Conservative Management of Non-Infected Diabetic Foot Ulcers Achieves Reliable Wound Healing and Limb Salvage in the Setting of Mild-Moderate Ischemia.

BACKGROUND: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system has been validated to predict wound healing among patients with critical limb threatening ischemia (CLTI). Our goal was to analyze the use of a previously reported conservative wound care approach to non-infected (foot infection score of zero), diabetic foot ulcers with mild-moderate peripheral arterial disease enrolled in a conservative tier of a multidisciplinary limb preservation program. METHODS: Veterans with CLTI and tissue loss were prospectively enrolled into our Prevention of Amputation in Veterans Everywhere (PAVE) program. All patients with wounds were stratified to a conservative approach based on perfusion evaluation and a validated pathway of care. Retrospective analysis of a prospectively maintained database was performed to evaluate all conservatively managed patients presenting without foot infection for the primary outcome of wound healing as well as secondary outcomes of time to wound healing, delayed revascularization, wound recurrence, and limb loss. RESULTS: Between January 2006 and December 2019, 1113 patients were prospectively enrolled into the PAVE program. A total of 241 limbs with 281 wounds (217 patients) were stratified to the conservative approach. Of these, 122 limbs (89 patients) met criteria of having diabetic foot wounds without infection at the time of enrollment and are analyzed in this report. Of the 122 limbs, 97 (79.5%) healed their index wound with a mean time to healing of 4.6 months (0.5-20 months). Wound recurrence ensued in 44 (45.4%) limbs, 93.2% of which healed again after recurrence. There were three (3.1%) limbs requiring major amputation in this group (one due to uncontrolled infection and two due to ischemic tissue loss). Of the 25 (20.5%) limbs that did not heal initially, four (16%) required amputation due to progressive symptoms of CLTI. CONCLUSIONS: In patients with diabetes and lower extremity wounds without infection in the setting of mild to moderate peripheral arterial disease, there appears to be an acceptable rate of index wound healing, and appropriate rate of recurrent wound healing with a low risk of limb loss. While wound recurrence is frequent, this can be successfully treated without the need for revascularization.

Arteriovenous fistula maturation: Physical exam versus flow study.

PURPOSE: The purpose of this study was to determine the utility of routine duplex flow study 4 to 6 weeks after primary AVF creation and to compare physical exam against a duplex flow study in predicting fistula maturation. A surveillance algorithm was established to evaluate the naïve fistula after primary creation. METHODS: This was a single institution retrospective review of 155 veterans with primary autogenous AVF creation from 2016 to 2018. All patients received a duplex flow study evaluation after primary creation. A comparison was made between physical exam (PE) and flow study at 4 to 6 weeks post creation. Sensitivities and specificities of physical exam and duplex flow study were compared head-to-head in predicting unassisted fistula maturation. A mature AVF was defined as a fistula that could be repetitively cannulated and provided adequate flow for dialysis. Failure of maturation was defined as an AVF that was never usable for dialysis. An abnormal duplex included thrombosis, stenosis (> 50% on gray scale imaging), inadequate vein diameter (< 4 mm), inadequate vein length or superficialization, or poor flow (< 500 ml/min). Bivariate comparisons were conducted using Pearson's χ², Fishers exact test, and Wilcoxon test depending on distribution. Significance was defined as P < 0.05. RESULTS: There were 53 patients with radiocephalic (RC) fistulas, 41 patients with brachiocephalic (BC) fistulas, and 6 patients with brachiobasilic (BB) fistulas. Of patients with a confirmed abnormal duplex ultrasound, 53% had an abnormal PE (sensitivity 53%; PPV 96.3%, P < 0.001). Of the patients with a confirmed normal duplex, 98% had a normal PE (specificity 98%; NPV 68.5%, P < 0.001). An abnormal duplex flow study had a 67% sensitivity for predicting AVF failure or need for reintervention while an abnormal physical examination had a 42% sensitivity in predicting AVF failure or need for reintervention (P < 0.001). In total, 48 fistulas needed reintervention, however only 20 (42%) were associated with an abnormal physical examination. Of those 48 reinterventions, 20 (42%) fistulas exhibited primary assisted maturation (P < 0.001). On duplex flow study alone, 32 patients had hemodynamically significant lesions necessitating reintervention, which went on to afford 9 (28%) primary assisted mature fistulas (P = 0.69). CONCLUSION: Abnormal duplex flow studies have a better sensitivity for detecting AVF failure or the need for reintervention compared to physical exam alone. An abnormal duplex correlates more with needing a reintervention to achieve maturation than physical exam. Therefore, we advocate routine use of a postoperative duplex flow study to identify potentially correctable issues and optimize fistula maturation.

5-Item Modified Frailty Index Predicts Outcomes After Below-Knee Amputation in the Vascular Quality Initiative Amputation Registry.

Patient frailty indices are increasingly being utilized to anticipate post-operative complications. This study explores whether a 5-factor modified frailty index (mFI-5) is associated with outcomes following below-knee amputation (BKA). All BKAs in the vascular quality initiative (VQI) amputation registry from 2012-2017 were reviewed. Preoperative frailty status was determined with the mFI-5 which assigns one point each for history of diabetes, chronic obstructive pulmonary disease or active pneumonia, congestive heart failure, hypertension, and nonindependent functional status. Outcomes included 30-day mortality, unplanned return to odds ratio (OR), post-op myocardial infarction (MI), post-op SSI, all-cause complication, revision to higher level amputation, disposition status, and prosthetic use. 2040 BKAs were performed. Logistic regression showed an increasing mFI-5 score that was associated with higher risk of combined complications (OR 1.22, confidence interval [CI] 1.07-1.38, P < .05), 30-day mortality (OR 1.60, CI 1.19-2.16, P < .05), post-op MI (OR 1.79, CI 1.30-2.45, P < .05), and failure of long-term prosthetic use (OR 1.17, CI 1.03-1.32, P < .05). In the VQI, every one-point increase in mFI-5 is associated with an increased risk of 22% for combined complications, 60% for 30-day mortality, nearly 80% for post-op MI, and 17% for failure of prosthetic use in BKA patients. The mFI-5 frailty index should be incorporated into preoperative planning and risk stratification.

A conservative approach to select patients with ischemic wounds is safe and effective in the setting of deferred revascularization.

OBJECTIVE: The Wound, Ischemia, and foot Infection classification system has been validated to predict benefit from inmediate revascularization and major amputation risk among patients with peripheral arterial disease. Our primary goal was to evaluate wound healing, limb salvage, and survival among patients with ischemic wounds undergoing revascularization when intervention was deferred by a trial of conservative wound therapy. METHODS: All patients with peripheral arterial disease and tissue loss are prospectively enrolled into our Prevention of Amputation in Veterans Everywhere limb preservation program. Limbs are stratified into a validated pathway of care based on predetermined criteria (immediate revascularization, conservative treatment, primary amputation, and palliative care). Limbs allocated to the conservative strategy that failed to demonstrate adequate wound healing and were candidates, underwent deferred revascularization. Rates of wound healing, freedom from major amputation, and survival were compared between patients who underwent deferred revascularization with those who received immediate revascularization by univariate and multivariate analysis. RESULTS: Between January 2008 and December 2017, 855 limbs were prospectively enrolled into the Prevention of Amputation in Veterans Everywhere program. A total of 203 limbs underwent immediate revascularization. Of 236 limbs stratified to a conservative approach, 185 (78.4%) healed and 33 (14.0%) underwent deferred revascularization (mean, 2.7 ± 2.6 months). The mean long-term follow-up was 51.7 ± 37.0 months. Deferred compared with immediate revascularization demonstrated similar rates of wound healing (66.7% vs 57.6%; P = .33), freedom from major amputation (81.8% vs 74.9%; P = .39), and survival (54.5% vs 50.7%; P = .69). After adjustment for overall Wound, Ischemia, and foot Infection stratification stages, deferred revascularization remained similar to immediate revascularization for wound healing (hazard ratio [HR], 1.5; 95% confidence interval [CI], 0.7-3.2), freedom from major amputation (HR, 0.7; 95% CI, 0.3-1.7) and survival (HR, 1.2; 95% CI, 0.6-2.4). CONCLUSIONS: Limbs with mild to moderate ischemia that fail a trial of conservative wound therapy and undergo deferred revascularization achieve similar rates of wound healing, limb salvage, and survival compared with limbs undergoing immediate revascularization. A stratified approach to critical limb ischemia is safe and can avoid unnecessary procedures in selected patients.

Multidisciplinary approach achieves limb salvage without revascularization in patients with mild to moderate ischemia and tissue loss.

OBJECTIVE: The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system has been validated to predict wound healing and limb salvage of patients with peripheral artery disease (PAD). Our goal was to evaluate the association between WIfI stage and wound healing, limb salvage, and survival in a select cohort of patients with PAD and tissue loss undergoing an attempt of wound healing without immediate revascularization (conservative approach) in a multidisciplinary wound program. METHODS: Veterans with PAD and tissue loss were prospectively enrolled in our Prevention of Amputation in Veterans Everywhere (PAVE) program. Limbs were stratified to a conservative, revascularization, primary amputation, and palliative limb care approach based on the patient's fitness, ambulatory status, perfusion evaluation, and validated pathway of care. Rates of wound healing, wound recurrence, limb salvage, and survival were retrospectively analyzed by WIfI clinical stages (stage 1-4) in the conservative group. Cox regression modeling was used to estimate clinical outcomes by WIfI stage. RESULTS: Between January 2006 and October 2017, there were 961 limbs prospectively enrolled in our PAVE program. A total of 233 limbs with 277 wounds were stratified to the conservative approach. WIfI staging distribution included 19.7% stage 1, 20.2% stage 2, 38.6% stage 3, and 21.5% stage 4. All ischemia scores were classified as 1 or 2. Advanced wound interventions and minor amputations were performed on 40 limbs (16.6%) and 57 limbs (23.7%), respectively. Average long-term follow-up was 41.4 ± 29.0 months. Complete wound healing without revascularization was achieved in 179 limbs (76.8%) during 4.4 ± 4.1 months. Thirty-four limbs (14%) underwent deferred revascularization because of a lack of complete wound healing. At long-term follow-up, wound recurrence per limb was 39%. Overall limb salvage at long-term follow-up was 89.3%. Stratified by WIfI stage, there was no statistically significant difference between groups for wound healing (P = .64), wound recurrence (P = .55), or limb salvage (P = .66) after adjustment for significant patient, limb, and wound characteristics. CONCLUSIONS: In select patients with mild to moderate ischemia and tissue loss, a stratified approach can achieve acceptable rates of wound healing and limb salvage, with limited need for deferred revascularization. WIfI clinical staging did not predict wound healing, limb salvage, or survival in this cohort.

Association between Preoperative Indications and Outcomes after Major Lower Extremity Amputation.

Despite aggressive limb salvage techniques, lower extremity amputation (LEA) is frequently performed. Major indications for LEA include ischemia and uncontrolled infection (UI). A review of the national Vascular Quality Initiative amputation registry was performed to analyze the influence of indication on outcomes after LEA. Retrospective review of the Vascular Quality Initiative LEA registry (2012-2017) identified all above- and below-knee amputations. Outcome measures included 30-day mortality, return to operating room (OR), postoperative myocardial infarctions, and postoperative SSI. Indications for surgery included ischemic rest pain, ischemic tissue loss (TL), acute limb ischemia (ALI), UI, and neuropathic TL. A total of 6701 patients met the inclusion criteria. The indications for surgery included TL (49.0%), UI (31.7%), ALI (8.0%), rest pain (6.6%), and neuropathic TL (2.3%). Patients with ALI had the highest 30-day mortality (12.0%) compared with TL (6.6%) and UI (6.4%) [P < 0.001]. The highest rate of return to OR occurred in the UI group (12.6%) [P < 0.001]. Multivariate analysis demonstrated that patients with UI have significantly higher rates of return to OR, whereas those with ALI have a 30-day mortality twice as high as other indications (both P < 0.001). These data can inform expectations after LEA based on the indications for surgery.

Trans-Atlantic Inter-Society Consensus Class D Aortoiliac Lesions: A Comparison of Endovascular and Open Surgical Outcomes.

OBJECTIVE. The purpose of this study is to compare the clinical and safety outcomes between two groups of patients with Trans-Atlantic Inter-Society Consensus class D (TASC II D) aortoiliac occlusive disease (AIOD): those with higher-risk comorbidity who underwent endovascular reconstruction and those with lower-risk comorbidity who underwent surgical bypass. MATERIALS AND METHODS. Thirty-two consecutive patients with symptomatic TASC II D AOID who underwent surgical bypass or endovascular reconstruction from 2012 to 2017 were retrospectively reviewed. Lesion characteristics, technical approach, survival, limb salvage, patency, and change in clinical symptoms were analyzed. RESULTS. Nineteen patients with higher comorbidity underwent endovascular reconstruction, whereas 13 patients with lower comorbidity underwent surgical bypass. Patients undergoing endovascular reconstruction had an older median age (67.0 vs 62.0 years; p = 0.007), higher rates of hypertension (94.7% vs 61.5%; p = 0.018) and coronary artery disease (26.3% vs 0%; p = 0.044), and advanced renal impairment (mean [± SD] chronic kidney disease stage, 1.4 ± 1.5 vs 0.7 ± 1.3; p = 0.005). There were no significant differences in Rutherford classification between the groups. During long-term follow-up of 2.76 years, endovascular reconstruction and surgical bypass showed equivalent rates of survival (89.5% vs 84.6%; p = 0.683), limb salvage (100.0% vs 92.3%; p = 0.219), and primary or primary-assisted patency (85% vs 85%; p = 0.98). Groups showed similar clinical improvements in walking distance, rest pain, and tissue loss at 30 days (95% vs 85%; p = 0.158) and at long-term follow-up (74% vs 62%; p = 0.599). CONCLUSION. For properly selected patients, the clinical outcomes of endovascular reconstruction versus surgical bypass for TASC II D AOID may be equivalent at 2.5 years after the procedure. The decreased operative risk associated with endovascular reconstruction suggests that it is the technique of choice for high-risk patients.

Early Surgical Referral for Penetrating Aortic Ulcer Leads to Improved Outcome and Overall Survival.

BACKGROUND: The natural history of penetrating aortic ulcer (PAU) has been variably described and clear guidelines are lacking. We reviewed our experience with PAUs in a tertiary referral center. METHODS: Imaging reports from January 2010 to December 2017 were retrospectively searched for the diagnosis of "penetrating aortic ulcer." Diagnosis was confirmed by review of imaging studies. Patient demographics, presenting symptoms, and anatomic characteristics were collected and analyzed for associations with need for surgical intervention, aortic complication, and overall survival. RESULTS: One hundred six patients with PAU were identified. Locations included 57 (53.8%) aortic arch, 24 (22.6%) descending thoracic, and 25 (23.5%) abdominal aorta. Dissection was present in 12 (11.4%) and acute rupture in 4 (3.8%) cases. At presentation, 57 (53.8%) patients were symptomatic. Forty-six (43.8%) patients were evaluated by cardiothoracic or vascular surgeons. Thirteen (12.3%) underwent surgical or endovascular repair and 10 (10.4%) had a change in medical management. Long-term follow-up (LTFU) was available in 30 patients for a mean of 36.5 ± 29.2 months. Twenty-one (70%, 21/30) demonstrated disease stability or resolution and 9 (30%, 9/30) worsened with 3 undergoing surgery. No PAU ruptured during follow-up. Patient demographics, presenting symptoms, and PAU morphology did not predict disease progression. Referral to a cardiovascular surgeon at initial presentation was associated with a 40% decreased likelihood of disease progression (P = 0.046) and a 60% survival advantage at LTFU (P = 0.037). CONCLUSIONS: PAU disease progression occurs in 30% of patients at LTFU of 36.5 ± 29.2 months. All patients identified with PAU on diagnostic imaging should be referred for a surgical evaluation and follow-up, as referral to cardiovascular surgeon is associated with improved disease course.

Debranching of Supra-aortic Vessels via Femoral Artery Inflow for Late Ascending Aortic Rupture.

A 56-year-old man with a history of Marfan's syndrome, total arch replacement, descending thoracic endovascular aortic repair, and twice redo sternotomy for pseudoaneurysm repair, presented with a pulsatile chest mass secondary to a contained rupture of the ascending aorta. The patient underwent supra-aortic debranching via the superficial femoral artery and ascending thoracic stent-graft placement under continuous transesophageal echocardiography. Completion angiography demonstrated successful exclusion of the contained rupture. Postoperatively, the patient was neurologically intact, the pulsatile mass resolved, and the bypass grafts remained patent. Chronic respiratory failure and multidrug-resistant pneumonia led to late mortality. This case demonstrates that hybrid repair is effective in the emergent setting of ascending aortic rupture. Debranching of the ascending arch using the superficial femoral artery as inflow is feasible and provides adequate cerebral perfusion despite the length of the bypass. The use of transesophageal echocardiography during stent-graft deployment allows precise device placement in the high-risk area of the ascending aorta proximal to the innominate artery.

Analysis of Patients Undergoing Major Lower Extremity Amputation in the Vascular Quality Initiative.

BACKGROUND: Despite an aggressive climate of limb salvage and revascularization, 7% of patients with peripheral artery disease undergo major lower extremity amputation (LEA). The purpose of this study was to describe the current demographics and early outcomes of patients undergoing major LEA in the Vascular Quality Initiative (VQI). METHODS: The VQI amputation registry was reviewed to identify patients who underwent major LEAs. Patient factors, limb characteristics, procedure type, and intraoperative variables were analyzed by the level of amputation. Factors associated with amputation level, 30-day complications, and mortality were analyzed using chi-squared analysis for significance with associated P values. Propensity score adjustment was used to balance statistically significant differences observed in subject characteristics by amputation level for the associated relative risk of a given outcome. RESULTS: Between 2013 and 2015, 2,939 major LEAs were recorded in the VQI amputation registry. The ratio of below-knee to above-knee amputation (BKA:AKA) was 1.29:1. The mean age was 66 years, 64% were male, 84% lived at home before admission, and 68% were ambulatory. Comorbidities included diabetes (67%), coronary artery disease (32%), end-stage renal disease (22%), and chronic obstructive pulmonary disease (23%). The mean preoperative ankle-brachial index (ABI) was 0.78. Overall, 43% had a history of prior ipsilateral revascularization. Indications for amputation were ischemic rest pain or tissue loss (58%), uncontrolled infection (31%), acute ischemia (9%), and neuropathic tissue loss (2%). The overall perioperative complication rate was 15%, 25% were discharged home, and the 30-day mortality was 5%. Patients who received an AKA versus BKA were more likely to be female (40.61% vs. 31.70%), more than age 70 (48.79% vs. 32.55%), underweight (18.63% vs. 9.18%), nonambulatory (40.22% vs. 25.18%), have an ABI <0.6 (58.00% vs. 45.26%), and carry nonprivate insurance (77.40% vs. 69.08%) (all P < 0.001). Patients undergoing AKA were less likely to have 30-day postoperative complications (12.24% vs. 17.87%) but had higher 30-day mortality (6.70% vs. 3.09%) than BKA patients (all P < 0.001). CONCLUSIONS: In the VQI registry, major LEA was performed predominantly for ischemic rest pain and tissue loss with a BKA:AKA ratio of 1.29:1. Patients undergoing AKA versus BKA were older, had lower ABI, lower rates of 30-day postoperative complications but higher rates of 30-day mortality. This registry offers an important real-world resource for studies pertaining to vascular surgery patients undergoing major lower extremity amputation.

Smoking Habits of Patients Undergoing Treatment for Intermittent Claudication in the Vascular Quality Initiative.

BACKGROUND: Society for Vascular Surgery practice guidelines for the medical treatment of intermittent claudication give a GRADE 1A recommendation for smoking cessation. Active smoking is therefore expected to be low in patients suffering from intermittent claudication selected for vascular surgical intervention. The aim of this study is to evaluate the prevalence of smoking in patients undergoing intervention for intermittent claudication at the national level and to determine the relationship between smoking status and intervention. METHODS: The Vascular Quality Initiative (VQI) registries for infra-inguinal bypass, supra-inguinal bypass, and peripheral vascular intervention (PVI) were queried to identify patients who underwent invasive treatment for intermittent claudication. Patient factors, procedure type (bypass versus PVI), and level of disease (supra-inguinal versus infra-inguinal) were evaluated for associations with smoking status (active smoking or nonsmoking) by univariate and covariate analysis. RESULTS: Between 2010 and 2015, 101,055 procedures were entered in the 3 registries, with 40,269 (40%) performed for intermittent claudication. Complete data for analysis were present in 37,632 cases. At the time of intervention, 44% of patients were active smokers, with wide variation by regional quality group (16-53%). In covariate analysis, active smoking at treatment was associated with age <70 years (prevalence ratio [PR] 2.42), male gender (PR 1.03), chronic obstructive pulmonary disease (PR 1.35), absence of prior cardiovascular procedures (PR 1.15), poor medication usage (PR 1.10), preoperative ankle-brachial index (ABI) <0.9 (PR 1.19), and supra-inguinal disease (PR 1.14). Invasiveness of treatment (PVI versus bypass procedures) was not significantly associated with smoking status. During follow-up, 36% of patients had quit smoking. Predictors of smoking cessation included age ≥70 years (RR 1.45), ABI ≥0.9 (RR 1.12), and bypass procedures (RR 1.22). CONCLUSIONS: At the time of treatment, 44% of patients undergoing intervention for intermittent claudication in the VQI were active smokers and there was a wide regional variation. Prevalence of active smoking was greater in the presence of younger age, fewer comorbidities, lower ABI, and supra-inguinal disease. Type of procedure performed, and in turn level of invasiveness required, did not appear to be influenced by smoking status. Elderly patients and those undergoing open procedures were more likely to quit smoking during follow up. These findings suggest opportunities for greater smoking cessation efforts before invasive therapies for intermittent claudication.