-Meier analysis. Results: In-hospital mortality was 0.2%. Cumulative 1-year survival was 98.2%, and freedom from MACCE was 94.7% ± 1.1%. Cumulative 4-year survival and freedom from MACCE were 91.2% ± 2.4% and 82.1% ± 3.0%, respectively. There were no significant differences in the baseline characteristics between the patients of the TCT group and the surgical arm of the Syntax trial. Repeat revascularization, MACCE, and symptomatic graft occlusion in the TCT group were significantly lower than in the Syntax trial. The event rate of myocardial infarction and all-cause death in the TCT group were significantly lower than those of the percutaneous coronary intervention arm of the Syntax trial. There was a clear trend toward a reduction of the event rate of stroke in the TCT group (0.8%) compared with the surgical arm of the Syntax trial (2.2%). There was no significant difference of stroke rate between the TCT group and the percutaneous coronary intervention arm of the Syntax trial. Conclusions: A state-of-the-art surgical technique such as off-pump coronary artery bypass grafting no-touch can further improve the advantage of surgical treatment with respect to percutaneous coronary intervention. Off-pump coronary artery bypass grafting no-touch surgery can be the treatment of choice for patients with three-vessel disease and left main stenosis.

Assisted circulation using the tandemheart® during very high-risk PCI of the unprotected left main coronary artery in patients declined for CABG (Article)

2009-08-01T00:00:00Z

Objectives: In a single center experience, we retrospectively evaluated the short-term safety and efficacy of the TandemHeart® percutaneous transseptal left ventricular assist (PTVA®) system to deliver extracorporeal circulatory support during catheter based treatment of the unprotected left main coronary artery (ULMCA). Background: Percutaneous Coronary Intervention (PCI) of the ULMCA usually has been restricted to patients who are hemodynamically unstable or ineligible for coronary artery bypass grafting (CABG). High-risk patients for CABG should be considered at increased risk for PCI as well. In these patients the TandemHeart PTVA System (p-LVAD) may provide a valuable safeguard to reduce procedural risks. Methods and Results: Between July 2002 and May 2008 the TandemHeart was used in 9 very high risk patients (Logistic Euro score: 13.64 (7.46-29.67); Syntax score:43 (41-50); Mayo Clinic Risk score (MCRS) 7 (6-8); age: median 65 (range 55-71) undergoing elective PCI for the novo lesions on the ULMCA. All patients were declined for CABG by a heart team. A "true" percutaneous insertion technique was used in all patients, technical success rate was 100%. The median (range) time for implementation of circulatory support was 27 min (24-30). A median (range) pump flow up to 4.36 (3.40-5.54) L/min was achieved with significant reduction of left ventricular filling pressures, pulmonary capillary wedge pressure and a small increase of systemic arterial pressures. Median (range) duration of support was 93 min (50.4-102). Successful weaning was achieved in all patients. There was no in hospital death, survival at 6 months was (89%), whereas vascular access site complications were seen in 4 patients (44.4%). Conclusions: In very high risk PCI, assisted circulation using the TandemHeart-PTVA provides effective, total left ventricular support and may contribute to a reduced procedural risk and improved survival. The rate of device related cardiac and vascular complications was acceptable.

Prognosis of patients undergoing cardiac surgery and treated with intra-aortic balloon pump counterpulsation prior to surgery: A long-term follow-up study (Article)

2009-08-01T00:00:00Z

The aim of this study was to evaluate short- and long-term outcome in patients undergoing coronary artery bypass grafting (CABG), who received an intra-aortic balloon pump (IABP) prior to surgery. Between January 1990 and June 2004, all patients (n=154) who received an IABP prior to on-pump CABG in our center were included. Patients received the IABP for vital indications (i.e. either unstable angina refractory to medical therapy or cardiogenic shock; group 1: n=99) or for prophylactic reasons (group 2: n=55). A Cox proportional hazards model was used to identify predictors of long-term all-cause mortality. Compared with the EuroSCORE predictive model, observed 30-day mortality in group 1 (15.2%) was slightly higher than predicted (10.3%). A decrease in 30-day mortality occurred in group 2 (median predicted mortality was 7.2% and observed was 0%). Cumulative 1-, 5-, and 6-year survival was 82.8±3.8%, 70.1±4.9%, and 67.3±5.1% for group 1 vs. 98.2±1.8%, 84.0±5.6% and 84.0±5.6% for group 2 (Log-rank: P=0.02). Logistic EuroSCORE (HR 1.03 w1.01-1.05x, Ps0.007) was an independent predictor of long-term all-cause mortality.

Therapeutic decisions for patients with symptomatic severe aortic stenosis: room for improvement? (Article)

2009-06-01T00:00:00Z

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 male. 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.

Patient outcome after aortic valve replacement with a mechanical or biological prosthesis: Weighing lifetime anticoagulant-related event risk against reoperation risk (Article)

2009-04-01T00:00:00Z

Objective: Although the results of aortic valve replacement with different valve prostheses are well documented in terms of survival, the risks of (valve-related) events are less well explored. Methods: We used a dataset of 3934 patients who underwent aortic valve replacement with either a bioprosthesis (73%) or a mechanical prosthesis (27%) between 1982 and 2003 to simulate the outcome of patients after aortic valve replacement with either valve type. With the use of microsimulation, we compared total age and gender-specific life expectancy, event-free life expectancy, reoperation-free life expectancy, lifetime risks of reoperation, and valve-related events for both valve types. Results: The total follow-up was 26,467 patient-years. The mean follow-up was 6.1 years in the biological arm and 8.5 years in the mechanical arm. The mean age at implantation was 70 and 58 years for biological and mechanical prostheses, respectively, and the percentage of concomitant coronary artery bypass grafting was 47% and 28%, respectively. For a 60-year-old man, simulated life expectancy in years for biological versus mechanical prostheses was 11.9 versus 12.2, event-free life expectancy was 9.8 versus 9.3, and reoperation-free life expectancy was 10.5 versus 11.9. Lifetime risk of reoperation was 25% versus 3%. Lifetime risk of bleeding was 12% versus 41%. Conclusion: Even for patients aged 60 years, event-free life expectancy is better with a bioprosthesis. Although the chance of reoperation is higher, the lifetime risk of bleeding is lower compared with a mechanical prosthesis. Comparing lifetime event risks between different types of valve prostheses provides more insight into patient outcome after aortic valve replacement and aids patient selection and counseling.

Complexity of Coronary Vasculature Predicts Outcome of Surgery for Left Main Disease (Article)

2009-04-01T00:00:00Z

Background: The SYNTAX score, a comprehensive angiographic scoring system, was recently developed as a tool for risk stratification during the SYNTAX trial (randomized trial comparing coronary artery bypass grafting with percutaneous coronary intervention). We applied the SYNTAX score in patients with left main coronary artery disease who underwent coronary artery bypass grafting to examine its role in predicting incidences of major adverse cardiac and cerebrovascular events (MACCE) within 30 days and 1 year. Methods: One hundred forty-eight patients were studied. Their angiograms were scored according to the SYNTAX score. The MACCE-free survival curves were estimated by the Kaplan-Meier method. Univariate and multivariate analyses determined risk factors for MACCE. Performance of the SYNTAX score was studied with respect to discrimination by receiver-operating characteristic curves with their area under the curve (c-index). Classification and regression tree analysis was performed to identify the best outcome predictors and develop a risk stratification model. Results: Overall SYNTAX score ranged from 11 to 53 (mean, 24 ± 9). At 30 days and 1 year, 15 (10%) and 19 (13%) patients experienced MACCE. Patients with a higher SYNTAX score had a significantly (p < 0.0001) poorer MACCE-free survival. In multivariate analysis, SYNTAX score, female sex, and incomplete revascularization were associated with a higher rate of MACCE in 30 days. The SYNTAX score was the single predictor for MACCE in 1 year. The c-index of the SYNTAX score was 0.88 for 30 days and 0.90 for 1 year, respectively. The SYNTAX score was the best single discriminator between patients with and those without MACCE, with a discrimination level of 36.5. Conclusions: The SYNTAX score is the first coronary vasculature complexity score predictive for postoperative outcome in patients with left main coronary artery disease undergoing coronary artery bypass grafting. The outcomes of the ongoing SYNTAX trial will definitively define the role of the SYNTAX score in predicting short-term and long-term incidence of MACCE.

Intraoperative Graft Patency Verification in Coronary Artery Surgery: Modern Diagnostic Tools (Article)

2009-04-01T00:00:00Z

Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease (Article)

2009-03-05T00:00:00Z

BACKGROUND Percutaneous coronary intervention (PCI) involving drug-eluting stents is increasingly used to treat complex coronary artery disease, although coronary-artery bypass grafting (CABG) has been the treatment of choice historically. Our trial compared PCI and CABG for treating patients with previously untreated three-vessel or left main coronary artery disease (or both). METHODS We randomly assigned 1800 patients with three-vessel or left main coronary artery disease to undergo CABG or PCI (in a 1:1 ratio). For all these patients, the local cardiac surgeon and interventional cardiologist determined that equivalent anatomical revascularization could be achieved with either treatment. A noninferiority comparison of the two groups was performed for the primary end point - a major adverse cardiac or cerebrovascular event (i.e., death from any cause, stroke, myocardial infarction, or repeat revascularization) during the 12-month period after randomization. Patients for whom only one of the two treatment options would be beneficial because of anatomical features or clinical conditions, were entered into a parallel, nested CABG or PCI registry. Results Most of the preoperative characteristics were similar in the two groups. Rates of major adverse cardiac or cerebrovascular events at 12 months were significantly higher in the PCI group (17.8%, vs. 12.4% for CABG; P=0.002), in large part because of an increased rate of repeat revascularization (13.5% vs. 5.9%, P<0.001); as a result, the criterion for noninferiority was not met. At 12 months, the rates of death and myocardial infarction were similar between the two groups; stroke was significantly more likely to occur with CABG (2.2%, vs. 0.6% with PCI; P = 0.003). CONCLUSIONS CABG remains the standard of care for patients with three-vessel or left main coronary artery disease, since the use of CABG, as compared with PCI, resulted in lower rates of the combined end point of major adverse cardiac or cerebrovascular events at 1 year. (CIinicaITriaIs.gov number, NCT00114972.).

The clinical outcome after coronary bypass surgery: A 30-year follow-up study (Article)

2009-02-01T00:00:00Z

Aims: To investigate the long-term clinical outcome (up to 30 years) after coronary artery bypass graft (CABG) surgery and to assess the life expectancy (LE) among subgroups of patients. Methods and results: We analysed the 30-year outcome of the first 1041 consecutive patients in our institution (age at operation 53 years, 88% male) who underwent venous CABG between 1971 and 1980. During follow-up, every 5-7 years follow-up status was obtained by reviewing the hospital records and from general practitioners and civil registries. Data were collected on death and repeat coronary revascularization procedures. Follow-up was complete in 98%. Median follow-up was 29 years (26-36 years). The cumulative 10-, 20-, and 30-year survival rates were 77%, 40%, and 15%, respectively. Overall, 623 coronary re-interventions were performed in 373 patients (36%). The cumulative 10-, 20-, and 30-year freedom from death and coronary re-intervention rates were 60%, 20%, and 6%, respectively. Age [hazard ratio (HR) 1.04/year], extent of vessel disease (VD) (two-VD HR 1.4; three-VD HR 1.9), left main disease (HR 1.6) and impaired left ventricular ejection fraction (LVEF) (HR 1.8) were independent predictors of mortality. We were able to assess the exact LE by calculating the area under the Kaplan-Meier curves. Overall LE after first CABG was 17.6 years. LE in patients with one-, two-, and three-VD was 21.4, 18.8, and 15.4 years, respectively (P < 0.0001). Patients with impaired LVEF had a significant shorter LE than patients with normal LVEF (13.9% vs. 19.3%; P < 0.0001). Conclusion: This 30-year follow-up study comprises the almost complete life cycle after CABG surgery. Overall median LE was 17.6 years. As the majority of the patients (94%) needed a repeat intervention, we conclude that the classic venous bypass technique is a useful but palliative treatment of a progressive disease.

Two cases of aneurysm of the anterior mitral valve leaflet associated with transcatheter aortic valve endocarditis: A mere coincidence? (Article)

2009-01-01T00:00:00Z

Intraoperative real time three-dimensional transesophageal echocardiographic measurement of hemodynamic, anatomic and functional changes after aortic valve replacement (Article)

2009-01-01T00:00:00Z

The traditional intraoperative two-dimensional transesophageal echocardiography (2DTEE) has limitations in measuring left ventricular ejection fraction (LVEF) because measurements rely on geometric assumptions. The availability of online software and real time three-dimensional transesophageal echocardiography (RT3D-TEE) makes intraoperative LVEF measurements fast and easy. This is the first report of intraoperative measurement of LVEF and aortic valve area (AVA) by RT3-DTEE in a patient who received transcatheter-based transapical aortic valve implantation.

Three life-years gained from smoking cessation after coronary artery bypass surgery: A 30-year follow-up study (Article)

2008-09-01T00:00:00Z

Background: Previous studies have shown that smoking cessation after a cardiac event reduces the risk of subsequent mortality in patients, but the effect of smoking cessation in terms of prolonged life-years is not yet known. Methods: We analyzed the 30-year clinical outcome of the first 1,041 consecutive patients (age at operation 51 years, 92% male) who successfully underwent isolated venous coronary artery bypass surgery between 1971 and 1980. All 551 smokers (53%) were included in this study. Of these, 43% stopped smoking throughout the first year whereas 57% persisted smoking. Results: The median follow-up was 29 years (range 26-36 years). The cumulative 10-, 20-, and 30-year survival rates were 88%, 49%, and 19%, respectively, in the group of patients who quit smoking, and only 77%, 36%, and 11%, respectively, in the persistent smokers (P < .0001). After adjusting for all baseline characteristics, smoking cessation remained an independent predictor of lower mortality (hazard ratio 0.60, 95% CI 0.48-0.72). We were able to assess the exact life expectancy by calculating the area under the Kaplan-Meier curves. Life expectancy in the quitters was 20.0 years and 17.0 years in the persistent smokers (P < .0001). Conclusions: Using 30-year follow-up data, we estimated that self-reported smoking cessation after coronary artery bypass surgery was associated with a life expectancy gain of 3 years. Smoking cessation turned out to have a greater effect on reducing the risk of mortality than the effect of any other intervention or treatment.

Management of elderly patients with aortic valve disease (Article)

2008-08-12T00:00:00Z

Increased life expectancy has resulted in a growing population of elderly people, among whom aortic stenosis is increasingly prevalent. For the majority of patients, the treatment of aortic stenosis is surgical, and every symptomatic patient should be considered for aortic valve replacement. Although operative mortality seems to be declining over time, a substantial number of patients do not undergo surgery because of excessive risk, advanced age, or treatment preference of either the patient or the physician. The challenge in the near future will be the enhancement of tools for proper clinical decision-making, so that patients can be stratified to appropriate treatment alternatives. Reports on the treatment of aortic valve stenosis should, therefore, include all patients presenting with the disease and not only those who receive surgery.

Frequency and pattern of de-novo three-vessel and left main coronary artery disease; insights from single center enrolment in the SYNTAX study (Article)

2008-08-01T00:00:00Z

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.

Epicardial coronary artery Doppler: Validation in the animal model (Article)

2008-08-01T00:00:00Z

The aim of the study was to validate a newly-designed epicardial coronary artery Doppler probe and test its detection of changes in coronary blood flow velocity. Left anterior descending (LAD) coronary blood flow and flow velocity were evaluated in four pigs with a pericoronary transit time flow (TTF) probe and a newly-designed epicardial Doppler micro-probe. Four consecutive measurements were taken for each of the following conditions: basal, partial stenosis, occlusion, and reperfusion of the LAD. Mean TTF value (mlymin) was 23.2±6.6 in basal condition, 16.2±5.7 after partial LAD stenosis, 0.1±0.3 during LAD occlusion, and 67.4±23.3 at reperfusion (P<0.001). Similar patterns were recorded in terms of Doppler velocity (cmys) with values of 4.0±1.9 in basal condition, 3.5±2.3 after partial LAD stenosis, 0.5±1.4 during LAD occlusion, and 11.1±5.5 at reperfusion (P<0.001). No significant differences in both TTF and Doppler velocity were detected between basal condition and partial LAD stenosis (Psns). Epicardial coronary arterial Doppler represents a valuable tool to detect coronary arterial flow velocity in basal condition. Although changes in flow velocity are easily recorded after coronary occlusion and reperfusion, modifications after partial coronary stenosis are not clearly defined.

Invited Commentary (Article)

2008-07-01T00:00:00Z

Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI) (Article)

2008-07-01T00:00:00Z

Aims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. Methods and results: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. Conclusion: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Transcatheter valve implantation for patients with aortic stenosis: A position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI) (Article)

2008-06-01T00:00:00Z

Optimum management of elderly patients with calcified aortic stenosis (Article)

2008-04-01T00:00:00Z

Increased life-expectancy has led to a growing elderly population frequently presenting with aortic stenosis. This review focuses on the pathogenesis of calcific aortic stenosis, diagnosis and possible ways to halt the progression to severe symptomatic aortic stenosis, methods of assessing symptoms and severity, and modalities and timing of aortic valve replacement. At present the treatment of aortic stenosis for the majority of patients is surgical, and any patient with symptomatic severe aortic stenosis should be considered for aortic valve replacement. This article also discusses the role of emerging techniques of closed heart valve implantation either transfemoral or transapical, and which patients might be candidates for these new approaches to the treatment of aortic stenosis in the elderly population.

Do We Need Separate Risk Stratification Models for Hospital Mortality After Heart Valve Surgery? (Article)

2008-03-01T00:00:00Z

Background: The EuroSCORE (European System for Cardiac Operative Risk Evaluation) is often used to benchmark and predict hospital mortality after cardiac surgery. Based mainly upon coronary surgery patients, EuroSCORE may not be optimal for valve surgery patients. We evaluated the New York (NY) State dedicated valve surgery models and compared their performance to the EuroSCORE model. Methods: Required model variables were collected prospectively for all patients, followed by calculation of predictive mortality rates using the logistic and additive EuroSCORE, the logistic and additive NY State models for valve surgery without concomitant coronary surgery (isolated valve surgery) and the logistic and additive NY State models for combined valve and coronary surgery. Results: Observed mortality was 2.8% (25 of 904) for isolated valve surgery and 6.8% (27 of 395) for valve plus coronary surgery. Logistic NY State and EuroSCORE expected mortality for isolated valve surgery was respectively 3.0% and 6.1%, and for valve plus coronary surgery 5.9% and 7.8%. The logistic NY State model for isolated valve surgery showed better discrimination (c-index 0.86 versus 0.76) and calibration than the logistic EuroSCORE. Discriminatory power for the logistic NY State model for valve plus coronary surgery was comparable to the logistic EuroSCORE (c-index 0.74 versus 0.72), as was calibration. Conclusions: Our results suggest that dedicated risk models for valve surgery may be useful to provide more valid estimates of hospital mortality after heart valve surgery. Further exploration is needed to demonstrate general applicability of our results and assess the possible additional value of separate models for isolated valve surgery and valve plus coronary artery surgery, or aortic and mitral valve surgery, or both.

Usefulness of microsimulation to translate valve performance into patient outcome: Patient prognosis after aortic valve replacement with the Carpentier-Edwards supra-annular valve (Article)

2007-09-01T00:00:00Z

Objective: Numerous reports have been published documenting the results of aortic valve replacement. It is often not easy to translate these outcomes involving the condition of the valve into the actual consequences for the patient. We previously developed an alternative method to study outcome after aortic valve replacement that allows direct estimation of patient outcome after aortic valve replacement: microsimulation modeling. The goal of this article is to provide insight into microsimulation methodology and to give an overview of the advantages and disadvantages of simulation methods (in particular microsimulation) in comparison with standard methods of outcome analysis. Methods: By using a primary dataset containing 1847 patients and 14,429 patient-years, advantages and disadvantages of standard methods of outcome analysis are discussed, and the potential role of microsimulation is illustrated by means of a step-by-step explanation of building, testing, and using such a model. Results: Total life expectancy, event-free life expectancy, and reoperation-free life expectancy for a 65-year-old male patient were 10.6 years, 9.2 years, and 9.8 years, respectively. Lifetime risk of reoperation due to structural valve deterioration was 13.3%. Conclusions: Microsimulation is capable of providing accurate estimates of age-related life expectancy and lifetime risk of reoperation for patients who underwent aortic valve replacement with the Carpentier-Edwards supra-annular valve. It provides a useful tool to facilitate and optimize the choice for a specific heart valve prosthesis in a particular patient.

Long-term follow-up and quality of life after closure of ventricular septal defect in adults (Article)

2007-08-01T00:00:00Z

Objective: To study patients who underwent surgical closure of a congenital ventricular septal defect (VSD) and presenting at adult age. Methods and results: A retrospective study was carried out of 28 patients (15 male) operated upon between 1980 and 2004. Patients were investigated by echocardiography, ECG and assessed for quality of life by a questionnaire. The indication for surgery was volume overload in 11 patients, endocarditis in 8, aortic valve regurgitation in 8 and the combination of a VSD with subvalvular aortic stenosis in 1. Follow-up was complete with a mean duration of follow-up of 13 years. There was no early or late mortality. One patient was reoperated for recurrent VSD. Twenty-five patients underwent echocardiography, which revealed a trivial residual VSD in two and mild aortic regurgitation in 10 (40%) patients. One patient was in atrial fibrillation. Health related quality of life in the dimensions cognitive functioning and sleep differed significantly from that of the general population. Conclusion: With a relative difference in indications for closure of a VSD in adulthood, surgical closure of VSD at adult age is an adequate and safe procedure, with good results on long-term follow-up. Progression of aortic valve regurgitation is a matter of concern.

Allografts for aortic valve or root replacement: insights from an 18-year single-center prospective follow-up study (Article)

2007-05-01T00:00:00Z

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.

Acute dehiscence of a valve prosthesis 5 years after implantation (Article)

2007-04-25T00:00:00Z

Propionibacterium acnes, a common human skin organism [Perry A.L., Lambert P.A., Under the microscope Propionibacterium acnes, Lett App Microbiol 2006; 42:185-186], mostly considered a contaminant, has rarely been associated with cases of infectious endocarditis [Vanagt W.Y., Daenen W.J., Delhaas T., Propionibacterium acnes endocarditis on an annuloplasty ring in an adolescent boy, Heart 2004; 90:56]. We report on a 48-year old man with a history of mitral valve replacement who acutely developed dyspnoea, tachypnoea and forward failure. Transesophageal echocardiography showed a dehiscence of the St. Jude mechanical mitral prosthesis necessitating urgent surgery. The prosthesis was replaced by another St. Jude mechanical valve. Blood cultures were initially negative but after a prolonged incubation period the tissue cultures became positive for Propionibacterium acnes. In cases of valvular dehiscence without macroscopic signs of endocarditis, communication between clinicians and the laboratory is important in order to incubate blood and tissue samples for a longer period of time to be able to detect exceptional causes of endocarditis.

Cyphering the Complexity of Coronary Artery Disease Using the Syntax Score to Predict Clinical Outcome in Patients With Three-Vessel Lumen Obstruction Undergoing Percutaneous Coronary Intervention (Article)

2007-04-15T00:00:00Z

The Syntax score (SXscore) was recently developed as a comprehensive angiographic scoring system aiming to assist in patient selection and risk stratification of patients with extensive coronary artery disease undergoing contemporary revascularization. A validation of this angiographic classification scheme is lacking. We assessed its predictive value in patients who underwent percutaneous intervention (PCI) for 3-vessel disease and explored its performance in comparison with the modified lesion classification system of the American Heart Association/American College of Cardiology. The SXscore, applied to 1,292 lesions in 306 patients who underwent PCI for 3-vessel disease in the Arterial Revascularization Therapies Study Part II, was 4 to 54.5, and after a median of 370 days (range 274 to 400) predicted the rate of major adverse cardiac and cerebrovascular events (hazard ratio 1.08/U increase, 95% confidence interval 1.05 to 1.11, p <0.0001), with patients in the highest SXscore tertile having a significantly higher event rate (27.9%) than patients in the lowest tertile (8.7%, hazard ratio 3.5, 95% confidence interval 1.7 to 7.4, p = 0.001). By multivariable analyses, SXscore independently predicted outcome with an almost fourfold adjusted increase in the risk of major adverse cardiac and cerebrovascular events in patients with high versus low values based on the discrimination level provided by classification and regression tree analysis. Compared with the modified lesion classification scheme of the American Heart Association/American College of Cardiology, SXscore showed a greater discrimination ability (c-index 0.58 ± 0.08 vs 0.67 ± 0.08, respectively, p <0.001) and a better goodness of fit with the Hosmer-Lemeshow statistic. In conclusion, the SXscore is a promising tool to risk stratify outcome in patients with extensive coronary artery disease undergoing contemporary PCI.

Virtual reality 3D echocardiography in the assessment of tricuspid valve function after surgical closure of ventricular septal defect (Article)

2007-03-12T00:00:00Z

Background. This study was done to investigate the potential additional role of virtual reality, using three-dimensional (3D) echocardiographic holograms, in the postoperative assessment of tricuspid valve function after surgical closure of ventricular septal defect (VSD). Methods. 12 data sets from intraoperative epicardial echocardiographic studies in 5 operations (patient age at operation 3 weeks to 4 years and bodyweight at operation 3.8 to 17.2 kg) after surgical closure of VSD were included in the study. The data sets were analysed as two-dimensional (2D) images on the screen of the ultrasound system as well as holograms in an I-space virtual reality (VR) system. The 2D images were assessed for tricuspid valve function. In the I-Space, a 6 degrees-of-freedom controller was used to create the necessary projectory positions and cutting planes in the hologram. The holograms were used for additional assessment of tricuspid valve leaflet mobility. Results. All data sets could be used for 2D as well as holographic analysis. In all data sets the area of interest could be identified. The 2D analysis showed no tricuspid valve stenosis or regurgitation. Leaflet mobility was considered normal. In the virtual reality of the I-Space, all data sets allowed to assess the tricuspid leaflet level in a single holographic representation. In 3 holograms the septal leaflet showed restricted mobility that was not appreciated in the 2D echocardiogram. In 4 data sets the posterior leaflet and the tricuspid papillary apparatus were not completely included. Conclusion. This report shows that dynamic holographic imaging of intraoperative postoperative echocardiographic data regarding tricuspid valve function after VSD closure is feasible. Holographic analysis allows for additional tricuspid valve leaflet mobility analysis. The large size of the probe, in relation to small size of the patient, may preclude a complete data set. At the moment the requirement of an I-Space VR system limits the applicability in virtual reality 3D echocardiography in clinical practice.