Publications by authors named "Michel S Makaroun"

168 Publications

New randomized controlled trials for abdominal aortic aneurysm treatment should focus on younger, good-risk patients.

J Vasc Surg 2021 Jun;73(6):2209

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

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http://dx.doi.org/10.1016/j.jvs.2020.11.053DOI Listing
June 2021

Poor runoff and distal coverage below the knee are associated with poor long-term outcomes following endovascular popliteal aneurysm repair.

J Vasc Surg 2021 Jul 20;74(1):153-160. Epub 2021 Apr 20.

University of Pittsburgh Medical Center, Heart and Vascular Institute, Pittsburgh, Pa. Electronic address:

Objective: Reports of good short-term outcomes for endovascular repair of popliteal artery aneurysms have led to an increased use of the technique. However, data are lacking on long-term limb-related outcomes and factors associated with the failure of endovascular repair.

Methods: All patients who underwent endovascular popliteal aneurysm repair (EPAR) at a single institution from January 2006 to December 2018 were included in the study. Demographics, indications, anatomic and operative details, and outcomes were reviewed. Long-term patency, major adverse limb event-free survival (MALE-FS) and graft loss/occlusion were analyzed with multivariable cox regression analysis and Kaplan-Meier curves.

Results: We included 117 limbs from 101 patients with a mean follow-up of 55.6 months (range, 0.43-158 months). The average age was 73 ± 9.3 years. Thirty-two patients (29.1%) were symptomatic (claudication, rest pain, tissue loss, or rupture). The stent grafts crossed the knee joint in 91.4% of cases. In all, 36.8% of procedures used one stent graft, 41.0% used two stent grafts, and 22.2% of procedures used more than two stent grafts. The median arterial length covered was 100 mm, with an average length of stent overlap of 25 mm. Tapered configurations were used in 43.8% of cases. The majority of limbs (62.8%) had a three-vessel runoff, 20.2% had a two-vessel runoff, and 17% has a one-vessel runoff. The Kaplan-Meier estimates of graft occlusion at 1 and 3 years were 6.3% and 16.2%, respectively. The 1- and 3-year primary patency rates were 88.2% and 72.6%, and the 1- and 3-year major adverse limb event-free survival (MALE-FS) rates were 82% and 57.4%. The 1- and 3-year survival rates were 92.9% and 76.2%, respectively. On multivariable Cox regression, aneurysm size, one-vessel runoff, and coverage below the knee were associated with a lower 3-year MALE-FS. Coverage below the knee was also associated with a lower 3-year MALE-FS. Other anatomic or technical details were not associated with limb-related events or patency.

Conclusions: This study is the largest single center analysis to describe the predictors of poor outcomes after EPAR. EPAR is a safe and effective way to treat popliteal artery aneurysms. Factors associated with poor MALE-FS after EPAR include single-vessel tibial runoff and coverage below the knee.
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http://dx.doi.org/10.1016/j.jvs.2020.12.062DOI Listing
July 2021

Comparable Patency of Open and Hybrid Treatment of Venous Anastomotic Lesions in Thrombosed Haemodialysis Grafts.

Eur J Vasc Endovasc Surg 2020 Dec 11;60(6):897-903. Epub 2020 Sep 11.

Division of Vascular Surgery, University of Pittsburgh Medical Centre, Pittsburgh, PA, USA. Electronic address:

Objective: Arteriovenous graft (AVG) failures are typically associated with venous anastomotic (VA) stenosis. Current evidence regarding AVG thrombosis management compares surgical with purely endovascular techniques; few studies have investigated the "hybrid" intervention that combines surgical balloon thrombectomy and endovascular angioplasty and/or stenting to address VA obstruction. This study aimed to describe outcomes after hybrid intervention compared with open revision (patch venoplasty or jump bypass) of the VA in thrombosed AVGs.

Methods: Retrospective cohort study. Consecutive patients with a thrombosed AVG who underwent thrombectomy between January 2014 and July 2018 were divided into open and hybrid groups based on VA intervention; patients who underwent purely endovascular thrombectomy were excluded. Patient demographics, previous access history, central vein patency, AVG anatomy, type of intervention, and follow up data were recorded. Kaplan-Meier curves were used to analyse time from thrombectomy to first re-intervention (primary patency) and time to abandonment (secondary patency). Cox regression analysis was performed to evaluate predictors of failure.

Results: This study included 97 patients (54 females) with 39 forearm, 47 upper arm, and 11 lower extremity AVGs. There were 34 open revisions (25 patches, nine jump bypasses) and 63 hybrid interventions, which included balloon angioplasty ± adjunctive procedures (15 stents, five cutting balloons). Technique selection was based on physician preference. Primary patency for the open and hybrid groups was 27.8% and 34.2%, respectively, at six months and 17.5% and 12.9%, respectively, at 12 months (p = .71). Secondary patency was 45.1% and 38.5% for open and hybrid treatment, respectively, at 12 months (p = .87). An existing VA stent was predictive of graft abandonment (hazard ratio 4.4, 95% confidence interval 1.2-16.0; p = .024). Open vs. hybrid intervention was not predictive of failure or abandonment.

Conclusion: Hybrid interventions for thrombosed AVGs are not associated with worse patency at six and 12 months compared with open revision.
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http://dx.doi.org/10.1016/j.ejvs.2020.08.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906772PMC
December 2020

Improved outcomes of endovascular repair of thoracic aortic injuries at higher volume institutions.

J Vasc Surg 2021 Apr 1;73(4):1314-1319. Epub 2020 Sep 1.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Background: The use of thoracic endovascular aortic repair (TEVAR) has significantly improved the ability to treat traumatic aortic injuries (tTEVAR). We sought to determine whether a greater center volume correlated with better outcomes.

Methods: Vascular Quality Initiative data of TEVAR (2011-2017) for trauma were used in the present analysis. Using the distribution of the annual case volume at the participating centers, the sample was stratified into three terciles. In-hospital mortality at high-volume centers (HVCs) and low-volume centers (LVCs) was compared after adjustment for risk factors established in our previous Vascular Quality Initiative-based risk model containing age, gender, renal impairment, left subclavian artery involvement, and select concomitant injuries.

Results: A total of 619 tTEVAR cases were studied across 74 centers. HVCs (n = 184 cases) had performed ≥4.9 cases annually and LVCs (n = 220 cases) had performed ≤2.4 cases annually. Both crude mortality (4.4% vs 8.6%; P = .22) and adjusted odds of mortality (odds ratio, 0.44; 95% confidence interval, 0.18-1.09; P = .08) showed a trend toward better outcomes for tTEVAR performed at HVCs than at LVCs. The addition of center volume to our previous multivariate model significantly improved its discriminative ability (C-statistic, 0.90 vs 0.88; P = .02). The overall TEVAR volume (for all indications) was not associated with increased odds of mortality for tTEVAR (odds ratio, 0.46; 95% confidence interval, 0.17-1.20; P = .11), nor did it improve the model's discriminative ability.

Conclusions: Higher volume centers showed improved perioperative mortality after tTEVAR. The thoracic aortic trauma volume was more predictive than the overall TEVAR volume, suggesting that technical expertise is not the driving factor. Stable patients might benefit from transfer to a higher volume center before repair.
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http://dx.doi.org/10.1016/j.jvs.2020.08.034DOI Listing
April 2021

Five-year results of the INSPIRATION study for the INCRAFT low-profile endovascular aortic stent graft system.

J Vasc Surg 2021 Mar 21;73(3):867-873.e2. Epub 2020 Jul 21.

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: We present the 5-year results of a prospective regulatory study of the INCRAFT device, a low-profile endovascular stent graft system for repair of abdominal aortic aneurysms.

Methods: This was an open-label prospective nonrandomized single-arm study enrolling in centers in the United States and Japan. The primary effectiveness outcome was successful aneurysm treatment and the primary safety outcome was the incidence of major adverse events at 30 days after the procedure. Major long-term outcomes were mortality, reintervention, adverse limb outcomes, and suprarenal stent fracture.

Results: One hundred and ninety patients (mean age, 73.8 ± 7.6 years; 90% male; 69% white and 30% Asian) were enrolled from 32 centers throughout the United States and Japan. Minimal access vessel size was less than 7 mm on both sides in 43.9% of the study cohort. Thirty-day major adverse events occurred in 3.2% of patients (6/190). Periprocedural technical success was 94.1% (176/187). Successful aneurysm treatment was 100% at 30 days and 87.9% at 1 year. Two patients required open conversion for thromboembolic complications, 3 developed new type I or III endoleaks, and 7 experienced graft or limb occlusion. Freedom from graft occlusion was 96 ± 2% at 1 year and 94 ± 2% at 5 years. Freedom from stent fracture was 97 ± 1% at 1 year and 87 ± 3% at 5 years. Freedom from aneurysm-related mortality was 99 ± 1% at 1 and 5 years.

Conclusions: This study demonstrates good efficacy and safety and a very low rate of aneurysm related deaths with the INCRAFT device in a population with a high proportion of challenging anatomy.
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http://dx.doi.org/10.1016/j.jvs.2020.06.128DOI Listing
March 2021

External validation of the Vascular Study Group of New England carotid endarterectomy risk predictive model using an independent U.S. national surgical database.

J Vasc Surg 2020 06 30;71(6):1954-1963. Epub 2019 Oct 30.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Previously, we described a Vascular Study Group of New England (VSGNE) risk predictive model to predict composite adverse outcomes (postoperative death, stroke, myocardial infarction, or discharge to extended care facilities) after carotid endarterectomy (CEA). The goal of this study was to externally validate this model using an independent database.

Methods: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) CEA-targeted database (2010-2014) was used to externally validate the risk predictor model of adverse outcomes after CEA previously created using the VSGNE carotid database. Emergent cases and those in which CEA was combined with another operation were excluded. Cases in which a discharge destination cannot be determined were also excluded. To assess the predictive power of our VSGNE prediction score within this sample, a receiver operating characteristic curve was constructed. Risk scores for each NSQIP patient were also computed using beta weights from the VSGNE CEA model. To further assess the construct validity of our VSGNE prediction score, the observed proportion of adverse outcomes was examined at each level of our prediction scale and within five roughly equally sized risk groups formed on the basis of our VSGNE prediction scores.

Results: In this database, 10,889 cases met our inclusion criteria and were used in this analysis. The overall rate of adverse outcomes in this cohort was 8.5%. External validation of the VSGNE model on this sample showed moderately good predictive ability (area under the curve = 0.745). Patients in progressively higher risk groups, based on their VSGNE model scores, exhibited progressively higher rates of observed adverse outcomes, as predicted.

Conclusions: The VSGNE CEA risk predictive model was externally validated on an NSQIP CEA-targeted sample and showed a fairly accurate global predictive ability for adverse outcomes after CEA. Although this model has a good population concordance, the lack of cut point indicates that individual risk prediction requires more evaluation. Further studies should be geared toward identification of variables that make this risk predictive model more robust.
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http://dx.doi.org/10.1016/j.jvs.2019.04.495DOI Listing
June 2020

Risk factors for mortality after endovascular repair for blunt thoracic aortic injury.

J Vasc Surg 2020 03 13;71(3):768-773. Epub 2019 Sep 13.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Despite high use of endovascular repair, blunt thoracic aortic injury (BTAI) leads to significant mortality. We sought to identify risk factors and create a predictive model for mortality after thoracic endovascular aortic repair (TEVAR) based on available preoperative clinical data.

Methods: We queried the Vascular Quality Initiative TEVAR dataset from April 2011 to November 2017 to identify patients with BTAI as the indication for repair. Patient characteristics, injury grade, timing of repair, and technical aspects including left subclavian artery (LSCA) involvement and coverage were evaluated. Logistic regression was used to identify univariable predictors of the primary outcome of in-hospital mortality. A multivariable model was constructed to predict in-hospital mortality after TEVAR for traumatic aortic injury. The model was tested as a prediction tool, internally validated using 10-fold cross-validation approach, externally validated using early and late split samples, and finally simplified into a scoring system.

Results: We identified 633 TEVAR cases performed for blunt trauma. The majority of patients were male (73.9%) with median age of 39 years (interquartile range, 27-56 years). Although 18.6% documented zone 2 or proximal involvement, 28.1% documented involvement or treatment of the LSCA. 8.9% of repairs were performed for a grade 1 injury, with an increase from 6.4% in 2014 to 16.7% in 2017 (P = .04). The overall in-hospital mortality rate was 7.3%. Independent predictors of mortality were age 60 year or greater (odds ratio [OR], 11.33; 95% confidence interval [CI], 5.30-24.23; P < .001), creatinine 1.2 or greater (OR, 5.28; 95% CI, 2.46-11.34; P < .001), male gender (OR, 4.26; 95% CI, 1.53-11.84; P = .005), Injury Severity Score of greater than 30 (OR, 3.86; 95% CI, 1.74-8.57; P = .001), and LSCA involvement (OR, 2.25; 95% CI, 1.11-4.53; P = .02). The model predicted in-hospital mortality with a C-statistic of 0.86 (95% CI, 0.80-0.92), and a simplified model based on a point system had a similar C-statistic of 0.86 (95% CI, 0.80-0.92; P = .44).

Conclusions: TEVAR for BTAI is associated with a 7.3% in-hospital mortality in the Vascular Quality Initiative. Treatment of grade 1 injuries has increased significantly in recent years. Factors most strongly associated with mortality include age, male gender, renal impairment, LSCA involvement, and high ISS score. A simple point score model based on these variables robustly predicts in-hospital mortality and may assist in appropriate patient selection and risk stratification.
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http://dx.doi.org/10.1016/j.jvs.2019.07.059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7082096PMC
March 2020

Nationwide trends in drug-coated balloon and drug-eluting stent utilization in the femoropopliteal arteries.

J Vasc Surg 2020 02 10;71(2):560-566. Epub 2019 Aug 10.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Drug-coated balloons (DCB) and drug-eluting stents (DES) have significantly altered treatment paradigms for femoropopliteal lesions. We aimed to describe changes in practice patterns as a result of the infusion of these technologies into the treatment of peripheral arterial disease.

Methods: We queried the Vascular Quality Initiative registry from 2010 to 2017 for all peripheral vascular interventions involving the superficial femoral artery and/or the popliteal artery. Cases were divided into a PRE and a POST era with a cutoff of September 2016, when specific device identity was first recorded in Vascular Quality Initiative. For each artery, a primary treatment was identified as either plain balloon angioplasty, atherectomy, DCB, bare-metal stent, or DES. The relative distribution of primary treatments between the PRE and POST eras was evaluated, as were lesion characteristics associated with DCB and DES use and regional variability in the adoption of these new technologies.

Results: Of 210,666 arteries in the dataset, 91,864 femoropopliteal arteries (across 74,842 procedures in 55,437 patients) were included. Each artery received 1.5 ± 0.6 treatments. Primary treatment use changed from 40% balloon angioplasty, 45% stenting, and 15% atherectomy in the PRE era to 22% plain balloon angioplasty, 26% bare-metal stent, 8% atherectomy, 37% DCB, and 8% DES in the POST era (P < .001). Forty-three percent of arteries received a drug-containing device as a primary or adjunctive therapy and 1.3% received both a DCB and DES in the POST era. DCB use as the primary treatment was highest in lesions with length 10.0 to 19.9 cm (42%), TransAtlantic InterSociety A, B, or C lesions (38%), and lesions with mild to no calcification (38%). DES use was highest in lesions with a length of 20 cm or more (12%), TransAtlantic InterSociety D lesions (13%), and lesions with moderate to severe calcification (9%). The range of use across 18 regions was 125 to 40% for DCB and 1% to 14% for DES. Regional variability was greater for DES (SD 4% vs mean 8%) than for DCB (SD 7% vs mean 29%).

Conclusions: There has been a rapid dissemination of DCB and DES technology in the femoropopliteal vessels, with nearly one-half of arteries receiving a drug-containing therapy in modern practice. DCBs are most used in medium length, minimally calcified lesions and DESs are most used in longer, more heavily calcified lesions. There is significant regional variability in adoption, especially with DES.
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http://dx.doi.org/10.1016/j.jvs.2019.05.034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7007839PMC
February 2020

Impact of Medicaid Expansion of the Affordable Care on the Outcomes of Lower Extremity Bypass for Patients With Peripheral Artery Disease in the Vascular Quality Initiative Database.

Ann Surg 2019 10;270(4):647-655

Division of Vascular and Endovascular Surgery, University of California San Diego, La Jolla, California.

Objective: The aim of this study was to evaluate changes in the utilization and outcomes of surgery after Medicaid Expansion (ME) for patients with peripheral artery disease (PAD).

Summary Background Data: Recent studies have demonstrated increased insurance coverage and improved care with the Affordable Care Act's (ACA) state expansion of Medicaid.

Methods: Infrainguinal bypass procedures performed due to occlusive pathology in the Vascular Quality Initiative database between 2010 and 2017 were included. Primary outcomes including postoperative mortality and major adverse limb events (MALE) at 1-year of follow-up were analyzed using interrupted time-series analysis (ITS).

Results: Out of 26,446 infrainguinal bypass procedures, 13,955 (52.8%) were included in this analysis. ME states witnessed an annual decrease in infrainguinal surgery for acute ischemia [annual change in post vs pre-ME period (95% confidence interval): -4.3% (-7.5% to -1.0%), P = 0.02] and an increase in revascularization for claudication [3.7% (1.7%-5.6%), P = 0.01]. Among nonacute cases, elective procedures increased in ME states [3.9% (0.1%-7.7%), P = 0.05] along with a significant annual decrease in in-hospital mortality [-0.4% (-0.8 to -0.02), P = 0.04) and MALE at 1 year of follow up [-9.0% (-20.3 to 2.3), P = 0.09]. These results were statistically significant after comparing them with the annual trend changes in states which did not adopt ME.

Conclusions: The adoption of ME in 2014 was associated with significant increase in the use of infrainguinal bypass for nonsevere and elective cases, along with improved in-hospital mortality and MALE at 1 year. Longer follow-up is needed to evaluate the impact of ME on other aspects of care and longer term outcomes of PAD patients.
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http://dx.doi.org/10.1097/SLA.0000000000003521DOI Listing
October 2019

Occult type I or III endoleaks are a common cause of failure of type II endoleak treatment after endovascular aortic repair.

J Vasc Surg 2019 02 29;69(2):432-439. Epub 2018 Jun 29.

Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Most type II endoleaks have a benign natural history, but 6% to 8% are associated with sac enlargement and respond poorly to treatment. Our aim was to evaluate whether these enlargements are associated with delayed or occult type I and III endoleaks.

Methods: Patients with interventions for endoleak after endovascular aortic repair from 2000 to 2016 were reviewed retrospectively. Patient demographics, comorbidities, endoleak type, secondary procedures, aortic sac growth (≥5 mm), and mortality were collected. Successful treatment was defined as endoleak resolution with no further aortic sac growth. Secondary procedures, ruptures, endograft explant, and death were captured.

Results: There were 130 patients diagnosed with a primary type II endoleak after endovascular aortic repair at a median of 1.3 months (interquartile range, 1.0-13.3 months). One hundred eighteen had their initial treatment for a primary type II. Twelve of the 130 were initially stable and observed, but were treated for a delayed type I or III endoleak. The 130 patients underwent 279 procedures for endoleaks (mean of 2.2 ± 1.3) over 6.9 ± 3.8 years of follow-up. Of the 118 patients treated for primary type II endoleaks, 26 (22.0%) later required interventions for delayed type I and III endoleaks. The mean time to intervention for a delayed type I or III endoleak was 5.4 ± 2.8 years. Overall, there were 16 type IA, 11 type IB, 2 type III, 7 combined type IA/IB, and 2 type IA/III delayed endoleaks. The odds of harboring a delayed type I or III endoleak was 22.0% before the first attempt at type II endoleak treatment, 35.1% before the second, 44.8% before the third, and 66.6% before the fourth attempts. Rapid aortic sac growth of ≥5 mm/y before initial endoleak treatment was associated with increased risk for delayed type I or III endoleak (47.8 vs 14.1%; P = .003). Patients with delayed type I or III endoleaks had a lower successful treatment rate (8.3% vs 52.3%; P = .001) than those with only type II endoleaks. Late rupture was increased with delayed type I or III endoleak (P = .002), whereas mortality (P = .96) and aortic-related mortality (P = .46) were similar. Graft explant (P = .06) trended toward an increase with a delayed type I or III endoleak, but was not statistically significant.

Conclusions: Failed attempts treating type II endoleaks and/or a rapid aortic sac growth of 5 mm/y or greater should raise the suspicion of a delayed or occult type I or III endoleak. Occult endoleaks are associated with decreased chance of endoleak resolution.
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http://dx.doi.org/10.1016/j.jvs.2018.04.054DOI Listing
February 2019

Outcomes and predictors of failure of iliac vein stenting after catheter-directed thrombolysis for acute iliofemoral thrombosis.

J Vasc Surg Venous Lymphat Disord 2019 Mar 16;7(2):153-161. Epub 2019 Jan 16.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Iliac vein stenting is recommended to treat venous outflow obstruction after catheter-directed thrombolysis for acute iliofemoral deep venous thrombosis (DVT). Data on the outcome of proximal and distal stent extension are limited. Proximal stent extension to the vena cava may obstruct the contralateral iliac vein, whereas distal extension below the inguinal ligament contradicts common practice for arterial stents. The aim of this retrospective study was to assess outcomes and predictors of failure of iliac vein stents and contralateral iliac vein thrombosis, taking into consideration stent positioning.

Methods: Consecutive patients who underwent thrombolysis and stenting for DVT between May 2007 and September 2017 were identified from a prospectively maintained database. The intraoperative venograms were reviewed for proximal stent placement (covering >50% contralateral iliac vein orifice) and distal placement across the inguinal ligament. End points were ipsilateral DVT recurrence, post-thrombotic syndrome (PTS; Villalta score ≥5), and contralateral DVT. Patients with chronic contralateral DVT or contralateral iliac vein stenting at baseline were excluded from the contralateral DVT outcome evaluation. Survival analysis and Cox regression models were used to determine outcomes.

Results: Of 142 patients lysed, 73 patients (12 bilateral DVTs; mean age, 45.8 ± 17.2 years; 46 female patients) were treated with various combinations of thrombolytic techniques and at least one self-expanding iliac stent (77 stented limbs). Thirty-day recurrence developed in nine (12.3%) patients. The 3-year primary patency and secondary patency rates were 75.2% and 82.2%, respectively. The single predictor for loss of primary patency was incomplete thrombolysis (≤50%; hazard ratio [HR], 7.41; P = .002). Overall, 3 of 12 (25%) stents extending below the inguinal ligament occluded at 1 month, 2 months, and 9 months, respectively. The overall rate of PTS (Villalta score ≥5) in the stented cohort was 14.4% at 5 years. This was predicted by incomplete lysis (<50%; HR, 7.09; P = .040), stent extension below the inguinal ligament (HR, 6.68; P = .026), and male sex (HR, 6.02; P = .041). Of the 17 stents that extended into the contralateral common iliac vein and 58 stents that did not, there were 1 (5.9%) and 5 (8.6%) contralateral DVTs (P = .588) at an average follow-up of 27.4 ± 33.7 and 22.2 ± 22.3 months (P = .552), respectively.

Conclusions: Iliac stenting after thrombolysis for acute DVT guarantees high patency and low PTS rates, provided adequate thrombus resolution has been achieved before stent placement. Stent placement below the inguinal ligament does not affect the patency but may be associated with a higher PTS rate. Stenting proximal to the iliocaval confluence, although a precipitating factor, may not independently increase the likelihood of contralateral DVT.
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http://dx.doi.org/10.1016/j.jvsv.2018.08.014DOI Listing
March 2019

Increasing use of open conversion for late complications after endovascular aortic aneurysm repair.

J Vasc Surg 2019 06 21;69(6):1766-1775. Epub 2018 Dec 21.

Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Open procedures are often required for late complications after endovascular aneurysm repair (EVAR). Our aim was to describe the indications for open interventions and their postoperative outcomes and to specifically examine our experience with limited conversions in which problem endoleaks are targeted without endograft explantation.

Methods: We reviewed patients from 2002 to 2017 who underwent any surgical abdominal aortic operation after a previous EVAR. Baseline characteristics, preoperative imaging, procedural details, and postoperative outcomes were reviewed. The primary end point was 30-day mortality.

Results: There were 102 patients who underwent open conversion 3.8 ± 3.1 years after EVAR. The numbers increased significantly in recent years, with 18 cases performed in 2016; 48.5% of patients had undergone 1.9 ± 1.0 prior endovascular interventions. The indication for surgical conversion was an endoleak in 85 patients and infection in 15. One patient had a limb occlusion and another a proximal aneurysm. The 30-day mortality was 6.2% in 65 patients treated electively for endoleak but higher in 20 ruptures (40.0%) and 15 infections (40.0%). In a multivariate logistic regression model, independent predictors of 30-day mortality were rupture (odds ratio [OR], 6.70; 95% confidence interval [CI], 1.75-25.60; P = .005), endograft infection (OR, 8.48; 95% CI, 1.99-36.20; P = .004), and use of a supraceliac clamp (OR, 4.80; 95% CI, 1.47-15.66; P = .009). Transient acute kidney injury (12.8%) and prolonged intubation (11.8%) were the most common postoperative complications. In 65 patients treated for endoleak without rupture, 37 underwent endograft explantation, whereas 28 had a graft-preserving intervention (branch vessel ligation for type II endoleak in 26, external banding of the aneurysm neck for type IA endoleak in 8). Mortality was 8.1% when the endograft was explanted and 3.6% when it was not (P = .63). During 3.0 ± 3.5 years of follow-up, there was one reintervention after endograft explantation (for rupture secondary to type IB endoleak) and two reinterventions after graft preservation (for a new type IA endoleak and a new type II endoleak). Survival was 87.4% at 1 year and 70.9% at 5 years.

Conclusions: Open conversion is playing an increasing role in the management of late EVAR complications. Endoleaks treated electively by open conversion are reasonably safe and show good midterm durability, even with graft-preserving interventions that avoid endograft explantation.
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http://dx.doi.org/10.1016/j.jvs.2018.09.049DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6548678PMC
June 2019

Peroneal bypass versus endovascular peroneal intervention for critical limb ischemia.

J Vasc Surg 2019 01 28;69(1):148-155. Epub 2018 Jun 28.

Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: The peroneal artery is a well-established target for bypass in patients with critical limb ischemia (CLI). The objective of this study was to evaluate the outcomes of peroneal artery revascularization in terms of wound healing and limb salvage in patients with CLI.

Methods: Patients presenting between 2006 and 2013 with CLI (Rutherford 4-6) and isolated peroneal runoff were included in the study. They were divided into patients who underwent bypass to the peroneal artery and those who underwent endovascular peroneal artery intervention. Demographics, comorbidities, and follow-up data were recorded. Wounds were classified by Wound, Ischemia, foot Infection (WIfI) score. The primary outcome was wound healing; secondary outcomes included mortality, major amputation, and patency.

Results: There were 200 limbs with peroneal bypass and 138 limbs with endovascular peroneal intervention included, with mean follow-up of 24.0 ± 26.3 and 14.5 ± 19.1 months, respectively (P = .0001). The two groups were comparable in comorbidities, with the exception of the endovascular group's having more patients with cardiac and renal disease and diabetes mellitus but fewer patients with smoking history. Based on WIfI criteria, ischemia scores were worse in bypass patients, but wound and foot infection scores were worse in endovascular patients. Perioperatively, bypass patients had higher rates of myocardial infarction (4.5% vs 0%; P = .012) and incisional complications (13.0% vs 4.4%; P = .008). At 12 months, the bypass group compared with the endovascular group had better primary patency (47.9% vs 23.4%; P = .002) and primary assisted patency (63.6% vs 42.2%; P = .003) and a trend toward better secondary patency (74.2% vs 63.5%; P = .11). There were no differences in the rate of wound healing (52.6% vs 37.7% at 1 year; P = .09) or freedom from major amputation (81.5% vs 74.7% at 1 year; P = .37). In a multivariate analysis, neuropathy was associated with improved wound healing, whereas WIfI wound score, cancer, chronic renal insufficiency, and smoking were associated with decreased wound healing. Treatment modality was not a significant predictor (P = .15).

Conclusions: Endovascular peroneal artery intervention results in poorer primary and primary assisted patency rates than surgical bypass to the peroneal artery but provides similar wound healing and limb salvage rates with a lower rate of complications. In appropriately selected patients, endovascular intervention to treat the peroneal artery is a low-risk intervention that may be sufficient to heal ischemic foot wounds.
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http://dx.doi.org/10.1016/j.jvs.2018.04.049DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6310052PMC
January 2019

Editor's Choice - Comparison of Outcomes After Open Surgical and Endovascular Lower Extremity Revascularisation Among End Stage Renal Disease Patients on Dialysis.

Eur J Vasc Endovasc Surg 2019 Feb 29;57(2):248-257. Epub 2018 Oct 29.

Department of Surgery, University of Pittsburgh School of Medicine, PA, USA.

Objectives: End stage renal disease (ESRD) patients with peripheral arterial disease (PAD) are at high risk of complications following open surgical revascularisation (OSR). Endovascular revascularisation (ER) is an option, but its role is unclear. This study sought to characterise the outcomes of ER and OSR in ESRD patients treated for claudication or critical limb ischaemia (CLI).

Methods: The United States Renal Data System was used to investigate outcomes after lower extremity ER and OSR from 2005 to 2011. Primary outcomes were mortality, amputation, and peri-procedural myocardial infarction (MI). Kaplan-Meier (K-M) estimates were generated for mortality and amputation, logistic regression models for 30 day predictors, and proportional hazards models for long-term predictors.

Results: A total of 20,347 patients underwent OSR and ER (20.3% OSR, 79.7% ER). CLI was the indication in 80.8% of ER and 88.4% of OSR. The unadjusted major amputation rate at 30 days was higher after ER compared with OSR (8.8% vs. 6.4%, p < .001). Conversely, the unadjusted mortality rate at 30 days was lower after ER compared with OSR (8.0% vs. 10.5%, p < .001). Multivariable logistic regression models adjusting for medical covariables and CLI versus claudication status demonstrated increased 30 day mortality risk with OSR compared with ER (OR 2.00, 95% CI 1.43-1.79, p < .001), MI (OR 1.38, 1.23-1.54, p < .001), and the combined endpoint of mortality and major amputation (OR 1.57, 1.16-2.12, p = .004), but lower odds of 30 day major amputation alone (OR 0.67, 0.58-0.77, p < .001). Proportional hazards models demonstrated increased long-term mortality risk with OSR compared with ER (HR 1.05, 1.00-1.09, p = .037), without a difference in major amputation (HR 0.99, 0.93-1.05, p = NS).

Conclusions: In this retrospective analysis of an administrative database, ESRD patients suffer from high mortality and amputation rates following lower extremity revascularisation. Compared with ER, OSR is associated with higher mortality. OSR has better 30 day limb salvage, although long-term outcomes are similar.
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http://dx.doi.org/10.1016/j.ejvs.2018.09.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6397783PMC
February 2019

Risk factors for perioperative mortality after revascularization for acute aortic occlusion.

J Vasc Surg 2018 12 23;68(6):1789-1795. Epub 2018 Jun 23.

Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Acute aortic occlusion (AAO) is a life-threatening event necessitating prompt revascularization to the pelvis and lower extremities. Because of its uncommon nature, outcomes after revascularization for AAO are not well characterized. Our aim was to describe the perioperative morbidity and mortality associated with revascularization and to identify the patients at highest risk.

Methods: A retrospective chart review was performed of patients who presented to our institution from 2006 to 2017 with acute distal aortic occlusion. Patients with a prior aortofemoral bypass were excluded, but those with aortoiliac stents were included. Baseline demographics and comorbidities, preoperative clinical presentation and imaging, procedural details, and postoperative hospital course were reviewed. The primary outcome was 30-day mortality, and major complications were evaluated as secondary outcomes. Logistic regression models were constructed to identify factors associated with 30-day mortality.

Results: We identified 65 patients who underwent revascularization for AAO. Median age was 63 years (range, 35-89 years), and 64.6% were male; 56.4% of patients presented within 24 hours of symptom onset, and 43.8% were treated within 6 hours of presentation. There were particularly high rates of prior coronary artery disease (62.3%) and chronic obstructive pulmonary disease (41.0%); 18.5% had prior iliac stents. Preoperative imaging in 44 patients showed occlusion of the inferior mesenteric artery in 36.0% and both internal iliac arteries in 34.7%. Treatments for revascularization included axillobifemoral bypass (55.4%), aortoiliac thromboembolectomy (15.4%), aortobifemoral bypass (13.9%), and aortoiliac stenting (15.4%). Overall 30-day mortality was 27.7% and was not affected by treatment modality. Mortality was highest in patients older than 60 years (40.5% vs 10.7%; P = .01) and those presenting with lactate elevation (45.5% vs 5.9%; P = .004) or motor deficit in at least one extremity (36.6% vs 9.5%; P = .03). Univariate predictors of 30-day mortality were age ≥60 years (odds ratio [OR], 5.68; 95% confidence interval [CI], 1.45-22.26; P = .01), presentation with motor deficit (OR, 5.48; 95% CI, 1.12-26.86; P = .04), presentation with elevated lactate level (OR, 13.33; 95% CI, 1.58-11.57; P = .02), history of prior stroke (OR, 4.80; 95% CI, 1.21-18.97; P = .03), and bilateral internal iliac artery occlusion (OR, 7.11; 95% CI, 1.54-32.91; P = .01). At least one postoperative complication was observed in 78.5% of patients, including acute kidney injury (56.9%, with 21.5% requiring hemodialysis), respiratory complications (46.2%), cardiovascular complications (33.9%), major amputation (15.4%, bilateral in 7.7%), and bowel ischemia (10.8%).

Conclusions: Even with prompt revascularization and despite the chosen treatment modality, AAO carries high risk of mortality and numerous life-threatening complications. Older patients presenting with elevated lactate levels, motor deficit, and bilateral internal iliac artery occlusions are at the highest risk of perioperative mortality. These factors may aid in risk stratification and managing expectations in this critically ill population.
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http://dx.doi.org/10.1016/j.jvs.2018.04.037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6252122PMC
December 2018

Contemporary Results of Surgical Management of Peripheral Mycotic Aneurysms.

Ann Vasc Surg 2018 Nov 8;53:86-91. Epub 2018 Jun 8.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.

Background: Mycotic aneurysms of the extremities occur infrequently but can cause severe life and limb complications. Traditional treatment typically includes debridement and revascularization, though in select patients ligation may be well tolerated. We reviewed our experience with these aneurysms treated with these 2 modalities.

Methods: A retrospective review of patients treated for peripheral mycotic aneurysms at one institution from January 2005 to December 2015 was performed under an institutional review board-approved protocol. Demographics, perioperative details, and long-term outcomes were collected, and standard statistical methods were used to compare treatments.

Results: We identified 28 patients with 29 peripheral mycotic aneurysms. Most patients (19: 67.9%) were male with an average age of 60.1 ± 17 years. Among cases with a known cause, direct injury to artery was the most common precursor to mycotic aneurysm formation; iatrogenic causes were the most common (15: 51.7%) followed by intravenous drug use (5: 17.2%). Distal bacterial translocation was the other cause of mycotic aneurysm formation due to osteomyelitis (2:10.5%) and bacterial endocarditis (1:3.5%). The causes of the remainder of cases (6:20.7%) were unknown. Symptoms included fever (46.4%), drainage (42.9%), rupture (35.7%), erythema (21.4%), and limb ischemia (17.9%). Staphylococcus aureus was the most common bacteria isolated (38.5%, from 7 positive blood cultures and 3 positive wound cultures) with 30% of these being methicillin-resistant Staphylococcusaureus), followed by Streptococcus species (11.5%), and other Staphylococcus (7.7%). Eight (30.7%) patients had negative cultures. The most common location of arterial aneurysm was the common femoral artery (17:58.6%), with 17.2% (5) occurring in the popliteal artery, 13.8% (4) in the brachial artery, 10.3% (3) in the radial or ulnar artery, and 3.5% (1) in the external iliac artery. Eighteen patients underwent revascularization, whereas 11 had resection/ligation without revascularization (4 femoral, 2 popliteal, 3 radial/ulnar, 1 brachial, and 1 external iliac). There was no significant difference in limb-threatening ischemia between these 2 groups (P = 0.14). Of those who were not revascularized, 1 developed significant initial ischemia but died before amputation, and the other underwent revascularization within 1 year after tolerating the initial ligation. Upper extremity aneurysms were more likely to be reintervention-free than those in the lower extremities (P = 0.01).

Conclusions: In this series, resection or ligation of peripheral mycotic aneurysms without revascularization was well tolerated. With close follow-up of these patients, resection or ligation may obviate the more extensive initial revascularization procedures in these infected fields.
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http://dx.doi.org/10.1016/j.avsg.2018.04.019DOI Listing
November 2018

Implementation of drug-eluting stents for the treatment of femoropopliteal disease provides significant cost-to-system savings in a single-state outpatient simulation.

J Vasc Surg 2018 11 18;68(5):1465-1472. Epub 2018 May 18.

Division of Vascular Surgery, Department of Surgery, UPMC, Pittsburgh, Pa.

Objectives: Initial data on drug-eluting stents (DES) shows that they may increase the durability of endovascular treatment of superficial femoral artery disease compared with traditional bare-metal stents (BMS). Observed decreased target lesion revascularization (TLR) rates have potential for cost savings despite an increased initial cost. The purpose of this study was to run a simulation model of progressive transition from BMS to DES over 5 years evaluating the overall cost impact of that transition.

Methods: Florida State Ambulatory Databases were searched for all patients undergoing superficial femoral artery stenting in 2013 using Current Procedural Terminology codes 37226 and 37227. A simulation model was developed to estimate the impact of a progressive transition from BMS to DES over a 5-year horizon in this patient population. Cost estimates were determined from available cost charge ratio data. For the 5-year model, 2013 served as the initial year with each subsequent year based on the expected number of interventions per year. Up to one TLR per patient was assumed for the model. The 5-year TLR rates for DES and other parameter estimates were based on pooled data from the literature. Institutional data were used to estimate that up to 48% of superficial femoral artery lesions would fit the instructions for use for the Zilver PTX (Cook Medical, Bloomington, Ind), which is currently the only DES approved by the U.S. Food and Drug Administration for peripheral interventions. The net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared with a scenario of BMS only. Multiple sensitivity analyses were performed on the base scenario.

Results: We identified 4107 peripheral interventions in the first year that fit our study. The overall cost for these procedures in Florida database was $51,362,142.00. In the base case scenario, DES was introduced slowly into the population at a rate of 8% per year up to 48% at the end of the model. This strategy resulted in an overall cost savings of $1,688,953.72 compared with the model with BMS alone. Sensitivity analyses including slower adoption of DES up to only 24% at 5 years, a 20% increase in TLR rates per year for the DES, and a 10% reduction in TLR rates per year for BMS still resulted in a net savings. As long as the additional cost of a DES compared with BMS is less than $677, the DES model remains less expensive.

Conclusions: The adoption of DES in lieu of traditional BMS can lead to significant cost savings in a single state model over a short time horizon.
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http://dx.doi.org/10.1016/j.jvs.2018.02.040DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394222PMC
November 2018

Catheter-directed interventions compared with systemic thrombolysis achieve improved ventricular function recovery at a potentially lower complication rate for acute pulmonary embolism.

J Vasc Surg Venous Lymphat Disord 2018 07 31;6(4):425-432. Epub 2018 Mar 31.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: Catheter-directed interventions (CDIs) are increasingly performed for acute pulmonary embolism (PE) as they are presumed to provide similar therapeutic benefits to systemic thrombolysis (ST) while decreasing the associated complications. The purpose of this study was to compare outcomes between CDI and ST.

Methods: Consecutive patients who underwent CDIs or ST for massive or submassive PE between 2006 and 2016 were identified. Clinical and echocardiographic parameters at baseline and after treatment were recorded. Clinical success was defined as decompensation resolution (or prevention) without major bleeding, stroke, other major treatment-related event, or in-hospital death. The χ test and t-test were used for between-groups comparisons.

Results: There were 213 patients who received CDIs (standard catheter thrombolysis in 56, ultrasound-assisted thrombolysis in 146, suction thrombectomies in 10, and pharmacomechanical thrombolysis in 1) and 104 patients who received ST (94 high dose [100 mg], 10 low dose [50 mg]). At baseline, CDI and ST groups had comparable echocardiographic parameters, demographics, and comorbidities, except for PE type (massive PE, 8.5% for CDIs vs 69.2% for ST; P < .001), age (60.2 ± 14.9 years for CDIs vs 55.9 ± 17.3 years for ST; P = .023), and renal function (glomerular filtration rate, 78.1 ± 33.7 mL/min/1.73 m for CDIs vs 64.1 ± 35.2 mL/min/1.73 m for ST; P = .001). Without stratifying per PE type, CDIs had a higher clinical success rate (87.8% vs 66.3%; P < .001) and a lower rate of major bleed (8.0% vs 19.2%; P = .003), stroke (1.4% vs 4.8%; P = .120), and death (1.4% vs 13.5%; P < .001). On stratifying by PE type, there was no difference in clinical success between groups. The mean reduction in right ventricular/left ventricular diameter ratio between baseline and the first post-treatment echocardiographic examination (within 30 days) was significantly higher for CDI (0.27 ± 0.20 vs 0.18 ± 0.15; P = .037). Beyond 30 days, there was no echocardiographic difference between groups. There was no significant difference in clinical outcomes and echocardiographic parameters between standard and ultrasound-assisted CDIs.

Conclusions: CDIs provide improved recovery of right ventricular function compared with ST. Major bleeding and stroke complications may be lower, but larger studies are needed to validate this. CDIs are complementary to ST, and their use should be individualized on the basis of the patients' clinical presentation, risk profile, and local resources.
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http://dx.doi.org/10.1016/j.jvsv.2017.12.058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151647PMC
July 2018

Outcomes of infrageniculate retrograde versus transfemoral access for endovascular intervention for chronic lower extremity ischemia.

J Vasc Surg 2018 10 31;68(4):1088-1095. Epub 2018 Mar 31.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: Retrograde infrageniculate access is an alternative treatment strategy for patients who have failed to respond to antegrade endovascular intervention. This study compares the outcomes of infrageniculate retrograde arterial access with the conventional transfemoral access for the endovascular management of chronic lower extremity ischemia.

Methods: This was a retrospective single-center review of retrograde endovascular intervention (REI) from 2012 to 2016. Indications for intervention, comorbidities, complications, procedural success, limb outcomes, and mortality were analyzed. Technical failure was defined as the inability to complete the procedure because of failed access or unsuccessful recanalization. Infrageniculate access and transfemoral access were obtained with ultrasound or angiographic roadmap guidance. Patency rates were calculated for technically successful interventions.

Results: There were 47 patients (85% presenting with critical limb ischemia) who underwent sheathless REI after failed antegrade recanalization of TransAtlantic Inter-Society Consensus class D infrainguinal lesions, whereas 93 patients (83% with critical limb ischemia) underwent standard transfemoral access. There were 16 (34%) femoropopliteal, 14 (30%) tibial, and 17 (36%) multilevel interventions in the retrograde group compared with 41 (41%) femoropopliteal, 20 (20%) tibial, and 39 (39%) multilevel interventions in the transfemoral group. Access sites for the retrograde group included the dorsalis pedis (26%), midcalf peroneal (24%), anterior tibial (22%), posterior tibial (26%), and popliteal (2%) arteries. Overall technical success was achieved in 57% of the retrograde group compared with 78% of the transfemoral group. Mean follow-up was 20 months (range, 1-45 months). There were no significant differences in the primary patency rates between the two groups at 1 year and 2 years. The primary assisted patency rates were significantly better in the transfemoral group at 1 year (66% vs 46%; P = .031) and 2 years (56% vs 29%; P = .031). The secondary patency rates were higher in the transfemoral group at 1 year (93% vs 83%; P = .079) and 2 years (91% vs 76%; P = .079), although this did not reach statistical significance. The rate of reintervention was 41% for the retrograde group vs 40% for the transfemoral group. Most of the reinterventions (70% in the retrograde group and 61% in the transfemoral group) were endovascular interventions for a restenosis or occlusion.

Conclusions: Infrageniculate access for REI can result in primary patency rates similar to those of antegrade interventions and does not compromise the access site. Technical failure is high in this initial experience and is mostly due to failed recanalization. Limb salvage may be achieved after technical failure with either repeated antegrade intervention or surgical bypass.
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http://dx.doi.org/10.1016/j.jvs.2018.01.028DOI Listing
October 2018

Prior Endovascular Intervention Is Not Detrimental to Pedal Bypasses for Ischemic Wounds.

Ann Vasc Surg 2018 Jul 23;50:80-87. Epub 2018 Feb 23.

Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA.

Background: Endovascular strategies are often preferred for revascularization of ischemic foot wounds secondary to infrapopliteal disease because of the less invasive technique and faster recovery. Bypass is typically reserved for failures or lesions not amenable to balloon angioplasty. However, the effects of an endovascular-first approach on subsequent bypass grafts are largely unknown. This study evaluates the effects of prior endovascular tibial interventions (PTIs) on successive bypasses to pedal targets.

Methods: Patients who presented with ischemic tissue loss and tibial arterial occlusive disease to University of Pittsburgh Medical Center between 2006 and 2013 and underwent a surgical bypass to pedal arteries were included in this study. A retrospective chart review was conducted to obtain patient demographics, past medical history, extent of disease, prior tibial endovascular interventions, the treatment intervention, subsequent interventions, wound healing status, limb salvage, and patient survival. The primary outcome was primary patency of the pedal bypass graft.

Results: From 122 eligible patients, 27 had a PTI, whereas 95 had no prior endovascular tibial intervention (nPTI) in the treatment of ischemic pedal wounds with mean follow-up of 24.5 and 20.5 months, respectively (P = 0.36). The 2 groups were largely similar in terms of demographics, comorbidities, wound size, and degree of ischemia. Runoff scores between the 2 groups were also comparable (5.0 ± 1.6 for PTI and 4.8 ± 1.9 for nPTI, P = 0.59). The plantar artery was a more common target vessel in the PTI group, whereas the posterior tibial artery was targeted more often in the nPTI group (P = 0.04). At 12 months, those with a PTI exhibited a shorter primary patency (34.8% vs. 60.2%, P = 0.04). In a multivariate model, PTI was a significant risk factor for primary patency loss (hazard ratio 2.51, P = 0.004). Primary assisted patency and secondary patency were similar between the 2 groups. Wound healing was improved in those patients who had a prior endovascular intervention with 63.8% healed at 1 year compared with only 34.8% of those without intervention (P = 0.01). Amputation-free survival was similar (P = 0.68), as was survival alone (P = 0.50).

Conclusions: Despite a decrease in primary patency, pedal bypass was not otherwise negatively affected by a PTI. Similar primary assisted patency, secondary patency, wound healing, and survival between the 2 patient populations indicate that an endovascular-first approach is a feasible treatment strategy to achieve similar clinical outcomes in the management of ischemic foot wounds.
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http://dx.doi.org/10.1016/j.avsg.2017.11.066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6014906PMC
July 2018

Bypass versus endovascular intervention for healing ischemic foot wounds secondary to tibial arterial disease.

J Vasc Surg 2018 07 11;68(1):168-175. Epub 2018 Jan 11.

Division of Vascular Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Pedal (inframalleolar) bypass is a long-standing therapy for tibial arterial disease in patients with ischemic tissue loss. Endovascular tibial intervention is an appealing alternative with lower risks of perioperative mortality or complications. Our objective was to compare the effectiveness of these two treatment modalities with respect to patency and limb-related clinical outcomes.

Methods: We performed a retrospective chart review of patients presenting between 2006 and 2013 with ischemic foot wounds and infrapopliteal arterial disease who underwent a revascularization procedure (either open surgical bypass to an inframalleolar target or endovascular tibial intervention). Data were collected on baseline demographics and comorbidities, procedural details, and postprocedure outcomes. The primary outcome was successful healing of the index wound, with mortality, major amputation, and patency assessed as secondary outcomes.

Results: We identified 417 patients who met our eligibility criteria; 105 underwent surgical bypass and 312 underwent endovascular intervention, with mean follow-up of 25.0 and 20.2 months, respectively (P = .08). The endovascular patients were older at baseline (P = .009), with higher rates of hyperlipidemia (P = .02), prior cerebrovascular accidents (P = .04), and smoking history (P = .04). Within 30 days postoperatively, there was no difference in mortality (P = .31), but bypass patients had longer hospital length of stay (P < .0001), higher rate of discharge to nursing facility (P < .001), and higher rates of myocardial infarctions (P = .03) and wound complications (P < .001). At 6 months, the rate of wound healing was 22.4% in the bypass group compared with 29.0% in the endovascular group (P = .02). At 1 year, survival was higher after bypass (86.2% vs 70.4%; P < .0001), but freedom from major amputation was similar (84.9% vs 82.8%; P = .42). Primary patency (53.1% vs 38.2%; P = .002) and primary assisted patency (76.6% vs 51.7%; P < .0001) were higher in the bypass group, but there was no difference in secondary patency (77.3% vs 73.8%; P = .13).

Conclusions: Endovascular tibial intervention is associated with poorer primary patency but similar secondary patency and wound healing rates compared with the "gold standard" of surgical bypass to a pedal target. In patients with tibial arterial disease, endovascular intervention should be considered a lower risk alternative to pedal bypass that provides similar clinical outcomes.
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http://dx.doi.org/10.1016/j.jvs.2017.10.076DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019116PMC
July 2018

Comparable perioperative mortality outcomes in younger patients undergoing elective open and endovascular abdominal aortic aneurysm repair.

J Vasc Surg 2018 05 31;67(5):1404-1409.e2. Epub 2017 Oct 31.

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa; VA Pittsburgh Health System, Pittsburgh, Pa.

Background: Evidence for benefit of endovascular aneurysm repair (EVAR) over open surgical repair for de novo infrarenal abdominal aortic aneurysms (AAAs) in younger patients remains conflicting because of heterogeneous study populations and small sample sizes. The objective of this study was to compare perioperative and short-term outcomes for EVAR and open surgery in younger patients using a large national disease and procedure-specific data set.

Methods: We identified patients 65 years of age or younger undergoing first-time elective EVAR or open AAA repair from the Vascular Quality Initiative (2003-2014). We excluded patients with pararenal or thoracoabdominal aneurysms, those medically unfit for open repair, and those undergoing EVAR for isolated iliac aneurysms. Clinical and procedural characteristics were balanced using inverse propensity of treatment weighting. A supplemental analysis extended the study to those younger than 70 years.

Results: We identified 2641 patients, 73% (n = 1928) EVAR and 27% (n = 713) open repair. The median age was 62 years (interquartile range, 59-64 years), and 13% were female. The median follow-up time was 401 days (interquartile range, 357-459 days). Unadjusted perioperative survival was 99.6% overall (open repair, 99.1%; EVAR, 99.8%; P < .001), with 97.4% 1-year survival overall (open repair, 97.3%; EVAR, 97.4%; P = .9). Unadjusted reintervention rates were five (open repair) and seven (EVAR) reinterventions per 100 person-years (P = .8). After propensity weighting, the absolute incidence of perioperative mortality was <1% in both groups (open repair, 0.9%, EVAR, 0.2%; P < .001), and complication rates were low. Propensity-weighted survival (hazard ratio, 0.88; 95% confidence interval, 0.56-1.38; P = .6) and reintervention rates (open repair, 6; EVAR, 8; reinterventions per 100 person-years; P = .8) did not differ between the two interventions. The analysis of those younger than 70 years showed similar results.

Conclusions: In this study of younger patients undergoing repair of infrarenal AAA, 30-day morbidity and mortality for both open surgery and EVAR are low, and the absolute mortality difference is small. The prior published perioperative mortality and 1-year survival benefit of EVAR over open AAA repair is not observed in younger patients. Further studies of long-term durability are needed to guide decision-making for open repair vs EVAR in this population.
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http://dx.doi.org/10.1016/j.jvs.2017.08.057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5916017PMC
May 2018

The associations of hemodialysis access type and access satisfaction with health-related quality of life.

J Vasc Surg 2018 01 16;67(1):229-235. Epub 2017 Aug 16.

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: In addition to age and comorbidities, health-related quality of life (HRQOL) is known to predict mortality in hemodialysis (HD) patients. Understanding the association of vascular access type with HRQOL can help surgeons to provide patient-centered dialysis access recommendations. We sought to understand the impact of HD access type on HRQOL.

Methods: We conducted a cross-sectional prospective study of community-dwelling prevalent HD patients in Pittsburgh, Pennsylvania. We assessed patient satisfaction with their access using the Vascular Access Questionnaire (VAQ) and HRQOL with the Short Form Health Survey. We compared access satisfaction and HRQOL across access types. We used logistic regression modeling to evaluate the association of access type with satisfaction and multivariate analysis of variance to evaluate the association of both of these variables on HRQOL.

Results: We surveyed 77 patients. The mean age was 61.8 ± 15.9 years. Arteriovenous fistula (AVF) was used by 62.3%, tunneled dialysis catheter (TDC) by 23.4%, and arteriovenous graft (AVG) by 14.3%. There was a significant difference in satisfaction by access type with lowest median VAQ score (indicating highest satisfaction) in patients with AVF followed by TDC and AVG (4.5 vs 6.5 vs 7.0; P = .013). Defining a VAQ score of <7 to denote satisfaction, AVF patients were more likely to be satisfied with their access, compared with TDC or AVG (77% vs 56% vs 55%; P = NS). Multivariate regression analysis yielded a model that predicted 46% of the variance of VAQ score; important predictors of dissatisfaction included <1 year on dialysis (β = 3.36; P < .001), increasing number of access-related hospital admissions in the last year (β = 1.69; P < .001), and AVG (β = 1.72; P = .04) or TDC (β = 1.67; P = .02) access. Mean physical and mental QOL scores (the composite scores of Short Form Health Survey) were not different by access type (P = .49; P = .41). In an additive multivariate analysis of variance with the two composite QOL scores as dependent variables, 25.8% of the generalized variance in HRQOL (effect size) was accounted for by access satisfaction with only an additional 3% accounted for by access type.

Conclusions: HD patients experience greatest satisfaction with fistula, and access satisfaction is significantly associated with better HRQOL. Controlling for access satisfaction, there is no significant independent association of access type on HRQOL. Future research should investigate the relationship between access satisfaction, adherence to dialysis regimens, mortality, and the consequent implications for patient-centered care.
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http://dx.doi.org/10.1016/j.jvs.2017.05.131DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6527443PMC
January 2018

An Accumulated Deficits Model Predicts Perioperative and Long-term Adverse Events after Carotid Endarterectomy.

Ann Vasc Surg 2018 Jan 6;46:97-103. Epub 2017 Jul 6.

Division of Vascular Surgery, Department of Surgery, UPMC, Pittsburgh, PA.

Background: There is increasing recognition that decreased reserve in multiple organ systems, known as accumulated deficits (AD), may better stratify perioperative risk than traditional risk indices. We hypothesized that an AD model would predict both perioperative adverse events and long-term survival after carotid endarterectomy (CEA), particularly important in asymptomatic patients.

Methods: Consecutive patients undergoing CEA between 1st January 2000 and 31st December 2010 were retrospectively identified. Seven of the deficit items from the Canadian Study of Health and Aging-frailty index (coronary disease, renal insufficiency, pulmonary disease, peripheral vascular disease, heart failure, hypertension, and diabetes) were tabulated for each patient. Predictors of perioperative and long-term outcomes were evaluated using regression analysis.

Results: About 1,782 CEAs in 1,496 patients (mean age: 71.3 ± 9.3 years, 56.3% male, 35.4% symptomatic) were included. The risk of major adverse events (stroke, death, or myocardial infarction) at 30 days for patients with ≤3 deficits was 2.53% vs. 8.81% for patients with ≥4 deficits (P < 0.001). For patients with ≥5 deficits, the risk was 15.18%. Each additional deficit increased the odds of a 30-day major adverse event and hospital stay >2 days by 1.64 (P < 0.001) and 1.15 (P < 0.001), respectively. In multivariate analysis, the presence of ≥4 deficits was more predictive of perioperative major adverse events (odds ratio [OR] = 3.62, P < 0.001) than symptomatology within 6 months (OR = 1.57, P = 0.08) or octogenarian status (OR = 2.00, P = 0.02). Kaplan-Meier analysis showed significantly decreased survival over time with accumulating deficits (P < 0.001). Patients with ≥4 deficits have a hazards ratio for death of 2.6 compared to patients with ≤3 deficits (P < 0.001). Overall survival is estimated at 79.5% (95% confidence interval [CI]: 0.77-0.82) at 5 years in patients with ≤3 deficits versus 52.4% (95% CI: 0.46-0.58) in patients with ≥4 deficits, respectively. In subgroup analysis of asymptomatic patients, 5-year survival for octogenarian male patients with ≥4 deficits was only 26.8%. For asymptomatic males aged 70-79 years with ≥4 deficits, 5-year survival was 59.9%.

Conclusions: An AD model is more predictive of perioperative adverse events after CEA than age or symptomatic status. This model remains predictive of long-term survival. In asymptomatic male octogenarians with 4 or more AD, 5-year survival is severely limited.
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http://dx.doi.org/10.1016/j.avsg.2017.06.150DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5828018PMC
January 2018

Predictors of failure and complications of catheter-directed interventions for pulmonary embolism.

J Vasc Surg Venous Lymphat Disord 2017 05;5(3):303-310

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa. Electronic address:

Objective: Catheter-directed interventions (CDIs) are increasingly performed for acute pulmonary embolism (PE) as they are presumed to provide similar therapeutic benefits to systemic thrombolysis while decreasing the dose of thrombolytic required and the associated risks. This study aimed to identify factors associated with CDI failure and to describe anticipated complications.

Methods: Consecutive patients who underwent CDI for massive or submassive PE between 2009 and 2015 were identified; outcomes and complications were retrospectively collected. CDI clinical failure was defined as major bleeding, perioperative stroke or other major adverse procedure-related event, decompensation for submassive or persistent shock for massive PE, need for surgical thromboembolectomy, or in-hospital death. Univariate analysis was used to study the factors associated with CDI failure.

Results: There were 102 patients who received a CDI during the study period (36 standard catheter thrombolysis, 60 ultrasound assisted, 6 other; age, 59.2 ± 15.9 years; male, 50 [49.0%]; massive PE, 14 [13.7%]). Five patients (4.9%) had a major contraindication and 15 patients (14.7%) had a minor contraindication to systemic thrombolysis. The mean alteplase dose was 28.2 ± 18.8 mg (range, 0-123 mg; three patients had already received systemic lysis). CDI failure occurred in 15 patients (14.7%; 7 in massive PE, 8 in submassive PE). Of these patients, seven had major bleeding events, whereas eight patients decompensated. Ten (9.8%) patients had minor bleeding events (four access related). Factors associated with CDI failure and major bleeding included massive PE, age ≥70 years, and major contraindication to thrombolytics. Both failures and bleeding events were independent of lysis dose and CDI technique.

Conclusions: CDIs for acute PE are not risk-free procedures, and their use should be individualized on the basis of a risk-benefit ratio. Particularly for patients with major contraindications to systemic thrombolytics, CDIs should be used selectively. Lytic dose, within the low-volume range administered in CDI, and type of CDI seem to have no impact on adverse events.
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http://dx.doi.org/10.1016/j.jvsv.2016.12.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6394221PMC
May 2017

Comparative effectiveness of anticoagulation on midterm infrainguinal bypass graft patency.

J Vasc Surg 2017 08 8;66(2):499-505.e2. Epub 2017 Apr 8.

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Objective: Therapeutic anticoagulation (AC) is used clinically for prolongation of infrainguinal bypass patency, but evidence for the efficacy of this practice is conflicting. The objective of our study was to determine the association of AC with bypass graft primary patency.

Methods: Clinical and comorbid data of patients undergoing infrainguinal bypass grafts to a below-knee target with at least 1 year of follow-up performed from 2003 to 2015 were obtained from the Society for Vascular Surgery Vascular Quality Initiative. Inverse propensity of treatment-weighted Cox regression was used to assess the effect of AC on patency in the total cohort while adjusting for clinical, operative, and comorbid differences between treatment groups. Subgroup analyses of distal targets and conduit type were performed. Perioperative complications were analyzed using propensity-weighted logistic regression.

Results: We identified 7612 bypass grafts with intact 1-year follow-up information from 2003 to 2015. The mean age was 67.5 ± 11.2 years; 30.5% (n = 2320) were female, and 28.6% (n = 2165) were discharged on therapeutic AC. The anticoagulated group had a higher rate of tibial, ankle, and pedal targets (52.1% [n = 1127] vs 47.6% [n = 2269]; P < .001), had a greater use of non-single-segment vein conduits (44.3% [n = 951] vs 26.5% [n = 1426]; P < .001), and was more likely to have had a previous ipsilateral bypass (27.2% [n = 589] vs 14.7% [n = 794]; P < .001) or stent (25.4% [n = 550] vs 20.9% [n = 1130]; P < .001). Estimated unadjusted primary patency was 70.8% ± 0.6% at 1 year and lower for anticoagulated bypasses (66.9% ± 1.2% vs 72.4% ± 0.7%; P < .001). Propensity-weighted analysis showed no significant association of AC with primary patency in the overall cohort (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.86-1.11; P = .8) but demonstrated a trend toward improvement of primary patency in those with a non-single-segment vein conduit to a below-knee popliteal target (HR, 0.85; 95% CI, 0.80-1.02; P = .09). AC was associated with significantly improved secondary patency in those with prosthetic bypass grafts (HR, 0.77; 95% CI, 0.62-0.96; P = .02) or prosthetic bypasses to an infrapopliteal target (HR, 0.72; 95% CI, 0.54-0.97; P = .02). Odds of postoperative wound complications were significantly higher in those receiving AC (odds ratio, 1.33; 95% CI, 1.11-1.61; P = .002).

Conclusions: This study does not demonstrate a significant impact of therapeutic AC on primary patency for infrainguinal bypass grafts. Treatment with AC may benefit secondary patency in those with a prosthetic bypass, especially to an infrapopliteal target, but at an increased risk of postoperative wound complications.
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http://dx.doi.org/10.1016/j.jvs.2016.12.141DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5524600PMC
August 2017

High mortality rates after both open surgical and endovascular thoracic aortic interventions in patients with end-stage renal disease.

J Vasc Surg 2017 10 8;66(4):991-996. Epub 2017 Apr 8.

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Background: Morbidity and mortality have improved with the evolution of endovascular techniques (thoracic endovascular aortic repair [TEVAR]) for thoracic aortic disease, but results after aortic intervention in patients with end-stage renal disease (ESRD) remain unclear. The objective of this study was to evaluate outcomes of open and endovascular descending thoracic aortic repair in dialysis-dependent patients.

Methods: We identified 352 patients with ESRD on dialysis undergoing open repair (n = 136) or TEVAR (n = 216) of the thoracic aorta from 2005 to 2008 using the United States Renal Data System database. Acute presentation was defined as ruptured aneurysm, dissection, or traumatic injury; all other interventions were considered elective. End points were 30-day mortality, overall survival, rates of perioperative complications, and procedural trends over time. Between-group comparisons and survival analysis used standard statistical methods. Logistic regression and Cox regression were performed using multivariate analysis.

Results: TEVAR subjects were older than those undergoing open repair (68.2 ± 11.5 vs 60.8 ± 13.2 years; P < .001); no other demographics differed. There were 303 patients who had thoracic or thoracoabdominal aneurysms; 47 (13.4%) were ruptured on presentation. There were 44 patients (12.5%) who had aortic dissection and 5 (1.4%) with aortic trauma. Overall 30-day mortality was 21.3% (n = 75), and it was greater for open repair (n = 41 [30.1%]) than for TEVAR (n = 34 [15.7%]; P = .002). Elective 30-day mortality for open repair (n = 27 [29.3%]) was also greater than for TEVAR (n = 24 [14.3%]; P = .005). Those with acute presentation trended toward higher mortality for open repair (n = 14 [31.8%] vs n = 10 [15.7%]; P = .17). Respiratory failure was higher for open repair (n = 69 [50.7%] vs n = 56 [25.9%]; P < .001); postoperative stroke was higher with TEVAR (n = 21 [9.7%] vs n < 10 [<7%]; P = .02). Estimated 1-year survival was 50% and did not differ between groups (44% for open repair, 53% for TEVAR). In multivariate analysis, TEVAR decreased odds of 30-day mortality compared with open repair (odds ratio, 0.41; 95% confidence interval, 0.24-0.71) but failed to demonstrate long-term survival advantage.

Conclusions: In ESRD patients, TEVAR provides short-term mortality benefits compared with open repair, but long-term mortality remains high regardless of treatment modality. Elective intervention for thoracic aortic disease in this population remains high risk and should be approached with caution.
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http://dx.doi.org/10.1016/j.jvs.2016.12.144DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5612851PMC
October 2017

Impact of Inferior Vena Cava Filter Placement on Short-Term Outcomes in Patients with Acute Pulmonary Embolism.

Ann Vasc Surg 2017 Jul 23;42:71-77. Epub 2017 Mar 23.

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA.

Background: Inferior vena cava filters (IVCFs) have been associated with improved survival in patients with acute pulmonary embolism (PE) in some studies. However, without randomization, those with early mortality who did not receive an IVCF might have died prior to treatment decision about filter placement, falsely contributing a survival advantage to those receiving IVCF and biasing the results of previous observational studies. The objective of this study is to evaluate the impact of IVCF on in-hospital mortality after adjusting for this survivor treatment selection.

Methods: National Inpatient Sample data sets from 2009 to 2012 were analyzed to assess the impact of IVCF placement on in-hospital mortality in all patients with acute PE. Subgroup analyses were performed in those with high-risk PE (hemodynamic shock) and also for those with both shock and concomitant thrombolysis. Inverse propensity-score weighting was used to balance clinical and comorbid differences between filter and nonfilter groups. To account for survivor treatment selection bias, an extended Cox model was fitted with IVCF placement as a time-dependent covariate.

Results: We identified 263,955 patients with acute PE over this period; 36,702 (13.9%) received IVCF. Those receiving IVCF in the unadjusted cohort were older (IVCF: 66.3 ± 15.9 vs. non-IVCF: 62.4 ± 17.4; P < 0.001) with higher rates of shock (6.8% vs. 3.8%; P < 0.001), deep venous thrombosis (32.8% vs. 13.9%; P < 0.001), thrombolytic therapy (5.9% vs. 1.6%; P < 0.001), and lower crude mortality (6.0% vs. 6.7%; P < 0.001). Propensity weighted extended Cox analysis showed that IVCF placement did not significantly decrease mortality hazard compared to an untreated patient (hazard ratio [HR]: 0.93, 95% confidence interval [CI]: 0.89-1.01). Similar results were seen in the combined high-risk and thrombolysis (HR: 0.85, 95% CI: 0.60-1.21) subgroup and associated with worse outcomes in the high-risk (HR: 1.2, 95% CI 1.11-1.38) subgroup.

Conclusions: Placement of IVCF in all patients with acute PE, in high-risk patients, or in high-risk patients concurrently treated with thrombolysis is not significantly associated with improvement of in-hospital mortality when accounting for survivor treatment selection bias.
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http://dx.doi.org/10.1016/j.avsg.2016.11.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5536973PMC
July 2017

Systemic thrombolysis increases hemorrhagic stroke risk without survival benefit compared with catheter-directed intervention for the treatment of acute pulmonary embolism.

J Vasc Surg Venous Lymphat Disord 2017 03 16;5(2):171-176.e1. Epub 2017 Jan 16.

Division of Vascular Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.

Background: Systemic thrombolysis (ST) and catheter-directed intervention (CDI) are both used in the treatment of acute pulmonary embolism (PE), but the comparative outcomes of these two therapies remain unclear. The objective of this study was to compare short-term mortality and safety outcomes between the two treatments using a large national database.

Methods: Patients presenting with acute PE were identified in the National Inpatient Sample (NIS) from 2009 to 2012. Comorbidities, clinical characteristics, and invasive procedures were identified using International Classification of Diseases, Ninth Revision (ICD) codes and the Elixhauser comorbidity index. To adjust for anticipated baseline differences between the two treatment groups, propensity score matching was used to create a matched ST cohort with clinical and comorbid characteristics similar to those of the CDI cohort. Subgroups of patients with and without hemodynamic shock were analyzed separately. Primary outcomes were in-hospital mortality, overall bleeding risk, and hemorrhagic stroke risk.

Results: Of 263,955 subjects with acute PE, 1.63% (n = 4272) received ST and 0.55% (n = 1455) received CDI. ST subjects were older, had more chronic comorbidities, and had higher rates of respiratory failure (ST, 27.9% [n = 1192]; CDI, 21.2% [n = 308]; P < .001) and shock (ST, 18.2% [n = 779]; CDI, 12% [n = 174]; P < .001). CDI subjects had higher rates of concurrent deep venous thrombosis (ST, 35.8% [n = 1530]; CDI, 45.9% [n = 668]; P < .001) and vena cava filter placement (ST, 31.1% [n = 1328]; CDI, 57% [n = 830]; P < .001). In the unmatched cohort, ST subjects had higher in-hospital mortality (ST, 16.7% [n = 714]; CDI, 9.4% [n = 136]; P < .001) and hemorrhagic stroke rates (ST, 2.2% [n = 96]; CDI, 1.4% [n = 20]; P = .041). After propensity matching, 1430 patients remained in each cohort; baseline characteristics of the matched cohorts did not differ significantly using standardized difference comparisons. Analysis of the matched cohorts did not demonstrate a significant effect of CDI on in-hospital mortality or overall bleeding risk but did show a significant protective effect against hemorrhagic stroke compared with ST (odds ratio, 0.47; 95% confidence interval, 0.27-0.82; P = .01). Subgroup analysis showed decreased odds of hemorrhagic stroke for CDI in the nonshock subgroup and increased procedural bleeding for CDI but no difference in hemorrhagic stroke risk in the shock subgroup.

Conclusions: ST for acute PE may not improve in-hospital mortality compared with CDI but increases the overall risk of hemorrhagic stroke compared with CDI. Further prospective studies should examine the comparative effectiveness and safety of these two treatments.
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http://dx.doi.org/10.1016/j.jvsv.2016.11.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5324829PMC
March 2017

Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks.

J Vasc Surg 2017 06 9;65(6):1598-1607. Epub 2017 Feb 9.

Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Objective: Early and midterm outcomes of the Prospective Aneurysm Trial: High Angle Aorfix Bifurcated Stent Graft (PYTHAGORAS) trial in patients with highly angulated aortic necks (≥60 degrees) have already been published and shown comparable outcomes to other endografts in normal anatomy. Herein, we present the long-term outcomes of the PYTHAGORAS trial of Aorfix (Lombard Medical, Irvine, Calif) for patients with highly angulated aortic neck anatomy.

Methods: The Aorfix endograft is a highly conformable nitinol/polyester device designed for transrenal fixation. The U.S. trial enrolled 218 patients and observed all patients at 1 month, 6 months, and 12 months and then annually for a total of 5 years. Endovascular aneurysm repair (EVAR)-specific complications were compared between the standard-angle (<60 degrees) and highly angulated (≥60 degrees) neck groups at 5 years using standard statistical methods. Kaplan-Meier analysis was performed to evaluate the overall 5-year survival and freedom from aneurysm rupture, aneurysm-related mortality, and reintervention.

Results: Of the 218 patients enrolled in the trial, there were 67 patients in the standard-angle neck group (I) and 151 patients in the highly angulated neck group (II). Mean proximal neck angle was 45 degrees in group I vs 83 degrees in group II (P < .001). At 5 years, 87% of surviving patients were followed up. The 5-year EVAR-specific results showed no type I or type III endoleak in either group, 4% migration in group I vs 3% in group II, and 4% sac expansion in group I vs 15.0% in group II (P ≥ .27). The 5-year freedom from all-cause mortality was 69% (73% in group I vs 68% in group II; P = .43); from aneurysm-related mortality, 96% (99% vs 95%; P = .44); from aneurysm rupture, 99% (99% vs 99%; P = 1.0); and from device-related secondary intervention, 83% (88% vs 80%; P = .18). None of these differed between groups.

Conclusions: The U.S. PYTHAGORAS trial of the Aorfix endograft is the first EVAR clinical trial to include a majority of highly angulated (≥60 degrees) infrarenal aortic necks and is the first to produce evidence after 5 years of implantation. Despite predictors of worse short- and long-term outcomes, pertinent outcomes were better than or similar to those of trials with less severe anatomy. These results support the use of this "on-label" endovascular option, particularly in patients with highly angulated aortic neck anatomy.
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http://dx.doi.org/10.1016/j.jvs.2016.10.120DOI Listing
June 2017