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The n e w e ng l a n d j o u r na l of m e dic i n e edi t or i a l Surgical Ventricular Reconstruction for Heart Failure Howard J. Eisen, M.D. Congestive heart failure is one of the leading causes of death and complications in the developed world, and coronary artery disease is the major cause of heart failure. Efforts to improve ventricular function, symptoms, and clinical outcomes in patients with heart failure have included neurohormonal inhibition with angiotensin-converting–enzyme inhibitors, angiotensin-receptor blockers, beta-blockers, and aldosterone antagonists, as well as cardiac resynchronization therapy. All these therapies have been shown in randomized clinical trials to be beneficial.1 However, none of them specifically address the coronary disease responsible for ischemic cardiomyopathy and myocardial infarction. Coronary-artery bypass grafting (CABG), which was first used to ameliorate symptoms, is now used to improve survival in selected patients with ischemic heart disease, although the improved outcome of percutaneous coronary intervention (PCI) has resulted in a reduction in the number of CABG procedures that are performed.2-4 CABG remains the standard of care for patients with disease involving at least three vessels or the left main coronary artery.5 Revascularization with CABG can improve the perfusion of viable myocardium but does not restore function in areas of infarction. The large, aneurysmal myocardial segments that were seen in the past in patients with myocardial infarction are seldom seen in the current era of coronary reperfusion. However, regional zones of myocardial dysfunction are still frequently observed. These areas of regional dysfunction may result in adverse cardiac remodeling and the progression of heart failure.6 A surgical procedure to reconstruct dysfunctional myocardial segments and favorably remodel the ventricle, known as surgical ventricular reconstruction, has been developed and is performed in selected patients, usually in conjunction with CABG7,8 (Fig. 1). Previously reported clinical studies of surgical ventricular reconstruction were not randomized and were conducted either in a single center or in multiple centers as observational studies.9-11 In this issue of the Journal, Jones et al.12 report the results of the Hypothesis 2 substudy of the Surgical Treatment for Ischemic Heart Failure (STICH) trial (ClinicalTrials.gov number, NCT00023595). This substudy compared CABG alone with the combined procedure of CABG with surgical ventricular reconstruction. Patients were required to have coronary disease amenable to CABG, a left ventricular ejection fraction of 35% or less, and a dominant anterior region of myocardial akinesia or dyskinesia that was amena ble to treatment with surgical ventricular reconstruction. All patients received standard medical and device therapy for heart failure. The results of the Hypothesis 1 substudy of the STICH trial, which compared medical therapy plus CABG with medical therapy alone, are not reported. In the Hypothesis 2 substudy, 1000 patients were recruited from 96 medical centers in 23 countries. The patients in the two study groups were closely matched in terms of demographic characteristics, coexisting illnesses, the proportion who were receiving specific heart-failure medications, the Canadian Cardiovascular Society (CCS) angina class, the New York Heart Association (NYHA) heart-failure class, coronary anatomy, and the extent of anterior myocardial akinesia or dyskinesia. Although Jones et al. indicate that the use of evidence-based medical therapy (including heart-failure medications, pacemakers, and cardio verter–defibrillators) was monitored throughout n engl j med 360;17 nejm.org april 23, 2009 Downloaded from www.nejm.org at VANDERBILT UNIVERSITY on May 14, 2009 . Copyright © 2009 Massachusetts Medical Society. All rights reserved. 1781 The n e w e ng l a n d j o u r na l of m e dic i n e A B Left atrium Left ventricle Left ventricle Damaged tissue Right ventricle Left ventricle Damaged tissue C Encircling suture being placed along the edge of normal ventricular wall E D Patch Patch Ventricular wall sutured over the patch in order to improve hemostasis and provide mechanical reinforcement Figure 1. Surgical Ventricular Reconstruction. An incision is made through the area of scarring in the left ventricle (Panel A), which is opened to identify the boundary between damaged and COLOR FIGURE healthy myocardium (Panel B). A purse-string suture is placed to encircle the scar, and the healthy portions of the ventricular wall are brought Rev1 together (Panel C). The suture is tightened or a patch is placed (Panel D), and the scarred sections left outside the chamber are closed03/24/09 (Panel E). Author Dr. Eisen Fig # 1 1782 n engl j med 360;17 nejm.org april 23, 2009 Title ME Downloaded from www.nejm.org at VANDERBILT UNIVERSITY on May . DE 14, 2009Jarcho Copyright © 2009 Massachusetts Medical Society. All rights reserved. Daniel Muller Artist AUTHOR PLEASE NOTE: editorial the trial, they have not provided information about rates of use of these therapies over time. Both CABG alone and the combined procedure were equally successful in improving the postoperative CCS angina class and NYHA heart-failure class. The two groups had similar improvements in the 6-minute walk test and similar reductions in symptoms. There was a greater reduction in the end-systolic volume index with the combined procedure (16 ml per square meter of body-surface area), as compared with CABG alone (5 ml per square meter). Unfortunately, these data were obtained from only 373 patients at baseline and at 4 months. The primary outcome of the trial was a composite of death from any cause or hospitalization for cardiac causes. There was no difference in the occurrence of the primary outcome between the CABG group (59%) and the combined-procedure group (58%). The 30-day surgical rates of death for CABG alone (5%) and for the combined procedure (6%) were similar and low overall, and no difference in the rate of death from any cause was observed in a median follow-up period of 48 months. Subgroup analyses showed no individual variables interacting significantly with studygroup assignment. This large clinical trial had many strengths, including an up-to-date approach to CABG, certification of surgeons and interventionalists in both PCI and CABG, and an attempt to standardize heart-failure therapies according to guidelines throughout the entire study population. The study also had some limitations, including sparse data regarding medical or device therapy used in each study group. The diversity of patients who were enrolled might have limited the ability of the investigators to identify particular groups or types of patients who might benefit from the combined procedure. Finally, more complete and longitudinal information on the end-systolic volume index might have provided an indication of whether ongoing ventricular remodeling occurred, which might have negated or mitigated the difference seen in the early postoperative period. On the basis of this trial, the routine use of surgical ventricular reconstruction in addition to CABG cannot be justified. Potential explanations for the lack of added efficacy of the combined procedure include the fact that current heartfailure therapies are very effective at limiting adverse remodeling. The addition of CABG may have enhanced this process, leaving little room for additional benefit from surgical ventricular reconstruction. We will have to wait for the results of the Hypothesis 1 substudy of the trial to know for sure. It is also apparent that surgical remodeling of the ventricle is different from remodeling induced by heart-failure therapies or cardiac resynchronization therapy and that the abrupt geometric reduction in ventricular dimensions with this procedure does not mimic the benefits derived from neurohormonal inhibition and perhaps revascularization. The extent of volume reduction from surgical ventricular reconstruction also may not be consequential. There may be specific subgroups of patients who might benefit from the combined procedure, but such an effect is not apparent so far in the results of the STICH trial and may be difficult to detect, given the diversity of the study population. Dr. Eisen reports receiving consulting and lecture fees from Medtronic and grant support from Medtronic and St. Jude. No other potential conflict of interest relevant to this article was reported. From the Division of Cardiology, Drexel University College of Medicine, Philadelphia. This article (10.1056/NEJMe0901815) was published at NEJM.org on March 29, 2009. 1. Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation 2005;112(12): e154-e235. 2. Kolessov VI. Mammary artery-coronary artery anastomosis as method of treatment for angina pectoris. J Thorac Cardiovasc Surg 1967;54:535-44. 3. Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery: survival data. Circulation 1983; 68:939-50. 4. Yusuf S, Zucker D, Peduzzi P, et al. Effect of coronary artery bypass graft surgery on survival: overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration. Lancet 1994;344:563-70. [Erratum, Lancet 1994;344:1446.] 5. Serruys PW, Morice M-C, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009;360:961-72. 6. Sutton MGS, Sharpe N. Left ventricular remodeling after myocardial infarction: pathophysiology and therapy. Circulation 2000;101:2981-8. 7. Dor V, Saab M, Coste P, Kornaszewska M, Montiglio F. Left ventricular aneurysm: a new surgical approach. Thorac Cardiovasc Surg 1989;37:11-9. 8. Ferrazzi P, Matteucci MLS, Merlo M, et al. Surgical ventricular reverse modeling in severe ischemic dilated cardiomyopathy: the relevance of the left ventricular equator as a prognostic factor. J Thorac Cardiovasc Surg 2006;131:357-63. 9. Menicanti L, Castelvecchio S, Ranucci M, et al. Surgical n engl j med 360;17 nejm.org april 23, 2009 Downloaded from www.nejm.org at VANDERBILT UNIVERSITY on May 14, 2009 . Copyright © 2009 Massachusetts Medical Society. All rights reserved. 1783 editorial therapy for ischemic heart failure: single-center experience with surgical anterior ventricular restoration. J Thorac Cardiovasc Surg 2007;134:433-41. 10. Athanasuleas CL, Stanley AWH Jr, Buckberg GD, Dor V, DiDonato M, Blackstone EH. Surgical anterior ventricular endocardial restoration (SAVER) in the dilated remodeled ventricle after anterior myocardial infarction. J Am Coll Cardiol 2001;37:1199209. 1784 11. Athanasuleas CL, Buckberg GD, Stanley AWH Jr, et al. Surgi- cal ventricular restoration in the treatment of congestive heart failure due to post-infarction ventricular dilation. J Am Coll Cardiol 2004;44:1439-45. 12. Jones RH, Velazquez EJ, Michler RE, et al. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med 2009;360:1705-17. Copyright © 2009 Massachusetts Medical Society. n engl j med 360;17 nejm.org april 23, 2009 Downloaded from www.nejm.org at VANDERBILT UNIVERSITY on May 14, 2009 . Copyright © 2009 Massachusetts Medical Society. All rights reserved.