Hosam F. El-Sayed

Early Experience With a Novel Hybrid Vascular Graft for Hemodialysis Access Creation in Patients With Disadvantaged Anatomy

Purpose: To describe the use of the Hybrid vascular graft in disadvantaged anatomy for hemodialysis access creation and compare outcomes to standard-wall polytetrafluoroethylene (PTFE) grafts. Methods: In a retrospective analysis, 25 patients (mean age 65±14 years; 13 men) who received the Hybrid graft were compared with 35 contemporaneous patients (mean age 63±12 years; 20 men) who received a standard PTFE graft for hemodialysis access over a 2-year period. Criteria for Hybrid graft placement were (1) exhausted or inadequate peripheral veins for arteriovenous fistula (AVF) creation and concomitant small target veins that precluded conventional PTFE graft placement, (2) previous graft anastomosis or a stent in the venous target at the level of the axilla, or (3) failed brachial-basilic or brachial-brachial upper arm transposition AVF with a small target vein at the axilla. Efficacy, anatomic and clinical considerations, and technique were reviewed; patency rates, complications, and reinterventions were examined. Results: Technical success was achieved in all cases, and all grafts were usable for hemodialysis. Seven of 25 Hybrid patients required stent-graft extensions and 3 patients required angioplasty to improve venous outflow at the time of Hybrid graft insertion. Three of 35 standard PTFE graft patients required angioplasty to improve venous outflow at the time of graft insertion. There was no perioperative mortality or procedure-related morbidity in either group. Median follow-up was 21 months. The patient survival estimate was 66% at 2 years. Estimated primary patency (24% vs 18%, p>0.05), assisted primary patency (34% vs 28%; p>0.05), and secondary patency rates (40% vs 38%, p≥0.05) at 24 months were equivalent for Hybrid vs PTFE grafts, respectively. Venous hypertension was not a complication following Hybrid graft implantation but was seen in 2 patients with the standard PTFE graft. Conclusion: The Hybrid graft offers a safe, technically effective alternative for patients with disadvantaged anatomy requiring hemodialysis access and has comparable outcomes to standard PTFE grafts. Further clinical experience and long-term data are required for determining the proper utility of this device in chronic dialysis-dependent patients.

“In situ” endografting in the treatment of arterial and graft infections

Objective: Endografts (eg, aortic aneurysm device or covered stent) are increasingly being used to temporize or treat arterial and graft infections in inaccessible areas, in patients with compromised anatomy, or in the presence of active bleeding or rupture. This summary examines the evidence for “in situ” endografting in the treatment these conditions. Methods: A two‐level search strategy of the literature (MEDLINE, PubMed, Google Scholar, and The Cochrane Library) was performed for relevant articles listed between January 2000 and December 2015. The review was confined to patients with primary and secondary bacterial or viral arterial infections, with or without fistulization and infection of bypass grafts and arteriovenous accesses. For the purposes of this summary, endografts can be considered to be an aortic aneurysm device or a covered stent. Results: There are no societal guidelines. Endografts have been successfully applied to mycotic arterial aneurysms, aortoenteric, aortobronchial, and arterioureteric fistulae, and to anastomotic bleeds secondary to infection. Multiple reports indicate success at the control of hemorrhage in all locations. Short‐term outcomes are good, but fatal infection‐related complications, especially if antibiotic therapy is halted, are well reported and necessitate a more definitive plan for the long term. Conclusions: Stent grafts remain an important and viable option for the treatment of mycotic aneurysms, aortoesophageal and aortobronchial fistulae, and infected pseudoaneurysms in anatomically or technically inaccessible locations. In patients with a short life span (<6 months), no further intervention is generally required. In patients with a predicted life span >6 months, careful consideration should be given to a more definitive procedure. Life‐long appropriate antibiotic therapy is strongly recommended for any patient receiving an endograft in an infected field.

Outcomes of Isolated Tibial Endovascular Interventions for Tissue Loss in CLI Patients on Hemodialysis

Purpose: To compare the objective performance goals (OPGs) and patient-centered outcomes of isolated tibial interventions in patients with tissue loss who were on hemodialysis (HD) to patients with tissue loss who were not on HD. Methods: Interrogation of a prospectively maintained database identified 242 critical limb ischemia (CLI) patients who underwent isolated tibial interventions for tissue loss in a single limb between 2007 and 2012. The 78 patients (mean age 66±12 years; 44 men) on HD were compared with 164 patients (mean age 50±13 years; 82 men) who were not on HD. There was an equal distribution of the tibial vessels treated; 152 (63%) patients had more than one treated tibial vessel. Patient-centered outcomes of clinical efficacy (absence of recurrent symptoms, maintenance of ambulation, and no major amputation), amputation-free survival (AFS), and freedom from major adverse limb events (MALE) were evaluated. The Society for Vascular Surgery OPGs were defined at 30 days and 1 year. Results: The 30-day major adverse cardiac events was significantly higher (p=0.004) in the HD group (5, 5%) compared with the no-HD group (0%), but both remained under the stated OPG of ≤10%. The 30-day MALE rates were significantly higher than the stated ≤9% OPG at 13% and 18% for the no-HD and HD groups, respectively. At 1 year, the rates for AFS, freedom from MALE, limb salvage, and survival did not achieve the stated Society for Vascular Surgery OPGs in the HD group. Clinical efficacy was 61% and 25% at 3 years for the no-HD and HD groups, respectively (p<0.01). Overall, AFS was 54% and 22% and freedom from MALE was 56% and 27% at 3 years for the no-HD and HD groups, respectively (both p<0.01). Conclusion: Tibial intervention for tissue loss in patients on HD is a valid treatment option but is associated with a high MALE rate. Three-year outcomes remain relatively poor, with <25% success in terms of clinical efficacy and AFS.

Treatment options and outcomes for caval thrombectomy and resection for renal cell carcinoma

OBJECTIVE Advanced renal cell carcinoma (RCC) has a significant predisposition to vascular invasion. Tumor vascular invasion and thrombus are found in the renal vein and the inferior vena cava (IVC) in up to 10% to 25% of patients. This study reviewed the current status of radical nephrectomy with IVC thrombectomy for advanced RCC. METHODS A two-level search strategy of the literature (MEDLINE, PubMed, The Cochrane Library, and Google Scholar) for relevant articles listed between January 2000 and December 2015 was performed. The review was confined to patients with primary RCC associated with vascular invasion. RESULTS Untreated RCC with intravascular thrombus has a median survival of 5 months. Surgical exposure and intervention are tailored to the level of tumor thrombus. The 30-day mortality for radical nephrectomy with IVC thrombectomy is low (1.5%-10%), and the complication rates have been reported to be 18%, 20%, 26%, and 47% for IVC tumor thrombus level I, II, III, and IV disease, respectively. Disease-specific survival ranges from 40% to 60% at 5 years after nephrectomy and removal of the intravascular tumor. CONCLUSIONS Radical nephrectomy with IVC thrombectomy is an effective cancer control operation that can be safely performed with acceptable mortality and morbidity. Preoperative imaging coupled with perioperative surgical management of the IVC is critical to procedural success and patient outcomes.

Objective performance goals after endovascular intervention for critical limb ischemia

OBJECTIVE During the last decade, primary endoluminal therapy for critical limb ischemia (CLI), assessed as rest pain and tissue loss of the lower extremity, has significantly increased. Reporting of patient-centered outcomes using the new Society for Vascular Surgery objective performance goals (OPGs) has been limited. This study examined the OPGs for infrainguinal endovascular management of CLI. METHODS A prospective database of patients undergoing endovascular treatment of the lower extremity for CLI between 2000 and 2011 was queried. Evaluated were clinical efficacy (absence of recurrent symptoms, maintenance of ambulation and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (MALEs; above-ankle amputation of the index limb or major reintervention - new bypass graft, jump/interposition graft revision). RESULTS A total of 728 patients (60% male; age, 68 ± 14 years) underwent lower extremity interventions for CLI (66% tissue loss); of these, 39% had superficial femoral artery and tibial interventions. Diabetes mellitus was present in 71%, hyperlipidemia in 64%, and chronic renal insufficiency in 37%. Technical success was 96%. The overall rate at 30 days of major adverse cardiovascular events (MACEs) was 3% and MALEs was 12%. At 5 years, clinical efficacy was (mean ± standard error of the mean) 42% ± 5%, amputation-free survival was 41% ± 7%, and freedom from MALEs was 51% ± 4%. Clinical efficacy was significantly different in those presenting with rest pain and tissue loss and in the anatomic high-risk group compared with the clinical high-risk group, and both were worse compared with the group without clinical or high-risk criteria. CONCLUSIONS Endoluminal therapy for CLI is associated with early low MACE rates but high MALE rates. When the key outcome of amputation free survival is considered, predictors of a better outcome were absence of current smoking, a lower modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) amputation risk score, better preoperative ambulation status, lower MACEs, and discharge disposition to home. The presence of tissue loss and anatomic risk factors negatively affect outcomes. Longer-term outcomes after endovascular intervention for CLI remain relatively poor, with <40% success in objective performance outcomes at 5 years.

Outcomes of intervention for cephalic arch stenosis in brachiocephalic arteriovenous fistulas

Background Development of recalcitrant stenotic lesions of the cephalic arch is a significant cause of dysfunction of brachiocephalic access arteriovenous fistulas (AVFs). Endovascular and surgical therapy can be used to treat cephalic arch stenosis. The aim of this study was to evaluate the outcomes of endovascular and surgical interventions for cephalic arch stenosis. Methods A retrospective review of all patients during a 16‐year period with a compromised but not occluded brachiocephalic AVF due to cephalic arch stenosis was undertaken. Patency, reintervention, infection, and functional dialysis rates were examined. Results From January 2000 to December 2015, 219 patients (67% female; mean age, 58 ± 20 years) with a failing brachiocephalic AVF underwent intervention at the cephalic arch. These interventions included angioplasty, primary stent placement, transposition, and bypass. The average time to intervention for cephalic arch stenosis was 1.7 years after primary access placement. The average number of percutaneous interventions before the decision to intervene surgically on the cephalic arch was three (range, two to six). Technical success was superior in the surgical groups (70% and 80% compared with 96% and 100% for balloon angioplasty, stenting, transposition, and bypass, respectively; P = .02). Major adverse cardiovascular events were overall low but significantly higher in the surgical groups (1%, 1%, 0.3%, and 0.3% for transposition, bypass, balloon angioplasty, and stenting, respectively; P = .02). Both surgical options carried significantly superior patency rates at 2 years for transposition, bypass, balloon angioplasty, and stenting, respectively (63%, 59%, 90%, and 92%; P = .04). There was a lower rate of interventions per person‐year of follow‐up in the surgical groups compared with the endovascular groups (1.9, 1.4, 3.5, and 3.1 for transposition, bypass, balloon angioplasty, and stenting, respectively; P = .04). Functional dialysis durations were significantly superior in the surgical groups compared with the endovascular group (P = .03). Conclusions Cephalic arch stenosis is a significant cause of brachiocephalic AVF malfunction. Surgical options offer superior long‐term patency and functional results and should be considered earlier in the treatment of this disease.

Outcomes of native superficial femoral artery chronic total occlusion recanalization after failed femoropopliteal bypass

Objective: When a bypass fails, the options are lysis, redo bypass, or endovascular intervention. If lysis of the original bypass is not considered an option, which is better—redo bypass or attempts at endovascular recanalization of the native system? This retrospective study examined the outcomes of native superficial femoral artery (SFA) chronic total occlusion (CTO) recanalization compared with redo bypass after failed femoropopliteal bypass. Methods: Patients presenting with a symptomatic failed femoropopliteal bypass that underwent attempted CTO endovascular (EV) recanalization of the native SFA or a redo femoropopliteal bypass (BP) from 2000 to 2015 were analyzed. Patients undergoing catheter‐directed thrombolysis were excluded. Time‐dependent outcomes were assessed with life‐table analyses. Factor analyses were performed using a Cox proportional hazard model for time‐dependent variables. Results: A total of 104 patients (69% male; average age, 65 years) underwent EV (n = 40) or BP (n = 64) after presentation with symptomatic occlusion of a previous femoropopliteal bypass graft (rest pain in 84% and life‐style limiting claudication in 16%, 79% to the above‐knee popliteal, 81% prosthetic). According to the TransAtlantic Inter‐Society Consensus for the Management of Peripheral Arterial Disease classification, 91% of the lesions were category D and 19% were category C. Tibial runoff was one tibial vessel in 79% of the patients and two or more runoff vessels in the remainder. Lesions treated endovascularly underwent primary stenting with a median of 3 stents used. Of the bypasses performed, 69% were to the below knee popliteal and remainder were to the proximal tibials (68% of the patients had a venous conduit). At 30 days in EV vs BP, major adverse cardiovascular events were 3% and 8% (P = .24), major adverse limb events were 25% and 11% (P = .01), and the amputation rate was 8% and 8% (P = .96), respectively. Amputation‐free survival was 33% ± 9% and 56% ± 8% (P = .02) and freedom from major adverse limb event was 19% ± 8% and 46% ± 7% (P = .04) at 3 years for EV vs BP, respectively. Conclusions: In a high‐risk cohort when thrombolysis is excluded, BP is superior to EV after failure of a femoropopliteal bypass.

Current Status of Clot Removal for Acute Pulmonary Embolism

Acute pulmonary embolism (PE) continues to carry a high mortality if not recognized early and treated aggressively. Rapid recognition and diagnosis remains the mainstay of all efforts. Risk stratification early is paramount to guide therapy and achieve successful outcomes. Pulmonary emboli can generally be classified as massive, submassive, or stable. Fibrinolysis and/or surgical embolectomy are recommended for the treatment of the patient with massive PE to rescue the patient and restore hemodynamic stability. Current trials support an aggressive approach. In submassive PE, determination of right ventricular (RV) strain by echocardiography and biomarker assessment (troponin and B-type natriuretic peptide) identify patients who can benefit from catheter-directed therapy with the therapeutic intent of achieving a rapid reduction of RV afterload, prevention of impending hemodynamic collapse and prolonged in-hospital and outpatient survival. Current trials have not shown long-term benefit for this approach to date, and thus, this therapy should only be offered to select patients. Stable PE can be treated using both an inpatient and an outpatient approach, based on the available infrastructure. Therapy for PE continues to evolve and stratification of risks and benefits remain the key to implementation of invasive strategies.