The Human Acellular Vessel (HAV) as a vascular conduit for infrainguinal arterial bypass.
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ABSTRACT:
SUBMITTER: Farazdaghi A
PROVIDER: S-EPMC10477679 | biostudies-literature | 2023 Sep
REPOSITORIES: biostudies-literature
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The Human Acellular Vessel (HAV) as a vascular conduit for infrainguinal arterial bypass.
Farazdaghi Armin A Sen Indrani I Anderson Peter B PB Shuja Fahad F Rasmussen Todd E TE
Journal of vascular surgery cases and innovative techniques 20230323 3
Autologous vein is the optimal conduit for peripheral arterial bypass surgery, a standard recently highlighted by findings from the BEST-CLI trial. The Human Acellular Vessel is a novel biologic conduit produced using regenerative medicine technologies with structural and mechanical properties like a human blood vessel. Not yet approved by the United States Food and Drug Administration, the Human Acellular Vessel is being studied as an alternative bypass conduit in patients with peripheral arter ...[more]
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Project description:BackgroundVein conduit is known to have better patency than prosthetic for infrainguinal bypass. Here we explore if racial disparities exist in infrainguinal bypass vein conduit use amid preoperative patient and systemic factors.MethodsRetrospective Society for Vascular Surgery Vascular Quality Initiative data for 23,959 infrainguinal bypasses between 2003 and 2017 for occlusive disease were analyzed. For homogeneity, only infrainguinal bypasses originating from the common femoral artery were included. Demographics of patients receiving vein vs prosthetic were compared and logistic regression analyses were performed with race and preoperative factors to evaluate for predictors of vein conduit use.ResultsAdjusted regression models demonstrated black patients were 76% as likely (p < .001) and Hispanic patients 79% as likely (p = .003) to have vein conduit compared to white patients. Factors positively correlating with vein use included vein mapping, more distal bypass target, tissue loss or acute ischemia bypass indications, commercial insurance, and weight. Factors against vein use included advanced age, female gender, ASA class 4, urgent procedure, preoperative mobility limitation, prior CABG or leg bypass, prior smoking, preoperative anticoagulation, and a bypass performed in the Southern US or before 2012. While black and Hispanic patients were less likely to receive vein, they were vein mapped at similar or higher rates than other groups.ConclusionRacial disparities exist in conduit use for infrainguinal bypass, with black and Hispanic patients less likely to receive vein bypasses. However, the contribution of race to conduit selection is small in adjusted and unadjusted models. Overall, pre-operative variables in the Vascular Quality Initiative poorly predicted vein conduit use for infrainguinal bypass.
| S-EPMC8058596 | biostudies-literature
Project description:Arterial tissue-engineering techniques that have been reported previously typically involve long waiting times of several months while cells from the recipient are cultured to create the engineered vessel. In this study, we developed a different approach to arterial tissue engineering that can substantially reduce the waiting time for a graft. Tissue-engineered vessels (TEVs) were grown from banked porcine smooth muscle cells that were allogeneic to the intended recipient, using a biomimetic perfusion system. The engineered vessels were then decellularized, leaving behind the mechanically robust extracellular matrix of the graft wall. The acellular grafts were then seeded with cells that were derived from the intended recipient--either endothelial progenitor cells (EPC) or endothelial cell (EC)--on the graft lumen. TEV were then implanted as end-to-side grafts in the porcine carotid artery, which is a rigorous testbed due to its tendency for graft occlusion. The EPC- and EC-seeded TEV all remained patent for 30 d in this study, whereas the contralateral control vein grafts were patent in only 3/8 implants. Going along with the improved patency, the cell-seeded TEV demonstrated less neointimal hyperplasia and fewer proliferating cells than did the vein grafts. Proteins in the mammalian target of rapamycin signaling pathway tended to be decreased in TEV compared with vein grafts, implicating this pathway in the TEV's resistance to occlusion from intimal hyperplasia. These results indicate that a readily available, decellularized tissue-engineered vessel can be seeded with autologous endothelial progenitor cells to provide a biological vascular graft that resists both clotting and intimal hyperplasia. In addition, these results show that engineered connective tissues can be grown from banked cells, rendered acellular, and then used for tissue regeneration in vivo.
| S-EPMC3107282 | biostudies-literature
Project description:ObjectiveThe optimal initial revascularization strategy remains uncertain for patients with peripheral arterial disease. The purpose of this study was to evaluate current nationwide selection and perioperative outcomes of patients undergoing bypass or endovascular intervention for infrainguinal disease in those with no prior ipsilateral revascularization.MethodsPatients undergoing nonemergent first-time infrainguinal revascularization were identified in the Targeted Vascular module of the National Surgical Quality Improvement Program (NSQIP) for 2011 to 2014 and stratified by symptom status (chronic limb-threatening ischemia [CLTI] or claudication). Patients treated with endovascular intervention were compared with those who underwent bypass. Multivariable logistic regression was used to evaluate current selection of patients and to establish independent associations between first-time procedures and postoperative outcomes.ResultsOf 5998 first-time infrainguinal revascularizations performed, 3193 were bypass procedures (63% for CLTI) and 2805 were endovascular interventions (64% for CLTI). Current patient characteristics associated with an endovascular-first approach as opposed to bypass-first in CLTI patients were age ≥80 years, tissue loss, nonsmoking, functional dependence, diabetes, dialysis, and tibial lesions, whereas age ≥80 years, nonwhite race, nonsmoking, diabetes, and tibial lesions were associated with an endovascular approach for claudication. In comparing first-time endovascular intervention with bypass, there was no difference in 30-day mortality in CLTI patients (univariate: 2.1% vs 2.2%; adjusted: odds ratio [OR], 0.7; 95% confidence interval [CI], 0.4-1.1) or claudication patients (0.3% vs 0.6%). Among CLTI patients, endovascular-first intervention was associated with lower rates of major adverse cardiovascular event (3.6% vs 4.7%; OR, 0.6; 95% CI, 0.4-0.9), surgical site infection (0.9% vs 7.7%; OR, 0.1; 95% CI, 0.1-0.2), bleeding (8.5% vs 17%; OR, 0.4; 95% CI, 0.3-0.5), unplanned reoperation (13% vs 17%; OR, 0.7; 95% CI, 0.5-0.8), and unplanned readmission (17% vs 18%; OR, 0.8; 95% CI, 0.7-0.9). Patients with claudication undergoing endovascular-first intervention also had lower rates of major adverse cardiovascular event (0.8% vs 1.6%; OR, 0.4; 95% CI, 0.2-0.95), surgical site infection (0.7% vs 6.6%; OR, 0.1; 95% CI, 0.04-0.2), bleeding (2.3% vs 6.0%; OR, 0.3; 95% CI, 0.2-0.5), unplanned reoperation (4.3% vs 6.6%; OR, 0.6; 95% CI, 0.4-0.9), and unplanned readmission (5.9% vs 9.0%; OR, 0.6; 95% CI, 0.4-0.8). Conversely, endovascular-first intervention was associated with a higher rate of secondary revascularizations within 30 days for CLTI (4.3% vs 3.1%; OR, 1.6; 95% CI, 1.04-2.3) but not for claudication (2.6% vs 1.9%; OR, 1.7; 95% CI, 0.9-3.4).ConclusionsAn endovascular-first approach as a revascularization strategy for infrainguinal disease was associated with substantially lower early morbidity but not mortality, at the cost of higher rates of postoperative secondary revascularizations. As a national representation of first-time revascularizations, this study highlights the early endovascular perioperative benefit, although more robust long-term data are needed to adopt either one strategy or the other in select patients with peripheral arterial disease.
| S-EPMC5741492 | biostudies-literature
Project description:(1) Background: High-level evidence on antithrombotic therapy after infrainguinal arterial bypass surgery in specific clinical scenarios is lacking. (2) Methods: A modified Delphi procedure was used to develop consensus statements. Experts voted on antithrombotic treatment regimens for three types of infrainguinal arterial bypass procedures: above-the-knee popliteal artery; below-the-knee popliteal artery; and distal, using vein, prosthetic, or biological grafts. The treatment regimens for these nine procedures were then voted on in three clinical scenarios: isolated PAOD, atrial fibrillation, and recent coronary intervention. (3) Results: The survey was conducted with 28 experts from 15 European countries, resulting in consensus statements on 25/27 scenarios. Experts recommended single antiplatelet therapy after above-the-knee popliteal artery bypasses regardless of the graft material used. For below-the-knee popliteal artery bypasses, experts suggested combining single antiplatelet therapy with low-dose rivaroxaban if the graft material used was autologous or biological. They did not recommend switching to triple therapy for patients on oral anticoagulants for atrial fibrillation or dual antiplatelet therapy in any scenario. (4) Conclusions: Great inconsistency in the antithrombotic therapy administered was found in this study. This consensus offers guidance for scenarios that are not covered in the current ESVS guidelines but must be interpreted within its limitations.
| S-EPMC10178874 | biostudies-literature
Project description:ObjectiveTherapeutic anticoagulation (AC) is used clinically for prolongation of infrainguinal bypass patency, but evidence for the efficacy of this practice is conflicting. The objective of our study was to determine the association of AC with bypass graft primary patency.MethodsClinical and comorbid data of patients undergoing infrainguinal bypass grafts to a below-knee target with at least 1 year of follow-up performed from 2003 to 2015 were obtained from the Society for Vascular Surgery Vascular Quality Initiative. Inverse propensity of treatment-weighted Cox regression was used to assess the effect of AC on patency in the total cohort while adjusting for clinical, operative, and comorbid differences between treatment groups. Subgroup analyses of distal targets and conduit type were performed. Perioperative complications were analyzed using propensity-weighted logistic regression.ResultsWe identified 7612 bypass grafts with intact 1-year follow-up information from 2003 to 2015. The mean age was 67.5 ± 11.2 years; 30.5% (n = 2320) were female, and 28.6% (n = 2165) were discharged on therapeutic AC. The anticoagulated group had a higher rate of tibial, ankle, and pedal targets (52.1% [n = 1127] vs 47.6% [n = 2269]; P < .001), had a greater use of non-single-segment vein conduits (44.3% [n = 951] vs 26.5% [n = 1426]; P < .001), and was more likely to have had a previous ipsilateral bypass (27.2% [n = 589] vs 14.7% [n = 794]; P < .001) or stent (25.4% [n = 550] vs 20.9% [n = 1130]; P < .001). Estimated unadjusted primary patency was 70.8% ± 0.6% at 1 year and lower for anticoagulated bypasses (66.9% ± 1.2% vs 72.4% ± 0.7%; P < .001). Propensity-weighted analysis showed no significant association of AC with primary patency in the overall cohort (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.86-1.11; P = .8) but demonstrated a trend toward improvement of primary patency in those with a non-single-segment vein conduit to a below-knee popliteal target (HR, 0.85; 95% CI, 0.80-1.02; P = .09). AC was associated with significantly improved secondary patency in those with prosthetic bypass grafts (HR, 0.77; 95% CI, 0.62-0.96; P = .02) or prosthetic bypasses to an infrapopliteal target (HR, 0.72; 95% CI, 0.54-0.97; P = .02). Odds of postoperative wound complications were significantly higher in those receiving AC (odds ratio, 1.33; 95% CI, 1.11-1.61; P = .002).ConclusionsThis study does not demonstrate a significant impact of therapeutic AC on primary patency for infrainguinal bypass grafts. Treatment with AC may benefit secondary patency in those with a prosthetic bypass, especially to an infrapopliteal target, but at an increased risk of postoperative wound complications.
| S-EPMC5524600 | biostudies-literature
Project description:Symptomatic peripheral arterial disease management involves medical treatment and interventional procedures. Intermittent claudication and critical limb threatened ischemia (CLTI) should be individually considered with specific outcomes and procedures. When intervention is required, an endovascular approach is usually the first-line option. Plain balloon angioplasty was previously used to dilate clinically significant femoropopliteal lesions with variable results. However, over recent years, the use of self-expanding nitinol stents has enabled treatment of long lesions, yielding significantly improved clinical results. Drug-eluting technology has also exhibited a capacity to limit in-stent restenosis and to drive target revascularization. Nevertheless, calcifications and elastic recoil of the arterial wall remain risk factors for early restenosis and failure. Therefore, vessel preparation using specific devices is required to modify vessel compliance and debulk obstructive calcification. In this short review, we provide an overview of the options for gaining lumen before stenting or dilation using drug-coated balloons.
| S-EPMC7539040 | biostudies-literature
Project description:ObjectivesTo evaluate the efficacy of percutaneous aspiration thrombectomy (PAT) for infrainguinal arterial thromboembolism in patients undergoing endovascular recanalization (EVR) and to investigate the predictors for thromboembolic complications.Materials and methodsIn total, 23 patients (23 limbs) who underwent PAT for thromboembolism (PAT group, PG) during EVR and 237 patients (302 limbs) who underwent successful EVR without thromboembolic complications (control group, CG) were enrolled. Immediate post-operation and follow-up outcomes were compared between the two groups. Multivariate analysis was performed to identify the predictors of thromboembolic complications. Technical success of PAT was defined as achievement of <30% residual stenosis and restoration of mTIMI grade 3.ResultsThe technical success rate was 95.7% in PG. After intervention, the ankle-brachial index (ABI), restoration of blood flow and improvement in dorsal/plantar arterial pulse score showed no significant differences between PG and CG. During follow-up in PG, a sustained ABI improvement was observed in 63.6% (70.9% in CG), an improvement in walking distance in 68.8% (79.9% in CG,), ulcer healing in 75.0% (71.7% in CG) and restenosis/occlusion in 31.8% (25.2% in CG). The limb salvage rate was 100% in PG (96.0% in CG), and pain relief was observed in 66.7% patients with critical limb ischaemia (81.6% in CG). Superficial femoral artery involvement [0.233; 95% confidence interval (CI), 0.108-0.461; P < 0.001], de-novo lesion occlusion (683.8; 95% CI, 36.5-12804.6; P < 0.001) and intraluminal angioplasty (118.4; 95% CI, 8.0-1758.0; P = 0.001) was associated with high incidence of thromboembolism.ConclusionPAT is a safe and effective treatment for thromboembolism during infrainguinal arterial EVR. SFA involvement, de-novo lesion occlusion and intraluminal angioplasty may be predictors of thromboembolic complications.
| S-EPMC4618847 | biostudies-literature
Project description:BackgroundVascular calcification is a predictor of poor clinical outcome during and after endovascular intervention. Guidewire crossing techniques and devices have been developed, but chronic total occlusions (CTOs) with severe calcification often prevent subintimal re-entry. We propose a novel guidewire crossing approach combined needle rendezvous with balloon snare technique, named the "needle re-entry" technique, for treatment of complex occlusive lesions.Main textA 73-year-old female with severe claudication in her right calf with ankle brachial index of 0.62, and a computed tomography angiogram showed a long occlusion with diffuse calcification in superficial femoral artery. She was referred to our department to have peripheral interventions. Since the calcified vascular wall of the lesion prevented the successful re-entry, the "needle re-entry" was performed. First, a retrograde puncture of the SFA, distally to the occlusion, was performed and an 0.018-in. guidewire with a microcatheter was inserted to establish a retrograde fashion. Second, an antegrade 5.0-mm balloon was advanced into a subintimal plane and balloon dilation at 6 atm was maintained. Third, an 18-gauge needle was antegradely inserted from distal thigh to the dilated 5.0-mm balloon. After confirming a balloon rupture by the needle penetration, we continued to insert the needle to meet the retrograde guidewire tip. Then, a retrograde 0.014-in. guidewire was carefully advanced into the needle hole, named the "needle rendezvous" technique. After further guidewire advancement to accomplish a guidewire externalization, the needle was removed. Finally, since the guidewire was passing through the 5.0-mm ruptured balloon, the balloon was withdrawn, and the guidewire was caught with the balloon and successfully advanced into the antegrade subintimal space, named the "balloon snare" technique. After the guidewire was advanced into the antegrade guiding sheath and achieved a guidewire externalization, an endovascular stent graft and an interwoven stent were deployed to cover the lesion. After postballoon dilation, an angiography showed a satisfactory result without complications. No restenosis, reintervention, and limb loss have been observed for one year follow-up period after this technique.ConclusionsThe "needle re-entry" technique is a useful guidewire crossing technique to revascularize femoropopliteal complex CTOs with severe calcification which prevent the achievement of guidewire crossing with the conventional procedures.
| S-EPMC8665915 | biostudies-literature
Project description:ObjectiveAlthough an increasing number of patients with peripheral arterial disease undergo multiple revascularization procedures, the effect of prior interventions on outcomes remains unclear. The purpose of this study was to evaluate perioperative outcomes of bypass surgery in patients with and those without prior ipsilateral treatment.MethodsPatients undergoing nonemergent infrainguinal bypass between 2011 and 2014 were identified in the National Surgical Quality Improvement Program Targeted Vascular module. After stratification by symptom status (chronic limb-threatening ischemia [CLTI] and claudication), patients undergoing primary bypass were compared with those undergoing secondary bypass. Within the secondary bypass group, further analysis compared prior bypass with prior endovascular intervention. Multivariable logistic regression analysis was used to establish the independent association between prior ipsilateral procedure and perioperative outcomes.ResultsA total of 7302 patients were identified, of which 4540 (62%) underwent primary bypass (68% for CLTI), 1536 (21%) underwent secondary bypass after a previous bypass (75% for CLTI), and 1226 (17%) underwent secondary bypass after a previous endovascular intervention (72% for CLTI). Prior revascularization on the same ipsilateral arteries was associated with increased 30-day major adverse limb event in patients with CLTI (9.8% vs 7.4%; odds ratio [OR], 1.4 [95% confidence interval (CI), 1.1-1.7]) and claudication (5.2% vs 2.5%; OR, 2.1 [95% CI, 1.3-3.5]). Similarly, secondary bypass was an independent risk factor for 30-day major reintervention (CLTI: OR, 1.4 [95% CI, 1.1-1.8]; claudication: OR, 2.1 [95% CI, 1.3-3.5]), bleeding (CLTI: OR, 1.4 [95% CI, 1.2-1.6]; claudication: OR, 1.7 [95% CI, 1.3-2.4]), and unplanned reoperation (CLTI: OR, 1.2 [95% CI, 1.0-1.4]; claudication: OR, 1.6 [95% CI, 1.1-2.1]), whereas major amputation was increased in CLTI patients only (OR, 1.3 [95% CI, 1.01-1.8]). Postoperative mortality was not significantly different in patients undergoing secondary compared with primary bypass (CLTI: 1.7% vs 2.2% [P = .22]; claudication: 0.4% vs 0.6% [P = .76]). Among secondary bypass patients with CLTI, those with prior bypass had higher 30-day reintervention rates (7.8% vs 4.9%; OR, 1.5 [95% CI, 1.0-2.2]) but fewer wound infections (7.3% vs 12%; OR, 0.6 [95% CI, 0.4-0.8]) compared with patients with prior endovascular intervention.ConclusionsPrior revascularization, in both patients with CLTI and patients with claudication, is associated with worse perioperative outcomes compared with primary bypass. Furthermore, prior endovascular intervention is associated with increased wound infections, whereas those with prior bypass had higher reintervention rates. The increasing prevalence of patients undergoing multiple interventions stresses the importance of the selection of patients for initial treatment and should be factored into subsequent revascularization options in an effort to decrease adverse events.
| S-EPMC5403541 | biostudies-literature
Project description:BackgroundLower extremity artery disease is increasingly prevalent, and complex lesions such as calcified chronic total occlusions pose significant challenges during endovascular therapy. The needle rendezvous technique, which involves puncturing a needle toward the guidewire within the lesion or lumen and advancing the guidewire into the needle lumen to achieve guidewire externalization, offers a potential solution. If device passage remains challenging, the Rendezvous-PIERCE technique can be subsequently employed by advancing the needle over the externalized guidewire to modify the lesion directly. This study aimed to evaluate the procedural outcomes of needle rendezvous in infrainguinal arterial occlusive lesions.MethodsThis single-center, retrospective, single-arm study included patients treated with needle rendezvous between August 2020 and March 2024. The primary outcome was technical success rate, defined as the device passage following guidewire externalization using needle rendezvous. Secondary outcomes included the rates of procedural success, complications, and 30-day clinical-driven target lesion revascularization (CDTLR).ResultsTwenty-five patients (25 limbs) with 52% on hemodialysis and 80% having chronic limb-threatening ischemia in 52% and 80% were enrolled. All cases involved bilateral calcified occlusions, and 72% targeted the infrapopliteal artery segment. The average needle rendezvous time was 3.7 ± 2.0 min. Rendezvous-PIERCE was performed in 28% of cases. All cases achieved 100% technical and procedural success, with no procedure-related complications. The 30-day CDTLR rate was 8%, limited to below-the-knee lesions.ConclusionsNeedle rendezvous is a safe and effective technique for treating complex infrainguinal arterial occlusions, providing a viable alternative when conventional methods fail.
| S-EPMC11522230 | biostudies-literature