Adhesive-enhanced sternal closure to improve postoperative functional recovery: a pilot, randomized controlled trial.

BACKGROUND: We previously established a proof-of-concept in a human cadaveric model where conventional wire cerclage was augmented with a novel biocompatible bone adhesive that increased mechanical strength and early bone stability. We report the results of a single-center, pilot, randomized clinical trial of the effects of adhesive-enhanced closure of the sternum on functional postoperative recovery. METHODS: In 55 patients undergoing primary sternotomy, 26 patients underwent conventional wire closure and were compared with 29 patients who underwent adhesive-enhanced closure, which consisted of Kryptonite biocompatible adhesive (Doctors Research Group Inc, Southbury, CT) applied to each sternal edge in addition to conventional 7-wire cerclage. Patients were monitored postoperatively at 72 hours, weekly for 12 weeks, and then after 12 months for incisional pain, analgesic use, and maximal inspiratory capacity measured by spirometry. Standardized assessment tools measured postoperative physical disability and health-related quality of life. RESULTS: No adverse events or sternal complications from the adhesive were observed early or after 12 months. Incisional pain and narcotic analgesic use were reduced in adhesive-enhanced closure patients. Inspiratory capacity was significantly improved, postoperative health-related quality of life scores normalized more rapidly, and physical disability scores were reduced. Computed tomography imaging was suggestive of sternal healing. CONCLUSIONS: Adhesive-enhanced closure is a safe and simple addition to conventional wire closure, with demonstrated benefits on functional recovery, respiratory capacity, incisional pain, and analgesic requirements. A large, multicenter, randomized controlled trial to examine the potential of the adhesive to prevent major sternal complications in higher risk patients is warranted.

Kryptonite bone cement prevents pathologic sternal displacement.

BACKGROUND: Wire cerclage closure of sternotomy is the standard of care despite evidence of pathologic sternal displacement (> 2 mm) during physiologic distracting forces (coughing). Postoperative functional recovery, respiration, pain, sternal dehiscence, and infection are influenced by early bone stability. This translational research report provides proof-of-concept (part A) and first-in-man clinical data (part B) with use of a triglyceride-based porous adhesive to rapidly enhance the stability of conventional sternal closure. METHODS: In part A, fresh human cadaver blocks were subjected to midline sternotomy and either conventional wire closure or modified adhesive closure. After 24 hours at 37 degrees C, using a biomechanical test apparatus, a step-wise increase in lateral distracting force simulated physiologic stress. Sternal displacement was measured by microdisplacement sensors. In part B, a selected clinical case series was performed and sternal perfusion assessed by serial single photon emission computed tomography imaging. RESULTS: Wire closure resulted in measurable bony displacement with increasing load. Pathologic displacement (> or = 2 mm) was observed in all regional segments at loads 400 newton (N) or greater. In contrast, adhesive closure completely eliminated pathologic displacement at forces 600 N or less (p < 0.001). In patients, adhesive closure was not associated with adverse events such as adhesive migration, embolization, or infection. There was excellent qualitative correlation between cadaver and clinical computed tomographic images. Sternal perfusion was not compromised by adhesive closure. CONCLUSIONS: This first-in-man series provides proof-of-concept indicating that a novel biologic bone adhesive is capable of rapid sternal fixation and complete elimination of pathologic sternal displacement under physiologic loading conditions. A randomized clinical trial is warranted to further define the potential risks and benefits of this innovative technique.

Risk-taking attitudes and their association with process and outcomes of cardiac care: a cohort study.

BACKGROUND: Prior research reveals that processes and outcomes of cardiac care differ across sociodemographic strata. One potential contributing factor to such differences is the personality traits of individuals within these strata. We examined the association between risk-taking attitudes and cardiac patients' clinical and demographic characteristics, the likelihood of undergoing invasive cardiac procedures and survival. METHODS: We studied a large inception cohort of patients who underwent cardiac catheterization between July 1998 and December 2001. Detailed clinical and demographic data were collected at time of cardiac catheterization and through a mailed survey one year post-catheterization. The survey included three general risk attitude items from the Jackson Personality Inventory. Patients' (n = 6294) attitudes toward risk were categorized as risk-prone versus non-risk-prone and were assessed for associations with baseline clinical and demographic characteristics, treatment received (i.e., medical therapy, coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI)), and survival (to December 2005). RESULTS: 2827 patients (45%) were categorized as risk-prone. Having risk-prone attitudes was associated with younger age (p < .001), male sex (p < .001), current smoking (p < .001) and higher household income (p < .001). Risk-prone patients were more likely to have CABG surgery in unadjusted (Odds Ratio [OR] = 1.21; 95% CI 1.08-1.36) and adjusted (OR = 1.18; 95% CI 1.02-1.36) models, but were no more likely to have PCI or any revascularization. Having risk-prone attitudes was associated with better survival in an unadjusted survival analysis (Hazard Ratio [HR] = 0.78 (95% CI 0.66-0.93), but not in a risk-adjusted analysis (HR = 0.92, 95% CI 0.77-1.10). CONCLUSION: These exploratory findings suggest that patient attitudes toward risk taking may contribute to some of the documented differences in use of invasive cardiac procedures. An awareness of these associations could help healthcare providers as they counsel patients regarding cardiac care decisions.

Using the cardiac depression scale in men recovering from coronary artery bypass surgery.

AIMS: To examine the utility and validate the use of the Cardiac Depression Scale in patients who had first-time coronary artery bypass graft surgery. BACKGROUND: The Beck Depression Inventory, though frequently used, may not be sufficiently sensitive for use in cardiac patients. The Cardiac Depression Scale has been shown to identify the range of depression in medical cardiac patients. DESIGN: Survey. METHODS: The Beck Depression Inventory and Cardiac Depression Scale were administered to 120 men at hospital discharge, as well as six, 12 and 36 weeks postoperatively. Cronbach's alpha scores were calculated for the measures at each point. Changes in scores over time were analysed using repeated measures analysis of variance. Associations between the measures scores were calculated using Pearson product-moment correlations. Agreement between the measures' dichotomised scores (depression/no depression) was examined using Cohen's Kappa statistic. RESULTS: Internal consistency was similar for the Beck Depression Inventory (0.793-0.904) and Cardiac Depression Scale (0.859-0.910). Depression scores decreased over time with the Beck Depression Inventory [F(2.50, 175.29) = 22.27, p < 0.001] and Cardiac Depression Scale [F(2.68, 190.37) = 13.18, p < 0.001]. The measures had similar power [Cohen's f = 0.65 (Beck Depression Inventory) and 0.43 (Cardiac Depression Scale)] to reveal changes over time. The continuous scores were highly correlated at each point [0.737 (p < 0.001)-0.819 (p < 0.001)]. However, when dichotomised scores were compared, the chance corrected level of agreement was less impressive [0.198 (p = 0.014)-0.381 (p < 0.001)]. CONCLUSIONS: The Cardiac Depression Scale may have utility for use with surgical cardiac patients. However, continued examination of this measure of depression is warranted. RELEVANCE TO CLINICAL PRACTICE: Given the prevalence of depression and its negative impact on coronary artery disease, it is important to identify even mild depression in cardiac patients. Using a measure of depression specifically for cardiac patients, rather than a generic measure, may best accomplish this goal.

The influence of coronary artery bypass graft harvest site on women's pain, functional status, and health services utilization throughout the first post-operative year: a longitudinal study.

BACKGROUND: Coronary artery bypass graft surgery is a commonly performed procedure aimed at managing coronary symptoms and prolonging life. Researchers have typically examined morbidity and mortality outcomes of predominantly male populations. Less is known about the influence of graft harvest site on recovery outcomes such as surgery-related pain, functional status, and health services utilization, especially in women. OBJECTIVES: We aimed to examine the relationships between coronary artery bypass graft harvest site (saphenous vein, internal mammary arteries or both) and surgery-related pain, functional status, health services use at 6 weeks, 12 weeks and 12 months post-operatively. DESIGN: Longitudinal extension survey following participation in a clinical trial. SETTING: Ten Canadian centres. PARTICIPANTS: Women (222) who participated in the Women's Recovery from Sternotomy Trial, underwent coronary artery bypass graft surgery with or without heart valve surgery, and completed the 12-month follow-up interview. METHODS: Harvest site data were collected by health record audit at the time of hospital discharge. Surgery-related pain, functional status, pain medication use and health services use data were collected by standardized interview over the telephone at 6 weeks, 12 weeks and 12 months post-operatively. Surgery-related pain and functional status were measured using the short Health Assessment Questionnaire. Health services use was measured by questionnaire and recorded as reported by the participants. RESULTS: Surgery-related pain, functional disability and health services use decreased over the first post-operative year. Participants who had left internal mammary artery grafts were more likely to have surgery-related pain (Adjusted Odds Ratio (AOR)=2.79; 95% Confidence Interval (CI) 1.40-5.70) and use pain medication (AOR=4.32; 95% CI 1.44-12.91) than those who had saphenous vein grafts. Conversely, participants who had saphenous vein grafts reported significantly more functional disability (AOR=2.63; 95% CI 1.16-6.25) over 12 months post-surgery than those with left internal mammary artery grafts. Participants who had pain over the course of follow-up were more likely to visit their family physician or nurse practitioner (p=0.017), visit another type of provider (i.e., naturopath or chiropractor, p=0.004), or use any health care service (p<0.0001). CONCLUSIONS: Following coronary artery bypass graft surgery, women who had left internal mammary artery grafts reported more pain and health services use while those who had saphenous vein grafts were more functionally disabled. Women who reported surgery-related pain also used more health services.

Elevated body mass index and use of coronary revascularization after cardiac catheterization.

BACKGROUND: Obese persons suffer discrimination in society that may extend to health care use. We investigated whether overweight and obese patients are as likely to undergo coronary reperfusion or revascularization as patients of normal body weight. METHODS: Detailed clinical data were collected for an inception cohort of patients from Alberta, Canada, who underwent cardiac catheterization between April 2001 and March 2004. The patients' likelihood of receiving any revascularization, percutaneous coronary intervention, or coronary artery bypass graft surgery in the year after cardiac catheterization was examined on the basis of body mass index (BMI) grouping. Use of revascularization was examined separately for patients with high- and low-risk coronary disease. RESULTS: Of 27,460 patients who had BMI data recorded, 24% were of normal weight, 42% were overweight, and 35% were obese. Although overweight and obese patients were more likely to have percutaneous coronary intervention (adjusted hazard ratio [HR]=1.07, 95% confidence interval [CI], 1.01-1.12 and HR 1.08, 95% CI, 1.01-1.13, respectively), obese patients (BMI>30) were less likely to receive coronary artery bypass graft surgery (adjusted HR=0.93, 95% CI, 0.87-1.00). This was primarily because of less use of coronary artery bypass graft surgery for the most obese patients (obesity class III) with low-risk coronary anatomy (adjusted HR=0.61, 95% CI, 0.36-1.02). CONCLUSION: The pattern of use of revascularization procedures after cardiac catheterization differs somewhat across BMI subgroups. These differences might be clinically appropriate, but they warrant further exploration.

A descriptive examination of the impact of sternal scar formation in women.

Formation of abnormal scars is a significant source of morbidity following sternotomy. We undertook a descriptive exploratory mixed methods study of women (n=13) who participated in the Women's Recovery from Sternotomy Trial to examine the: (1) qualitative impact of the cosmetic result of sternotomy, and (2) quantitative association between subjective satisfaction and objective ratings of the sternal scar. Conventional content analysis was used to analyze the data generated from semi-structured interviews. Though the participants appreciated that having the scar was a cost of reaping the benefits of having cardiac surgery, they were not well prepared to learn to live with the scar. The scar was a poignant personal reminder that they had a health problem and underwent a distressing surgery, and it often rendered them feeling less attractive. The scar also had a public presence that they perceived rendered judgment from others. There was little association between the participants' subjective satisfaction (rated on a likert-type scale) and the objective scar rating using the Beausang Clinical Scar Assessment (r=0.348, p=0.294). The subjective perception of the sternal scar is of importance to women. Thus, appropriate preparation, post-operative counseling and support regarding the sternal scar are warranted.

Examining oral intake temperature in cardiac surgery patients.

The effect of restricting the temperature of cardiac surgery patients' oral intake to room temperature or warmer, over the first 3 postoperative days, on gastrointestinal (GI) symptoms was examined. In all, 57 patients were randomly assigned to receive the intervention or usual care. GI symptoms were measured daily over the first 5 postoperative days. Following hospital discharge, GI symptoms and return to function data were collected over 4 postoperative weeks. On Postoperative Day 1, 41% of patients reported having GI symptoms, and they were significantly associated with higher cross-clamp time. Symptoms dissipated over time. There were no differences between the study groups in GI symptoms or return to function. Nearly 70% of patients who withdrew from the study were randomized to the intervention group. Difficulty associated with adhering to the study protocol was their primary reason for withdrawing. Given these findings, a large-scale clinical trial may not be warranted.

Peer support. An under-recognized resource in cardiac recovery.

BACKGROUND: Cardiovascular disease remains the leading cause of mortality and premature death in western societies. Thus, rates of interventions such as coronary artery bypass surgery are continuing to grow. Health care reform and initiatives to reduce health care expenditures have resulted in early patient discharge from hospital following cardiac surgery. With subsequent cutbacks in nursing support and community-based care, patients are leaving hospital less prepared and supported to deal with the changes that occur during the first weeks of recovery. AIMS: To examine the theoretical assumptions that support the contention that peer support is an under-utilized resource for patients who are recovering from cardiac surgery and the challenges to evaluating peer support interventions. METHODS: A review of current literature, which focuses on cardiac surgery recovery, transitions, social support, and peer support interventions. RESULTS: Peer support (lay assistance from individuals who possess experiential knowledge and similar characteristics), a form of social support, is a viable and potentially sustainable mechanism to put in place during transitional life events such as recovery from cardiac surgery. CONCLUSIONS: Further investigation is needed of peer support interventions for cardiac surgery patients. Specifically, investigations of the influence of peer support interventions on recovery and health outcomes are necessary in this patient population. Yet, challenges exist to undertaking well-designed investigations of social interventions such as peer support.

Sex differences in outcomes after cardiac catheterization: effect modification by treatment strategy and time.

CONTEXT: Studies comparing outcomes of cardiac care in women vs men yield various results, with some suggesting worse outcomes for women and others suggesting equivalent outcomes. OBJECTIVE: To determine whether extent of coronary disease, treatment strategy, and follow-up time influence the risk of death in women vs men among patients who have had cardiac catheterization. DESIGN, SETTING, AND PATIENTS: We studied a large inception cohort by using detailed clinical data from a registry of 37 401 patients undergoing cardiac catheterization in Alberta, Canada, from 1995-2000, with follow-up through December 31, 2001. MAIN OUTCOME MEASURES: The risk of death for women vs men was assessed for all patients combined and then in analyses stratified by degree of coronary anatomic risk and by treatment strategy (no revascularization, percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG] surgery). The latter analysis included a graphic assessment of the changing relative risk over time for women vs men. RESULTS: Women had higher 1-year mortality than men did (5.6% vs 4.6%; P<.001). However, stratified analyses demonstrated that sex differences in risk occurred only early after catheterization and were most apparent among patients undergoing revascularization. The early risk-adjusted relative risks for women vs men were elevated at 3.49 (95% confidence interval [CI], 1.95-6.24) for CABG surgery and 2.38 (95% CI, 1.48-3.83) for PCI on day 1 after catheterization, with a subsequent decrease in relative risk over time to equivalence in risk between sexes before 1 year. CONCLUSIONS: Sex-based differences in death rates after cardiac catheterization are time- and treatment-specific. This finding may at least partially explain the discrepancies in results from earlier studies on sex differences in outcomes of cardiac care.