Publications by authors named "Sean P Lyden"

74 Publications

Ipsilateral Iliac Branch Repair Using a Looped Wire, Precannulated Gate Technique.

J Endovasc Ther 2021 Jan 22:1526602821989335. Epub 2021 Jan 22.

Division of Vascular Surgery & Endovascular Therapy, University of Pennsylvania, Philadelphia, PA, USA.

Purpose: To describe a novel, entirely ipsilateral femoral technique for distal endograft extension using the Gore Iliac Branch Endoprosthesis.

Technique: Femoral arterial access is obtained on the side of the intended repair, and a 16F sheath is inserted over a stiff wire. A looped wire is used to pre-cannulate the internal gate of the IBE device prior to insertion, and the device is then positioned and deployed. This through-wire guides access over the IBE flow divider and into the internal gate with a steerable sheath. The internal iliac artery is then selected, and a Viabahn VBX balloon-expandable stent (W.L. Gore, Flagstaff, AZ) is advanced into position and deployed. We present the successful completion of this technique in 4 patients.

Conclusion: This novel technique allows distal endograft extension with an IBE device using only ipsilateral femoral access and is particularly useful for patients with aneurysmal iliac degeneration in the setting of prior open or endovascular aneurysm repair. This eliminates the need for upper extremity access or contralateral femoral access and navigation across the steep flow divider.
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http://dx.doi.org/10.1177/1526602821989335DOI Listing
January 2021

Mesenteric artery stenosis.

Vasc Med 2021 Feb 27;26(1):113-116. Epub 2020 Dec 27.

Johns Hopkins Center for Vascular Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

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http://dx.doi.org/10.1177/1358863X20979734DOI Listing
February 2021

Carotid endarterectomy remains safe in high-risk patients.

J Vasc Surg 2020 Oct 8. Epub 2020 Oct 8.

Department of Vascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objective: Carotid endarterectomy (CEA) is a proven intervention for stroke risk reduction in symptomatic and asymptomatic patients. High-risk patients are often offered carotid stenting to minimize the risk and optimize the outcomes. As a referral center for high-risk patients, we evaluated and analyzed our experience with high-risk CEA patients.

Methods: We retrospectively reviewed consecutive patients who had undergone CEA at a tertiary referral center. The demographics, indications for surgery, physiologic and anatomic risk factors, intraoperative surgical management, perioperative complications, morbidity, and mortality were analyzed. The high-risk physiologic factors identified included an ejection fraction <30%, positive preoperative stress test results, and compromised pulmonary function test results. The high-risk patients included those requiring home oxygen, those with a partial pressure of oxygen of <60 mm Hg, and patients with a forced expiratory volume in 1 second of <30%. The high-risk anatomic factors identified included previous head and/or neck radiation, a history of ipsilateral neck surgery, contralateral nerve palsy, redo CEA, previous ipsilateral stenting, contralateral occlusion, contralateral CEA, nasotracheal intubation, and digastric muscle division. After propensity score matching, patients with and without high-risk physiologic and anatomic factors were compared. The primary outcomes were a composite of stroke, myocardial infarction, and 30-day mortality. The secondary outcomes were cranial injury and surgical site infection.

Results: During a 10-year period, 1347 patients had undergone CEA at the Cleveland Clinic main campus. Of the 1347 patients, 1152 met the criteria for analysis. Propensity score matching found adequate matches for 424 high-risk patients, with 173 patients having at least one physiologic high-risk factor and 293 at least one anatomic high-risk factor. No significant differences were found in the primary composite outcome or any of its components. Overall, the stroke rate for the standard-risk and high-risk patients was 1.9% and 1.4%, respectively. The high-risk patients were significantly more likely to have experienced a cranial nerve injury, although most were temporary. When patients with one or multiple risk factors were analyzed, no significant difference was found in the primary composite outcome or any of its components. Patients with two or more risk factors were significantly more likely to have experienced a cranial nerve injury, with most being temporary.

Conclusions: In our large series, CEA remained a viable and safe surgical solution for patients with high-risk anatomic and physiologic risk factors, with acceptable stroke, myocardial infarction, and 30-day mortality rates.
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http://dx.doi.org/10.1016/j.jvs.2020.08.149DOI Listing
October 2020

COVID era "essential surgery" dialysis access management considerations.

J Vasc Surg 2020 Dec 14;72(6):1845-1849. Epub 2020 Aug 14.

Department of Vascular Surgery, Cleveland Clinic, Cleveland, Ohio.

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http://dx.doi.org/10.1016/j.jvs.2020.07.071DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7426228PMC
December 2020

Endovascular Intervention for the Treatment of Trans-Atlantic Inter-Society Consensus (TASC) D Femoropopliteal Lesions: A Systematic Review and Meta-Analysis.

Cardiovasc Revasc Med 2021 Jan 12;22:52-65. Epub 2020 Jun 12.

Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of Colorado, Denver, CO, USA. Electronic address:

Purpose: Advancements in the endovascular treatment of femoropopliteal atherosclerotic lesions have led to treatment of more complex lesions, particularly long lesions. The aim of this study was to determine the meta-analytic primary patency and need for re-intervention among patients treated for very long lesions (>200 mm) at the femoropopliteal segment and to identify potential risk factors for loss of patency.

Methods: This study was performed according to the PRISMA guidelines. A random effects model meta-analysis was conducted, and the I-square was used to assess heterogeneity.

Results: Fifty-one studies comprised of 3029 patients were included. The mean lesion length was 269 mm. The primary patency rate at 30 days, 6 m, 1-, 2- and 5-years of follow-up was 98%, 76%, 62%, 55%, and 39% respectively. The incidence of TLR was 16% at one year and 32% at two years. The secondary patency rate at 1, 2, 3 and 5 years was 85%, 71%, 64%, and 64% respectively. Heparin bonded ePTFE covered stents (69%) and paclitaxel eluting stents (73%) demonstrated higher 1-year primary patency rates than self-expanding nitinol stents (55%) or uncoated percutaneous transluminal angioplasty (PTA) with provisional stenting (54%). Lesions treated with a heparin bonded ePTFE covered stent had statistically significant higher odds of remaining patent at 1-year of follow-up (OR: 2.74; 95%CI: 1.63-4.61; p < 0.001) than lesions treated with BMS or PTA. Patients with long femoropopliteal lesions causing critical limb ischemia (CLI) developed restenosis or occlusion more often than patients treated for claudication (HR: 1.63; 95%CI: 1.06-2.49; p = 0.026) during an average follow-up of 26 months.

Conclusion: Primary stenting of femoropopliteal TASC D lesions using drug eluting stents or covered stents results in sustained patency over time. PTA or uncoated nitinol stents demonstrated lower patency rates. However, additional comparative studies are needed to determine the efficacy of newer technologies for the treatment of complex femoropopliteal lesions and provide evidence for the most optimal treatment approach.
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http://dx.doi.org/10.1016/j.carrev.2020.06.014DOI Listing
January 2021

Jugular Venous Aneurysm.

Ann Vasc Surg 2020 Oct 19;68:567.e5-567.e9. Epub 2020 May 19.

Department of Vascular Medicine, Heart & Vascular Institute, Cleveland Clinic, Cleveland, OH. Electronic address:

Jugular venous aneurysms are uncommon and can involve the internal, external, and anterior jugular veins. These aneurysms may be congenital or acquired secondary to malignancy, inflammation, trauma or arteriovenous fistulas. Treatment strategies are not clearly defined and involve either surveillance of asymptomatic aneurysms or resection, excision, and ligation of the aneurysmal vein. In this case series, we discuss the presentation, diagnostics, treatments and outcomes in 3 patients with jugular venous aneurysms.
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http://dx.doi.org/10.1016/j.avsg.2020.04.075DOI Listing
October 2020

Mortality and Paclitaxel-Coated Devices: An Individual Patient Data Meta-Analysis.

Circulation 2020 Jun 6;141(23):1859-1869. Epub 2020 May 6.

Cardiovascular Division, Vanderbilt University Medical Center, Nashville, TN (J.A.B.).

Background: Paclitaxel-containing devices (PTXDs) significantly reduce reintervention in patients with symptomatic femoropopliteal peripheral artery disease. A recent aggregate-data meta-analysis reported increased late mortality in patients with peripheral artery disease treated with PTXDs. We performed an individual patient data meta-analysis to evaluate mortality.

Methods: Manufacturers of US Food and Drug Administration-approved and commercially available devices in the United States provided deidentified individual patient data for independent analysis. Cox proportional hazards 1-stage meta-analysis models using intention-to-treat methods were used for the primary analysis. A secondary analysis of recovered missing vital status data was performed. The impact of control crossover to PTXDs, cause-specific mortality, and drug dose mortality were assessed.

Results: A total of 2185 subjects and 386 deaths from 8 PTXD trials with 4-year median follow-up were identified. The primary analysis indicated a 38% (95% CI, 6% to 80%) increased relative mortality risk, corresponding to 4.6% absolute increase, at 5 years associated with PTXD use. Control and treatment arm loss to follow-up and withdrawal were 24% and 23%, respectively. With inclusion of recovered vital status data, the excess relative mortality risk was 27% (95% CI, 3%-58%). This observation was consistent across various scenarios, including as-treated analyses, with no evidence of increased risk over time with PTXDs. Mortality risk tended to be increased for all major causes of death. There were no subgroup differences. No drug dose-mortality association was identified.

Conclusions: This individual patient data meta-analysis, based on the most complete available data set of mortality events from PTXD randomized controlled trials, identified an absolute 4.6% increased mortality risk associated with PTXD use.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.044697DOI Listing
June 2020

Impact of posthospital syndrome on outcomes of elective endovascular repair of abdominal aortic aneurysm.

J Vasc Surg 2020 11 2;72(5):1618-1625. Epub 2020 Apr 2.

Department of Vascular Surgery, Sydell and Arnold Miller Heart and Vascular Institute, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address:

Objective: Posthospital syndrome (PHS) is an acquired, transient period of health vulnerability after a hospital admission for acute illness. It is characterized by physiologic deconditioning secondary to stressors from disruption in circadian rhythm, depletion of nutritional and physiologic reserve as well as the pain and discomfort associated with hospitalization. PHS is reported as an independent risk factor for readmission and adverse postoperative outcomes. The aim of this study is to investigate whether preoperative hospitalization affects outcomes of elective endovascular repair of abdominal aortic aneurysm (EVAR).

Methods: The Healthcare Cost and Utilization Project State Inpatient Database for California (2009-2011) were queried using International Classification of Disease Codes, Ninth Edition, codes of 441.4 (abdominal aneurysm without mention of rupture), 397.1 (EVAR with graft), and 397.8 (EVAR with branching or fenestrated graft). PHS exposure is defined as any inpatient admission 30 or fewer days before elective EVAR. Primary outcomes are all-cause mortality and overall complications. Secondary outcomes include length of stay (LOS), 30-day readmission, and hospital charge.

Results: A total of 6155 patients were identified. of which 327 patients (5.6%) had more than one episode of hospital admission 30 days or less before elective EVAR. In-hospital mortality was comparable after PHS exposure (P = .09). However, PHS exposure was associated with increased 30-day readmission (9.5% vs 18.4%; P < .001), LOS (3.0 vs 4.5 days; P < .001), and overall complications (14.8% vs 24.5%; P < .001). Risk adjustment was made based on age, sex, race, baseline comorbidities, and reason for preoperative admission. Multivariate logistic regression analysis demonstrated that PHS exposure was a predictor for longer LOS (odds ratio [OR], 2.5; 95% confidence interval [CI], 2.0-3.2; P < .001), higher incidence of 30-day readmission (OR, 2.0; 95% CI, 1.4-2.6; P < .001), and overall complications (OR, 1.7; 95% CI, 1.3-2.2; P < .001). Additional cost associated with increased 30-day readmission attributable to PHS exposure was estimated at $448,302 per 100 cases.

Conclusions: PHS is an independent risk-adjusted predictor for increased LOS, 30-day readmission, and overall complications after elective EVAR. Recent hospital admission should be assessed carefully before elective EVAR. Medical optimization with an attempt to delay elective surgery by up to 30 days may help to improve surgical outcomes and decrease unnecessary health care expenditures.
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http://dx.doi.org/10.1016/j.jvs.2020.01.063DOI Listing
November 2020

Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms.

J Vasc Surg 2020 10 12;72(4):1360-1366. Epub 2020 Mar 12.

Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston, Mass. Electronic address:

Background: This study reports the clinical impact of iliac artery aneurysms (IAAs) in a population of patients with juxtarenal and thoracoabdominal aortic aneurysms being treated with fenestrated or branched aortic endografts.

Methods: Data from 364 patients with IAA (33%) were extracted from the 1118 patients treated for juxtarenal or thoracoabdominal aortic aneurysms with a fenestrated or branched aortic endograft in a physician-sponsored investigational device exemption trial (2001-2016). IAAs were defined as ≥21 mm in diameter, as measured by an imaging core laboratory. Outcomes were assessed by univariate and multivariable analysis.

Results: IAAs were unilateral in 219 (60%) and bilateral in 145 (40%) of the 364 patients. Treatment was iliac leg endoprosthesis without coverage of the hypogastric artery (seal distal to the IAA in the common iliac artery), placement of a hypogastric branched endograft in 105 (21%), and hypogastric artery coverage with extension into the external iliac artery in 103 (20%); 67 (13%) were untreated. Procedure duration was longer for those with IAA (5.3 ± 1.79 hours vs 4.6 ± 1.74 hours; P < .001), although hospital stay was not. There was no difference in aneurysm-related mortality and all-cause mortality for patients with unilateral and bilateral IAAs compared with those without an IAA. Treatment of patients with a hypogastric branched endograft had similar all-cause mortality compared with treatment of patients without a hypogastric branched endograft but also with an IAA. Reintervention rates were significantly higher in those with bilateral IAAs compared with no IAA (hazard ratio, 1.886; P < .001). Spinal cord ischemia trended higher in patients with bilateral IAA.

Conclusions: IAA management at the time of fenestrated or branched endovascular aneurysm repair increases procedure time without increasing hospitalization. The reintervention rate and spinal cord ischemia rate are higher in patients with bilateral IAA compared with those with no IAA.
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http://dx.doi.org/10.1016/j.jvs.2019.12.040DOI Listing
October 2020

Midterm outcomes of subclavian artery revascularization in the setting of thoracic endovascular aortic repair.

J Vasc Surg 2020 10 22;72(4):1222-1228. Epub 2020 Feb 22.

Department of Vascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objective: The outcomes of subclavian artery revascularization (SAR) have been examined extensively in the setting of atherosclerotic occlusive disease but have been poorly characterized in the setting of thoracic endovascular aortic repair (TEVAR). As trials for branched thoracic endovascular stent grafts materialize, the outcomes of the subclavian artery branched prosthesis will need to be compared with TEVAR with SAR by carotid-subclavian bypass or subclavian transposition.

Methods: A database of 1516 patients undergoing TEVAR from 2000 to 2015 was queried. Of those undergoing TEVAR, 19% (282 patients) also underwent SAR. Patient demographics, TEVAR indication, 30-day morbidity and mortality, and midterm patency and survival were analyzed.

Results: During the study period, 282 patients underwent 288 SARs in the setting of TEVAR. A total of 269 (93%) carotid-subclavian bypasses and 19 (7%) subclavian artery transpositions were performed; 76% of the SARs occurred before TEVAR, 14% occurred concurrently with TEVAR, and 10% occurred after TEVAR. The most common indications for TEVAR was aortic aneurysm (56%), chronic aortic dissection with aneurysmal degeneration (23%), and aortic dissections (13%). The 30-day ipsilateral stroke rate was 3.5%. Eight patients (2.8%) underwent an unplanned return to the operating room (2.1% for hematoma evacuation and 0.7% for management of chyle leak). Six patients (2.1%) sustained a nerve injury. The mean follow-up was 4.2 years. All-cause 30-day mortality was 4.6%. The overall survival rates at 1 year, 5 years, and 10 years were 82%, 60%, and 42%, respectively. The median survival was 7.2 years. Four patients were found to have a failure in primary patency during follow-up. All four patients had undergone a carotid-subclavian bypass. The 1-, 2-, and 5-year primary patency rates were 99.5%, 98.9%, and 98.0%, respectively, for carotid-subclavian bypass and 100% for carotid-subclavian transposition.

Conclusions: During our 16-year study, we found SAR in the setting of TEVAR to be associated with low morbidity, durable long-term patency, and infrequent need for reintervention.
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http://dx.doi.org/10.1016/j.jvs.2019.11.049DOI Listing
October 2020

Carotid Artery Stenting in Asymptomatic Carotid Artery Stenosis: JACC Review Topic of the Week.

J Am Coll Cardiol 2020 02;75(6):648-656

Heart and Vascular Division, Texas Health Dallas, Dallas, Texas.

The advance of therapies to reduce the stroke impact of asymptomatic carotid artery stenosis has proved difficult over the last decade. Disagreement concerning the underlying randomized control trials has limited entry into the care arena of endovascular therapies. Recently, advances in percutaneous therapies for carotid artery disease have been reported and provide a substantial database supporting the further incorporation of endovascular-based therapies in patients who need revascularization and meet selection criteria. With a second randomized control trial now published, it is time for a re-evaluation of endovascular therapy as a component of carotid artery care. This review describes the advances in the field in the last 5 years, clarifying the current position of these therapies in the care of the patient with asymptomatic carotid artery disease.
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http://dx.doi.org/10.1016/j.jacc.2019.11.054DOI Listing
February 2020

Similar 5-year outcomes between female and male patients undergoing elective endovascular abdominal aortic aneurysm repair with the Ovation stent graft.

J Vasc Surg 2020 07 13;72(1):114-121. Epub 2019 Dec 13.

Division of Vascular and Endovascular Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass. Electronic address:

Objective: Female patients undergoing endovascular aneurysm repair (EVAR) for infrarenal abdominal aortic aneurysms present with more challenging anatomy and historically have worse outcomes compared with men. The Ovation Abdominal Stent Graft platform (Endologix, Irving, Calif) contains a polymer-filled proximal sealing ring and has a low-profile delivery system, potentially beneficial in female patients. We therefore investigated differences in long-term outcomes between men and women treated with this device.

Methods: We used data collected prospectively in the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, comprising five trials and the European Post-Market Registry. Anatomic characteristics of the proximal aneurysm neck and iliac arteries were compared between male and female patients. Outcomes were 5-year freedom from type IA and type I/III endoleaks, abdominal aortic aneurysm-related reinterventions, and overall survival. We used Kaplan-Meier analysis to estimate survival proportions and tested univariate differences in survival using log-rank tests. Cox proportional hazards modeling was used to adjust for baseline differences.

Results: We identified 1045 (81%) male and 251 (19%) female patients undergoing EVAR. Female patients were older (mean age, 75 ± 8.4 years vs 73 ± 8.1 years; P < .006). Aneurysm diameter (52 ± 7.5 mm vs 55 ± 9.2 mm; P < .001) and proximal neck diameter (21 ± 3.3 mm vs 23 ± 2.9 mm; P < .001) were smaller in female patients, but adjusted for body surface area, female patients had relatively larger aneurysms and aneurysm necks. Furthermore, female patients presented with shorter proximal necks, smaller iliac artery diameters, more angulated necks, and higher rates of reverse-tapered necks. Five-year freedom from type IA endoleak was similar between men and women (97% vs 96%; P = .38), as was freedom from type I/III endoleaks (91% vs 94%; P = .37) and reinterventions (91% vs 93%; P = .67). Five-year survival was 81% for female patients, similar to the 79% in male patients (P = .55), with one aneurysm-related death in female patients (0.4%) and five in male patients (0.8%; P = .76). Risk-adjusted analyses showed no association between sex and type IA endoleak (hazard ratio [HR], 1.4; 95% confidence interval [CI], 0.6-3.1; P = .41), type I/III endoleak (HR, 1.4; 95% CI, 0.7-2.8; P = .33), reintervention (HR, 1.0; 95% CI, 0.6-2.0; P = .77), and overall mortality (HR, 0.7; 95% CI, 0.4-1.1; P = .14).

Conclusions: Female patients undergoing EVAR with the Ovation platform presented with substantially more adverse proximal neck characteristics. Despite these differences, 5-year freedom from endoleaks and overall survival did not differ between sexes.
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http://dx.doi.org/10.1016/j.jvs.2019.08.275DOI Listing
July 2020

Retinal artery occlusion does not portend an increased risk of stroke.

J Vasc Surg 2020 07 13;72(1):198-203. Epub 2019 Dec 13.

Department of Vascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address:

Objective: The aim of this study was to determine the subsequent risk of stroke after a diagnosis of retinal artery occlusion (RAO). We hypothesized that the risk would be low and comparable to that of the general population. RAO is relatively rare and often incorrectly diagnosed. We believe our institution is in a unique position to investigate this relationship with both a high-volume eye center and vascular laboratory.

Methods: This was a retrospective, single-institution review of 221 patients diagnosed with RAO from 2004 to 2018, confirmed with fluorescein angiography. Demographics, comorbidities, imaging of the carotid arteries, and prospective events, such as stroke, myocardial infarction (MI), and death, were recorded. Time to first stroke, first MI, and death was estimated using Kaplan-Meier estimation separately and as a composite end point.

Results: There were 221 patients identified with a confirmed diagnosis of RAO. The mean age in the cohort was 66.1 years; 53% of patients were male, and 29% were diabetic. Median length of follow-up was 2.2 years. Five patients (2.3%) had a documented stroke; four of the five strokes occurred at the time of RAO, with one that was contralateral occurring at 1.2 years. There were eight MIs (3.6%) in the cohort, two of which resulted in death. Twenty-two patients (10%) experienced a stroke, MI, or death. There were 141 (63.8%) patients who had carotid imaging performed, of whom 20 (14.2%) were found to have >50% stenosis.

Conclusions: The rate of stroke in patients with confirmed RAO was 2.3%; however, excluding concurrent ischemic events, the risk was <1%. The incidence of carotid artery stenosis >50% was 14.2%. The authors conclude that the risk of stroke after confirmed RAO is lower than previously reported and comparable to prior population-based studies of all at-risk adults.
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http://dx.doi.org/10.1016/j.jvs.2019.08.279DOI Listing
July 2020

Evolving Management of Distal Anastomotic Technical Issues During Open Aortic Aneurysm Repair.

Ann Vasc Surg 2020 Apr 18;64:132-142. Epub 2019 Oct 18.

Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH. Electronic address:

Background: Thrombosis of the iliac anastomosis is an important complication of open aortic aneurysm repair. We evaluated our evolving management of this complication to an endovascular approach and compared it with open revision to the common femoral artery.

Methods: Consecutive patients undergoing open aortic aneurysm repair from January 2009 through November 2016 at our institution were reviewed. Patients who developed iliac limb flow issues or thrombosis intraoperatively or within 48 hrs postoperatively were identified. Patients were grouped by management strategies of either 1) an endovascular approach including iliac angiography, thrombectomy if needed, and stenting or 2) open surgical revision of the iliac anastomosis with or without bypass to the common femoral artery. Demographics, comorbidities, operative variables, and outcomes were retrospectively analyzed between groups. Primary patency and mortality were assessed by Kaplan-Meier estimates.

Results: There were 711 patients who underwent aortoiliac aneurysm repair during the study period. 43/711 patients (6.0%) developed early perioperative iliac limb flow issues including thrombosis. Twenty-nine patients (31 limbs) were managed by an endovascular approach, and 14 patients (15 limbs) were managed by open surgical revision. The mean age of the cohort was 69 years, and 27 patients (62.8%) were male. Preoperative creatinine and diabetes frequency were higher in patients managed by an endovascular approach, although no other differences existed between preoperative comorbidities. Thrombosis or limb flow issues presented intraoperatively more commonly in the open surgical group and in the first 24 hrs postoperatively in the endovascular group. All patients had complete restoration of outflow as a result of the rescue procedure. Transfusion requirements and crystalloid replacement were significantly higher in the open surgical group. Length of stay, perioperative complications, and mortality were similar between groups. Overall, 21/31 limbs in the endovascular group and 9/15 limbs in the open surgical group had postoperative imaging, with mean follow-up of 35.0 and 55.6 months, respectively. Only one patient in the cohort lost patency: an iliofemoral jump graft that presented with late infection after postoperative wound infection, requiring staged extra-anatomic bypass and explant at 12 months. Three-year primary patency was 100% for the endovascular group and 85.7% for the surgical group by Kaplan-Meier method (P = 0.32). Endovascular management became our institution's primary salvage approach during the study. Whereas 8/15 limbs (53.3%) were managed by an endovascular approach from 2009-2011, 23/31 (74%) were managed by iliac stenting from 2012-2016.

Conclusions: Endovascular management of iliac limb flow issues or thrombosis after open aneurysm repair is potentially a viable alternative to open surgical revision in the early postoperative period.
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http://dx.doi.org/10.1016/j.avsg.2019.09.033DOI Listing
April 2020

Morphologic and Operative Evolution of Open Ruptured Abdominal Aortic Aneurysm Repair.

Ann Vasc Surg 2020 Feb 16;63:68-82. Epub 2019 Oct 16.

Cleveland Clinic Foundation, Department of Vascular Surgery, Cleveland, OH. Electronic address:

Background: Increased use of endovascular repair for intact abdominal aortic aneurysms has fundamentally shifted the approach to ruptured aneurysms. Unfortunately, not all patients are anatomically suited for endovascular repair. It is hypothesized that, in the endovascular era, patients undergoing open repair are increasingly complex; with an unknown impact on postoperative morbidity and mortality.

Material And Methods: The Cleveland Clinic Foundation database was queried for all patients undergoing open repair of ruptured abdominal aortic aneurysms (rAAA) from 2006 to 2015. Electronic medical charts and cross-sectional imaging were retrospectively reviewed. The overall patient cohort was dichotomized between early (E-OR, 2006 to 2010) and late open repairs (L-OR, 2011 to 2015). Groups were compared based on demographic, anatomic, and perioperative variables. The primary endpoint was perioperative mortality. Secondary endpoints included overall mortality, late aneurysm-related mortality, and perioperative morbidity.

Results: Of 140 patients who underwent open repair of rAAA (63, E-OR; 77, L-OR), 76% had cross-sectional imaging available for review. Aneurysm repairs in the later time period had significantly shorter infrarenal neck lengths, were more likely to have a prior aortic intervention, tended to have poor access vessels, and were more likely to require visceral or renal revascularization (each P < 0.05). While late survival did not differ between time periods, perioperative mortality (27 vs. 46%, P = 0.021) and late aneurysm-related mortality (29.9% vs. 47.6%, P = 0.031) was lower for L-OR compared with E-OR. While no anatomic variables significantly impacted survival, early time period of repair, presence of chronic kidney disease, and need for cardiopulmonary resuscitation were predictive of both perioperative and overall mortality on univariate and multivariate analysis.

Conclusions: Despite the increasing anatomic and operative complexity of patients undergoing open repair of rAAAs, perioperative mortality and late aneurysm-related mortality have improved over time. These results highlight the need for both systems and expertise needed to appropriately treat this changing patient population.
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http://dx.doi.org/10.1016/j.avsg.2019.08.098DOI Listing
February 2020

Factors predicting failure of retrieval of inferior vena cava filters.

J Vasc Surg Venous Lymphat Disord 2020 01 13;8(1):44-52. Epub 2019 Oct 13.

Department of Vascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address:

Objective: Inferior vena cava (IVC) filters have been commonly used to prevent pulmonary embolism in patients with deep vein thrombosis. However, IVC filters have been associated with risks, including IVC perforation, filter migration, fracture, and thrombosis. Filter retrieval has not always been successful. Our objective was to identify the factors associated with failure of retrieval of IVC filters.

Methods: The present study was an institutional review board-approved retrospective medical record review of patients who had undergone IVC filter retrieval attempts at the Department of Vascular Surgery at Cleveland Clinic from 2011 to 2018. The patients were identified by International Classification of Diseases code query, and data were gathered regarding demographics, filter position, procedure details, and patient outcomes. Computed tomography imaging and venography was used to determine the IVC filter location before retrieval.

Results: We identified 295 filter retrieval attempts in 294 patients. No procedural IVC ruptures, morbidity, or mortality occurred. Retrieval was successful for 249 filters (84.4%). The median filter dwell time was 196 days for the successful retrievals compared with 375 days for the failed retrieval attempts (P = .004). Penetration of the filter tines through the caval wall occurred in 291 filters (98.6%). However, the hook/apex (HA) of 31 filters (10.5%) had become embedded or had penetrated through the caval wall. The hook/apex and collar (HA+C) of 33 filters (11.2%) were embedded or had penetrated through the caval wall. The failure rate of filter retrieval with the HA embedded was 48.4% (15 of 31). The failure rate with the HA+C embedded was 66.7% (22 of 33). Finally, the failure rate for filters without these issues was 3.9% (9 of 231). The failure rate for HA and HA+C was greater than that for those without these issues (P < .001) but did not differ between the two issues (P = .14). Among those with computed tomography scans, the association of any portion of the filter with other adjacent retroperitoneal structures was not related to an increased rate of retrieval failure (P = .16). Complex retrieval methods involving endobronchial forceps, ballooning, or snaring the collar of the filter was associated with increased retrieval failure compared with simple retrieval involving snaring the hook of the filter (P < .001). The failure rates decreased over time (P = .004). Of the patients with failed retrieval attempts, 8% experienced subsequent venous thromboembolism.

Conclusions: Retrieval should be attempted for all IVC filters, irrespective of the chronicity and complexity, given the procedural safety. Tine penetration was nearly ubiquitous; however, IVC filters with the HA or HA+C imbedded into or penetrating through the caval wall was a predictor of retrieval failure.
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http://dx.doi.org/10.1016/j.jvsv.2019.07.010DOI Listing
January 2020

Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.

Circulation 2019 10 30;140(14):1145-1155. Epub 2019 Sep 30.

Cleveland Clinic, OH (S.P.L.).

Background: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients.

Methods: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry). All serious adverse events including deaths were adjudicated by a blinded, third-party, independent Clinical Events Committee. Kaplan-Meier estimates in the RCTs were compared with restricted mean survival time. Predictors of death were assessed with hazard ratios (HRs) and Cox proportional hazards modeling.

Results: Baseline characteristics were similar in the patients treated with DCB and PTA in the pooled RCT analysis, with the exception that the DCB cohort was younger (67.4±9.7 versus 69.4±9.4 years, =0.02), smoked more frequently (86.6% versus 78.8%, =0.02), and were less often treated for recurrent lesions (8.8% versus 14.7%, =0.04). In the RCTs, patients treated with DCB had all-cause mortality rates that were not different from those of patients treated with PTA (Kaplan-Meier estimates 1.8±0.7% versus 1.3±0.9%, 6.5±1.2% versus 5.9±1.9%, and 9.3±1.5% versus 9.9±2.4% at 1, 2, and 3 years, respectively, =0.86). All-cause mortality rates were similar in a 1906-patient pooled nonrandomized DCB data set (Kaplan-Meier estimates of 2.1%, 4.9%, and 7.0% at 1, 2, and 3 years, respectively). Clinical Events Committee-adjudicated causes of death were balanced between the DCB and PTA cohorts. Multivariable Cox modeling identified age (HR, 1.06; 95% CI, 1.04-1.08; <0.001), diabetes mellitus (HR, 1.42; 95% CI, 1.01-2.00; =0.04), congestive heart failure (HR, 1.88; 95% CI, 1.12-3.16; =0.02), and renal insufficiency (HR, 2.00; 95% CI, 1.33-3.01; <0.001) as predictors of mortality. Paclitaxel exposure was unrelated to mortality (HR, 1.04; 95% CI, 0.98-1.10; =0.23).

Conclusions: The mortality rates for patients treated with the DCB and uncoated PTA were indistinguishable over 3-year follow-up. Additional patient-level, adequately powered meta-analyses with larger RCT data sets will be needed to confirm the generalizability of these findings.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT02110524, NCT01858363, NCT01858428, NCT03421561, NCT01912937, NCT01927068, and NCT02769273.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.040518DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6784772PMC
October 2019

Five-year results of endovascular abdominal aortic aneurysm repair with the Ovation abdominal stent graft.

J Vasc Surg 2020 05 9;71(5):1528-1537.e2. Epub 2019 Sep 9.

Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, Mass. Electronic address:

Objective: Endovascular abdominal aortic aneurysm repair (EVAR) has been rigorously compared with open repair for the treatment of abdominal aortic aneurysms in randomized trials and observational studies, but a comparison of individual devices is lacking, and single-device registries and trials are limited by small sample size. Here we report a descriptive analysis of the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, pooled results of multiple studies evaluating the midterm results of EVAR with the Ovation Abdominal Stent Graft Platform.

Methods: This is a retrospective analysis of the ENCORE database, a cohort of patients undergoing EVAR with the Ovation platform composed of pooled, prospectively collected data from 1296 patients from five clinical trials and the prospectively maintained European Union Post-Market Registry. The primary outcomes were 5-year rates of type IA and type I or III endoleak. Secondary outcomes included were 30-day mortality, 30-day major adverse event, technical success (successful deployment of the aortic body and iliac limbs), as well as 5-year survival, and freedom from aneurysm-related mortality, type II endoleak, device-related intervention, aneurysm rupture, sac expansion, and conversion to open repair.

Results: A total of 1296 patients were included in the analysis. The average age was 73 ± 8 years and 81% of patients were male. Fifty percent of patients had complex aortic anatomy, (neck length <10 mm, neck diameter >28 mm, neck angle >60°, reverse neck taper >10%, distal common iliac artery diameter <10 mm, or external iliac artery diameter <6 mm). Technical success was 99.7%. Thirty-day mortality was 0.3%, 30-day rate of major adverse event was 1.6%, and polymer leak rate was 0.2%. Freedom from type IA endoleak at 1, 3, and 5 years was 97.6%, 97.1%, and 95.8%, respectively; type I or III endoleak at 1, 3, and 5 years was 96.9%, 95.7%, and 94.0%, respectively. Freedom from device-related reintervention at 1, 3, and 5 years was 96.2%, 94.4%, and 92.4% and primary freedom from sac expansion was 97.0% at 1 year, 90.3% at 3 years, and 84.9% at 5 years. Freedom from all-cause mortality and aneurysm-related mortality at 5 years were 78.9% and 99.3%, respectively.

Conclusions: This analysis of the ENCORE database demonstrates that EVAR with the Ovation platform has favorable midterm durability evidenced by successful aneurysm exclusion and 5-year freedom from aneurysm-related mortality.
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http://dx.doi.org/10.1016/j.jvs.2019.06.196DOI Listing
May 2020

Improving midterm results justify the continued use of bare-metal stents for endovascular therapy for chronic mesenteric ischemia.

J Vasc Surg 2020 01 18;71(1):111-120. Epub 2019 Jul 18.

Department of Vascular Surgery, Cleveland Clinic and Foundation, Cleveland, Ohio.

Objective: The objective of this study was to evaluate the contemporary results of interventions in the celiac axis (CA) and superior mesenteric artery (SMA) for chronic mesenteric ischemia (CMI) and factors associated with patency and symptom-free survival.

Methods: A retrospective review of patients with CMI treated with angioplasty and stenting with bare-metal stents from 2003 to 2014 was conducted. Demographic, history, risk factor, preoperative testing, and technical variables were collected and subject to univariate analysis, with end points of patency loss. The patients were divided into early (2003-2008) and late (2009-2014) groups to compare early and contemporary results. Correlates of patency were then subject to further univariate and multivariable analysis.

Results: From 2003 to 2014, there were 150 patients (39 men, 111 women; age, 70.7 ± 11.1 years) with CMI who underwent interventions on the CA (56 vessels) and the SMA (133 vessels); 38 patients had both CA and SMA intervention. Primary patency for the CA was 86% (95% confidence interval [CI], 73-99) at 1 year and 66% (95% CI, 46-87) 3 years; for the SMA, primary patency was 81% (95% CI, 72-89) at 1 year and 69.0% (95% CI, 58-81) at 3 years. Increased age was associated with improved results in the SMA (hazard ratio [HR], 0.96; 95% CI, 0.92-1.00; P = .028). Chronic total occlusion in the SMA conferred worse patency compared with stenosis (HR, 2.38; 95% CI, 1.03-5.47; P = .042), and younger patients (<70 years) had a higher proportion of SMA occlusion (38.9% vs 22.8; P = .045). In the SMA, comparing early (2003-2008; 68 patients) vs late (2009-2014; 65 patients), primary patency was better in the late experience (3 years, 59% vs 77%; P = .016). The late cohort was older (early, 68.1 ± 12.5 years vs 72.5 ± 9.7 years; P = .024). The late cohort had a higher incidence of ostial flaring of the stent (early, 44.1%; late, 72.3%; P < .001). Multivariable analysis revealed only ostial flaring to be associated with improved patency in the SMA (HR, 0.29; 95% CI, 0.12-0.69; P = .006).

Conclusions: Intervention for CMI has acceptable midterm results, and with experience and adoption of newer techniques, the results appear to be improving. Patients older than 70 years have better results than younger patients, and this may reflect a more malignant presentation in the younger patients. Ostial flaring proved to be the single factor on multivariate analysis associated with improved patency and was adopted in the late group. These data support the continued use of bare-metal stents in the treatment of CMI.
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http://dx.doi.org/10.1016/j.jvs.2019.01.094DOI Listing
January 2020

Editor's Choice - Cryopreserved Allografts for Arterial Reconstruction after Aorto-Iliac Infection: A Systematic Review and Meta-Analysis.

Eur J Vasc Endovasc Surg 2019 Jul 12;58(1):120-128. Epub 2019 Jun 12.

Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH, USA.

Objective: Native and aortic graft infections are rare, but they represent one of the most life threatening complications of vascular surgery. Several materials and surgical approaches have been developed so far. Among them, cryopreserved allografts have been proposed as a treatment option. A systematic review and meta-analysis was conducted to investigate the role of cryopreserved allografts for arterial reconstruction after aorto-iliac infection.

Methods: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Patient baseline characteristics were investigated, along with 30 outcomes after use of cryopreserved arterial allografts for reconstruction after aorto-iliac infection. Pooled proportions with 95% CIs of outcome rates were calculated.

Results: A total of 31 studies, including 1,377 patients, finally participated in the meta-analysis. Among the early outcomes, 30 day mortality was 14.91% (95% CI 11.78-18.31). Peri-anastomotic rupture/allograft disruption rate was 5.90% (95% CI 2.77-9.88), while pooled aneurysmal degeneration/allograft dilatation was 4.99% (95% CI 1.60-9.68). A pooled rate of 3.11% (95% CI 1.60-4.98) was estimated for pseudoaneurysm formation after the use of cryopreserved arterial allografts, while the allograft thrombotic/stenotic complication rate and peri-anastomotic infection were 12.19% (95% CI 7.90-17.15) and 3.32% (95% CI 1.90-5.03), respectively. Mortality during follow up was 19.24% (95% CI 11.97-27.58), while allograft related mortality during follow up was 3.58% (95% CI 1.56-6.15). A pooled allograft related re-operation rate was estimated at 24.87% (95% CI 17.89-32.51).

Conclusions: The use of cryopreserved allograft seems to be a safe and durable option with acceptable outcomes for treatment of aorto-iliac infection.
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http://dx.doi.org/10.1016/j.ejvs.2019.03.003DOI Listing
July 2019

The Majority of Patients Have Diagnostic Evaluation Prior to Major Lower Extremity Amputation.

Ann Vasc Surg 2019 Jul 4;58:78-82. Epub 2019 Feb 4.

Department of Vascular Surgery, Heart and Vascular Institute, Cleveland, OH.

Background: Critical limb ischemia (CLI) patients who do not undergo revascularization are at great risk for major lower extremity (LE) amputation. It has been reported that less than half (49%) of a reference Medicare amputation population had any diagnostic vascular evaluation prior to a major LE amputation. We were surprised by these data so we reviewed the preoperative evaluation in all patients who had a major LE amputation. We propose that significantly more patients will have a vascular evaluation prior to major LE amputation at a tertiary care referral center when a vascular surgeon does the amputation.

Methods: A retrospective analysis of major LE amputations was performed. Patient demographics, comorbidities, type of amputation, reason for amputation, Rutherford classification, and type of preoperative vascular examination were evaluated.

Results: Over 4 years, 281 patients required major LE amputation. Above-knee amputation was performed in 39.1% of patients, whereas below-knee amputation was performed in 60.9%. Amputation was performed due to CLI in 92.9% of patients, whereas 7.1% of amputations were performed due to diabetes or other reasons. Preoperative vascular evaluation was performed in 100% of patients undergoing major LE amputation. Vascular surgeon pulse examination was most common (99.3%) followed by pulse volume recordings/ankle-brachial index (78.8%), angiography (54.8%), computed tomography angiography (29.3%), duplex ultrasonography (41.3%), and magnetic resonance angiography (0.4%). Amputations most commonly occurred due to Rutherford classification VI (63.3%) with 97.2% of patients having Rutherford IV-VI classification.

Conclusions: Preoperative vascular evaluation prior to major LE amputation is achievable in the majority of patients, reported here in 100% of patients undergoing a major LE amputation. This allows us to evaluate the patient for revascularization options prior to amputation for possible limb salvage.
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http://dx.doi.org/10.1016/j.avsg.2018.10.038DOI Listing
July 2019

Management of failed endovascular aortic aneurysm repair with explantation or fenestrated-branched endovascular aortic aneurysm repair.

J Vasc Surg 2018 12 21;68(6):1676-1687.e3. Epub 2018 Jun 21.

Department of Vascular Surgery, Cleveland Clinic, Cleveland, Ohio.

Objective: The incidence of failed endovascular aneurysm repair (EVAR) is increasing, and understanding the different methods of management and repair is paramount. The objective of this study was to evaluate the clinical management and rescue of failed EVAR by either explantation or fenestrated-branched EVAR (F/B-EVAR).

Methods: A retrospective analysis (1999-2016) of 247 patients who underwent either explantation (n = 162) or F/B-EVAR (n = 85) for failed EVAR was performed. F/B-EVAR was performed under a physician-sponsored investigational device exemption. Demographics of the patients, clinical presentation and failure etiology, perioperative management, rate of reinterventions, morbidity, and mortality were analyzed. Those undergoing surgical explantation were compared with those undergoing F/B-EVAR conversion. Statistical analysis included multivariable logistic regressions, Fisher exact test, and χ test.

Results: The majority of patients were male (n = 216 [87%]), with a mean age of 75 years (range, 50-93 years). The mean time from primary EVAR was higher in F/B-EVAR (46 ± 7 months vs 69 ± 41 months; P < .001). Graft manufacturer did not differ between those requiring explantation and those having endovascular rescue (P = .170). All emergencies (n = 24 [10%]) and infections (n = 28 [11%]) were treated with open conversion. Endoleak was the most common reason for failure in both explantation and F/B-EVAR groups (75% vs 64%, respectively; P = .052). Type I endoleak was the most common endoleak reported in both groups, occurring more frequently in F/B-EVAR (64% vs 40%; P < .001); type II endoleak was more common in those undergoing open repair (28% vs 2%; P < .001). Graft migration (12% vs 26%; P = .005) and neck degeneration/disease progression (14% vs 59%; P < .001) were more prevalent in F/B-EVAR, but aneurysm enlargement was more common in explantation (68% vs 33%; P < .001). Thirty-day reintervention rates did not differ between F/B-EVAR and explantation (odds ratio, 0.6258; 95% confidence interval, 0.2-1.86; P = .4115); however, 30-day mortality was lower in the F/B-EVAR group (5% vs 10%; P = .0192). Similarly, aneurysm-related mortality was also lower in the F/B-EVAR group (hazard ratio, 0.0683; 95% confidence interval, 0.01-0.44; P = .0048). A subset analysis excluding emergencies and infections did not alter the lack of difference in terms of freedom from reinterventions (P = .1175), 30-day mortality (P = .6329), or aneurysm-related mortality (P = .7849).

Conclusions: Explantation and F/B-EVAR are necessary options in treating patients with failed EVAR, and both techniques have competitive results. Different modes of failure may point to a preferred method of treatment; consequently, rescue of failed EVAR should be individualized according to each patient's presentation and resources available.
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http://dx.doi.org/10.1016/j.jvs.2018.03.418DOI Listing
December 2018

Primary Stenting Is Not Necessary in Benign Central Venous Stenosis.

Ann Vasc Surg 2018 Jan 12;46:322-330. Epub 2017 Aug 12.

Department of Surgery, University of South Carolina and the Palmetto Health-USC Medical Group, Columbia, SC.

Background: The aim of this study is to evaluate central venous stenosis (CVS) etiologies and presentation within a vascular surgery practice. We evaluated endovascular treatment modalities and the patency rates of our interventions.

Methods: Five-year retrospective review of endovascular intervention for CVS. Patient demographics, medical comorbidities, and variables were collected including etiology, indwelling device, previous upper extremity (UE) deep venous thrombosis, long-term UE indwelling device (defined as >30 days), malignancy status, hypercoagulable disorders, history of radiation or mediastinal fibrosis or masses, and anticoagulation and/or antiplatelet therapy. Follow-up variables included symptoms, imaging, and anticoagulation and/or antiplatelet utilization. Living patients without recent follow-up were contacted with a telephone survey regarding current symptoms. Patency was evaluated by imaging or clinically by recurrence of signs or symptoms through January 2016.

Results: A total of 61 patients underwent attempted endovascular CVS interventions from January 2007 to 2013. Forty-seven (83%) patients had successful interventions. There were 22 (36%) end-stage renal disease (ESRD) patients. The primary etiology in 79% of patients was benign CVS secondary to an indwelling device. Eighty-nine percent of the interventions were primary angioplasty (PTA). The overall primary patency rates at 6, 12, and 24 months were 49%, 34%, and 24%, respectively. Secondary patency rates at 6, 12, and 24 months were 97%, 93%, and 88%, respectively. There were no statistical differences in demographics or outcomes in patients treated successfully with PTA or those requiring stenting. There was no statistical difference in the patency rates between ESRD and non-ESRD patients. Previous interventions were not a predictor of loss of patency.

Conclusions: Our study supported the rising trend of benign CVS predominantly secondary to indwelling devices. We demonstrated acceptable secondary patency with PTA alone. This study adds further support for a primary angioplasty strategy in treating benign CVS. The optimal endovascular treatment for benign CVS is still undefined.
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http://dx.doi.org/10.1016/j.avsg.2017.07.001DOI Listing
January 2018

Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies.

Circulation 2017 Sep 20;136(12):1102-1113. Epub 2017 Jul 20.

From Icahn School of Medicine at Mount Sinai, New York City (P.K., P.F.); Division of Cardiovascular Medicine, Emory University Hospital, Atlanta, GA (K.N.); Mission Cardiovascular Research Institute, Fremont, CA (A.J.); North Carolina Heart and Vascular, UNC-Rex Healthcare, Raleigh (R.S.); Pinnacle Health Cardiovascular Institute, Harrisburg, PA (W.B.B.); Yuma Cardiology Associates, Yuma Regional Medical Center, AZ (J.C.); Department of Angiology, Hanusch Hospital, Vienna, Austria (M.W.); Division of Angiology, Medical University Graz, Austria (M.B.); Metro Health University of Michigan Health, Wyoming, MI (J.A.M.); Yale University School of Medicine, New Haven, CT (C.M.-H.); VasCore, Massachusetts General Hospital, Boston (M.R.J.); Department of Interventional Radiology, Auckland City Hospital, New Zealand (A.H.H.); and Department of Vascular Surgery, Cleveland Clinic, OH (S.P.L.).

Background: Drug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease.

Methods: In the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2-4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty [PTA]) (n=100). The primary safety end point was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable.

Results: In the ILLUMENATE Pivotal Study, baseline characteristics were similar between groups: 50% had diabetes mellitus, 41% were women, mean lesion length was 8.3 cm, and 44% were severely calcified. The primary safety end point was met (92.1% for DCB versus 83.2% for PTA, =0.025 for superiority) and the primary patency rate was significantly higher with DCB (76.3% for DCB versus 57.6% for PTA, =0.003). Primary patency per Kaplan-Meier estimates at day 365 was 82.3% for DCB versus 70.9% for PTA (=0.002). The rate of clinically driven target lesion revascularization was significantly lower in the DCB cohort (7.9% versus 16.8%, =0.023). Improvements in ankle-brachial index, Rutherford class, and quality of life were comparable, but the PTA cohort required twice as many revascularizations. Pharmacokinetic outcomes showed that all patients had detectable paclitaxel levels after DCB deployment that declined within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL).

Conclusions: The data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour.

Clinical Trial Registration: URL: http://clinicaltrials.gov. Unique identifiers: NCT01858428 and NCT01912937.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.117.028893DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5598919PMC
September 2017

Patient-level meta-analysis of 999 claudicants undergoing primary femoropopliteal nitinol stent implantation.

Catheter Cardiovasc Interv 2017 Jun 17;89(7):1250-1256. Epub 2017 Mar 17.

Massachuessttes General Hospital, Boston, Massachuessttes.

Condensed Abstract: The factors that impact the clinical effectiveness of bare nitinol stents in claudicants with symptomatic femoropopliteal atherosclerosis are incompletely known. The authors analyzed variables that may influence stent durability and provide a benchmark for their effectiveness. Data analyzed from six studies (999 patients) included baseline noninvasive hemodynamic tests, angiographic characteristics, ultrasound defined stent patency and target lesion revascularization through 12-months. Baseline ankle-brachial index and lesion length predicted stent patency and target lesion revascularization and when combined interacted significantly to better predict outcomes. This meta-analysis provides an important comparator against which emerging therapies that treat claudicants with femoropopliteal atherosclerosis can be assessed.

Subject Code: Peripheral Artery Disease BACKGROUND: The performance of bare metal nitinol stents in patients with symptomatic femoropopliteal peripheral artery disease (PAD) is not well defined.

Methods: Patient-level data from six large prospective trials sponsored by medical device manufacturers was abstracted and analyzed to identify a cohort of patients with claudication and femoropopliteal artery occlusive disease. Twelve-month binary patency and target lesion revascularization (TLR) rates were primary outcomes. Stent patency was assessed by duplex ultrasonography (DUS) and TLR was a clinically driven intervention. To characterize the effects of patient characteristics on the outcomes, meta-regression was performed via mixed effects logistic regression models with patient-level covariates.

Results: About 999 patients were analyzed; the mean ABI was 0.68 ± 0.18, the mean lesion length was 84 ± 53 mm, the mean lesion stenosis was 78%, and nearly two thirds of patients had mild to severe calcification. The mean Rutherford clinical category was 2.7 ± 0.6 and ranged from 2.6 to 2.8 in all studies. The 12-month patency across all studies was 69.8% and TLR rates ranged from 9.2% to 19.7%. Multivariable analysis demonstrated that baseline ABI and baseline target lesion length predicted both primary patency and TLR. Further, these two variables interacted significantly to better predict TLR outcomes when used in combination.

Conclusion: The 12-month clinical effectiveness of bare nitinol stents to treat patients with symptomatic femoropopliteal PAD is acceptable and is impacted by clinical and lesion-specific characteristics. These data provide an important and useful benchmark to compare the clinical benefit of emerging endovascular PAD therapies. © 2017 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.27029DOI Listing
June 2017

Outcomes after Partial Endograft Explantation.

Ann Vasc Surg 2016 Feb 30;31:1-7. Epub 2015 Nov 30.

Department of Vascular Surgery, Cleveland Clinic Foundation, Cleveland, OH.

Background: To evaluate the aneurysm-related complications and device issues in patients who underwent partial endograft explantation during late conversion of endovascular aneurysm repair (EVAR) to open repair.

Methods: A retrospective analysis was performed on patients who had partially explanted endografts during late conversion between 1999 and 2012. Medical records were reviewed for patient demographics, subsequent operations, and aneurysm-related complications. Postoperative abdominal X-ray films and computed tomography scans were analyzed for endograft migration, component separation, device fracture, and arterial growth or aneurysm issues.

Results: Between 1999 and 2012, 22 patients had late conversion after EVAR with portions of the device left in situ. Five of the partially removed devices were Zenith, 6 Talent, 5 Ancure, 3 AneuRx, 2 Excluder endografts, and 1 Cook Aorto uni-iliac (AUI) graft. There were 4 in hospital mortalities. There were no graft migrations, component separations, device fractures, new aneurysmal degeneration, or ruptures with a median follow-up of 26.5 months.

Conclusions: Partial endograft removal during late conversion is not associated with complications from the remaining device pieces during follow-up. We recommend further study of this patient population.
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http://dx.doi.org/10.1016/j.avsg.2015.09.018DOI Listing
February 2016

Late graft explants in endovascular aneurysm repair.

J Vasc Surg 2014 Apr 28;59(4):886-93. Epub 2013 Dec 28.

Department of Vascular Surgery, Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, Cleveland, Ohio.

Objective: With more than a decade of use of endovascular aneurysm repair (EVAR), we expect to see a rise in the number of failing endografts. We review a single-center experience with EVAR explants to identify patterns of presentation and understand operative outcomes that may alter clinical management.

Methods: A retrospective analysis of EVARs requiring late explants, >1 month after implant, was performed. Patient demographics, type of graft, duration of implant, reason for removal, operative technique, length of stay, complications, and in-hospital and late mortality were reviewed.

Results: During 1999 to 2012, 100 patients (91% men) required EVAR explant, of which 61 were placed at another institution. The average age was 75 years (range, 50-93 years). The median length of time since implantation was 41 months (range, 1-144 months). Explanted grafts included 25 AneuRx (Medtronic, Minneapolis, Minn), 25 Excluder (W. L. Gore & Associates, Flagstaff, Ariz), 17 Zenith (Cook Medical, Bloomington, Ind), 15 Talent (Medtronic), 10 Ancure (Guidant, Indianapolis, Ind), 4 Powerlink (Endologix, Irvine, Calif), 1 Endurant (Medtronic), 1 Quantum LP (Cordis, Miami Lakes, Fla), 1 Aorta Uni Iliac Rupture Graft (Cook Medical, Bloomington, Ind), and 1 homemade tube graft. Overall 30-day mortality was 17%, with an elective case mortality of 9.9%, nonelective case mortality of 37%, and 56% mortality for ruptures. Endoleak was the most common indication for explant, with one or more endoleaks present in 82% (type I, 40%; II, 30%; III, 22%; endotension, 6%; multiple, 16%). Other reasons for explant included infection (13%), acute thrombosis (4%), and claudication (1%). In the first 12 months, 23 patients required explants, with type I endoleak (48%) and infection (35%) the most frequent indication. Conversely, 22 patients required explants after 5 years, with type I (36%) and type III (32%) endoleak responsible for most indications.

Conclusions: The rate of EVAR late explants has increased during the past decade at our institution. Survival is higher when the explant is done electively compared with emergent repair. Difficulty in obtaining a seal at the initial EVAR often leads to failure ≤1 year, whereas progression of aneurysmal disease is the primary reason for failure >5 years.
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http://dx.doi.org/10.1016/j.jvs.2013.10.079DOI Listing
April 2014

The hyperglycemic response to major noncardiac surgery and the added effect of steroid administration in patients with and without diabetes.

Anesth Analg 2013 May 4;116(5):1116-22. Epub 2013 Apr 4.

Departments of General Anesthesiology and Outcomes Research, Cleveland Clinic, Cleveland, Ohio 44195, USA.

Background: The pattern and magnitude of the hyperglycemic response to surgical stress, the added effect of low-dose steroids, and whether these differ in diabetics and nondiabetics remain unclear. We therefore tested 2 hypotheses: (1) that diabetics show a greater increase from preoperative to intraoperative glucose concentrations than nondiabetics; and (2) that steroid administration increases intraoperative hyperglycemia more so in diabetics compared with nondiabetics.

Methods: Patients scheduled for major noncardiac surgery under general anesthesia were enrolled and randomized to preoperative IV 8 mg dexamethasone or placebo, stratified by diagnosis of diabetes. Patients were part of a larger underlying trial (the Dexamethasone, Light Anesthesia and Tight Glucose Control [DeLiT] Trial). IV insulin was given when glucose concentration exceeded 215 mg/dL. The primary outcome measure was the change in glucose from the preoperative to maximal intraoperative glucose concentration. We also report the time-dependent pattern of intraoperative hyperglycemia.

Results: Ninety patients (23% with diabetes) were randomized to dexamethasone, and 95 (29% with diabetes) were given placebo. The mean ± SD change from preoperative to maximal intraoperative glucose concentration was 63 ± 69 mg/dL in diabetics and 72 ± 45 mg/dL in nondiabetics. The mean covariable-adjusted change (95% confidence interval) in nondiabetics was 29 (13, 46) mg/dL more than in diabetics (P < 0.001). For all patients combined, mean glucose increased slightly from preoperative to incision, substantially from incision to surgery midpoint, and then remained high and fairly stable through emergence, with nondiabetic patients showing a greater increase (P < 0.001). For nondiabetics, the mean increase in glucose concentration (97.5% CI) was 29 (9, 49) mg/dL more in patients given dexamethasone than placebo (P = 0.0012). However, there was no dexamethasone effect in diabetics (P = 0.99).

Conclusions: Treatment of intraoperative hyperglycemia should account for the hyperglycemic surgical stress response trend depending on the stage of surgery as well as the added effects of steroid administration. Denying steroid prophylaxis for postoperative nausea and vomiting for fear of hyperglycemic response should be reconsidered given the limited effect of steroids on intraoperative blood glucose concentrations.
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http://dx.doi.org/10.1213/ANE.0b013e318288416dDOI Listing
May 2013

Endovascular treatment of acute limb ischemia: review of current plasminogen activators and mechanical thrombectomy devices.

Authors:
Sean P Lyden

Perspect Vasc Surg Endovasc Ther 2010 Dec;22(4):219-22

Lerner Cleveland Clinic College of Medicine at Case Western Reserve University, Desk H32, Department of Vascular Surgery, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA.

Acute limb ischemia occurs in 15% to 20% of patients with chronic peripheral arterial disease. Off-label use of tissue plasminogen activators is the most common approach for patients with ischemic limbs that can wait 24 to 48 hours to restore flow. In the past decade, mechanical thrombectomy devices that use aspiration, maceration, or ultrasound waves have been developed to allow more rapid restoration of flow. Combination therapy with both mechanical and pharmacologic thrombolysis has become commonplace without randomized data to support its use. This article reviews acute limb ischemia and data regarding pharmacologic and mechanical thrombolysis.
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http://dx.doi.org/10.1177/1531003511400624DOI Listing
December 2010