Three-year outcome of the heparin-bonded Viabahn for superficial femoral artery occlusive disease.

OBJECTIVE: Self-expanding covered stents for superficial femoral artery (SFA) occlusive disease have undergone an evolution during the years. Early results of the latest generation, the heparin-bonded Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) with a contoured proximal edge, were promising, with reported 1-year primary patency rates of 73% to 78% in long lesions. The aim of this study was to present the 3-year outcome of the heparin-bonded Viabahn for SFA occlusive disease. METHODS: All patients treated with a heparin-bonded Viabahn in three centers between April 2009 and December 2011 were included in the study and retrospectively analyzed. Clinical state in Rutherford category, ankle-brachial indexes, and duplex ultrasound scans were the features of follow-up at 6 weeks and 6, 12, 24, and 36 months. Primary end points of the study were the 3-year primary, primary assisted, and secondary patency rates. RESULTS: A total of 73 SFAs in 70 patients were treated with a heparin-bonded Viabahn and included in the study. Fifty-four patients were male (77%), and the mean age was 70.0 ± 9.1 years. The mean lesion length was 17.4 ± 7.0 cm, and 84% were classified TransAtlantic Inter-Society Consensus II types C and D. The median follow-up was 25 months (range, 2-55 months). The 3-year primary, primary assisted, and secondary patency rates were 59%, 71%, and 82%, respectively, with a 3-year freedom from amputation of 100%. CONCLUSIONS: The use of a heparin-bonded Viabahn for SFA occlusive disease is related to patency rates within limits of surgical reconstruction. The procedure is related to low morbidity and amputation rates.

Conservative Treatment in Selected Patients with Severe Critical Limb Ischemia.

OBJECTIVE: To assess the outcome of conservative treatment of severe critical limb ischemia (CLI) classified as Rutherford 5/6. BACKGROUND: The preferred therapy for CLI is either endovascular revascularization or bypass surgery. With a growing aged population with more serious comorbidities, these therapies are not always a viable option. Primary amputation leads to decreased mobility and a reduced quality of life. There is a lack of literature regarding the outcome of conservative therapy. METHODS: Hospital charts were reviewed of all patients who were diagnosed with Rutherford classification 5-6 and received conservative treatment and lacked interventional options. Outcome measures were mortality, complete wound closure, and limb salvage rate. RESULTS: 38 patients were included with a median age of 80 years (range 57-97). The amputation rate during follow-up was 16%. In 58% of patients, complete wound closure was achieved. All-cause mortality was 58% with a 2-year survivability rate of 55%. CONCLUSIONS: Conservative management in our selected patients with CLI results in a moderate rate of wound closure and acceptable amputation rates albeit with a high mortality rate. For patients not eligible for endovascular revascularization or bypass surgery, conservative treatment could be a viable option besides primary limb amputation.

The outcome of failed endografts inserted for superficial femoral artery occlusive disease.

OBJECTIVE: Endografts represent a relatively new treatment modality for occlusive disease of the superficial femoral artery, with promising results. However, endografts may occlude collateral arteries, which may affect outcome in case of failure. The purpose of this study was to analyze the clinical outcome of failed endografts in patients with superficial femoral artery occlusive disease. METHODS: All patients treated with one or more polytetrafluorethylene-covered stents between November 2001 and December 2011 were prospectively included in a database. Patients with a failure of the endograft were retrospectively analyzed. Clinical and hemodynamic parameters were assessed before the initial procedure and at the time of failure. Outcome of secondary procedures was analyzed. RESULTS: Among the 341 patients who were treated during the study period, 49 (14.4%) failed during follow-up. Mean (standard deviation) Rutherford category at failure did not differ from the category as scored before the initial procedure (3.1 [1.3] vs 3.3 [0.6]; P = .33). Forty-three percent of patients (n = 21) presented with the same Rutherford category as before the initial procedure, 37% (n = 18) with an improved category, and 20% (n = 10) with a deteriorated category. The ankle-brachial index was significantly lower at the time of failure (0.66 [0.19] vs 0.45 [0.19[; P <.002). Seventy-six percent of patients with a failure needed secondary surgery, of which 25% were below knee. The 1-year primary, primary-assisted, and secondary patency rates of secondary bypasses were 55.1%, 62.3%, and 77.7%, respectively. The amputation rate was 4.1% (n = 2). CONCLUSIONS: Failure of endografts is not associated with a deterioration in clinical state and is related to a low amputation rate. The hypothesis that covered stents do not affect options for secondary reconstructions could not be confirmed, as 25% of patients with a failure underwent a below-knee bypass. Secondary surgical bypasses are correlated with poor patency. The amputation rate after failure is low.

Outcome of thrombolysis and thrombectomy for thrombosed endografts inserted in the superficial femoral artery for occlusive disease.

PURPOSE: To evaluate the efficacy and outcome of thrombolysis and thrombectomy for thrombosed polytetrafluoroethylene stent-grafts inserted in the superficial femoral artery (SFA) for occlusive disease. METHODS: A retrospective review was conducted of 79 consecutive patients with a thrombosed SFA endograft between November 2001 and December 2011. Of these, 46 (58%) were treated with thrombolysis (n=40, 87%) or thrombectomy (n=6, 13%) and form the study group (33 men; median age 66.8 years, range 30-80). Median time from stent-graft insertion to thrombosis was 3 months (range 0-53). RESULTS: Thrombolysis was successful in 38 (95%) patients over a mean 24 hours (range 3-48); one patient had failed lysis and another died during lytic treatment. Thrombectomy was successful in all 6 patients. Thrombosis without a causal lesion was significantly more common in occlusions that presented <30 days after insertion (p=0.01). Over a median follow-up of 14 months (range 1-69), reinterventions were performed for restenosis in 12 patients and reocclusion in 14 patients, all within 18 months after thrombolytic treatment. More than a third of patients (16/45) had definitive failures (2/6 from the thrombectomy group); 4 were treated conservatively (no/minor symptoms) and 12 had bypass grafts. Three (7%) patients eventually required a major amputation. The primary, assisted primary, and secondary patency rates of thrombolysis at 6 months were 56%, 56%, and 68%, respectively. Secondary patency for the entire cohort was 58% at 1 year. CONCLUSION: Thrombolysis and thrombectomy of thrombosed endografts in the SFA is effective and safe. Patency rates after treatment are moderate, but prolonged secondary patency can be achieved.

Results of heparin-bonded ePTFE-covered stents for chronic occlusive superficial femoral artery disease.

OBJECTIVE: The purpose of this study was to assess the 1-year patency rates of heparin-bonded covered stents in the treatment of chronic occlusive disease of the superficial femoral artery (SFA). METHODS: All patients treated with a heparin-bonded endograft between April 2009 and October 2010 for chronic occlusive disease of the SFA were prospectively gathered in a database and retrospectively analyzed. Primary, primary-assisted, and secondary patency rates, assessed by ultrasound scanning, were analyzed at 1-year, as were the complication rates and mortality. RESULTS: A total of 56 limbs were treated with a heparin-bonded covered stent in 53 patients for chronic ischemia Rutherford category 3 (n = 36), 4 (n = 5), 5 (n = 11), and 6 (n = 1). Lesions were classified as TransAtlantic Inter-Society Consensus (TASC)-2-B (n = 9), C (n = 14), and D (n = 33), and the mean treated lesion length was 18.5 ± 7.7 cm. Postoperative complications occurred in 7.5%, including hematoma (n = 1), edema (n = 1), pneumonia (n = 1), and urinary retention (n = 1), and the 30-day mortality rate was 0%. The mean follow-up was 413 ± 208 days. At 1 year, the primary patency was 76%, the primary-assisted patency 82%, and the secondary patency 89%. The limb salvage rate was 100%. CONCLUSIONS: Heparin-bonded covered stents seem to provide a valid alternative to surgical treatment of long occlusive lesions in the SFA. Randomized trials and long-term data are required before considering the technique as a new standard of care.

The combined ipsilateral antegrade-retrograde approach to insert an endoluminal femoropopliteal bypass.

The endoluminal femoropopliteal bypass is a minimally invasive treatment modality for occlusive superficial femoral artery disease. Technical failure of endovascular treatment of chronic total occlusions is often caused by the inability to re-enter the true lumen. Re-entry devices have a high technical success-rate, but increased procedural costs. We describe an alternative technique using an ipsilateral combined antegrade-retrograde approach to insert an endoluminal femoropopliteal bypass. In a supine position, with the leg elevated at 30 degrees, the popliteal artery is punctured and a 4F introducer sheath is introduced. The occlusion is crossed from distal to proximal and the wire is advanced through a 6F sheath that is positioned in the common femoral artery. The occlusion is predilated from proximal and the "re-entry" site is identified on an angiogram. The wire is then withdrawn into the balloon catheter and advanced intraluminally into one of the crural vessels. After confirming the intraluminal position of the wire, the 4F sheath is removed, and the endoluminal bypass is created in a standardized fashion. The ipsilateral antegrade-retrograde approach is a fast, inexpensive, and easy-to-learn technique, using standard materials only. The distal entry of the occlusion will lead to a minimization of the length of the endoluminal bypass, thereby possibly sparing collaterals and future surgical options.

1-Year Results of a Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endoluminal to Femoropopliteal Bypass.

OBJECTIVES: This study sought to compare heparin-bonded endografts with femoropopliteal bypass, including quality of life, using general health and disease-specific questionnaires as well as patency rates. BACKGROUND: Endovascular treatment continues to advance and is gaining acceptance as primary treatment for long occlusive or stenotic lesions in the superficial femoral artery. Heparin-bonded expanded polytetrafluoroethylene endografts have been related to outcomes comparable to bypass surgery, but this has not been tested in a randomized fashion. METHODS: A multicenter randomized-controlled trial was performed comparing femoropopliteal bypass with heparin-bonded expanded polytetrafluoroethylene endografts. Data were analyzed on an intention-to-treat and per-protocol manner. RESULTS: A total of 129 patients were randomized and 125 patients were treated, 63 in the endoluminal and 62 in the surgical group (42 venous, 20 prosthetic). Enrollment was terminated before reaching the predefined target number for patency. Baseline characteristics and anatomical data were similar. Patients were treated for critical limb ischemia in 38.1% and 32.2% in the endoluminal and surgical arms, respectively. Mean lesion length was 23 cm in both groups and lesions were largely TransAtlantic Inter-Society Consensus II D. Hospitalization time and 30-day morbidity were significantly lower in the endoluminal group, without differences in serious adverse events (n = 5 each; surgical: 4 venous and 1 polytetrafluoroethylene bypass). There were no significant differences in Rutherford category between groups at any time point. At 30 days the endoluminal group showed a greater improvement in quality-of-life scores. At 1 year, these differences had largely disappeared and no differences in primary (endoluminal: 64.8%; surgical: 63.6%), assisted primary (endoluminal: 78.1%; surgical: 79.8%), secondary patency (endoluminal: 85.9%; surgical: 83.3%), and target vessel revascularization (endoluminal: 72.1%; surgical: 71.0%) were observed. Limb salvage rate was 100% in both groups. CONCLUSIONS: Heparin-bonded endoluminal bypass for long segment lesions shows promising results (less morbidity, faster recovery, and improvement in quality of life with indistinguishable patency rates at 1 year) compared with surgical bypass. Long-term results have to be awaited.

SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial.

BACKGROUND: Endovascular treatment options for the superficial femoral artery are evolving rapidly. For long lesions, the venous femoropopliteal bypass considered to be superior above the prosthetic bypass. An endoluminal bypass, however, may provide equal patency rates compared to the prosthetic above knee bypass. The introduction of heparin-bonded endografts may further improve patency rates. The SUrgical versus PERcutaneous Bypass (SuperB) study is designed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life, related to a decreased complication rate, or not. METHODS/DESIGN: Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous whenever possible, and 2. the heparin-bonded endoluminal bypass. The power analysis was based on a non-inferiority principle, with an effect size of 90% and 10% margins (alpha 5%, power 80%). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is primary patency and quality of life evaluated by the RAND-36 questionnaire and the Walking Impairment Questionnaire. Secondary endpoints include secondary patency, freedom-from-TLR and complications. DISCUSSION: The SuperB trial is a multicentre randomized controlled trial designed to show non-inferiority in patency rates of the heparin-bonded endograft compared to the surgical bypass for treatment of long SFA lesions, and to prove a better quality of life using the heparin bonded-endograft compared to surgically treatment, related to a reduction in complications. TRIAL REGISTRATION: Clinicaltrials: NCT01220245.

Peritoneal transforming growth factor beta-1 expression during prolonged laparoscopic procedures.

BACKGROUND: Laparoscopic surgery may affect peritoneal physiology. Short-term laparoscopic surgery does not affect peritoneal transforming growth factor beta (TGF-b1) expression. The current study was conducted to evaluate the hypothesis that prolonged laparoscopic surgery may affect peritoneal TGF-b1 expression. STUDY DESIGN: In the first study, 24 patients scheduled for a right colonic resection were enrolled in the trial. Twelve underwent conventional surgery (CCR) and 12 were operated on laparoscopically (LCR). In the second study, 12 patients undergoing laparoscopic gastric bypass (LGB) surgery for morbid obesity were included. Biopsies of the parietal peritoneum were taken at standardized moments during the procedures. Tissue concentrations of active and total TGF-b1 were measured by using enzyme-linked immunosorbent assays. RESULTS: During the LCR, there was a significant increase in peritoneal active TGF-b1 levels (P < 0.05). A similar, but not significant, trend was observed during the CCR. A similar pattern was seen in the total TGF-b1 concentrations during both procedures. The LGB procedure did not affect peritoneal active or total TGF-b1 concentrations. During the procedure, both the active and total TGF-b1 levels were significantly higher in the LCR, when compared to the LGB, group (P < 0.05). CONCLUSIONS: Prolonged laparoscopic surgery may affect peritoneal TGF-b1 expression, depending on the procedure performed. Considering the role of TGF-b1 in various biologic processes, including adhesiogenesis and oncology, these results may have clinical consequences.

Decreased peritoneal expression of active transforming growth factor ß1 during laparoscopic cholecystectomy with heated carbon dioxide.

BACKGROUND: Laparoscopic surgery involves the establishment of a pneumoperitoneum, mostly using carbon dioxide. Cooling of the peritoneum, due to insufflation, may traumatize the peritoneum and disturb local biological processes. The current study was performed to assess the effect of the temperature of carbon dioxide on peritoneal transforming growth factor ß1 (TGF-ß1) expression. DESIGN: Patients were randomized into 2 groups. In one group, a pneumoperitoneum was created with carbon dioxide at room temperature; in the other, with carbon dioxide at body temperature. Peritoneal biopsy specimens were taken at the start and end of surgery. SETTING: Community hospital. PATIENTS: Thirty patients scheduled for laparoscopic cholecystectomy. MAIN OUTCOME MEASURES: Tissue concentrations of total and active TGF-ß1 were measured using enzyme-linked immunosorbent assays. RESULTS: At the start of surgery, there were no significant differences between groups in the total and active fractions of TGF-ß1. At the end of the procedure, the peritoneal active TGF-ß1 concentrations were significantly lower (P = .03) in patients receiving carbon dioxide at body temperature. In contrast, the concentrations of total TGF-ß1 did not differ between groups. A slight, nonsignificant increase in total and active TGF-ß1 levels was observed in patients receiving unheated carbon dioxide. The ratio of active to total TGF-ß1 did not change during procedures, and there were no differences between groups. CONCLUSIONS: Heating of carbon dioxide, used for insufflation, to body temperature decreases the expression of active TGF-ß1 in the peritoneum. Considering the broad biological effects of TGF-ß1, including the regulation of peritoneal healing and oncological processes, this observation might have clinical repercussions.