Graft-related Adverse Events Research Articles

Long-Term Outcomes of Endovascular Repair Within and Outside the Instructions for Use in Korean Patients With Abdominal Aortic Aneurysm.

Endovascular aneurysm repair (EVAR) has been used worldwide to treat abdominal aortic aneurysms (AAAs). Outcomes after EVAR within and outside the instruction for use (IFU) remain controversial. We analyzed long-term outcomes of EVAR within-the-IFU compared with that outside-the-IFU and baseline clinical/anatomical characteristics that influence outcomes of EVAR. The study included 546 patients who underwent EVAR for infrarenal AAA from 1997 to 2021 at 2 Korean medical centers. The primary endpoint was graft-related adverse events (GRAEs), including type 1 or 3 endoleak, reintervention (included open conversion), aneurysm sac enlargement, aneurysm-related mortality (ARM), rupture, stent-graft migration, and stent thrombotic occlusion. The patients who underwent EVAR outside the IFU were 287 (52.6%). A neck angle of >60° was most common outside the IFU criteria (n=146, 50.9%). This study revealed that patients outside the IFU had a higher rate of GRAEs compared with patients within the IFU (hazard ratio [HR]: 1.879; 95% confidence interval [CI]: 1.045-2.386). A neck angle of >60° was a significant risk factor for GRAEs (adjusted HR: 2.229; 95% CI: 1.418-3.503), type 1 or 3 endoleak (adjusted HR: 2.640; 95% CI: 1.343-5.189), and reintervention (adjusted HR: 1.891; 95% CI: 1.055-3.388). Our study revealed EVAR with outside the IFU was associated with increased GRAEs, mainly attributed to endoleak and ARM, compared with EVAR with within the IFU. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak, and reintervention. Our study revealed endovascular aneurysm repair (EVAR) with outside-the-instruction for use (IFU) was associated with increased graft-related adverse events (GRAEs) compared with EVAR with within-the-IFU. In the low-risk population, the incidence of GRAEs and Aneurysm related mortality were higher in the outside-the-IFU group rather than within-the-IFU group. In addition, severe neck angulation was an independent risk factor for GRAEs, type 1 or 3 endoleak and reintervention.

Early Results of Elective Endovascular Repair of Infrarenal Abdominal Aortic Aneurysms With the MinosTM Stent-Graft System.

A variety of last-generation endografts are currently available for standard endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs). The purpose of this study is to report the preliminary clinical outcomes of the Minos trimodular stent-graft system, which was recently introduced to the European market. Between February 2020 and 2022, we treated 41 consecutive AAA patients (mean age 72.2±8.5, 37 males) with elective standard EVAR using the Minos. The mean maximum diameter of AAAs was 54.7±6.6 mm, the mean proximal neck's (PN) diameter was 24.8±2.7 mm, while the relevant length and angulation were 16.0 mm and 21.7°, respectively. Overall, 22 (53.6%) patients presented with shorter and angulated PN, according to the stent-graft's instructions of use, and in 6 (14.6%) patients the PN angulation >60° was combined with concomitant iliac angulation >60°. Eleven (26.8%) EVARs were performed with concomitant enormous iliac artery narrowing and tortuosity. Finally, in 19 (46.3%) AAAs, the distal iliac landing zone was aneurysmatic and they were treated with the bell-bottom technique in 17 patients and with limb extension to the external iliac artery in two cases. We evaluated technical and clinical success of the index procedures, which was based on the combination of five factors: freedom from EVAR-related mortality, from graft-related endoleak of any type, from migration at any part of graft as well the absence of notable increase AAA's sac maximum diameter and the patency of bifurcated stent-graft and of access vessels. Primary technical and clinical success of index procedures was 100%. During a median 12-month radiological follow-up the clinical success remained 100%. No type I or III endoleak, stent-graft migration, EVAR-related death, AAA rupture, or graft-related adverse events or reinterventions were documented. Four (9.8%) type II endoleaks were detected with stable AAA sac diameter. The overall incidence of sac regression was 34.1% (n=14). The preliminary results of our series showed that Minos provided excellent feasibility and safety features even through angulated and tortuous iliac vessels and in short and angulated PNs. The overall clinical success at 1 year suggests that performance of Minos follows very high standards. Further validation of these promising results with long-term data is acquired to complete the evaluation of this recently introduced stent-graft system. The current study explored the clinical performance of a new in market ultra-low profile bifurcated abdominal aortic stent-graft, the MINOS. The early and 12-month results of study suggest that implantation of this stent-graft in standard EVAR, even in hostile proximal aortic neck and iliac vessels conditions, follows very high clinical standards and encourage the further clinical use of MINOS.

Liver transplantation of partial grafts after ex situ splitting during hypothermic oxygenated perfusion-The HOPE-Split pilot study.

Partial liver grafts from ex situ splitting are considered marginal due to prolonged static cold storage. The use of ex situ hypothermic oxygenated perfusion (HOPE) may offer a strategy to improve preservation of ex situ split grafts. In this single-center pilot study, we prospectively performed ex situ liver splitting during HOPE (HOPE-Split) for adult and pediatric partial grafts over a 1-year period (November 1, 2020 to December 1, 2021). The primary safety endpoint was based on the number of liver graft-related adverse events (LGRAEs) per recipient, including primary nonfunction, biliary complications, hepatic vascular complications, and early relaparotomies and was compared with consecutive single-center standard ex situ split transplantations (Static-Split) performed from 2018 to 2020. Secondary endpoints included preservation characteristics and early outcomes. Sixteen consecutive HOPE-Split liver transplantations (8 HOPE-Split procedures) were included and compared with 24 Static-Splits. All HOPE-Split grafts were successfully transplanted, and no graft loss nor recipient death was encountered during the median follow-up of 7.5 months (interquartile range, 5.5-12.5). Mean LGRAE per recipient was similar in both groups (0.31 ± 0.60 vs. 0.46 ± 0.83; p=0.78) and split duration was not significantly increased for HOPE-Split (216 vs. 180 min; p=0.45). HOPE-Split grafts underwent perfusion for a median of 125 min, which significantly shortened static cold storage (472 vs. 544 min; p=0.001), whereas it prolonged total ex vivo preservation (595 vs. 544 min; p=0.007) and reduced neutrophil infiltration on reperfusion biopsies (p=0.04) compared with Static-Split. This clinical pilot study presents first feasibility and safety data for transplantation of partial liver grafts undergoing ex situ split during HOPE and suggests improved preservation compared with static ex situ splitting. These preliminary results will allow to set up large-scale trials on the use of machine perfusion in pediatric and split-liver transplantation.

Long-term outcomes of endovascular aneurysm repair according to instructions for use adherence status

ObjectiveEndovascular aneurysm repair (EVAR) has become the standard treatment for abdominal aortic aneurysms (AAAs). Endovascular device manufacturers have defined specific anatomic criteria for the aneurysm characteristics that should be observed as instructions for use (IFU) for specific grafts. In clinical practice, the prevalence of performing EVAR outside the IFU has been high. In the present study, we aimed to determine the effects of nonadherence to the IFU on the outcomes. MethodsPatients who had undergone EVAR for an infrarenal AAA between 2005 and 2013 were included. IFU nonadherence was defined as any violation of device-specific IFU criteria and was compared with IFU adherence. The primary outcomes were all-cause mortality, aneurysm-related mortality, AAA rupture, graft-related adverse events (GRAEs), including limb-related adverse events, and type Ia endoleaks. A second aim was to study whether the prevalence of EVAR performed outside the IFU has increased over time. ResultsA total of 258 patients were included, 144 (55.8%) of whom had been treated according to the IFU and 114 (44.2%) outside the IFU. In the IFU nonadherence group, all-cause mortality (hazard ratio [HR], 1.39; 95% confidence interval [CI], 1.02-1.89; P = .037) and aneurysm-related mortality (HR, 5.1; 95% CI, 1.4-18.6; P = .015), and the incidence of AAA rupture (HR, 5.4; 95% CI, 1.1-26.6; P = .036) and GRAEs (HR, 1.7; 95% CI, 1.1-2.8; P = .025). No significant association was found between the incidence of type Ia endoleaks and neck-related IFU or limb-related adverse events and iliac-related IFU. However, neck length was a risk factor for type Ia endoleaks (HR, 18.2, 95% CI, 6.3-52.2; P < .001), aneurysm-related mortality (HR, 8.7; 95% CI, 1.8-41.6; P = .007), AAA rupture (HR, 21.7; 95% CI, 2.8-166; P = .003), and GRAEs (HR, 4.4; 95% CI, 2.0-9.7; P < .001). An IFU violation regarding neck angulation was also a risk factor for all-cause mortality (HR, 2.0; 95% CI, 1.1-3.7; P = .032), aneurysm-related mortality (HR, 7.6; 95% CI, 1.4-42.8; P = .021), AAA rupture (HR, 79.4; 95% CI, 6.3-999; P = .001), and GRAEs (HR, 4.3; 95% CI, 1.9-9.5; P < .001). The prevalence of EVAR performed outside the IFU did not increase over time. ConclusionsPerforming EVAR outside the IFU had a negative effect on outcomes, including all-cause mortality, aneurysm-related mortality, AAA rupture, and GRAEs. Neck angulation and neck length seemed to be the most crucial aneurysm characteristics.

Implanted pluripotent stem-cell-derived pancreatic endoderm cells secrete glucose-responsive C-peptide in patients with type 1 diabetes

An open-label, first-in-human phase 1/2 study is being conducted to evaluate the safety and efficacy of pancreatic endoderm cells (PECs) implanted in non-immunoprotective macroencapsulation devices for the treatment of type 1 diabetes. We report an analysis on 1 year of data from the first cohort of 15 patients from a single trial site that received subcutaneous implantation of cell products combined with an immunosuppressive regimen. Implants were well tolerated with no teratoma formation or severe graft-related adverse events. After implantation, patients had increased fasting C-peptide levels and increased glucose-responsive C-peptide levels and developed mixed meal-stimulated C-peptide secretion. There were immunosuppression-related transient increases in circulating regulatory Tcells, PD1high Tcells, and IL17A+CD4+ Tcells. Explanted grafts contained cells with a mature β cell phenotype that were immunoreactive for insulin, islet amyloid polypeptide, and MAFA. These data, and associated findings (Shapiro etal., 2021), are the first reported evidence of meal-regulated insulin secretion by differentiated stem cells in patients.

Outcomes after Standalone Use of Gore Excluder Iliac Branch Endoprosthesis for Endovascular Repair of Isolated Iliac Artery Aneurysms

The aim of our study was to describe outcomes of stand-alone use (i.e., without concomitant implantation of an aortic stent graft) of the Gore Excluder iliac branch endoprosthesis (IBE) for elective endovascular repair of isolated iliac artery aneurysms. We evaluated all consecutive patients electively treated for isolated iliac artery aneurysms using standalone Gore Excluder IBE (January 2014-December 2018). Early (i.e., 30-day) endpoints were technical success, mortality, major adverse events (MAEs), and major access-site complications. Late endpoints were survival, freedom from aortic-related mortality (ARM), internal iliac artery (IIA) primary patency, IIA branch instability, graft-related adverse events (GRAEs), secondary interventions, endoleaks (ELs), aneurysm sac behavior, and new-onset buttock claudication (BC). A total of 11 consecutive patients (10 men; median age 75years) were included. The technical success rate was 100%. At 30days, mortality, MAEs, and major access-site complications were all 0%. Survival and freedom from ARM were 91% and 100%, respectively; only one nonaortic related death was recorded during follow-up. At a median follow-up of 14months, IIA primary patency, IIA branch instability, and GRAEs were 100%, 0%, and 0%, respectively. No instances of graft migration ≥10mm were detected. No graft-related secondary interventions were recorded, and 2 patients required a procedure-related secondary intervention 3months after the index procedure (1 common femoral artery endarterectomy and 1 external iliac artery stenting). Although new-onset type 1 or type 3 ELs were never noted, one patient developed a new-onset type 2 EL. Aneurysm sac regression ≥5mm was noted in 6 patients (55%), whereas in the remaining ones, the sac size was stable. No instances of new-onset BC were noted. Use of standalone Gore Excluder IBE for elective endovascular repair of isolated iliac artery aneurysms is a safe, feasible, and effective treatment option. These results may support use of the technique as an effective means of endovascular reconstruction in patients with suitable anatomy.

Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study

BackgroundSparing Aortic Valve procedure requires to reproduction of the geometry of the physiologic anatomy of the aortic root. Thus, the materials adopted may make a difference. CARDIOROOT is a one-piece collagen-coated woven vascular graft with pseudo-sinuses, which was designed for use in the treatment of aortic root disease. We report the results of a prospective, multicenter, observational post-market surveillance study evaluating the safety and performance of the CARDIOROOT in patients requiring aortic root surgery.MethodsPatients with aortic root disease suitable for treatment with a vascular graft with pseudo-sinuses CARDIOROOT graft were eligible for participation. The enrolled patients were assessed intraoperatively, post-operatively, at discharge and at 1-year. Sites assessed complications at each visit, and recorded any reported adverse events. The study endpoint was mortality and complications through 1-year post-procedure.ResultsFifty-two patients were enrolled from 6 European centers. All procedures were technically successful. Operative mortality was 1.9%: one patient suffered hemorrhagic shock unrelated to the graft 1 day following surgery. At 1-year follow-up the survival rate was 96.2%, with a late death due to pneumonia 5 months post-procedure. Eleven serious adverse events occurred in 7 patients, which included cardiac complications (pericardial effusion, myocardial infarction and ventricular arrhythmia), infection (pericardial infection, deep sternal infection and superficial sternal infection), vascular disorders, including hemorrhagic shock and pleural effusion requiring drainage. Nine of the 11 events were deemed procedure-related by the local investigator, and all were deemed unrelated to the device. There were no reports of graft-related adverse events, infection, occlusion or graft failure.ConclusionsThe results of this 1-year follow-up study showed that the CARDIOROOT vascular graft is safe and effective for the treatment of aneurysmal aortic root in immediate and mid-term follow-up. However, longer term follow-up is needed before conclusions can be made on the long-term safety and effectiveness.Trial registrationClinicalTrials.gov Identifier: NCT01609270. Registered 31 May 2012.

Long-term survival after endovascular and open repair in patients with anatomy outside instructions for use criteria for endovascular aneurysm repair

BackgroundRandomized controlled trials of long-term survival for infrarenal abdominal aortic aneurysms have compared open surgical repair (OSR) with endovascular aneurysm repair (EVAR) in patients with suitable aortic anatomy for EVAR. However, in clinical practice, patients who do not meet instructions for use (IFU) criteria are often still treated by EVAR despite that some studies show higher graft-related adverse events. The goal of this study was to compare the long-term survival of EVAR and OSR in patients with anatomy outside IFU criteria for EVAR. MethodsThis multicenter retrospective cohort study included patients with at least one anatomic IFU violation for EVAR undergoing either elective EVAR or elective OSR for abdominal aortic aneurysm. Demographics, anatomic data, and follow-up data of patients were collected from three academic centers from 2003 to 2016. Device-specific IFU were used for EVAR patients, whereas generic IFU for EVAR were applied to the OSR patients. The primary outcomes were 30-day mortality and long-term all-cause mortality. Secondary outcomes were aneurysm-related mortality and perioperative complications at 30 days. Kaplan-Meier survival and Cox proportional hazards modeling were performed. Inverse propensity score weights were used to adjust for differences in treatment selection. ResultsThe study population included 202 EVAR patients and 224 OSR patients with at least one anatomic IFU violation for EVAR. EVAR patients were older (78.1 ± 7.3 vs 70.9 ± 7.0 years; P < .001) and less likely to be hypertensive (69.3% vs 79.0%; P = .02) compared with OSR patients. OSR patients were more likely to have proximal aortic neck IFU violations (75.0% vs 47.1%; P < .001) and were less likely to have iliac IFU violations (65.2% vs 79.2%; P < .001). All-cause mortality was 37.6% in the EVAR group and 24.1% in the OSR group with a median follow-up time of 5.2 (3.5-7.2) and 5.4 (2.8-9.3) years, respectively (P < .002). Kaplan-Meier survival analysis revealed a significant association between patients undergoing OSR and increased long-term survival (log-rank P < .0001). When adjusted for possible confounders and weighted for propensity for treatment through Cox hazard modeling, the association remained significant (hazard ratio, 0.6; 95% confidence interval, 0.4-0.9). Aneurysm-related mortality was 3.5% in the EVAR group and 2.2% in the OSR group during long-term follow-up (P < .001). ConclusionsOur study identified that patients with IFU violations have higher overall long-term survival with open surgery compared with EVAR. Caution should be applied in considering standard EVAR for patients with anatomy outside of IFU.

Any nonadherence to instructions for use predicts graft-related adverse events in patients undergoing elective endovascular aneurysm repair

BackgroundA variety of devices exist for endovascular aneurysm repair (EVAR). Device-specific instructions for use (IFU) detail anatomic constraints to application and deployment of devices and are developed from rigorous bench testing. Nonadherence to IFU occurs frequently to avoid open surgery. The purpose of this study was to determine if IFU violations are associated with increased risk of graft-related adverse events (GRAEs) during follow-up. MethodsThis multicenter retrospective observational study included patients undergoing elective endovascular repair for abdominal aneurysmal disease with three different devices. Demographics, anatomic data, and follow-up data were collected on patients from 2005 to 2014. IFU violations were device specific and included neck diameter, length, and angulation and iliac artery diameter and length. GRAEs included a composite outcome of reintervention, migration, endoleak (type II excluded), rupture, limb occlusion, sac growth, and aneurysm-related mortality during the follow-up period. Kaplan-Meier survival and Cox proportional hazards modeling were performed. Any IFU violations as well as neck-specific IFU violations were analyzed. ResultsIn 461 patients undergoing EVAR, 43.8% had at least one IFU violation. Patients with IFU violations were more likely to have peripheral vascular disease (12.4% vs 7.3%) and were less likely to be male (78.7% vs 90.3%). The most frequent IFU violations included diameter deviations of the neck (15.2%) and of the iliac artery (21.4%). Overall, the GRAE rate was 12.8%. Median follow-up time was 1.9 and 2.1 years for patients with and without an IFU violation, respectively. Kaplan-Meier survival revealed a significant association between the presence of an IFU violation and GRAEs (log-rank, P = .031). When adjusted for clinical variable through Cox hazard modeling, the association remained significant (hazard ratio 1.8; 95% confidence interval, 1.05-3.1). When neck-specific violations were considered independently, Kaplan-Meier survival (log-rank, P = .003) and Cox modeling (hazard ratio, 2.2; 95% confidence interval, 1.2-4.0) revealed a significant association between neck-specific IFU violation and GRAEs. ConclusionsA total of 43.8% of patients undergoing EVAR had a device-specific IFU violation, indicating that implanters are pushing the boundaries of device capabilities. Our study identified that any IFU violation was significantly associated with GRAEs over time. Caution should be applied to patients being considered for EVAR when IFU deviations exist.

A novel equine-derived pericardium membrane for dural repair: A preliminary, short-term investigation.

Background:A large variety of biological and artificial materials are employed in dural repair, each of them with major limitations. Autologous grafts have limited availability and require an additional incision and surgical time. Cadaveric preparations and heterologous materials entail the risk of iatrogenic transmission of prions, whereas synthetic substitutes have been reported to cause inflammatory reactions and graft rejection. An equine-derived pericardium membrane has been developed (Heart®, Bioteck, Vicenza, Italy) with mechanical and safety-related features that could make it suitable for neurosurgical application.Aims:This preliminary study aimed to evaluate the short-term safety and efficacy of the Heart® membrane in dural repair procedures following meningioma surgeries.Subjects and Methods:Medical records of patients who were surgically treated for an intracranial meningioma and underwent duraplasty with the Heart® membrane were reviewed retrospectively. The occurrence of any graft-related complications such as cerebrospinal fluid (CSF) leakage, postoperative hematoma, wound infection, meningitis, and neurological symptoms was analyzed.Results:Eight patients were identified as meeting the inclusion criteria. A watertight closure was achieved in all of them. Postoperatively, no patients exhibited CSF leak, cerebral contusion, hemorrhage, or wound infection. The 1-month radiological follow-up revealed no evidence of pseudomeningocele, wound breakdown, or meningitis. Neurologic complications were observed in three patients but not directly imputable to the dural substitute or its application.Conclusions:In all the patients, the pericardium membrane enabled achievement of a watertight dural closure without graft-related adverse events. Further investigations should be performed to assess medium- and long-term clinical outcomes in a larger set of patients.

Endovascular Aneurysm Repair Treatment of Aortoiliac Aneurysms: Can Iliac Branched Devices Prevent Gluteal Claudication?

PurposeTo compare the risk of gluteal claudication after endovascular aneurysm repair (EVAR) of aortoiliac aneurysms by interventional exclusion of the internal iliac artery (IIA) with plugs or coils versus a branch iliac device to maintain pelvic blood supply and to identify risk factors for postoperative gluteal claudication. Materials and MethodsA retrospective analysis of a prospectively collected data set included patients with aortoiliac aneurysms treated with EVAR from January 2007 to December 2013 at a tertiary referral vascular unit. Descriptive and procedural data were obtained from a database of prospectively enrolled patients. Medical records of 112 consecutive patients treated with EVAR were scrutinized for graft-related adverse events and pelvic ischemia. The occurrence of gluteal claudication was determined from medical records. ResultsIliac occlusion was performed in 115 limbs, and a branch iliac device was placed in 25 limbs. Gluteal claudication developed in 38% of limbs treated with IIA exclusion but in none of the limbs treated with branch iliac devices (P < .001). Procedure time, fluoroscopy time, and use of iodine contrast material did not differ between the two groups. The incidence of gluteal claudication was higher when coils rather than plugs were used for embolization of the IIA before EVAR (P = .002). ConclusionsThe findings suggest that the use of a branch iliac device significantly reduces the risk of gluteal claudication after EVAR of aortoiliac aneurysm.

Human Cadaveric Pericardial Graft for the Surgical Correction of Peyronie’s Disease

In patients with stable penile deformity secondary to Peyronie's disease (PD) penile straightening can be achieved with plaque incision or partial excision and grafting. We present our experience with human cadaveric pericardium for tunica albuginea grafting for men undergoing penile reconstruction for Peyronie's disease. We retrospectively reviewed our experience with 40 men with PD who underwent penile straightening with partial plaque excision and grafting using human cadaveric pericardium from January 1999 to January 2003. All 40 men were evaluable for preoperative, operative and postoperative characteristics. Mean postoperative followup was 22.0 months. Mean preoperative penile curvature was 69.1 degrees. Subjectively 36 of the 40 patients (90%) graded preoperative erection as sufficiently rigid for coitus and 100% had sufficiently rigid erection for coitus following intracorporeal papaverine injection. Mean pericardial graft size was 4.9 x 4.8 cm. Postoperatively 39 of the 40 patients (98%) had successful penile straightening, 38 (95%) achieved coitus, 28 (70%) achieved full, unaided erection and 12 (30%) had some degree of erectile dysfunction (ED) requiring pharmacological assistance for intercourse. There were no significant differences in ED risk factors, plaque location, graft size or complications in men who did and did not have ED postoperatively (p >0.05). There were no major complications or graft related adverse events. Human cadaveric pericardium is a safe, readily available and pliable tissue for tunica albuginea grafting following PD plaque incision or partial excision. Careful patient selection must be emphasized and particular attention must be given to deformity stability and preoperative erectile function to maximize surgical outcome.