Shipra Arya

Frailty increases the risk of 30-day mortality, morbidity, and failure to rescue after elective abdominal aortic aneurysm repair independent of age and comorbidities

BACKGROUND Frailty, defined as a biologic syndrome of decreased reserve and resistance to stressors, has been linked to adverse outcomes after surgery. We evaluated the effect of frailty on 30-day mortality, morbidity, and failure to rescue (FTR) in patients undergoing elective abdominal aortic aneurysm (AAA) repair. METHODS Patients undergoing elective endovascular AAA repair (EVAR) or open AAA repair (OAR) were identified in the National Surgical Quality Improvement Program database for the years 2005 to 2012. Frailty was assessed using the modified frailty index (mFI) derived from the Canadian Study of Health and Aging (CSHA). The primary outcome was 30-day mortality, and secondary outcomes included 30-day morbidity and FTR. The effect of frailty on outcomes was assessed by multivariate regression analysis, adjusted for age, American Society of Anesthesiology (ASA) class, and significant comorbidities. RESULTS Of 23,207 patients, 339 (1.5% overall; 1.0% EVAR and 3.0% OAR) died ≤30 days of repair. One or more complications occurred in 2567 patients (11.2% overall; 7.8% EVAR and 22.1% OAR). Odds ratios (ORs) for mortality adjusted for age, ASA class, and other comorbidities in the group with the highest frailty score were 1.9 (95% confidence interval [CI], 1.2-3.0) after EVAR and 2.3 (95% CI, 1.4-3.7) after OAR. Similarly, compared with the least frail, the most frail patients were significantly more likely to experience severe (Clavien-Dindo class IV) complications after EVAR (OR, 1.7; 95% CI, 1.3-2.1) and OAR (OR, 1.8; 95%, CI, 1.5-2.1). There was also a higher FTR rate among frail patients, with 1.7-fold higher risk odds of mortality (95% CI, 1.2-2.5) in the highest tertile of frailty compared with the lowest when postoperative complications occurred. CONCLUSIONS Higher mFI, independent of other risk factors, is associated with higher mortality and morbidity in patients undergoing elective EVAR and OAR. The mortality in frail patients is further driven by FTR from postoperative complications. Preoperative recognition of frailty may serve as a useful adjunct for risk assessment.

Association of a frailty screening initiative with postoperative survival at 30, 180, and 365 days

Importance As the US population ages, the number of operations performed on elderly patients will likely increase. Frailty predicts postoperative mortality and morbidity more than age alone, thus presenting opportunities to identify the highest-risk surgical patients and improve their outcomes. Objective To examine the effect of the Frailty Screening Initiative (FSI) on mortality and complications by comparing the surgical outcomes of a cohort of surgical patients treated before and after implementation of the FSI. Design, Setting, and Participants This single-site, facility-wide, prospective cohort quality improvement project studied all 9153 patients from a level 1b Veterans Affairs medical center who presented for major, elective, noncardiac surgery from October 1, 2007, to July 1, 2014. Interventions Assessment of preoperative frailty in all patients scheduled for elective surgery began in July 2011. Frailty was assessed with the Risk Analysis Index (RAI), and the records of all frail patients (RAI score, ≥21) were flagged for administrative review by the chief of surgery (or designee) before the scheduled operation. On the basis of this review, clinicians from surgery, anesthesia, critical care, and palliative care were notified of the patient’s frailty and associated surgical risks; if indicated, perioperative plans were modified based on team input. Main Outcomes and Measures Postoperative mortality at 30, 180, and 365 days. Results From October 1, 2007, to July 1, 2014, a total of 9153 patients underwent surgery (mean [SD] age, 60.3 [13.5] years; female, 653 [7.1%]; and white, 7096 [79.8%]). Overall 30-day mortality decreased from 1.6% (84 of 5275 patients) to 0.7% (26 of 3878 patients, P < .001) after FSI implementation. Improvement was greatest among frail patients (12.2% [24 of 197 patients] to 3.8% [16 of 424 patients], P < .001), although mortality rates also decreased among the robust patients (1.2% [60 of 5078 patients] to 0.3% [10 of 3454 patients], P < .001). The magnitude of improvement among frail patients increased at 180 (23.9% [47 of 197 patients] to 7.7% [30 of 389 patients], P < .001) and 365 days (34.5% [68 of 197 patients] to 11.7% [36 of 309 patients], P < .001). Multivariable models revealed improved survival after FSI implementation, controlling for age, frailty, and predicted mortality (adjusted odds ratio for 180-day survival, 2.87; 95% CI, 1.98-4.16). Conclusions and Relevance Implementation of the FSI was associated with reduced mortality, suggesting the feasibility of widespread screening of patients preoperatively to identify frailty and the efficacy of system-level initiatives aimed at improving their surgical outcomes. Additional investigation is required to establish a causal connection.

Development and Initial Validation of the Risk Analysis Index for Measuring Frailty in Surgical Populations

Importance Growing consensus suggests that frailty-associated risks should inform shared surgical decision making. However, it is not clear how best to screen for frailty in preoperative surgical populations. Objective To develop and validate the Risk Analysis Index (RAI), a 14-item instrument used to measure surgical frailty. It can be calculated prospectively (RAI-C), using a clinical questionnaire, or retrospectively (RAI-A), using variables from the surgical quality improvement databases (Veterans Affairs or American College of Surgeons National Surgical Quality Improvement Projects). Design, Setting, and Participants Single-site, prospective cohort from July 2011 to September 2015 at the Veterans Affairs Nebraska–Western Iowa Heath Care System, a Level 1b Veterans Affairs Medical Center. The study included all patients presenting to the medical center for elective surgery. Exposures We assessed the RAI-C for all patients scheduled for surgery, linking these scores to administrative and quality improvement data to calculate the RAI-A and the modified Frailty Index. Main Outcomes and Measures Receiver operator characteristics and C statistics for each measure predicting postoperative mortality and morbidity. Results Of the participants, the mean (SD) age was 60.7 (13.9) years and 249 participants (3.6%) were women. We assessed the RAI-C 10 698 times, from which we linked 6856 unique patients to mortality data. The C statistic predicting 180-day mortality for the RAI-C was 0.772. Of these 6856 unique patients, we linked 2785 to local Veterans Affairs Surgeons National Surgical Quality Improvement Projects data and calculated the C statistic for both the RAI-A (0.823) and RAI-C (0.824), along with the correlation between the 2 scores (r = 0.478; P < .001). Of these 2785 patients, there were sufficient data to calculate the modified Frailty Index for 1021, in which the C statistics were 0.865 (RAI-A), 0.797 (RAI-C), and 0.811 (modified Frailty Index). The correlation between the RAI-A and RAI-C was 0.547, and the correlations of the modified Frailty Index to the RAI-A and RAI-C were 0.301 and 0.269, respectively (all P < .001). A cutoff of RAI-C of at least 21 classified 18.3% patients as “frail” with a sensitivity of 0.50 and specificity of 0.82, whereas the RAI-A was less sensitive (0.25) and more specific (0.97), classifying only 3.7% as “frail.” Conclusions and Relevance The RAI-C and RAI-A represent effective tools for measuring frailty in surgical populations with predictive ability on par with other frailty tools. Moderate correlation between the measures suggests convergent validity. The RAI-C offers the advantage of prospective, preoperative assessment that is proved feasible for large-scale screening in clinical practice. However, further efforts should be directed at determining the optimal components of preoperative frailty assessment.

Outcomes after late explantation of aortic endografts depend on indication for explantation.

BACKGROUND With the growing prevalence of endovascular repair for abdominal aortic aneurysm (AAA), the number of patients requiring graft explantation is increasing. Therefore, knowledge related to outcomes after explantation may lead to improvement in surgical options. In this study we compare our experience with explantation of aortic endografts, based on indication. METHODS The medical records of all aortic procedures performed at our center were queried during the period from 2002 to 2012. Relevant data from patients needing explantation of aortic endografts were analyzed using Fishers exact test, t-test, and Kaplan-Meier analysis. RESULTS Thirty-nine patients underwent aortic endograft explantation (64.1% men). Mean age was 71.9 years with a mean aneurysm size of 6.8 cm (range 3.5-10.7 cm). Hypertension (97.4%), hyperlipidemia (76.9%), and history of smoking (82%) were the most prevalent risk factors. Mean time to explant was 41.7 months (range 2.2-118.4 months). The primary explant indication was endoleak in 27 (69.2%) and infection in 12 (30.8%) patients. The endoleak group consisted of 13 type I, 8 type II, 1 type III, 4 endotension, 1 rupture, and 4 patients with multiple endoleaks. Seven patients were symptomatic, whereas 2 had ruptured aneurysms. Half of the patients in the infection group required supraceliac clamping for explantation. Operative blood loss (P = 0.08) and need for transfusion (P = 0.005) were significantly higher in the infection group. Thirty-day morbidity was 51.8% for the endoleak group and 83% for the infection group (P = 0.08). There were only 2 deaths in the cohort within 30 days, both in the infection group. Twenty-seven patients were alive at a mean follow-up of 1.9 years (range 0.1-8.4 years). CONCLUSIONS Endograft explantation is a challenging operation with high morbidity and mortality. Furthermore, patients with an infectious etiology have significantly worse outcomes than those requiring explantation for endoleaks.

Procedure-specific venous thromboembolism prophylaxis: A paradigm from colectomy surgery

BACKGROUND Colectomy patients are at high-risk for venous thromboembolism (VTE), but associated risk factors and best prophylaxis in this defined population are only generalized. METHODS Fifteen hospitals prospectively collected pre-, peri-, and postoperative variables related to VTE and prophylaxis, in addition to the variables defined by the National Surgical Quality Improvement Program between 2008 and 2009 concerning open and laparoscopic colectomy patients with 30-day outcomes. Symptomatic VTE was the primary outcome, and risk factors were tested for association with VTE using multiple logistic regression. RESULTS The cohort included 3,464 patients with a mean age of 65; 53% were female. Overall, the 30d incidence of VTE was 2.2%. VTE prophylaxis included sequential compression devices (SCDs, 11%) alone; pharmacologic prophylaxis alone (15%); and both SCDs and pharmacologic prophylaxis (combined prophylaxis, 74%). VTE was associated with each additional year of age (OR, 1.05; 95% CI 1.02-1.06, P < .001); increased body mass index (OR 1.03; CI 1.01-1.05; P = .02); preoperative anemia (OR 2.4; CI 1.2-4.8; P = .011); contaminated wound (OR 3.4; CI 1.6-7.3; P < .01); postoperative surgical site infection (OR 2.5; CI 1.2-5.2; P < .011); and postoperative sepsis/pneumonia (OR 3.6;CI 1.9-6.7; P < .01). Postoperative factors alone accounted for 32% of VTE risk. When controlling for all other factors, only combination prophylaxis was protective against VTE (OR 0.48; CI 0.27-0.9; P = .02). Operative time, presence of disseminated malignancy, anastomotic leak, transfusion, urinary tract infection, and laparoscopic procedure were not significantly associated with VTE. Propensity matching showed that unfractionated heparin was equivalent to low molecular weight heparin, and the transfusion rate was not increased with pharmacologic prophylaxis compared to SCDs alone. CONCLUSION Regardless of preoperative factors, VTE prophylaxis using a combination of SCDs and chemoprophylaxis was associated with significant reduction in VTE and should be standard care for patients after colectomy.

Rifampin Soaking Dacron-Based Endografts for Implantation in Infected Aortic Aneurysms—New Application of a Time-Tested Principle

Infections involving the aorta are associated with high rates of morbidity and mortality, and their management is complex. Saturating Dacron grafts in rifampin (60 mg/mL) inhibits the growth of organisms commonly found to be involved in both primary aortic infections and aortoenteric fistulas. Open repair and replacement of the aorta with rifampin-soaked Dacron grafts is frequently used in clinical practice and is considered a viable option for open repair with a low recurrence of infection; however, the morbidity and mortality of the procedure is significant. More recently, patients who are high risk for open surgery have been managed with endografts to treat infected aortas and aortoenteric fistulas with limited success, a high recurrence rate, and elevated mortality. We describe a technique to expose Dacron endografts with rifampin delivered via injection port or into the sheath before deployment in selected patients with aortic infections. We used this novel technique in 2 patients who were high risk for open repair: 1 with a bleeding aortoenteric fistula and 1 with mycotic abdominal aortic aneurysm. The first patient tolerated 1.5 years without surgical correction of the duodenal defect after placement of a rifampin-treated endograft. This allowed her to recover and ultimately undergo definitive repair under elective circumstances. Our second patient remains without evidence of recurrence 1 year after implantation for a mycotic abdominal aortic aneurysm. Following the principles of rifampin use in open vascular repairs, treating Dacron endografts with rifampin may add similar antimicrobial resistance when used to treat selected aortic infections.

Patient Frailty and Discharge Disposition following Radical Cystectomy

Background Patients with bladder cancer who are treated with cystectomy are at high risk for complications and prolonged length of stay. This population tends to be of advanced age with underlying comorbidities, and thus more likely to have decreased physiologic reserve (ie, frailty). Our objective was to evaluate the relationship between frailty and discharge disposition for patients with bladder cancer treated with cystectomy. Materials and Methods Using data from the National Surgical Quality Improvement Program, we identified patients with bladder cancer undergoing cystectomy (2011‐2014). Our exposure of interest was frailty, based on the 11‐point modified Frailty Index (mFI). Patients were deemed robust (mFI = 0), pre‐frail (mFI = 0.09‐0.18), or frail (mFI ≥ 0.27). Our outcome of interest was discharge disposition defined as home, skilled nursing facility, and rehabilitation dichotomized as home versus non‐home for multivariable logistic regression analysis. We then generated predicted probabilities of non‐home discharge based on frailty and in‐hospital complications. Results Among 4330 patients treated with radical cystectomy, 32.8% were robust, 65.1% were pre‐frail, and 2.2% were frail. Overall, 86.2% were discharged home, 4.4% to a rehabilitation facility, and 9.4% to a skilled nursing facility. Frail patients were more likely to be discharged to non‐home care (vs. robust, odds ratio, 2.33; 95% confidence interval, 1.34‐4.03), which was independent of whether they experienced a major complication prior to discharge. Conclusion Frailty is a significant predictor of non‐home discharge following radical cystectomy. This finding was independent of inpatient complications. These data will assist providers in setting patient expectations and have important implications for allocating postoperative resources. Micro‐Abstract Among 4330 patients undergoing radical cystectomy in the National Surgical Quality Improvement Program from 2011 through 2014, frail patients, as determined by the modified Frailty Index, were more likely to be discharged to a location other than home (odds ratio, 2.33; 95% confidence interval, 1.34‐4.03). Predicting non‐home discharge may assist providers in setting expectations and allocating postoperative resources.

Gender and frailty predict poor outcomes in infrainguinal vascular surgery

BACKGROUND Women have poorer outcomes after vascular surgery as compared to men as shown by studies recently. Frailty is also an independent risk factor for postoperative morbidity and mortality. This study examines the interplay of gender and frailty on outcomes after infrainguinal vascular procedures. MATERIALS AND METHODS The American College of Surgeons National Surgical Quality Improvement Program database was used to identify all patients who underwent infrainguinal vascular procedures from 2005-2012. Frailty was measured using a modified frailty index (mFI; derived from the Canadian Study of Health and Aging). Univariate and multivariate analysis were performed to investigate the association of preoperative frailty and gender, on postoperative outcomes. RESULTS Of 24,645 patients (92% open, 8% endovascular), there were 533 deaths (2.2%) and 6198 (25.1%) major complications within 30 d postoperatively. Women were more frail (mean mFI = 0.269) than men (mean mFI = 0.259; P < 0.001). Women and frail patients (mFI>0.25) were more likely to have a major morbidity (P < 0.001) or mortality (P < 0.001) with the highest risk in frail women. On multivariate logistic regression analysis, female gender and increasing mFI were independently significantly associated with mortality (P < 0.05) as well as major complications. The interaction of gender and frailty in multivariate analysis showed the highest adjusted 30-d mortality and morbidity in frail females at 2.8% and 30.1%, respectively and that was significantly higher (P < 0.001) than nonfrail males, nonfrail females and frail males. CONCLUSIONS Female gender and frailty are both associated with increased risk of complications and death following infrainguinal vascular procedures with the highest risk in frail females. Further studies are needed to explore the mechanisms of interaction of gender and frailty and its effect on long-term outcomes for peripheral vascular disease.

Improved trends in patient survival and decreased major complications after emergency ruptured abdominal aortic aneurysm repair

BACKGROUND Improved trends in patient survival and decreased major complications after emergency ruptured abdominal aortic aneurysm (AAA) repair. Emergency AAA repair carries a high risk of morbidity and mortality. This study seeks to examine morbidity and mortality trends from the National Surgical Quality Improvement Program (NSQIP) database, and identify potential risk factors. METHODS All emergency AAA repairs were identified using the NSQIP database from 2005 to 2011. Univariate analysis (using the Student t, χ(2), and Fishers exact tests) and multivariate logistic regression was performed to examine trends in mortality and morbidity. RESULTS Out of 2761 patients who underwent emergency AAA repair, 321 (11.6%) died within 24 hours of surgery. Of the remaining 2440 patients, 1133 (46.4%) experienced major complications and 459 (18.8%) died during the postoperative period. From 2005 to 2011, there was a significant decrease in patient mortality, particularly in patients who survived the perioperative period (P = .002). Total complications increased overall (P < .0001); however, major complications decreased from 58.7% in 2005 to 42.6% in 2011 (P < .0001) among patients who survived beyond 24 hours. The use of endovascular aortic repair (EVAR) increased over the study period (P < .0001). On multivariate analysis of patients who survived past the initial 24-hour period, advancing age (odds ratio [OR], 1.1; 95% confidence interval [CI], 1.0-1.1), chronic obstructive pulmonary disease (OR, 2.6; 95% CI, 1.7-4.1), dependent functional status (OR, 2.0; 95% CI, 1.2-3.2), and presence of a major complication (OR, 3.1; 95% CI, 2.0-5.0) were significantly associated with death, whereas presence of a senior resident (OR, 0.4; 95% CI, 0.3-0.6) or fellow (OR 0.3; 95% CI, 0.2-0.6) was inversely associated with death. EVAR was not associated with death, but was associated with 30-day complications (OR, 0.5; 95% CI, 0.3-0.6). CONCLUSIONS Patient survival has increased from 2005 to 2011 after emergency AAA repair, with a significant improvement particularly in patients who survive past the first 24 hours. EVAR was not associated with mortality, but was protective of 30-day complications. Although the total number of complications increased, the number of major complications decreased over the study period, suggesting that newer techniques and patient care protocols may be improving outcomes.

Preoperative antiplatelet and statin treatment was not associated with reduced myocardial infarction after high-risk vascular operations in the Vascular Quality Initiative

OBJECTIVE Medical management with antiplatelet (AP) and statin therapy is recommended for nearly all patients undergoing vascular surgery to reduce cardiovascular events. We assessed the association between preoperative use of AP and statin medications and postoperative in-hospital myocardial infarction (MI) in patients undergoing high-risk open surgery. METHODS We studied patients who underwent elective suprainguinal (n = 3039) and infrainguinal (n = 8323) bypass and open infrarenal abdominal aortic aneurysm repair (n = 3007) in the Vascular Quality Initiative (VQI, 2005-2014). We assessed the association between AP or statin use and in-hospital postoperative MI and MI/death. Multivariable logistic analyses were performed to identify the patient, procedure, and preoperative medication factors associated with postoperative MI and MI/death across procedures and patient cardiac risk strata. Secondary end points included bleeding, transfusion, and thrombotic complications. RESULTS Most patients were taking both AP and statin preoperatively (56% both agents vs 19% AP only, 13% statin only, and 12% neither agent). Use of both agents was more common for patients in the highest cardiac risk stratum (low, 54%; intermediate, 59%; high, 61%; P < .01). Increased cardiac risk was associated with higher MI rates (1.8% vs 3.8% vs 6.5% for low, intermediate, and high risk; P < .01). By univariate analysis, MI rate was paradoxically higher for patients taking both agents (3.7%, vs statin only 2.8%, AP only 2.6%, or neither AP nor statin 2.4%; P = .003). After multivariable adjustment, rates of MI in patients taking preoperative AP only (odds ratio [OR], 0.9; 95% confidence interval [CI], 0.7-1.2) and statin only (OR, 0.8; 95% CI, 0.6-1.2) were not different from those in patients taking either or neither medication (neither agent compared with taking both agents: OR, 1.0; 95% CI, 0.7-1.4; P > .05 for all). Similarly, rates of MI/death were not associated with medication status after multivariable adjustment. Estimated blood loss >1 liter (OR, 2.4; 95% CI, 1.6-3.7; P < .01) and transfusions of 1 or 2 units (OR, 2.5; 95% CI, 2.0-3.3; P < .01) and ≥3 units (OR, 4.0; 95% CI, 3.1-5.3; P < .01) were highly associated with MI, with similar findings related to composite MI/death in multivariable analysis. Rates of blood loss were slightly higher with AP use for all procedures; however, increased transfusions occurred only for infrainguinal bypass with AP use. Rates of reoperation for bleeding, graft thrombosis, or graft revision did not differ by preoperative AP use. CONCLUSIONS Preoperative AP and statin medications as used in VQI were not associated with the rate of in-hospital MI/death after major open vascular operations. Rather, predicted cardiac risk and operative blood loss were significantly associated with in-hospital MI or MI/death. AP and statin medications appear to be more useful in reducing late mortality than early postoperative MI/death in VQI. However, they were not harmful, so their long-term benefit argues for continued use.