Coronary Artery Disease: Mack MJ

Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA, Masoudi FA, Brindis RG, Beckman KJ, Chambers CE, Ferguson TB, Garcia MJ, Grover FL, Holmes DR, Klein LW, Limacher M, Mack MJ, Malenka DJ, Park MH, Ragosta M, Ritchie JL, Rose GA, Rosenberg AB, Shemin RJ, Weintraub WS, Wolk MJ, Allen JM, Douglas PS, Hendel RC, Peterson ED. · Division of Cardiology, Duke University Medical Center, Durham, NC, USA. · Catheter Cardiovasc Interv. · Pubmed #19127535 No free full text.

Abstract: The American College of Cardiology Foundation (ACCF), Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and the American Association for Thoracic Surgery, along with key specialty and subspecialty societies, conducted an appropriateness review of common clinical scenarios in which coronary revascularization is frequently considered. The clinical scenarios were developed to mimic common situations encountered in everyday practice and included information on symptom status, extent of medical therapy, risk level as assessed by noninvasive testing, and coronary anatomy. Approximately 180 clinical scenarios were developed by a writing committee and scored by a separate technical panel on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization was considered appropriate and likely to improve health outcomes or survival. Scores of 1 to 3 indicate revascularization was considered inappropriate and unlikely to improve health outcomes or survival. The mid range (4 to 6) indicates a clinical scenario for which the likelihood that coronary revascularization would improve health outcomes or survival was considered uncertain. For the majority of the clinical scenarios, the panel only considered the appropriateness of revascularization irrespective of whether this was accomplished by percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). In a select subgroup of clinical scenarios in which revascularization is generally considered appropriate, the appropriateness of PCI and CABG individually as the primary mode of revascularization was considered. In general, the use of coronary revascularization for patients with acute coronary syndromes and combinations of significant symptoms and/or ischemia was viewed favorably. In contrast, revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy were viewed less favorably. It is anticipated that these results will have an impact on physician decision making and patient education regarding expected benefits from revascularization and will help guide future research.

Mack MJ, Duhaylongsod FG. · No affiliation provided · J Thorac Cardiovasc Surg. · Pubmed #12324721 No free full text.

This publication has no abstract.

Mack MJ. · Heart Hospital Baylor Plano, Dallas, Texas 75230, USA. · Curr Opin Cardiol. · Pubmed #18830071 No free full text.

Abstract: PURPOSE OF REVIEW: Intraoperative graft assessment in coronary artery bypass grafting is infrequently performed. Nevertheless, studies show an immediate graft closure rate of 5-9% and a 1-year closure rate of 20-30%. RECENT FINDINGS: Coronary angiography is the 'gold standard' for graft assessment yet has been seldom employed because of logistical problems and image quality. Two methods, transit time flow measurement and intraoperative fluorescence imaging are simple, safe, and expeditious. Intraoperative graft failure detection rates of 2-5% have been reported. SUMMARY: Early graft occlusion occurs frequently after coronary artery bypass grafting. Two relatively simple but underutilized methods of intraoperative graft assessment have been shown to be predictive of graft failure. Wider use of these techniques as well as wider availability of hybrid operating rooms, which will allow intraoperative coronary angiography, may reduce graft failure.

Taggart DP, Kaul S, Boden WE, Ferguson TB, Guyton RA, Mack MJ, Sergeant PT, Shemin RJ, Smith PK, Yusuf S. · Department of Cardiac Surgery, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom. · J Am Coll Cardiol. · Pubmed #18308155 No free full text.

Abstract: For coronary artery disease with unprotected left main stem (LMS) stenosis, coronary artery bypass grafting (CABG) is traditionally regarded as the "standard of care" because of its well-documented and durable survival advantage. There is now an increasing trend to use drug-eluting stents for LMS stenosis rather than CABG despite very little high-quality data to inform clinical practice. We herein: 1) evaluate the current evidence in support of the use of percutaneous revascularization for unprotected LMS; 2) assess the underlying justification for randomized controlled trials of stenting versus surgery for unprotected LMS; and 3) examine the optimum approach to informed consent. We conclude that CABG should indeed remain the preferred revascularization treatment in good surgical candidates with unprotected LMS stenosis.

Mack MJ. · Cardiopulmonary Research Science and Technology Institute, Dallas, Texas, USA. · Curr Opin Cardiol. · Pubmed #17921739 No free full text.

Abstract: PURPOSE OF REVIEW: Clinical decision-making in coronary artery disease relies heavily on evidence-based medicine. Data from randomized controlled trials constitute the highest order of evidence and remain the standard for comparisons between therapies. While comprehensive, observational databases lack the scientific rigor of randomized controlled trials, they represent a more accurate accounting of everyday clinical care. Which data are more relevant to clinical practice?. RECENT FINDINGS: At least 11 randomized controlled trials and three meta-analyses comparing coronary artery bypass grafting and percutaneous coronary intervention exist, which all largely show no difference in death or myocardial infarction between the two treatments but more repeat revascularization with percutaneous coronary intervention. All these studies, however, are subject to the biases of trial design, which impact the external validity of the results. Analyses of four observational databases show a survival advantage in multivessel disease with coronary artery bypass grafting. Although these are reflective of real world clinical practice, they are subject to 'treatment bias', some of which can be corrected by risk adjustment. SUMMARY: Information from both randomized controlled trials and outcomes databases is necessary to determine appropriate strategy for individual patients. Reliance on data solely from either source is insufficient. It is incumbent on the treating physician to know not only the results of published studies, but also the limitations of that information.

Mack MJ. · Medical City Hospital, Cardiopulmonary Research Science and Technology Institute, Dallas, TX 75230, USA. · Surg Endosc. · Pubmed #16557422 No free full text.

Abstract: Cardiac surgery has been the last of the surgical specialties to embrace the principles of minimal invasiveness. The complexity and invasiveness of the procedures have presented both a problem and an opportunity to make the procedures less invasive. Beginning with initial attempts at coronary artery bypass surgery through limited access with and without robotics, a number of other cardiac procedures currently are being performed by minimally invasive approaches. These include mitral valve repair, transapical aortic valve implant, limited access, and totally endoscopic pulmonary vein isolation for the treatment of atrial fibrillation and the treatment of aortic aneurysmal disease by thoracic endografting. The experience with less invasive surgery in other specialties has served as cross-fertilization for minimally invasive cardiac surgery.

Mack MJ. · Medical City Dallas Hospital and the Cardiopulmonary Research Science and Technology Institute (CRSTI), Dallas, TX 75230, USA. · Am Heart Hosp J. · Pubmed #15815135 No free full text.

Abstract: Beating heart techniques were introduced into coronary artery bypass graft (CABG) surgery in the mid 1990s in an attempt to decrease the complications associated with the use of cardiopulmonary bypass. Significant advances in technique and technology, including suction stabilizers and exposure devices, have now allowed all coronary vessels to be routinely approached without the support of cardiopulmonary bypass, while maintaining hemodynamic stability. Currently, approximately 25% of all CABG is performed without cardiopulmonary bypass in the United States. An extensive body of literature attests to the strong interest in the technique and the outcomes available for analysis. Although randomized trials do not yet show a mortality benefit, they are all underpowered to do so. A review of large retrospective databases does appear to demonstrate a mortality benefit, but patient selection contributes bias. Strong evidence of benefit exists for blood loss/transfusion, postoperative renal failure, sternal infection, myocardial injury, extubation time, length of stay, and cost savings. Particular benefit is apparent in high-risk patient subgroups, including the elderly, reoperative patients, and those with significant comorbidities. Off-pump CABG does appear to make a difference in improved outcomes by maintaining the excellent results of traditional on-pump CABG, but with less perioperative complications.

Magee MJ, Mack MJ. · Cardiopulmonary Research Science and Technology Institute (CRSTI), 7777 Forest Lane, Suite A-323, Dallas, TX 75230, USA. · Curr Opin Cardiol. · Pubmed #12466701 No free full text.

Abstract: Significant progress in cardiac surgery, and specifically the surgical management of coronary artery disease, has been due in large part to enabling technology. Robotic systems have been recently developed and refined for use in cardiac surgery to facilitate, among other procedures, a totally endoscopic approach to coronary artery bypass surgery. These systems enhance precision through endoscopic approaches by specifically addressing the inherent limitations of conventional endoscopic coronary microsurgical instrumentation via computerized, digital interface, telemanipulation technology. With a combined experience of 125 patients, several groups have independently demonstrated the clinical feasibility of totally endoscopic coronary artery bypass with two commercially available robotic telemanipulation systems. Additional enabling technology is needed to overcome the challenges currently limiting development and widespread application of totally endoscopic off-pump multivessel coronary artery bypass surgery.

Dewey TM, Mack MJ. · Medical City Dallas, 7777 Forest Lane, Suite 323, Dallas, TX 75230, USA. · Curr Cardiol Rep. · Pubmed #10980860 No free full text.

Abstract: Coronary artery bypass grafting without the aid of cardiopulmonary bypass (CPB) continues to gain popularity as an alternative to standard techniques of revascularization. CPB with cardioplegic arrest is associated with complications that may negate an otherwise technically flawless procedure. Experience has identified aspects crucial to the success of off-pump bypass grafting, such as patient selection, anesthetic and operative technique, and grafting sequence. We review recent technical advances and reported results for multivessel bypass grafting without CPB.

Mack MJ. · Cardiopulmonary Research Science And Technology Institute, Dallas, TX 75230, USA. · Eur J Cardiothorac Surg. · Pubmed #10613572 links to  free full text

Abstract: Although cardiac surgery has made significant contributions to the cardiac health of millions of patients over the past 40 years, it has evolved from an 'emerging growth' to a 'mature' industry. Along with this maturation has come an 'inertia of success' and lack of innovation. Minimally invasive cardiac surgery is an attempt to develop more patient friendly cardiac procedures yet maintain the superior long term results of conventional cardiac surgery. A broad spectrum of new surgical techniques and technical innovations has been fostered. The impact has been not only that of 'discontinuous innovation' of a new type of cardiac surgery but also a significant 'coat-tail' effect of 'upgrading' conventional cardiac surgery. It is difficult to adapt to change. But if we maintain an open-mindedness toward evolution with a firm foundation in proven standards, our patients will be the beneficiaries.

Magee MJ, Alexander JH, Hafley G, Ferguson TB, Gibson CM, Harrington RA, Peterson ED, Califf RM, Kouchoukos NT, Herbert MA, Mack MJ, Anonymous00006. · Cardiopulmonary Research Science and Technology Institute, Dallas, Texas, USA. · Ann Thorac Surg. · Pubmed #18222251 No free full text.

Abstract: BACKGROUND: This analysis compares 1-year vein graft patency and major adverse cardiac and cerebral events (MACCE [death, myocardial infarction, or stroke]) in on-pump and off-pump patients enrolled in PREVENT IV (the PRoject of Ex-vivo Vein graft ENgineering via Transfection IV). METHODS: The PREVENT IV was a multicenter (107 sites) randomized trial of edifoligide to prevent vein graft failure from neointimal hyperplasia in 3,014 patients undergoing primary, isolated coronary artery bypass grafting (CABG) with at least two vein grafts. One-year angiographic follow-up was completed on 1,920 patients (4,736 grafts) with MACCE follow-up on 99.4% of enrolled patients. RESULTS: In all, 2,377 procedures (78.9%) were on pump and 637 (21.1%) were off pump. On-pump patients had more chronic lung disease (17% versus 11%; p < 0.001), congestive heart failure (10% versus 7%; p = 0.03), lower mean ejection fraction (50% versus 55%; p < 0.001), and worse target artery quality (good 63.8% versus 68.1%; fair 26.4% versus 22.7%; poor 9.8% versus 9.2%; p < 0.001). Vein graft failure (more than 75% graft stenosis) in on- versus off-pump patients was 25.3% versus 25.7% (p = 0.62). After adjusting for differences in significant predictors of vein graft failure (target artery quality, surgery time, endoscopic vein harvest, more than 1 distal anastomosis/graft, and patient weight), the odds of vein graft failure was 0.82 (95% confidence interval: 0.67 to 1.00; p = 0.05) for on-pump versus off-pump patients. One-year mortality for on- versus off-pump patients was 3.3% versus 2.5% (p = 0.30); and MACCE was 15.4% versus 11.3% (p = 0.01). The adjusted hazard ratio for 1-year MACCE was 1.31 (95% confidence interval: 1.01-1.69; p = 0.01) for on pump versus off pump. CONCLUSIONS: Observed saphenous vein failure rate was 25% in both groups. One-year clinical outcomes (MACCE) were better with off-pump than with on-pump CABG, suggesting benefits not related to vein graft patency.

Damiano RJ, Tabaie HA, Mack MJ, Edgerton JR, Mullangi C, Graper WP, Prasad SM. · Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri 63110, USA. · Ann Thorac Surg. · Pubmed #11605613 No free full text.

Abstract: BACKGROUND: This multicenter prospective trial was designed to assess the safety and efficacy of using a robotically-assisted microsurgical system to create endoscopic coronary anastomoses. METHODS:. Thirty-two patients scheduled for elective primary coronary surgery underwent endoscopic anastomosis of the left internal thoracic artery (LITA) to the left anterior descending (LAD) artery. Three thoracic ports (two for instruments and one for a camera) were placed, and a robotic system was used to perform the LITA-LAD graft. Conventional techniques were used to perform the other grafts. Thirty-one patients underwent median sternotomy and 1 patient underwent a limited anterior thoracotomy. RESULTS:. Graft flow was measured in the operating room and averaged 37 +/- 19 mL/min. Mean anastomosis time was 24 +/- 9 minutes. There were three intraoperative revisions (9%). Two were for inadequate flow and one for an inadvertent injury. Each of these grafts was successfully revised by hand. There were no technical failures of the robotic system. Average postoperative length of stay was 5.5 +/- 2.7 days. There were three reoperations for bleeding, but none of these were related to the LAD anastomosis. Two months following the operation, selective angiography revealed a graft patency of 93%. The patients have been followed for 16 +/- 4 months. CONCLUSIONS: This initial prospective multicenter trial documents the feasibility of robotically-assisted coronary bypass grafting. Further trials are warranted to establish the safety and efficacy of this new technology.

Dewey TM, Magee M, Edgerton J, Vela R, Prince SL, Acuff T, Mack MJ. · Cardiopulmonary Research Science and Technology Institute, Dallas, Texas, USA. · Circulation. · Pubmed #11568038 links to  free full text

Abstract: BACKGROUND: Progression of disease and bypass graft attrition results in a population of patients who require repeated coronary interventions. Frequently, these patients have patent internal mammary artery grafts and require isolated intervention to the circumflex distribution. As an alternative to high-risk repeated sternotomy and conventional bypass surgery or catheter-based intervention, the circumflex marginal vessels may be approached by thoracotomy. We reviewed our experience in revascularizing the circumflex distribution with off-pump techniques via left mini-thoracotomy. METHODS AND RESULTS: Thirty-two patients underwent off-pump bypass grafting of the circumflex vessels via thoracotomy from December 1995 to April 2000. Twenty-seven patients presented with circumflex disease after having previous bypass grafting. Five patients, who presented with circumflex disease and either nondiseased or ungraftable disease in their other arteries, were revascularized as a primary procedure. There was no observed mortality. Seven patients (22%) required inotropes on leaving the operating room, and 3 patients (9.4%) received transfusion of packed red blood cells. There was 1 reoperation for bleeding and 1 patient with a postoperative neurological deficit. There were no perioperative myocardial infarctions. The average length of stay was 4.8 days from time of surgery to discharge. CONCLUSIONS: Off-pump grafting via thoracotomy provides a safe and effective alternative approach for patients requiring limited revascularization. Potential cardiac injury and danger to viable grafts from repeated sternotomy is minimized, and manipulation of the diseased ascending aorta is avoided. Morbidity, hospital length of stay, and cost are less than for conventional repeated coronary bypass surgery.

Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW, Anonymous00010. · Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands. · N Engl J Med. · Pubmed #19228612 No free full text.

Abstract: 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. (ClinicalTrials.gov number, NCT00114972.)

Mack MJ, Prince SL, Herbert M, Brown PP, Katz M, Palmer G, Edgerton JR, Eichhorn E, Magee MJ, Dewey TM. · Cardiopulmonary Research Science and Technology Institute, Dallas, Texas, USA. · Ann Thorac Surg. · Pubmed #18640323 No free full text.

Abstract: BACKGROUND: Randomized trials have compared coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). However, results of these trials in select patients may not accurately reflect current clinical practice using drug-eluting stents (DES) and off-pump CABG. We undertook a prospective registry of coronary revascularization by CABG on-pump and off-pump, and PCI with or without DES, to determine clinical outcomes. METHODS: All patients undergoing isolated coronary revascularization in 8 community-based hospitals were enrolled. Preprocedural, intraprocedural, and postprocedural data were captured, with outcomes obtained at 18 months by patient and physician contact, and the Social Security Death Index. RESULTS: The study enrolled 4336 patients, 71.2% PCI and 28.8% CABG. DESs were used in 2249 PCIs (73.1%), and 596 CABG procedures (47.8%) were off-pump. Incidence of major adverse cardiac events at 18 months was 14.7% for CABG vs 23.3% for PCI (p < 0.001). Cardiac death and myocardial infarction had similar rates. The need for repeat revascularization was significantly less with CABG (6.2% vs 13.6%, p < 0.001). Hazard ratio of CABG to PCI was 0.76 (95% confidence interval, 0.571 to 0.872). CABG outcome was similar on-pump and off-pump, as was repeat revascularization with DES (12.1%) vs BMS (14.9%; p = 0.096). Overall event-free survival was 85.3% in CABG and 76.8% in PCI (p < 0.001). CONCLUSIONS: Rates of repeat revascularization were significantly higher for PCI than for CABG, but mortality and myocardial infarction were the same. There were no significant differences in outcomes between DES and BMS or between on-pump and off-pump CABG.

Palmer G, Herbert MA, Prince SL, Williams JL, Magee MJ, Brown P, Katz M, Mack MJ. · Central Florida Regional Hospital, Sanford, Florida, USA. · Ann Thorac Surg. · Pubmed #17307446 No free full text.

Abstract: BACKGROUND: The Coronary Artery Revascularization (CARE) study is a multicenter observational registry of coronary revascularization by percutaneous and surgical techniques. As a substudy of this registry, we analyzed the current practice and outcomes of on-pump and off-pump coronary artery bypass graft (CABG) surgery. METHODS: Procedural and outcomes data were prospectively collected for all patients undergoing isolated CABG in eight community-based hospitals in the HCA Hospital System between February 1 and July 31, 2004. Twelve-month follow-up was obtained by patient contact, phone, questionnaire, and the National Death Index. RESULTS: Isolated coronary artery revascularization procedures were done in 1251 patients, with 12-month follow-up data available on 1149 (91.8%); 654 patients (52.3%) were operated on-pump and 597 (47.7%) had off-pump procedures. On-pump versus off-pump results were mean number of grafts, 3.4 +/- 1 versus 2.9 +/- 1.2 (p < 0.001); operative mortality, 1.7% versus 1.7% (p = 1.00); permanent stroke, 0.9% versus 0.7% (p = 0.51); reoperation for bleeding, 2.6% versus 1.0% (p = 0.037); prolonged ventilation, 10.0% versus 3.4% (p < 0.001); atrial fibrillation, 23.8% versus 14.9% (p < 0.001); need for transfusion, 51.0% versus 34.9% (p < 0.001); intensive care unit length of stay, 68.1 +/- 97.0 hours versus 59.3 +/- 109.4 hours (p = 0.16); and hospital length of stay, 7.5 days versus 6.2 days (p < 0.001). At 12 months, there was no difference in total cardiac mortality on-pump versus off-pump (4.9% versus 4.6%, p = 0.88), myocardial infarction (1.0% versus 0.7%, p = 0.76), need for repeat revascularization (2.8% versus 4.1%, p = 0.70), or total overall major adverse cardiac outcomes (8.7 versus 9.4, p = 0.69). CONCLUSIONS: Current approaches to coronary revascularization using both on-pump and off-pump techniques at individual surgeon discretion, which varies significantly in the community setting, leads to acceptable outcomes. Although perioperative complications were less off-pump, mortality was the same, both in the perioperative period and at 12 months. Fewer grafts in the off-pump group appeared to be related to disease burden and not incomplete revascularization. Cardiac death, myocardial infarction, and the need for repeat revascularization were equal at 12 months.

Ong AT, Serruys PW, Mohr FW, Morice MC, Kappetein AP, Holmes DR, Mack MJ, van den Brand M, Morel MA, van Es GA, Kleijne J, Koglin J, Russell ME. · Thoraxcentre, Erasmus Medical Centre, Rotterdam, The Netherlands. · Am Heart J. · Pubmed #16781219 No free full text.

Abstract: BACKGROUND: Changes in the treatment of coronary artery disease both surgically and percutaneously have rendered the major randomized trials historical. Furthermore, the restrictive criteria of previous trials excluded most patients treated in daily practice. Although coronary surgery is still considered the current, evidence-based, gold-standard treatment of left main (LM) and 3-vessel coronary disease, the added benefit of drug-eluting stents has further expanded the use of percutaneous coronary intervention (PCI) beyond less complex populations in daily practice. STUDY DESIGN: The 1500-patient, prospective, multicenter, multinational (European and North American), randomized SYNTAX study with nested registries will enroll "all-comers." Consecutive patients with de novo 3-vessel disease (3VD) and/or LM disease will be screened for eligibility by the Heart Team (composed of an interventionalist, a cardiac surgeon, and the study coordinator) at each site and then allocated to either (1) the randomized cohort, if comparable revascularization can be achieved by either PCI or coronary artery bypass surgery (CABG), or (2) to one of the nested registries for CABG-ineligible patients (PCI registry) or for PCI-ineligible patients (CABG registry). Randomized patients will be stratified based on LM disease and diabetes by site. The primary end point for the randomized comparison is noninferiority of major adverse cardiac and cerebral events between the 2 groups at 1 year. To adequately project the expected enrollment rate per site, a run-in phase was mandated for each site interested in participating in the trial. Both cardiothoracic and interventional cardiology departments within the same institution were asked to complete a questionnaire regarding their frequency of treatment of LM and 3VD over a retrospective 3-month period. IMPLICATIONS: By replacing most traditional inclusion and exclusion criteria with the real-world decision between the cardiothoracic surgeon and the interventionalist, this study will define the roles of CABG and PCI using drug-eluting stents in the contemporary management of LM and 3VD. Results of the run-in phase were used by the steering committee to determine eligibility and to project enrollment for each site.

Edgerton JR, Herbert MA, Prince SL, Horswell JL, Michelson L, Magee MJ, Dewey TM, Edgerton ZJ, Mack MJ. · Cardiopulmonary Research Science and Technology Institute, Dallas, Texas, USA. · Ann Thorac Surg. · Pubmed #16731140 No free full text.

Abstract: BACKGROUND: We analyzed data from patients undergoing off-pump isolated coronary artery bypass grafting surgery (OPCABG) to determine if immediate extubation in the operating room affected the incidence of postoperative atrial fibrillation. METHODS: The study group comprised 2,376 consecutive OPCABG patients operated on between January 1, 2000, and December 31, 2004, by 22 surgeons at 18 hospitals. The data were subjected to univariate, multivariate analysis of variance, and logistic analysis. Logistic regression of matched groups was used to eliminate the effect of some confounding variables. RESULTS: Patients immediately extubated after surgery had a reduced incidence of atrial fibrillation (10.6% versus 18.5%; p < 0.001), shorter length of stay (4.8 +/- 3.5 versus 6.3 +/- 5.2 days; p < 0.001), and also reduced mortality (1.1% versus 2.4%; p = 0.04). Logistic analysis identified as significant factors for postoperative atrial fibrillation, postoperative ventilator usage (p < 0.001; odds ratio [OR] = 1.63; 95% confidence interval [CI]: 1.24 to 2.14), male sex (p = 0.002; OR = 1.51; 95% CI: 1.17 to 1.96), previous CABG (p = 0.005; OR = 0.43; 95% CI: 0.24 to 0.78). Congestive heart failure may also be a contributing factor. In patient groups matched for their risk of mortality, postoperative ventilator use (p < 0.001; OR = 1.80; 95% CI: 1.31 to 2.47), increasing age, and male sex were all statistically significant risk factors. When patient groups were matched on a combination of factors including preoperative beta-blocker usage, pulmonary disease, and smoking, postoperative ventilator use (p = 0.005; OR = 1.66; 95% CI: 1.16 to 2.38), along with increasing age, male sex, and previous CABG (reduced odds of atrial fibrillation developing) were statistically significant. CONCLUSIONS: Immediate extubation after OPCABG appears to reduce the incidence of postoperative atrial fibrillation independent of comorbidities.

Kappetein AP, Dawkins KD, Mohr FW, Morice MC, Mack MJ, Russell ME, Pomar J, Serruys PW. · Department of Thoracic Surgery, ErasmusMC, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands. · Eur J Cardiothorac Surg. · Pubmed #16497510 links to  free full text

Abstract: OBJECTIVE: Percutaneous coronary intervention with drug-eluting stents is challenging coronary artery bypass grafting (CABG) as the gold standard for treatment of three-vessel and left main coronary disease. We evaluated the current practice pattern in hospitals throughout Europe and USA. METHODS: To qualify for participation in the SYNTAX (Synergy between PCI with TAXUS drug-eluting stent and Cardiac Surgery) study, a randomized trial comparing percutaneous coronary intervention with drug-eluting stent versus coronary artery bypass grafting for three-vessel and left main disease, 104 centers were asked to provide their case volume in 3 months in 2004. Anonymous procedural data were collected. RESULTS: A total of 12,072 patients were recorded. Coronary artery bypass grafting was the most frequently performed procedure (N=8895, 74%). Three-vessel disease (3VD) predominated in this population (N=8532, 71%) versus left main (N=3540, 29%). In the 3-month period, per center a mean of 8.3 patients with left main and 22.3 patients with three-vessel disease were treated by percutaneous coronary intervention, while 26.0 patients with left main and 60.3 patients with three-vessel disease were treated by coronary artery bypass grafting. In USA, percutaneous coronary intervention for left main and/or three-vessel disease was performed in 18% of the cases while this was performed in 29% of the cases in Europe. Of all CABG procedures, only 12% were done with total arterial grafting while 7% were treated with only venous grafts. CONCLUSIONS: In patients with multivessel or left main disease, still coronary artery bypass grafting remains the dominant revascularization strategy. Percutaneous coronary intervention is performed frequently without supporting data from the literature. Percutaneous coronary intervention for this indication is performed more often in Europe than in USA. Only a minority of the patients receives total arterial grafting in case of coronary artery bypass grafting. The SYNTAX trial with randomized and registry cohorts should provide guidance for selecting the preferred form of treatment.

Dewey TM, Herbert MA, Prince SL, Robbins CL, Worley CM, Magee MJ, Mack MJ. · Cardiopulmonary Research Science and Technology Institute, Dallas, Texas, USA. · Ann Thorac Surg. · Pubmed #16427858 No free full text.

Abstract: BACKGROUND: Cardiovascular disease remains the most frequent cause of death for patients with end-stage renal disease. To determine the long-term benefit of surgical revascularization in this high-risk population, we studied our patients with ESRD having coronary artery bypass graft surgery (CABG), comparing the results of off-pump to on-pump revascularization. As a baseline reference group, we used dialysis patients with a diagnosis of coronary artery disease who did not have surgical revascularization or percutaneous coronary interventions. The control group data set was obtained from the United States Renal Data System. METHODS: From January 1995 through July 2003, 158 patients with end-stage renal disease who were on hemodialysis (excluding those in cardiogenic shock, needing resuscitation, and with emergent or salvage status) underwent CABG. Fifty-nine patients (37.3%) had off-pump revascularization, and 99 patients (62.7%) had bypass grafting utilizing extracorporeal circulation. Preoperative risk factors and operative results were analyzed, and longitudinal survival data obtained. RESULTS: The mean follow-up time was 39.1 months (median, 33.1) for the on-pump patients and 18.3 months (median, 14.7) for off-pump. The total number of anastomoses per off-pump patient was 2.4 +/- 1.0, and with cardiopulmonary bypass (CPB), it was 3.3 +/- 0.9 (p < 0.001). Patients revascularized off-pump had an operative mortality rate of 1.7%, whereas patients grafted using CPB had an operative mortality of 17.2% (p = 0.003). The predicted risk of mortality for the off-pump group (9.3% +/- 7.4%) was not statistically different from the on-pump cohort (9.1% +/- 7.7%, p = not significant). Logistic regression analysis indicates that CPB use was an independent risk factor for early death (p = 0.01, odds ratio = 13.6, 95% confidence interval: 1.7 to 110). Long-term follow-up demonstrated that the patients revascularized using CPB had improved survival compared with the off-pump patients and the control population. CONCLUSIONS: Off-pump CABG improves early mortality rate when compared with conventional revascularization. Despite a greater operative mortality, however, long-term survival is improved in the patients revascularized with CPB as compared with the off-pump cohort, suggesting possible advantages from a more complete revascularization in this population.

Mack MJ. · Cardiopulmonary Research Science and Technology Institute, Dallas, Texas 75230, USA. · J Card Surg. · Pubmed #15245460 No free full text.

Abstract: BACKGROUND: Reoperative coronary artery bypass grafting (CABG) has been associated with higher mortality and morbidity than first-time CABG. Off-pump surgery has been introduced in an effort to reduce morbidity associated with traditional on-pump CABG. However, these techniques present unique challenges in the reoperative setting. A review of our experience was undertaken to determine safety, efficacy, and technical challenges in beating heart reoperative CABG. METHODS: From January 1999 through April 2003 reoperative CABG procedures performed by a single surgeon were treated on an "intention to treat" basis without cardiopulmonary bypass. A standardized operative technique employing suction stabilization and exposure devices were used for sternotomy procedures with stabilization devices employed for limited access single-vessel revascularization. RESULTS: Eighty-six of eighty-seven (99%) consecutive patients undergoing reoperative CABG had the procedure initiated off-pump. There were 24 of 62 females/males (28%/72%) with a mean age of 64.3 (34 to 92). Eighty-one of eighty-six (94.2%) procedures were successfully completed off-pump. Five (5.8%) conversions were due to hemodynamic instability, inability to dissect dense adhesions (2), inability to locate an intramyocardial LAD (1). The procedures were performed via a median sternotomy in 67 patients (78%) and by limited anterior or lateral thoracotomy in 19 patients (22%). The operative mortality was 2 of 86, predicted risk 6.7%. There was no mortality in the converted patients. Postoperative length of stay was 5.5 days. There were no strokes or perioperative myocardial infarctions. Complications included reoperation for bleeding in 2.2%. Sixty-one of sixty-six (92.4%) patients were able to be extubated in the operating room. The rate of transfusion was 23 in 86 patients (26.5%), and atrial fibrillation was 5 in 86 patients (5.8%). CONCLUSION: Off-pump CABG can technically be performed safely in most patients presenting for reoperative CABG. Outcomes appear to be improved compared with published outcomes of reoperative on-pump CABG surgery.

Dewey TM, Crumrine K, Herbert MA, Leonard A, Prince SL, Worley C, Edgerton JR, Magee MJ, Mack MJ. · Cardiopulmonary Research Science and Technology Institute, Dallas, Texas 75230, USA. · Ann Thorac Surg. · Pubmed #15111139 No free full text.

Abstract: BACKGROUND: To determine the extended results of mechanical connectors we compared the 1-year outcomes of patients having beating heart coronary artery bypass surgery with at least one sutured or mechanically connected proximal vein graft anastomosis. METHODS: From May 2001 to December 2001, 166 patients were identified as having undergone off-pump bypass grafting utilizing at least one St. Jude symmetry aortic connector (St Jude Medical Anastomotic Technology Group, St. Paul, MN). Follow-up for major adverse cardiac events (MACEs), which is defined as cardiac mortality, myocardial infarction, or revascularization of a previous target vessel, was obtained on 162 patients (97.6%). A control group of 159 patients was identified from a cohort of patients having beating heart surgery with one or more sutured proximal vein graft anastomosis in the preceding year. The MACE follow-ups were obtained in 136 patients (85.6%) by direct telephone contact. RESULTS: Patients with connectors showed an accelerated number of MACEs beginning approximately 180 days from the time of surgery and stabilizing at approximately 300 days. Logistic regression analysis identified the presence of diabetes as a significant preoperative risk factor predisposing patients to earlier onset of MACEs (p = 0.03) with an odds ratio of 2.9 (95% confidence interval, 1.1 to 7.6). Insulin dependent diabetics showed no differences between connector and control patients in the frequency or timing of MACEs. Connector patients using oral hypoglycemic agents demonstrated a significant deviation (p = 0.01) from a similar control population in the prevalence and timing of MACEs. CONCLUSIONS: Connector patients showed an increased incidence of early MACEs. These events were characterized by an increased requirement for early target vessel revascularization and were predominantly in noninsulin-dependent diabetics.

Mack MJ, Brown PP, Kugelmass AD, Battaglia SL, Tarkington LG, Simon AW, Culler SD, Becker ER. · Medical City Dallas Hospital, Dallas, Texas, USA. · Ann Thorac Surg. · Pubmed #14992867 No free full text.

Abstract: BACKGROUND: Current practice, trends, and early outcomes in patients undergoing surgical and percutaneous coronary interventions (PCI) are changing and subject to speculation. METHODS: 148,396 consecutive patients in 69 HCA, Inc hospitals who underwent either PCI or coronary artery bypass grafting (CABG) were tracked in the HCA Casemix Database from 1999 through the first quarter of 2002. Comorbid conditions, procedures, complications, and outcome variables were defined through International Classification of Diseases, Ninth Revision coding. Odds ratios (OR) for death and other procedure-related complications were estimated using logistic regression adjusting for age, sex, and 31 other patient clinical and procedural characteristics. RESULTS: Now 65.4% of all coronary revascularization is by PCI with a 6.8% annual rate of increase whereas CABG volume is declining by 1.9% per year. However the majority of these changes occurred between 1999 and 2000 with only small changes in the last 3 years. Coronary artery bypass grafting is still utilized primarily for multivessel disease (3.38 bypasses per patient) whereas PCI is predominately (83%) still limited to single-vessel intervention. Unadjusted mortality rates over the full 13-quarter period were 1.25% for PCI and 2.63% for CABG (p < 0.001), with PCI rates remaining constant and CABG mortality declining. Twenty-three percent of CABG is performed off pump with a lower mortality than conventional on-pump CABG (2.37% versus 2.69%, p < 0.001). Percutaneous coronary intervention patients have lower mortality (OR 0.51), and fewer acute renal failure (OR 0.39), neurologic (OR 0.12), and cardiac (OR 0.16) complications than CABG patients (p < 0.001). CONCLUSIONS: Interventions for coronary artery disease continue to rise primarily due to an increase in PCI. The volume of PCI continues to increase relative to CABG. Although adverse outcomes are higher after CABG, the proportion of multivessel disease treated is greater. The difference in adverse outcomes between CABG and PCI remains small and continues to decline.

Mack MJ, Pfister A, Bachand D, Emery R, Magee MJ, Connolly M, Subramanian V. · Cardiopulmonary Research Science and Technology Institute, Medical City Dallas Hospital, TX, USA. · J Thorac Cardiovasc Surg. · Pubmed #14752427 No free full text.

Abstract: BACKGROUND: Coronary artery bypass grafting can now be performed with or without cardiopulmonary bypass. Our objective was to determine whether off-pump coronary artery bypass grafting is associated with better early outcomes compared with conventional coronary artery bypass grafting. METHODS: In 4 centers with off-pump coronary surgery experience, a retrospective analysis of all coronary artery bypass grafting in a 3-year period was performed. Groups were compared to determine selection criteria, mortality, and morbidity, then computer-matched by propensity score to control for selection bias. Multivariate logistic regression identified risk factors predictive of mortality. Specific subgroups most likely to benefit were identified. RESULTS: In all, 17,401 isolated coronary artery bypass grafts were performed, 7283 (41.9%) off-pump coronary artery bypass grafts and 10,118 (58.1%) conventional coronary artery bypass with cardiopulmonary bypass. Factors determining selection of patients for off-pump coronary artery bypass grafting included female gender (55.5% vs 44.5%), preexisting renal failure (57.0% vs 43.0%), and reoperations (52.6% vs 47.4%). Operative mortality was 2.8%; off-pump coronary artery bypass grafting versus conventional coronary artery bypass with cardiopulmonary bypass (1.9% vs 3.5%, P <.001) had the same predicted risk. Of the patients with multivessel disease, 11,548 were matched by propensity scoring. Mortality was significantly less in the off-pump coronary artery bypass grafting group (2.8% vs 3.7%, P <.001). By multivariate logistic regression analysis of the matched sample, predictors for mortality were female gender (odds ratio 1.83, confidence interval 1.37-2.44), preexisting renal failure (odds ratio 2.85, confidence interval 2.64-4.95), history of stroke (odds ratio 1.74, confidence interval 1.08-2.80), previous coronary artery bypass grafting surgery (odds ratio 4.22, confidence interval 2.92-6.09), use of cardiopulmonary bypass (odds ratio 2.08, confidence interval 1.52-2.83), and recent myocardial infarction (odds ratio 2.31, confidence interval 1.68-3.22). Cardiopulmonary bypass was predictive of mortality in reoperations, female patients, and patients aged >or= 75 years. Off-pump coronary artery bypass grafting was associated with less morbidity, including reductions in blood transfusion (32.6% vs 40.6%, P <.001), stroke (1.4% vs 2.1%, P =.002), renal failure (2.6% vs 5.2%, P <.001), pulmonary complications (4.1% vs 9.5%, P <.001), reoperation (1.7% vs 3.2%, P <.001), atrial fibrillation (21.1% vs 24.99%, P <.001), and gastrointestinal complications (3.6% vs 4.8%, P =.02). CONCLUSION: In 4 centers with beating-heart operation experience, there is an overall early benefit in off-pump surgery, especially in patients traditionally considered at high risk for coronary artery bypass grafting.

Mack MJ. · Cardiopulmonary Research Science and Technology Institute and Medical City Dallas Hospital, Dallas, Texas, USA. · Ann Thorac Surg. · Pubmed #14667693 No free full text.

Abstract: Initial pioneering efforts of direct coronary artery bypass were all performed on a beating heart. Although originally introduced into cardiac surgery for the repair of intracardiac defects, the ability of John Gibbon's heart-lung machine to create a motionless, bloodless operative field catalyzed coronary artery bypass surgery. During the ensuing decades tens of millions of patients benefited from coronary revascularization on cardiopulmonary bypass. As we celebrate the 50th anniversary of the invention of the heart-lung machine the landscape of interventional treatment of coronary artery disease has shifted dramatically. Although instrumental in the genesis of the field of coronary revascularization, the role of the heart-lung machine has now diminished. Two thirds of all coronary revascularization is now performed by percutaneous approaches and one fourth of all coronary artery bypass grafting procedures are performed without the heart-lung machine. However owing to the complexity of patients now requiring revascularization as well as recently introduced incremental improvements to cardiopulmonary bypass including coated, low prime circuits, closed integrated systems, and pharmacologic adjuncts Gibbon's heart-lung machine will continue to play an integral role in this field.