Randomized Clinical Trial of Comprehensive Geriatric Assessment and Optimization in Vascular Surgery

Abstracts Michael C. Dalsing, MD, SECTION EDITOR Randomized Clinical Trial of Comprehensive Geriatric Assessment and Optimization in Vascular Surgery Partridge JS, Harari D, Martin FC, Peacock JL, Bell R, Mohammed A, et al. Br J Surg 2017; doi:10.1002/bjs.10459. Conclusions: In this study of patients aged 65 years or older undergoing vascular surgery, preoperative comprehensive geriatric assessment and optimization was associated with a shorter length of hospital stay, a lower incidence of complications and the patients were less likely to be discharged to a higher level of dependency. Summary: This is a single-center randomized controlled trial (RCT) in a teaching hospital with a tertiary referral practice. The treatment options were comprehensive geriatric assessment and optimization versus usual care. The patients had to be over 65 years of age and scheduled for elective endovascular or open abdominal aortic aneurysm (AAA) repair or lowerlimb bypass surgery. Randomization was internet-based and carried out on a 1:1 allocation and stratified according to gender and site of surgical procedure. The patients were sent to a standard pre-assessment clinic or a comprehensive geriatric assessment and optimization clinic. The latter was conducted in a geographically separate clinic area at a different hospital site and by different staff to minimize bias. Comprehensive geriatric assessment was guideline based and delivered by a multidisciplinary team (geriatrician, nurse specialist, social worker, occupational therapist) which devised an individual plan with advice regarding the prevention and management of anticipated postoperative complications. The standard control group treatment was a nurse-led preoperative assessment clinic where protocol-driven assessment of anesthetic and medical issues were conducted, the patient was given a grade of “fit” or “unfit” for anesthesia/surgery and no optimization advice provide but they were referred to a physician specialist or the general practitioner if deemed high risk. Postoperative care was delivered to both groups by a surgical team unaware of the patient’s involvement in the study but aware of any individualized care plan as documented in the electronic medical record. The primary outcome was length of hospital stay (LOS). Secondary outcomes were new co-morbid diagnoses, postoperative medical and surgical complications (including delirium), discharge to a higher level of care dependency and readmission to the hospital within 30 days. Statistical analysis of means (continuous data) or frequencies and percentage (categorical data) was standard based on intention to treat. The average stay was determined from historical hospital data and a 25% reduction was considered clinically and financially significant. The analysis was conducted unblinded by a statistician who was not part of the clinical trial team. A total of 209 patients were recruited from November 2012 to February 2014 with 105 assigned to the control and 104 to the intervention arm. LOS was available for 91 control and 85 interventional patients with those lost due to need for emergency operation, failed to undergo intervention, failure to undergo assessment or death prior to surgery (one in each group). The mean LOS in the intervention group was reduced by 40% compared to the control group (ratio of geometric means, 0.60; 95% confidence interval, 0.46-0.79; P < .001), which equated to almost 2 days and was unchanged when baseline difference in history of cerebrovascular disease, falls and smoking were adjusted for statistically. There was a lower incidence of delirium (11% vs 24%; P ¼ .018), cardiac complications (8% vs 27%; P ¼ .001) and bladder/bowel complications (33% vs 55%; P ¼ .003) in the intervention group compared with the control group. Patients in the intervention group were less likely to require discharge to a higher level of dependency (4 of 85 vs 12 of 91; P ¼ .051). The detailed preoperative geriatric assessment identified previously unrecognized disease and statistically so when compared to standard assessment in terms of delirium risk, COPD, cognitive impairment and chronic renal disease. This resulted in statistically more medication changes; referrals for physiotherapy, occupational therapy and social work involvement; referral to memory clinic and longer-term follow-up by the general practitioner and other specialties. Comments: Older patients are at higher risks of postoperative complications and increased dependence on others for care and a comprehensive assessment and plan to optimize their preoperative status is beneficial. The major benefit is likely the recognition of previously unrecognized medical issues which can be addressed pre-, intra-, and postoperatively. This has been demonstrated in those hospitalized

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with medical issues as analyzed in a Cochrane review and metaanalysis (Ellis G, Whitehead MA, O’Neill D, Langhorne P, Robinson D. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev 2011;(7):CD006211). There have also been many recent articles pushing this concept in the surgical arena, this study targets those needing elective vascular surgery. It utility is demonstrated in this article but the real world issue is availability of geriatric specialties and reimbursement for the work done. This is one aspect of care that will need to be captured in any bundled payment modeling.

The Relationship Between Smoking Intensity and Subclinical Cardiovascular Injury: The Multi-Ethnic Study of Atherosclerosis (MESA) Al Rifai M, DeFillippis AP, McEvoy JW, Hall ME, Acien AN, Jones MR, et al. Atherosclerosis 2017;258:119-30. Conclusions: Smoking intensity was associated with early biomarkers of chronic vascular disease, particularly, markers of systemic inflammation of which serum high-sensitivity C-reactive protein (hsCRP) may be the most sensitive. Summary: The Multi-Ethnic Study of Atherosclerosis (MESA) is a prospective cohort investigation aimed at studying the significance of subclinical cardiovascular injury. This study recruited 6814 participants aged 45-84 who identified themselves into 4 ethnic categories (White, African-American, Hispanic/Latino, or Chinese-American) from 6 U.S. field centers (Maryland, Illinois, New York, North Carolina, California, and Minnesota) during 2000 to 2002. They were free of clinical cardiovascular disease (CVD) at enrollment. This study includes self-reported current cigarette smokers at baseline who smoked at least 1 cigarette/day. Those missing information on cigarette exposure were excluded (66) as were the 7 reporting > 100 cigarettes per day to minimize the influence of extremes. Tobacco exposure was estimated by self-reporting on a questionnaire and separated the patients as never versus current or former smoker; duration of smoking in years, the average number of cigarettes/day and packs/day and pack-years. In a subset of 3965 patients, smoking was also evaluated by urinary cotinine using immunoassay collected mid-to-late morning with instruction to not smoke the morning of urine collection. Smoking intensity was defined separately by number of cigarettes/day and cotinine levels, which have been shown to correlate with self-reported cigarette count. For continuous variables, the number of cigarettes/day and natural logarithm (in)-transformed cotinine were used. In categorical analyses, number of cigarettes/day was 1-9, 10-20 and > 20 while the urinary cotinine was divided into tertiles. Measurement of biomarkers of subclinical cardiovascular injury included those associated with inflammation (serum high-sensitivity C-reactive protein (hsCRP), serum interleukin-2 soluble receptor alpha (IL-2 sRa), serum interleukin-6 (IL-6), tumor necrosis factor a soluble receptor (sTNF-R1), thrombosis (serum fibrinogen, d-dimer, plasma homocysteine), endothelial injury (urine albumin, serum creatinine, urinary albumin:creatinine ratio and estimated glomerular filtration rate (eGFR)), vascular function (aortic distensibility as assessed by gradient echo phase-contrast MRI imaging with electrocardiographic gating while carotid intima-media thickness (IMT) and carotid distensibility were obtained from duplex imaging), and brachial flow-mediated dilation (FMD) as determined by duplex imaging). Subclinical myocardial injury was determined by serum cardiac troponin T (TnT). Demographic variables were self-reported and other covariates were measured including body mass index (BMI), heart rate (HR), blood pressure, serum glucose after a 24 hour fast (diabetes defined as > 126 mg/dl or on medications), intentional exercise was evaluated by the MESA Typical Week Physical Activity Survey (TWPAS). Biomarkers were modeled as absolute and percent change using multivariable-adjusted linear regression models adjusted for cardiovascular risk factors and smoking duration. The final sample size consisted of 843 current smokers who smoked between 1 and 72 cigarettes/day and of which 450 had measurements of baseline urinary cotinine. The mean age was 58 (6 9) years, 54% were male and 34% were white, 5% Chinese-American, 39% African-American and 22% Hispanic. The mean number of cigarettes/day was 13 (6 10) and the median duration of smoking was 39 (6 15) years. Those smoking >20 cigarettes/day were more likely to be male, white, physically inactive,