Infragenicular Polytetrafluoroethylene Bypass with Tapered versus Straight Vascular Grafts: Results from a Prospective Multicenter Cohort Study

Both straight and tapered arterial grafts are commonly used for infragenicular bypass surgery. Opinions vary considerably regarding the use of each type of graft and depend on individual experience, as no trial yet has assessed clinical outcomes comparing both groups. We conducted a prospective, multicenter, cohort study to analyze results for each graft type. From a total of 81 patients, 50 underwent infragenicular bypass surgery with straight PTFE prostheses and 31 with tapered prostheses in a prospective, multicenter trial. Six different centers for vascular surgery took part in the trial. In clinical follow-up at discharge as well as 3, 6, 12, 18, 24, and 36 months after revascularization, various parameters were evaluated comparing patency rates, limb salvage, and major amputation rates. Significant differences were found in limb salvage rates between the two groups. Patients receiving a straight graft fared better in this regard. Further data suggest that short-term primary patency is also improved in straight prostheses. Sixty-four percent of these remained patent after 1 year, while only 50% of tapered prostheses were still patent. No differences between the groups were found for secondary patency. The advantages of straight prostheses seem to be reduction of thrombus formation and intimal hyperplasia. Furthermore, it appears that the surgeons participating in this study prefer the use of straight prostheses. Even though the group of patients that received tapered grafts had slightly more unfavorable preoperative conditions, the data still support the superiority of straight vascular grafts. However, prospective randomized trials are necessary to evaluate the benefit of different bypass designs definitively.     

Infragenicular Bypass Graft for Limb Salvage Using Polytetrafluoroethylene and Distal Vein Cuff as the First Alternative in Patients Without Ipsilateral Greater Saphenous Vein

The objectives of this study were to evaluate the results of polytetrafluoroethylene infragenicular bypass grafts with a distal interposition vein cuff in patients with critical limb ischemia in the absence of ipsilateral greater saphenous vein. From January 1997 to June 2002, 58 consecutive below-knee bypass grafts with PTFE and distal interposition vein cuff were performed in 57 patients with a median age of 70.8 years. The distal anastomosis was located at the infragenicular popliteal artery in 18 cases and at tibial vessels in 40. Primary patency, secondary patency, and limb salvage were analyzed using the Kaplan-Meier method. During a median follow-up of 14.4 months (range, 1-50) 26 cases of graft occlusion and 19 major amputations were registered. The primary and secondary patency rates at 12, 24, and 36 months were 57%, 54%, and 47% and 61%, 58%, and 50%, respectively. Limb salvage rates reached 69%, 69%, and 59% at 12, 24, and 36 months. When below-knee revasculanzation is required in patients with limb-threatening ischemia, in the absence ipsilateral greater saphenous vein, PTFE grafts with a distal vein cuff are a reasonable substitute with acceptable long-term patency and limb salvage rates.     

Total Extracardiac Right Heart Bypass Using a Polytetrafluoroethylene Graft

A bstract Background : With regard to hemodynamics and late arrhythmias, total cavopulmonary connection has been accepted as a superior technique as compared to Fontan type procedures. However, intra-atrial baffles for lateral tunnel or conduit remain construction retain some similar disadvantages. Patients and Methods : As an alternative to total cavopulmonary connection, total extracardiac right heart bypass using a polytetrafluoroethylene tube for the inferior vena cava to pulmonary artery connection may obviate some problems. Five patients with complex heart disease necessitating one ventricle repair underwent this procedure successfully. Results : Aortic cross-clamp time ranged from 0 to 24 minutes (mean = 15.8 min). No case required takedown or an additional step. Although the follow-up periods have been relatively short (mean = 19 months), all patients are well and no arrhythmic event or thromboembolic episode has occurred. Conclusions : As a simple, safe, and reproducible procedure, total extracardiac right heart bypass is an alternative to Fontan or total cavopulmonary connection procedure.     

Patency Rates of Cuffed and Noncuffed Extended Polytetrafluoroethylene Grafts in Dialysis Access: A Prospective,Randomized Study

Background  Although autogenous arteriovenous fistulae are the optimal route for dialysis access, extended polytetrafluoroethylene (ePTFE) grafts continue to be the preferred access for patients without suitable superficial veins. Among the common complications related to dialysis grafts, thrombosis due to graft outlet stenosis is the most frequently encountered clinical problem. A cuffed graft was designed to eliminate the outflow turbulence to reduce outlet stenosis and to enhance the clinical patency of ePTFE grafts. We conducted a prospective, randomized study to compare the clinical outcomes of cuffed ePTFE grafts and noncuffed grafts in dialysis access. Methods  Between November 2004 and October 2005, 89 ePTFE grafts were implanted for hemodialysis access in the upper extremities of end-stage renal patients. Graft selection was randomized, with patients receiving a cuffed graft (Venaflo) or a regular noncuffed graft (Stretch Gore-Tex). All patients were monitored for signs of thrombosis or other complications. Primary and secondary graft patency was analyzed by using a life-table analysis, and the log-rank test was applied to compare graft patencies. Results  Demographic data for both groups were similar without statistical difference. The primary patency rates and secondary patency rates at 12 months after implantation were 56% and 91% for cuffed grafts, and 41% and 78% for noncuffed grafts, respectively. The cuffed group outperforms the noncuffed group regarding primary and secondary patencies statistically. However, the incidence of other complications that required further surgery was similar in both groups. Conclusions  This investigation revealed that the cuffed ePTFE graft, which was designed to decrease graft outlet stenosis, may enhance the clinical patency rates of dialysis grafts.     

Laparoscopic vs Open Roux-en-Y Gastric Bypass: A Prospective Randomized Trial

Background: The feasibility of laparoscopic Roux-en-Y gastric bypass (Lap-RYGBP) for morbid obesity is well documented. In a prospective randomized trial, we compared laparoscopic and open surgery. Methods: 51 patients (48 females, mean (± SD) age 36 ± 9 years and BMI 42 ± 4 kg/m²) were randomly allocated to either laparoscopy (n=30) or open surgery (n=21). All patients were followed for a minimum of 1 year. Results: In the laparoscopy group, 7 patients (23%) were converted to open surgery due to various procedural difficulties. In an analysis, with the converted patients excluded, the morphine doses used postoperatively were significantly (p< 0.005) lower in the laparoscopic group compared to the open group. Likewise, postoperative hospital stay was shorter (4 vs 6 days, p<0.025). Six patients in the laparoscopy group had to be re-operated due to Roux-limb obstruction in the mesocolic tunnel within 5 weeks. The weight loss expressed in decrease in mean BMI units after year was 14 and 13 after 1 ± 3 ± 3 laparoscopy and open surgery,respectively (not significant). Conclusions: Both laparoscopic and open RYGBP are effective and well received surgical procedures in morbid obesity. Reduced postoperative pain, shorter hospital stay and shorter sick-leave are obvious benefits of laparoscopy but conversions and/or reoperations in 1/4 of the patients indicate that Lap-RYGBP at present must be considered an investigational procedure.     

Comparison of Precuffed and Vein-Cuffed Expanded Polytetrafluoroethylene Grafts for Infragenicular Arterial Reconstructions:A Case-Matched Study

Distal vein cuff interposition is often added to prosthetic infragenicular arterial reconstruction in an attempt to improve hemodynamics and patency rates. The purpose of this study was to compare the outcome of a precuffed expanded polytetrafluroethylene (ePTFE) graft with a vein-cuffed ePTFE graft for infragenicular bypass. We reviewed the clinical outcome of 77 patients with critical limb ischemia without available autologous vein conduits who underwent arterial reconstruction of 80 limbs to below-knee popliteal or tibioperoneal vessels using either ePTFE precuffed graft (precuffed group, 38 patients 40 limbs) or ePTFE vein-cuffed graft (vein-cuffed group, 39 patient, 40 limbs). Precuffed group patients were enrolled in a prospective cohort study. Vein-cuffed group patients consisted of consecutive case-matched patients operated on during the same study period. End points were primary graft patency and limb salvage rates. There were 42 males and 35 females with a mean age of 73.4 years (range, 44-92 years). Both groups were matched to demographics, risk factors for atherosclerosis, previous ipsilateral reconstruction, and location of the distal anastomosis. Proximal anastomosis was to the common (n=68) or superficial (n=12) femoral arteries. Distal anastomosis was to the below-knee popliteal (n=28), anterior tibial (n=12), posterior tibial (n=15) and peroneal (n=25) arteries. Operative mortality was 1.3%. Graft patency at dismissal was 90% and 95% in the precuffed and vein-cuffed groups, respectively. The mean follow-up was 25.7 months (range, 2.4-61 months). Primary patency rates at 1 and 3 years were 70% and 57% in the precuffed group, and 78% and 54% in the vein-cuffed group (p=0.32). Limb salvage rates at 1 and 3 years were 97% and 70% in the precuffed group, and 95% and 81 % in the vein-cuffed group (p=0.49). Overall patient survival at 1 and 3 years was 81 % and 57%, respectively. In this case-control study, results of precuffed ePTFE graft were similar to those obtained with vein-cuffed ePTFE grafts. The precuffed ePTFE graft is an adequate alternative conduit for infragenicular arterial reconstruction in patients with critical limb ischemia and no available autologous veins.Presented at the 32^nd Annual Symposium on Vascular Surgery, Society for Clinical Vascular Surgery, Rancho Mirage, CA, March 10–13, 2004.     

A Multicenter, Randomized, Controlled Trial Comparing Bupivacaine with Ropivacaine for Labor Analgesia

Background: A meta-analysis of studies comparing high doses of bupivacaine with ropivacaine for labor pain found a higher incidence of forceps deliveries, motor block, and poorer neonatal outcome with bupivacaine. The purpose of this study was to determine if there is a difference in these outcomes when a low concentration of patient-controlled epidural bupivacaine combined with fentanyl is compared with ropivacaine combined with fentanyl.

Methods: This was a multicenter, randomized, controlled trial, including term, nulliparous women undergoing induction of labor. For the initiation of analgesia, patients were randomized to receive either 15 ml bupivacaine, 0.1%, or 15 ml ropivacaine, 0.1%, each with 5 [mu]g/ml fentanyl. Analgesia was maintained with patient-controlled analgesia with either local anesthetic, 0.08%, with 2 [mu]g/ml fentanyl. The primary outcome was the incidence of operative delivery. We also examined other obstetric, neonatal, and analgesic outcomes.

Results: There was no difference in the incidence of operative delivery between the two groups (148 of 276 bupivacaine recipients vs. 135 of 279 ropivacaine recipients;P = 0.25) or any obstetric or neonatal outcome. The incidence of motor block was significantly increased in the bupivacaine group compared with the ropivacaine group at 6 h (47 of 93 vs. 29 of 93, respectively;P = 0.006) and 10 h (29 of 47 vs. 16 of 41, respectively;P = 0.03) after injection. Satisfaction with mobility was higher with ropivacaine than with bupivacaine (mean +/- SD: 76 +/- 23 vs. 72 +/- 23, respectively;P = 0.013). Satisfaction for analgesia at delivery was higher for bupivacaine than for ropivacaine (mean +/- SD: 71 +/- 25 vs. 66 +/- 26, respectively;P = 0.037).     

A Multicenter, Randomized Trial Comparing Calcium Hydroxylapatite to Two Hyaluronic Acids for Treatment of Nasolabial Folds

INTRODUCTION In this study, we examined Radiesse (calcium hydroxylapatite; CaHA), Juvederm 24 (hyaluronic acid; HA-1A), Juvederm 24HV (HA-1B), and Perlane (HA-2) for patient satisfaction, likelihood to return, immediate efficacy, and duration of correction.
OBJECTIVE This multicenter, blinded, randomized study compares patient satisfaction variables, efficacy, and durability of CaHA gel and HA for correction of nasolabial folds (NLFs) through 12 months after 4-month touch-up.
METHODOLOGY A total of 205 randomized patients received either CaHA gel or HA for NLF treatment at initial visit and 4-month touch-up. Patients returned at 4, 8, and 12 months after the second injection for evaluation. Surveys measured patient satisfaction; effectiveness measures included the Global Aesthetic Improvement Scale (GAIS).
RESULTS More CaHA gel patients were satisfied or extremely satisfied than each HA tested. At 8 months, significantly more CaHA gel–treated NLFs were improved on the GAIS than any HA. The volumes of CaHA gel and three HA materials injected through 4 months were 2.2, 2.9, 4.8, and 2.9 mL, respectively ( p <.005). No serious adverse events were observed.
CONCLUSIONS In this controlled study, CaHA gel ranked highest in patient satisfaction and likelihood to return. The material was more effective and longer lasting than each HA in maintaining NLF augmentation.     

A Prospective, Double-Blind, Multicenter, Randomized Trial Comparing Ertapenem 3 Vs ≥5 Days in Community-Acquired Intraabdominal Infection

Severe secondary peritonitis is diagnosed in only 20–30% of all patients, but studies to date have persisted in using a standard fixed duration of antibiotic therapy. This prospective, double-blind, multicenter, randomized clinical study compared the clinical and bacteriological efficacy and tolerability of ertapenem (1 g/day) 3 days (group I) vs ≥5 days (group II) in 111 patients with localized peritonitis (appendicitis vs non-appendicitis) of mild to moderate severity, requiring surgical intervention. In evaluable patients, the clinical response as primary efficacy outcome were assessed at the test-of-cure 2 and 4 weeks after discontinuation of antibacterial therapy. Ninety patients were evaluable. In groups I and II, 92.9 and 89.6% of patients were cured, respectively; 95.3% in group I and 93.7% in group II showed eradication. These differences were not statistically significant. The most frequent bacteria recovered were Escherichia coli and Bacteroides fragilis. A wound infection developed in seven patients (7.7%) and an intraabdominal infection in one patient (1.1%). There was a low frequency of drug-related clinical or laboratory adverse effects in both groups. Our study demonstrated that, in patients with localized community-acquired intraabdominal infection, a 3-day course of ertapenem had the same clinical and bacteriological efficacy as a standard duration. Italian study group: Paolo Mazzocchi, Luigi Solinas, and Fulvio D’Ostuni, Department “Paride Stefanini”, University “La Sapienza”, Rome, Italy; Roberto Caronna, Department of Emergency Surgery, University “ La Sapienza”, Rome, Italy; Antonino Buffone, Department of Emergency Surgery, University of Catania, Catania, Italy; Teresa Verde and Claudia Massaiu, Department of Emergency Surgery, University of Sassari, Sassari, Italy; Dario Di Miceli, Department of Surgery, Catholic University of Rome, Rome, Italy; Salvatore Di Muria, Department of Surgery, S. Giovanni Bosco Hospital, Naples, Italy; Edoardo Cervi, Department of Surgery, University of Brescia, Brescia, Italy; Fausto Catena, Department of Emergency Surgery, University of Bologna, Bologna, Italy; Massimo Coletti and Stefano Scozzafava, Department of Emergency Surgery, University “La Sapienza”, Rome, Italy This paper was presented at the 20th meeting of the International Society for Digestive Surgery, Rome, Italy, November 29–December1, 2006.