James B. McClurken

ACCF/AHA/SCAI 2013 Update of the Clinical Competence Statement on Coronary Artery Interventional Procedures A Report of the American College of Cardiology Foundation/American Heart Association/American College of Physicians Task Force on Clinical Competence and Training (Writing Committee to Revise the 2007 Clinical Competence Statement on Cardiac Interventional Procedures)

Granting clinical staff privileges to physicians is the primary mechanism institutions use to uphold quality care. The Joint Commission requires that medical staff privileges be based on professional criteria specified in medical staff bylaws. Physicians themselves are charged with defining the

Standard criteria for an acceptable donor heart are restricting heart transplantation

BACKGROUND The lack of satisfactory donor organs limits heart transplantation. The purpose of this study was to determine whether the criteria for suitability of donors may be safely expanded. METHODS One hundred ninety-six heart transplantations were performed on 192 patients at our institution from January 1992 to 1995 and were divided into two groups. Group A donors (n = 113) conformed to the standard criteria. Group B donors (n = 83) deviated by at least one factor and consisted of the following: 16 hearts from donors greater than 50 years of age, 33 with myocardial dysfunction (echocardiographic ejection fraction = 0.35 +/- 0.10, dopamine level exceeding 20 micrograms.kg-1.min-1, and resuscitation with triiodothyronine), 33 undersized donors with donor to recipient weight ratios of 0.45 +/- 0.04, 48 with extended ischemic times of 297.4 +/- 53.6 minutes, 25 with positive blood cultures, 16 with positive hepatitis C antibody titers, and 7 with conduction abnormalities (Wolff-Parkinson-White syndrome, prolonged QT interval, bifascicular block). RESULTS Thirty-day mortality was 6.2% (7/113) in group A and 6.0% (5/83) in group B. Mortality in group A was attributed to 3 patients with myocardial dysfunction, 2 with infection, 1 with acute rejection, and 1 with pancreatitis; group B had 2 with myocardial dysfunction, 1 with infection, 1 with aspiration, and 1 with bowel infarction. At 12 months, survival and hemodynamic indices were similar between the groups. Of the 16 recipients with hepatitis C-positive hearts, 5 have become hepatitis C positive with mild hepatitis (follow up, 6 to 30 months). CONCLUSIONS Expanding the criteria for suitability of donor hearts dramatically increases the number of transplantations without compromising recipient outcome.

Management of the sensitized cardiac recipient : the use of plasmapheresis and intravenous immunoglobulin

Abstract:  Previously, we reported that the combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg) allow sensitized patients to undergo orthotopic heart transplantation (OHT), even across a positive crossmatch. In the current study, the effect of that combination, PP +IVIg, on survival of a larger group of such recipients is investigated. The latter group (I) consisted of 35 sensitized patients who received PP + IVIG together with standard immunosuppressive drugs. Rejection was seen in 11 patients, findings strongly suggestive of a vascular (humoral) being identified in five of those cases. Four deaths occurred, two of them in the immediate post‐operative period, one after almost six months, and one after almost two yr post‐OHT. Follow‐up range 4.5 months to 7.8 yr post‐OHT (average = 1.1 yr). Patient survival was analyzed after generation of a Kaplan–Meier plot. Comparison with a control OHT group (II) given standard immunosuppressive drugs only (N = 276) showed enhanced survival of group I (p = 0.0414 by log‐rank test). We conclude that the combination of PP and IVIG (i) is associated with declines in T‐ and B‐percent‐reactive antibody and in crossmatch positivity, and (ii) is very useful in the management of the sensitized cardiac patient undergoing OHT, often allowing a successful outcome to transplantation in the face of a positive crossmatch.

Gait Speed and Operative Mortality in Older Adults Following Cardiac Surgery

IMPORTANCE Prediction of operative risk is a critical step in decision making for cardiac surgery. Existing risk models may be improved by integrating a measure of frailty, such as 5-m gait speed, to better capture the heterogeneity of the older adult population. OBJECTIVE To determine the association of 5-m gait speed with operative mortality and morbidity in older adults undergoing cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS A prospective cohort study was conducted from July 1, 2011, to March 31, 2014, at 109 centers participating in the Society of Thoracic Surgeons Adult Cardiac Surgery Database. The 5-m gait speed test was performed in 15 171 patients aged 60 years or older undergoing coronary artery bypass graft, aortic valve surgery, mitral valve surgery, or combined procedures. MAIN OUTCOMES AND MEASURES All-cause mortality during the first 30 days after surgery; secondarily, a composite outcome of mortality or major morbidity during the index hospitalization. RESULTS Among the cohort of 15 171 patients undergoing cardiac surgery, the median age was 71 years and 4622 were female (30.5%). Compared with patients in the fastest gait speed tertile (>1.00 m/s), operative mortality was increased for those in the middle tertile (0.83-1.00 m/s; odds ratio [OR], 1.77; 95% CI, 1.34-2.34) and slowest tertile (<0.83 m/s; OR, 3.16; 95% CI, 2.31-4.33). After adjusting for the Society of Thoracic Surgeons predicted risk of mortality and the surgical procedure, gait speed remained independently predictive of operative mortality (OR, 1.11 per 0.1-m/s decrease in gait speed; 95% CI, 1.07-1.16). Gait speed was also predictive of the composite outcome of mortality or major morbidity (OR, 1.03 per 0.1-m/s decrease in gait speed; 95% CI, 1.00-1.05). Addition of gait speed to the Society of Thoracic Surgeons predicted risk resulted in a C statistic change of 0.005 and integrated discrimination improvement of 0.003. CONCLUSIONS AND RELEVANCE Gait speed is an independent predictor of adverse outcomes after cardiac surgery, with each 0.1-m/s decrease conferring an 11% relative increase in mortality. Gait speed can be used to refine estimates of operative risk, to support decision-making and, since incremental value is modest when used as a sole criterion for frailty, to screen older adults who could benefit from further assessment.

Knowledge Gaps in Cardiovascular Care of the Older Adult Population

The incidence and prevalence of most cardiovascular disorders increase with age, and cardiovascular disease is the leading cause of death and major disability in adults ≥75 years of age; however, despite the large impact of cardiovascular disease on quality of life, morbidity, and mortality in older adults, patients aged ≥75 years have been markedly underrepresented in most major cardiovascular trials, and virtually all trials have excluded older patients with complex comorbidities, significant physical or cognitive disabilities, frailty, or residence in a nursing home or assisted living facility. As a result, current guidelines are unable to provide evidence-based recommendations for diagnosis and treatment of older patients typical of those encountered in routine clinical practice. The objectives of this scientific statement are to summarize current guideline recommendations as they apply to older adults, identify critical gaps in knowledge that preclude informed evidence-based decision making, and recommend future research to close existing knowledge gaps. To achieve these objectives, we conducted a detailed review of current American College of Cardiology/American Heart Association and American Stroke Association guidelines to identify content and recommendations that explicitly targeted older patients. We found that there is a pervasive lack of evidence to guide clinical decision making in older patients with cardiovascular disease, as well as a paucity of data on the impact of diagnostic and therapeutic interventions on key outcomes that are particularly important to older patients, such as quality of life, physical function, and maintenance of independence. Accordingly, there is a critical need for a multitude of large population-based studies and clinical trials that include a broad spectrum of older patients representative of those seen in clinical practice and that incorporate relevant outcomes important to older patients in the study design. The results of these studies will provide the foundation for future evidence-based guidelines applicable to older patients, thereby enhancing patient-centered evidence-based care of older people with cardiovascular disease in the United States and around the world.

Outcomes after emergency department thoracotomy for penetrating cardiac injuries: a new perspective.

Previous reports have described penetrating cardiac injuries as the anatomic injury with the greatest opportunity for emergency department thoracotomy (EDT) survival. We hypothesize that actual survival rates are lower than that initially reported. A retrospective review of our EDT experience was performed. Data collected included injury mechanism and location, presence of measurable ED vital signs, initial ED cardiac rhythm, GCS, method of transportation, and survival. Logistic regression analysis identified predictors of survival. Ninety-four of 237 patients presented penetrating cardiac injuries after EDT. Eighty-nine patients (95%) were males. Measurable ED vital signs were present in 15 patients (16%). Cardiac injuries were caused by GSW in 82 patients (87%) and SW in 12 patients (13%). Fifteen patients (16%) survived EDT and were taken to the operating room, while eight patients (8%) survived their entire hospitalization. All survivors were neurologically intact. Survival rates were 5% for GSW and 33% for SW. Mechanism of injury (SW), prehospital transportation by police, higher GCS, sinus tachycardia, and measurable ED vital signs were associated with improved survival. In urban trauma centers where firearm injuries are much more common than stabbings, the presence of a penetrating cardiac injury may no longer be considered a predictor of survival after EDT.

Defining the role of aprotinin in heart transplantation

BACKGROUND Heart transplantation is associated with excessive bleeding due to recipient coagulopathy, frequent need for reoperative median sternotomy, and prolonged cardiopulmonary bypass. Aprotinin reduces bleeding and the inflammatory response after cardiopulmonary bypass, but there are concerns about efficacy and side effects. METHODS To determine the role of aprotinin in primary and reoperative sternotomy heart transplantation, we studied 70 patients undergoing heart transplantation between August 1993 and October 1994. Thirty-eight undergoing primary sternotomy for heart transplantation and receiving no aprotinin were randomized to group A (n = 20); patients in group B (n = 18) received the full recommended dose. Similarly, 32 patients undergoing reoperative heart transplantation were randomized to group C (n = 16), receiving no aprotinin, and to group D (n = 16), receiving aprotinin at the full recommended dose. All patients received the same immunosuppression regimen. Similarities in the groups included recipient age, weight, preoperative hemodynamic indices, creatinine, creatinine clearance, platelet count, hemoglobin, percentage receiving warfarin, prothrombin time, partial thromboplastin time, cardiopulmonary bypass time, and creatinine level at 48 hours. RESULTS There were no significant differences postoperatively between groups A and B. Differences (p < 0.05) 24 hours postoperatively between groups C and D, respectively, included: total blood product requirement (5.9 +/- 3.8 versus 3.6 +/- 2.0 U), total fluid balance (+752 +/- 300 versus -250 +/- 185 mL), chest tube drainage (894 +/- 120 versus 526 +/- 95 mL), alveolar-arterial O2 difference (120.4 +/- 45.9 versus 95.5 +/- 33.5), and pulmonary artery mean pressures (28.2 +/- 4.6 versus 21.1 +/- 3.5 mm Hg). CONCLUSIONS Aprotinin decreases bleeding after reoperative heart transplantation without renal dysfunction. Decreased inflammation is manifested as reduced fluid requirement and improved pulmonary and right heart function, which benefit patients during the posttransplantation period. Aprotinin at recommended doses is effective and safe for patients undergoing reoperative heart transplantation.

Cardiac transplantation across a positive prospective lymphocyte cross-match in sensitized recipients.

Abstract: Background: Although there is an increasing body of evidence for a deleterious effect of mismatched donor HLA antigens on the outcome of human cardiac transplantation, the role of anti‐HLA lymphocytotoxic antibodies remains controversial. Thus, their appearance after cardiac transplantation has been associated with poor outcome by some groups; whereas others have reported them to be of no clinical significance. Furthermore, their presence prior to cardiac transplantation has also been the subject of similarly conflicting reports. The deleterious effect of such pre‐existing antibodies has been predicted by a positive lymphocyte cross‐match (LCM), which, for most patients awaiting renal transplantation and in many requiring a cardiac allograft, leads to cancellation of the operation. The reason for undertaking the current study was to test the hypothesis that the constraints which a positive LCM result impose in preventing renal transplantation may not apply to orthotopic heart transplantation (OHT).

Pre-transplant obesity in heart transplantation: Are there predictors of worse outcomes?

Objective. Morbid obesity is increasingly observed in patients being evaluated for heart transplantation and represents a relative contraindication. We sought to evaluate the influence of pre-transplant obesity on morbidity and mortality after heart transplantation. Design. We retrospectively reviewed 90 consecutive patients with preoperative obesity (BMI ≥ 30) and 90 age matched patients with normal weight (BMI 19 – 26) who underwent heart transplantation at our institution between January 1997 and December 2005. Results. Morbidly obese patients experienced higher rates of pre-transplant diabetes (29% vs 15%, p < 0.05) and prolonged waiting time before transplantation (191.4±136.1 vs 117.4±143.2 days, p < 0.001). There were no significant differences in post-operative complications including rejection and major and minor infections. There was no difference in actuarial survival between the obese and control groups after a mean follow-up of 4.26±2.95 years (p = 0.513, log-rank statistic 0.452). Causes of death did not differ. Cox proportional hazard analysis revealed increased association of peripheral vascular disease (HR 31.718, p = 0.001), and pre operative inotropic support (HR 33.725, p = 0.013) with increased mortality in the obese group. Conclusions. This study suggests morbid obesity does not affect survival or rates of infection and rejection after heart transplantation.

Knowledge Gaps in Cardiovascular Care of Older Adults: A Scientific Statement from the American Heart Association, American College of Cardiology, and American Geriatrics Society: Executive Summary

The incidence and prevalence of most cardiovascular disorders increase with age, and cardiovascular disease (CVD) is the leading cause of death and major disability in adults aged 75 and older. Despite the effect of CVD on quality of life, morbidity, and mortality in older adults, individuals aged 75 and older have been markedly underrepresented in most major cardiovascular trials, and virtually all trials have excluded older adults with complex comorbidities, significant physical or cognitive disabilities, frailty, or residence in nursing homes and assisted living facilities. As a result, current guidelines are unable to provide evidence‐based recommendations for diagnosis and treatment of older adults typical of those encountered in routine clinical practice. The objectives of this scientific statement are to summarize current guideline recommendations as they apply to older adults, identify critical gaps in knowledge that preclude informed evidence‐based decision‐making, and recommend future research to close existing knowledge gaps. To achieve these objectives, a detailed review was conducted of current American College of Cardiology/American Heart Association (ACC/AHA) and American Stroke Association (ASA) guidelines to identify content and recommendations that explicitly targeted older adults. A pervasive lack of evidence to guide clinical decision‐making in older adults with CVD was found, as well as a paucity of data on the effect of diagnostic and therapeutic interventions on outcomes that are particularly important to older adults, such as quality of life, physical function, and maintenance of independence. Accordingly, there is a critical need for a multitude of large population‐based studies and clinical trials that include a broad spectrum of older adults representative of those seen in clinical practice and that incorporate relevant outcomes important to older adults in the study design. The results of these studies will provide the foundation for future evidence‐based guidelines applicable to older adults and enhance person‐centered care of older individuals with CVD in the United States and around the world.