William P. Shutze Sr. M.D.

Barry, I.P., Barns, M., Verhoeven, E., Wong, J., Dubenec, S., Heyligers, J.M., Milner, R., Shutze, W.P., Bachoo, P., Vlaskovky, P. and Mwipatayi, B.P. (2021). “Excluder Stent Graft-Related Outcomes in Patients with Aortic Neck Anatomy Outside of Instructions For Use (IFU) within the Global Registry for Endovascular Aortic Treatment (GREAT): Mid-term Follow-Up Results.” Ann Vasc Surg Jun 25;S0890-5096(21)00426-X. [Epub ahead of print].

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BACKGROUND: The utilisation rate of endovascular aortic aneurysm repair (EVAR) has increased continuously over the past two decades. EVAR is still performed frequently in patients with an unfavourable proximal seal zone, despite the associated late complications. PURPOSE: We aimed to evaluate the mid-term durability of the GORE® EXCLUDER® AAA Endoprosthesis, featuring the C3 delivery system, in patients with a proximal neck anatomy outside the instructions for use (IFU). PROCEDURES: A retrospective sub-analysis of the Global Registry for Endovascular Aortic Treatment including patients treated for abdominal aortic aneurysms with the GORE® EXCLUDER® AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, Arizona) was performed. A “challenging neck” was defined as those treated outside the IFU with an aortic neck length <15 mm and/or aortic neck angle >60°. Cox proportional analyses were used to test for time-to-event differences between those treated within and outside the IFU while accounting for covariates, specifically proximal neck length and neck angle. The main outcomes assessed were 5-year all-cause mortality, 5-year endoleak development (type I or III), and 5-year device-related reinterventions. FINDINGS: Of the 3,324 patients included in the analysis, 411 (12.4%) had a challenging neck and 2,913 (87.6%) did not. The patients in the challenging neck group were significantly older (74.9 years vs. 73.2 years, p=<0.0001) and had a significantly larger aortic aneurysm diameter at the time of the intervention than those treated within the IFU (61.2 mm vs 56.4 mm, p<0.0001), shorter proximal neck length (18 mm vs 30 mm, p<0.0001) and larger infrarenal neck angle (60.8° vs 25.8°, p<0.0001). In the multivariate analysis, brachial access site and challenging neck were not independent risk factors; increased age was associated with a shorter time to mortality (hazard ratio 1.051, 95% confidence interval 1.039-1.062, p<0.0001), as was the use of tobacco (hazard ratio 1.329, 95% confidence interval 1.124-1.571, p=0.0009). The 5-year all-cause mortality (36.2% vs. 27.5%, p=0.002) and aorta-related mortality (3.8% vs 1.1%, p=0.002) were significantly higher in the challenging neck group. The risk of death within 5 years also increased significantly at 1.1% per millimetre increase in the abdominal aortic aneurysm diameter (p=0.0005). Furthermore, the rates of type Ia endoleak development (7% vs. 1.2%, p<0.001) and requirement for reintervention (13.3% vs. 9.7%, p<0.001) were higher in those treated outside the IFU (challenging neck group). CONCLUSIONS: Treatment with the Excluder AAA Endograft outside the IFU was associated with higher 5-year mortality values, increased type Ia endoleak development rates, and a greater need for reintervention compared with treatment within the IFU. This reiterates that fenestrated and open treatments should be strongly considered in cases with aortic neck anatomies outside the IFU. Infrarenal endovascular intervention outside the IFU should only be used when there is no alternative, with meticulous procedural planning and intervention to promote satisfactory outcomes.

Shutze, W., Gable, D., Ogola, G., Yasin, T., Madhukar, N., Kamma, B., Alniem, Y. and Eidt, J. (2021). “Sex, Age, and Other Barriers for Prosthetics Referral Following Amputation and the Impact on Survival.” J Vasc Surg May 31;S0741-5214(21)00839-9. [Epub ahead of print].

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BACKGROUND: Despite advances in peripheral vascular disease treatment, lower extremity amputation continues to be necessary in a significant number of patients. Up to 80% of amputees are not referred for prosthetic fitting. The factors contributing to referral decisions have not been adequately investigated, nor has the impact of prosthetic referral on survival. We characterized differences between patients who were successfully referred to our in-house prosthetists compared to those that were not, and identified factors associated with prosthetic referral and predictive of survival. METHODS: This was a retrospective analysis of all patients that underwent lower-extremity amputation by surgeons in our practice from January 1, 2010 to June 30, 2017. Age, sex, race, body mass index (BMI), diabetes, hypertension, hyperlipidemia, end stage renal disease, prior coronary artery bypass graft surgery, congestive heart failure, tobacco use, American Society of Anesthesiologists (ASA) score, previous arterial procedure, chronic obstructive pulmonary disease, statin use, postoperative ambulatory status, level of amputation, stump revision, and referral for prosthesis were collected. Survival was determined from a combination of sources, including the Social Security Death Master Index, multiple genealogic registries, and internet searches. Multivariable logistic regression was used to determine risk factors associated with prosthesis referral. Multivariable Cox proportional hazard regression with time dependent covariates was performed to assess risk factors associated with 5-year mortality. RESULTS: There were 293 patients included in this study. Mean age was 66 years and mean body mass index 27 kg/m(2). The majority of patients were male (69%), white (53%), with diabetes (65.4%) and hypertension (77.5%), and underwent below-the-knee amputation (BKA) (73%), . Prosthetic referral occurred in 123 (42.0%). Overall 5-year survival was 61.7% (95%CI, 55.9%-68.1%) (BKA 64.7% [95%CI, 57.9%-72.3%], above-the-knee amputation 53.8 % [95%CI, 43.4%-66.6%]). On multivariate analysis age >70 years, female sex, diabetes, ASA score 4 or 5, and current tobacco use were associated with no referral for prosthetic fitting. Patients with BMI 25-30, a previous arterial procedure, BKA, and history of stump revision were more likely to be referred. Factors associated with decreased survival were: increasing age, higher ASA class, Black race, and BMI; prosthetics referral was seen to be protective. CONCLUSION: We identified multiple patient factors associated with prosthetic referral, as well as several characteristics predictive of reduced survival after amputation. Being referred for prosthetic fitting was associated with improved survival not explained by patient characteristics and comorbidities. Further research is needed to determine whether the factors identified as associated with non-referral are markers for patient characteristics that make them clinically unsuitable for prosthetic fitting or if they are symptoms of unconscious bias or of patient’s access to care.

Baxter, R. D., S. K. Hansen, C. E. Gable, J. M. DiMaio, W. P. Shutze and D. R. Gable (2020). “Outcomes of Open versus Percutaneous Access for Patients Enrolled in the GREAT Registry.” Ann Vasc Surg Jun 27;S0890-5096(20)30534-3. [Epub ahead of print.].

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BACKGROUND: Arterial access and device delivery in endovascular aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) have evolved from open femoral or iliac artery exposure to selective percutaneous arterial access. Although regional application of percutaneous access for these two procedures varies widely, the use of this technique continues to increase. [1,2] Currently, differences in the use of percutaneous access between EVAR and TEVAR have not been well explored. The Gore Global Registry for Endovascular Aortic Treatment (GREAT) registry collected relevant data for evaluation of these issues as well as the comparative results between open and percutaneous approaches in regards to complication rates and length of stay. METHODS: This study was performed via a retrospective review of patients from the GREAT registry (Clinicaltrials.gov no. NCT01658787). The primary variable of this study was access site complications including postoperative hematoma, vessel dissection, and pseudoaneurysm. Patients were categorized by abdominal (EVAR) and thoracic (TEVAR) aortic procedures using percutaneous-only, cutdown-only, and combined vascular access techniques for a total of 6 groups. Standard statistical methodology was used to perform single- and multi-variable analysis of a variety of covariates including length of stay (LOS), geographical location of procedure, procedural success rate and access sheath size. RESULTS: Of 4,781 patients from the GREAT registry, 3,837 (80.3%) underwent EVAR and 944 (19.7%) underwent TEVAR with percutaneous-only access techniques being used in 2,017 (42.2%) and cutdown-only in 2,446 (51.2%). There was variable application of percutaneous access by geographic region with Australia and New Zealand using this technique more frequently and Brazil using percutaneous access the least. No significant difference in the rate of access site complications were detected between the 6 groups of patients in the study; however, significantly lower rates of access site complications were associated with percutaneous-only compared with both cutdown-only and combined techniques (p=0.03). Also associated with significantly higher rates of access site complications was longer lengths of stay (p<0.01). Average LOS was 5.2 days and was higher in the TEVAR group (10.1 days) compared to EVAR (4.0 days, p<0.05). Increased sheath size does not appear to increase the risk of access site complication. CONCLUSIONS: There was no significant difference found in the complication rate between percutaneous and cutdown access techniques. This analysis demonstrates that percutaneous-only access is safe, has low complication rates, and has lower LOS compared to open access or combined access techniques.

Mwipatayi, B. P., T. Anwari, J. Wong, E. Verhoeven, S. Dubenec, J. M. Heyligers, R. Milner, C. Mascoli, M. Gargiulo and W. P. Shutze (2020). “Sex-related outcomes after endovascular aneurysm repair within the Global Registry for Endovascular Aortic Treatment (GREAT).” Ann Vasc Surg Mar 16. pii: S0890-5096(20)30207-7. [Epub ahead of print].

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BACKGROUND: Abdominal aortic aneurysms (AAAs) are more common in men. However, women have been shown to have more short- and long-term adverse outcomes after endovascular aneurysm repair (EVAR). This disparity is thought to be multifactorial, including anatomical differences, hormonal differences, older age of presentation, and a greater degree of preoperative comorbidities. METHODS: A retrospective analysis that included data for 3758 patients from the Global Registry for Endovascular Aortic Treatment (GREAT) was conducted. Patients were recruited into GREAT between August 2010 and October 2016 and received the Gore Excluder stent graft for infrarenal AAAs repair. Cox multivariate regression analyses were performed to analyse any re-intervention and device related intervention rates. RESULTS: Of the 3758 patients, 3220 were male (mean age 73 years) and 538 were female (mean age 75 years). Women had higher prevalence rates of chronic obstructive pulmonary disease (P <0.0001) and renal insufficiency (P = 0.03), whilst men had higher rates of cardiovascular comorbidities. The AAAs in women were smaller in diameter with shorter and more angulated necks. Women did not experience a significantly higher rate of endoleaks, but did exhibit higher re-intervention rates, including re-intervention for device related issues. In terms of mortality, aorta related mortality was most prevalent within the first 30 days post procedure in both sexes. CONCLUSION: Women were treated at an older age and had a more hostile aneurysmal anatomy. Although the mortality rates were lower in women, they had significantly higher rates of re-intervention, and thus higher morbidity rates post EVAR.

Shutze, W., R. Shutze, P. Dhot and G. O. Ogola (2019). “Patient-reported outcomes of endovenous superficial venous ablation for lower extremity swelling.” Phlebology 34(6): 391-398.

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Objective: To evaluate the effect of endovenous ablation in patients presenting with leg swelling. Methods: We identified Clinical, Etiology, Anatomy, Pathophysiology (CEAP) clinical class 3 (C3) patients undergoing endovenous ablation from 21 January 2005 to 19 March 2015 with an 810-nm or 1470-nm laser. Patients were surveyed regarding the degree of edema, use of compression stockings, and satisfaction with the procedure. Results: A total of 1634 limbs were treated by endovenous ablation for incompetent saphenous veins with or without adjunctive segmental varicose vein microphlebectomy. Of these, 528 limbs were treated for CEAP C3. The average time period from the procedure date until the survey date was 1494 days (range, 562–2795 days). Ninety-two respondents accounted for 130 ablations in 128 limbs with an average venous segmental disease score of 2.7. Ninety-seven limbs (75.8%) had reduced or resolved swelling, 29 limbs (22.6%) were unchanged, and 2 limbs (1.6%) had increased swelling. The vast majority (81%) were satisfied with their decision to have the procedure. Conclusions: Endovenous ablation for edema secondary to superficial venous insufficiency is effective and has high patient satisfaction. Further investigation is needed regarding risk factors for immediate failure and delayed recurrence of edema.