Endovascular Management of Chronic Limb-Threatening Ischemia (CLTI) in the Elderly: A Focus on Frailty, Wound Healing, and Outcomes.

BACKGROUND: In India, a significant scarcity of published data exists regarding chronic limb-threatening ischemia (CLTI) and its management, especially among the elderly population. CLTI, often accompanied by frailty poses a significant healthcare challenge. While endovascular interventions offer hope, there remains a dearth of outcome data for this age group. This study seeks to address this critical gap by investigating the impact of frailty on outcomes, emphasizing amputation-free survival (AFS), wound healing, and health-related quality of life (HRQoL). METHODS: Our study included 131 elderly CLTI patients aged ≥70 years who underwent infrainguinal endovascular interventions between April 2018 and August 2021, with a follow-up period of 2 years. Among the patients, 93.9% had diabetes mellitus and 82.4% had hypertension. Clinical frailty was assessed using the clinical frailty scale (CFS). Patients were categorized into group 1 (CFS 1-5) and group 2 (CFS 6-9). Primary outcomes were AFS, wound healing, HRQoL, and their association with frailty. Secondary outcomes included technical success, procedure-related complications, major adverse limb events, major adverse cardiac events, vessel patency, re-intervention rates, and mortality rates including periprocedural and overall mortality. RESULTS: Technical success was achieved in 86.3% of patients, with frailty significantly influencing this outcome. Group 2 exhibited reduced technical success (80.8%) compared to group 1 (93.1%). The major amputation rate was 9.2%, with higher rates in group 2 [univariate hazard ratio: 5.20; P = 0.033]. Similarly, group 2 showed elevated overall mortality [univariate hazard ratio: 5.18; P < 0.001]. AFS at 1 and 2 years were 67.9% and 55%, respectively, with higher rates in group 1. Wound healing was achieved in 76.1% of patients (83/109), with frailty significantly associated with delayed wound healing (P < 0.001). Vessel patency at 1 year was observed in 88.8% of patients. HRQoL significantly improved postintervention, with vascular quality of life questionnaire-6 (VascuQol-6) scores increasing from an average of 9 of 24 at baseline to 20 of 24 at 2 years. Frailty score significantly correlated with VascuQol-6 scores at 1 and 2 years (P < 0.0012). Group 1 exhibited higher VascuQol-6 scores than group 2, indicating improved HRQoL during follow-up. CONCLUSIONS: Successful endovascular treatments in high-risk CLTI patients promote improved wound healing and post-treatment quality of life. Frailty should be assessed before endovascular interventions as it correlates with adverse outcomes, including amputations and mortality. While revascularization holds promise, caution is advised for frailer patients, emphasizing the importance of personalized care and tailored treatments for elderly CLTI patients.

Successful endovascular management of coral reef aortic occlusion.

Transaortic thromboendarterectomy and bypass have been the conventional treatment for coral reef aortic occlusions but are associated with significant mortality, morbidity and reintervention rate since these patients often present with heart failure, uncontrolled hypertension and renal dysfunction. Endovascular treatment has not become popular because of fear of aortic rupture and visceral ischemia. We present our experience with endovascular management of 10 patients with coral reef aorta. Uncontrolled hypertension, chronic renal disease, disabling claudication, and critical limb ischemia with tissue loss were the presenting symptoms. Seven patients had infrarenal aortic occlusion, and 3 had occlusion at renal and suprarenal aorta. Eight had involvement of the visceral vessels and 3 had renal artery stenosis. Common iliac, femoral and subclavian were the other arteries involved. All procedures were done under local anaesthesia. Aortic stenting was done in 7 and aortoiliac stent in 3. Two had covered stents and the rest had bare metal stents. Two had renal artery stenting. In 2 patients with suprarenal aortic occlusion, intravascular lithotripsy was used prior to aortic stenting. We achieved technical success in all patients with control of blood pressure and increase in Ankle Brachial Index (ABI). One patient died due to acute coronary event 2 months later.

Stem cell therapy for reconstruction of alveolar cleft and trauma defects in adults: A randomized controlled, clinical trial.

BACKGROUND: Stem cell therapy with bone marrow-derived mesenchymal stem cells is a promising tissue engineering strategy to promote regeneration of craniofacial bone. PURPOSE: To determine whether cell therapy with ex vivo expanded stem cell populations would be safe and efficacious in the regeneration of large alveolar defects in patients with a history of cleft palate or craniofacial trauma. MATERIALS AND METHODS: Eighteen patients (10 patients with traumatic injury and 8 patients with cleft palate) presenting with missing teeth associated with horizontal alveolar bone deficiencies were included in this randomized controlled clinical trial. Patients were randomized to receive either conventional autogenous block grafts or stem cell therapy. After a healing period of 4 months the treated sites were re-entered and the bone width re-assessed prior to implant placement. Implant stability was evaluated through torque testing of the implant upon insertion and at 6 months postloading. RESULTS: The mean gain in bone width was 1.5 ± 1.5 mm in the stem cell therapy group and 3.3 ± 1.4 mm in the control group. Overall, bone gain was higher in trauma patients as compared to patients with cleft palate, for both the control and the stem cell therapy groups. Most postoperative complications were wound dehiscences and incision line openings. Implants were placed successfully in 5 out of 10 patients in the stem cell therapy group and in all 8 patients in the control group. One implant from the control/cleft palate group failed before loading, while the rest of the implants were loaded successfully and remained stable at 6 months. The patients who did not receive implants were re-treated with autogenous block bone graft. CONCLUSION: The ability of stem cells to treat large alveolar defects is safe, yet, their ability to completely reconstitute large alveolar defects is limited. This approach requires further optimization to meet the outcomes seen using current methods to treat large defects, particularly those resultant of cleft palate.

Treatment of newly diagnosed myeloma: Bortezomib-based triplet.

We review the options for the treatment of newly diagnosed myeloma in a patient who is a candidate for autologous stem cell transplantation (ASCT). Bortezomib, lenalidomide, dexamethasone (VRD) has been studied in two randomized trials as first-line therapy. In one of these trials, VRD demonstrated improved overall survival compared with lenalidomide plus dexamethasone (Rd). By contrast, phase III data with overall survival differences are not available for other bortezomib-containing regimens compared with modern lenalidomide-containing regimens. Carfilzomib-lenalidomide-dexamethasone (KRD) is an alternative promising regimen but has only been evaluated in small phase II studies in the frontline setting. More data are needed before this regimen can be recommended to standard risk patients with newly diagnosed myeloma. A phase III trial comparing VRD and KRD is ongoing.

Optimized cell survival and seeding efficiency for craniofacial tissue engineering using clinical stem cell therapy.

Traumatic injuries involving the face are very common, yet the clinical management of the resulting craniofacial deficiencies is challenging. These injuries are commonly associated with missing teeth, for which replacement is compromised due to inadequate jawbone support. Using cell therapy, we report the upper jaw reconstruction of a patient who lost teeth and 75% of the supporting jawbone following injury. A mixed population of bone marrow-derived autologous stem and progenitor cells was seeded onto ß-tricalcium phosphate (ß-TCP), which served as a scaffold to deliver cells directly to the defect. Conditions (temperature, incubation time) to achieve the highest cell survival and seeding efficiency were optimized. Four months after cell therapy, cone beam computed tomography and a bone biopsy were performed, and oral implants were placed to support an engineered dental prosthesis. Cell seeding efficiency (>81%) of the ß-TCP and survival during the seeding process (94%) were highest when cells were incubated with ß-TCP for 30 minutes, regardless of incubation temperature; however, at 1 hour, cell survival was highest when incubated at 4°C. Clinical, radiographic, and histological analyses confirmed that by 4 months, the cell therapy regenerated 80% of the original jawbone deficiency with vascularized, mineralized bone sufficient to stably place oral implants. Functional and aesthetic rehabilitation of the patient was successfully completed with installation of a dental prosthesis 6 months following implant placement. This proof-of-concept clinical report used an evidence-based approach for the cell transplantation protocol used and is the first to describe a cell therapy for craniofacial trauma reconstruction.