Off-pump coronary artery bypass surgery compared with stent implantation and on-pump bypass surgery: clinical outcome and cost-effectiveness at one year.

BACKGROUND: Coronary revascularisation by means of surgery or percutaneous intervention plays an important role in the management of patients with ischaemic heart disease. Coronary bypass surgery without cardiopulmonary bypass (off-pump surgery) has been reintroduced into clinical practice to avoid complications related to the use of cardiopulmonary bypass. It is unknown whether off-pump surgery can match the outcomes of bypass surgery with cardiopulmonary bypass (on-pump surgery) or intracoronary stent implantation. METHODS: The Octopus study comprised two multicentre randomised trials. In the Octopump trial, on-pump surgery was compared with off-pump surgery (139 vs. 142 patients). In the Octostent trial stent implantation was compared with off-pump surgery (138 vs. 142 patients). The primary cardiac endpoint was survival free from the following cardiovascular events: stroke, myocardial infarction and repeated coronary revascularisation. Secondary endpoints included quality of life and cost-effectiveness. The uncertainty surrounding the cost-effectiveness analysis was addressed by bootstrapping. RESULTS: Octopump trial: at one year, event-free survival in the on-pump group was 90.6% and in the off-pump group 88.0% (difference 2.6%, 95% CI-4.6 to 9.8). Quality-adjusted years of life were 0.83 and 0.82 (p=0.81), respectively. On-pump surgery was associated with €2089 (14.1%) additional direct medical costs per patient (p<0.01). Off-pump was more cost-effective than on-pump surgery in 95% of bootstrap estimates. Octostent trial: at one year, event-free survival in the stent group was 85.5% and in the off-pump surgery group 91.5% (difference -6.0%, 95% CI -13.5 to 1.4). Quality-adjusted years of life were 0.82 and 0.79 (p=0.09), respectively. Stent implantation reduced direct medical costs by €2813 (26.0%) per patient (p=0.01). Stent implantation was more cost-effective in 95% of bootstrap estimates. CONCLUSION: In selected patients eligible for bypass surgery, there was no difference in cardiac outcome between on-pump and off-pump surgery. Off-pump surgery, however, was more cost-effective than on-pump surgery and may be preferred from an economic perspective. In selected patients eligible for percutaneous coronary intervention, stent implantation was more cost-effective than off-pump surgery while maintaining comparable cardiac outcome. Therefore, stent implantation rather than off-pump surgery can be recommended as a first-choice revascularisation strategy.

Association between early and three month cognitive outcome after off-pump and on-pump coronary bypass surgery.

OBJECTIVE: To describe the association between cognitive outcome in the first postoperative week and that at three months after both off-pump and on-pump coronary bypass surgery, and to make a direct comparison of early cognitive outcome after off-pump versus on-pump surgery. DESIGN: Randomised trial with an additional prediction study within the two randomised groups. SETTING: Three centres for heart surgery in the Netherlands. PATIENTS: 281 patients, mean age 61 years. INTERVENTIONS: Participants were randomly assigned to off-pump or on-pump coronary bypass surgery. MAIN OUTCOME MEASURES: Cognitive outcome, assessed by psychologists who administered neuropsychological tests one day before and four days and three months after surgery. A logistic regression model was used to study the predictive association between early cognitive outcome, together with eight clinical variables, and cognitive outcome after three months. RESULTS: Cognitive outcome in the first week after surgery was determined for 219 patients and was a predictor of cognitive decline after three months. This association was stronger in on-pump patients (odds ratio (OR) 5.24, p < 0.01) than in off-pump patients (OR 1.80, p = 0.23). Early decline was present in 54 patients (49%) after off-pump surgery and 61 patients (57%) after on-pump surgery (OR 0.73, p = 0.25). CONCLUSIONS: In patients undergoing first time coronary bypass surgery, early cognitive decline predicts cognitive outcome after three months. Early cognitive decline is not significantly influenced by the use of cardiopulmonary bypass.

[Limited tuberculin screening participation amongst travellers to countries with high tuberculosis incidence; reason to consider BCG vaccination for some travellers]. / Beperkte deelname aan tuberculinescreening onder reizigers naar landen met hoge tuberculose-incidentie; reden om voor sommigen BCG-vaccinatie te overwegen.

OBJECTIVE: To determine the compliance amongst Dutch travellers to high tuberculosis-incidence countries with a screening procedure involving a tuberculin skin test before and after the trip. DESIGN: Prospective study. METHOD: Nine hundred and eighty-eight tuberculin-negative Dutch people who travelled to high tuberculosis-incidence countries for 3 to 12 months were studied for their compliance with an advised screening procedure of repeat tuberculin skin testing 2 to 4 months after return. At 2 of the 4 participating health services, data were also collected on extra calls made and the pertinent time investments. RESULTS: Five hundred and ninety-nine travellers (61%) were compliant with the screening procedure. Of those for whom the data was available (n = 417), 33% (98/300) of the compliant travellers required extra calls. These took an average of 30 min per extra traveller tested as a result. Compliance varied according to health service and was better amongst travellers to Africa. In addition, non-compliance was independently associated with male sex, work being the main travel purpose, and an undecided duration of travel on departure. CONCLUSIONS: Compliance of Dutch travellers with tuberculin skin-test screening is limited, particularly if no extra calls are issued. Bacillus Calmette-Guérin vaccination appears to be preferable for travellers with undecided travel duration and persons travelling for work on a frequent basis.

[Pulmonary thromboendarterectomy: an effective surgical treatment for cor pulmonale due to chronic pulmonary emboli]. / Pulmonalistrombo-endarteriëctomie: een effectieve chirurgische behandeling voor patiënten met cor pulmonale door chronische longembolie.

OBJECTIVE: To evaluate the initial experience with pulmonary thromboendarterectomy for cor pulmonale due to chronic pulmonary embolism. METHOD: In the period 1 April 1996 to 31 October 2001, 18 patients with right ventricular failure due to chronic thromboembolic pulmonary hypertension were operated on. Their mean age was 54 (SD: 14) years. Preoperatively, all of the patients were in functional New York Heart Association (NYHA) class III or IV. Pulmonary angiography revealed pulmonary hypertension with an increased pulmonary vascular resistance, as well as typical angiographic signs of unresolved chronic emboli. Pulmonary thromboendarterectomy was performed via median sternotomy, using extracorporeal circulation and intermittent deep hypothermic circulatory arrest. The patients were monitored via the outpatients' department. RESULTS: From a technical viewpoint, the procedure was performed successfully in all of the patients. Initially the pulmonary thromboendarterectomy was performed unilaterally (n = 7), which did not decrease pulmonary artery pressure significantly. The following 11 patients were treated bilaterally; in them thromboendarterectomy required an average of circulatory arrest totalling 64 (SD: 30) min with 161 (SD: 35) min of myocardial ischemia. After bilateral pulmonary thromboendarterectomy, the pulmonary artery pressure decreased from 45 (SD: 13) to 28 (SD: 9) mmHg (p = 0.001). Reperfusion pulmonary oedema, requiring prolonged ventilation, occurred in 3 patients. There was no operative or later mortality. At a mean follow-up of 28 (SD: 19) months, all but one of the patients were in functional NYHA class I or II. Echocardiography revealed reduced right ventricular dimensions and pulmonary artery pressures. One patient, with mainly distally located obstructions, exhibited no substantial improvement. CONCLUSION: The initial experience with pulmonary thromboendarterectomy for patients with cor pulmonale due to chronic pulmonary emboli demonstrated satisfactory mid-term follow-up data.

Report of the Dutch experience with the Ross procedure in 343 patients.

OBJECTIVE: Limited information is available on outcome after autograft aortic valve replacement, in particular with respect to the durability of the autograft and of the allograft used to reconstruct the right ventricular outflow tract. A retrospective follow-up study of all patients who underwent a Ross procedure in the Netherlands since 1988 was done to obtain an overview of the Dutch experience with this procedure. METHODS: From 1988 to January 2000, 348 Ross procedures were performed in nine centers in the Netherlands. Pre-operative, peri-operative and follow-up data from 343 patients in seven centers (99% of all Dutch autograft patients) were collected and analyzed. RESULTS: Mean patient age was 26 years (SD 14, range 0-58) and male/female ratio was 2.1. Bicuspid valve or other congenital heart valve disease was the most common indication for operation. The root replacement technique was used in 95% of patients and concomitant procedures were done in 12%. Hospital mortality was 2.6% (N=9). Mean follow-up was 4 years (median 3.8, SD 2.8, range 0-12.5). Overall cumulative survival was 96% at 1 year (95% confidence interval (CI) 94-98%) and 94% at 5 and 7 post-operative years, respectively (95% CI 91-97%). At last follow-up, 87% of the surviving patients was in New York Heart Association (NYHA) class I. Independent predictors of overall mortality were pre-operative NYHA class IV/V and longer perfusion time. Autograft reoperation had to be performed in 14 patients and reintervention on the pulmonary allograft in 10 patients. Freedom from any valve-related reintervention was 88% at 7 years (95% CI 81-94%). CONCLUSIONS: The Dutch experience with the Ross procedure is favorable, with low operative mortality and good mid-term results. Although both the autograft in aortic position and the allograft in the right ventricular outflow tract have a limited durability, this has not yet resulted in considerable reoperation rates and associated morbidity and mortality.

Early outcome after off-pump versus on-pump coronary bypass surgery: results from a randomized study.

BACKGROUND: The use of cardiopulmonary bypass during coronary artery bypass surgery (CABG) has been associated with substantial morbidity. The recent introduction of cardiac stabilizers facilitates CABG without cardiopulmonary bypass (off-pump CABG), but it is unknown whether cardiac outcome after off-pump surgery is similar to that for the on-pump procedure. METHODS AND RESULTS: In a multicenter trial, 281 patients (mean age 61 years, SD 9 years) were randomly assigned to off-pump or on-pump CABG. In-hospital results and cardiac outcome and quality of life after 1 month are presented. Cardiac outcome was defined as survival free of stroke, myocardial infarction, and coronary reintervention. The mean numbers of distal anastomoses per patient were 2.4 (SD 1.0) and 2.6 (SD 1.1) in the off-pump and on-pump groups, respectively. Completeness of revascularization was similar in both groups. Blood products were needed during 3% of the off-pump procedures and 13% of the on-pump procedures (P<0.01). Release of creatine kinase muscle-brain isoenzyme was 41% less in the off-pump group (P<0.01). Otherwise, no differences in complications were found postoperatively. Off-pump patients were discharged 1 day earlier. At 1 month, operative mortality was zero in both groups, and quality of life had improved similarly. In both groups, 4% of the patients had recurrent angina. The proportions of patients surviving free of cardiovascular events were 93.0% in the off-pump group and 94.2% in the on-pump group (P=0.66). CONCLUSIONS: In selected patients, off-pump CABG is safe and yields a short-term cardiac outcome comparable to that of on-pump CABG.

A versatile tool for exposure in minimally invasive surgery.

BACKGROUND: Endoscopic surgery in a major cavity in the body requires space for manipulation and presentation of the target organ or site. For coronary artery grafting on the working heart, additional local cardiac wall immobilization is indispensible. METHODS: A passive hydraulic arm was developed to be mounted on the operating table rail. The development focused on the arm's versatility, durability, flexibility in manipulation, and extreme stiffness when in position. RESULTS: The arm was flexible and easy to manipulate. The tip did not move during tightening, and the arm was stiff once tightened. The arm was successfully used in small and full access beating heart coronary bypass grafting, through the latter(i.e., sternotomy) for multivessel revascularization. Immobilization and presentation were achieved by suction fixation, allowing accurate anastomosis suturing. CONCLUSIONS: The arm enabled effective target site presentation and stabilization on the working heart. According to these observations, it may be useful as a basic tool for endoscopic surgery.

The left gastric artery as an in-situ conduit in coronary artery bypass grafting.

Unsuitability of the in-situ right gastroepiploic artery in coronary bypass grafting occurs. Sometimes free-grafting can be performed, although this should not be considered in patients with a diseased ascending aorta. We describe the successful use of the left gastric artery as an alternative in-situ arterial conduit in a patient with a severely atherosclerotic ascending aorta.

A review of 1,582 consecutive Octopus off-pump coronary bypass patients.

BACKGROUND: Off-pump coronary bypass may provide a safer form of surgical revascularization by avoiding the unwanted complications of cardiopulmonary bypass, particularly in the increasingly complex patients being referred for operation. This study reviews the entire experience of the Medtronic Octopus System (Medtronic, Minneapolis, MN) for beating heart bypass from 7 surgeons. Demographics, operative procedures, early outcomes, and trends in usage were examined. METHODS: Patients were selected for off-pump procedures by the individual surgeons. Data were entered prospectively into locally maintained databases and then collected for collation and analysis. RESULTS: A total of 1,582 consecutive Octopus patients were entered, representing the entire Octopus experience of each surgeon. Proportions of off-pump procedures relative to standard bypass increased over time, as did the percentage of patients receiving three or more grafts, 24.6% in 1997 and 55.9% in 1999. A total of 3,653 anastomoses were performed, 1,905 to the left anterior descending system, 837 to the circumflex distribution, and 911 to the right coronary territory. Morbidity was low. Few patients required conversion to cardiopulmonary bypass (2.6%; 0.2% urgently). Permanent stroke occurred in 0.6% and myocardial infarction in 1.2%. Operative mortality was 1%. CONCLUSIONS: Octopus off-pump bypass was demonstrated to be a safe procedure with widening applicability. With experience surgeons tend to apply the system to increasing proportions of their patients and are able to revascularize all coronary territories.

Heart displacement during off-pump CABG: how well is it tolerated?

BACKGROUND: Heart displacement during off-pump coronary artery bypass grafting (CABG) is necessary to expose the anastomosic sites. We analyzed the hemodynamic changes in relation to the grafted arteries. METHODS: The relationship between surgical exposure and hemodynamic management was assessed in 150 consecutive patients undergoing off-pump CABG utilizing the Octopus Tissue Stabilization System (Medtronic, Minneapolis, MN). RESULTS: Surgical exposure by anterolateral thoracotomy showed no significant hemodynamic changes. Through sternotomy, stroke volume was significantly reduced by dislocation at all target sites: by 6% at the left anterior descending artery (LAD), 25% at the diagonal branch artery (D), 14% at the right coronary artery (RCA), and 21% at the obtuse marginal artery (OM). The application of head-down positioning (LAD, 56%; D, 74%; RCA, 90%; OM, 96%) increased not only surgical exposure but also preload, producing correction of ventricular filling pressures and output. In a minority of cases, dopamine (3 to 5 microg x kg(-1) x min(-1)) was added to maintain baseline hemodynamic values (LAD, 5%; D, 15%; RCA, 7%; OM, 28%). CONCLUSIONS: Revascularization during anterolateral thoracotomy was uneventful. The sternotomy approach with heart displacement induced right heart compression. Mainly fluid redistribution was sufficient to correct cardiac output. Once stabilized, systemic circulation remained unchanged during revascularization.

The Octopus Study: rationale and design of two randomized trials on medical effectiveness, safety, and cost-effectiveness of bypass surgery on the beating heart.

The Octopus Study consists of two multicenter randomized clinical trials in which coronary artery bypass grafting on the beating heart (off-pump CABG) using the Utrecht Octopus Method is compared to intracoronary stent implantation and conventional CABG. The primary endpoint in the comparison of off-pump CABG versus stent implantation (OctoStent Trial) is medical effectiveness (i.e., absence of reintervention and major adverse cardiac and cerebrovascular events at 1 year after treatment). The primary endpoint in the comparison of off-pump CABG versus conventional CABG (OctoPump Trial) is cerebral safety (i.e., absence of cognitive deficits and cerebrovascular events at 3 months after treatment). Secondary endpoints in both trials include presence and severity of angina, quality of life, exercise capacity, and cost-effectiveness. A total of 560 patients will be enrolled. A random sample of 210 patients will undergo repeat angiography at 1 year to assess angiographic restenosis rate and graft patency. Including 1-year follow-up, the study will last for 3 years. Control Clin Trials 2000;21:595-609

When and how to shunt the coronary circulation in off-pump coronary artery bypass grafting.

OBJECTIVE: To assess the sequelae of temporary coronary artery occlusion in off-pump, beating heart CABG, i.e. ischemia, hemodynamic instability and the need for conversion to cardiopulmonary bypass. METHODS: In 200 patients (150 male), mean age 60 (range 35-81) years, 365 distal anastomoses were performed, i.e. 1.8 anastomoses per patient through limited and full access. One hundred seventy six LAD, 61 diagonal, 71 RCA, 7 RPD and 50 circumflex branches were grafted. Patients were pretreated with calcium antagonists, long-acting beta-blockade and had thoracic epidural blockade. The anastomosis was constructed using two microvascular clamps, preceded by ischemic preconditioning in non-occlusive disease. Myocardial ischemia was defined as > 1 mm S-T segment elevation. A simple aorto-coronary shunt, consisting of two intravenous catheters and a 10 cm connecting tube (flow > 20 ml/min), was used in critical ischemia. RESULTS: Ischemia occurred during 35 (10%) temporary coronary artery occlusions. Fifteen of these (43%) were RCA. In five of these 15 patients, all with non-occlusive disease, critical ischemia occurred with bradycardia, third-degree heart block and subsequently severe hypotension, which normally requires conversion to cardio-pulmonary bypass. Following introduction of the shunt (4 patients) electrocardiographic and hemodynamic parameters normalized within 30 s. The off-pump procedures could be continued uneventfully. There were no peri-operative infarctions. CONCLUSION: Temporary segmental occlusion is an effective method for anastomosis suturing in off-pump, beating heart CABG. Critical ischemia was observed rarely, only in the RCA and in non-occlusive disease. Temporary aorto-coronary shunting could avoid conversion to cardiopulmonary bypass and myocardial infarction.

False aneurysm of the right internal mammary artery.

False aneurysms of the internal mammary artery are extremely rare. A case of false aneurysm of a branch of the right internal mammary artery after median sternotomy is reported. A large right-sided mediastinal mass was seen on the thoracic radiogram. A false aneurysm was suspected on CT-scan and confirmed by angiography. In the same setting percutaneous embolization was performed.

Exposure of circumflex branches in the tilted, beating porcine heart: echocardiographic evidence of right ventricular deformation and the effect of right or left heart bypass.

OBJECTIVE: In off-pump coronary surgery, exposure of posterior vessels via sternotomy causes deterioration of cardiac function. Changes in ventricular geometry, valve competence, and hemodynamics after retraction of the beating heart were studied. Subsequently, the modifying effect of right or left heart bypass was investigated. METHODS: In six 80-kg pigs, an ultrasound probe was attached to the backside of the left ventricle and the heart was fully retracted with a suction tissue stabilizer. Five pigs underwent additional pump support. RESULTS: During retraction, the right ventricle was squeezed between the pericardium and interventricular septum, thereby decreasing its diastolic cross-sectional area by 62% +/- 6% (P <.001) while, concomitantly, right ventricular end-diastolic pressure increased to 165% +/- 19% (P =.004) of basal values. Stroke volume and mean arterial pressure decreased by 29% +/- 6% and 23% +/- 8% (P =.007 and P =.02, respectively). Left ventricular shape became somewhat elliptic without changes in preload pressure, and its diastolic cross-sectional area decreased by 20% +/- 3% (P =.001). All valves were competent. Right heart bypass restored left ventricular cross-sectional area, stroke volume, and mean arterial pressure. In contrast, left heart bypass increased blood pressure only marginally. CONCLUSIONS: Ninety-degree anterior displacement of the beating porcine heart caused primarily right ventricular dysfunction as a result of mechanical interference with diastolic expansion without concurring valvular incompetence. Right heart bypass normalized stroke volume and mean arterial pressure by increasing left ventricular preload; in contrast, left heart bypass failed to restore systemic circulation.

Embracing the heart: perioperative management of patients undergoing off-pump coronary artery bypass grafting using the octopus tissue stabilizer.

OBJECTIVE: To describe hemodynamic alterations during coronary artery bypass grafting (CABG) without extracorporeal circulation using the Octopus Tissue Stabilizer, and to describe the two anesthetic management protocols based on either general anesthesia with opioids (34 patients) or general anesthesia with high thoracic epidural anesthesia (TEA; 66 patients). DESIGN: A prospective observational report. SETTING: An academic university heart center. PARTICIPANTS: First 100 patients undergoing CABG using the Octopus Tissue Stabilizer. INTERVENTIONS: None. MAIN RESULTS: Current management provided satisfactory results in preventing hypoperfusion of the heart and inadequate systemic circulation without the use of major pharmacologic interventions. Movement of the heart to reach the target site of anastomosis caused hemodynamic alterations. These could easily be corrected by anesthetic interventions, such as fluid load and low doses of inotropes. High TEA allows earlier extubation compared with the opioid anesthesia technique (0.9 v 4.5 hours). Perioperative management and the incidence of postoperative complications did not differ between anesthetic techniques. Major complications, such as death, intraoperative myocardial infarction, and stroke, did not occur. CONCLUSION: Both anesthetic protocols are safe and effective in handling these patients. Off-pump CABG surgery requires anesthetic interventions because hemodynamic alterations are caused by the presentation of the heart to the surgeon. The complication rate is low but needs to be evaluated, compared with conventional CABG, in a prospective randomized study. High thoracic epidural anesthesia allows early recovery, but improved outcome could not be proved in this patient group.

A novel one-shot anastomotic stapler prototype for coronary bypass grafting on the beating heart: feasibility in the pig.

OBJECTIVE: The nonpenetrating, arcuate-legged clip has proved its ability to provide a high-quality microvascular anastomosis. This study assessed the feasibility of constructing a coronary end-to-side anastomosis on the beating heart with a novel mechanical, sutureless anastomotic device that applies 12 circumferential clips simultaneously. METHODS: In 14 consecutive pigs (70-90 kg), the left internal thoracic artery (diameter, 3 mm) was grafted to the left anterior descending coronary artery (diameter, 3 mm) by means of a one-shot anastomotic stapler prototype. Endothelial denudation, medial necrosis, and intimal hyperplasia were analyzed quantitatively and compared with those seen in conventionally sutured anastomoses (n = 4). RESULTS: In 8 of 14 anastomoses, the one-shot anastomotic stapler successfully applied all 12 clips circumferentially across the everted arteriotomy edges. In the remaining, either 1 (n = 4) or 3 and 4 adjoining malaligned clips had to be replaced manually with a single-clip applicator. Coronary occlusion was limited to approximately 3 minutes. At follow-up, all anastomoses were patent angiographically. At 2 days, in 2 of 7 cases, a local coronary dissection was observed, and there was a considerable loss of endothelial cells and medial damage. At 28 days, however, minimal intimal hyperplasia was seen at the anastomotic lining, although more pronounced when compared with conventionally sutured anastomoses. CONCLUSIONS: The one-shot anastomotic stapler prototype enabled short-occlusive (3 minutes), sutureless end-to-side grafting on the beating porcine heart. In spite of early endothelial and medial damage and 2 local dissections, all anastomoses remained patent with minimal intimal hyperplasia at 4 weeks.

Coronary artery bypass grafting without cardiopulmonary bypass.

In off-pump coronary artery grafting, cardiopulmonary bypass and its associated maneuvers, i.e., aortic manipulation and global cardiac arrest, may be avoided, and thus its morbidity and mortality may be reduced. Modern tissue stabilizers allow accurate construction of anastomosis and are now considered indispensable. Currently, there are two groups of stabilizers, i.e., those based on suction-fixation and those based on pressure-fixation. Each has specific applications. The popularity of off-pump coronary bypass surgery is increasing, from the patient's perspective and from the perspective of cost containment. Proper patient selection is crucial. The procedure is technically demanding. It is expected that by the year 2000 10% of coronary surgery will be off-pump, particularly by direct vision techniques. From the currently available, nonrandomized, prospective studies, the preliminary conclusion seems justified that, in selected patients, off-pump bypass grafting is as accurate as conventional bypass grafting, with lower morbidity and mortality. This includes fast recovery and early resumption of premorbid activities in most patients. Particularly, therefore, the procedure is also cost saving. Prospective randomized studies are necessary to quantify these statements.

Off-pump coronary bypass grafting: how to use the Octopus Tissue Stabilizer.

Off-pump coronary artery bypass grafting requires immobilization of the coronary artery. A suction device (Octopus Tissue Stabilizer), attached to the epicardium and connected rigidly to the operating table rail, was used through limited and full surgical access for single-vessel and multivessel arterial revascularization, respectively. An outline for its application, as used by us to construct 122 anastomoses in 70 patients, including posterior wall grafting (in 9 patients) and sequential grafting on the anterior wall (in 17 patients), is presented.