Critical limb ischemia, particularly Rutherford class 5 and 6, presents challenges for vascular and foot and ankle surgeons alike, especially in patients with medical comorbidities such as renal insufficiency and diabetes mellitus. Historically, physicians were left with few or no options following the failure of common interventions such as endovascular intervention and arterial bypass. New treatment options have arisen including percutaneous deep vein arterialization (pDVA) via LimFlow (LimFlow, Inc), which provides new opportunities for limb salvage but gives rise to a new challenge to the foot and ankle surgeon regarding postoperative management. We present a series of patients with diagnosis of Rutherford class 5 or 6 critical limb ischemia that presented to our institution following pDVA utilizing LimFlow technology. We present clinical pearls for the postoperative management of various levels of forefoot amputation. We found that with close clinical monitoring, 3 patients (75%) were able to avoid major amputation following pDVA at a minimum of nine months. One patient did expire without sufficient clinical follow-up to determine a final clinical outcome.
Level of Clinical Evidence: 4
VASCULAR DISEASE MANAGEMENT 2020;17(7):E131-E136.
Key words: Angioplasty, endovascular, foot, ischemia, LimFlow, Rutherford, salvage
Critical limb ischemia (CLI) is the end stage of peripheral arterial disease (PAD) and occurs in 1-3% of PAD patients. Patients commonly present with life changing symptoms such as severe rest pain, ulcers, or gangrenous changes and reduced quality of life. Two-year survival rate for patients with a diagnosis of CLI is 41%.1 Documented risk factors for development of CLI include diabetes mellitus, tobacco use, renal disease, and increased age.2
Previous treatment options for CLI included vascular/endovascular interventions, extensive wound care, multiple minor amputations, or major amputation such as below-knee or above-knee amputation. Recently, a new intervention, pDVA, has presented as a treatment alternative for patients with severe no option CLI.3 This procedure allows for the arterialization of a peripheral vein to increase blood flow to the distal lower extremity. This increased blood flow leads to increased perfusion and healing potential but also presents some clinical challenges to the foot and ankle physician when postoperatively managing patients following forefoot amputation. These challenges include decreased venous outflow leading to edema and possible hematoma formation. This is further complicated by the need for continued anticoagulation secondary to recent endovascular intervention. In addition, it is noted that it typically takes the newly placed arteriovenous graft/fistula 6-8 weeks to mature and become fully functional. In the cases that we present we were unable to delay surgical intervention due to the presence of gangrenous lesions in the forefoot. This case series focuses on the postoperative treatment protocol of the lead investigator, which we hope can be used by other foot and ankle surgeons to help guide postoperative treatment and improve clinical outcomes.
We present the case of a 78-year-old female patient who presented to our institution in August of 2018 for transmetatarsal amputation of the right foot secondary to dry gangrene. The patient was treated at our institution from July 2018 through August 2018. Continued follow-up was obtained after the patient returned to her out of state podiatrist. The patient had a known medical history of normocytic anemia, hypertension, and peripheral arterial disease with critical limb ischemia, Rutherford class 6. The patient also admitted to a history of rest pain and was noted to have a 60-pack/year smoking history but denied current use. When the patient presented to our institution she had undergone pDVA in June 2018 at an outside institution. It should be noted that the patient was on triple anticoagulation therapy consisting of Plavix, Eliquis, and Aspirin. Patient had previously failed endovascular arterial revascularization of the right lower extremity earlier in June 2018.
In July 2018 the patient presented to our institution with dry gangrenous changes of the right distal foot. Patient underwent transmetatarsal amputation (TMA) of the right foot. No evidence of gross infection was noted at time of surgical intervention. Minimal bleeding was noted from the plantar soft tissue flap. A closed suction drain was inserted, the wound was closed in standard fashion, and a negative pressure wound dressing was applied overlying the surgical site (Figure 1). The patient was placed in a mildly compressive dressing and posterior splint and admitted to the hospital for continued monitoring. On post op day 1 (POD 1), the patient was experiencing significant postoperative pain to the right foot. Pain management was consulted, and the patient received a right sciatic nerve block with indwelling catheter. On POD 2 the patient was re-evaluated, and pain was well controlled. The negative pressure wound dressing was removed and a well-padded posterior splint was reapplied to the right lower extremity in anticipation of discharge and the patient traveling back to her out of state home. At the time of dressing change no residual signs of infection or frank ischemia were present at surgical site. Patient was discharged on Augmentin 875 PO BID for 10 days and instructed to remain non-weight bearing to the right lower extremity.
Patient followed-up with her out of state podiatrist following discharge and developed ischemic changes and breakdown of previous TMA with a non-healing ulceration. On POD 21 patient was noted to have incisional gangrene with decreased pedal Doppler readings in an outside podiatrist office. Patient returned to her endovascular surgeon and underwent further peripheral vascular intervention. It was found that the pDVA site had thrombosed. An atherectomy was performed and blood flow was reestablished. Patient returned to our institution on POD 37 for further surgical intervention (Figure 2). Patient underwent a Chopart’s amputation with peroneus brevis tendon transfer, percutaneous Achilles tendon lengthening, and application of antibiotic beads. Surgical incision was primarily closed and incisional negative pressure wound vac was applied (Figure3). A closed suction drain was inserted at this time. The patient was readmitted for continued medical management. On POD 38 patient was noted to be resting comfortably with mild residual pain noted to the right lower extremity. Approximately 3 cc of sanguinous drainage was noted in the closed suction drain. On POD 39 surgical site was evaluated and noted to be well coapted with no evidence of necrosis. Approximately 6 cc of sanguinous drainage was present in the closed suction drain. At this time a negative pressure wound dressing was placed over the incision and well padded posterior splint reapplied. On POD 42, the negative pressure wound dressing was removed from the right foot. The surgical site was well coapted with no evidence of dehiscence or necrosis. Minimal sanguinous drainage was noted within the closed suction drain. Wet to dry dressing was applied to the right lower extremity at this time. On POD 43, the closed suction drain was removed from the right foot and the surgical site was dressed with betadine moist to dry dressing and a well-padded posterior splint was applied. The patient was discharged back to her out of state home at this time with wound care instructions consisting of Monday, Wednesday, and Friday dressing changes and follow-up instructions for her outside podiatrist. The patient was instructed to remain strictly non-weight bearing to the right foot. Close follow-up was maintained with her outside podiatrist and the patient was noted to be fully healed and ambulating in March of 2019 (Figure 4).
We present the case of a 85-year-old female patient who presented to our institution in September of 2018 with gangrenous changes to the right 5th digit and lateral foot. Patient was treated at our institution from September 2018 through June 2019. Additional follow-up was obtained from her outside wound care specialist. The patient was noted to have a past medical history of anemia, peripheral arterial disease with CLI, Rutherford class 6, atrial fibrillation, hypertension, hyperlipidemia, and diabetes mellitus. The patient denied any previous tobacco use. The patient had previously undergone multiple endovascular procedures as well as previous right hallux amputation and partial amputation of the right second and third digits. Patient underwent right 4th and 5th digit amputations and was discharged home 2 days following. The patient returned to her vascular surgeon in May of 2019 with new ischemic changes to the right foot. She stated that she had slept with a high-grade compression stocking on the right foot. Attempt was made for further endovascular intervention and approximately 1 week later the patient underwent pDVA of the right posterior tibial artery. The patient returned to our institution in early June 2019 and was found to have gangrenous changes of the right forefoot. Lisfranc amputation was performed the following day. A closed suction drain was applied to the right foot with light compression dressing and a well-padded posterior splint was applied. On POD 1 approximately 25 cc of sanguineous drainage was noted in closed suction drain. On POD 2 surgical dressing was changed without evidence of necrosis to the right foot. Approximately 20 cc of serosanguinous drainage was noted. A well-padded Jones compression type posterior splint was reapplied to right lower extremity. On POD 5 patient was discharged to her out of state home with home health care. Closed suction drain was removed prior to discharge. Communication was maintained with her out of state wound care specialist and patient was noted to be fully healed and ambulating at 9 months.
We present the case of a 67-year-old male patient who presented to our institution in September of 2018 with a full thickness dehiscence of a previous transmetatarsal amputation. Patient was treated at our institution from September 2018 through October 2018. Additional follow-up was obtained from his outside podiatrist. Patient had a past medical history of diabetes mellitus, end stage renal disease on hemodialysis, coronary artery disease with history of CABG, and peripheral arterial disease with critical limb ischemia, Rutherford class 6. The patient admitted to a 60-plus-pack/year smoking history but stated he had not smoked in the previous 20 years. Patient had undergone pDVA at an outside institution 1 week prior. Prior to pDVA, the patient had an unsuccessful attempt at endovascular intervention followed by transmetatarsal amputation at an outside facility. The plantar flap was noted to be necrotic and non viable at time of presentation. Patient was taken for debridement of non-viable soft tissue and Lisfranc amputation. Antibiotics beads were inserted and negative pressure wound dressing was applied. A closed suction device was utilized and patient was placed in a Jones compression posterior splint. On POD 2 negative pressure dressing was changed and no evidence of hematoma or necrosis was noted. Minimal drainage was noted within the closed suction drain. On POD 4 the dressing was again changed, and the closed suction drain was removed. Right lower extremity was then redressed with dry sterile dressing and Jones compression splint. The patient was discharged back to his out of state home on POD 5. The patient returned to our institution on POD 9 secondary to necrosis of the Lisfranc amputation site. Sanguinous drainage was noted. On POD 10 a bedside drainage of the amputation site was performed and 7 cc of sanguinous drainage was noted. On POD 13 the patient returned to the operating room for an open Chopart’s amputation, insertion of antibiotic beads, and application of negative pressure wound dressing. On POD 15 wound vac was changed to the operative site. Mild periwound ischemic changes were noted. Patient returned to the operating room on POD 16 for delayed primary closure, tendo Achilles lengthening, and tendon transfers. All necrotic tissue was debrided prior to closure. A residual wound of approximately 12.2 cm x 5.5 cm was noted and was covered with an acellular xenograft. Surgical dressing and well-padded posterior splint were applied at this time. On POD 18 dressings were changed with no evidence of residual infection or necrosis noted. On POD 24 the patient was discharged to his out of state home. Follow-up was maintained with the patient through an outside podiatrist and the patient was noted to have undergone below-knee amputation secondary to failure of wound to heal and persistent gangrenous changes.
We present the case of a 46-year-old male patient who presented to our institution in March of 2018 secondary to non-healing ulceration of his left foot following transmetatarsal amputation in November 2017 at an outside institution. The patient was treated at our institution in March 2018. Additional follow-up was obtained from the patient’s outside podiatrist. The patient had a past medical history of coronary artery disease, hypertension, peripheral neuropathy, and peripheral arterial disease, Rutherford class 5/6. The patient had previous tobacco use of an unknown duration. He stated that he had stopped smoking approximately 1-year prior. The patient had previously undergone pDVA at an outside institution. He was followed clinically for 8 months and underwent revisional transmetatarsal amputation, Achilles tendon lengthening, and anterior ankle arthroplasty to help relieve boney equinus which was felt to be limiting dorsiflexion and creating increased pressures along the surgical incision, subsequently limiting healing potential. The patient was placed into a Jones compressive type dressing and posterior splint and discharged home on POD 0. Contact was maintained with the patient’s outpatient podiatrist and the patient was noted to be healed and ambulating 6 months post intervention.
We present the case of a 67-year-old male patient who presented to our institution in February of 2020 secondary to gangrenous changes to the left forefoot. Patient was noted to have a past medical history of chronic kidney disease without dialysis, hypertension, gout, anemia, and peripheral vascular disease, Rutherford class 6. The patient had no known history of tobacco use. The patient had a history of multiple unsuccessful endovascular interventions and an open bypass procedure. He had undergone pDVA in the days prior to presenting to our institution. Patient underwent transmetatarsal amputation with primary closure of the left foot and was placed into a well-padded posterior splint. A closed suction drain was placed at the time of closure and the patient was admitted to the hospital for continued observation. Pain management was consulted secondary to chronic pain and a history of substance abuse. Surgical site was evaluated on POD 2. No evidence of hematoma, seroma, or ischemic changes were noted to the left foot. Drain was left in place at this time. A Jones compression type posterior splint was then reapplied to the left lower extremity. On POD 6 the surgical site was again reevaluated. It remained stable with no evidence of ischemia, hematoma, or seroma noted. The closed suction drain was noted to have 10 cc of serosanguinous drainage and the decision was made for the drain to remain in place at the time of discharge. The patient was discharged home on the afternoon of POD 6 and was seen in the outpatient office on POD 11. At that time no evidence of necrosis, ischemia, or infection was noted. The closed suction drain was removed and the patient was placed into a Jones compression type posterior splint. Patient presented to an outside institution on POD 12 with respiratory distress. It is noted that patient expired on POD 16 secondary to respiratory failure and cardiac arrest.
A moderate amount of research exists describing pDVA and its effectiveness in leading to successful limb salvage; however, we were not able to find any publications regarding the postoperative management of patients post minor amputation following pDVA. As a result we felt that it was clinically relevant to present our clinical findings and treatment approach for postoperative management following minor amputation. Four of our patients were admitted following minor amputation for close clinical follow-up with a multidisciplinary team. One patient was treated on an outpatient basis secondary to no primary amputation being performed. The most commonly seen complication was localized hematoma and venous congestion leading to skin flap necrosis.
We determined that localized compression of the surgical site, often with negative pressure wound therapy over closed surgical incisions, was beneficial to control edema, venous congestion, and hematoma formation. Additionally the use of closed suction drains has shown therapeutic benefits by aiding the prevention of hematoma formation. Although commonly contraindicated in patients with peripheral arterial disease near constant elevation of the surgical extremity was required. This was done as an additional step to prevent venous congestion and early hematoma formation. We feel that an extended inpatient hospital stay is warranted in this patient population to help facilitate observation as well as monitoring for hematoma and adequate tissue perfusion. In addition we feel as though a course of IV antibiotics is beneficial, even without underlying soft tissue infection, secondary to the presence of a large endovascular stent.
Although no literature was shown to specifically discuss the management of postoperative patients following minor amputation the overall success for limb salvage following arterialization of a peripheral vein has been reported at nearly 75%. Jacob et al included 15 patients in a clinical study and found that in 12 of 15 (75%), limbs were successfully salvaged with only 3 major amputations.4 Additionally, Mutirangura et al looked at a cohort of 26 patients and found that 19 patients (73.1%) had complete resolution of lower extremity wounds following venous arterialization.5 In their study 6 patients (23.1%) underwent major amputation. In our experience we have demonstrated similar results with 3 patients (75%) avoiding major amputation with complete healing of lower extremity ulcerations. One patient (25%) required major amputation (Table 1). One patient did expire without sufficient clinical follow-up to determine a final clinical outcome.
In conclusion we feel that pDVA provides patients who are diagnosed with severe CLI a viable alternative to major amputation. However these patients present the foot and ankle surgeon with an unusual clinical challenge secondary to compromised venous outflow from a now adequately perfused lower extremity. This case series presents clinical pearls for immediate postoperative management of patients following minor amputation. A multidisciplinary team approach is required in an inpatient setting for successful management in our opinion. Edema management, drain utilization, and elevation of the operative extremity, even in the face of peripheral vascular disease, are important factors that cannot be overlooked in this patient population.
Acknowledgements: Special thank you is given to Dr. Jihad A. Mustapha, MD, and Dr. Fadi Saab, MD.
Disclosure: The authors report no financial relationships or conflicts of interest regarding the content herein.
Manuscript submitted May 17, 2020, final version accepted May 22, 2020.
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