Comparison of outcomes for balloon angioplasty, atherectomy, and stenting in the treatment of infrapopliteal disease for chronic limb-threatening ischemia.

OBJECTIVE: We evaluated limb salvage (LS), amputation-free survival (AFS), and target extremity reintervention (TER) after plain old balloon angioplasty (POBA), stenting, and atherectomy for treatment of infrapopliteal disease (IPD) with chronic limb-threatening ischemia (CLTI). METHODS: All index peripheral vascular interventions for IPD and CLTI were identified from the Vascular Quality Initiative registry. Of the multilevel procedures, the peripheral vascular intervention type was indexed to the infrapopliteal segment. Propensity score matching was used to control for baseline differences between groups. Kaplan-Meier and Cox regression were used to calculate and compare LS and AFS. RESULTS: The 3-year LS for stenting vs POBA was 87.6% vs 81.9% (P = .006) but was not significant on Cox regression analysis (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.56-0.76; P = .08). AFS was superior for stenting vs POBA (78.1% vs 69.5%; P = .001; HR, 0.73; 95% CI, 0.60-0.90; P = .003). LS was similar for POBA and atherectomy (81.9% vs 84.8%; P = .11) and for stenting and atherectomy (87.6% vs 84.8%; P = .23). The LS rate after propensity score matching for POBA vs stenting was 83.4% vs 88.2% (P = .07; HR, 0.71; 95% CI, 0.50-1.017; P = .062). The AFS rate for stenting vs POBA was 78.8% vs 69.4% (P = .005; HR, 0.69; 95% CI, 0.54-0.89; P = .005). No significant differences were found between stenting and atherectomy (P = .21 for atherectomy; and P = .34 for POBA). The need for TER did not differ across the groups but the interval to TER was significantly longer for stenting than for POBA or atherectomy (stenting vs POBA, 12.8 months vs 7.7 months; P = .001; stenting vs atherectomy, 13.5 months vs 6.8 months; P < .001). CONCLUSIONS: Stenting and atherectomy had comparable LS and AFS for patients with IPD and CLTI. However, stenting conferred significant benefits for AFS compared with POBA but atherectomy did not. Furthermore, the interval to TER was nearly double for stenting compared with POBA or atherectomy. These factors should be considered when determining the treatment strategy for this challenging anatomic segment.

Optimal medical management in patients undergoing peripheral vascular interventions for chronic limb-threatening ischemia is associated with improved outcomes.

OBJECTIVE: Optimizing medical management and risk factor modification are underused strategies in patients with chronic limb-threatening ischemia (CLTI), despite evidence of improved outcomes. The Vascular Quality Initiative (VQI) registry is a tool to improve quality of vascular care. In this study, we used the VQI to evaluate trends in medical management in patients with CLTI undergoing peripheral vascular interventions (PVI), and the impact of changes in management on overall survival (OS), amputation-free survival (AFS), and limb salvage (LS). METHODS: Patients undergoing index PVI for CLTI between 2012 and 2016, with ≥24 months of follow-up were identified from the national VQI registry. Patient details including smoking status and medication use, OS, LS, and AFS were analyzed with linear-by-linear association, t test, and logistic regression. RESULTS: There were 12,370 PVI completed in 11,466 patients. There was a significant increase in infrapopliteal interventions (from 29.8% to 39.0%; P < .001) and PVI performed for tissue loss (from 59.1% to 66.5%; P < .001). The percentage of current smokers at time of PVI decreased (from 36.2% to 30.7%; P = .036). At discharge, statins were initiated in 25%, aspirin in 45%, and P2Y12 therapy in 58% of patients not receiving these medications before PVI. Over the course of follow-up, dual antiplatelet therapy (DAPT) (from 41.1% to 48.0%; P < .001), angiotensin-converting enzyme (ACE) inhibitor (from 46.2% to 51.3%; P < .001), and statin (from 70.4% to 77.5%; P < .001) use increased. Combined DAPT, ACE inhibitor and statin use increased from 33.6% to 39.6% (P ≤ .001). Significant improvement in 24-month OS and AFS was noted (OS, from 90.9% to 93.7% [P = .002]: AFS, from 81.2% to 83.1% [P = .046]), but not LS (from 89.6% to 89.0%; P = .83). Combined therapy with P2Y12 inhibitors, statins and ACE inhibitors was an independent predictor of improved OS (hazard ratio, 0.61; 95% confidence interval, 0.39-0.96; P = .034). DAPT was independent predictor of improved LS (hazard ratio, 0.83; 95% confidence interval, 0.79-0.87; P < .007). CONCLUSIONS: Antiplatelet, ACE inhibitor, and statin use increased over the study period and was associated with improved OS and AFS. LS trends did not change significantly over time, possibly owing to the inclusion of patients with a greater disease burden or inadequate medical management. Medical management, although improved, remained far from optimal and represents an area for continued development.

P2Y12 inhibitor monotherapy is associated with superior outcomes as compared with aspirin monotherapy in chronic limb-threatening ischemia.

OBJECTIVE: Antiplatelet therapy is recommended in patients with peripheral arterial disease to reduce cardiovascular risk and improve outcomes. However, issues including the drug of choice and use of dual antiplatelet therapy (DAPT) vs monotherapy remain unclear. This study aims to compare the impact of aspirin (ASA) monotherapy, P2Y12 monotherapy, and DAPT on limb salvage (LS), amputation-free survival (AFS), and overall survival (OS) in patients undergoing lower extremity peripheral endovascular intervention (PVI) for chronic limb-threatening ischemia (CLTI). METHODS: The Vascular Quality Initiative PVI registry was used to identify index procedures completed for CLTI between March 1, 2010 and September 30, 2017. Patients were categorized by antiplatelet use at the time of last follow-up. Patients not on antiplatelet therapy were compared with ASA, P2Y12 monotherapy, and DAPT. Propensity score-matched samples were created for direct ASA vs P2Y12 and P2Y12 vs DAPT comparisons; veracity was confirmed by χ2 and Hosmer-Lemeshow tests. Kaplan-Meier and Cox regression were performed for OS, AFS, and LS. RESULTS: A total of 12,433 index PVI were completed for CLTI in 11,503 subjects in the pre-matched sample. Antiplatelet use at follow-up was: 12% none, 31% ASA, 14% P2Y12, and 43% DAPT. Median follow-up was 1389 days. P2Y12 monotherapy was associated with improved outcomes as compared with ASA monotherapy, OS (87.8% vs 85.5%l P = .026; Cox hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.68-0.98; P = .03), AFS (79.6% vs 74.8%; P < .001; Cox HR, 0.75; 95% CI, 0.65-0.86; P < .001) and LS (89.5% vs 86.8%; P = .013; Cox HR, 0.74; 95% CI, 0.60-0.91; P = .004). P2Y12 monotherapy and DAPT had comparable OS (87.8% vs 88.9%; P = .62; Cox HR, 0.94; 95% CI, 0.77-1.14; P = .50), AFS (79.6% vs 81.5%; P = .33; Cox HR, 0.92; 95% CI, 0.78-1.07; P = .28), and LS (91.7% vs 89.4; P = .03; Cox HR, 0.80; 95% CI, 0.64-1.00; P = .06). CONCLUSIONS: P2Y12 monotherapy was associated with superior OS, AFS, and LS as compared with ASA monotherapy, and comparable OS, LS, and AFS with DAPT in patients undergoing PVI for CLTI. P2Y12 monotherapy may be considered over ASA monotherapy and DAPT in patients with CLTI, especially in patients with high bleeding risk.

Need for Routine Preoperative Insertion of Indwelling Urinary Catheter Prior to Endovascular Repair of Abdominal Aortic Aneurysm.

BACKGROUND: Evaluate outcomes following urinary catheter (UC) versus no urinary catheter (NUC) insertion in elective endovascular repair (EVAR) of abdominal aortic aneurysm (AAA). METHODS: Retrospective record review of all elective EVAR at a university affiliated medical center over a 5-year period. Statistical analysis included Chi Sq, Independent Student t Test. RESULTS: Six surgeons performed 272 elective EVAR. Three surgeons preferred selective insertion of indwelling UC, such that 86 (32%) EVAR were completed without indwelling urinary catheters (NUC). Differences between NUC versus UC included; male: (86% vs. 70%; P = 0.004), CAD: (45% vs. 33%; p = 0.046), conscious sedation: (36% vs. 8%; P < 0.001), bilateral percutaneous EVAR (PEVAR): (100% vs. 90%; P = 0.01), within ProglideTM IFU guidelines (87% vs 75%; P = .05), major adverse operative event (MAOE): (3.5% vs. 10%; P = 0.05) and mean operative time (185 ± 73 vs. 140 ± 37; P < 0.001). Intra-operative catheterization was never required among NUC. Postoperative adverse urinary events (AUE) were more common among UC (11.4% vs. 8.1%; P = 0.41); with longer times to straight catheterization/reinsertion (1575 ± 987 vs, 522 ± 269 min; P = 0.015) and lower likelihood of eligibility for same day discharge (SDD); (41% vs. 59%; P = 0.008). Ineligibility for SDD was due to AUE in 18% of UC patients. CONCLUSION: Selective preoperative UC insertion should be considered for EVAR, with particular consideration to no preoperative catheterization in men meeting Proglide IFU. Adverse urinary events occurred less frequently among NUC and were identified/ treated earlier. Moreover, AUEs were the most common reason for potential SDD ineligibility among UC patients. Selective policies may facilitate SDD.

Improved survival with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in chronic limb-threatening ischemia.

OBJECTIVE: Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) reduce the risk of cardiovascular events in patients with peripheral artery disease. However, their effect on limb-specific outcomes is unclear. The objective of this study was to assess the effect of ACE inhibitors/ARBs on limb salvage (LS) and survival in patients undergoing peripheral vascular intervention (PVI) for chronic limb-threatening ischemia (CLTI). METHODS: The Vascular Quality Initiative registry was used to identify patients undergoing PVI for CLTI between April 1, 2010, and June 1, 2017. Patients with complete comorbidity, procedural, and follow-up limb and survival data were included. Propensity score matching was performed to control for baseline differences between the groups. LS, amputation-free survival (AFS), and overall survival (OS) were calculated in matched samples using Kaplan-Meier analysis. RESULTS: A total of 12,433 limbs (11,331 patients) were included. The ACE inhibitors/ARBs group of patients had significantly higher prevalence of coronary artery disease (31% vs 27%; P < .001), diabetes (67% vs 57%; P < .001), and hypertension (94% vs 84%; P < .001) and lower incidence of end-stage renal disease (7% vs 12%; P < .001). Indication for intervention was tissue loss in 64% of the ACE inhibitors/ARBs group vs 66% in the no ACE inhibitors/ARBs group (P = .005). Postmatching survival analysis at 5 years showed improved OS (81.8% vs 79.9%; P = .01) and AFS (73% vs 71.5%; P = .04) with ACE inhibitors/ARBs but no difference in LS (ACE inhibitors/ARBs, 88.3%; no ACE inhibitors/ARBs, 88.1%; P = .56). After adjustment for multiple variables in a Cox regression model, ACE inhibitors/ARBs were associated with improved OS (hazard ratio, 0.89; 95% confidence interval, 0.80-0.99; P = .03) and AFS (hazard ratio, 0.92; 95% confidence interval, 0.84-0.99; P = .04). CONCLUSIONS: ACE inhibitors/ARBs are independently associated with improved survival and AFS in patients undergoing PVI for CLTI. LS rates remained unaffected. Further research is required to investigate the use of ACE inhibitors/ARBs in this population of patients, especially CLTI patients with other indications for therapy with ACE inhibitors/ARBs.

The selection of patients for ambulatory endovascular aneurysm repair of elective asymptomatic abdominal aortic aneurysm.

OBJECTIVES: To identify candidates undergoing elective endovascular aneurysm repair (EVAR) of asymptomatic infrarenal abdominal aortic aneurysm who are eligible for early (≤6 hours) hospital discharge or to have EVAR performed in free-standing ambulatory surgery centers. METHODS: A retrospective medical record review of all elective EVAR performed at a university medical center over 5 years was undertaken. Potential candidates for early discharge or to have EVAR performed in a free-standing ambulatory surgery setting were defined as those who used routine monitoring services only or had self-limited minor adverse events (AE) that were identified, treated, and resolved within 6 hours of surgery. Risk factors for ineligibility were determined by logistic regression. Sensitivity, specificity, negative and positive predictive values were measured to determine the veracity of the risk factor profile. RESULTS: There were 272 elective EVARs; the mean patient age was 74 years (range, 52-94 years), and 75% were male. Twenty-five operative major AEs (MAE) occurred in 21 patients (7.7%): bleeding (5.9%), thrombosis (1.8%), and arterial injury (1.8%). Percutaneous EVAR (PEVAR) attempted in 260 patients (96%) was successful in 238 (88%). Failed PEVAR was associated with operative MAE (P < .001). Combined operative/postoperative MAE occurred in 43 patients (15.8%); 17 (6%) required intensive care admission; 88% directly from the operating room/postanesthesia care unit. Only two MAE (0.7%) occurred beyond 6 hours; (congestive heart failure at 24 hours, thrombosis/reoperation at 15 hours). Other AE included nausea (17%), blood pressure alteration (15%), and urinary retention (13%). Need for nonroutine services or treatment of other AE occurred in 131 (48%) patients with 79 (29%) developing or requiring treatment ≥6 hours postoperatively. However, 22 (8%) were treated/resolved in <6 hours; 30 (11%) patients required monitoring only and 36% had no complications, so, overall eligibility for same-day discharge/free-standing ambulatory surgery center was 55%. Failed PEVAR (odds ratio [OR], 2.37; 95% confidence interval [CI], 1.25-4.49; P = .008), PEVAR performed outside of instructions for use (IFU) criteria (OR, 2.84; 95% CI, 1.07-7.56; P = .037), Endologix AFX graft (OR, 1.66; 95% CI, 1.19-2.33; P = .003) were independent predictors of MAE or AE occurring/requiring treatment >6 hours postoperatively; EVAR, which did not require an additional aortic cuff, was associated with a lower incidence (OR, 0.17; 95% CI, 0.04-0.65; P = .01). Neither aortic nor limb IFU were independent predictors. Profiles using PEVAR IFU, PEVAR failure, and graft type demonstrated only moderate sensitivity (63%), specificity (71%), positive predictive value (70%), and negative predictive value (63%). CONCLUSIONS: More than one-half of all patients who undergo EVAR are ready for discharge within 6 hours postoperatively. Failed PEVAR, aortic cuffs, and Endologix AFX graft were independent predictors of MAE or AE occurring/requiring treatment for ≥6 hours. However, sensitivity parameters of this profile were insufficient to advocate EVAR in free-standing ambulatory surgical units at this time, but hospital-based ambulatory admission with same-day discharge would be a viable option because of easy inpatient transition for those requiring continued care.

Outcomes after Lower Extremity Revascularization for Treatment of Critical Limb Ischemia with Tissue Loss in Patients with Chronic Immune-Mediated Inflammatory Disease.

BACKGROUND: To evaluate outcomes after lower extremity revascularization for critical limb ischemia with tissue loss in patients with chronic immune-mediated inflammatory disease. METHODS: A retrospective medical record review of all lower extremity revascularization for critical limb ischemia with tissue loss at a university-affiliated hospital over a 3-year period was completed for demographics, comorbidities, lower extremity revascularization indication, angiogram results, complications, mortality, limb salvage, and reintervention. Chronic immune-mediated inflammatory disease (CIID) and control (no autoimmune disease) were compared by chi-squared test, Student's t-test, Kaplan-Meier, and Cox Regression. RESULTS: There were 349 procedures performed (297 patients): (1) 44 (13%) primary amputations and (2) 305 (87%) lower extremity revascularizations, in which 83% were endovascular interventions; 12% was bypass; and 5% was hybrid, in which 40% was infrainguinal and 60% was infrageniculate, 72% Wounds Ischemia Infection Score System (WIFi) tissue loss class 2-3, 35% CIID. No differences were noted between CIID and control for primary amputation (P = 0.11), lower extremity revascularization type (P = 0.50), or lower extremity revascularization anatomic level (P = 0.43). Mean age was 71 + 13 years, and 56% of the patients were of male gender. Those with CIID were of similar age as controls (71 ± 14 vs. 71 ± 13; P = 0.87) and presented with comparable runoff: (1) ≤1 vessel (52% vs. 47%; P = 0.67), (2) WIFi tissue loss classification class 2-3 (66% vs. 76%; P = 0.09), and (3) WIFi infection classification class 2-3 (29% vs. 30%; P = 0.9). They were also less likely to be male (47% vs. 61%; P = 0.022) or current smokers (13% vs. 27%; P = 0.008). Postoperative mortality (P = 0.70) morbidity and reoperation (0.31) were comparable. Twenty-four-month survival was similar for CIID and control (83% ± 5% vs. 86% + 3%; P = 0.78), as was the amputation-free interval (69% ± 5% vs. 61% ± 4%; P = 0.18) and need for target extremity revascularization (40% vs. 53%; P = 0.04). Use of steroids and other anti-inflammatory medications was associated with improved 24-month amputation-free interval (87% ± 9% vs. 63% ± 3%; P = 0. 05). Dialysis (odds ratio: 2.6; 1.5-4.7; P = 0.001), WIFi infection class 2-3 (odds ratio: 2.8; 1.6-4.9; P < 0.001), prerunoff vessel (0-1 vs. 2-3) to the foot (odds ratio: 0.52; 0.37-0.73; P < 0.001), steroids/other anti-inflammatory agents (0.29; 0.06-0.96; P = 0.04), and statins (0.44; 0.25-0.77; P = 0.005) were independent predictors of 24-month amputation-free interval (Cox proportional hazard ratio). CONCLUSIONS: Patients with critical limb ischemia, tissue loss, and concomitant CIID can be successfully treated with lower extremity revascularization with similar limb salvage and need for reintervention. Steroid/anti-inflammatory use appears beneficial.

Factors that affect cost and clinical outcome of endovascular aortic repair for abdominal aortic aneurysm.

OBJECTIVE: This study evaluated the effect of indication for use (IFU), additional graft components, and percutaneous closure of endovascular aortic repair (PEVAR) on clinical outcomes and cost of endovascular aortic repair (EVAR). METHODS: Clinical and financial data were obtained for all elective EVARs completed at a university-affiliated medical center between January 2012 and June 2013. Data were analyzed by χ2, Student t-test for independent samples, and Kaplan-Meier survival. RESULTS: There were 67 elective EVARs. Additional cuffs/extensions were used in 37%, increasing the baseline graft cost by 36% (P < .001), total costs by 20% (P < .001), and negatively affecting the contribution margin. Aortic neck IFU (P = .02), failure of the index graft to seal the neck (P = .02), and need for an additional cuff (P = .008) were related to the need for reintervention for type Ia endoleak for graft B (Excluder; W. L. Gore and Associates, Flagstaff, Ariz), whereas limb IFU was related to the need for additional limb extension for graft A (Powerlink; Endologix, Irvine, Calif; P < .001). Limb extension (P = .06) and failure of the index graft to provide an adequate seal (P < .001) were associated with reintervention for type Ib endoleak. Reintervention-free rates at 24 months were 96% for graft A and 94% for graft B (P =.54), but different patterns in reintervention emerged: graft A required reoperation early (<2 months) then stabilized; graft B did not require reintervention until 24 months, but rates increased substantially by 25 months. PEVAR was attempted in 61 (91%): 49 (73%) bilaterally, 7 (10%) unilaterally, and 5 (8%) failed. The mean number of closure devices was four (range, 1-9): $1000 (3.5% of total cost). Bilateral PEVAR was associated with shorter operating time than unilateral PEVAR/failed PEVAR (P < .001) and lower operating room use costs (P = .005) and total hospital costs (P = .003) than failed PEVAR. The contribution margin was higher for bilateral PEVAR than unilateral PEVAR/failed PEVAR (P = .005). Patients with bilateral PEVAR and unilateral PEVAR were more often discharged on postoperative day 1 than those with failed PEVAR (P = .002). Hospital length of stay (P = .49), operating room duration (P = .31), and total costs (P = .72) were similar for unsuccessful PEVAR and EVAR completed with cutdown. CONCLUSIONS: Higher rates of reintervention occurred when EVAR was performed outside of IFU guidelines or when additional components were needed. Additions raised graft costs significantly above baseline. Notable differences in graft performance in complex anatomy and varied patterns of reoperation could be useful in the graft selection process to improve outcome and contain costs. Bilateral PEVAR was associated with lower costs and postoperative day 1 discharge. Attempting PEVAR may be reasonable unless there is serious concern for failure.

Potential clinical feasibility and financial impact of same-day discharge in patients undergoing endovascular aortic repair for elective infrarenal aortic aneurysm.

OBJECTIVE: The purpose of this study was to evaluate the potential feasibility and financial impact of same-day discharge after elective endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm. METHODS: All elective EVARs performed between January 2012 and June 2013 were identified. Demographics, comorbidities, complications, nursing care, financial data, and length of stay were analyzed. RESULTS: Sixty-seven (73%) EVARs were performed electively, 73% percutaneously. Intraoperative complications were blood loss requiring transfusion (4.5%), thrombosis (3%), femoral artery injury (1.5%), postoperative urinary retention (4.5%), myocardial infarction (3%), respiratory failure (1.5%), congestive heart failure (1.5%), and hemodynamic or rhythm alterations (37%; evident in 88% <6 hours; 13% required therapy). Monitoring only was needed in 28 patients (42%), intensive care in 15%. Seventy-two percent were discharged on postoperative day one; 6% were readmitted <30 days. Telemetry, oxygen, intravenous hydration, and urinary catheters (routine services) were used for shorter periods in uncomplicated patients and those discharged on postoperative day 1. Total hospital costs were $29,479: operating room, 80.3%; anesthesia, 2.2%; preadmission, 1%; postanesthesia unit, 3.1%; intensive care unit, 1.9%; floor, 4.7%; laboratory and diagnostic tests, 1.2%; pharmacy, 1.4%; other, 4.2%. Total cost was similar for those discharged <20 hours or ≥24 to 31 hours postoperatively (P = .51) and for monitoring only vs others ($28,146 vs $30,545; P = .12). Pharmacy ($351 vs $509; P = .05), laboratory work ($86 vs $355; P = .01), and diagnostic testing ($4 vs $254; P = .02) costs were lower for uncomplicated cases. CONCLUSIONS: Same-day discharge is clinically feasible in >40% of elective EVARs but requires coordination for adequate postoperative monitoring. Significant savings are unlikely as most cost is operating room and device related, and further reduction of costs in uncomplicated cases is unlikely.

Outcomes after endovascular intervention for chronic critical limb ischemia.

OBJECTIVE: This study evaluated outcomes after endovascular intervention (EVI) for chronic critical limb ischemia (CLI) by Rutherford category (RC) 4, rest pain; and 5, tissue loss. METHODS: The medical records of all EVI performed for RC-4 to RC-5 by vascular surgeons at a single institution during a 3-year period were reviewed for sustained clinical success (SCS), defined as Rutherford improvement score (RIS) 2(+), without target extremity revascularization (TER). The RC-5 group was evaluated for patency until healing and healing ≤4 months without recurrence or new ulceration. Secondary sustained clinical success (SSCS) was a RIS of 2(+) with TER. The RC-5 group was evaluated for patency until healing and healing at any time during follow-up, without recurrent or new ulceration. Significance was established at the 0.05 level. RESULTS: Of 106 EVI performed for CLI, 78 (74%) were RC-5. There were 39 (37%) men. Mean age was 73 ± 12 years. Mean follow-up was 19 months (range, 1-44 months). RC-5 patients were significantly more likely than RC-4 to be diabetic (58% vs 32%; P = .020), dialysis dependent (14% vs 0%; P = .036), and to require distal EVI (53% vs 29%; P = .029). RC-4 patients were more likely to be current smokers (57% vs 32%; P = .023). At 24 months, survival was comparable, with RC-4 at 84% ± 8% vs RC-5 at 62% ± 7% (P = .09), but limb salvage was significantly better for RC-4 (100%) vs RC-5 (83% ± 4%; P = .026), as was SCS (48% vs 21%; P = .006) and SSCS (85% vs 39%; P < .001). Independent predictors of failed SSCS were diabetes (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.07-7.46; P = .036), congestive heart failure (CHF; OR, 3.62; 95% CI, 1.19-10.99; P = .023), and RC-5 (OR, 5.5; 95% CI, 2.4-30.3; P = .001). SSCS was 94% in RC-4 patients without diabetes mellitus (DM) or CHF and 10% in RC-5 with DM or CHF (P < .001) but improved to 67% in RC-5 when neither CHF nor DM were present (P = .004). CONCLUSIONS: RC-4 have fewer comorbidities, less advanced ischemia, and better outcome than RC-5. These groups should be evaluated individually. Limb salvage was acceptable, yet early wound healing without TER (SCS) occurred in only 21%. RC-5, DM, and CHF were predictors of poor SSCS. Careful selection of patients should improve outcome.

Endovascular intervention for treatment of claudication: is it cost-effective?

BACKGROUND: Treatment of claudication with endovascular intervention (EVI), a procedure designed to enhance quality of life, is on the rise despite being expensive. We examined clinical outcomes and costs for treatment of claudication with EVI. METHODS: Records of all EVI performed at a University Health Center during a single year were reviewed for functional capacity, Trans-Atlantic Inter-Society Council (TASC) classification, procedure, reintervention, and financial data. Sustained clinical success (SCS) (improvement without target extremity revascularization [TER]) and secondary sustained clinical success (SSCS) (improvement with TER) were tracked over 2 years follow-up. RESULTS: There were 77 patients (90 limbs). Mean follow-up was 14.8 +/- 7.7 months (1-30). Procedural success was 94%. Two-year SCS and SSCS were found to be 28 +/- 9% and 49 +/- 11%, respectively. SCS differed significantly from TASC (p = 0.02), whereas SSCS did not (p = 0.33). Mean time to reintervention was 11.7 +/- 6.6 months. Two-year TER-free rate (65 +/- 7%) did not differ significantly by procedure (p = 0.26), the artery treated (p = 0.24), or TASC (p = 0.18). Two-year costs for EVI were $13,886, differing significantly by TASC (p = 0.017) and by the artery treated (p < 0.001). Estimated cost for a 3-month trial of supervised exercise and pharmacotherapy was $1,376, and the maintenance cost over a 2 year follow-up period was $6,602. CONCLUSIONS: TER was necessary in more than one-third of limbs to maintain 2-year SSCS in 49% of patients. EVI was twice as expensive as estimated 2-year costs for supervised exercise and pharmacotherapy, and 10 times more costlier than a 3-month trial. Mandating a trial of conservative therapy before EVI merits consideration.

Hospital costs for endovascular and open repair of abdominal aortic aneurysm.

BACKGROUND: To evaluate hospital costs and reimbursement for open (OAAA) and endovascular (EVAAA) repair of abdominal aortic aneurysm. STUDY DESIGN: Review of all patients who underwent OAAA or EVAAA in two teaching hospitals during the period January 1, 2000, to December 31, 2000, was completed for the following: demographics, Diagnosis Related Group (DRG), resource use, length of stay, hospital costs, and reimbursement data. RESULTS: There were 130 abdominal aortic aneurysm procedures performed. Fifty-seven (44%) OAAA were completed; EVAAA was attempted in 73 (56%). Seventy EVAAA patients (96%) had endografts placed, and three (4%) required conversion to open repair. Significant differences were noted between OAAA and EVAAA in operative time (311.7 +/- 107.5 minutes versus 263.4 +/- 110.8 minutes, respectively, p = 0.02), ICU admission and length of stay (100%, 5.0 +/- 6.1 days versus 29%, 1.4 +/- 7.1 days, respectively, p = 0.003), and hospital length of stay (12.6 +/- 14.8 days versus 4.9 +/- 13.4 days, respectively, p = 0.002). Total costs were $17,539.00 for EVAAA and $9,042.00 for OAAA. EVAAA was profitable ($3,072.00) for Medicare DRG 110 classification, but significant loss occurred with DRG 111 ($5,065.00). Contract renegotiation with private payers (to cover graft costs) was necessary to avoid substantial per- patient loss ($12,108.00). Overall net per-patient profit for EVAAA was $737.00. CONCLUSIONS: Endovascular abdominal aortic aneurysm repair is significantly more expensive than open repair, with the major portion attributed to graft cost. Although ICU use and total length of stay decreased with EVAAA, overall costs were not substantially reduced. Hospitals must develop new financial strategies and improve the efficiency of their infrastructures in order to offer EVAAA.

Procedural trends in the treatment of peripheral arterial disease by insurer status in New York State.

BACKGROUND: Type or lack of insurance may affect access to care, treatment, and outcomes. We evaluated trends for surgical management of all peripheral arterial disease (PAD) in-hospital admissions by insurer status in New York State. STUDY DESIGN: Statewide Planning and Research Cooperative System (SPARCS) data were obtained and cross-referenced for diagnostic and procedure codes. Data from 2001 to 2002 were averaged and used as a baseline. Change in indication, volume of admissions, procedures, and amputations were calculated for the years 2003 to 2008 and were analyzed by insurer status. RESULTS: There were 83,949 admissions. Endovascular intervention (EVI) increased tremendously for all indications and was used equally in the insured and uninsured. Among critical limb ischemia admissions, patients with private insurance were significantly more likely to be admitted for rest pain and significantly less likely to be admitted for gangrene (p < 0.001). Admission for gangrene declined for all. As EVI increased, amputation decreased and was significantly lowest in patients with private insurance (p < 0.001). Amputation was significantly higher in Medicaid than other insured (Medicaid vs private, p < 0.001; Medicaid vs Medicare, p = 0.003), but comparable to the uninsured (p = 0.08). Age greater than 65 years and low socioeconomic class or minority status were significant risks for gangrene (p = 0.014; p < 0.001) and ultimate amputation (p = 0.05; p < 0.001). Lack of insurance may pose a similar risk. CONCLUSIONS: EVI increased tremendously and was used without disparity across insurer status. Amputation declined steadily and may have been related to increased EVI or to decreased admission for gangrene. Advanced age, low socioeconomic class or minority status, and lack of insurance negatively affect presentation and limb salvage. Universal health care may be beneficial in improving outcomes but must address root causes for delayed presentation.

Lower extremity endovascular interventions: can we improve cost-efficiency?

OBJECTIVE: Management of lower extremity arterial disease with endovascular intervention is on the rise. Current practice patterns vary widely across and within specialty practices that perform endovascular intervention. This study evaluated reimbursement and costs of different approaches for offering endovascular intervention and identified strategies to improve cost-efficiency. METHODS: The medical records of all patients admitted to a university health system during 2005 for an endovascular intervention were retrospectively reviewed. Procedure type, setting, admission status, and financial data were recorded. Groups were compared using analysis of variance, Student t test for independent samples, and chi2. RESULTS: A total of 296 endovascular interventions were completed, and 184 (62%) met inclusion criteria. Atherectomy and stenting were significantly more costly when performed in the operating room than in the radiology suite: atherectomy, dollars 6596 vs dollars 4867 (P = .002); stent, dollars 5884 vs dollars 3292, (P < .001); angioplasty, dollars 2251 vs dollars 1881 (P = .46). Reimbursement was significantly higher for inpatient vs ambulatory admissions (P < .001). Costs were lowest when the endovascular intervention was done in the radiology suite on an ambulatory basis and highest when done as an inpatient in the operating room (dollars 5714 vs dollars 12,278; P < .001). Contribution margins were significantly higher for inpatients. Net profit was appreciated only for interventions done as an inpatient in the radiology suite. Reimbursement, contribution margins, and net profit were significantly lower among private pay patients in both the ambulatory and inpatient setting. The 30-day hospital readmission after ambulatory procedures was seven patients (6%). CONCLUSIONS: Practice patterns for endovascular interventions differ considerably. Costs vary by procedure and setting, and reimbursement depends on admission status and accurate documentation; these dynamics affect affordability. Organizing vascular services within a hub will ensure that care is delivered in the most cost-efficient manner. Guidelines may include designating the radiology suite as the primary venue for endovascular interventions because it is less costly than the operating room. Selective stenting policies should be considered. Contracts with private insurers must include carve-outs for stent costs and commensurate reimbursement for ambulatory procedures, and Current Procedural Terminology (CPT; American Medical Association, Chicago, Ill) coding must be proficient to make ambulatory endovascular interventions fiscally acceptable.

The new training paradigms and the unfilled match positions of 2004: will history repeat itself?

OBJECTIVE: The new millennium has seen an increase in vascular residency vacancies. The American Board of Vascular Surgery recently proposed new training paradigms, but their impact on recruitment remains unknown. We surveyed vascular fellows regarding factors and timing of career decisions to determine an optimal strategy for recruitment. METHODS: Surveys were sent electronically to vascular residents for completion. Data were analyzed using SPSS software. Additional data were obtained from the National Resident Matching Program. RESULTS: Of the 90 fellows that responded, 84% committed to vascular surgery during residency. Of these, 18% decided during postgraduate year 1, 54% by year 2, 84% by year three, and 95% by year 4. Sixteen percent of all trainees decided in medical school. Seventy-three percent of residents performed a minimum of 20 to 50 cases before reaching a decision. Among the group deciding between years 2 to 4 of residency, there was a significant difference in the number of vascular rotations before career commitment (P = .0001). In the 2004 Match, 21% of vascular residency positions were unfilled, up from 12% in 2003, 9% in 2002, and 4% in 2001. CONCLUSIONS: Leaders in the field of vascular surgery have proposed focused training through the new paradigms. The incline in unmatched vascular residency positions over the past 4 years highlights the importance of a strategic plan to optimize recruitment. Few current trainees decided early in training about career choice, and volume appears critical to the decision process. Utilizing the current matching system (an 18-month process) and without any proactive change in recruitment, an integrated program after medical school would be reasonable for only 16% of applicants, or the 3+3 option for 54% of residents. For the new paradigms to be successful and to prevent more unfilled positions, increased medical student integration into vascular rotations and early active exposure to endovascular and open procedures during general surgical training will be necessary across the country.