The Safety and Effectiveness of the Prostar XL Closure Device Compared to Open Groin Cutdown for Endovascular Aneurysm Repair.

OBJECTIVE: The aim of this study is to compare the outcomes of percutaneous femoral closure with the Prostar XL for endovascular aneurysm repair (EVAR) to those of open femoral cutdown, and to evaluate factors which may predict the failure of percutaneous closure. METHODS: Patients undergoing endovascular aneurysm repair for an infrarenal abdominal aortic aneurysm between 2005 and 2013 were included. Patient characteristics, anatomic femoral artery measurements, and postoperative complications were recorded retrospectively. Operator experience was defined with a cut-off point of >30 Prostar XL closures performed. Comparisons were made per access site. RESULTS: A total of 443 access sites were included, with percutaneous closure used in 257 cases (58.0%) and open cutdown in 186 cases (42.0%). The complication rate was 2.7% for the percutaneous and 4.3% for the open cutdown group (P = .482). No significant differences between groups were found with respect to 30-day mortality, wound infections, thrombosis, seromas, or bleeding complications. Fourteen failures (5.4%) of percutaneous closure occurred. The success rates were similar for experienced and unexperienced operators (94.2% vs 95.5%, P = .768). Renal insufficiency was more common in the failed than in the successful percutaneous closure group (64.3% vs 24.7%, P = .003). Common femoral artery calcification or diameter, BMI, sheath size, or operator experience did not predict failure. No further complications were seen in follow-up CT at 1-3 years postoperatively. CONCLUSION: The use of the Prostar XL is safe compared to open cutdown. The success rate is 94.6%. Operator experience, sheath size, obesity, or femoral artery diameter or calcification do not appear to predict a failure of percutaneous closure. Complications seem to occur perioperatively, and late complications are rare.

Endovascular Repair of Abdominal Aortic Aneurysms is a Valid Alternative to Open Repair also in Patients Treated Outside of Instructions for Use Criteria.

PURPOSE: It remains unclear whether endovascular aneurysm repair, in the long term, is less effective than open surgery due to need for reinterventions and close monitoring. We aimed to evaluate this matter in a real-life cohort. METHODS: We collected consecutive patients treated with EVAR or OSR between January 2005 and December 2013. Primary outcomes were 30-day, 90-day and long-term all-cause mortality. Secondary outcomes were 30-day reintervention rate and reintervention-free survival. We evaluated also a subpopulation who did not adhere to IFU. RESULTS: The inclusion criteria were met by 416 patients. 258 (62%) received EVAR, while 158 (38%) underwent OSR. The 30- or 90-day mortality was similar between groups (p = 0.272 and p = 0.346), as ARM (p = 0.652). The 30-day reintervention rate was higher in the OSR group (p < 0.001), but during follow-up, it was significantly higher in the EVAR group (log-rank: 0.026). There were 114 (44.2%) non-IFU patients in the EVAR group, and we compared them with OSR group. There was no significant difference in all-cause mortality at 30 or 90 days, nor in the long term (p = 1; p = 1 and p = 0.062). ARM was not affected by the procedure technique (p = 0.136). The short-term reintervention rate was higher in the OSR group (p = 0.003), while in the long-term EVAR, patients experienced more reinterventions (log-rank = 0.0.43). CONCLUSION: No significant difference in survival was found between EVAR and OSR, independent of adherence to IFU. EVAR may be considered for surgical candidates.

Reliability and Safety of Individualized Follow-up Based on the 30-day Computed Tomography Angiogram after Endovascular Aneurysm Repair.

BACKGROUND: Most patients undergo uneventful surveillance after endovascular aneurysm repair (EVAR), and therefore, unmodified surveillance protocols are ineffective. An example of a modified follow-up protocol was introduced by the European Society for Vascular Surgery (ESVS) in January 2019. One feature of this protocol is that for the patients with adequate sealing and without any detectable endoleak at 30 days, the next scheduled follow-up could be at 5 years. The purpose of this study was to analyze retrospectively the applicability of this protocol. METHODS: Between 2005 and 2013, 348 patients were treated electively for abdominal aortic aneurysm (AAA) with a standard EVAR. All patients were annually followed and they were retrospectively fitted into the ESVS follow-up protocol based on imaging findings. RESULTS: The mean follow-up was 74 months (standard error 2.1; range, 0-165 months). Thirty-day mortality was 1.1% (n = 4). Imaging data for those surviving the first 30 days were available for 98.8% (n = 340) subjects. At a 1-month control examination, 79.3% (n = 276) of the patients had no detectable endoleak and sealing was adequate (≥1 cm). Of those patients, with the lowest risk, 11.6% (n = 32) required reintervention for graft-related complication during the next 5 years. In all, complications requiring treatment that would have been missed by following the suggested protocol included type 1A endoleak (n = 7), type 1B (n = 10), type 2 (n = 7), migration (n = 2), thrombosis (n = 10), kinking (n = 1), and ruptured AAA (n = 6). The sensitivity of 30-day computed tomography angiogram was 34.9% (95% confidence interval 21.01-50.93%) and specificity 83.3% (95% confidence interval 78.57-87.41%) for finding significant complications during first 5 years. CONCLUSIONS: Based on our findings, by following the example ESVS follow-up protocol, we would have missed major life-threatening complications. Significant stent-graft failures occur during the first 5 years, even for those with noncomplicated post-EVAR findings in the first computed tomography angiogram at 1 month.

Long-term outcomes of endovascular aneurysm repair according to instructions for use adherence status.

OBJECTIVE: Endovascular aneurysm repair (EVAR) has become the standard treatment for abdominal aortic aneurysms (AAAs). Endovascular device manufacturers have defined specific anatomic criteria for the aneurysm characteristics that should be observed as instructions for use (IFU) for specific grafts. In clinical practice, the prevalence of performing EVAR outside the IFU has been high. In the present study, we aimed to determine the effects of nonadherence to the IFU on the outcomes. METHODS: Patients who had undergone EVAR for an infrarenal AAA between 2005 and 2013 were included. IFU nonadherence was defined as any violation of device-specific IFU criteria and was compared with IFU adherence. The primary outcomes were all-cause mortality, aneurysm-related mortality, AAA rupture, graft-related adverse events (GRAEs), including limb-related adverse events, and type Ia endoleaks. A second aim was to study whether the prevalence of EVAR performed outside the IFU has increased over time. RESULTS: A total of 258 patients were included, 144 (55.8%) of whom had been treated according to the IFU and 114 (44.2%) outside the IFU. In the IFU nonadherence group, all-cause mortality (hazard ratio [HR], 1.39; 95% confidence interval [CI], 1.02-1.89; P = .037) and aneurysm-related mortality (HR, 5.1; 95% CI, 1.4-18.6; P = .015), and the incidence of AAA rupture (HR, 5.4; 95% CI, 1.1-26.6; P = .036) and GRAEs (HR, 1.7; 95% CI, 1.1-2.8; P = .025). No significant association was found between the incidence of type Ia endoleaks and neck-related IFU or limb-related adverse events and iliac-related IFU. However, neck length was a risk factor for type Ia endoleaks (HR, 18.2, 95% CI, 6.3-52.2; P < .001), aneurysm-related mortality (HR, 8.7; 95% CI, 1.8-41.6; P = .007), AAA rupture (HR, 21.7; 95% CI, 2.8-166; P = .003), and GRAEs (HR, 4.4; 95% CI, 2.0-9.7; P < .001). An IFU violation regarding neck angulation was also a risk factor for all-cause mortality (HR, 2.0; 95% CI, 1.1-3.7; P = .032), aneurysm-related mortality (HR, 7.6; 95% CI, 1.4-42.8; P = .021), AAA rupture (HR, 79.4; 95% CI, 6.3-999; P = .001), and GRAEs (HR, 4.3; 95% CI, 1.9-9.5; P < .001). The prevalence of EVAR performed outside the IFU did not increase over time. CONCLUSIONS: Performing EVAR outside the IFU had a negative effect on outcomes, including all-cause mortality, aneurysm-related mortality, AAA rupture, and GRAEs. Neck angulation and neck length seemed to be the most crucial aneurysm characteristics.

The effect of suprarenal graft fixation during endovascular aneurysm repair on short- and long-term renal function.

OBJECTIVE: The effect of suprarenal fixation (SR) compared with infrarenal fixation (IR) on renal function during endovascular aneurysm repair (EVAR) remains controversial. This study aims to compare the renal outcomes between fixation types in short- and long-term follow-up. METHODS: Patients undergoing EVAR for infrarenal abdominal aortic aneurysm between 2005 and 2013 were included. The estimated glomerular filtration rate (eGFR) was measured at baseline and during a follow-up of 5 years. A decline in renal function was defined as a 20% or greater decrease in the eGFR. Changes in the eGFR were compared between SR and IR groups at 1 to 7 days, 30 days, and 1 to 5 years postoperatively. Preoperative renal insufficiency was defined as an eGFR of less than 60 mL/min/1.73 m2, and those patients were included in the subanalyses. RESULTS: A total of 358 patients were included. Among these, 267 (74.6%) had SR and 91 (25.4%) had IR fixation. A decrease in renal function occurred more commonly after SR than after IR in 1 to 7 days postoperatively (P = .009), but no difference was noticed at 30 days and 1 to 5 years. Regardless of the fixation method, renal function steadily decreased steadily over time after EVAR (estimate -3.13 per a year; 95% confidence interval, -3.40 to -2.85; P < .001). Patients with preexisting renal insufficiency were included in subgroup analyses, and those with SR were more often found to have a decline in eGFR 5 years postoperatively than their counterparts with IR (59.5% vs 20.0%; P = .036). CONCLUSIONS: An immediate postoperative decrease in renal function was seen more often after SR fixation than IR fixation but this difference was transient. SR fixation is a safe method for patients with normal renal function. Long-term results seems to favor IR over SR in patients with preexisting renal insufficiency.

Mortality Following Bariatric Surgery Compared to Other Common Operations in Finland During a 5-Year Period (2009-2013). A Nationwide Registry Study.

PURPOSE: A concern regarding the safety of bariatric surgery may explain the fact that only a minor fraction of morbidly obese patients has access to it. This is a population-based, nationwide study reporting 30-day, 90-day, and 1-year mortality rates following bariatric surgery in comparison with mortality rates after other common operations in Finland. MATERIALS AND METHODS: Patients undergoing surgery between January 2009 and December 2013 were included. Data on surgical procedures were obtained from the national hospital discharge registry, and cause of death was obtained from Statistics Finland. RESULTS: Inclusion criteria were met by 156,536 patients. Of these, 3918 underwent surgery for morbid obesity. Three patients (0.08%) died within 30 days following bariatric surgery. The 30-day mortality rate was lower only following prostatectomy. Compared with bariatric surgery, the hazard ratios (HR) for 1-year postoperative mortality were significantly higher for elective cholecystectomy (HR 2.38, 95% CI 1.39-4.08, p = 0.002), hysterectomy (HR 2.87, 95% CI 1.68-4.92, p < 0.001), knee arthroplasty (HR 2.23, 95% CI 1.31-3.81, p = 0.003), hip arthroplasty (HR 11.7, 95% CI 6.90-19.8, p < 0.001), colorectal resections (HR 27.5, 95% CI 16.2-46, p < 0.001), gastric resection (HR 53.0, 95% CI 30.2-93.2, p < 0.001), gastrectomy (HR 74.7, 95% CI 43.0-130, p < 0.001), and coronary artery bypass grafting (HR 30.7, 95% CI 17.4-54.3, p < 0.001). CONCLUSION: Mortality rates following bariatric surgery are low and similar or lower than mortality rates following all other common elective surgeries.

[Fast track bariatric surgery]. / Lihavuuskirurgia nopean toipumisen ohjelmalla.

BACKGROUND: Relatively little is known about the use of fast track protocols in bariatric surgery. MATERIAL AND METHODS: We carried out an observational study of 422 consecutive patients who underwent bariatric surgery by a fast track protocol. RESULTS: Mean length of stay was 1.3 days, median 1 day. Of all patients, 83% were discharged on the first postoperative day. Three patients (0.7%) had life-threatening complications. The readmission rate was 4.7%, and 3.3% of the patients had to be reoperated. The body weight dropped 31% in a year. CONCLUSIONS: Early discharge does not seem to increase postoperative morbidity or readmissions.

Outcome of Laparoscopic Gastric Bypass (LRYGB) with a Program for Enhanced Recovery After Surgery (ERAS).

BACKGROUND: Enhanced recovery after surgery (ERAS) programs are well established for patients undergoing colorectal surgery. Relatively little is known about ERAS following bariatric surgery in general or following laparoscopic Roux-en-Y gastric bypass (LRYGB) in particular. PATIENTS AND METHODS: This is a prospective, observational study of 388 consecutive patients that underwent LRYGB with ERAS in a general hospital. The ERAS protocol included standardizations of pre-, intra-, and postoperative modalities in order to reduce the stress response of the patients. Primary outcome measures were length of stay (LOS), postoperative morbidity, readmissions, and reoperations. RESULTS: Mean (SD) baseline body mass index (BMI) and age was 46.4 (6.7) kg/m(2) and 45.1 (11.2) years, respectively. Fifty-four percent of the patients were on medication for hypertension (HT) and 38 % for type 2 diabetes mellitus (DM2). Mean (SD) and median (range) surgical time was 73.8 (16.9) and 65 (40-143) min, respectively. Mean LOS was 1.3 days (1.1), median 1 day (1-14). Of all patients, 322 (83 %) were discharged on the first postoperative day (POD). Overall morbidity was 9.8 %. Three patients (0.8 %) had life-threatening complications. The readmission rate was 4.9 %, and 3.4 % of the patients had to be reoperated. With a follow-up rate of 83 % at 1 year, total weight loss (TWL) was 31 % and excess BMI loss (EBMIL) 70 %. Total remission of DM2 and HT was achieved in 70 and 42 % of the patients, respectively. CONCLUSION: Enhanced recovery following LRYGB with ERAS programs is possible and safe even in a low volume, general hospital. Early discharge does not increase postoperative morbidity or readmissions.