Outcomes of Endurant II Stent Graft According to Anatomic Severity Grade Score.

OBJECTIVES: This study's objective was to evaluate Endurant II (Medtronic Inc, Minneapolis, Minnesota) stent graft's early and midterm outcomes and compare the results according to the anatomic severity grade (ASG) scores. METHODS: This was a retrospective study of patients treated with the Endurant II stent graft between January 2013 and May 2021. The patients were divided into 2 independent groups, including those with a low ASG score (score <14) and a high ASG score (score >14). RESULTS: A total of 165 consecutive patients (89% males, age 74±8 years) were included. There were 110 (67%) patients in the low-score group and 55 (33%) patients in the high-score group. Technical success was achieved in all cases. Primary clinical success at 30 days was 100% and at 1 year was 96%. Median operative time was longer in the high-score group with no statistical significance (133 vs 120 minutes, p=0.116). The median dose area product of low-score patients (50.9 Gy·cm2; IQR 22.4-75.5 Gy·cm2) was significantly lower than high-score patients (85.0 Gy·cm2; IQR 46.5-127.9 Gy·cm2) with p=0.025. Median fluoroscopic time was lower in low-score patients (17 minutes; IQR 13-24 minutes) compared with high-score patients (19 minutes; IQR 16-23 minutes) without a significant difference at p=0.148. At a midterm follow-up of 32 months (range 2-63 months), combined complications (29% vs 8%, p<0.001) and implant-related complications (13% vs 4%, p=0.043) were higher in the high-score group. Systemic complications at 30 days were higher in the high-score group without a statistically significant difference (15% vs 11%, p=0.500). The Kaplan-Meier estimate of freedom from reintervention was significantly higher in the low-risk group at 1 (97% vs 90%), 2 (96% vs 88%), and 3 years (96% vs 85%) with (p=0.035). The cumulative survival rate was significantly higher in the low-score group than high-score group (p=0.001) at 1 (99% vs 87%), 2 (98% vs 85%), and 3 years (96% vs 82%). CONCLUSIONS: Endurant II endovascular aneurysm repair seems to be safe in both low-score and high-score patients. However, patients in the high-score group showed more implant-related complications and midterm mortalities than those in the low-score group.

Neoaortoiliac system and cryopreserved human allograft for the treatment of aortic graft infections.

OBJECTIVE: To report and compare neoaortoiliac system reconstruction and cryopreserved human allograft in treating aortic graft infections. METHODS: We retrospectively analysed the data of the patients treated for aorto graft infections between January 2015 and May 2021 in our hospital. The clinical data, diagnostic procedures, and surgical options were evaluated. The primary endpoint of this study was the 30-day and 1-year mortality; secondary endpoints were major postoperative complications. RESULTS: We retrospectively reviewed a series of 31 consecutive patients (28 males; median age 72 years, range, 50-87 years) with aortic graft infection treated with NAIS (n = 20, 65%) or cryopreserved allograft (n = 11, 36%). The clinical presentation included fever attacks in 18 (58%) patients, abdominal pain in 15 (48%) patients, haemodynamic instability in 6 (19%) patients, and haematemesis in 2 (7%) patients. The median operative time of the NAIS was longer than CHA without a statistically significant difference (458 min vs. 359 min, p = .505). The postoperative morbidity for all patients was 81%, with no significant difference between NAIS and CHA groups (85% vs. 73%, p = .638). There was no limb thrombosis of the new reconstructions. Limb loss occurred in 4 (13%) patients, including 2 (10%) NAIS patients and 2 (18%) CHA patients. One NAIS patient developed complications in the form of a distal (femoral) disruption of the vein 15 days after surgery. There were no significant differences between NAIS and CHA groups in ICU stay (12 vs 8 days, .984) but in hospitalization (22 vs 33, p = .033). The most common bacteria isolated were staphylococci strains in 15 (48%). In 13 (36%) patients, candida was positive. The in-hospital 30-day and 1-year mortality for all patients was 16% (5/31) and 29% (9/31), with no significant differences between NAIS and CHA at 30 days (25% vs. 0, p = .133) or 1 year (35% vs. 18%, .429). Five NAIS patients died during the hospital stay; three of them had end-of-life decisions. After a median follow-up of 16 months (1-66 months), 12 (39%) patients died, including 9 patients with NAIS and 3 with CHA reconstructions. The causes of death included overwhelming sepsis in 5 (42%) patients, graft disruption in one (8%) NAIS patient, non-small cell lung cancer in one (8%) patient, COVID-19 in one (8%) patient and unknown causes (8%) in one. CONCLUSIONS: Non-staged neoaortoiliac system reconstruction and cryopreserved human allografts show comparable short- and midterm results for treating aortic graft infections. However, both procedures remain challenging with high morbidity and mortality rates.

[Effectiveness of Mucosal Advancement Flaps in Surgery of Perianal Fistulas from Crohn´s Disease and Cryptoglandular Fistulas - a Long-term Follow-up Study]. / Effektivität von Mukosa Muskel Flaps in der Behandlung von perianalen Fisteln bei Morbus Crohn und kryptoglandulären Fisteln ­ eine Langzeit-Follow-up-Studie.

AIM: Surgical treatment of perianal fistulae originating from Crohn's Disease (CD) or cryptoglandular abscess (CGA) remains a challenge. Data on long-term healing rates are scarce. We aimed to evaluate the long-term success rate of mucosal advancement flap (MAF) operations. METHODS: This single centre retrospective analysis was performed at a tertiary referral centre (Charité University Hospital Berlin, Campus Benjamin Franklin) between March 1, 2010 and March 31, 2020. Patients with complex perianal fistulae originating from CD or CGA treated with MAF were included. Long-time healing rates of MAF in CGA and CD were compared. Regression analysis was used to identify predictive factors for definitive healing. RESULTS: 83 patients (24 CD, 59 CGA,) were included. Median follow-up for CD was 5.4 and 1.9 years for CGA. Definitive healing of fistulae was achieved in 19 (79.2%) CD patients (p = 0.682) and in 44 (74.6%) CGA patients. Healing time was significantly shorter in CGA than in CD (9.3 months [standard deviation: SD= 11.3 months] vs. 30.9 months [SD = 23.5 months]; p < 0.001). Treatment with biologicals (hazard ratio: HR = 0.18, 95%-confidence interval: 95%-CI = 0.06-0.59, p = 0.004) and diverting ileostomy (HR = 0.29, 95%-CI = 0.10-0.85, p = 0.023) in CD were independent predictors for MAF success. Simultaneous medication with azathioprine in CD was an independent predictor for MAF failure (HR = 3.20, 95%-CI = 1.05-9.81, p = 0.041). CONCLUSION: This study demonstrates that surgical therapy of perianal fistulae with MAF is successful in about 75% of patients overall. Patients with MC benefit from biologicals and a diverting ileostomy. Treatment with azathioprine had a negative impact on recurrence rates. Repeated MAF operations did not increase the risk of failure in subsequent operations.

Outcomes of Candida and Non-Candida Aortic Graft Infection.

OBJECTIVE: To evaluate and compare the outcomes of Candida- and non-Candida-associated aortic graft infections. METHODS: We retrospectively analyzed the data from patients treated for aortic graft infection from 2015 to 2021 in our hospital. RESULTS: A total of 66 patients (56 men; median age, 69 years; range, 50-87 years) were admitted with aortic graft infection, including 21 (32%) patients in the Candida group and 45 (68%) in the non-Candida group. The average time between initial operation and presentation of aortic graft infection was 50 months (range, 1-332 months). Graft-enteric fistulas (GEFs) were more often in the Candida group (57% vs 27%, P = .017). The most proven causative fungal specimen was C. albicans in 16 (76%) patients. Non-albicans Candida was found in 9% of all patients and 29% of the Candida patients. The median ICU length of stay was longer in the Candida group than non-Candida (10 vs 9 days, P = .012). Additionally, the median hospital length of stay was longer in the Candida group (33 vs 22 days, P = .048). There were no statistically significant differences between Candida and non-Candida groups according to the in-hospital mortality (24% vs 24%, P = .955), and 1-year mortality (38% vs 38%, P = .980). CONCLUSIONS: Patients with bacterial and fungal aortic graft infections have high rates of morbidity and mortality. We found no significant differences in postoperative morbidity and mortality between Candida and non-Candida patients. However, the ICU and hospital length of stay were longer in the Candida group.

Evaluation of Open Surgical and Endovascular Treatment Options for Visceral Artery Erosions after Pancreatitis and Pancreatic Surgery.

PURPOSE: To report and compare the results of endovascular and open surgical treatment for erosion bleeding of visceral arteries following pancreatitis and pancreatic surgery. MATERIALS AND METHODS: This retrospective study included 65 consecutive patients (46 males, mean age 63 ± 14 years) presenting with visceral artery erosions between January 2011 and December 2020. Endpoints were technical success, freedom from reintervention, stent-graft-related complications, and 30-day and one-year mortality. RESULTS: The causes of erosion bleeding included complications of surgical treatment for the pancreas and upper gastrointestinal tract (75%), pancreatitis (19%), and spontaneous bleeding (6%). Pancreatectomy was performed in 34 (52%) patients, representing 2% of all pancreatectomy procedures (n = 1645) performed in our hospital during the study period. A total of 37 (57%) patients underwent endovascular treatment (EVT), and 28 (43%) patients had open surgery (OS) as a primary treatment. Eight of 37 (22%) patients in the EVT group underwent stent-graft treatment of the eroded vessels and 28 (78%) coil embolization. Six (9%) patients underwent reintervention with no significant differences between EVT and OS groups (11% vs. 7%, p = 0.692). Postoperative morbidity and complications in 52% of all patients were higher in the OS group than in the EVT group (41% vs. 68%, p = 0.029). The in-hospital 30-days mortality rate for all patients was 25%, and it was higher in the OS group than in the EVT group (14% vs. 39%, p = 0.017). CONCLUSIONS: An endovascular-first strategy for treating visceral arteries erosions may be preferred to reduce the complications associated with open surgery if patients are hemodynamically stable and have no anastomotic insufficiency. Endovascular treatment may be associated with better in-hospital survival when compared to primary open surgery. Further studies are required to identify the optimal approach.

Retraction: Bruder, L. et al. Transcatheter Decellularized Tissue-Engineered Heart Valve (dTEHV) Grown on Polyglycolic Acid (PGA) Scaffold Coated with P4HB Shows Improved Functionality over 52 Weeks due to Polyether-Ether-Ketone (PEEK) Insert. J. Funct. Biomater. 2018, 9(4), 64.

Due to human error, the authors included some of the experimental data in this article [...].

Transcatheter Decellularized Tissue-Engineered Heart Valve (dTEHV) Grown on Polyglycolic Acid (PGA) Scaffold Coated with P4HB Shows Improved Functionality over 52 Weeks due to Polyether-Ether-Ketone (PEEK) Insert.

Many congenital heart defects and degenerative valve diseases require replacement of heart valves in children and young adults. Transcatheter xenografts degenerate over time. Tissue engineering might help to overcome this limitation by providing valves with ability for self-repair. A transcatheter decellularized tissue-engineered heart valve (dTEHV) was developed using a polyglycolic acid (PGA) scaffold. A first prototype showed progressive regurgitation after 6 months in-vivo due to a suboptimal design and misguided remodeling process. A new geometry was developed accordingly with computational fluid dynamics (CFD) simulations and implemented by adding a polyether-ether-ketone (PEEK) insert to the bioreactor during cultivation. This lead to more belly-shaped leaflets with higher coaptation areas for this second generation dTEHV. Valve functionality assessed via angiography, intracardiac echocardiography, and MRI proved to be much better when compared the first generation dTEHV, with preserved functionality up to 52 weeks after implantation. Macroscopic findings showed no thrombi or signs of acute inflammation. For the second generation dTEHV, belly-shaped leaflets with soft and agile tissue-formation were seen after explantation. No excessive leaflet shortening occurred in the second generation dTEHV. Histological analysis showed complete engraftment of the dTEHV, with endothelialization of the leaflets and the graft wall. Leaflets consisted of collagenous tissue and some elastic fibers. Adaptive leaflet remodeling was visible in all implanted second generation dTEHV, and most importantly no fusion between leaflet and wall was found. Very few remnants of the PGA scaffold were detected even 52 weeks after implantation, with no influence on functionality. By adding a polyether-ether-ketone (PEEK) insert to the bioreactor construct, a new geometry of PGA-scaffold based dTEHV could be implemented. This resulted in very good valve function of the implanted dTEHV over a period of 52 weeks.

Computational modeling guides tissue-engineered heart valve design for long-term in vivo performance in a translational sheep model.

Valvular heart disease is a major cause of morbidity and mortality worldwide. Current heart valve prostheses have considerable clinical limitations due to their artificial, nonliving nature without regenerative capacity. To overcome these limitations, heart valve tissue engineering (TE) aiming to develop living, native-like heart valves with self-repair, remodeling, and regeneration capacity has been suggested as next-generation technology. A major roadblock to clinically relevant, safe, and robust TE solutions has been the high complexity and variability inherent to bioengineering approaches that rely on cell-driven tissue remodeling. For heart valve TE, this has limited long-term performance in vivo because of uncontrolled tissue remodeling phenomena, such as valve leaflet shortening, which often translates into valve failure regardless of the bioengineering methodology used to develop the implant. We tested the hypothesis that integration of a computationally inspired heart valve design into our TE methodologies could guide tissue remodeling toward long-term functionality in tissue-engineered heart valves (TEHVs). In a clinically and regulatory relevant sheep model, TEHVs implanted as pulmonary valve replacements using minimally invasive techniques were monitored for 1 year via multimodal in vivo imaging and comprehensive tissue remodeling assessments. TEHVs exhibited good preserved long-term in vivo performance and remodeling comparable to native heart valves, as predicted by and consistent with computational modeling. TEHV failure could be predicted for nonphysiological pressure loading. Beyond previous studies, this work suggests the relevance of an integrated in silico, in vitro, and in vivo bioengineering approach as a basis for the safe and efficient clinical translation of TEHVs.