Six-year outcomes of a phase II study of human-tissue engineered blood vessels for peripheral arterial bypass.

Objective: The human acellular vessel (HAV) was evaluated for surgical bypass in a phase II study. The primary results at 24 months after implantation have been reported, and the patients will be evaluated for ≤10 years. Methods: In the present report, we have described the 6-year results of a prospective, open-label, single-treatment arm, multicenter study. Patients with advanced peripheral artery disease (PAD) requiring above-the-knee femoropopliteal bypass surgery without available autologous graft options had undergone implantation with the HAV, a bioengineered human tissue replacement blood vessel. The patients who completed the 24-month primary portion of the study will be evaluated for ≤10 years after implantation. The present mid-term analysis was performed at the 6-year milestone (72 months) for patients followed up for 24 to 72 months. Results: HAVs were implanted in 20 patients at three sites in Poland. Seven patients had discontinued the study before completing the 2-year portion of the study: four after graft occlusion had occurred and three who had died of causes deemed unrelated to the conduit, with the HAV reported as functional at their last visit. The primary results at 24 months showed primary, primary assisted, and secondary patency rates of 58%, 58%, and 74%, respectively. One vessel had developed a pseudoaneurysm deemed possibly iatrogenic; no other signs of structural failure were reported. No rejections or infections of the HAV occurred, and no patient had required amputation of the implanted limb. Of the 20 patients, 13 had completed the primary portion of the study; however, 1 patient had died shortly after 24 months. Of the remaining 12 patients, 3 died of causes unrelated to the HAV. One patient had required thrombectomy twice, with secondary patency achieved. No other interventions were recorded between 24 and 72 months. At 72 months, five patients had a patent HAV, including four patients with primary patency. For the entire study population from day 1 to month 72, the overall primary, primary assisted, and secondary patency rate estimated using Kaplan-Meier analysis was 44%, 45%, and 60% respectively, with censoring for death. No patient had experienced rejection or infection of the HAV, and no patient had required amputation of the implanted limb. Conclusions: The infection-resistant, off-the-shelf HAV could provide a durable alternative conduit in the arterial circuit setting to restore the lower extremity blood supply in patients with PAD, with remodeling into the recipient's own vessel over time. The HAV is currently being evaluated in seven clinical trials to treat PAD, vascular trauma, and as a hemodialysis access conduit.

Strategy of pulseless pink supracondylar humerus fracture treatment in children: a comparison of two approaches.

PURPOSE: The appropriate treatment of pulseless pink supracondylar humerus fractures (SCHF) remains controversial. In this study, the outcomes of two treatment approaches (with and without vascular surgery) were compared. MATERIAL AND METHODS: This was a retrospective multicenter study of patients with pulseless pink SCHFs treated in ten pediatric surgery, trauma, or orthopedics departments in the Czech and Slovak Republic between 2014 and 2018. RESULTS: Of the total 3608 cases of displaced SCHF, 125 had the pulseless pink SCHF. Of those, 91% (114/125) did not undergo vascular surgery and 9% (11/125) underwent vascular surgery. The patients who did undergo vascular surgery had radial artery pulsation restored more frequently in the operating room (73% vs. 36%; p = 0.02), within 6 h (91% vs. 45%; p = 0.004), and within 24 h of surgery (91% vs. 57%; p = 0.05). However, 72 h after surgery, there was no significant difference in palpable radial artery pulsation between the vascular surgery and the non-vascular surgery groups (91% vs. 74%; p = 0.24). Additionally, no significant differences in long-term neurological (9% vs. 22%; p = 0.46) or circulatory (9% vs. 7%; p = 0.57) deficits were found between the two groups. CONCLUSION: While vascular surgery in patients with pulseless pink SCHFs is associated with a more prompt restoration of radial artery pulsation, no statistical significant differences in terms of the restoration of neurological deficits or the risks of long-term neurological or circulatory deficits were found between patients with and without vascular surgery.

Arterial reconstruction with human bioengineered acellular blood vessels in patients with peripheral arterial disease.

OBJECTIVE: Vascular conduit is essential for arterial reconstruction for a number of conditions, including trauma and atherosclerotic occlusive disease. We have developed a tissue-engineered human acellular vessel (HAV) that can be manufactured, stored on site at hospitals, and be immediately available for arterial vascular reconstruction. Although the HAV is acellular when implanted, extensive preclinical and clinical testing has demonstrated that the HAV subsequently repopulates with the recipient's own vascular cells. We report a first-in-man clinical experience using the HAV for arterial reconstruction in patients with symptomatic peripheral arterial disease. METHODS: HAVs were manufactured using human vascular smooth muscle cells grown on a biodegradable scaffold. After the establishment of adequate cell growth and extracellular matrix deposition, the vessels were decellularized to remove human cellular antigens. Manufactured vessels were implanted in 20 patients with symptomatic peripheral arterial disease as above-knee, femoral-to-popliteal arterial bypass conduits. After HAV implantation, all patients were assessed for safety, HAV durability, freedom from conduit infection, and bypass patency for 2 years. RESULTS: Twenty HAVs were placed in the arterial, above-knee, femoral-to-popliteal position in patients with rest pain (n = 3) or symptomatic claudication (n = 17). All HAVs functioned as intended and had no evidence of structural failure or rejection by the recipient. No acute HAV infections were reported, but three surgical site infections were documented during the study period. Three non-HAV-related deaths were reported. One vessel developed a pseudoaneurysm after suspected iatrogenic injury during a balloon thrombectomy. No amputations of the HAV implanted limb occurred over the 2-year period, and no HAV infections were reported in approximately 34 patient-years of continuous patient follow-up. CONCLUSIONS: Human tissue engineered blood vessels can be manufactured and readily available for peripheral arterial bypass surgery. Early clinical experience with these vessels, in the arterial position, suggest that they are safe, have acceptable patency, a low incidence of infection, and do not require the harvest of autologous vein or any cells from the recipient. Histologic examination of tissue biopsies revealed vascular remodeling and repopulation by host cells. This first-in-man arterial bypass study supports the continued development of human tissue engineered blood vessels for arterial reconstruction, and potential future expansion to clinical indications including vascular trauma and repair of other size-appropriate peripheral arteries.

The ultrasonography evaluation of talar dysplasia as a potential prognostic factor for predicting the course and outcomes of clubfoot deformity treatment using Ponseti technique.

OBJECTIVE: The aim of this study was to assess the role of sonographic evaluation of Talar dysplasia in predicting the outcome of standard Ponseti method in the treatment of clubfoot deformity. METHODS: A total 23 children (15 boys and 8 girls; mean age: 18.2 ± 5.4 days (8-32)) who underwent Ponseti treatment were included in the study. Before the treatment, maximal talus length of affected and non-affected feet were measured by US and relative talar dysplasia ratio (RTDR) was calculated. The patients were categorized 2 groups according to RTDR: group A - mild and group B - severe deformity. Pirani score was used for clinical evaluation. The groups were compared in terms of number of the applied casts, need of percutaneous tenotomy of Achilles tendon (AchT) and frequency of deformity recurrence. RESULTS: Pirani score was 4.46 for population (4.33 for group A; 4.54 for group B). Number of casts significantly differed between groups (p < 0.001) and positive correlation was found (r = 0.851, p < 0.001). AchT was performed in 56% cases for group A and in 86% cases for group B; no statistically significant difference was obtained (p = 0.162). Recurrence occurred in 2 patients belonging to group B without significant difference compared to group A (p = 0.502). CONCLUSION: Talar dysplasia assessment appeared as a promising prognostic factor for predicting the outcome of the Ponseti technique in treatment of clubfoot deformity. LEVEL OF EVIDENCE: Level IV, diagnostic study.

Low contrast media volume in pre-TAVI CT examinations.

PURPOSE: To evaluate image quality using reduced contrast media (CM) volume in pre-TAVI assessment. METHODS: Forty-seven consecutive patients referred for pre-TAVI examination were evaluated. Patients were divided into two groups: group 1 BMI < 28 kg/m(2) (n = 29); and group 2 BMI > 28 kg/m(2) (n = 18). Patients received a combined scan protocol: retrospective ECG-gated helical CTA of the aortic root (80kVp) followed by a high-pitch spiral CTA (group 1: 70 kV; group 2: 80 kVp) from aortic arch to femoral arteries. All patients received one bolus of CM (300 mgI/ml): group 1: volume = 40 ml; flow rate = 3 ml/s, group 2: volume = 53 ml; flow rate = 4 ml/s. Attenuation values (HU) and contrast-to-noise ratio (CNR) were measured at the levels of the aortic root (helical) and peripheral arteries (high-pitch). Diagnostic image quality was considered sufficient at attenuation values > 250HU and CNR > 10. RESULTS: Diagnostic image quality for TAVI measurements was obtained in 46 patients. Mean attenuation values and CNR (HU ± SD) at the aortic root (helical) were: group 1: 381 ± 65HU and 13 ± 8; group 2: 442 ± 68HU and 10 ± 5. At the peripheral arteries (high-pitch), mean values were: group 1: 430 ± 117HU and 11 ± 6; group 2: 389 ± 102HU and 13 ± 6. CONCLUSION: CM volume can be substantially reduced using low kVp protocols, while maintaining sufficient image quality for the evaluation of aortic root and peripheral access sites. KEY POINTS: • Image quality could be maintained using low kVp scan protocols. • Low kVp protocols reduce contrast media volume by 34-67 %. • Less contrast media volume lowers the risk of contrast-induced nephropathy.

Automated Tube Voltage Selection for Radiation Dose Reduction in CT Angiography Using Different Contrast Media Concentrations and a Constant Iodine Delivery Rate.

OBJECTIVE: The purpose of this study was to systematically investigate radiation dose reduction using automated tube voltage selection during CT angiography (CTA) and to evaluate the impact of contrast medium (CM) injection protocols on dose reduction. MATERIALS AND METHODS: A circulation phantom containing the thoracic and abdominal vasculature was used. Four different concentrations of CM (iopromide 300 and 370 mg I/mL and iomeprol 350 and 400 mg I/mL) were administered while maintaining an identical iodine delivery rate (1.8 g I/s) and total iodine load (20.0 g). Three different scanning protocols for CTA of the thoracoabdominal aorta were used: protocol A, no dose modulation; protocol B, automated tube current modulation (CARE Dose4D); and protocol C, automated tube voltage selection (CARE kV). The dose-length product was recorded to calculate the effective dose. Attenuation values (in Hounsfield units), image noise levels, and signal-to-noise ratios (SNRs) in six predefined intravascular sites (three thoracic and three abdominal) were measured by two readers. All values were analyzed using the Kruskal-Wallis test and two-way ANOVA. RESULTS: There was a significant reduction in the effective dose (in millisieverts) for protocols B (mean ± SD, 2.03 ± 0.1 mSv) and C (1.00 ± 0.0 mSv) compared with protocol A (4.34 ± 0.0 mSv). The dose was reduced by 53% for protocol B and by 77% for protocol C. No significant differences were found in the effective dose among the different CM injection protocols within the scanning protocols; all p values were > 0.05. The attenuation values and SNRs were comparable among all the different CM injection protocols; all p values were > 0.05. CONCLUSION: A large radiation dose reduction (77%) can be achieved using automated tube voltage selection independent of the CM injection protocol.

Robot-assisted right colectomy: surgical technique and review of the literature.

Following the successful introduction of robotic surgery to the field of urology and gynecology, its use gained even more interest among those in the field of colorectal surgery. Rectal resection is believed to be among the best suited for robotic assistance. In particular, the right hemicolectomy procedure has been proposed as a training tool in order to gain clinical experience with the robot. This article and attached video demonstrates, in detail, the robot-assisted right hemicolectomy, including key landmarks of the procedure. The case presented involved a 58-year-old man with an advanced cecal adenocarcinoma. In our opinionrobot-assisted right colon resection is a procedure that offers particular value for the novice robotic team who is in the beginning stages of their colorectal surgery experience. Although no concrete advantages for use of the robot in this particular procedure have been demonstrated in the literature, because it is a relatively straightforward and simple procedure, it can serve as a valuable training tool for the novice robotic surgeon.

The clinicopathological determinants of native arteriovenous fistula failure in patients on maintenance hemodialysis.

BACKGROUND: Progressive narrowing of the venous part of dialysis fistulae is caused by hemodynamic and inflammatory factors. OBJECTIVES: The pathogenic and clinical determinants of deterioration of the functioning of arteriovenous fistulae in chronically hemodialyzed patients were evaluated. MATERIAL AND METHODS: The hemodynamic parameters and the activity of inflammatory growth factors in the vessel wall of newly implanted fistulae were assessed and correlated with the clinical course of 34 hemodialyzed patients. Measurements taken at the time of implanting the fistulae included blood flow in the venous part of the anastomosis and its widest diameter by ultrasound Power Doppler, a histopathologic examination of fistula wall samples and measurements of mRNA expression for growth factors PDGFß1 and TGFß in the fistula wall. The results were correlated with clinical data from 36 months' observation: duration of fistula maturation, adequacy of dialysis treatment (eKt/V), the patient's survival, morbidity linked with vascular access problems and general cardiovascular morbidity. RESULTS: The mean duration of fistula maturation was 44.9 days (N = 43, SD = 38.6), whereas the average duration of fistula usage as dialysis access was 795.9 ± 480.6 days. Fistula blood flow at the time of implantation, averaged 1782.2 ± 1735.3 ml/min. The mean number of hospitalization days due to vascular access morbidity was 9.9 ± 15.6 days and it correlated positively with the fistula blood flow (R = 0.596, P = 0.004). There was a negative correlation between the expression of PDGFß1 mRNA and fistula blood flow (R = -0.673, P = 0.011), as well as between TGFß expression and patient survival (R = -0.722, P = 0.002). CONCLUSIONS: Inflammatory activity of the vessel wall growth factors PDGFß1 and TGFß implies impairment of fistula function and the patient's cardiovascular morbidity.