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.Peer reviewe

Infrarenaalisen aortan avokirurgian erikoislääkärikoulutuksen haasteet leikkausten muuttuessa mini-invasiivisiksi

Teema : aortt

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.publishedVersionPeer reviewe

Routine Inferior Mesenteric Artery Embolisation is Unnecessary Before Endovascular Aneurysm Repair

Peer reviewe

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.publishedVersionPeer reviewe

The effect of percutaneous transluminal angioplasty of superficial femoral artery on pulse wave features

We aimed to analyze the effects of percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) on arterial pulse waves (PWs). Altogether 24 subjects i.e. 48 lower limbs were examined including 26 treated lower limbs having abnormal ankle-to-brachial pressure index (ABI) (ABI1.3) and 22 non-treated lower limbs. The measurements were conducted in pre-, peri- and post-treatment phases as well as in follow-up visit after 1 month. Both ABI and toe pressures measured by standard equipment were used as reference values. PW-derived parameters include ratios of different peaks of the PW and time differences between them as well as aging index. Both treated and non-treated limbs were compared in pre- and post-treatment as well as follow-up visit conditions. The results were evaluated in terms of statistical tests, Bland-Altman-plots, free-marginal multirater κ-analysis and multiple linear regression analysis. PTA was found to cause small changes to the studied PW-derived parameters of the treated limb which were observed immediately after the treatment, but the changes were more pronounced in the follow-up visit. In addition, we observed that the endovascular instrumentation itself does not cause significant changes to the PW-derived parameters. The results show that PW-analysis could be a useful tool for monitoring the treatment-effect of the PTA. However, because the pre-treatment differences of the treated and non-treated limb were small, further studies with subjects having no arterial diseases are required. The study demonstrates the potential of the PW analysis in monitoring vascular abnormalities.acceptedVersionPeer reviewe

Induction of CD73 prevents death after emergency open aortic surgery for a ruptured abdominal aortic aneurysm : a randomized, double-blind, placebo-controlled study

Mortality remains high after emergency open surgery for a ruptured abdominal aortic aneurysm (RAAA). The aim of the present study was to assess, if intravenous (IV) Interferon (IFN) beta-1a improve survival after surgery by up-regulating Cluster of differentiation (CD73). This is a multi-center phase II double-blind, 2:1 randomized, parallel group comparison of the efficacy and safety of IV IFN beta-1a vs. placebo for the prevention of death after open surgery for an infra-renal RAAA. All study patients presented a confirmed infra-renal RAAA, survived the primary emergency surgery and were treated with IFN beta-1a (10 mu g) or matching placebo for 6 days after surgery. Major exclusion criteria included fatal hemorrhagic shock, chronic renal replacement therapy, diagnosed liver cirrhosis, severe congestive heart failure, advanced malignant disease, primary attempt of endovascular aortic repair (EVAR), and per-operative suprarenal clamping over 30 min. Main outcome measure was all-cause mortality at day 30 (D30) from initial emergency aortic reconstruction. The study was pre-maturely stopped due to a reported drug-drug interaction and was left under-powered. Out of 40 randomized patients 38 were included in the outcome analyses (27 IFN beta-1a and 11 placebo). There was no statistically significant difference between treatment groups at baseline except more open-abdomen and intestinal ischemia was present in the IFN beta-1a arm. D30 all-cause mortality was 22.2% (6/27) in the IFN beta-1a arm and 18.2% (2/11) in the placebo arm (OR 1.30; 95% CI 0.21-8.19). The most common adverse event relating to the IFN beta-1a was pyrexia (20.7% in the IFN beta-1a arm vs. 9.1% in the placebo arm). Patients with high level of serum CD73 associated with survival (P = 0.001) whereas the use of glucocorticoids and the presence of IFN beta-1a neutralizing antibodies associated with a poor CD73 response and survival. The initial aim of the trial, if postoperative INF beta-1a treatment results on better RAAA survival, could not be demonstrated. Nonetheless the anticipated target mechanism up-regulation of CD73 was associated with 100% survival. According to present results the INF beta-1a induced up-regulation of serum CD73 was blocked with both use of glucocorticoids and serum IFN beta-1a neutralizing antibodies. The study was pre-maturely stopped due to interim analysis after a study concerning the use if IV IFN beta-1a in ARDS suggested that the concomitant use of glucocorticoids and IFN beta-1a block the CD73 induction.Peer reviewe

Routine Inferior Mesenteric Artery Embolisation is Unnecessary Before Endovascular Aneurysm Repair

Objective: A type II endoleak is the most common complication during surveillance after endovascular aneurysm repair (EVAR), and a patent inferior mesenteric artery (IMA) is a known risk factor for an endoleak. The effect of routine IMA embolisation prior to EVAR on overall outcome is unknown. The aim of the study was to compare two strategies: routine attempted IMA embolisation prior to EVAR (strategy in centre A) and leaving the IMA untouched (strategy in centre B). Methods: Patients were treated with EVAR in two centres during the period 2005 – 2015, and the data were reviewed retrospectively. The primary endpoints were re-intervention rate due to type II endoleaks and the late IMA embolisation rate. Secondary endpoints included EVAR related re-intervention, sac enlargement, aneurysm rupture, and open conversion rates. Results: Strategy A was used to treat 395 patients. The IMA was patent in 268 (67.8%) patients, and embolisation was performed in 164 (41.5%). The corresponding figures for strategy B were 337 patients with 279 (82.8%) patent IMAs, two (0.6%) of which were embolised. The mean duration of follow up was 70 months for strategy A and 68.2 months for strategy B. The re-intervention rates due to a type II endoleak were 12.9% and 10.4%, respectively (p = .29), with no significant difference in the rate of re-interventions to occlude a patent IMA (2.0% and 4.7%, respectively; p = .039). The EVAR related re-intervention rate was similar, regardless of strategy (24.1% and 24.6%, respectively; p = .93). Significant sac enlargement was seen in 20.3% of cases treated with strategy A and in 19.6% treated with strategy B (p = .82). The rupture and conversion rates were 2.5% and 2.1% (p = .69) and 1.0% and 1.5% (p = .40), respectively. Conclusion: The strategy of routinely embolising the IMA does not seem to yield any significant clinical benefit and should therefore be abandoned.publishedVersionPeer reviewe

Induction of CD73 prevents death after emergency open aortic surgery for a ruptured abdominal aortic aneurysm: a randomized, double-blind, placebo-controlled study

Mortality remains high after emergency open surgery for a ruptured abdominal aortic aneurysm (RAAA). The aim of the present study was to assess, if intravenous (IV) Interferon (IFN) beta-1a improve survival after surgery by up-regulating Cluster of differentiation (CD73). This is a multi-center phase II double-blind, 2:1 randomized, parallel group comparison of the efficacy and safety of IV IFN beta-1a vs. placebo for the prevention of death after open surgery for an infra-renal RAAA. All study patients presented a confirmed infra-renal RAAA, survived the primary emergency surgery and were treated with IFN beta-1a (10 mu g) or matching placebo for 6 days after surgery. Major exclusion criteria included fatal hemorrhagic shock, chronic renal replacement therapy, diagnosed liver cirrhosis, severe congestive heart failure, advanced malignant disease, primary attempt of endovascular aortic repair (EVAR), and per-operative suprarenal clamping over 30 min. Main outcome measure was all-cause mortality at day 30 (D30) from initial emergency aortic reconstruction. The study was pre-maturely stopped due to a reported drug-drug interaction and was left under-powered. Out of 40 randomized patients 38 were included in the outcome analyses (27 IFN beta-1a and 11 placebo). There was no statistically significant difference between treatment groups at baseline except more open-abdomen and intestinal ischemia was present in the IFN beta-1a arm. D30 all-cause mortality was 22.2% (6/27) in the IFN beta-1a arm and 18.2% (2/11) in the placebo arm (OR 1.30; 95% CI 0.21-8.19). The most common adverse event relating to the IFN beta-1a was pyrexia (20.7% in the IFN beta-1a arm vs. 9.1% in the placebo arm). Patients with high level of serum CD73 associated with survival (P = 0.001) whereas the use of glucocorticoids and the presence of IFN beta-1a neutralizing antibodies associated with a poor CD73 response and survival. The initial aim of the trial, if postoperative INF beta-1a treatment results on better RAAA survival, could not be demonstrated. Nonetheless the anticipated target mechanism up-regulation of CD73 was associated with 100% survival. According to present results the INF beta-1a induced up-regulation of serum CD73 was blocked with both use of glucocorticoids and serum IFN beta-1a neutralizing antibodies. The study was pre-maturely stopped due to interim analysis after a study concerning the use if IV IFN beta-1a in ARDS suggested that the concomitant use of glucocorticoids and IFN beta-1a block the CD73 induction.</p