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.

Long-Term Outcome of Patients with Peripheral Arterial Disease and Tissue Loss Stratified to a Nonrevascularization Approach.

BACKGROUND: To evaluate the long-term outcome of patients presenting with peripheral artery disease (PAD) and tissue loss that were stratified in our limb preservation program to receive aggressive wound care without revascularization. METHODS: Veterans presenting with PAD and nonhealing wounds were prospectively enrolled into our Prevention of Amputation in Veterans Everywhere (PAVE) program. Patients were stratified according to management strategies, which include: revascularization, primary amputation, palliative limb care, and aggressive local wound care without revascularization (conservative group). This study focuses on the conservative cohort. Wound presentation, type of wound care provided, wound care-associated procedures, healing rates, revascularization, major amputation, wound recurrences, management of recurrent wounds, and patient survival were analyzed. RESULTS: Between January 2006 and November 2014, 601 patients were prospectively enrolled in our PAVE program. A total of 203 limbs in 183 patients with 231 wounds were allocated to the conservative group based on a validated pathway of care. Mean follow-up for this cohort was 33.6 months (range, 1.5-104). Complete wound healing was achieved in 148 limbs (73%). The mean time to healing was 4.1 months. Twenty-four limbs (11.8%) received "late revascularization" (beyond 6 months from enrollment). Overall limb preservation was 90% at 4 years, with 57% freedom from wound recurrence. In patients with recurrence over 80% were successfully managed without revascularization. Limb loss was attributed to infection in most cases. CONCLUSIONS: In this selected group, an initial approach with aggressive wound care without revascularization appears justified with good limb salvage. Long-term analysis demonstrated a notable incidence of wound recurrence (43%) albeit most recurrences can be successfully managed without the need for late revascularization and no increased incidence of limb loss.

Clinical outcomes of patients with peripheral artery disease and lower extremity wounds based on a predetermined intention-to-treat strategy.

Achieving healing in patients with peripheral artery disease and lower extremity wounds represent a significant clinical challenge. Important outcome measures that define a successful therapeutic approach include wound healing rate, time to heal, and recurrence with time. This article reviews our experience managing a peripheral artery disease patient cohort at a Veterans Affairs medical center based on the initial clinical evaluation stratification and prospective enrollment into a predetermined treatment strategy.

Management of lower extremity wounds in patients with peripheral arterial disease: a stratified conservative approach.

BACKGROUND: Traditional wound care algorithms include aggressive detection of peripheral arterial disease (PAD) and treatment with revascularization for all patients with PAD and lower extremity wounds. Not every patient with PAD and a wound meets Transatlantic Inter-Society Consensus (TASCII) criteria for critical limb ischemia. We hypothesize that a conservative approach to selected patients with PAD and lower extremity wounds may be safe, provide acceptable limb salvage, and that failure of this approach does not translate into increased limb loss. METHODS: Veterans referred with PAD and nonhealing ulcers/wounds were prospectively enrolled into our Prevention of Amputation Care Team program. Patients were stratified according to management strategies which included revascularization, primary amputation, palliative limb care, and aggressive local care without revascularization (conservative group). Patients were assigned to conservative management group on the basis of transcutaneous oxygen measurement (TcpO2) and ankle-brachial index (ABI). Healing rates, need for "late" revascularization, major amputation rates, and survival of this conservative group were analyzed in terms of ABI and ankle pressures. RESULTS: Between January 2006 and March 2009, a total of 190 lower extremity wounds in 178 patients with PAD were analyzed. Forty-nine patients with 52 wounds (27.9%) were deemed candidates for conservative treatment. During mean follow-up of 14.5 months, complete wound healing was documented in 33 patients (35 wounds: 67%). Mean time to complete wound healing was 4.5 months. Predictors of healing included mean ABI (0.62 vs. 0.42 [p < 0.001]) and ankle pressures >70 mm Hg (p = 0.025). Sixteen patients (17 wounds: 33%) were not healed at the time of analysis. Of these, three patients (four wounds: 8%) showed active healing and 13 (13 wounds: 25%) failed conservative management. Nine patients (9 wounds: 17%) underwent late revascularization. There was one case of amputation (2%) and six cases of mortalities (12.2%). There was no increase in the rates of limb loss and mortality in patients who failed conservative management and underwent "late" revascularization. CONCLUSIONS: Conservative management of lower extremity nonhealing wounds in selected patients with PAD is successful in over two-thirds of the patients. The failure of conservative management does not increase mortality or amputation rates. When the TcPO2 is >30 mm Hg, the ABI and the TASC II definition of critical limb ischemia predict wound healing and should be key factors in considering conservative therapy.

Carotid artery stenting in high-risk patients: midterm mortality analysis.

Carotid artery interventions are predicated on early and late survival to prevent ischemic strokes. The technical feasibility of carotid artery stenting (CAS) has been established. Short-term results have been conflicting. Despite this, many practices have adopted CAS as an alterative to carotid endarterectomy in high-risk patients. Long-term protective benefits, however, are less established in high-risk patients. Midterm results following CAS in our high-risk protocol were analyzed to determine specific and all-cause mortality rates (beyond 30 days). We retrospectively evaluated a prospective carotid artery stent registry from October 2003 to February 2006. Demographics, high-risk indication, presence of carotid symptoms, prior history of cancer, periprocedural success, complications, as well as follow-up including readmission rate as well as specific etiology of death were recorded. Fifty patients with critical carotid stenosis (mean stenosis 90%) underwent CAS. This cohort met high-risk criteria due to physiologic reasons in 26 patients and anatomic factors in 22 cases. Two patients met both criteria. Indications were symptomatic disease in 14 (30%) and asymptomatic in 36 cases. The overall 30-day stroke, myocardial infarction, and death rate was 2%. No minor or major strokes were recorded within 30 days postprocedure. Overall average follow-up was 11-28 months. Stroke-free survival was 94% for all patients. Overall 1-year survival was 75% for all patients, significantly higher for the asymptomatic group (88%) (p < 0.01). Late mortality after 30 days was 11 cases (22%) at an average of 9 months post-CAS, ranging 3-13 months. No late mortality was due to ischemic stroke. Specific etiologies of mortality included end-stage cardiac disease (n = 1), recurrent or metastatic cancer (n = 2), acute cardiac event (n = 1), infectious complications (n = 3), and other (n = 3). Only symptomatic indication was predictive of late mortality. Clinicians may continue to cautiously offer CAS to asymptomatic high-risk patients given their anticipated longevity. Symptomatic patients, despite poor midterm survival, do achieve freedom from neurologic death following CAS.

Pharmacologic risk factor treatment of peripheral arterial disease is lacking and requires vascular surgeon participation.

The pharmacologic treatment of the cardiovascular comorbidities in patients with peripheral arterial disease (PAD) can have a profound effect on the outcomes of these patients. Guidelines for the treatment of hypertension, hyperlipidemia, diabetes, and tobacco use have been published by the American Heart Association and American College of Cardiology (AHA/ACC). Patients with PAD are often under-treated for these conditions. We sought to evaluate the adherence to these established guidelines in all new patients presenting with PAD to a vascular surgery clinic and delineate the opportunity for vascular surgeon involvement in these treatments. Consecutive new patients with symptomatic, objectively proven PAD (ankle-brachial index < 0.9) were evaluated in a vascular surgery clinic by a staff vascular surgeon. PAD risk factors, pre-visit medications, and prior cardiovascular interventions were recorded. Patients were stratified whether they were receiving appropriate preventive pharmacotherapy and whether they were meeting AHA/ACC goals. In patients without prior cardiovascular history, screening for these conditions was performed. One hundred sixty-seven new patients were evaluated over a 1-year period. Objectively diagnosed PAD included intermittent claudication in 115 (69%) and critical limb ischemia in 52 (31%) patients. Average age was 67.8 years, and 73 patients (44%) were current smokers. At initial evaluation, only 115 (69%) patients reported antiplatelet use. Patients with a recorded diagnosis of hypertension met clinical guidelines in 39 instances (71%). Eighteen patients (20%) with diabetes mellitus had poor glycemic control (Hgb-A1C > 7.0%). Seventeen (19%) of 88 patients with a history of hyperlipidemia were not adequately treated. Vascular surgeon medical interventions resulted in 31% of patients being started on antiplatelet therapy, 29% of hypertension therapies were modified, 19% of established lipid therapy was modified, and lipid therapy was initiated in 20%. A new diagnosis of hypertension was made in 10 cases (6%) and hyperlipidemia in 13 cases (7%). Despite clear guidelines for the medical community regarding cardiovascular prevention, a large percentage of patients with symptomatic PAD presenting to the vascular surgery clinic are not receiving appropriate therapy for their comorbidities or are not meeting the established goals. Vascular surgeons have an important role in promoting vascular health through the systemic prevention of ischemic events.