Directional Atherectomy With Antirestenotic Therapy Versus PTA/Supera Stenting for Popliteal Artery Lesions: A Propensity-Matched Analysis.

PURPOSE: This study examines the use and impact of directional atherectomy with antirestenotic therapy (DAART) versus angioplasty plus Supera stent implantation on the outcomes during endovascular treatment of popliteal lesions in clinical practice. METHODS: Overall 143 consecutive patients (mean age 75.0±12.2 years, 72% male), with isolated atherosclerotic disease of the popliteal artery who underwent endovascular treatment using DAART therapy or percutaneous transluminal angioplasty (PTA)/Supera stenting of the popliteal artery between January 2016 and December 2021 were identified from a retrospectively database. Patient and plaque characteristics were collected. A propensity-score matched, case-control analysis was conducted to balance covariates between the group of patients who underwent DAART and the one treated by PTA/Supera stenting. RESULTS: A total of 51 patients (35.7%) showed severe claudication and 92 (64.3%) critical limb ischemia. There was a trend toward longer treated lesions (90.4±81 vs 72.5±5.3 mm, p=0.089) and more chronic total occlusions (60.5% vs 46.8%, p=0.058) in the PTA/Supera stenting group, although not reaching statistically significance. Moderate-to-severe calcification was present in most lesions treated (75.8% of DAART group, 80.2% of PTA/Supera stenting group, and 78.3% of total cohort). Among the 53 case-matched pairs of patients treated with DAART or PTA/Supera stenting, there were no significant differences in short-term outcomes, including rate of technical success (96.2% vs 98.1%, p=0.232), procedural success (88.7% vs 90.1%, p=0.251), distal embolization (1.9% vs 1.9%, p=0.178), dissection (5.7% vs 1.9%, p=0.268), perforation (3.8% vs 5.6%, p=0.163), hospital discharge (1.2±0.1 vs 1.0±0.1, p=0.325), 30 day minor (28.3% vs 32.1%, p=0.264) or major amputation rates (7.5% vs 3.8%, p=0.107), and 30 day mortality (1.9% vs 1.9%, p=0.173). At 1 year, there was no difference in primary patency (73.6% vs 77.4%, p=0.233), primary assisted patency (81.3% vs 84.9%, p=0.167), secondary patency (86.8% vs 92.5%, p=0.094), ipsilateral minor (35.8% vs 39.6%, p=0.472) or major amputation (9.4% vs 7.5%, p=0.186), ankle brachial index improvement (0.32±0.12 vs 0.37±0.37, p=0.401), or mortality (5.7% vs 5.7%, p=0.121) rate between patients who underwent DAART or PTA/Supera stenting for popliteal lesions. CONCLUSION: Twelve-month results following DAART technique or PTA/Supera stenting of atherosclerotic lesions of the popliteal artery are not different, regardless of patient and plaque characteristics. CLINICAL IMPACT: The DAART technique for the treatment of popliteal artery atherosclerotic disease is presented as a "leave nothing behind" strategy with on-year clinical outcomes similar to ATP/Supera stenting.

Quality of Life for Patients Receiving Elective Interventions for Abdominal Aortic Aneurysms.

Objectives: Information on the quality of life of patients operated on for abdominal aortic aneurysm (AAA) is scarce. The objective of this study was to analyse these patients' health-related quality of life (HRQoL). Materials and Methods: This was a cross-sectional observational study. Patients undergoing elective AAA surgery from January 2013 to December 2020 were included. The Spanish version of the SF-36 questionnaire was administered to participants one to sixty months after surgery. Results: During the study period, 178 patients underwent surgery for AAA, 109 (61.23%) had open abdominal aortic repair (AAR) and 69 (38.54%) had endovascular aneurysm repair (EVAR). Mortality before the month of surgery was higher among those treated by AAR than EVAR (2.7% and 1.45%, respectively), while late mortality was higher in the EVAR group than in the AAR group (11.5% and 2.7%, respectively). In the late postoperative period, 12.5% of patients who underwent AAR presented complications compared to 25% of those treated with EVAR. The questionnaire was administered to 151 patients (91 AAR and 60 EVAR patients). The AAR patients compared to the EVAR patients had significantly higher mean scores on the health scales of the SF-36 questionnaire in Physical Function (p = 0.001), Vitality (p = 0.003), General Health (p = 0.37), Social Function (p = 0.023) and Mental Health (p = 0.006). Scores on the Mental Summary Component were significantly higher in the AAR group (p = 0.026). Conclusions: The group of patients treated with AAR showed the highest average scores on the scales of the SF-36 questionnaire in Physical Function, Vitality, General Health and Mental Health. The worst result was found in the Social Function scale for EVAR patients and was related to a higher rate of late complications.

Association of Age and Surgical Technique with the Quality of Life of Male Patients Treated for Abdominal Aorta Aneurysms: A Cross-Sectional Study.

OBJECTIVES: The achievement of a good health-related quality of life (HRQoL) has become one of the primary objectives of medical-surgical interventions. The objective of this study is to determine the HRQoL of patients who underwent abdominal aortic aneurysm (AAA) surgery and to analyse the influence of age on HRQoL. MATERIALS AND METHODS: This is an observational cross-sectional study with 151 male patients who underwent an operation for AAAs between January 2013 and December 2020 in two hospital centres. HRQoL was assessed with the Spanish version of the 36-Item Short Form Survey (SF-36), starting in the month following the surgical intervention. Statistical analyses were performed using hypothesis tests and multivariate linear regression. RESULTS: The mean age of the patients was 73 years (SD: 7), and the mean interval between surgery and the interview was 37 months (SD: 27). The scores of the Physical Function (p = 0.001), Vitality (p = 0.016), Social Function (p = 0.014), and Mental Health (p = 0.007) dimensions of the SF-36 were significantly lower in the older age groups. In addition, the scores on the Physical Summary Component (p = 0.003) and the Mental Summary Component (p = 0.026) were significantly lower among individuals older than 70 years of age. The HRQoL in patients who underwent operations for AAAs was similar to that reported in the general population of Spain. Patients with an aorto-aortic shunt had better scores on the Physical Function (Beta: 10; p = 0.014) and Mental Health (Beta: 8.12; p = 0.040) dimensions than those who had an aorto-bi-iliac or bifemoral shunt, regardless of the age of the patients at operation. CONCLUSION: Among patients who underwent an operation for an AAA, there was a negative association between the age at operation and scores on the Physical Function, Vitality, Social Function, and Mental Health dimensions of the SF-36. The type of surgical technique influences the evolution of Physical Function and Mental Health scores, regardless of age.

Quality of Life of Patients Treated for Abdominal Aortic Aneurysm: Open Surgery and Endoprosthesis.

OBJECTIVES: To determine the degree of long-term health-related quality of life (HRQoL) of patients undergoing surgery for abdominal aortic aneurysm (AAA) and to analyze the results according to the type of treatment, namely, open abdominal repair (OAR) or endoprosthesis (EVAR). PATIENTS AND METHODS: This was a prospective cross-sectional observational study. Patients receiving intervention for AAA between January 2013 and December 2020 were included. The Spanish version of the SF-36 questionnaire was used. A single survey was performed on all patients, and the time elapsed since the intervention was recorded. RESULTS: On all health scales and in the two groups of patients, the highest scores were recorded at six months postoperatively. At that time, the EVAR and OAR groups had similar values. Between 13 and 16 months postoperatively, EVAR patients presented a transient but significant decrease in their scores for physical function (p = 0.016), vitality (p = 0.035) and social function (p = 0.041). From that moment, there were progressive decreases in the scores of the two groups of patients on all the scales of the SF-36 questionnaire, although this trend was less pronounced in the OAR group. At 60 months after the intervention, the latter group showed significantly higher values than EVAR for physical function (p = 0.01), vitality (p = 0.032) and mental health (p = 0.029). Additionally, at 60 months after the intervention, the Sum of the psychological component (MCS) and Sum of the physical component (PCS) scores were significantly higher in the OAR group (p = 0.040 and p = 0.039, respectively). CONCLUSIONS: In the short term, patients treated for AAA by EVAR or OAR showed similar results on the SF-36 questionnaire. In the long term, patients treated by EVAR had lower scores on the physical function, vitality and mental health scales.

Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in diabetic patients with critical limb ischemia with no possibility of revascularization: study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial).

BACKGROUND: Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety, and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. METHODS: A multicenter, randomized double-blind, placebo-controlled trial has been designed. Ninety eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: control group (n = 30), low-cell dose treatment group (n = 30), and high-cell dose treatment group (n = 30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. DISCUSSION: Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. TRIAL REGISTRATION: ClinicalTrials.gov NCT04466007 . Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.

Effectiveness and safety of 1470-nm diode laser fulguration in the management of diffuse venous malformations.

BACKGROUND: Venous malformations (VMs) are the most frequent congenital vascular malformations. Pain and deformity are the main symptoms and usually progressive in untreated patients. Current therapeutic options are surgery (frequently partial resections with an uncomfortable postoperative period), sclerotherapy (often limited because of the need for high doses and the potential subsequent toxicity), and percutaneous intralesional laser treatment. The main objective of our study was to analyze efficiency and safety of 1470-nm diode laser treatment in the management of diffuse VMs. METHODS: We included patients treated between 2012 and 2018 whose quality of life was severely impaired. Data regarding laser settings, previous and subsequent D-dimer and fibrinogen blood levels, preprocedural and postprocedural assessment of pain by means of a visual analog scale, and reported complications were collected. RESULTS: Twenty-six procedures were performed in 17 patients (76% women); 59% were sporadic VMs, 70% had previously undergone other treatments, and 53% needed continuous analgesic treatment. The median pain reduction after the intervention, measured on the visual analog scale, was 5 points (P < .001). A significant decrease in the postoperative D-dimer values (P = .003) was observed in all patients. There were five postoperative complications in four patients, and none was life-threatening. CONCLUSIONS: The diode laser appears to be effective for treatment of diffuse VMs. It allows a reduction of the volume and symptoms of the malformation and is well tolerated by the patients. There is no currently described limitation in terms of dosage or number of procedures, making this a good alternative therapeutic option for these malformations.

The effects of allogenic stem cells in a murine model of hind limb diabetic ischemic tissue.

BACKGROUND: Diabetes is one of the major risk factors for peripheral arterial disease. In patients in whom surgery cannot be performed, cell therapy may be an alternative treatment. Since time is crucial for these patients, we propose the use of allogenic mesenchymal cells. METHODS: We obtained mesenchymal cells derived from the fat tissue of a healthy Sprague-Dawley rat. Previous diabetic induction with streptozotocin in 40 male Sprague-Dawley rats, ligation plus left iliac and femoral artery sections were performed as a previously described model of ischemia. After 10 days of follow-up, macroscopic and histo-pathological analysis was performed to evaluate angiogenic and inflammatory parameters in the repair of the injured limb. All samples were evaluated by the same blind researcher. Statistical analysis was performed using the SPSS v.11.5 program (P < 0.05). RESULTS: Seventy percent of the rats treated with streptozotocin met the criteria for diabetes. Macroscopically, cell-treated rats presented better general and lower ischemic clinical status, and histologically, a better trend towards angiogenesis, greater infiltration of type 2 macrophages and a shortening of the inflammatory process. However, only the inflammatory variables were statistically significant. No immunological reaction was observed with the use of allogeneic cells. DISCUSSION: The application of allogeneic ASCs in a hind limb ischemic model in diabetic animals shows no rejection reactions and a reduction in inflammatory parameters in favor of better repair of damaged tissue. These results are consistent with other lines of research in allogeneic cell therapy. This approach might be a safe, effective treatment option that makes it feasible to avoid the time involved in the process of isolation, expansion and production of the use of autologous cells.

Endovascular treatment of posttraumatic pseudoaneurysm of the common carotid artery.

Carotid artery injuries with pseudoaneurysm are uncommon but associated with central neurologic dysfunction. We present a case of posttraumatic pseudoaneurysm of the right common carotid artery treated by implantation of a covered stent. A 44-year-old woman with multiple injuries after fall from height presents a small dissection flap of the right common carotid artery (RCCA) on the initial computed tomography angiography (CTA). Fifteen days later a 10 mm pseudoaneurysm is observed on control CTA. We decided endovascular treatment. Through right femoral access with a long introducer sheath placed in the innominate artery, we implanted a covered stent Advanta V12 9 × 38 mm in the RCCA. The patient was discharged from the hospital with antiplatelet therapy without any neurological dysfunction and complete exclusion of the pseudoaneurysm. Use of covered stents has emerged as a safe and effective alternative to surgical repair of carotid injuries.

Experimental model for coadjuvant treatment with mesenchymal stem cells for aortic aneurysm.

UNLABELLED: Many factors are possibly involved in the inflammatory process which causes the degeneration of the arterial wall in the formation of Abdominal Aortic Aneurysms. During the last years different experimental models have been published to treat this fault of the arterial walls. Parallel the clinical treatment has evolved. With this work we have tried to develop an animal model basing on the clinical current treatment. Finally, we propose a treatment based on mesenchymal cells to disable local immune response, preventing excessive fibrosis, apoptosis, and inducing intrinsic cellular progenitors. OBJECTIVE: To present a reproducible superior animal model of experimentation, intending to show that mesenchymal stem cells inserted in the sac of an artificial aneurysm are able to survive, so that they can be made accountable for a subsequent beneficial effect upon this condition. METHODS: Six Landrace-White pigs, weighing around 25Kg. We generate 2 aneurysms of abdominal aorta (2x1cm) with Dacron's patches. Later we treat the aneurysms endoscopic with a covered endograft. Finally, in one of the aneurysmal sac we introduce 1cc fibrin sealant and in another 1 cc of fibrin sealant with 10 million MSC. Animals were sacrificed at 24 hs and 1, 3, 5, 7 and 9 weeks. Samples of aneurysms were processed histologically (H&E and Masson). The injected cells were located by immunofluorescence (GFP market). RESULTS: The surgical technique is reproducible and similar to those conducted in common clinical practice. Histological cross-section samples of cases treated with MSC and analyzed by a blind researcher present a lower inflammation reaction, or with longer evolution time than in controls. Immunofluorescence studies have detected cells marked with GFP up to three weeks after treatment. CONCLUSION: This reproducible animal model is similar to common clinical treatment. MSC can stand alive at least for three weeks since their implantation within an aneurysm sac. This may improve the results of conventional endovascular treatment by the stabilization of the aneurysmal sac.