Short-term Patency Rates Research Articles

Gore Iliac Branch Endoprosthesis for treatment of bilateral common iliac artery aneurysms

ObjectiveThe Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) has recently been approved by the Food and Drug Administration for treatment of common iliac artery (CIA) aneurysms. Despite early excellent results in clinical trial, none of 63 patients were treated for bilateral iliac aneurysms. The goal of this study was to examine real-world experience using the Gore IBE for bilateral CIA aneurysms. MethodsA retrospective review of an international multicenter (16 U.S., 8 European) experience using the Gore IBE to treat bilateral CIA aneurysms was performed. Cases were limited to those occurring after Food and Drug Administration approval (February 2016) in the United States and after CE mark approval (November 2013) in Europe. Demographics of the patients, presentation, anatomic characteristics, and procedural details were captured. ResultsThere were 47 patients (45 men; mean age, 68 years; range, 41-84 years) treated with bilateral Gore IBEs (27 U.S., 20 European). Six patients (12.7%) were symptomatic and 12 (25.5%) patients were treated primarily for CIA aneurysm (aorta <5.0 cm). Mean CIA diameter was 40.3 mm. Four patients had aneurysmal internal iliac arteries (IIAs). Two of these were sealed proximally at the IIA aneurysm neck and two required coil embolization of IIA branches to achieve seal in the largest first-order branches. Technical success was achieved in 46 patients (97.9%). No type I or type III endoleaks were noted. There was no significant perioperative morbidity or mortality. IIA branch adjunctive stenting was required in four patients (one IIA distal dissection, three kinks). On follow-up imaging available for 40 patients (85.1%; mean, 6.5 months; range, 1-36 months), 12 type II endoleaks (30%) and no type I or type III endoleaks were detected. Two of 80 (2.5%) IIA branches imaged were occluded; one was intentionally sacrificed perioperatively. ConclusionsPreservation of bilateral IIAs in repair of bilateral CIA aneurysms can be performed safely with excellent technical success and short-term patency rates using the Gore IBE device. Limb and branch occlusions are rare, usually are due to kinking, and can almost always be treated successfully with stenting.

In Vivo Evaluation of Short-Term Performance of New Three-Layer Collagen-Based Vascular Graft Designed for Low-Flow Peripheral Vascular Reconstructions.

Aim The aim of this study was to evaluate short-term patency of the new prosthetic graft and its structural changes after explantation. Methods The study team developed a three-layer conduit composed of a scaffold made from polyester coated with collagen from the inner and outer side with an internal diameter of 6 mm. The conduit was implanted as a bilateral bypass to the carotid artery in 7 sheep and stenosis was created in selected animals. After a period of 161 days, the explants were evaluated as gross and microscopic specimens. Results The initial flow rate (median ± IQR) in grafts with and without artificial stenosis was 120 ± 79 ml/min and 255 ± 255 ml/min, respectively. Graft occlusion occurred after 99 days in one of 13 conduits (patency rate: 92%). Wall-adherent thrombi occurred only in sharp curvatures in two grafts. Microscopic evaluation showed good engraftment and preserved structure in seven conduits; inflammatory changes with foci of bleeding, necrosis, and disintegration in four conduits; and narrowing of the graft due to thickening of the wall with multifocal separation of the outer layer in two conduits. Conclusions This study demonstrates good short-term patency rates of a newly designed three-layer vascular graft even in low-flow conditions in a sheep model.

A New Supermicrosurgery Training Model of Saphenous Artery and Great Saphenous Vein Anastomosis for Development of Advanced Microsurgical Skills.

Background This study aimed to confirm the feasibility and reliability of saphenous artery (SA) and great saphenous vein (GSV) anastomosis as a new supermicrosurgery training model and to compare the one-way-up anastomosis with the currently used end-to-end anastomosis technique. Methods Twenty supermicrosurgical anastomoses were performed in 10 Sprague Dawley rats. The external diameters of SA and GSV were measured using Leica LAS EZ software. The right-side SA and GSV anastomoses were performed using the standard end-to-end anastomosis technique. The left-side SA and GSV anastomoses were performed using the one-way-up technique with 11-0 monofilament-interrupted sutures. The duration of the surgery, patency rates, and technical challenges of the two anastomoses methods were compared. Results The mean external diameters of SA and GSV were 0.273 ± 0.03 and 0.291 ± 0.02 mm, respectively, which qualify these vessels for supermicrosurgical training. The vessels were easily accessible and both anastomosis techniques were feasible. The one-way-up technique was proven to be faster as compared with the end-to-end anastomosis technique (artery: 34 ± 2.55 vs. 40.4 ± 2.97 minutes, p = 0.02; and vein: 37 ± 4.85 vs. 44 ± 2.35 minutes, p = 0.05, respectively). Short-term patency rates for arteries and veins were 100% for both techniques. Seven-day anastomosis patency rates for arteries and veins were 80 and 100% for the end-to-end technique and 100 and 80% for the one-way-up technique, respectively. Conclusions We confirmed that saphenous pedicle is suitable for creating a supermicrosurgery training model for practicing the ultrafine motor skills. To the best of our knowledge, this is the first report on supermicrosurgery of SA and GSV in the rat model.

Network meta-analysis of balloon angioplasty, nondrug metal stent, drug-eluting balloon, and drug-eluting stent for treatment of infrapopliteal artery occlusive disease

We aimed to conduct a network meta-analysis of mixed treatments for the infrapopliteal artery occlusive disease. We searched randomized controlled trials (RCTs) regarding balloon angioplasty (BA), nondrug metal stent (NDMS), drug-eluting balloon (DEB), or drug-eluting stent (DES) in PubMed, Embase, CENTRAL, Ovid, Sinomed, and other relevant websites. We selected and assessed the trials that met the inclusion criteria and conducted a network meta-analysis using the ADDIS software. We included 11 relevant trials. We analyzed data of 1322 patients with infrapopliteal artery occlusive disease, of which 351 were in the NDMS vs. DES trials, 231 in the NDMS vs. BA trials, 490 in the BA vs. DEB trials, 50 in the DEB vs. DES trials, and 200 in the BA vs. DES trials. The network meta-analysis indicated that with NDMS as the reference, DES had a better result with respect to restenosis (odds ratio [OR], 5.16; 95% credible interval [CI], 1.58-18.41; probability of the best treatment, 84%) and amputation (OR, 2.50; 95% CI, 0.81-7.11; probability of the best treatment, 61%) and DEB had a better result with respect to target lesion revascularization (TLR; OR, 3.74; 95% CI, 0.78-17.05; probability of the best treatment, 57%). Moreover, with BA as the reference, NDMS had a better result with respect to technical success (OR, 0.10; 95% CI, 0.00-1.15; probability of the best treatment, 86%). Our meta-analysis revealed that DES is a better treatment with respect to short-term patency and limb salvage rate, NMDS may provide a better technical success, and DEB and DES are good choices for reducing revascularization.

In Situ Venous Bypass for Chronic Hand Ischemia: A Review of 25 Cases in 23 Patients.

Chronic ischemia of the hand in the setting of atherosclerotic disease is a challenging problem that leads to serial amputations and significant morbidity. Salvage using an in situ venous bypass has been described. In selected cases, leaving the vein in situ for bypass allows a good size match for anastomosis at the wrist or palmar arch. Due to the rarity of the condition, there is a paucity of data regarding the efficacy of this technique. Outcomes in 23 consecutive patients that underwent a total of 25 in situ vein grafts over a 16-year period were retrospectively reviewed. Eighteen were men and 5 were women with a mean age of 61 years. Target vessels at the wrist or palmar arch were identified on preoperative vascular imaging. The cephalic vein (n = 19, 76%) was most commonly used followed by the basilic vein (n = 6, 24%). Overall patency rate at a mean follow-up period of 12.1 months was 92%. Success as determined by both symptomatic improvement and resolution of the ischemic changes or toleration of revision amputation was achieved in 16 (64%) cases. Postoperative complications occurred in ten cases (40 %). Progression of ischemia occurred in 7 cases (28 %) and 3 (12 %) of these cases required a hand amputation. In situ vein grafts in the upper extremity offer good short-term patency rates and can be used for salvage of chronic hand ischemia.

SHORT TERM AND LONG TERM FOLLOW UP OF CORONARY ARTERY BYPASS GRAFT(CABG) PATIENTS BY 256-SLICE MULTI-DETECTOR CT ANGIOGRAPHY: ASSESSMENT OF PATENCY AND PREDICTORS OF GRAFT OCCLUSION

Recent studies have shown the ability of Multi-detector CT angiography (MDCT) scans in determining Coronary Artery Bypass Graft (CABG) outcomes. As a result, we preformed this study to explore short-term and long-term patency rate, and associated risk factors of graft occlusion during follow up,

The Gore Hybrid Vascular Graft in renovisceral debranching for complex aortic aneurysm repair

This study reports our initial experience with the Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) for staged hybrid open renovisceral debranching and endovascular aneurysm repair in patients affected by thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysms (PAAAs). Between December 2012 and December 2013, we analyzed outcomes of 13 patients who underwent open surgical debranching of renovisceral vessels for thoracoabdominal aortic aneurysm and PAAAs. All patients were considered at high risk for conventional surgery. Inclusion criterion was treatment by open surgical debranching of at least one visceral artery (renal artery, superior mesenteric artery [SMA], or celiac trunk [CT]) using the GHVG. In a second step, the aortic stent graft was implanted to exclude the aneurysm. If required, parallel grafts to the remaining visceral arteries were deployed in the same procedure. One patient had a symptomatic descending thoracic aortic aneurysm and another had a ruptured PAAA. Perioperative measured outcomes were immediate technical success rate, mortality, and morbidity. Median follow-up was 24.8months (range, 0-15; mean, 8.2; standard deviation, 4months). All open surgical debranching of renovisceral vessels were completed as intended. GHVG was used to revascularize 20 visceral vessels in 13 patients with a mean of 1.54 vessels per patient. Six renal arteries (30%; 2 right and 4 left), 9 SMAs (45%), and 5 CTs (25%) were debranched. In nine of 13 (66%) patients, other renovisceral arteries were addressed with chimney/periscope, Viabahn Open Revascularization Technique, and end-to-side anastomosis. Two of 13 patients (15%) died of bowel ischemia. Neither patient had GHVG revascularization to the SMA or CT. Perioperative complications occurred in three patients (23%; 1 renal hematoma, 1 respiratory insufficiency, and 1 small-bowel ischemia related to a SMA GHVG thrombosis). At 24months, estimated survival was 85%, and estimated primary and secondary patency were 94% and 100%, respectively. This limited series extracted from a more consistent hybrid procedure experience showed a mortality rate similar to most recent reports. Technical feasibility and the short-term patency rate of the GHVG for renovisceral debranching during staged hybrid open and endovascular procedures were satisfactory. Use of GHVGs may represent a useful revascularization adjunct to minimize visceral ischemia in these challenging patients.

Early Vascular Consultation in the Setting of Oncologic Resections: Benefit for Patients and a Continuing Source of Open Vascular Surgical Training

Oncologic surgeons have become more aggressive at tumor resections that often require complex open vascular interventions. Vascular surgeons may be consulted preoperatively to aid in these cases, or commonly called into the operating room for an urgent consult. These operations provide a challenge to the vascular surgeon and also an opportunity for open vascular surgical training of residents. We present our experience with vascular surgical interventions during oncologic resections. A retrospective review of a prospectively maintained vascular registry was performed to identify patients undergoing vascular surgery in the setting of oncologic resections. Tumor histology, location, type of vascular intervention, vascular, and oncologic outcomes were recorded and reviewed. Over a 7-year period, 21 oncologic cases involving vascular surgeons were identified. Tumor types included sarcoma (9), adenocarcinoma (4), germ cell (4), paraganglioma (2), and others (2). Tumor locations included abdominal/pelvic (15), cervical (3), and extremity (3). Complete resection was achieved in 18 of the 19 patients; 2 patients underwent exploration alone for carcinomatosis. Vascular surgical procedures included bypass grafts in 7 patients, resection with primary repair in 5 patients, ligation/excision in 4 patients, and arterial mobilization in 3 patients. No major vascular complications occurred. Short-term patency rates were 100%. Survival rates following therapeutic resection were 90%, 80%, and 80% at 1, 3, and 5years, respectively. Vascular surgeons were involved in the preoperative planning in 11 cases (52%). Patients with preoperative vascular consultation had significantly fewer vascular injuries, a nonsignificant trend toward lower blood loss, and a nonsignificant trend toward improved survival than those with urgent intraoperative vascular consultation. Vascular interventions can lead to favorable long-term outcomes during definitive oncologic resection of diverse tumor histologies and locations. Vascular surgeons must be prepared to participate, frequently urgently, in oncologic procedures. Standard open techniques employing all aspects of vascular exposures continue to be integral to vascular surgery training. Preoperative consultation between the oncologic and vascular surgeons may lead to improved outcomes.

Fatigue and in vivo validation of a peritoneum-lined self-expanding nitinol stent-graft.

To assess the fatigue and in vivo performance of a new stent-graft incorporating bovine peritoneum lining that is designed for application in peripheral vascular occlusive disease. Bovine peritoneum-lined stent-grafts were subjected to accelerated in vitro pulsatile fatigue and axial/torsional fatigue testing designed to simulate 10 years of physiological strain on the devices. At specified times the devices were evaluated for stent fracture, suture failure, or tissue tearing. Seven dogs underwent bilateral common iliac artery (CIA) balloon angioplasty injury with unilateral placement of the peritoneum-lined stent-graft. Angiography and intravascular ultrasound were performed prior to treatment, after treatment, and prior to sacrifice at 30 days. Vessels were perfusion fixed and histologically evaluated at 5 regions: above stent, proximal stent, mid stent, distal stent, and below stent. No evidence of stent, suture, or tissue failure was present during or after pulsatile and axial/torsional fatigue testing. At 30±0.3 days after implantation, all vessels were patent. The average lumen area at explantation across stented vessels was 25.45 mm(2). Lumen areas tended to be reduced above (23.57 mm(2)) and below (24.17 mm(2)) the stent. Lumen areas were consistent across stented regions at explantation (proximal stent 27.80 mm(2), mid stent 25.88 mm(2), and distal stent 25.81 mm(2)). The mean neointimal area in peritoneum-lined stents was 2.02±1.52 mm(2), with a neointima:media ratio of 1.03±0.50. These values were significantly lower in the above and below stent areas than in the stented regions, but there was no difference in either measure within the proximal, mid, or distal stent. The custom-designed peritoneum-lined stent-graft is promising for clinical peripheral applications due to its ability to resist relevant long-term physiological stresses and outstanding short-term patency rates in canine implantations.

Endovascular Treatment of Abdominal Aortic Aneurysms Involving Iliac Bifurcation: Role of Iliac Branch Graft Device in Prevention of Buttock Claudication

The aim of this study was to describe our early experience with the use of iliac branch grafts (IBGs) in aortoiliac aneurysm repair at our institution and to evaluate the technical feasibility, short-term patency rate, and potential clinical benefits, with special focus on prevention of buttock claudication. From March 2009 to November 2010, 9 consecutive patients (all men), mean age 71.1 years (range 62-80 years), underwent IBG implantation at our institution. Indications were abdominal aortic aneurysm (AAA) with common iliac artery (CIA) involvement (n = 7), bilateral CIA aneurysm (n = 1), and AAA with bilateral CIA and unilateral IIA involvement (n = 1). Postoperative endoleaks and patency rate were determined with computed tomography (CT) within 1 month of implantation and 1 year thereafter, with concurrent clinical evaluation for pelvic ischemia. Mean follow-up period was 14.7 (range 9-29) months. Technical success rate, as defined by successful implantation of the iliac branch graft (IBG) with no intraprocedural type I or type III endoleak, was 100%. The mean hospitalization duration was 4 days (range 3-6 days), with 0% mortality at 30 days. There were 3 cases of type II endoleak detected perioperatively, which were treated conservatively. Two endoleaks sealed spontaneously on the 1-month CT scan and 1 persists without aneurysm sac expansion. All stent-implanted aortic and iliac aneurysms remained stable in size during follow-up, with no aneurysm rupture or death recorded. All stent-implanted iliac branches remained patent on follow-up and all patients were asymptomatic. Iliac branch graft placement is a feasible technique with excellent short-term results in the treatment of abdominal aortic aneurysms involving the iliac bifurcation. This technique can efficiently prevent buttock claudication.

Fully‐covered, self‐expandable metal stents (CSEMS) in malignant distal biliary strictures: Mid‐term evaluation

Limited data exist regarding fully-covered, self-expandable metal stents (CSEMS) with anchoring fins for the management of malignant distal biliary strictures. The aim of this study is to evaluate their safety and patency. Over a period of 2 years, 70 patients (45 males, 66 ± 13 years) underwent endoscopic retrograde cholangiopancreatography (ERCP) with placement of a 10-mm (67 patients) or 8-mm diameter (3 patients) CSEMS for the palliation of distal malignant biliary obstruction (pancreatic [53] or other [17]). Data were collected prospectively for survival and stent patency; complications were evaluated retrospectively. After CSEMS placement, 17 patients proceeded to surgery, and 53 patients were deemed unresectable. Mean survival for non-surgical candidates was 180 days (range: 15-1091), and 170 days (range: 9-589) for patients who underwent surgical management. CSEMS were left in place and remained patent for a mean of 163 days (range: 15-1091) in non-surgical candidates, and a mean of 55 days (range: 5-126) in surgical candidates. Complications during placement included wire perforations (4) and proximal deployment requiring repositioning (4), one of which was complicated by a bile leak. Post-procedure complications were observed in 24 cases (34%) and included post-ERCP pancreatitis (8, with 2 of them severe), post-procedure pain (5, with 3 requiring admission), cholecystitis (3), stent occlusion (3), cholangitis (2), proximal migration (1), post-sphincterotomy bleeding (1), and sepsis leading to death (1). CSEMS appear to provide acceptable short-term patency rates; however, their limited long-term patency and high complication rate might limit their widespread use. Further long-term prospective data are required to confirm this observation.

Extracranial-Intracranial Bypass Surgery Using a Radial Artery Interposition Graft for Cerebrovascular Diseases

To investigate the efficacy of extracranial-intracranial (EC-IC) bypass surgery using a radial artery interposition graft (RAIG) for surgical management of cerebrovascular diseases. The study involved a retrospective analysis of 13 patients who underwent EC-IC bypass surgery using RAIG at a single neurosurgical institute between 2003 and 2009. The diseases comprised intracranial aneurysm (n=10), carotid artery occlusive disease (n=2), and delayed stenosis in the donor superficial temporal artery (STA) following previous STA-middle cerebral artery bypass surgery (n=1). Patients were followed clinically and radiographically. Bypass surgery was successful in all patients. At a mean follow-up of 53.4 months, the short-term patency rate was 100%, and the long-term rate was 92.3%. Twelve patients had an excellent clinical outcome of Glasgow Outcome Scale (GOS) 5, and one case had GOS 3. Procedure-related complications were a temporary dysthesia on the graft harvest hand (n=1) and a hematoma at the graft harvest site (n=1), and these were treated successfully with no permanent sequelae. In one case, spasm occurred which was relieved with the introduction of mechanical dilators. EC-IC bypass using a RAIG appears to be an effective treatment for a variety of cerebrovascular diseases requiring proximal occlusion or trapping of the parent artery.

Cerebral revascularization using cadaveric vein grafts

Background Use of cadaveric cryopreserved saphenous vein grafts (CSVGs) has been described for peripheral vascular and coronary revascularization. The aim of this study is to recognize CSVGs as a potential alternative to autologous conduits for extracranial-intracranial (EC-IC) bypass in patients without available or suitable saphenous vein graft or radial artery. We report the short-term patency rate of CSVGs in EC-IC bypass. Methods We present our preliminary experience in 10 patients using CSVG for cerebral revascularization. Data regarding operative indications, patient demographics, and bypass patency were collected. Results The average age was 56 years old with equal sex distribution. The indications for the procedure were giant aneurysms in 7 patients, medically refractory vertebrobasilar ischemia in 2, and a skull base tumor in 1. ABO/Rh blood group compatible CSVG was used in each case. Postoperative angiography demonstrated patency in all cases. Quantitative magnetic resonance angiography was performed in 8 patients, demonstrating a mean bypass flow of 109 mL/min ± 19 mL/min (mean ± SE). Conclusions Use of CSVG for EC-IC bypass has not previously been reported. In our series, the short-term patency rate was 100%, better than that found in cardiac and peripheral vascular series, possibly because of the higher flow in EC-IC bypasses. Our preliminary experience suggests that CSVGs may be an option in patients without available autologous conduits, although longer follow-up is needed to assess long-term patency.

Long-term responses of porcine coronary arteries to overlapping thin-strut, bioabsorbable coated low-dose paclitaxel-eluting stent

Purpose: The purpose of our study was to evaluate the procedural success, 6-month patency, and clinical outcome of a new 4F sheath-compatible, selfexpanding nitinol stent after failed conventional angioplasty or atherectomy of infrapopliteal lesions in critical limb ischemia (CLI). Methods: Clinical records of 13 patients with CLI (Rutherford class 4–6), who underwent stent implantation following percutaneous transluminal angioplasty (PTA) and/or atherectomy were reviewed. Stent placement was carried out due flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical evaluation and color-flow and duplex Doppler ultrasonography were performed. Technical success, primary patency at 6 months, and clinical improvement as defined by Rutherford with clinical and hemodynamic measures and complications were evaluated. Results: A total of 19 arterial territories were intervened upon. 4F Sheathcompatible, self-expanding nitinol stent system (XPERT; Abbott Vascular) with a diameter of 3–5 mm and a length of 20–60 mm was used. A total of 29 stents were deployed. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 90%. The mean resting ankle-brachial index at baseline was 0.40±0.1 and significantly increased to 0.90±0.13 (Pb.001) at 24 h after intervention and 0.84±0.15 at 6-month follow-up (P b.001). The sustained clinical improvement rate was 78% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 85%. One patient (7.7%) developed major access site bleeding requiring transfusion. Conclusions: Nitinol self-expanding stents in infrapopliteal arteries can be deployed safely with good short-term patency rate and clinical benefit in the treatment of CLI.

Safety and clinical benefits of nitinol self-expanding stents in infrapopliteal arteries in patients with critical limb ischemia

Purpose: The purpose of our study was to evaluate the procedural success, 6-month patency, and clinical outcome of a new 4F sheath-compatible, selfexpanding nitinol stent after failed conventional angioplasty or atherectomy of infrapopliteal lesions in critical limb ischemia (CLI). Methods: Clinical records of 13 patients with CLI (Rutherford class 4–6), who underwent stent implantation following percutaneous transluminal angioplasty (PTA) and/or atherectomy were reviewed. Stent placement was carried out due flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical evaluation and color-flow and duplex Doppler ultrasonography were performed. Technical success, primary patency at 6 months, and clinical improvement as defined by Rutherford with clinical and hemodynamic measures and complications were evaluated. Results: A total of 19 arterial territories were intervened upon. 4F Sheathcompatible, self-expanding nitinol stent system (XPERT; Abbott Vascular) with a diameter of 3–5 mm and a length of 20–60 mm was used. A total of 29 stents were deployed. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 90%. The mean resting ankle-brachial index at baseline was 0.40±0.1 and significantly increased to 0.90±0.13 (Pb.001) at 24 h after intervention and 0.84±0.15 at 6-month follow-up (P b.001). The sustained clinical improvement rate was 78% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 85%. One patient (7.7%) developed major access site bleeding requiring transfusion. Conclusions: Nitinol self-expanding stents in infrapopliteal arteries can be deployed safely with good short-term patency rate and clinical benefit in the treatment of CLI.

Novel thin-strut, bioabsorbable sol-gel coated, low-dose paclitaxel-eluting stent: evaluation in porcine coronary arteries

Purpose: The purpose of our study was to evaluate the procedural success, 6-month patency, and clinical outcome of a new 4F sheath-compatible, selfexpanding nitinol stent after failed conventional angioplasty or atherectomy of infrapopliteal lesions in critical limb ischemia (CLI). Methods: Clinical records of 13 patients with CLI (Rutherford class 4–6), who underwent stent implantation following percutaneous transluminal angioplasty (PTA) and/or atherectomy were reviewed. Stent placement was carried out due flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical evaluation and color-flow and duplex Doppler ultrasonography were performed. Technical success, primary patency at 6 months, and clinical improvement as defined by Rutherford with clinical and hemodynamic measures and complications were evaluated. Results: A total of 19 arterial territories were intervened upon. 4F Sheathcompatible, self-expanding nitinol stent system (XPERT; Abbott Vascular) with a diameter of 3–5 mm and a length of 20–60 mm was used. A total of 29 stents were deployed. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 90%. The mean resting ankle-brachial index at baseline was 0.40±0.1 and significantly increased to 0.90±0.13 (Pb.001) at 24 h after intervention and 0.84±0.15 at 6-month follow-up (P b.001). The sustained clinical improvement rate was 78% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 85%. One patient (7.7%) developed major access site bleeding requiring transfusion. Conclusions: Nitinol self-expanding stents in infrapopliteal arteries can be deployed safely with good short-term patency rate and clinical benefit in the treatment of CLI.

Cutting balloon angioplasty of autogenous infrainguinal bypasses: Short-term safety and efficacy

This study evaluated the safety and efficacy of cutting balloon angioplasty in the treatment of infrainguinal vein bypass graft stenosis. Data from a prospective database, supplemented by chart review, were obtained on all patients who underwent cutting balloon angioplasty of lower extremity vein bypass grafts at a single institution during a 4-year period. Noninvasive duplex ultrasound imaging of grafts, along with measurement of ankle-brachial indices and digital pressures, was performed on all patients before and after treatment with the cutting balloon. Efficacy of cutting balloon angioplasty and procedural complications were analyzed. Data from noninvasive vascular testing were compared using the two-tailed paired Student t test. Patency rates were calculated using the Kaplan-Meier method. Differences in patency rates were compared using the log-rank test. From July 2002 to February 2006, 109 cutting balloon angioplasties were performed on 70 bypasses in 61 patients. There were 12 complications in 109 procedures (11%), only one of which required immediate operative intervention. Initial technical success was 96%. Noninvasive vascular testing indicators significantly improved immediately after intervention: peak systolic graft velocity decreased from 360 +/- 158 cm/s to 143 +/- 67 cm/s (P < .001), ankle-brachial index improved from 0.55 +/- 0.3 to 0.85 +/- 0.2 (P < .001), and digital pressure increased from 31 +/- 30 mm Hg to 62 +/- 32 mm Hg (P < .001). Patency rates at 6 months according to the Kaplan-Meier method were primary patency, 48% (95% confidence interval [CI], 0.36 to 0.60); assisted primary patency, 72% (95% CI, 0.61 to 0.83); and secondary patency, 99% (95% CI, 0.97 to 1.00). At 6 months, cumulative limb salvage was 94% (95% CI, 0.89 to 1.00). Cutting balloon angioplasty of infrainguinal vein bypass graft stenosis is technically feasible but is associated with a relatively high complication rate and a relatively low short-term patency rate.

Combined stent placement and high dose PGE1 drip infusion for chronic occlusion of the superficial femoral artery as a modality to salvage chronic critical limb ischemia

Purpose To assess the initial effect, short-term patency, and limb salvage rates of combined stent placement and high-dose prostaglandin E-1 (PGE1) drip infusion for chronic occlusion of the superficial femoral artery (SFA). Materials and methods A total of 15 arteriosclerotic occlusive lesions of the SFA were treated in 11 consecutive patients (mean age: 78.4 years old). All cases were of category 4 or 5, based on the criteria of the Society of Vascular Surgery and Intermittent Society for Cardiovascular Surgery (SVC/ISCVS). In all cases a self-expandable stainless steel stent was implanted. PGE1 treatment was started 3–5 days before stent placement and continued for 7–10 days after the intervention. The technical success, limb salvage outcomes, patency rates, and complications were examined. Results In all cases, the technical success rate of the procedure was 100%. After stent implantation, the clinical status of all cases was improved by at least +2, and major amputation was not required in any cases. The 12-month primary, secondary patency rates, and limb salvage rate were 57%, 100%, and 100%, respectively. Conclusion Combined stent placement and high-dose PGE1 drip infusion is a treatment of choice for salvaging the lower limb of a patient with chronic critical ischemia.

Initial Clinical Experience with the 4-F Self-expanding XPERT Stent System for Infrapopliteal Treatment of Patients with Severe Claudication and Critical Limb Ischemia

To evaluate the primary success and short-term patency associated with a new 4-F sheath-compatible self-expanding nitinol stent after failed conventional angioplasty of distal popliteal and infrapopliteal lesions in severe lifestyle-limiting claudication (LLC) and chronic critical limb ischemia (CLI). Between May 2003 and July 2005, 35 patients with Rutherford category 3-5 disease (16 patients with CLI, 19 patients with LLC) underwent percutaneous transluminal angioplasty (PTA) and stent implantation. Indications for stent placement were residual stenosis, flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical investigation, color-flow and duplex Doppler ultrasonography, and digital subtraction angiography were performed. Technical success, primary patency at 6 months, clinical improvement as defined by Rutherford with clinical and hemodynamic measures, and complications were evaluated. A total of 22 patients underwent distal popliteal artery stent placement and 13 underwent tibioperoneal artery stent placement. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 82%. The mean resting ankle-brachial index at baseline was 0.50 +/- 0.16 and significantly increased to 0.90 +/- 0.17 at 12-24 hours after intervention and 0.82 +/- 0.24 at latest follow-up (P < .001 for both). The sustained clinical improvement rate was 80% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 100%. The rate of major complications was 17%. Infrapopliteal application of the new nitinol stent is a safe, feasible, and effective method with good short-term patency rate in the treatment of severe LLC and chronic CLI.

Comparing vein with collagen impregnated woven polyester prosthesis in above-knee femoropopliteal bypass grafting

Objective Despite many clinical studies, there is still uncertainty as to whether venous material is superior to prosthetic materials for femoropopliteal reconstruction proximal to the knee joint. A prospectively randomized clinical trial was designed to evaluate the effectiveness of reversed saphenous vein in comparison with that of collagen impregnated woven polyester prosthesis in above-knee arterial reconstruction. Methods In a 3-year period, 103 above-knee femoropopliteal bypass graft operations were performed and followed in 85 patients (52 male, 33 female). The indication for operation was severe claudication in 74 cases, rest pain in 7 cases, and ulceration in 4 cases. For the bypass graft, a reversed saphenous vein was used in each of 51 cases, and a collagen impregnated woven polyester prosthesis was used in each of 52 cases. Preoperative risk factors were diabetes (24%), a history of myocardial infarction (23%), and current status with respect to smoking (74%). There was no hospital mortality; 5% of patients had minor postoperative complications. Results After 2 years of follow-up, the primary patency was 81% for saphenous vein and 67% for collagen impregnated woven polyester prosthesis ( P = 0.065); the secondary patency was 81% for saphenous vein and 77% for collagen impregnated woven polyester prosthesis ( P = 0.298). During this follow-up period of 2 years, we found no statistically significant difference in primary and secondary patency between saphenous vein and collagen impregnated woven polyester prosthesis. We found no predictive factor for the occlusion of either bypass graft. Conclusion The use of collagen impregnated woven polyester prosthesis above the knee is a reasonable alternative in femoropopliteal bypass grafting that is associated with acceptable short-term patency rates.