Joseph F. Sabik

Standardized Bleeding Definitions for Cardiovascular Clinical Trials A Consensus Report From the Bleeding Academic Research Consortium

Advances in antithrombotic therapy, along with an early invasive strategy, have reduced the incidence of recurrent ischemic events and death in patients with acute coronary syndromes (ACS; unstable angina, non–ST-segment–elevation myocardial infarction [MI], and ST-segment–elevation MI).1,–,4 However, the combination of multiple pharmacotherapies, including aspirin, platelet P2Y12 inhibitors, heparin plus glycoprotein IIb/IIIa inhibitors, direct thrombin inhibitors, and the increasing use of invasive procedures, has also been associated with an increased risk of bleeding. Editorial see p 2664 Bleeding complications have been associated with an increased risk of subsequent adverse outcomes, including MI, stroke, stent thrombosis, and death, in patients with ACS and in those undergoing percutaneous coronary intervention (PCI),5,–,10 as well as in the long-term antithrombotic setting.11,12 Thus, balancing the anti-ischemic benefits against the bleeding risk of antithrombotic agents and interventions is of paramount importance in assessing new therapies and in managing patients. Prior randomized trials comparing antithrombotic agents suggest that a reduction in bleeding events is associated with improved survival.13,14 Because prevention of major bleeding may represent an important step in improving outcomes by balancing safety and efficacy in the contemporary treatment of ACS, bleeding events have been systematically identified as a crucial end point for the assessment of the safety of drugs during the course of randomized clinical trials, and are an important aspect of the evaluation of new devices and interventional therapies.15 Unlike ischemic clinical events (eg, cardiac death, MI, stent thrombosis), for which there is now general consensus on end-point definitions,16,17 there is substantial heterogeneity among the many bleeding definitions currently in use. Lack of standardization makes it difficult to optimally organize key clinical trial processes such as adjudication, and even more difficult to interpret relative …

2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease: Executive Summary A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons

WRITING COMMITTEE MEMBERS* Stephan D. Fihn, MD, MPH, Chair†; Julius M. Gardin, MD, Vice Chair*‡; Jonathan Abrams, MD‡; Kathleen Berra, MSN, ANP*§; James C. Blankenship, MD*\; Apostolos P. Dallas, MD*†; Pamela S. Douglas, MD*‡; JoAnne M. Foody, MD*‡; Thomas C. Gerber, MD, PhD‡; Alan L. Hinderliter, MD‡; Spencer B. King III, MD*‡; Paul D. Kligfield, MD‡; Harlan M. Krumholz, MD‡; Raymond Y.K. Kwong, MD‡; Michael J. Lim, MD*\; Jane A. Linderbaum, MS, CNP-BC¶; Michael J. Mack, MD*#; Mark A. Munger, PharmD*‡; Richard L. Prager, MD#; Joseph F. Sabik, MD***; Leslee J. Shaw, PhD*‡; Joanna D. Sikkema, MSN, ANP-BC*§; Craig R. Smith, Jr, MD**; Sidney C. Smith, Jr, MD*††; John A. Spertus, MD, MPH*‡‡; Sankey V. Williams, MD*†

Durability of mitral valve repair for degenerative disease

BACKGROUND Degenerative mitral valve disease is the most common cause of mitral regurgitation in the United States. Mitral valve repair is applicable in the majority of these patients and has become the procedure of choice. OBJECTIVE This study was undertaken to identify factors influencing the durability of mitral valve repair. PATIENTS AND METHODS Between 1985 and 1997, 1072 patients underwent primary isolated mitral valve repair for valvular regurgitation caused by degenerative disease. Repair durability was assessed by multivariable risk factor analysis of reoperation. It was supplemented by a search for valve-related risk factors for death before reoperation. Three hospital deaths occurred (0.3%); complete follow-up (4152 patient-years) was available in 1062 of 1069 hospital survivors (99.3%). RESULTS At 10 years, freedom from reoperation was 93%. Among 30 patients who required reoperation for late mitral valve dysfunction, the repair failed in 16 (53%) as a result of progressive degenerative disease. Durability of repair was adversely affected by pathologic conditions other than posterior leaflet prolapse, use of chordal shortening, annuloplasty alone, and posterior leaflet resection without annuloplasty. Durability was greatest after quadrangular resection and annuloplasty for posterior leaflet prolapse and was enhanced by the use of intraoperative echocardiography. Death before reoperation was increased in patients having isolated anterior leaflet prolapse or valvular calcification and by use of chordal shortening or annuloplasty alone. CONCLUSIONS Repair durability is greatest in patients with isolated posterior leaflet prolapse who have posterior leaflet resection and annuloplasty. Chordal shortening, annuloplasty alone, and leaflet resection without annuloplasty jeopardize late results.

2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

L. David Hillis, MD, FACC, Chair†; Peter K. Smith, MD, FACC, Vice Chair*†; Jeffrey L. Anderson, MD, FACC, FAHA*‡; John A. Bittl, MD, FACC§; Charles R. Bridges, MD, SCD, FACC, FAHA*†; John G. Byrne, MD, FACC†; Joaquin E. Cigarroa, MD, FACC†; Verdi J. DiSesa, MD, FACC†; Loren F. Hiratzka, MD, FACC, FAHA†; Adolph M. Hutter, Jr, MD, MACC, FAHA†; Michael E. Jessen, MD, FACC*†; Ellen C. Keeley, MD, MS†; Stephen J. Lahey, MD†; Richard A. Lange, MD, FACC, FAHA†§; Martin J. London, MD ; Michael J. Mack, MD, FACC*¶; Manesh R. Patel, MD, FACC†; John D. Puskas, MD, FACC*†; Joseph F. Sabik, MD, FACC*#; Ola Selnes, PhD†; David M. Shahian, MD, FACC, FAHA**; Jeffrey C. Trost, MD, FACC*†; Michael D. Winniford, MD, FACC†

Minimally invasive approach for aortic valve operations

A minimally invasive procedure for performing repair or replacement of the aortic valve has been developed that simplifies the technique and reduces surgical trauma.

2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery

Alice K. Jacobs, MD, FACC, FAHA, Chair Jeffrey L. Anderson, MD, FACC, FAHA, Chair-Elect Nancy Albert, PhD, CCNS, CCRN, FAHA Mark A. Creager, MD, FACC, FAHA Steven M. Ettinger, MD, FACC Robert A. Guyton, MD, FACC Jonathan L. Halperin, MD, FACC, FAHA Judith S. Hochman, MD, FACC, FAHA

Axillary artery: An alternative site of arterial cannulation for patients with extensive aortic and peripheral vascular disease☆☆☆★★★♢

The increasing number of patients with extensive aortic and peripheral vascular atherosclerosis or aneurysms who are undergoing cardiac operations present difficult decisions as to the optimal site of arterial cannulation for cardiopulmonary bypass. Femoral artery cannulation is the most common alternative to ascending aortic cannulation, but severe iliofemoral disease or the danger of atheroemboli caused by retrograde perfusion through an atherosclerotic or aneurysmal descending aorta may make this approach impossible or undesirable. We have used axillary artery cannulation for cardiac operations in 35 patients for indications including severe aortic atherosclerosis (n = 16), extensive aortic aneurysms (n = 11), and aortic dissection (n = 8). The cardiac operations performed were coronary artery bypass grafting (n = 9) aortic valve replacement (n = 1), aortic valve replacement and coronary artery bypass grafting (n = 5), repair of mitral valve periprosthetic leak (n = 1), and resection of ascending and/or aortic arch (n = 19). Deep hypothermia with circulatory arrest was used in 26 patients and retrograde cerebral perfusion in 18. All patients awoke from the operation and no patient had a cerebrovascular accident. One patient required axillary artery thrombectomy and one patient had a mild ipsilateral brachial plexus paresis after the operation. Four patients died in the hospital. We conclude that axillary artery cannulation is a safe and effective means of providing antegrade arterial flow during cardiopulmonary bypass in patients with severe atherosclerotic or aneurysmal disease. This strategy may lower the prevalence of stroke associated with cardiopulmonary bypass in these patients.

Minimally invasive valve operations.

BACKGROUND To reduce the morbidity from valvular heart operations, a right parasternal approach was introduced. We report our initial experience with the procedure. METHODS From January 1996 through July 1996, 115 patients underwent primary isolated valve procedures. One hundred (85%) patients underwent the operation through a right parasternal incision. RESULTS There was one hospital death secondary to a stroke on the fifth postoperative day. Three patients (two with aortic valve operations and one having a mitral valve procedure) required conversion to sternotomy. Mean aortic occlusion time was 71 minutes; mean cardiopulmonary bypass time was 93 minutes. Mean stay in the intensive care unit was 27 hours and mean hospital postoperative stay was 5.7 days. Seventy-seven percent of the patients did not receive blood transfusions. Comparison with median sternotomy demonstrated a reduction in both postoperative length of stay and direct hospital costs. CONCLUSIONS We conclude that this minimally invasive approach is safe for a variety of valve procedures and is effective in reducing surgical trauma and cost.

Long-term effectiveness of operations for ascending aortic dissections

OBJECTIVE To evaluate long-term effectiveness of a strategy for managing the aortic root and distal aorta according to the pathology in ascending aortic dissection. METHODS From 1978 to 1995, 208 patients underwent operations for acute (n = 135) and chronic (n = 73) ascending aortic dissection. Surgical strategies included valve resuspension with supracoronary aortic root repair and ascending aortic graft for normal sinuses and valve (n = 135), composite valve and ascending aortic graft for abnormal sinuses and valve (n = 47), and valve replacement and supracoronary ascending aortic graft for normal sinuses and abnormal valve (n = 26). Resection extended into the arch only if the intimal tear originated in or extended to the aortic arch (n = 31). RESULTS Hospital mortality was 14%. Cardiogenic shock (P =.002) and concomitant coronary artery bypass grafting (P =.001) were associated with increased risk; use of circulatory arrest (P =.0003) decreased risk. Survival was 87%, 68%, and 52% at 30 days, 5 years, and 10 years, respectively. Advanced age, earlier date of operation, composite graft, and arch resection were associated with decreased survival; residual distal dissected aorta was not. Reoperation was required for 5 proximal and 8 distal problems. CONCLUSIONS In both acute and chronic ascending aortic dissections, (1) circulatory arrest is associated with low early mortality; (2) with normal sinuses and valve, supracoronary repair of the dissected aortic root and valve resuspension is effective long term; and (3) residual distal dissected aorta does not decrease late survival and has a low risk of aneurysmal change and reoperation for at least 10 years.

Temporal Onset, Risk Factors, and Outcomes Associated With Stroke After Coronary Artery Bypass Grafting

CONTEXT Stroke is a devastating and potentially preventable complication of coronary artery bypass graft (CABG) surgery. Better understanding of the timing and risk factors for stroke associated with CABG are needed. OBJECTIVES To investigate temporal trends in stroke after CABG and to identify stroke risk factors and association with longitudinal outcomes. DESIGN, SETTING, AND PATIENTS Prospective study conducted from 1982 through 2009 at a single US academic medical center among 45,432 consecutive patients (mean age, 63 [SD, 10] years) undergoing isolated primary or reoperative CABG surgery. Strokes occurring following CABG were recorded prospectively and classified as having occurred intraoperatively or postoperatively. Complications and survival after stroke were assessed in propensity-matched groups. INTERVENTION CABG performed using 4 different operative strategies (off-pump, on-pump with beating heart, on-pump with arrested heart, on-pump with hypothermic circulatory arrest). MAIN OUTCOME MEASURES Hospital complications; late survival. RESULTS Among 45,432 patients undergoing CABG surgery, 705 (1.6% [95% confidence interval {CI}, 1.4%-1.7%]) experienced a stroke. The prevalence of stroke peaked in 1988 at 2.6% (95% CI, 1.9%-3.4%), then declined at 4.69% (95% CI, 4.68%-4.70%) per year (P = .04), despite increasing patient comorbidity. Overall, 279 strokes (40%) occurred intraoperatively and 409 (58%) occurred postoperatively (timing indeterminate in 17 patients). Postoperative stroke peaked at 40 hours, decreasing to 0.055%/d (95% CI, 0.047%-0.065%) by day 6. Risk factors for both intraoperative and postoperative stroke included older age (odds ratio, 8.5 [95% CI, 3.2-22]) and variables representing arteriosclerotic burden. Intraoperative stroke rates were lowest in off-pump CABG (0.14% [95% CI, 0.029%-0.40%]) and on-pump beating-heart CABG (0% [95% CI, 0%-1.6%]), intermediate with on-pump arrested-heart CABG (0.50% [95% CI, 0.41%-0.61%]), and highest with on-pump CABG with hypothermic circulatory arrest (5.3% [95% CI, 2.0%-11%]). Patients with stroke had worse adjusted hospital outcomes, longer intensive care and postoperative stays, and worse downstream survival (mean, 11 [SD, 8.6] years). CONCLUSION Among patients undergoing CABG surgery at a single center over the past 30 years, the occurrence of stroke declined despite an increasing patient risk profile, and more than half of strokes occurred postoperatively rather than intraoperatively.