Iliac-femoral venous stenting for lower extremity venous stasis symptoms.

BACKGROUND: Venous outflow obstruction may play a role in patients with chronic venous stasis symptoms who fail to improve despite conventional modalities of treatment that focus on the reflux component of the disease with little attention to the possibility of an obstructive component. The introduction of minimally invasive venous stenting using venography and intravenous ultrasonography (IVUS) provides the ability to treat the "obstructive" component of the disease. METHODS: We undertook a retrospective review of 56 limbs in 53 patients with chronic venous stasis symptoms. Initial transcutaneous Doppler ultrasonographic evaluation of the inferior vena cava, iliac, femoral, greater saphenous, and perforator veins was performed looking for any evidence of deep venous thrombosis, superficial venous thrombosis, perforator veins, and reflux (location and degree). Afterword, the patients were managed in the conventional fashion (leg elevation, compression, and great saphenous vein (GSV) and perforator ablation, if present) for a period of 3 months. If ulcer healing was not noted, iliac-femoral venography and IVUS were undertaken. A significant stenosis was defined as a 50% reduction in vein cross-sectional area as measured by IVUS.(1,2,3) Stenotic lesions were managed with stenting followed by balloon angioplasty. Patients were followed up for ulcer healing or improvement of stasis symptoms. RESULTS: Of the 56 limbs, 10 (17.8%) had postthrombotic changes, 7 (12.5%) had incompetent perforators, and 27 (48.2%) had an incompetent superficial venous system. In the stented group (n = 29), 3 limbs had perforator ablation alone, 13 limbs had GSV ablation alone, and 1 limb had both perforator and GSV ablation. In the unstented group (n = 27), 10 limbs had GSV ablation alone, and 3 limbs had both perforator and GSV ablation. The overall incidence of deep reflux was 51.8%; 17 of 29 limbs (58.6%) in the stented group had evidence of deep reflux, and 12 of 27 limbs (44.4%) in the unstented group had deep reflux. All venograms except one (98.2%) were performed under local anesthesia with sedation. The procedure was performed in an ambulatory setting in 69.6% (39 of 56) of the limbs. CEAP clinical severity class distribution was as follows: C2, 4%; C3, 16%; C4, 18%; C5, 5%; C6, 57%. Over half of the limbs (29 of 56) were found to have stenotic lesions and required stenting. Eight patients (11 limbs) did not return for ulcer healing assessment. The majority (19 of 29) of limbs in the stented group had a CEAP of 6. Among the patients with CEAP 6 who returned for follow-up (n = 26), 7 had no evidence of stenosis and required no stenting. Only one of those (14.3%) healed his ulcers after 3 months (average follow-up of 4.8 months). The remainder 19 limbs were found to have stenotic lesions and underwent stenting. The ulcers healed in 11 of those (58%) over a period of 1 week to 8 months (average of 5 months), with average follow-up of 3.6 months (p = 0.08). The cumulative primary and secondary patency rates were 93.1% (27 of 29) and 100% (29 of 29), respectively. Two stent thromboses occurred within 4 weeks of the initial procedure. Both occurred in patients with postthrombotic obstruction. One patient developed a superficial femoral artery pseudoaneurysm. CONCLUSION: Over half of our patients with open ulcers had stenotic lesions. The ulcers healed in 58% of the stented limbs. That indicates that outflow obstruction may play a significant role in patients with chronic venous stasis symptoms, especially those with open ulcers who failed to respond to other treatment modalities. The procedure itself is relatively safe and simple and can be performed on an ambulatory basis.

Full metal jacket stenting of the superficial femoral artery: a retrospective review.

BACKGROUND: The technique of long segment stenting of the superficial femoral artery (SFA) has been associated with poorer short- and long-term results. The full metal jacket (FMJ) stenting is typically described as long segment continuous stenting of a vessel segment. Initially, this technique was described in percutaneous coronary interventions. However, until recently, FMJ of the SFA has not been studied. We examined our experience with FMJ of the SFA to evaluate the outcomes and the safety of this technique. METHODS: Retrospective data were gathered for peripheral angioplasties and stenting for the period between January 2005 and December 2008. The cases involving FMJ stenting of the SFA were identified by angiographic findings and the operative dictations providing the stent data. Selective FMJ stenting of the SFA was performed for the residual stenosis after balloon angioplasty of the SFA because of either dissection or significant recoil. The cases with concomitant iliac artery angioplasty and/or stenting were excluded from the data set for analysis. The variables for the evaluation were primary patency rate, mortality rate, and limb salvage rate, which were stratified on the basis of the risk factors. RESULTS: A total of 63 cases involving FMJ stenting of the SFA were identified from the database of 707 patients who had peripheral endovascular interventions between January 2005 and December 2008. Average age of the patients was 70 years (range: 52-104 years, SD: 10.1 years). There were no transatlantic inter-society consensus (TASC) A lesions, 11% (7/63) of the lesions were TASC B, 68% (43/63) were TASC C, and 21% (13/63) were TASC D. The median primary patency rate was 9 months (95% CI: 5.06-12.94). The mortality rate was 4% at 6-month follow-up. The limb salvage rate was 85.7%. In all, 65% (41/63) of the patients were claudicants, whereas 23% (15/63) had intervention for some form of tissue loss (ischemic ulcer, gangrene). Associated infrapopliteal intervention was performed in 15.9% of the patients. Average creatinine level was 1.67 (range: 0.7-10.9, SD: 2.03) and 49% (31/63) of the patients had diabetes. The average 6-month patency rate was 55% (SD: 0.5). Multivariate logistic regression analysis showed that diabetes (OR: 0.33, p = 0.044, 95% CI: 0.11-0.97) and a creatinine level of ≥1.6 (OR: 0.16, p = 0.038, 95% CI: 0.03-0.9) were the independent risk factors for loss of patency in <6 months. CONCLUSION: Our experience suggests promising results for the technique of FMJ of the SFA and also that further examination of the technique is warranted.

Spontaneous recanalization of an occluded internal carotid artery.

Recanalization after extracranial internal carotid artery (ICA) occlusion is a rare phenomenon and the natural history of the disease is largely unknown. There have been few cases reported in the published data, including early recanalization after a cerebrovascular accident (CVA). We report a case of a 74-year-old man who presented with a CVA and a history of multiple CVAs in the past, the last episode being a year ago. Multiple imaging modalities, including duplex scans, computerized tomographic angiograms, and fluoroscopy-guided angiogram of bilateral carotid arteries, showed occlusion of the left ICA in the past. The duplex scan performed 8 months later demonstrated late spontaneous recanalization of the occluded left ICA. The patient underwent successful carotid endarterectomy. The pathophysiology, natural history, and possible surveillance strategy are discussed in this case report.

Prospective randomized study comparing the clinical outcomes between inferior vena cava Greenfield and TrapEase filters.

OBJECTIVE: Although anticoagulation remains the mainstay of treatment for deep venous thrombosis, the use of inferior vena cava (IVC) filters when anticoagulation has failed or when contraindicated remains a safe and effective treatment. Greenfield (Boston Scientific, Natick, Mass) and TrapEase (Cordis, Bridgewater, NJ) filters are arguably among the most popular filtration devices. The Greenfield filter (12F introducer) has been in use for >30 years and has been well studied. The TrapEase filter (6F introducer) has been used since 2000, with a limited number of studies. Good guidelines to help determine which filter to use in any given situation are lacking; therefore, this randomized study prospectively compared the clinical outcomes (access-site thrombosis, filter thrombosis, and symptomatic pulmonary embolism [PE]) between these filters. METHODS: Between July 2006 and November 2008, 156 patients (63 men, 93 women; mean age, 75 years; range, 38-101 years) were randomized: 84 to Greenfield and 72 to TrapEase IVC filter insertion in the infrarenal position using angiographic guidance. Postoperative follow-up comprised serial lower extremity and IVC/iliac vein (IV) duplex imaging (78.2%) at day 1, week 1, every 3 months for the first year, and every 6 months for the second year; clinical evaluation, and clinic visits. During this period, 349 patients (143 men, 206 women; mean age, 75 years; range, 24-96 years) were not randomized. RESULT: The indications for filter placement, in the 156 randomized patients, were gastrointestinal bleeding, 37; intracranial hemorrhage, 12; free-floating clot, 19; failure of anticoagulation, 29; PE, 27; prophylactic, 4; and others, 32. During a mean 12-month follow-up (range, 0-39 months), symptomatic IVC/IV thrombosis developed in five patients (6.94%) in the TrapEase group and none in the Greenfield group (P = .019). No filter migration, access-site thrombosis, misplacement, or IVC perforation occurred. Recurrent PE was suspected in one of the five patients with IVC/IV thrombosis. Overall mortality was 42.3% (66 patients), and 30-day mortality was 13.5% (21 patients: 10 TrapEase, 11 Greenfield). The study was initially designed to recruit 360 patients in both TrapEase and Greenfield filters in 2 years to demonstrate any statistical significance but was prematurely concluded due to the interim results. CONCLUSION: A higher rate of symptomatic IVC/IV thrombosis is associated with TrapEase filter placement. However, the TrapEase filter still has a selective clinical role in the prevention of thromboembolism in selected patients who are coagulopathic. This is the first randomized prospective study comparing IVC filters since their inception in 1967.

Use of the StarClose device for closure of inadvertent subclavian artery punctures.

PURPOSE: The placement of central catheters is a common procedure. It is also associated with multiple known complications. One of the potential complications that carry high morbidity and morality is arterial puncture and cannulation. Herein, we describe five case reports of a central line that was inadvertently placed in the subclavian artery and successfully removed using a StarClose device (Abbott Laboratories, Redwood CA). METHODS/RESULTS: A retrospective chart review of a prospectively maintained database was performed. We identified five cases of inadvertent subclavian artery cannulation during central venous catheter placement. All catheters were removed successfully either in the operating room under fluoroscopic guidance or at the bedside with closure of the arteriotomy using the StarClose device. No cases required conversion to an open procedure for repair. No postremoval hematomas, bleeding episodes, myocardial infarctions, arrhythmias, or adverse clinical sequelae were identified. DISCUSSION: Based on our limited experience, we feel that this method can be performed safely and expeditiously not only in the operating room but also at the bedside.

Iatrogenic injuries of the common femoral artery (CFA) and external iliac artery (EIA) during endograft placement: an underdiagnosed entity.

OBJECTIVE: Early limb occlusions following endovascular treatment of aorto-iliac aneurysmal disease is not uncommon (4%-13%). To assess whether the femoral artery entry site could potentially cause this complication, we prospectively evaluated the ipsilateral common femoral artery (CFA) and distal external iliac artery (EIA) with intraoperative duplex scans (IDS). METHODS: There were 134 patients with infrarenal nonruptured abdominal aorto-iliac aneurysms treated with endografts since 2002 at our institution. Age ranged from 65 to 89 years (mean: 77 +/- 7 years). Aneuryx (n = 41), Zenith (n = 50), and Excluder (n = 43) endografts were used for repair. All procedures were performed via open exposure of the CFA. Introducer diameter varied from 12 mm to 22 mm. All patients underwent IDS of the CFA and distal EIA after repair of the arteriotomies. RESULTS: In 34 patients (25%), we documented intimal dissections causing severe (>70%) stenoses. Of the 271 arteries that were examined, 38 (14%) had abnormal findings that demanded intervention. These were repaired with flap excision, tacking sutures revision, or patch angioplasty (n = 36). Repeat IDS confirmed the adequacy of the repair. No statistical difference was noted if the site of larger introducer sheath and the incidence of flap formation. In addition, 10 small flaps or plaques were visualized but did not create significant stenosis. No differences were noted in the incidence of positive duplex exams between each type graft (P = .4). No early or late iliac limb occlusions were noted. Follow-up of 94% was obtained. CONCLUSIONS: Completion arterial duplex scans are helpful in detecting a substantial number of clinically unsuspected technical defects caused by introducer sheaths. Timely diagnosis and repair of these defects may decrease the incidence of early limb occlusion following endograft placement.

Predictive factors of success following radio-frequency stylet (RFS) ablation of incompetent perforating veins (IPV).

OBJECTIVE: To evaluate potential predictive factors associated with success or failure of incompetent perforating veins (IPVs) treated with radio-frequency stylet (RFS). METHODS: Over the last 12 months in this observational study, 38 consecutive patients with various degrees of venous insufficiency and IPVs underwent 48 office-based radio-frequency ablation procedures (1 - C 3; 7 - C 4; 10 - C 5; 30 - C 6) in 44 limbs. There were 21 females and 17 males with a mean age of 67 +/- 17 years (38-93 years) who had a total of 93 IPVs (40 calf; 53 ankle). Eighteen patients (47%) had ipsilateral great saphenous vein (GSV) radio-frequency closures performed prior to current procedure. The venous flow pattern was classified by spectral waveform analysis as "normal" (spontaneous with respiratory phasicity) in 33 patients and "pulsatile" (with bidirectional cardiac phasicity) in five patients. Follow-up duplex scans were performed from 3 to 7 days postprocedure. Statistical analyses were performed for determining correlation between the various factors such as, age, pulsatile flow, CEAP class, prior GSV ablation, vein diameter, reflux, and patency. RESULTS: The mean number of ablated IPVs was 1.94 +/- 0.38 ranging from 1-3. Immediate success rate was 88% (82 cases, 32 patients). IPVs had a duplex measured mean diameter of 3.8 +/- 1.1 mm (2-6.6 mm). Eleven IPVs remained patent in six patients. There was no significant difference between the patent and the obliterated IPV groups concerning age (P = 0.75), prior GSV ablation (P = .19), IPV diameter (P = .08) and CEAP classification. Conversely, four of the five procedures (80%) performed in patients with "pulsatile" venous flow failed, while only two of the remaining 43 procedures (4.7%) in patients with "normal" venous flow failed (P < .001). CONCLUSION: These data show that a pulsatile venous flow pattern is a significant predictor of failure following RFS for IPVs.

Self-assessment of the training of vascular fellows: survey results of 219 vascular fellows from 2004 through 2007.

Introduction. In an attempt to identify the concerns of vascular fellows regarding their training in vascular surgery, we conducted a survey consisting of 22 questions at an annual national meeting from 2004 to 2007. Methods. The fellows were asked to assess various aspects of their training as excellent, satisfactory, or mixed. Results. 76% were satisfied with their endovascular experience during their fellowship while 82% were satisfied with their experience with open cases. The distribution of non-learning cases was felt to be excellent, satisfactory, or required some or much improvement in: 45%, 44%, 8%, and 2% respectively. However, only 61% felt that their vascular laboratory experience was excellent or satisfactory. Only 36% actually performed the vascular duplex exam, and only 49% felt that they would feel comfortable in managing a vascular laboratory. Conclusions. The results of this Survey suggest that several significant issues are reflected in the minds of vascular trainees.

Efficient myocyte gene delivery with complete cardiac surgical isolation in situ.

BACKGROUND: Previously, we used cardiopulmonary bypass with incomplete cardiac isolation and antegrade administration of vector for global cardiac gene delivery. Here we present a translatable cardiac surgical procedure that allows for complete surgical isolation of the heart in situ with retrograde (through the coronary venous circulation) administration of both vector and endothelial permeabilizing agents to increase myocyte transduction efficiency. METHODS: In 6 adult dogs the heart was completely isolated with tourniquets placed around both vena cavae and cannulas and all pulmonary veins. On cardiopulmonary bypass, the aorta and pulmonary artery were crossclamped, and the heart was isolated. Crystalloid cardioplegia at 4 degrees C containing 10(13) particles of adenovirus encoding LacZ and 15 microg of vascular endothelial growth factor was infused retrograde into the coronary sinus and recirculated for a total of 30 minutes. The dogs were then weaned from cardiopulmonary bypass and allowed to recover. With a catheter, 3 control dogs underwent retrograde infusion of the same cocktail without cardiac isolation or cardiopulmonary bypass. RESULTS: Beta-galactosidase activities in the cardiopulmonary bypass group were several orders of magnitude higher in both the right and left ventricles when compared with those in the control group (P < .05). X-gal staining from the cardiopulmonary bypass group showed unequivocal evidence of myocyte gene expression globally in a significant proportion of cardiac myocytes. No myocyte gene expression was observed in the control group. CONCLUSION: A novel cardiac surgical technique has been developed. This approach with cardiac isolation and retrograde delivery of vector through the coronary sinus results in efficient myocyte transduction in an adult large animal in vivo.

Uniform scale-independent gene transfer to striated muscle after transvenular extravasation of vector.

BACKGROUND: The muscular dystrophies exemplify a class of systemic disorders for which widespread protein replacement in situ is essential for treatment of the underlying genetic disorder. Somatic gene therapy will require efficient, scale-independent transport of DNA-containing macromolecular complexes too large to cross the continuous endothelia under physiological conditions. Previous studies in large-animal models have revealed a trade-off between the efficiency of gene transfer and the inherent safety of the required surgical and pharmacological interventions to achieve this. METHODS AND RESULTS: Rats and dogs underwent limb or hemibody isolation via atraumatic tourniquet placement or myocardial isolation via heterotopic transplantation. Recombinant adenovirus (10(13) particles per kilogram) or recombinant adeno-associated virus (10(14) genome copies/kg) encoding the lacZ transgene was delivered through pressurized venous infusion without pharmacological mediators. Muscle exhibited almost 100% myofiber transduction in rats and dogs by X-galactosidase staining and significantly higher beta-galactosidase levels compared with nonpressurized delivery. No significant difference was seen in beta-galactosidase levels between 100- or 400-mm Hg groups. The <50-mm Hg group yielded inhomogeneous and significantly lower transgene expression. CONCLUSIONS: Uniform scale- and vector-independent skeletal and cardiac myofiber transduction is facilitated by pressurized venous infusion in anatomic domains isolated from the central circulation without pharmacological interference with cardiovascular homeostasis. We provide the first demonstration of uniform gene transfer to muscle fibers of an entire extremity in the dog, providing a firm foundation for further translational studies of efficacy in canine models for human diseases.

Homograft aortic root replacement during pregnancy.

Operative cardiac interventions have been performed on pregnant women with varying degrees of success since the late 1950s. Currently, reported maternal mortality for cardiac operations is similar to the mortality rate for nonpregnant female patients. However, fetal mortality remains high, at approximately 20%. Aortic root replacement with an aortic homograft in a 34-year-old pregnant woman with bacterial endocarditis at 18 weeks gestation is presented. Fetal echocardiography during and after bypass was employed.