1-year Patency Research Articles

ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.

To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities. This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA. The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186). The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial)

Several studies have compared primary endoscopic ultrasound (EUS)-guided biliary drainage to endoscopic retrograde cholangiopancreatography (ERCP) with insertion of metal stents in unresectable malignant distal biliary obstruction (MDBO) and the results were conflicting. The aim of the current study was to compare the outcomes of the procedures in a large-scale study. This was a multicenter international randomized controlled study. Consecutive patients admitted for obstructive jaundice due to unresectable MDBO were recruited. Patients were randomly allocated to receive EUS-guided choledocho-duodenostomy (ECDS) or ERCP for drainage. The primary outcome was the 1-year stent patency rate. Other outcomes included technical success, clinical success, adverse events, time to stent dysfunction, reintervention rates, and overall survival. Between January 2017 and February 2021, 155 patients were recruited (ECDS 79, ERCP 76). There were no significant differences in 1-year stent patency rates (ECDS 91.1% vs ERCP 88.1%, P= .52). The ECDS group had significantly higher technical success (ECDS 96.2% vs ERCP 76.3%, P < .001), whereas clinical success was similar (ECDS 93.7% vs ERCP 90.8%, P= .559). The median (interquartile range) procedural time was significantly shorter in the ECDS group (ECDS 10 [5.75-18] vs ERCP 25 [14-40] minutes, P < .001). The rate of 30-day adverse events (P= 1) and 30-day mortality (P= .53) were similar. Both procedures could be options for primary biliary drainage in unresectable MDBO. ECDS was associated with higher technical success and shorter procedural time then ERCP. Primary ECDS may be preferred when difficult ERCPs are anticipated. This study was registered to Clinicaltrials.gov NCT03000855.

Long-Term Outcomes of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique in Patients With Aorto-Iliac Occlusive Disease.

The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction is an endovascular technique, developed to reconstruct the aortic bifurcation in the most optimal anatomical and physiological manner. Short-term data were promising, but long-term data are still lacking. The objective was to report the long-term outcomes of CERAB for extensive aorto-iliac occlusive disease and to identify predictors for loss of primary patency. Consecutive electively treated patients with CERAB for aorto-iliac occlusive disease in a single hospital were identified and analyzed. Baseline and procedural data and follow-up were collected at 6-weeks, 6 months, 12 months, and annually thereafter. Technical success, procedural, and 30-day complications were evaluated, as well as overall survival. Patency and freedom from target lesion revascularization rates were analyzed using Kaplan Meier curves. Uni- and multivariate analysis were performed to identify possible predictors of failure. One hundred and sixty patients were included (79 male). Indication for treatment was intermittent claudication for 121 patients (75.6%) and 133 patients (83.1%) had a TASC-II D lesion. Technical success was obtained in 95.6% of patients and the 30-day mortality rate was 1.3%. The 5-year primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization (CD-TLR) rate of 84.4%. The strongest predictor of loss of primary patency of CERAB was a previous aorto-iliac intervention (odds ratio [OR]=5.36 (95% confidence interval [CI]: 1.30; 22.07), p=0.020). In patients not previously treated in the aorto-iliac tract, 5-year primary, primary assisted, and secondary patency rates were 85.1%, 94.4%, and 96.9%, respectively. At 5-year follow-up, an improved Rutherford was found in 97.9% of patients and the freedom from major amputation rate was 100%. The CERAB technique is related to good long-term outcomes, particularly in primary cases. In patients that had prior treatment for aorto-iliac occlusive disease, there were more reinterventions and therefore surveillance should likely be more intense. The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction was designed to improve outcomes of endovascular treatment of extensive aorto-iliac occlusive disease. At 5-year follow-up clinical improvement was found in 97.9% of patients without major amputations. The 5-year overall primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization rate of 84.4%. Significantly better patency rates were observed for patients that were never treated before in the target area. The data implicate that CERAB are a valid treatment option for patients with extensive aorto-iliac occlusive disease. For patients previously treated in the target area, other treatment options might be considered, or more intensive follow-up surveillance is warranted.

Fracking compared to conventional balloon angioplasty alone for calcified common femoral artery lesions using intravascular ultrasound analysis: 12-month results

BackgroundFracking is a novel technique to crack calcified lesions by hydraulic pressure. This study aimed to compare the performance of fracking and conventional balloon angioplasty without stenting for calcified common femoral artery (CFA) lesions using intravascular ultrasound (IVUS) analysis.MethodsThis retrospective, single-center, comparative observational study included 59 patients (67 limbs) with calcified CFA lesions treated with either fracking (n = 30) or balloon angioplasty (n = 29) between January 2018 and December 2020. The primary endpoint was 1-year primary patency. The secondary endpoints included procedure success, freedom from target lesion revascularization (TLR), procedure-related complications, and freedom from major adverse limb events (MALE). Predictors of restenosis were identified using multivariate Cox proportional hazards analysis.ResultsThe mean follow-up duration was 403 ± 236 days. The fracking group had significantly higher incidence of 1-year primary patency (89.8% versus 49.2%, P < 0.001), procedure success (96.9% versus 74.3%, P = 0.009), and freedom from TLR (93.5% versus 74.2%, P = 0.038) than the balloon group. The rate of freedom from MALE was significantly higher in the fracking group than in the balloon group (76.9% versus 48.6%, P = 0.033). The groups had no significant difference in procedure-related complications (6.2% versus 5.7%, P = 0.928). A larger postprocedural IVUS-estimated minimum lumen area (MLA) was associated with a lower risk of restenosis (hazard ratio, 0.78; 95% confidence interval, 0.67–0.91; P < 0.001), with a cut-off value of 16.0 mm2 determined using receiver operating characteristics curve analysis. The incidence of 1-year primary patency in patients with a postprocedural MLA ≥16.0 mm2 (n = 37) was significantly higher than that in those with a postprocedural MLA < 16.0 mm2 (n = 30) (87.8% versus 44.6%, P < 0.001).ConclusionThis study demonstrated the superior procedural efficacy of fracking compared to balloon angioplasty in treating calcified CFA lesions. The safety outcomes after fracking were comparable to those after balloon angioplasty. Large postprocedural MLA was an independent positive predictor of patency.

Stenting performs better than drug-coated balloon angioplasty in popliteal lesions

BackgroundPeripheral arterial disease (PAD) is a common and highly morbid disease. Although there have been recent advancements in the endovascular modalities to treat PAD, comparisons of these strategies, especially in the popliteal region, remain underinvestigated. The objective of this study was to compare midterm outcomes in patients with PAD undergoing treatment with both novel and SS compared with drug-coated balloon (DCB) angioplasty. MethodsAll patients at a multi-institution health system treated for PAD in the popliteal region from 2011 to 2019 were identified. Presenting features, operative details, and outcomes were included in the analysis. Patients who underwent popliteal revascularization with stents were compared with DCB. SS were compared separately with novel dedicated stents. Two-year primary patency was the primary outcome. ResultsWe included 408 patients (72.7 ± 11.8 years old; 57.1% men) in the analysis. There were 221 (54.7%) patients who underwent popliteal stenting and 187 (45.3%) who underwent popliteal DCB. There were high rates of tissue loss in both groups (57.9% vs 50.8%; P = .14). Stented patients had longer lesions (112.4 ± 3.2 vs 100.2 ± 5.8 mm; P = .03) and higher rates of concomitant superficial femoral artery treatment (88.2% vs 39.6%; P < .01). Chronic total occlusions accounted for the majority of lesions treated (stent 62.4%, DCB 64.2%). Perioperative complications were similar between groups. Primary patency for the stented group was higher at two years than the DCB group (61.0% vs 46.1%; P = .03). When evaluating stented patients only, SS had higher 2-year patency than novel stents in the popliteal segment (69.6% vs 51.4%; P = .04). On multivariable analysis, stenosis, as opposed to chronic total occlusion, was associated with improved patency (hazard ratio, 0.49; 95% confidence interval, 0.25-0.96; P = .04), whereas novel stents were associated with worse primary patency (hazard ratio, 2.01; 95% confidence interval, 1.09-3.73; P = .03). ConclusionsIn a population of patients with severe vascular disease, stents do not have inferior patency and limb salvage rates compared with DCB angioplasty when treating the popliteal region. For patients with advanced vascular disease, and especially tissue loss, stents and DCB are both beneficial when treating popliteal lesions.

Mid-term Renal and Mesenteric Artery Outcomes During Fenestrated and Branched Endovascular Aortic Repair for Complex Abdominal and Thoracoabdominal Aortic Aneurysms in The United States Aortic Research Consortium.

To report mid-term outcomes of renal-mesenteric target arteries (TA) after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysm (TAAAs). TA instability (TAI) is the most frequent indication for reintervention after FB-EVAR. Data from consecutive patients enrolled in nine prospective non-randomized physician-sponsored investigational device exemption (PS-IDE) studies between 2005 and 2020 were reviewed. TA outcomes through 5 years of follow-up were analyzed for vessels incorporated by fenestrations or directional branches (DBs), including TA patency, endoleak, integrity failure, reintervention, and instability. A total of 1,681 patients had 6349 renal-mesenteric arteries were targeted using 3720 fenestrations (59%), 2435 DBs (38%) and 194 scallops (3%). Mean follow was 23±21 months. At 5-years, TAs incorporated by fenestrations had higher primary (95±1% vs. 91±1%, P<0.001 ) and secondary patency (98±1% vs. 94±1%, P<0.001) , and higher freedom from TAI (87±2% vs. 84±2%, P=0.002) compared to TAs incorporated by DBs, with no differences in other TA events. DBs targeted by balloon-expandable stent-grafts (BESGs) had significantly lower freedom from TAI (78±4% vs. 88±1%, P=0.006 ), TA endoleak (87±3% vs. 97±1%, P<0.001 ), and TA reintervention (83±4% vs. 95±1%, P<0.00 1 ) compared to those targeted by self-expandable stent-grafts (SESGs). Incorporation of renal and mesenteric TA during FB-EVAR is safe and durable with high 5-year patency rates and low freedom from TAI. DBs have lower patency rates and lower freedom from TAI than fenestrations, with better performance for SESGs as compared to BESGs.

Stent Implantation and Thromboendarterectomy for the Common Femoral Artery in Real-World Practice.

To compare the outcomes of thromboendarterectomy (TEA) and endovascular therapy (EVT) with stenting for patients with atherosclerotic common femoral artery (CFA) occlusive disease. From a retrospective registry of 1193 consecutive patients with CFA treatment performed between 2018 and 2020 at 66 institutions in Japan, we identified patients who underwent TEA (n=432) or stent implantation (n=157). The primary outcome measures were the 1-year primary patency of TEA versus stenting with propensity score matching. The secondary outcome measures were perioperative complications, length of hospital stay, any reintervention, limb salvage, and overall survival. Interaction analysis for primary patency was performed with propensity score stratification to determine the appropriate target population for CFA stenting. Propensity score matching extracted 101 pairs (101 patients in the EVT group and 253 patients in the TEA group). The 1-year primary patency rate was significantly higher in the TEA cohort (92.8% vs 84.6%, p=0.006). The freedom from reintervention rate was also significantly higher in the TEA cohort (94.0% vs 89.9%, p=0.030). However, the 1-year limb salvage (98.7% vs 100.0%, p=0.32), 1-year overall survival (90.8% vs 85.0%, p=0.14), and frequency of perioperative complications were not significantly different between the cohorts (6.9% vs 14.2%, p=0.10). Based on interaction analysis, the superiority of TEA over EVT in terms of patency was less apparent in patients with advanced age and chronic heart failure. Thromboendarterectomy was superior to stenting in terms of primary patency and freedom from revascularization at 1 year. There was no significant difference in the incidence of perioperative complications between both groups. Thromboendarterectomy may be recommended as the standard treatment strategy for patients with atherosclerotic CFA disease, whereas stenting may be considered for patients with advanced age and chronic heart failure. Thromboendarterectomy compared to stenting was the preferred revascularization strategy for patients with CFA disease in terms of primary patency and freedom from target lesion revascularization during the 1st year. The difference was attenuated in subgroups with advanced age (85 years or older) or chronic heart failure, thus stenting may be considered in patients with these backgrounds.

Indications for a “Surgery-First” Approach for the Treatment of Lower Extremity Arterial Disease

In recent years, there has been a tendency towards an "endovascular-first" approach for the treatment for femoropopliteal arterial disease. The purpose of this study is to determine if there are patients that are better served with an initial femoral-popliteal bypass (FPB) rather than an endovascular attempt at revascularization. A retrospective analysis of all patients undergoing FPB between June 2006-December 2014 was performed. Our primary endpoint was primary graft patency, defined as patent using ultrasound or angiography without secondary intervention. Patients with <1-year follow-up were excluded. Univariate analysis of factors significant for five-year patency was performed using χ2 tests for binary variables. A binary logistic regression analysis incorporating all factors identified as significant by univariate analysis was used to identify independent risk factors for five-year patency. Event-free graft survival was evaluated using Kaplan-Meier models. We identified 241 patients undergoing FPB on 272 limbs. FPB indication was disabling claudication in 95 limbs, chronic limb-threatening ischemia (CLTI) in 148, and popliteal aneurysm in 29. In total, 134 FPB were saphenous vein grafts (SVG), 126 were prosthetic grafts, 8 were arm vein grafts, and 4 were cadaveric/xenografts. There were 97 bypasses with primary patency at five or more years follow-up. Grafts patent at five years by Kaplan-Meier analysis were more likely to have been performed for claudication or popliteal aneurysm (63% 5-year patency) as compared with CLTI (38%, P < 0.001). Statistically significant predictors (using log rank test) of patency over time were use of SVG (P = 0.015), surgical indication of claudication or popliteal aneurysm (P < 0.001), Caucasian race (P = 0.019) and no history of COPD (P = 0.026). Multivariable regression analysis confirmed these four factors as significant independent predictors of 5-year patency. Of note, there was no statistical correlation between FPB configuration (above or below knee anastomosis, in-situ vs reversed saphenous vein) and 5-year patency. There were 40 FPB in Caucasian patients without a history of COPD receiving SVG for claudication or popliteal aneurysm that had a 92% estimated 5-year patency by Kaplan-Meier survival analysis. Long-term primary patency that was substantial enough to consider open surgery as a first intervention was demonstrated in Caucasian patients without COPD, having good quality saphenous vein, and who underwent FPB for claudication or popliteal artery aneurysm.

Two-Stage Offers No Advantages over Single-Stage Arteriovenous Creation: An Analysis of Multicenter National Data

Traditionally, arteriovenous fistulas (AVF) involving the basilic vein (BV) have been created in 1 or 2 stages to allow time for the vein to enlarge before superficialization for potential better fistula maturation. Previous single institution studies and meta-analyses have found conflicting outcomes between single-stage and 2-stage procedures. Our study aims to use a large national database to assess the difference in outcomes between single-stage and 2-stage procedures for dialysis access. We studied all patients undergoing BV AVF creation in the Vascular Quality Initiative (VQI) from 2011 to 2021. Patients were split into single-stage or a planned 2-stage procedure for dialysis access. Primary outcomes included dialysis use with index fistula, maturity rate, and number of days from surgery to fistula use. Secondary outcomes included patency (defined by physical exam or imaging on follow-up), 30-day mortality, and postoperative complications (bleeding, steal syndrome, thrombosis, or neuropathy). Logistic regression models were used to assess the association between staged dialysis access procedures and primary outcomes of interest. The cohort consisted of 22,910 individuals of which 7,077 (30.9%) had a 2-staged dialysis access procedure and 15,833 (69.1%) had a single-staged procedure. Average follow-up was 345days in the single stage and 420days for 2-stage. Baseline characteristics were significantly different between the 2 groups in terms of medical comorbidities. Primary outcomes were significant for more patients in the 2-stage group undergoing dialysis with the index fistula compared to single stage (31.5% vs. 22.2%, P<0.0001), significant decrease in days to use in current dialysis patients (103.9days single stage versus 141.0days 2-stage, P<0.0001), and no difference in maturity at follow-up (19.3% single-stage and 17.4% 2-stage, P=0.354). Secondary outcomes revealed no difference in 30-day mortality or patency (89.8% single-stage and 89.1% 2-stage, P=0.383), but a significant difference in postoperative complications with a 2-stage procedure compared to 1-stage (1.6% vs. 1.1%, P=0.026). Finally, a spline model was used to determine that a preoperative vein of 3mm or less could be a cutoff in which a 2-stage procedure might be beneficial. This study demonstrates that when dialysis access fistulas are created using the BV, there is no difference in maturity rate or 1-year patency when assessing single-stage versus 2-stage procedures. However, 2-stage procedures significantly delay the time of first use of the fistula and increase postoperative complications. Therefore, we suggest performing single stage procedures when the vein is of appropriate diameter to minimize multiple procedures, complications and expedite time to maturity.

The Results of Femorofemoral Bypass Using a Saphenous Vein Graft as an Alternative to PTFE Grafts.

This study aimed to report the results of femorofemoral bypass (FFB) using a great saphenous vein (GSV) graft as an alternative to polytetrafluoroethylene (PTFE) grafts. From January 2012 to December 2021, 168 patients who underwent FFB (PTFE, 143; GSV, 25) were included. The patients' demographic features and surgical intervention results were retrospectively reviewed. There were no intergroup differences in patients' demographic features. In GSV vs. PTFE grafts, the superficial femoral artery provided statistically significant inflow and outflow (P<0.001 for both), and redo bypass was more common (P=0.021). The mean follow-up duration was 24.7±2.3 months. The primary patency rates at 3 and 5 years were 84% and 74% for PTFE grafts and 82% and 70% for GSV grafts, respectively. There was no significant intergroup difference in primary patency (P=0.661) or clinically driven target lesion revascularization (CD-TLR)-free survival (P=0.758). Clinical characteristics, disease details, and procedures were analyzed as risk factors for graft occlusion. Multivariate analysis revealed that none of the factors was associated with an increased risk of FFB graft occlusion. FFB using PTFE or GSV grafts is a useful method with an approximately 70% 5-year primary patency rate. The GSV and PTFE grafts showed no difference in primary patency or CD-TLR-free survival during follow-up; however, FFB using GSV may be an option in selective situations.

Impact of calcification on clinical outcomes after drug‐coated balloon angioplasty for superficial femoral artery disease: Assessment using the peripheral artery calcification scoring system

To investigate whether the severity of calcification assessed by the peripheral artery calcification scoring system (PACSS) was associated with clinical outcomes of drug-coated balloon (DCB) angioplasty for femoropopliteal lesions. We retrospectively analyzed 733 limbs with intermittent claudication of 626 patients, who underwent DCB angioplasty for de novo femoropopliteal lesions between January 2017 and February 2021 at sevencardiovascular centers in Japan. The patients were categorized using the PACSS classification (grades 0-4: no visible calcification of the target lesion, unilateral wall calcification < 5 cm, unilateral calcification ≥ 5 cm, bilateral wall calcification < 5 cm, and bilateral calcification ≥ 5 cm, respectively). The main outcome was primary patency at 1 year. The Cox proportional hazards analysis was used to explore whether the PACSS classification was an independent predictor of clinical outcomes. The distribution of PACSS was grade 0 in 38%, grade 1 in 17%, grade 2 in 7%, grade 3 in 16%, and grade 4 in 23%. The 1-year primary patency rates in these grades, respectively, were 88.2%, 89.3%, 71.9%, 96.5%, and 82.6%, respectively (p < 0.001). Multivariate analysis disclosed that PACSS grade 4 (hazard ratio: 1.82, 95% confidence interval 1.15-2.87, p = 0.010) was associated with restenosis. The PACSS grade 4 calcification was independently associated with poor clinical outcomes after DCB angioplasty for de novo femoropopliteal lesions.

Impact of Revascularization Technique on the Outcomes of Peripheral Graft Revision Procedures

The acute occlusion of a peripheral bypass graft leads to acute limb ischemia (ALI) and threatens the viability of the limb if left untreated. The aim of the present study was to analyze the results of surgical and hybrid revascularization techniques for patients with ALI due to peripheral graft occlusions. A retrospective analysis of 102 patients undergoing treatment for ALI due to peripheral graft occlusion between 2002 and 2021 was carried out at a tertiary vascular center. Procedures were classified as surgical when only surgical techniques were used and as hybrid when surgical procedures were combined with endovascular techniques such as balloon or stent angioplasty or thrombolysis. Endpoints were primary and secondary patency and amputation-free survival after 1 and 3years. Of all patients, 67 met the inclusion criteria, 41 were treated surgically and 26 by hybrid procedures. There were no significant differences in the 30-day patency rate, 30-day amputation rate, and 30-day mortality. The 1- and 3-year primary patency rates were 41.4% and 29.2% overall, respectively; 45% and 32.1% in the surgical group, respectively; and 33.2% and 26.6% in the hybrid group, respectively. The 1- and 3-year secondary patency rates were 54.1% and 35.8% overall, respectively; 52.5% and 34.2% in the surgical group, respectively; and 54.4% and 43.5% in the hybrid group, respectively. The 1- and 3-year amputation-free survival rates were 67.5% and 59.2%, overall, respectively; 67.3% and 67.3% in the surgical group, respectively; and 68.5% and 48.2% in the hybrid group, respectively. There were no significant differences between the surgical and the hybrid groups. The results of surgical and hybrid procedures after bypass thrombectomy for ALI to eliminate the cause of infrainguinal bypass occlusion are comparable with good midterm results in terms of amputation-free survival. New endovascular techniques and devices need to be established in comparison to the results of these proven surgical revascularization methods.

Three-Year Patency Results following Endovascular Transvenous Femoropopliteal Bypass

Background and Objectives: Peripheral artery disease is one of the most common vascular pathologies. There is an ongoing debate among specialists on whether open or endovascular revascularization is preferred in cases of complex superficial femoral artery (SFA) lesions. The purpose of this study was to assess patency results of a relatively new transvenous endovascular bypass device. This could add to existing evidence and aid in comparison between open and endovascular bypass. Materials and Methods: Patients with complex TASC-C and D SFA lesions who had indications for revascularization were identified. Prospective analysis of stent graft patency from 54 transvenous femoropopliteal bypass procedures was performed. Patency was assessed by Duplex ultrasound every six months. Kaplan-Meier analysis was performed to assess primary, primary-assisted, and secondary patency of transvenous bypass. Results: Following endovascular transvenous femoropopliteal bypass, 3-year graft primary, primary-assisted, and secondary patency was 43.8%, 66.3%, and 73.9%, respectively. Conclusions: Transvenous endovascular femoropopliteal bypass is a viable option for selected patients who lack adequate saphenous vein or have comorbidities that increase the risk of open femoropopliteal bypass. Strict post-operative follow-up is necessary to improve patency rates.

Association of Anticoagulation and Major Adverse Limb Events After Index Peripheral Endovascular Intervention

Dual-antiplatelet therapy is commonly prescribed after endovascular intervention for peripheral artery disease. However, it is not known whether therapeutic anticoagulation affects outcomes after peripheral endovascular intervention. We sought to investigate whether therapeutic anticoagulation after peripheral endovascular intervention is associated with lower risk of major adverse limb events (MALEs) and all-cause mortality. We studied patients who underwent index endovascular intervention for peripheral artery disease in the Vascular Study Group of New England (2010 to 2018). The main exposure was anticoagulation at the time of discharge. Outcomes included patency loss (occlusion or target lesion reintervention), MALE (any major amputation or reintervention), and all-cause mortality. We compared outcomes between patients who received anticoagulation on discharge versus those who did not receive anticoagulation using Kaplan-Meier survival analysis and Cox regression. In the cohort of 6,809 patients, 15% were discharged on an anticoagulant (mostly warfarin). These patients had a higher prevalence of acute or chronic limb ischemia than those not receiving an anticoagulant (74% vs 47%, p < 0.001) and were less likely to receive any antiplatelet agent after peripheral endovascular intervention (5% vs 14%, p < 0.001). After risk adjustment, compared with patients not on an anticoagulant, patients receiving therapeutic anticoagulation had a higher risk of 2-year patency loss (hazard ratio [HR] 1.41, 95% confidence interval [CI] 1.05 to 1.89), MALE (HR 1.39, 95% CI 1.09 to 1.76), and all-cause mortality (HR 1.24, 95% CI 1.05 to 1.47). In conclusion, anticoagulation after peripheral endovascular intervention was associated with higher risk of adverse events, including patency loss, MALE, and all-cause mortality.

Assessment of 3-Year Patency after Endoluminal versus Surgical Bypass Therapy for Complex Femoropopliteal Artery Disease

PurposeTo compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass for complex femoropopliteal (FP) arterial lesions. Materials and MethodsIn this retrospective multicenter study, 530 patients with symptomatic peripheral artery disease (Rutherford classification 1–3, 66.0%; 4–6, 34.0%) who underwent either endoluminal bypass with Viabahn stent grafts (n = 276) or surgical bypass (n = 254) (with saphenous vein grafts, 74.4%; prosthetic grafts, 25.6%) for FP arterial lesions between 2010 and 2018 were analyzed. The propensity score-matched analysis was performed to compare the 3-year clinical outcomes of endoluminal bypass with those of surgical bypass. The primary end point was primary patency (freedom from restenosis). The secondary end points were secondary patency, freedom from target lesion revascularization (TLR), limb salvage, and overall survival. The interaction effect of baseline characteristics on the association of the revascularization strategy with the risk of restenosis was analyzed using the Poisson mixed-effect model. ResultsThe propensity score-matched analysis extracted 107 pairs. After propensity score matching, the primary patency rate at 1, 2, and 3 years was 84.5%, 75.1%, and 70.9%, respectively, for the endoluminal bypass group versus 78.6%, 73.3%, and 72.0%, respectively, for the surgical bypass group (P = .65). There was no significant difference in secondary patency, freedom from TLR, limb salvage, and overall survival (all P > .05). The subsequent interaction analysis revealed that the involvement of popliteal lesions, small distal reference vessel diameters, and long lesions favored surgical bypass over endoluminal bypass because of improved primary patency (all P for interaction < .05). ConclusionsThe 3-year clinical outcomes after endoluminal bypass or surgical bypass for FP arterial lesions were similar.

Use of Endoscopic Vein Harvest Yields Improved Outcomes in Popliteal Artery Aneurysm Repair

There is growing literature showing that endoscopic vein harvest (EVH) is safe, with excellent patency rates and decreased wound complications when treating infrainguinal occlusive disease. Our institution has performed EVH since 2003 with a dedicated team of providers specializing in endoscopic vein harvest. The purpose of this study was to evaluate major outcomes of EVH as an adjunct to standard, open operative repair of popliteal artery aneurysms. We performed a 12-year retrospective single-institution chart review from January 2005 to December 2017, identifying all patients undergoing popliteal artery aneurysm repair with EVH. Primary outcomes were procedural technical success, operative time, wound complication, major morbidity, and freedom from amputation. A total 37 limbs (in 31 patients) received EVH popliteal artery aneurysm repair at an average age of 65.2±10years; 65% of the patients presented without symptoms or with claudication and 35% with rest pain or tissue loss. Coexisting aneurysm was present in 68% of patients: 49% had contralateral popliteal artery aneurysms and 19% had concurrent aortic aneurysms. Of 37 limbs, 33 (89%) were treated through a medial approach with aneurysm ligation, and 4 patients (11%) were treated through a posterior approach. The average vein size was 4.4±1.1mm, with 86% harvested by the ipsilateral great saphenous vein. Average operative time was 3.89±0.82hr, with a median hospitalization of 2days and a median of 1day of intravenous narcotics use. Only 2 patients (5.4%) had Szilagyi class-2 surgical site infections remedied with debridement and antibiotics. Kaplan-Meier data showed a 5-year primary patency of 82.3% and primary-assisted patency of 88.2%. Additionally, 30-day primary patency was 89.2% and primary-assisted patency of 97.3%. EVH for popliteal aneurysmal disease provides a safe and efficacious means of popliteal artery aneurysm repair with shorter hospitalization, lower wound complication rates, and excellent long-term patency compared to standard open technique.

Novel Scaffolds for the Treatment of Below-the-Knee Peripheral Arterial Disease With Chronic Limb Threatening Ischemia: A Review

Below-the-knee (BTK) peripheral arterial disease (PAD) is a significant source of cardiovascular morbidity and mortality. Patients with chronic limb-threatening ischaemia in BTK PAD represent one of the highest-risk cohorts of PAD patients, with little progress having been made regarding long-term patency and mortality over the past four decades. Although conventional balloon angioplasty has long been the standard of care, several novel scaffolds have been introduced over the past decade with promising 1-year patency rates and freedom from clinically driven target limb revascularisation, which may herald a new age of endovascular intervention for BTK PAD. In this review, we present a critical appraisal of the literature surrounding novel scaffolds and drug-eluting technology in the treatment of BTK PAD.

Balloon Bronchoplasty for the Treatment of Bronchial Stenosis After Lung Transplantation: A Single-Center 10-Year Experience.

To assess the safety and efficacy of balloon dilatation under dual guidance using fluoroscopy and bronchoscopy for treating bronchial stenosis following lung transplantation (LT), and to elucidate the factors associated with patency after the procedure. From September, 2012, to April, 2021, 50 patients (mean age ± standard deviation, 54.4 ± 12.2 years) with bronchial stenosis among 361 recipients of LT were retrospectively analyzed. The safety of balloon dilatation was assessed by evaluating procedure-related complications. Efficacy was assessed by evaluating the technical success, primary patency, and secondary patency. Primary and secondary cumulative patency rates were calculated using the Kaplan-Meier method. The factors associated with patency after the procedure were evaluated using multivariable Cox hazard proportional regression analysis. In total, 65 bronchi were treated with balloon dilatation in 50 patients. The total number of treatment sessions was 277 and the technical success rate was 99.3% (275/277 sessions). No major procedure-related complications were noted. During the mean follow-up period of 34.6 ± 30.8 months, primary patency was achieved in 12 of 65 bronchi (18.5%). However, the patency rate improved to 76.9% (50 of 65 bronchi) after repeated balloon dilatation (secondary patency). The 6-month, 1-year, 3-year, and 5-year secondary patency rates were 95.4%, 90.8%, 83.1%, and 78.5%, respectively. The presence of clinical symptoms was a significant prognostic factor associated with reduced primary patency (adjusted hazard ratio [HR], 0.465; 95% confidence interval [CI], 0.220-0.987). Early-stage treatment ≤ 6 months (adjusted HR, 3.588; 95% CI, 1.093-11.780) and prolonged balloon dilatation > 5 min (adjusted HR, 3.285; 95% CI, 1.018-10.598) were associated with significantly higher secondary patency. Repeated balloon dilatation was determined to be safe and effective for treating bronchial stenosis following LT. Early-stage treatment and prolonged balloon dilatation could significantly promote long-term patency.

An Observational Study on Clinical Profile and Management of Transatlantic Intersociety Consensus II C and D Aortoiliac and Femoropopliteal Occlusive Diseases: Role of Hybrid Procedures in Hybrid Operation Theater

Objective: Peripheral arterial disease is a powerful predictor of the loss of limb and even loss of life. Endovascular treatment (ET) and hybrid procedures are gradually replacing open procedures. The purpose of this study is to evaluate the management outcome of transatlantic intersociety consensus (TASC) C and D aortoiliac (AI) and femoropopliteal (FP) disease by various methods. Materials and Methods: Prospective observational study was done at Army Hospital (Research and Referral) Delhi Cantt from June 2015 to January 2017. Patients with TASC C and D AI and FP lesions were included. Patients were treated with either open, endovascular or hybrid technique and followed at 1, 3, and 6 months. Results: A total of 110 (36 AI and 74 FP) patients were included. 96.3% were smokers. Seventeen were TASC C and 93 were TASC D lesions. Fourteen out of 17 TASC C lesions could be managed by endovascular, two by hybrid and only one required open reconstruction. Whereas 58 out of 93 TASC D lesions needed to be opened, 15 were endovascular, and the rest 20 cases were managed by hybrid procedures. One had an iliac artery rupture managed with bypass graft. We have seven mortalities two within 30 days and five from 30 days to 1-year primary and secondary patency for ET was 72.4% and 80%, for open surgery was 76.2% and 93% and for hybrid procedure was 60% and 77.7%. Conclusions: Hybrid therapy simplifies and allows the one-step treatment with complex peripheral multifocal steno-obstructive vascular disease with high technical success rate and excellent long-term patency in few patients.

Outcomes of a bypass-first strategy in chronic limb-threatening ischemia based on the Global Vascular Guidelines.

The Global Vascular Guidelines (GVGs) recommend initial revascularization (bypass or endovascular therapy) for chronic limb-threatening ischemia (CLTI) based on anatomical complexity and limb severity. This decision is made based on a prediction of the outcomes after endovascular intervention. This study was performed to evaluate outcomes after distal bypass in cases recommended for GVG bypass. A total of 239 distal bypasses for CLTI were evaluated in 195 patients with a GVG bypass recommendation treated between 2009 and 2020 at a single center in Japan. Comparisons were made between crural and pedal bypass cases. The 195 patients (median age, 77years; 67% male) underwent 133 crural bypasses (106 patients; 54%) and 106 pedal bypasses (89 patients; 46%). Hemodialysis was more common in pedal cases than in crural cases (P= .03). Hospital deaths occurred in two cases (1%) within 30days. The whole cohort has a follow-up rate of 96% over a mean of 28± 26months, with 3-year limb salvage rates of 87% and 3-year primary, assisted primary, and secondary patency rates of 40%, 65%, and 67%, all without significant differences between crural and pedal cases. The 1-year wound healing rate was 88% and tended to be higher in crural cases than in pedal cases (P= .068). The 3-year survival rate was 52% in the cohort and did not differ significantly between crural and pedal cases. Patients with CLTI with a GVG bypass recommendation had acceptable limb salvage, graft patency, wound healing, and survival after distal bypass, regardless of the bypass method. These findings indicate that a GVG bypass recommendation as an initial revascularization method is valid in the real world.