Comparison of perioperative costs with fast-track vs standard endovascular aneurysm repair.

BACKGROUND: Perioperative health care utilization and costs in patients undergoing elective fast-track vs standard endovascular aneurysm repair (EVAR) remain unclear. METHODS: The fast-track EVAR group included patients treated with a 14 Fr stent graft, bilateral percutaneous access, no general anesthesia or intensive care monitoring, and next-day hospital discharge. The standard EVAR group was identified from Medicare administrative claims using a matching algorithm to adjust for imbalances in patient characteristics. Hospital outcomes included operating room time, intensive care monitoring, hospital stay, secondary interventions, and major adverse events (MAEs). Perioperative outcomes occurring from hospital discharge to 30 days postdischarge included MAE, secondary interventions, and unrelated readmissions. RESULTS: Among 1000 matched patients (250 fast-track; 750 standard), hospital outcomes favored the fast-track EVAR group, including shorter operating room time (2.30 vs 2.83 hrs, P<0.001), shorter hospital stay (1.16 vs 1.69 d, P<0.001), less need for intensive care monitoring (4.4% vs 48.0%, P<0.001), and lower secondary intervention rate (0% vs 2.4%, P=0.01). Postdischarge outcomes also favored fast-track EVAR with a lower rate of MAE (0% vs 7.2%, P<0.001) and all-cause readmission (1.6% vs 6.8%, P=0.001). The total cost to the health care system during the perioperative period was $26,730 with fast-track EVAR vs $30,730 with standard EVAR. Total perioperative health care costs were $4000 (95% CI: $3130-$4830) lower with fast-track EVAR vs standard EVAR, with $2980 in savings to hospitals and $1030 savings to health care payers. CONCLUSION: A fast-track EVAR protocol using a 14 Fr stent graft resulted in shorter procedure time, lower intensive care utilization, faster discharge, lower incidence of MAE, lower readmission rates, and lower perioperative costs compared to standard EVAR.

Early Outcomes with Fast-Track EVAR in Teaching and Nonteaching Hospitals.

BACKGROUND: The influence of hospital teaching status on fast-track endovascular aneurysm repair (EVAR) outcomes is unknown. This study explored the feasibility, safety, and effectiveness of a fast-track EVAR protocol at teaching and nonteaching hospitals. METHODS: Patients underwent a fast-track EVAR protocol composed of bilateral percutaneous access using a 14F stent graft, avoidance of general anesthesia and intensive care admission, and next-day discharge. Patients were followed up for 1 month post-treatment. Participating hospitals were categorized by teaching status (teaching versus nonteaching) and compared for perioperative and 30-day outcomes. RESULTS: Between October 2014 and May 2016, 250 patients were enrolled at 31 centers in the United States. The study included 186 patients treated among 21 teaching hospitals and 64 patients treated among 10 nonteaching hospitals. Fast-track EVAR protocol completion was higher at teaching hospitals (91% vs. 73%, P = 0.01). Intensive care admission was avoided in 99% of patients at teaching hospitals versus 84% at nonteaching hospitals (P < 0.001). The ability to complete all other fast-track EVAR elements was proportionally higher at teaching hospitals, but differences were not statistically different. In-hospital outcomes by teaching status were comparable overall. Median time to discharge was 25 and 26 hr, respectively. There were no reports of type III endoleak, abdominal aortic aneurysm rupture, or secondary intervention. Comparing teaching versus nonteaching hospitals, there were no differences in major adverse events (1% vs. 0%), type I endoleak (0% vs. 2%), limb occlusion (1% vs. 0%), all-cause mortality (1% vs. 0%), and 30-day readmissions (1% vs. 3%). CONCLUSIONS: A fast-track EVAR protocol can be implemented with high success in well-selected patients at teaching and nonteaching hospitals. Health care resource utilization, perioperative data, and 30-day outcomes were excellent overall, with higher frequency of intensive care admission at nonteaching hospitals.

Perioperative Outcomes From the Prospective Multicenter Least Invasive Fast-Track EVAR (LIFE) Registry.

PURPOSE: To determine the feasibility, perioperative resource utilization, and safety of a fast-track endovascular aneurysm repair (EVAR) protocol in well-selected patients. METHODS: Between October 2014 and May 2016, the LIFE (Least Invasive Fast-track EVAR) registry ( ClinicalTrials.gov identifier NCT02224794) enrolled 250 patients (mean age 73±8 years; 208 men) in a fast-track EVAR protocol comprised of bilateral percutaneous access using the 14-F Ovation stent-graft, no general anesthesia, no intensive care unit (ICU) admission, and next-day discharge. The primary endpoint was major adverse events (MAE) through 30 days. The target performance goal for the MAE endpoint was 10.4%. RESULTS: Vascular access, stent-graft delivery, and stent-graft deployment success were 100%. A total of 216 (86%) patients completed all elements of the fast-track EVAR protocol. Completion of individual elements was 98% for general anesthesia avoidance, 97% for bilateral percutaneous access, 96% for ICU avoidance, and 92% for next-day discharge. Perioperative outcomes included mean procedure time of 88 minutes, median blood loss of 50 mL, early oral nutrition (median 6 hours), early mobilization (median 8 hours), and short hospitalization (median 26 hours). Fast-track EVAR completers had shorter procedure time (p<0.001), less blood loss (p=0.04), faster return to oral nutrition (p<0.001) and ambulation (p<0.01), and shorter hospital stay (p<0.001). With 241 (96%) of the 250 patients returning for the 30-day follow-up, the MAE incidence was 0.4% (90% CI 0.1% to 1.8%), significantly less than the 10.4% performance goal (p<0.001). No aneurysm rupture, conversion to surgery, or aneurysm-related secondary procedure was reported. There were no type III endoleaks and 1 (0.4%) type I endoleak. Iliac limb occlusion was identified in 2 (0.8%) patients. The 30-day hospital readmission rate was 1.6% overall. CONCLUSION: A fast-track EVAR protocol was feasible in well-selected patients and resulted in efficient perioperative resource utilization with excellent safety and effectiveness.

A Multicenter, Retrospective Study of the Effectiveness of the Trellis-8 System in the Treatment of Proximal Lower-Extremity Deep Vein Thrombosis.

BACKGROUND: Deep vein thrombosis (DVT) occurs in up to 600,000 patients in the United States annually and can lead to long-term morbidity because of the post-thrombotic syndrome. The multicenter isolated-pharmacomechanical thrombolysis device (ISOL-8) study was designed to determine the safety and efficacy of the Trellis™-8 peripheral infusion system when used as the primary intervention to achieve DVT thrombolysis in patients with proximal lower-extremity occlusive DVT, and track the incidence and severity of the post-thrombotic syndrome (PTS) symptoms in patients 2 years after treatment. METHODS: Data were collected retrospectively from 6 centers on patients treated with the Trellis-8 system, an isolated-pharmacomechanical thrombolysis device (IPMTD). Patients with occlusive lower-extremity DVT involving at least the iliac and/or common femoral vein were included. Patient demographics, medical history, procedure outcomes, complications, and follow-up venous duplex and Venous Clinical Severity Score (VCSS) were collected through 24 months. Data analysis of outcomes were performed at 1 and 12 months. A 24-month analysis was not performed because of the small number of patients for whom 24-month data could be collected. RESULTS: A total of 151 limbs in 139 patients were treated with IPMTD. The mean ± standard deviation (SD) procedure time was 122.6 ± 63.4 min. Single session treatment was delivered in 69.9% (93 of 133) of cases. Occlusive DVT extended from the femoral into the external and/or common iliac vessel segments in most of the cases (113 of 151 limbs; 74.8%). Before treatment, 23.2% (35 of 151) of the treated limbs, based on a history of prior ipsilateral DVT or preoperative imaging revealing chronic venous scar, were expected to have some chronic venous disease despite presenting with acute symptoms. After treatment, 43.7% (66 of 151) of the limbs showed evidence of chronic thrombus. The average amount (mean ± SD) of thrombolysis, as determined by venogram, was highest in patients who had acute thrombus (81 ± 19.7%), compared with subacute thrombus (61 ± 22.5%) and complex cases involving acute and/or subacute thrombus on chronic scar (56 ± 26.5%). VCSS scoring showed the number of patients with none and/or mild pain, varicose veins, and skin changes at 1-month remained stable at 12 months whereas the percent of patients with none and/or mild venous edema improved from 71.7% at 1 month (38 of 53) to 86.8% (46 of 53) at 12 months. Twenty-four-month follow-up data were available for only 15% (23 of 151) of patients. No clinically significant pulmonary emboli or major periprocedural bleeding events were reported. CONCLUSIONS: Patients with acute lower-extremity DVT involving the proximal veins can be safely and successfully treated with IPMTD. Major procedural bleeding was absent. The occurrence of severe PTS after primary treatment with Trellis-8 system IPMTD is low. Further long-term follow-up data are needed to confirm the benefit of intervention for thrombus removal compared with standard medical management.

Endovascular exclusion of popliteal artery aneurysms with expanded polytetrafluoroethylene stent-grafts: early results.

There is increasing interest in using endovascular methods instead of surgical reconstruction to treat popliteal artery aneurysms. Exclusive use of the Viabahn stent-graft, a nitinol stent covered with expanded polytetrafluoroethylene, was assessed in the treatment of patients who presented with popliteal artery aneurysms in the absence of acute limb ischemia. Technical success, endoleaks, graft patency, freedom from amputation, and aneurysm sac flow and size changes were assessed by duplex ultrasound. From June 2004 to March 2006, 16 men (mean age, 76 years; range, 65-83) underwent endovascular exclusion of 23 popliteal artery aneurysms (mean diameter, 2.5 cm; range, 1.3-6.7 cm). Nine lesions had partial thrombus on preprocedural duplex imaging. Nineteen of the 23 limbs treated had at least 2-vessel tibial artery runoff. Procedures were performed under local anesthesia using ipsilateral percutaneous antegrade arterial access. All patients received 75 mg/day of clopidogrel afterward. Follow-up assessments included direct clinical examinations and duplex ultrasonography performed 1, 3, 6, and 12 months after the procedure. Primary patency and amputation-free survival were calculated using Kaplan-Meier analysis. Complete aneurysm exclusion (technical success) was achieved in all cases. During the mean follow-up of 7 months (range, 1-21 months), 22 of 23 treated limbs remained asymptomatic. One stent-graft thrombosis occurred 6 months after the procedure and was successfully treated with percutaneous mechanical thrombectomy, balloon angioplasty of a stent-graft stenosis, and insertion of an uncovered nitinol stent. No popliteal artery aneurysm sac size enlargements or endoleaks were detected. At 12 months, the treated limb mean ankle-brachial index was 1.0 (range, 0.82-1.31) and the primary and secondary patency rates were 93% and 100%, respectively. Early results with Viabahn endovascular stent-graft exclusion of asymptomatic popliteal artery aneurysms are promising. Patient selection for endovascular repair depends on suitable popliteal artery anatomy, extent of aneurysmal degeneration, and quality of tibial arterial runoff.

Internal iliac artery occlusion using a stent-graft tunnel during endovascular aneurysm repair: a new alternative to coil embolization.

PURPOSE: To report a new endovascular technique for internal iliac artery (IIA) occlusion during stent-graft treatment in patients with aortoiliac aneurysm. TECHNIQUE: Stent-grafts measuring 20 to 28 mm in diameter and 37.5 mm long were deployed at the iliac bifurcation to occlude the IIA at its origin. Subsequent deployment of an aortic bifurcation endograft with ipsilateral extension into the external iliac artery was through this iliac stent-graft tunnel. This approach has been used in 5 patients with abdominal aortic aneurysm and common iliac artery aneurysm (n=4) or isolated iliac artery aneurysm. Proximal IIA occlusion was achieved in all cases with no distal type I endoleak. IIA patency on the side opposite to the tunnel procedure was preserved in each case. No patient described new onset of pelvic ischemic symptoms. Over a mean 10-month follow-up (range 1-12), there was no secondary procedure required for type I endoleak. Three patients had a CIA aneurysm diameter change of -1, -4, and 0 mm at 1 year. CONCLUSIONS: This new method for IIA occlusion at its origin without coil embolization may prove to be a useful adjunct to endovascular aortoiliac aneurysm repair. The technique is simple, rapid, and may minimize the risk of pelvic ischemia.

Do donor characteristics really matter? Short- and long-term impact of donor characteristics on recipient survival, 1995-1999.

We reviewed the impact of multiple donor characteristics on recipient mortality by univariate and multivariate analyses in a cohort of heart donors from 1995 to 1999. A sub-cohort of donors was also selected who met "marginal" criteria, and the early and late survival of these patients was then compared. Surrogates of donor size (donor weight, donor body mass index [BMI], BMI mismatch >20%), under-resuscitation (hematocrit, 24-hour fluid intake) and age >56 years were significantly associated with peri-operative mortality in the univariate analysis; in the multivariate analysis, only average donor heart rate at procurement (p =.001), donor hematocrit (p =.02) and donor weight (p =.05) were significantly associated. Few donor characteristics actually impact significantly on recipient outcome, and thus recipient characteristics may figure more prominently than those of the donor toward the risk of death after transplantation.