Oded Olsha

Angioplasty with stent graft versus bare stent for recurrent cephalic arch stenosis in autogenous arteriovenous access for hemodialysis: A prospective randomized clinical trial

BACKGROUND Early recurrent stenosis of the cephalic arch in autogenous arteriovenous access for hemodialysis is a common problem that requires stenting to prevent thrombosis. Because the results of stenting are unsatisfactory, we compared the efficacy of stent grafts with bare stents in these patients. METHODS All patients who presented with recurrent cephalic arch stenosis >50% within 3 months of successful balloon angioplasty were randomized to have angioplasty and stenting with either a bare nitinol stent or a stent graft. Outcome was assessed by angiography 3 months later. Restenosis was defined as >50% narrowing of the stent lumen or of the vessel margin up to 0.5 cm adjacent to the stent. There were no exclusions. RESULTS This report includes data on the outcome of 25 consecutive patients with recurrent cephalic arch stenosis who were treated from April to August 2006. At 3 months, three patients had died and one had undergone a renal transplant. The 21 patients who had angiography at 3 months had patent stents. Restenosis rates were seven of 10 (70%) in the bare stent group and two of 11 (18%) in the stent graft group (P = .024). Life-table analysis at 3 and 6 months showed that primary patency was 82% in the stent graft group and 39% in the bare stent group. One-year primary patency was 32% in the stent graft group and 0% in the bare stent group (P = .0023). During a mean follow-up of 13.7 months, nine patients died, four in the bare stent group and five in the stent graft group. Two patients in the stent graft group had received a renal transplant. The number of interventions per patient-year was 1.9 in the bare stent group and 0.9 in the stent graft group (P = .02). CONCLUSIONS The use of stent grafts in angioplasty for recurrent cephalic arch stenosis significantly improved short-term restenosis rates and long-term patency compared with the use of bare stents. The significant improvement that emerged during the study caused accrual of patients to be halted for ethical reasons. This study altered our usage of stents for venous stenoses in arteriovenous accesses by eliminating bare nitinol stents in favor of stent grafts.

A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery

BACKGROUND This randomized, double-arm trial was designed to study the benefit of a novel device (MarginProbe, Dune Medical Devices, Caesarea, Israel) in intraoperative margin assessment for breast-conserving surgery (BCS) and the associated reduction in reoperations. METHODS In the device group, the probe was applied to the lumpectomy specimen and additional tissue was excised according to device readings. Study arms were compared by reoperation rates and by correct surgical reaction confirmed by histology. RESULTS Three hundred patients were enrolled. Device use was associated with improved correct surgical reaction, defined as additional re-excision in all histologically detected positive margins, with tumor within 1 mm of inked margin. The repeat lumpectomy rate was significantly reduced by 56% in the device arm: 5.6% versus 12.7% in the control arm. There were no differences in excised tissue volume or cosmetic outcome. CONCLUSIONS Intraoperative use of the MarginProbe for positive margin detection is safe and effective in BCS and decreases the rate of repeat operations.

Stent graft treatment for hemodialysis access aneurysms

BACKGROUND Aneurysms that develop in arteriovenous accesses as a result of repeated punctures are sometimes complicated by infection or ischemia causing sloughing of the overlying skin, which may endanger the access and risk major bleeding and other complications. Surgical revision may necessitate the temporary use of a central venous catheter until dialysis can be resumed via the access. We used stent grafts in selected patients for the exclusion of access aneurysms. METHODS Twenty of 63 patients requiring access revision for complication of an aneurysm from February 2005 to December 2009 underwent ambulatory endovascular stent graft deployment. Indications included signs of impending rupture, questionable viability of overlying skin, pain, infection, and limitation of cannulation sites by the size or number of the aneurysms. Endovascular treatment always included angioplasty of associated outflow or central vein stenoses at the same ambulatory session. RESULTS Twenty patients with complicated access aneurysms were treated by endovascular stent graft exclusion at an average of 4.8 ± 4.3 years (range, 0.2 to 16.1 years) after access construction: nine graft pseudoaneurysms, nine native vein aneurysms, and two acute iatrogenic pseudoaneurysms. Six patients had skin erosion over the aneurysm, and 12 had painful aneurysms and clinical signs of compromised blood supply to the skin. Another two patients with an acute giant false aneurysm occurring during endovascular procedures were treated in the same interventional session by the stenting technique to control bleeding. All the aneurysms underwent endovascular exclusion without complications. Only one infected puncture site failed to heal within 2 months of stenting and was closed surgically 10 months later due to persistent localized graft infection, but with no further bleeding episodes. Only one aneurysm did not reabsorb within 3 months. Patients with painful skin ischemia had immediate pain relief. All patients also had stenosis in the draining veins necessitating additional percutaneous transluminal angioplasty. Only one patient required hospitalization (for intravenous antibiotic treatment of staphylococcal sepsis). No patients required a central catheter for hemodialysis. One access occluded due to cephalic arch stenosis in a noncompliant patient. Functional patency was 87% at 12 months, with a median follow-up of 15 months (range, 6.3 to 55.5 months). CONCLUSION Endovascular treatment with stent grafts in complicated access aneurysms is a simple, safe and rapid ambulatory procedure that enables treatment of both the aneurysm and its accompanying draining vein stenosis. It enables continued cannulation of the existing access and avoids the use of central catheters.

PRIMARY FOREARM ARTERIOVENOUS FISTULA FOR HEMODIALYSIS ACCESS AN INTEGRATED APPROACH TO IMPROVE OUTCOMES

PURPOSE Maximizing the ratio of primary arteriovenous fistula (PAVF) over bridge graft fistula (BGF) for hemodialysis access is a primary recommendation of the National Kidney Foundation published as Dialysis Outcomes Quality Initiative (DOQI). Imaging, anesthetic and surgical techniques were taken into account to achieve this and other goals, including extensive use of forearm vessels to lower immediate and early failure rates and prolong the useful life of PAVFs. DESIGN Prospective non-randomized study. METHODS High-resolution duplex ultrasonography (DUS) was added to careful clinical assessment in planning and follow-up of the dialysis access. Brachial plexus block, which allowed the use of an arterial tourniquet and gave a postoperative sympathectomy type effect, was used for anesthesia, and together with meticulous surgical technique, prevented spasm. Access puncture, post-operative follow-up and surgical revisions were planned in close cooperation with the nephrology team. FINDINGS Ninety (57.3%) of the 157 fistulas constructed for new hemodialysis access between August 1998 and March 2000 were PAVFs. Seventy-three (81.1%) of these were confined to the forearm and comprise the study population, with a mean follow-up of 8.4+/-4.4 months. There were no immediate failures in the study group. The early failure rate (1 month) was 6.8% and revisions based on DUS were easily accomplished in all cases. The one year assisted primary patency rate was 81.8% and the secondary patency rate at 18 months was 98.6%. CONCLUSIONS DUS for planning and follow-up of PAVF along with careful surgical technique under a brachial plexus blockade can achieve a PAVF/BGF ratio well above 50% with a low early failure rate and a high secondary patency rate. Algorithms are presented to achieve these goals.

Vascular access in hemodialysis patients older than 80 years.

OBJECTIVE There is a worldwide surge in numbers of elderly people requiring hemodialysis accompanying the prevailing increase in longevity. There is a trend for central venous catheters to be preferentially placed in elderly patients, whereas others recommend routine use of grafts for surgical access. In our center, age has not been a consideration in deciding to construct arteriovenous access for hemodialysis. We reviewed our experience with arteriovenous access surgery in all hemodialysis patients aged 80 years and older to determine if this approach is justified in terms of patency and life expectancy. METHODS A retrospective study was made of all patients aged 80 years and older who had surgery from January 2005 to December 2009 at our national vascular access referral center. All patients had preoperative mapping and had fistula construction if the vein size was at least 3 mm. Otherwise they had brachiobasilic or brachioaxillary grafts. All patients had routine access surveillance by Doppler ultrasound (duplex) and physical examination at regular intervals, and interventions were carried out according to the findings. Type of access, success rate, maturation, primary and secondary patency, and patient survival in the age group older than 80 years were noted. RESULTS During the study period, 134 patients had 146 new accesses. There were 128 autogenous accesses (30 forearm, 91 upper arm, and seven transposed basilic veins) and 18 prosthetic accesses. Overall primary patency was 39%, 33%, and 23% at 12, 24, and 36 months. Secondary patency was 92%, 83%, and 77% at 12, 24, and 36 months. There was no significant difference in patency between the different types of accesses and between diabetic and nondiabetic patients. Eleven upper arm and four forearm fistulas had delayed maturation or nonmaturation. The relative risk for delayed maturation or nonmaturation of forearm fistulas (13.3%) compared with brachial-cephalic fistula (12.1%) was 1.1030 (95% confidence interval, 0.3973-3.204; P = .8571). Median patient survival was 38 months, with 49 dying during follow-up. CONCLUSIONS Contrary to recent recommendations favoring grafts for hemodialysis in patients older than 80 years, most elderly patients in this study were found to have vasculature that was suitable for autogenous access construction, with patency rates similar to those of their younger counterparts when adequate preoperative planning and postoperative maintenance were carried out. Age alone should not disqualify patients older than 80 years from access surgery for hemodialysis, nor should age disqualify these patients from the Fistula First Initiative.

Intraoperative Palpation for Clinically Suspicious Axillary Sentinel Lymph Nodes Reduces the False-Negative Rate of Sentinel Lymph Node Biopsy in Breast Cancer

Abstract:  Axillary sentinel lymph node biopsy (SLNB) is widely used to identify the first lymph node draining breast tumors. When the sentinel lymph node is free of metastasis, axillary dissection is avoided because the rest of the nodes are expected to be negative as well. A false‐negative rate of 5% is considered acceptable. In the case of a false‐negative SLNB, adjuvant local and systemic treatments might be suboptimal. We assessed the effect of intraoperative axillary palpation for clinically suspicious lymph nodes that are not otherwise detected by radioactive tracer or blue dye on the false‐negative rate of SLNB in breast cancer patients. Our prospective database of patients having surgery for primary invasive breast cancer and who had a SLNB from 2000 to 2004 was reviewed. Only patients with clinically negative nodes preoperatively were included. The procedure included preoperative injection of radiotracer, with dye injection as backup, and intraoperative palpation of the axilla for suspicious lymph nodes that were not radioactive or blue. Of the 290 patients, 89 (30.7%) had sentinel node involvement by tumor. Seven patients had clinically suspicious nodes identified solely by palpation and not by tracer, in addition to sentinel lymph nodes detected by tracer. In five of the seven patients, the nodes harbored metastasis. In four of these five patients (4.5% of the 89 patients with axillary involvement), the palpable nodes were the only ones involved. A generous axillary incision and systematic palpation of the axilla reduces the false‐negative rate and should be a part of the SLNB procedure.

Precision of In-Hospital Triage in Mass-Casualty Incidents after Terror Attacks

INTRODUCTION Proper management of mass-casualty incidents (MCIs) relies on triage as a critical component of the disaster plan. OBJECTIVE [corrected] The objective of this study was to assess the precision of triage in mass-casualty incidents. METHODS The precision of decisions made by two experienced triage officers was examined in two large MCIs. These decisions were compared to the real severity of injury as defined by the Israeli Defence Forces (IDF) classification of severity of injuries and the Injury Severity Score (ISS). RESULTS Two experienced trauma physicians triaged a total of 94 casualties into 77 mild, seven moderate, and 10 severe casualties. Based on the IDF criteria, there were 74 mild, five moderate, and 15 severe casualties. Based on ISS scoring, there were 78 mild (ISS <9), five moderate (9 < or = ISS < 16), and 11 severe (ISS <16) casualties. Of 15 severely injured victims defined by the IDF classification of injury severity, the triage officers identified only seven (47%). CONCLUSION Primary triage, even when carried out by experienced trauma physicians, can be unreliable in a MCI.

A prospective randomized study of heparin-bonded graft (Propaten) versus standard graft in prosthetic arteriovenous access

OBJECTIVE Prosthetic grafts continue to be required for hemodialysis access when the options for native fistulas have been exhausted. The inferior long-term patency of grafts makes the possibility of preventing occlusion with heparin-bonded grafts an attractive alternative. We carried out a prospective randomized study to compare the patency of standard grafts with heparin-bonded grafts. METHODS Patients with end-stage renal failure requiring a prosthetic access were randomized to receive either a standard expanded polytetrafluorethylene (ePTFE) graft or a heparin-bonded ePTFE graft. Patients were enrolled from June 2007 until November 2011 and were followed up until July 2013, when the study concluded. RESULTS In this study, 160 patients were randomized and followed up for a median of 23.5 months. No patient was lost to follow-up. Primary patency was 35% and 14% for heparin-bonded grafts and 29% and 12% for standard ePTFE grafts at 6 and 12 months, respectively (P = .48). Assisted primary patency was 54%, 41%, and 27% for heparin-bonded grafts and 41%, 30%, and 23% for standard grafts at 12, 24, and 36 months, respectively (P = .12). Secondary patency was 83%, 83%, and 81% for heparin-bonded grafts and 81%, 73%, and 68% for standard grafts at 12, 24, and 36 months, respectively (P = .33). There were significantly fewer thromboses in heparin-bonded grafts during the first 5 months (P = .020). Of 80 standard grafts, 24 were eventually abandoned vs 17 heparin-bonded grafts (P = .188). Bleeding complications, infections, and intervention rates were similar in both groups. CONCLUSIONS Heparin-bonded grafts demonstrated a trend to improved patency, but the difference was not statistically significant. Heparin-bonded grafts had a significantly lower early thrombosis rate that was sustained only for the first 5 months of follow-up.

Thrombolysis for early failure of prosthetic arteriovenous access.

BACKGROUND Early failure (within 6 weeks of construction) of prosthetic arteriovenous access (AVA) is traditionally treated by surgical revision rather than endovascular intervention because it is assumed to be related to technical factors related to the surgery. This premise is not evidence based and our results for surgical thrombectomy have been poor. Based on our previous experience with angiography and thrombolysis in newly constructed autogenous AVAs, we changed our approach to perform endovascular thrombolysis initially, instead of proceeding directly to surgical revision. METHODS We prospectively studied all patients who had an early failure of new prosthetic AVA from January 2000 to June 2004 to determine the cause of and treat the occlusions by endovascular means. Thrombolysis took place at least 7 days after surgery, allowing sufficient tissue incorporation to prevent puncture site bleeding. No patients were excluded from the study. RESULTS During the 54 months of the study, 269 prosthetic AVAs were constructed at our center. Twenty patients had early occlusion. The mean time from creation of the prosthetic AVA to occlusion was 15.8 +/- 10.9 (median 13, range 3-41) days and the mean time to intervention was 25.0 +/- 11.6 (median 21, range 9-54) days. Of the 20 patients, 17 underwent successful endovascular thrombolysis. The only patient of the 20 found to have a technical problem related to surgery had this resolved angiographically. There was one complication in a patient with failed endovascular thrombolysis, who had extravasation from the arterial anastomosis that halted the procedure. This patient later had surgical revision in keeping with the angiographic findings. Cumulative patency rates at 6 months and 1 year were 75% and 68%, respectively. CONCLUSIONS Endovascular thrombolysis for early occlusion of prosthetic AVAs is feasible, safe, and is associated with a good patency rate. It appears to be a better initial approach than surgical revision in these patients because technical-surgical problems related to AVA construction are rare.

Stent Grafts for Central Venous Occlusive Disease in Patients with Ipsilateral Hemodialysis Access

PURPOSE To assess long-term outcomes of stent grafts in patients with symptomatic central venous stenoses and occlusions ipsilateral to hemodialysis grafts or fistulas. MATERIALS AND METHODS The study included 52 of 55 consecutive patients with symptomatic stenoses of the central veins draining upper limb dialysis access grafts or fistulas treated with stent grafts. Indications for stent grafts were poor angioplasty results, rapid recurrence, or total occlusion. Endpoints were lesion patency and access patency following intervention. Mean follow-up was 25 months with a median of 24 months and 1.25 additional procedures per patient year. Patency rates were calculated using Kaplan-Meier analysis. RESULTS All stent grafts were successfully deployed. The lesion patency rates at 6, 12, 24, and 36 months after intervention were 60%, 40%, 28%, and 28%. The access patency rates at 6, 12, 24, and 36 months after intervention were 96%, 94%, 85%, and 72%. There was one major complication and no minor complications. In 40 patients (77%), the internal jugular vein confluence was covered by the stent graft. In five patients, the dialysis circuits became occluded, with no clinical sequelae in four; one patient was lost to follow-up. The contralateral brachiocephalic vein was covered in three patients (6%), preventing contralateral access construction in one patient. CONCLUSIONS Central vein stent graft placement in patients with hemodialysis access is associated with prolonged access patency. Coverage of major vein confluences, which occurred in 83% of the patients in this series, can compromise future access and should be avoided whenever possible by careful technique.