Use of Omniflow® II Biosynthetic Graft for the Treatment of Vascular Graft and Endograft Infections

Background: Vascular graft/endograft infection is a rare but life-threatening complication of cardiovascular surgery and remains a surgical challenge. Several different graft materials are available for the treatment of vascular graft/endograft infection, each having its own advantages and disadvantages. Biosynthetic vascular grafts have shown low reinfection rates and could be a potential second best after autologous veins in the treatment of vascular graft/endograft infection. Therefore, the aim of our study was to evaluate the efficacy and morbidity of Omniflow® II for the treatment of vascular graft/endograft infection.Methods: A multicenter retrospective cohort study was performed to evaluate the use of Omniflow® II in the abdominal and peripheral region to treat vascular graft/endograft infection between January 2014 and December 2021. Primary outcome was recurrent vascular graft infection. Secondary outcomes included primary patency, primary assisted patency, secondary patency, all-cause mortality, and major amputation.Results: Fifty-two patients were included with a median follow-up duration of 26.5 (10.8–54.8) months. Nine (17%) grafts were implanted in intracavitary position and 43 (83%) in peripheral position. Most grafts were used as femoral interposition (n = 12, 23%), femoro-femoral crossover (n = 10, 19%), femoro-popliteal (n = 8, 15%), and aorto-bifemoral (n = 8, 15%) graft. Fifteen (29%) grafts were implanted extra-anatomically and 37 (71%) in situ. Eight patients (15%) presented with reinfection during follow-up, most of these patients received an aorto-bifemoral graft (n = 3, 38%). Intracavitary vascular grafting had a 33% (n = 3) reinfection rate and peripheral grafting 12% (n = 5; P = 0.025). The estimated primary patencies at 1, 2, and 3 years were 75%, 72%, and 72% for peripherally located grafts and 58% (at all timepoints) for intracavitary grafts (P = 0.815). Secondary patencies at 1, 2, and 3 years were 77% (at all timepoints) for peripherally located prostheses and 75% (at all timepoints) for intracavitary prostheses (P = 0.731). A significantly higher mortality during follow-up was observed in patients who received an intracavitary graft compared to patients with a peripheral graft (P = 0.003).Conclusions: This study highlights the efficacy and safety of the Omniflow® II biosynthetic prosthesis for the treatment of vascular graft/endograft infection, in absence of suitable venous material, with acceptable reinfection, patency, and freedom of amputation prevalences, especially in replacing peripheral vascular graft/endograft infection. However, a control group with either venous reconstruction or another alternative graft is needed to make firmer conclusions.</p

Short-Term Results of A Randomized Trial Comparing Remote Endarterectomy and Supragenicular Bypass Surgery for Long Occlusions of the Superficial Femoral Artery [The REVAS Trial]

AbstractObjectiveTechniques for surgical repair of Trans-Atlantic Inter-Society Consensus (TASC) C and D lesions of the superficial femoral artery (SFA) are supragenicular bypass grafting or the less invasive remote endarterectomy (RSFAE). This trial compares the patency rates of both techniques.DesignRandomized, multicenter trial.Materials and methods116 patients were randomized to RSFAE (n=61) and supragenicular bypass surgery (n=55). Indications for surgery were claudication (n=77), rest pain (n=21), or tissue loss (n=18).ResultsMedian hospital stay was 4 days in the RSFAE group compared with 6 days in the bypass group (p=0.004). Primary patency after 1-year follow-up was 61% for RSFAE and 73% for bypass (p=0.094). Secondary patency was 79% for both groups. Subdividing between venous (n=25) and prosthetic grafts (n=30) shows a primary patency of 89% and 63% respectively at 1-year follow-up (p=0.086).ConclusionRSFAE is a minimally invasive adjunct in the treatment of TASC C and D lesions of the SFA, with shorter admittance and a comparable secondary patency rate to bypass. The venous bypass is superior to both RSFAE and PTFE bypass surgery, but only 45% of patients had a sufficient saphenous vein available.This study is registered with ClinicalTrials.gov, number NCT00566436

PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories): Overview of Design and Rationale of an International Prospective Peripheral Arterial Disease Study

Background: Health status outcomes, including symptoms, functional status, and quality of life, are critically important outcomes from patients’ perspectives. The PORTRAIT study (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) was designed to prospectively define health status outcomes and examine associations between patients’ characteristics and care to these outcomes among those presenting with new-onset or worsened claudication. Methods and Results: PORTRAIT screened 3637 patients with an abnormal ankle-brachial index and new, or worsened, claudication symptoms from 16 peripheral arterial disease (PAD) specialty clinics in the United States, the Netherlands, and Australia between June 2, 2011, and December 3, 2015. Of the 1608 eligible patients, 1275 (79%) were enrolled. Before treatment, patients were interviewed to obtain their demographics, PAD symptoms and health status, psychosocial characteristics, preferences for shared decision-making, socioeconomic, and cardiovascular risk factors. Patients’ medical history, comorbidities, and PAD diagnostic information were abstracted from patients’ medical records. Serial information about patients’ health status, psychosocial, and lifestyle factors was collected at 3, 6, and 12 months by a core laboratory. Follow-up rates ranged from 84.2% to 91%. Clinical follow-up for PAD-related hospitalizations and major cardiovascular events is ongoing. Conclusions: PORTRAIT systematically collected serial PAD-specific health status data as a foundation for risk stratification, comparative effectiveness studies, and clinicians’ adherence to quality-based performance measures. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01419080.Kim G. Smolderen, Kensey Gosch, Manesh Patel, W. Schuyler Jones, Alan T. Hirsch, John Beltrame, Rob Fitridge, Mehdi H. Shishehbor, Johan Denollet, Patrick Vriens, Jan Heyligers, Nancy Stone, MEd, Herbert Aronow, J. Dawn Abbott, Clementine Labrosciano, Rudolf Tutein-Nolthenius, John A. Spertu

Solitary iliac branch endoprosthesis placement for iliac artery aneurysms

Background: Isolated iliac artery aneurysms (IAAs), accounting for 2% to 7% of all abdominal aneurysms, are often treated with the use of iliac branched endografts. Although outside the manufacturer’s instructions for use, iliac branched devices can be used solely, without the adjunctive placement of an endovascular aneurysm repair device, for the treatment of an isolated IAA. In the present study, we have described the outcomes of the use of the Gore iliac branched endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, Ariz), without the support of an infrarenal endovascular aneurysm repair device, for the exclusion of an isolated IAA. The present study was an international multicenter retrospective cohort analysis. Methods: All the patients who had undergone treatment with a solitary IBE for IAA exclusion from January 11, 2013 to December 31, 2018 were retrospectively reviewed. The primary outcome was technical success. The secondary outcomes included mortality, intraoperative and postoperative complications, and reintervention. Results: A total of 18 European and American centers participated, with a total of 51 patients in whom 54 IAAs were excluded. The technical success rate was 94.1%, with an assisted technical success rate of 96.1%. No 30-day mortality occurred, with 98.1% patency of the internal and external iliac artery found at 24 months of follow-up. At 24 months of follow-up, 81.5% of the patients were free of complications and 90% were free of a secondary intervention. Conclusions: Treatment with a solitary IBE is a safe and, at midterm, an effective treatment strategy for selected patients with a solitary IAA. (J Vasc Surg 2022;75:1268-75.

Quality of life after endovascular and open AAA repair. Results of a randomised trial

Aim. To compare the quality of life (QoL) in the first postoperative year after elective endovascular abdominal aortic aneurysm repair (EVAR) and open repair (OR) in a randomised study. Methods. In the Dutch Randomised Endovascular Aneurysm Management (DREAM) trial, patients are randomly allocated to EVAR or OR. QoL questionnaires (SF-36 and EuroQoL-5D) were sent to all patients preoperatively (PREOP) and at five time points in the first postoperative year (3W, 6W, 3M, 6M and 12M). Between November 1999 and August 2002, 153 patients (141 male; 12 female) were randomised (78 EVAR and 75 OR; one crossover from OR to EVAR). The EuroQoL-5D scores and the eight domains of the SF-36 for the two groups were compared using the Mann-Whitney test. Changes over time were analysed using the Wilcoxon sign test. Results. There were no statistically significant differences in baseline characteristics (age, gender and SVS risk factors). The preoperative QoL scores of the study group were similar to the QoL scores of the general population of the same age. After 3W the OR group showed a significant decrease on the EuroQol-5D (p = 0.022) and in six of the eight SF-36 domains. The EVAR group also showed a significant decrease on the EuroQol-5D (p = 0.004) and in 5 of the 8 domains of the SF-36. At 6W the EuroQol-5D had recovered to baseline in the OR group and the decreased domains of the SF-36 had partially recovered. In the EVAR group the EuroQol-5D and three of the five decreased SF-36 domains, had returned to baseline. From 6M on, the OR group reported a significantly higher score on the EuroQoL-5D than the EVAR group (p = 0.045 (6M) and p = 0.001 (12MA)). Conclusion. In the early postoperative period there is a small, yet significant QoL advantage for EVAR compared to OR. At 6 months and beyond, patients reported better QoL after OR than after EVAR

Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms

Objective: Randomized trials have shown an initial survival benefit of endovascular over conventional open abdominal aortic aneurysm repair but no long-term difference up to 6 years after repair. Longer follow-up may be required to demonstrate the cumulative negative impact on survival of higher reintervention rates associated with endovascular repair. Methods: We updated the results of the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial, a multicenter, randomized controlled trial comparing open with endovascular aneurysm repair, up to 15 years of follow-up. Survival and reinterventions were analyzed on an intention-to-treat basis. Causes of death and secondary interventions were compared by use of an events per person-year analysis. Results: There were 178 patients randomized to open and 173 to endovascular repair. Twelve years after randomization, the cumulative overall survival rates were 42.2% for open and 38.5% for endovascular repair, for a difference of 3.7 percentage points (95% confidence interval, -6.7 to 14.1; P = .48). The cumulative rates of freedom from reintervention were 78.9% for open repair and 62.2% for endovascular repair, for a difference of 16.7 percentage points (95% confidence interval, 5.8-27.6; P = .01). No differences were observed in causes of death. Cardiovascular and malignant disease account for the majority of deaths after prolonged follow-up. Conclusions: During 12 years of follow-up, there was no survival difference between patients who underwent open or endovascular abdominal aortic aneurysm repair, despite a continuously increasing number of reinterventions in the endovascular repair group. Endograft durability and the need for continued endograft surveillance remain key issues