Long-term outcomes of below-the-knee bypass surgery using heparin-bonded expanded polytetrafluoroethylene grafts.

PURPOSE: To report the outcomes of below-the-knee (BK) bypass surgery using heparin-bonded expanded polytetrafluoroethylene (ePTFE) grafts, performed in two centers since its launch in Japan. METHODS: We conducted a retrospective analysis of databases from two medical centers, evaluating 51 limbs in 42 consecutive patients with peripheral arterial disease (PAD), who underwent BK bypass surgery using heparin-bonded ePTFE grafts between October, 2013 and April, 2023. RESULTS: Thirty-three limbs (64.7%) were classified as Rutherford category 4-6 and 33 limbs (64.7%) had a history of ipsilateral revascularization. Technical success was achieved in 98% of the patients. The 30 day mortality rate was 2.4% (n = 1) and the overall 30 day complication rate was 9.5% (n = 4). The median follow-up period was 38 (interquartile range 13-67) months. Three patients required major amputation and 14 died during follow-up. Primary patency rates at 1, 3, and 5 years were 67.8%, 57.5%, and 46.5%, respectively, while secondary patency rates for these periods were 84.6%, 70.0%, and 66.0%, respectively. Overall survival rates at 1, 3, and 5 years were 90.1%, 74.5%, and 70.9%, respectively. CONCLUSIONS: BK bypass surgery using heparin-bonded ePTFE graft is a viable and durable option for patients with PAD, who are deemed unsuitable for autologous vein bypass surgery.

Early Clinical Results From the Japanese Prospective Multicenter Study to Evaluate Zenith Alpha Abdominal Stent Graft for Abdominal Aortic Aneurysm (JUSTICE) Registry Demonstrate Acceptable Limb Patency at 12 Months.

PURPOSE: Recent reports of the Zenith Alpha abdominal endovascular graft (Zenith Alpha AAA, Cook, Inc., Bloomington, Indiana) have demonstrated an unexpectedly high incidence of limb graft occlusion (LGO). The purpose of this study was to prospectively evaluate the performance of the Zenith AAA in Japan, with a specific focus on LGO. MATERIALS AND METHODS: All endovascular aneurysm repairs (EVARs) for abdominal aortic aneurysms performed using the Zenith Alpha AAA from July 2020 to October 2021 in 23 Japanese hospitals were prospectively evaluated. All computed tomographic images were analyzed in the core laboratory. Late complications were defined as any aneurysm-related events occurring >30 days after EVAR, including aneurysm sac enlargement of >5 mm and any reinterventions performed. Endoleaks without sac enlargement or reintervention were excluded as late complications. RESULTS: During the study period, 147 EVARs were performed using the Zenith Alpha AAA. The mean patient age was 76.5±7.7 years, 84.4% of patients were male, and the mean aneurysm diameter was 52.4±9.2 mm. Instruction-for-use violations were observed in 76 patients (51.7%), primarily associated with a severely angulated proximal neck (>60°). There were six intraoperative complications and 62 additional intraoperative treatments reported, most of which involved preemptive coil embolization of the inferior mesenteric artery (37 cases). Technical success, defined as the absence of type 1 or 3 endoleaks on final angiography, was achieved in 99.3% of patients. At 12 months, there was only one case of type 1/3 endoleak (0.8%) and one aneurysm sac enlargement exceeding 5 mm (0.8%); however, a high incidence of type 2 endoleaks was observed in 35.2% of patients, and aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients. Nine late complications were observed, and the rate of freedom from late complications at 12 months was 93.5%, encompassing four LGOs and one limb graft stenosis (3.4%). CONCLUSIONS: In contrast to recent reports, our Japanese multicenter prospective study demonstrated satisfactory early clinical results, including an acceptable LGO rate, for the low-profile Zenith Alpha AAA. Long-term follow-ups will be performed to confirm the persistence of these outcomes. CLINICAL IMPACT: This study prospectively evaluated the performance of 147 Zenith Alpha AAAs used for endovascular aneurysm repair with core-lab adjudication focusing especially on limb graft occlusion (LGO). At 12 months, aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients, and there was only one type 1/3 endoleak, one aneurysm sac enlargement (>5 mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg." 5mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg.

Long-Term Outcomes of a Japanese Prospective Multicenter Registry Using a Heparin-Bonded Expanded Polytetrafluoroethylene Graft for Above-the-Knee Femoropopliteal Bypasses.

BACKGROUND: Despite the widespread use of PROPATEN®, a bioactive heparin-bonded expanded polytetrafluoroethylene graft, in bypass surgery, there are only a few reports of long-term results. We evaluated the long-term results of PROPATEN®use for above-knee femoropopliteal bypass (AKFPB).Methods and Results: After PROPATEN®-based AKFPB, patients were prospectively registered at 20 Japanese institutions between July 2014 and October 2017 to evaluate long-term results. During the median follow-up of 76 months (interquartile range 36-88 months) for 120 limbs (in 113 patients; mean [±SD] age 72.7±8.1 years; 66.7% male; ankle-brachial index [ABI] 0.45±0.27; lesion length 26.2±5.7 cm; chronic limb-threatening ischemia in 45 limbs), there were 8 major amputations; however, clinical improvement was sustained (mean [±SD] ABI 0.87±0.23) and the Rutherford classification grade improved in 105 (87.5%) limbs at the latest follow-up. At 8 years, the primary patency, freedom from target-lesion revascularization, secondary patency, survival, and amputation-free survival, as estimated by the Kaplan-Meier method, were 66.3±4.8%, 71.5±4.4%, 86.5±3.4%, 53.1±5.0%, and 47.4±5.3%, respectively. CONCLUSIONS: This multicenter prospective registry-based analysis showed sustained excellent clinical improvement and secondary patency for up to 8 years following PROPATEN®-based AKFPB. PROPATEN®constitutes a durable and good revascularization option for complex superficial femoral artery lesions, especially when endovascular treatment is inappropriate or an adequate venous conduit is unavailable.

Use of Recombinant Human Soluble Thrombomodulin in a Patient with Disseminated Intravascular Coagulation Associated with Abdominal Aortic Aneurysm: A Case Report.

We herein present a case involving an 86-year-old man with abdominal aortic aneurysm complicated by symptomatic disseminated intravascular coagulation (DIC). The patient received preoperative treatment for DIC using recombinant human soluble thrombomodulin (rTM) followed by open surgical repair of the aneurysm. The patient's coagulopathy cleared quickly after the start of rTM, and the intraoperative and postoperative course went smoothly. The patient was followed without anticoagulant medication, and there was no recurrence of DIC during 14 months of follow-up. The preoperative administration of rTM can be a useful choice to assist safe treatment of aortic aneurysm complicated by aneurysm-related DIC.

Outcomes of Femoral Endarterectomy with Superficial Tributary Vein Patch Angioplasty.

BACKGROUND: Surgical endarterectomy is still considered the gold standard for the treatment of common femoral artery (CFA) occlusive disease. The present study evaluated the outcomes of CFA endarterectomy with patch angioplasty using the superficial tributary vein (STV) of the great saphenous vein. METHODS: This was a single-center, retrospective study. We reviewed our institutional data of consecutive patients who received elective CFA endarterectomy between January 2014 and December 2021. RESULTS: During the study period, CFA endarterectomy with STV patch angioplasty was performed in 49 limbs in 42 patients, including 33 limbs (67.3%) treated by hybrid procedure combining CFA endarterectomy with endovascular treatment. Technical success was achieved in 100% of subjects. The median ankle brachial pressure index improved from 0.57 (0.43-0.67) preoperatively to 0.96 (0.77-0.99) postoperatively (P < 0.001). The 30-day mortality rate was 2.0% (n = 1). The overall 30-day complication rate was 6.1% (n = 3) and the local complication rate was 2.0% (n = 1). No aneurysmal dilatation or rupture of an STV patch was observed at a median follow-up of 22 months. The 1-year and 2-year primary patency rates were 97.4% and 97.4%, respectively. CONCLUSIONS: The efficacy and patency of CFA endarterectomy with STV patch angioplasty were similar to those of conventional CFA endarterectomy. STV patch angioplasty is a durable procedure and may improve the outcomes of CFA endarterectomy through a reduction in the risk of postoperative local complications by avoiding the use of a prosthetic patch and by preserving the main great saphenous vein.

Total Arch Debranching Thoracic Endovascular Aortic Repair Using Femoral Artery Inflow.

Some patients with aortic arch aneurysm are ineligible for open repair because of excessive perioperative risk, and others may not be suited for total endovascular repair due to anatomic constraints. We herein report a case of aortic arch aneurysm in a 94-year-old woman. The patient underwent hybrid aortic arch repair consisting of total arch debranching using bilateral femoral artery inflow and thoracic endovascular aortic repair. The patient was discharged without complications and is in good condition with dependent ambulation at 14 months of follow-up. Although a careful selection of cases is highly recommended, the use of the femoral artery inflow for arch debranching is considered to be a viable rescue option for high-risk patients.

Drug Eluting Versus Covered Stent for Femoropopliteal Artery Lesions: Results of the ULTIMATE Study.

OBJECTIVE: Stent grafts (SG) and drug eluting stents (DES) have emerged to combat intimal hyperplasia. It remains unclear which type of stent yields superior outcomes in femoropopliteal (FP) arterial lesions. This study compared the clinical data between the VIABAHN SG and the Eluvia DES two years after endovascular treatment. METHODS: In this retrospective multicentre study, 504 cases with a lesion length > 10 cm treated either with SG or DES were analysed. Ankle brachial index (ABI) measurements were conducted before and after the endovascular procedure, and every three months thereafter. When the ABI dropped ≥ 0.15 compared with the baseline value, a duplex ultrasound was conducted to check stent patency. The outcome measures were stent patency rates, freedom from target lesion revascularisation (TLR), stent thrombosis, and acute limb ischaemia (ALI) accompanying loss of patency rates. Propensity score matching (PSM) was performed to adjust for confounding baseline characteristics. RESULTS: PSM extracted 219 limbs in the SG group and 109 limbs in the DES group. Compared with the SG group, the DES group had statistically significantly higher rates of freedom from TLR (86.0 ± 4.2% vs. 73.1 ± 4.8%, p = .040), and ALI accompanying loss of patency (98.9 ± 1.1% vs. 93.5 ± 1.8%, p = .029) at two years. Primary patency (75.9 ± 5.9% vs. 69.5 ± 5.9%, p = .087) and freedom from stent thrombosis (90.4 ± 3.3% vs. 81.2% ± 3.0%, p = .11) were not statistically significantly different. For lesions ≤ 15 cm, primary patency in the DES group was statistically significantly better than the SG group. CONCLUSION: FP lesions treated with Eluvia DES had a higher primary patency rate in lesions ≤ 15 cm, freedom from clinically driven TLR and ALI accompanying loss of patency than the VIABAHN SG.

Effects of Suprarenal Aortic Cross-Clamping and Adjunctive Renal Reconstruction on Outcomes of Open Abdominal Aortic Aneurysm Repair.

PURPOSE: To analyze our contemporary experience in open abdominal aortic aneurysm (AAA) repair. We focused on the effects of suprarenal (SR) aortic cross-clamping and adjunctive renal reconstruction (RR) on postoperative outcomes. METHODS: We retrospectively reviewed our institutional data of 141 consecutive patients who received elective open AAA repair between January 2014 and December 2020. RESULTS: Seventy-five procedures were performed with SR aortic cross-clamping, 20 of which required an adjunctive RR. Patients in the SR group had a higher incidence of postoperative acute kidney injury (AKI) (18.7% vs. 7.6%, P = 0.045). There were no significant between-group differences in other major complications. The 30-day mortality rate in the infrarenal (IR) and SR groups was 0% and 1.3%, respectively. After a median follow-up of 33 months, the rates of chronic renal decline in the IR (18.2%) and SR (21.3%) groups were similar. All reconstructed renal arteries were patent without reintervention. The 5-year overall survival rate in the IR and SR groups was 88.8% and 83.2%, respectively. CONCLUSIONS: SR aortic cross-clamping was associated with postoperative AKI but neither SR aortic cross-clamping nor RR affected the long-term renal function or mortality. Open repair remains an essential option for patients with AAA, especially those with complex anatomy.

Use of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Renal Artery Reconstruction.

BACKGROUND: The purpose of this study was to analyze our initial experience in renal artery reconstruction with heparin-bonded expanded polytetrafluoroethylene (ePTFE) grafts. METHODS: The authors retrospectively reviewed the data of consecutive patients who received open renal reconstruction with a heparin-bonded ePTFE graft at our institution between January 2014 and December 2019. RESULTS: A total of 22 renal reconstructions with a heparin-bonded ePTFE graft were performed in 17 consecutive patients. In all cases, renal reconstruction was a concomitant procedure during surgical or endovascular aortic procedures. Postoperative complications within 30 days were observed in 9 (53%) patients, including acute kidney injury (n = 6), pneumonia (n = 1), retrograde type B aortic dissection (n = 1), and lower limb ischemia (n = 1). The 30-day mortality rate was 0%. In a median follow-up period of 32 (19-39) months, all grafts were patent without re-intervention. Six patients with preoperative stage 2 chronic kidney disease progressed to stage 3 during follow-up. No patient required temporary or permanent hemodialysis. One patient died from intestinal ischemia at 23 months after surgery. CONCLUSIONS: This study showed that the patency after open renal reconstruction with a heparin-bonded ePTFE graft was excellent, with acceptable renal outcomes, and demonstrates its safety as a concomitant procedure during an aortic procedure. Heparin-bonded ePTFE grafts are a feasible and effective choice for open renal reconstruction in contemporary practice.

Calciphylaxis After Aortic Valve Replacement in a Patient with End-Stage Renal Disease.

In this study, we report a case of a patient on dialysis who presented necrotic lesions on the legs and penile ulceration 7 years after a mechanical aortic valve replacement. The diagnosis of calciphylaxis was not confirmed even after skin biopsy, and multidisciplinary management was not initiated until the patient was admitted with septic shock. Cardiovascular surgeons should be aware of warfarin-induced calciphylaxis, whose pathophysiology differs from that of atherosclerosis. Considering poor long-term survival of dialysis patients, mechanical valves should be reserved only for those patients whose estimated survival is longer than the time taken for a biological valve to deteriorate.

Endovascular coil embolization of a large tibioperoneal trunk pseudoaneurysm.

Infrapopliteal artery aneurysms are rare, and tibioperoneal trunk aneurysms are even rarer. We herein report an unusual case of large tibioperoneal trunk pseudoaneurysm. The patient underwent successful endovascular exclusion of the pseudoaneurysm by coil embolization with stent assistance. The clinical features and management of tibioperoneal trunk aneurysms are also discussed in this article.

Two-Year Results of a Multicenter Prospective Observational Study of the Zenith Spiral-Z Limb Deployed in the External Iliac Artery During Endovascular Aneurysm Repair.

BACKGROUND: Limited data is available on the use of a polyester graft limb with a helical stent configuration deployed in the external iliac artery (EIA) during endovascular aneurysm repair (EVAR), so we prospectively analyzed the efficacy of the Zenith Spiral-Z limb deployed in the EIA.Methods and Results:Patients undergoing EVAR using a Zenith stent-graft and Spiral-Z limb deployed in the EIA were prospectively registered in 24 Japanese institutions from June 2017 to November 2017. In total, 65 patients (74 limbs) (mean age: 77.1±8.0 years, 87.7% men, mean abdominal aortic aneurysm (AAA) diameter: 51.9±7.2 mm, mean iliac artery aneurysm (IAA) diameter: 38.3±10.0 mm) were registered and followed up. The most common reason for deployment in the EIA was a common IAA (43 limbs, 58.1%), and 8 limbs (10.8%) had a bare nitinol stent placed at the Spiral-Z limb. A total of 61 patients (70 limbs) completed a 24-month follow-up. There were 2 Spiral-Z limb stenoses and 1 occlusion, leading to a primary patency of 95.5% and a secondary patency of 100%, at 24 months. Buttock claudication occurred in 24.3% of the limbs treated at 1 month but decreased to 4.3% at 24 months. CONCLUSIONS: Our multicenter prospective study showed that Spiral-Z limb deployed in the EIA was associated with satisfactory results and seems to be a durable option, even in the era of iliac branch devices.

An Unusual Variational Anatomy of the Medial Circumflex Femoral Artery: A Case Report of a Post-catheterization Femoral Arteriovenous Fistula.

The medial circumflex femoral artery (MCFA) typically presents as a major branch of the profunda femoris artery or it can also directly originate from the common femoral artery. Many anatomical variations of the MCFA have been described due to their clinical significance. We herein report a case of an unusual anatomical variation of the MCFA crossing anterior to the femoral vein that led to iatrogenic arteriovenous fistula formation after cardiac catheterization. The identification of such rare vascular anatomical variations is of great importance when attempting femoral arterial or venous puncture in order to minimize unnecessary complications.

Midterm Results of a Japanese Prospective Multicenter Registry of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Above-the-Knee Femoropopliteal Bypass.

BACKGROUND: This study prospectively analyzed the midterm results of above-the-knee femoropopliteal bypass (AKb) using bioactive heparin-bonded expanded polytetrafluoroethylene (HB-ePTFE) graft in patients with femoropopliteal occlusive disease.Methods and Results:This prospective, multicenter, non-randomized study reviewed limbs undergoing AKb with HB-ePTFE graft for femoropopliteal lesion in 20 Japanese institutions between July 2014 and October 2017. Primary efficacy endpoints were primary, primary assisted, and secondary graft patency. Safety endpoints included any major adverse limb event and perioperative mortality. During the study period, 120 limbs of 113 patients (mean age, 72.7 years) underwent AKb with HB-ePTFE grafts. A total of 45 patients (37.5%) had critical limb ischemia and 17 (15.0%) were on hemodialysis (HD). Median duration of follow-up was 16 months (range, 1-36 months). Estimated 1- and 2-year primary, primary assisted, and secondary graft patency rates were 89.4% and 82.7%, 89.4% and 87.2%, and 94.7% and 92.5%, respectively. On univariate analysis of 2-year primary graft patency, having 3 run-off vessels, cuffed distal anastomoses, no coronary artery disease, and no chronic kidney disease requiring HD were significantly associated with favorable patency. CONCLUSIONS: AKb using HB-ePTFE grafts achieved favorable 2-year graft patency. AKb using HB-ePTFE grafts may therefore be an acceptable, highly effective treatment option for femoropopliteal artery lesions.

Paravesical space arteriovenous malformation as a specific subgroup of pelvic vascular anomaly: a case series and review of literature.

Treatment of pelvic arteriovenous malformations (AVMs) is frequently challenging because of the complex structures and anatomical diversity among cases. We present a case series of six patients with pelvic AVMs. All patients had a similar anatomical structure consisting of multiple feeders from the unilateral internal iliac artery, collecting into a dilated venous sac in the unilateral paravesical space and draining into a single outflow, eventually joining the pre-prostatic vein or internal iliac vein. Five among these patients were successfully treated by catheter-directed embolo-sclerotherapy. In addition to our six cases, we identified six previous case reports of pelvic AVM with similar anatomical characteristics. Herein, we summarize the clinical and anatomical features of these 12 paravesical AVM cases. In all cases, the patients were men; the AVM was predominantly located at the right paravesical space and demonstrated good therapeutic effect of catheter-directed embolosclerotherapy. These paravesical AVMs may constitute a new subgroup of pelvic vascular anomalies with the same etiology that are treatable by adequate catheter intervention.

Simultaneous assessment of blood coagulation and hematocrit levels in dielectric blood coagulometry.

BACKGROUND: In a whole blood coagulation test, the concentration of any in vitro diagnostic agent in plasma is dependent on the hematocrit level but its impact on the test result is unknown. OBJECTIVE: The aim of this work was to clarify the effects of reagent concentration, particularly Ca2+, and to find a method for hematocrit estimation compatible with the coagulation test. METHODS: Whole blood coagulation tests by dielectric blood coagulometry (DBCM) and rotational thromboelastometry were performed with various concentrations of Ca2+ or on samples with different hematocrit levels. DBCM data from a previous clinical study of patients who underwent total knee arthroplasty were re-analyzed. RESULTS: Clear Ca2+ concentration and hematocrit level dependences of the characteristic times of blood coagulation were observed. Rouleau formation made hematocrit estimation difficult in DBCM, but use of permittivity at around 3 MHz made it possible. The re-analyzed clinical data showed a good correlation between permittivity at 3 MHz and hematocrit level (R2=0.83). CONCLUSIONS: Changes in the hematocrit level may affect whole blood coagulation tests. DBCM has the potential to overcome this effect with some automated correction using results from simultaneous evaluations of the hematocrit level and blood coagulability.

Prediction of Venous Thromboembolism after Total Knee Arthroplasty Using Dielectric Blood Coagulometry.

BACKGROUND: Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE) frequently occurs in patients undergoing total knee arthroplasty (TKA). This study aimed to evaluate the efficacy of dielectric blood coagulometry (DBCM) as a new technique for predicting postoperative VTE. METHODS: Thirty patients undergoing TKA were enrolled. DVT was diagnosed by ultrasonography preoperatively and on the fourth or fifth postoperative day. Enhanced computed tomography was performed to detect PE on the fourth postoperative day. The day after surgery, a blood sample was measured by DBCM. All patients received fondaparinux or low-molecular-weight heparin for postoperative thromboprophylaxis. RESULTS: Eighteen of the 30 patients had DVT postoperatively, and 10 had asymptomatic PE. Seven patients had both DVT and PE. The patterns of permittivity as a function of time and frequency from the DBCM measurement were different between patients with and without VTE. The sensitivity and specificity of the parameter constructed from a set of permittivities at the frequencies of 2.5 kHz, 1 MHz, and 10 MHz were 90% and 78%, respectively. CONCLUSIONS: DBCM was effective and efficient for predicting VTE after TKA.

Progression of perianeurysmal inflammation after endovascular aneurysm repair for inflammatory abdominal aortic and bilateral common iliac artery aneurysms.

The use of endovascular aneurysm repair (EVAR) to treat inflammatory abdominal aortic aneurysms (IAAAs) has been reported, and this procedure appears to be preferable to open surgical repair because of intraoperative difficulties related to inflammation. We herein report a case of IAAA and bilateral inflammatory common iliac artery aneurysms that was successfully treated with bifurcated stent grafting. The perianeurysmal inflammation worsened postoperatively, requiring the placement of a ureteric stent. EVAR is feasible in cases of inflammatory aneurysms; however, the potential for an inflammatory response should be taken into account when considering the application of EVAR in patients with IAAA.

Early experience with the endowedge technique and snorkel technique for endovascular aneurysm repair with challenging neck anatomy.

OBJECTIVES: This study was evaluating the outcomes of endovascular aneurysm repair (EVAR) using the endowedge technique (EnT) and/or snorkel technique (SnT) for abdominal aortic aneurysms (AAAs). MATERIALS AND METHODS: The patients treated with EnT and/or SnT were retrospectively reviewed between January 2010 and June 2013. All patients underwent EVAR under general anesthesia. Bilateral femoral arterial access was obtained through bilateral femoral cut-down to place the stent graft mainbody, and brachial arterial access was obtained percutaneously to perform the EnT and/or SnT. RESULTS: Three patients were treated with unilateral EnT, 1 with unilateral SnT, two with bilateral SnT, and two with combined EnT/SnT. A total of 12 renal arteries was attempted to preserve, and could be successfully performed by these techniques in 11 renal arteries. After complete deployment of the endograft, intraoperative angiography showed no type Ia EL. During the median follow-up of 11 months (range: 2-22 months), no deaths nor aneurysm enlargement occurred, and all treated renal arteries were patent without further intervention. CONCLUSIONS: Our findings suggest that the management of AAAs by EVAR with EnT and/or SnT could achieve an adequate proximal seal, and preserve renal artery perfusion in patients with unfavorable neck anatomy.