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.

Comparative Effectiveness of Second Vasoactive Agents in Septic Shock Refractory to Norepinephrine.

OBJECTIVE: We aim to identify the appropriate vasoactive agent in patients with septic shock who are refractory to optimal doses of norepinephrine. METHODS: In this retrospective observational cohort study over a 4-year period, patients who received norepinephrine within 24 hours of ICU admission and a second agent within 48 hours were enrolled. RESULTS: Among 2640 patients screened, 234 patients were enrolled, aged 60.8 ± 17.8 years, Acute Physiology and Chronic Health Evaluation IV 98.3 ± 27.5, 81.6% mechanically ventilated, and 65.8% in-hospital mortality. Within 96 hours, 2.8 ± 1.0 vasoactive agents were administered. Fifty, 50, 66, and 68 patients received dobutamine, dopamine, phenylephrine, and vasopressin as the second agent, with crude in-hospital mortality 40.0%, 66.0%, 74.2%, and 76.5%, respectively, P < .001. Survival analysis showed a statistically significant difference in survival time by second vasoactive agent, P < .001. After adjusting for confounding variables, dobutamine showed significant decreased odds ratio (OR) for mortality compared to vasopressin: OR 0.34 (95% confidence interval 0.14-0.84, P = .04). The relative risk of dying was 55.8% lower in patients receiving dobutamine versus vasopressin, P < .01. CONCLUSION: Dobutamine is associated with decreased mortality compared to other second vasoactive agents in septic shock when norepinephrine is not sufficient. A prospective randomized trial examining the outcome impact of the second vasoactive agent is needed.

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.