Efficacy and safety of regenerated cellulose topical gauze haemostats in managing secondary haemostasis: a randomised control trial.

OBJECTIVE: To compare the efficacy and safety of HemoStyp (United Health Products, US), a neutralised oxidised regenerated cellulose (NORC) and Surgicel (Johnson & Johnson, US), an oxidised regenerated cellulose (ORC), in the management of bleeding of surgical wounds during abdominal, thoracic and vascular surgeries. METHOD: This study was a prospective, non-inferiority, multicentre, randomised, open-label trial. Surgical procedures were performed according to expected standard of care and in compliance with all relevant laws and institutional guidelines. Patients who developed Lewis Bleeding Scale grade 1 and grade 2 bleeds not controlled through conventional techniques were randomised to either the NORC or ORC treatment arms. Bleeding was measured every 30 seconds after treatment, ending at five minutes after haemostasis was achieved or at 10 minutes if haemostasis was not achieved. RESULTS: A total of 236 patients were included in the study. There was a total of seven adverse events in the study, none of which had causality related to either the NORC or ORC. For all surgical procedures, haemostasis was achieved more quickly with the NORC than the ORC (p<0.0001). In addition, haemostasis for all patients was achieved in under two minutes for the NORC compared with 81% of patients in the ORC groups. For Lewis Bleeding Scale grade 1 bleeds, the median time to control bleeding was 24 seconds in the NORC group and 51 seconds for the ORC group. For grade 2 bleeds, time to control bleeding was 76 seconds and 116 seconds, respectively. CONCLUSION: For patients in this study, haemostasis was achieved more quickly in the NORC treatment group compared with the ORC group, in patients with Lewis grade 1 or 2 bleeds caused by surgical wounds generated during abdominal, thoracic and vascular surgeries.

Transcatheter aspiration of large pacemaker and implantable cardioverter-defibrillator lead vegetations facilitating safe transvenous lead extraction.

AIMS: Treatment of patients with systemic cardiac implantable electronic device (CIED) infection with large lead vegetations is challenging and associated with relevant morbidity and mortality. To avoid complications from open surgical extraction, a novel approach with percutaneous aspiration of large vegetations prior to transvenous lead extraction was instituted. The results of this treatment concept were retrospectively analysed in this multicentre study. METHODS AND RESULTS: One hundred and one patients [mean age 68.2 ± 13.1 (30-92) years] were treated in four centres for endovascular CIED infection with large lead vegetations. Mean lead vegetation size was 30.7 ± 13.5 mm. Two hundred and forty-seven leads were targeted for extraction (170 pacemaker leads, 77 implantable cardioverter-defibrillator leads). Mean lead implant duration was 81.7 (1-254) months. The transcatheter aspiration system with a specialized long venous drainage cannula and a funnel-shaped tip was based on a veno-venous extracorporeal circuit with an in-line filter. The aspiration of vegetations showed complete procedural success in 94.0% (n = 95), partial success in 5.0% (n = 5). Three major complications (3.0%) were encountered. Complete procedural success (per lead) of the subsequently performed transvenous lead extraction procedure was 99.2% (n = 245). Thirty-day mortality was 3.0% (n = 3). Five patients (5.0%) died in the further course on Days 51, 54, 68, 134, and 182 post-procedure (septic complications: n = 4; heart failure: n = 1). CONCLUSION: The percutaneous aspiration procedure is highly effective and is associated with a low complication profile. The aspiration of vegetations immediately prior and during the lead extraction procedure may avoid septic embolization into the pulmonary circulation. This may potentially lead to a long-term survival benefit.

Percutaneous Vacuum-Assisted Thrombectomy Device Used for Removal of Large Vegetations on Infected Pacemaker and Defibrillator Leads as an Adjunct to Lead Extraction.

This case series reports our early experience with a minimally invasive percutaneous method of safely removing large vegetations during lead extraction in septic cardiac implantable electronic devices (CIED). Debate exists concerning the management of vegetations involving these devices. Lead extraction is mandated for infections, but vegetations may embolize, causing complications. Surgical debridement is recommended; alternatives include cardiopulmonary bypass, minimally invasive thoracotomy, or transatrial approaches. The AngioVac device allows percutaneous right heart bypass and suction removal of vegetations under echocardiographic and fluoroscopic guidance. This case series describes our first 20 patients, all critically ill with persistent sepsis and vegetations despite long-term antibiotics. This series includes patients who would not have been eligible for alternative procedures due to contraindications and highlights the potential role of this new technology.

Endovascular abdominal aortic aneurysm repair in the octogenarian.

The aim of this study was to analyze patient outcomes following endovascular repair of infrarenal abdominal aortic aneurysms (EAR) among patients 80 years of age or older. In this study, reporting standards of the Ad Hoc Committee for Standardized Reporting Practices for Endovascular Aortic Aneurysm Repair of the Society of Vascular Surgery/American Association for Vascular Surgery (SVS/AAVS) were followed. Between August 8, 1996 and February 12, 2001 EAR was performed in 31 patients (29 male and 2 female) with an average age of 83 +/- 3 years and an average maximum aneurysm diameter of 59 +/- 7 mm. Overall technical success was 90% (28/31) with a single acute conversion and a 6% (2/32) incidence of major morbidity. There were no in-hospital deaths, but two patients (6%) died within 30 days of intervention. Four endoleaks, two type I and two type II, were observed within the first 30 days after endograft implantation and three new type II endoleaks were noted after implant periods that exceeded 1 month. Average follow-up was 16 months, with a single aneurysm-related death that occurred after late conversion to open repair, 2 years following initial endovascular treatment. Kaplan-Meier analysis revealed 3-, 12-, and 24-month estimated survivals of 93% (+/-5), 75% (+/-8), and 68% (+/-10), respectively. Clinical success rates were 90% (+/-5), 90% (+/-5), and 72% (+/-17) at 12, 24, and 36 months, respectively. We conclude that, in the octogenarian with mild to moderate medical comorbidities, endovascular aneurysm repair provides an alternative to open AAA repair with low operative morbidity and good clinical success rates. Elevated SVS/AAVS medical comorbidity scores were not associated with increased operative mortality rates, but they did show a trend toward decreased mid-term survival. Careful consideration of life expectancy and the probability of rupture, as with traditional AAA repair, should dictate necessity for intervention.

Conservatism and new technology: the impact on abdominal aortic aneurysm repair.

The last decade has represented a time of fundamental change in the treatment of abdominal aortic aneurysms (AAAs). Potentially, vascular surgeons will either acquire catheter-based skills or relinquish the care for many patients with infrarenal AAA. We investigated AAA referral patterns and method of AAA repair after the establishment of an endovascular AAA program at our institution. We conducted a retrospective review of elective AAA repairs after the initiation of an endovascular AAA program in April 1994. Six vascular surgeons performed all procedures with a clear distinction between the surgeons (n=3) who performed traditional AAA repair only and those (n=3) who managed AAAs by means of either endovascular or traditional treatment. From April 1994 through December 2000, 740 elective AAA repairs were performed. During this time the mean number of AAA repairs has been 106/year ranging from 75 to 155/year. More notable however is the steady increase in the percentage of endovascular AAA repairs from 6 per cent of all AAA repairs in 1994 to 61 per cent in 2000. During this time traditional surgeons have experienced a plateau in total AAA repairs performed per year with their number of open repairs decreasing by 36 per cent. At the same time endovascular surgeons have seen a progressive rise in total AAA cases including an increase of 200 per cent in open repairs and of 1367 per cent in endovascular repairs. Our vascular surgeons who repair AAA utilizing both endovascular and open techniques have experienced an increase in aneurysm referrals since the advent of an endovascular AAA program. Those who have not adopted endovascular skills have seen a decline in their aneurysm practice. The larger question about whether or not to embrace new technology before the availability of long-term follow-up remains unanswered.

Platelets: is aspirin sufficient or must we know how to pronounce abciximab?

Although vascular disease may present with symptoms that are representative of a focal exacerbation of atherosclerosis, it is inherently a systemic disease. Consequently, vascular surgeons must be capable of recommending to their patients pharmacologic approaches that will decrease future risk of cardiovascular-related morbidity and death. Antiplatelet treatments, in particular, have been shown to reduce future cerebrovascular and coronary events. Moreover, these medications have utility in maintaining peripheral vessel and graft patency after surgical bypass, endarterectomy, or percutaneous translumenal angioplasty. The future of optimal antiplatelet therapy will consist of strategies that block multiple platelet activation pathways simultaneously. Moreover, the use of directed antiplatelet medications promises more effective control of platelet physiology with a concomitant increase in safety. The authors review herein current recommendations for the use of aspirin, thienopyridines, and GP IIb/IIIa inhibitors in patients with peripheral vascular disease.

Endoluminal versus open treatment of descending thoracic aortic aneurysms.

PURPOSE: This report describes the authors' initial experience with the Excluder thoracic endoprosthesis (W. L. Gore and Associates, Inc, Flagstaff, Ariz) and the thoracic Talent endoprosthesis (Medtronic AVE, Sunrise, Fla) and their safety and efficacy in the primary endovascular repair of descending thoracic aortic aneurysms (TAAs). In addition, comparison with a historic nonrandomized cohort of patients that had undergone open repair of descending TAAs is reported. PATIENTS AND METHODS: Repair of TAA (mean diameter, 68 +/- 22 mm) was attempted in 19 patients with the Excluder (n = 14) and the Talent (n = 5) endoprostheses between March 1999 and January 2000. This group was compared with a historic nonrandomized cohort of 10 patients that had undergone open repair of anatomically similar descending TAA (mean diameter, 74 +/- 22 mm) between January 1996 and January 1998. The mean age in the endovascular group was 70.6 +/- 5.3 years versus 70.1 +/- 4.5 years in the historic open group. All the procedures were performed in a standard operating room with angiographic capabilities. In the historic open group, each standard tube graft repair of descending TAA was performed by one of three staff surgeons. RESULTS: Endograft deployment was successful in 18 patients (95%). The procedure was aborted in one patient (Excluder) because of small iliac arteries and access difficulty. The average operative time was 155 +/- 62 minutes, with a mean blood loss of 325 +/- 353 mL (versus 256 +/- 102 minutes and 1205 +/- 1493 mL, respectively, in the open group). Eight patients needed the planned use of more than one component for enhanced sealing or additional length in the endovascular group. No type I endoleaks were identified on the intraoperative completion angiography. One perioperative mortality occurred in the endovascular group and the open group. In the endovascular group, other complications included retroperitoneal hematoma and external iliac artery dissection (n = 1), lymphocele (n = 1), and common femoral artery pseudoaneurysm (n = 1). In the open group, other complications included ischemic colitis (n = 1), severe renal insufficiency (n = 2), wound infection (n = 1), and stroke (n = 1). In the endovascular group, the length of stay was 6.2 +/- 3.3 days (range, 1 to 13 days), with only nine patients needing intensive care, whereas in the open group, the length of stay was 16.3 +/- 6.7 days, with all patients needing intensive care. Endoleaks, graft migrations, or ruptures were not seen on the 1-month, 6-month, and 12-month follow-up computed tomographic scans in the endovascular group. On the average, aneurysm size decreased from 68 +/- 22 mm to 58 +/- 13 mm, to 51 +/- 14 mm, and to 49 +/- 12 mm at 1, 6, and 12 months after endovascular repair, respectively. No spinal cord ischemia was seen in either group. CONCLUSION: The endoluminal repair was effective in exclusion of descending TAAs from the systemic circulation in this selected group of patients. In this short-term follow-up, compared with the nonrandomized historic cohort of open descending TAA repair, the endovascular group had significantly shorter operating times and hospital and intensive care unit stays and lower operative blood loss. Further follow-up and continued assessment of the long-term durability of these devices in elective and emergency circumstances are warranted.

Distal septic emboli and fatal brachiocephalic artery mycotic pseudoaneurysm as a complication of stenting.

The use of percutaneous angioplasty with subsequent intravascular metallic stent placement has gained increasing acceptance over the past decade. Infections of these stents appear to be uncommon; however, the rarity of this complication may in part be the result of a lack of availability of long-term follow-up data. A number of examples of infected cardiac and peripheral vascular stents have been reported, often with fatal consequences. Herein, we report a 74-year-old woman who underwent subclavian and brachiocephalic artery angioplasty and stent placement for symptomatic stenoses. Six months after the initial intervention, the patient returned with restenosis of the stents and underwent repeat angioplasty to restore full patency. Two weeks later, the patient was readmitted with generalized malaise and multiple erythematous, macular lesions on the right forearm and hand. Blood cultures grew Staphylococcus aureus, and a computed tomographic scan of the chest showed a large brachiocephalic artery pseudoaneurysm with surrounding hematoma. Despite prompt surgical intervention, this complication proved ultimately fatal. Infections of metallic endovascular stents are potentially life-threatening complications and must be addressed urgently, including possible surgical intervention.

Covered stent exclusion of dialysis access pseudoaneurysms.

BACKGROUND: The traditional repair of hemodialysis graft pseudoaneurysms has been to surgically replace that segment of involved PTFE graft material or autogenous vein. We report a novel approach to these lesions, employing a covered stent (Wallgraft) for exclusion of arteriovenous graft (AVG) and arteriovenous fistula (AVF) pseudoaneurysms. METHODS: Ten patients with AVG or AVF pseudoaneurysms were treated endoluminally by covered stent exclusion. Wallgraft implantations were performed in the operating room with interventional capabilities under local anesthesia through a percutaneous access. Follow-up included physical examination at 2 weeks and duplex ultrasound of AVG/ AVF at 6 months after surgery. RESULTS: Ten patients with pseudoaneurysmal degeneration of their AVG/AVF were identified. The mean diameter of the pseudoaneurysmal segment was 3 cm (range, 1.5-5 cm). Immediately following covered stent implantation all the patients had palpable pulses in the pseudoaneurysms despite adequate coverage by angiography. At the 2-week follow-up visit all had lost the palpable pseudoaneurysm pulsation while the AVGs remained functional in nine patients. One patient had early thrombosis of the AVG. The follow-up duplex scans at 6 months showed complete exclusion of the pseudoaneurysms in seven patients. Two patients had thrombosis of their dialysis access, at 3 weeks (n = 1) and 3 months (n = 1) post-implantation. CONCLUSION: Endovascular covered stent exclusion of AV dialysis access pseudoaneurysms is safe and technically feasible in eliminating flow through dialysis access pseudoaneurysms and represents a novel and simple approach to this common problem, prolonging the functional life of the access site.

Coil embolization combined with carotid-subclavian bypass for treatment of subclavian artery aneurysm.

PURPOSE: To report 2 cases of proximal subclavian artery aneurysm treated with carotid-subclavian bypass and coil embolization. CASE REPORTS: A subclavian artery aneurysm was discovered incidentally during presurgical coronary angiography in 2 men (72 and 63 years of age). Both patients underwent planned carotid endarterectomy, during which a carotid-subclavian bypass was created with a Dacron graft; the distal subclavian artery was also ligated. The aneurysm was completely excluded from the circulation by coil embolization in a separate procedure. The patients were discharged after 3 days with no adverse events. Magnetic resonance angiography at 6 months showed continued aneurysm exclusion in both cases. The patients continue to be well >1 year after treatment. CONCLUSIONS: Embolization with supraclavicular bypass represents a viable alternative to traditional thoracotomy and subclavian artery reconstruction for treatment of subclavian artery aneurysms.

Iliac artery kinking with endovascular therapies: technical considerations.

Iliac artery tortuosity should be considered when planning endovascular interventions from a femoral approach. Stiff guide wires across tortuous iliac segments can introduce foreshortening and temporary kinking. Recognition of this phenomenon and its implications is important when making anatomic measurements before endovascular device placement, when assessing iliac runoff, and when considering adjunctive procedures after aortoiliac interventions. Two illustrative cases of external iliac artery kinking are presented, one during an abdominal aortic aneurysm endograft procedure and another encountered during stent placement in an external iliac artery dissection. In both cases, the temporary nature of the deformity was recognized, avoiding unnecessary additional intervention.

Endovascular repair of abdominal aortic aneurysms: risk stratified outcomes.

OBJECTIVE: The impact of co-morbid conditions on early and late clinical outcomes after endovascular treatment of abdominal aortic aneurysm (AAA) was assessed in concurrent cohorts of patients stratified with respect to risk for intervention. SUMMARY BACKGROUND DATA: As a minimally invasive strategy for the treatment of AAA, endovascular repair has been embraced with enthusiasm for all prospective patients who are suitable anatomical candidates because of the promise of achieving a durable result with a reduced risk of perioperative morbidity and mortality. METHODS: From April 1994 to March 2001, endovascular AAA repair was performed in 236 patients using commercially available systems. A subset of patients considered at increased risk for intervention (n = 123) were categorized, as such, based on a preexisting history of ischemic coronary artery disease, with documentation of myocardial infarction (60%) or congestive heart failure (35%), or due to the presence of chronic obstructive disease (21%), liver disease, or malignancy. RESULTS: Perioperative mortality (30-day) was 6.5% in the increased-risk patients as compared to 1.8% among those classified as low risk (P = NS). There was no difference between groups in age (74 +/- 9 years vs. 72 +/- 6 years; mean +/- SD), surgical time (235 +/- 95 minutes vs. 219 +/- 84 minutes), blood loss (457 +/- 432 mL vs. 351 +/- 273 mL), postoperative hospital stay (4.8 +/- 3.4 days vs. 4.0 +/- 3.9 days), or days in the ICU (1.3 +/- 1.8 days vs. 0.5 +/- 1.6 days). Patients at increased risk of intervention had larger aneurysms than low-risk patients (59 +/- 13 mm vs. 51 +/- 14 mm; P <.05). Stent grafts were successfully implanted in 116 (95%) increased-risk versus 107 (95%) low-risk patients (P = NS). Conversion rates to open operative repair were similar in increased-risk and low-risk groups at 3% and 5%, respectively. The initial endoleak rate was 22% versus 20%, based on the first CT performed (either at discharge or 1 month; P = NS). To date, increased-risk patients have been followed for 17.4 +/- 15 months and low-risk patients for 16.3 +/- 14 months. Kaplan-Meier analysis for cumulative patient survival demonstrated a reduced probability of survival among those patients initially classified as at increased risk for intervention (P <.05, Mantel-Cox test). Both cohorts had similar two-year primary and secondary clinical success rates of approximately 75% and 80%, respectively. CONCLUSIONS: Early and late clinical outcomes are comparable after endovascular repair of AAA, regardless of risk-stratification. Notably, 2 years after endovascular repair, at least one in five patients was classified as a clinical failure. Given the need for close life-long surveillance and the continued uncertainty associated with clinical outcome, caution is dictated in advocating endovascular treatment for the patient who is otherwise considered an ideal candidate for standard open surgical repair.

Endovascular aortic aneurysm operations.

Options for the treatment of abdominal and thoracic aortic aneurysms are in a state of evolutionary change. The development and continued refinement of the endoluminal approaches has decreased the need for open aortic aneurysm surgery. Endovascular stent graft technology is an area of active research in which both the delivery systems and the endografts are undergoing continued improvement so that patients with what was previously thought to be unfavorable anatomy may be treated by these means. The design and deployment techniques of the currently available endografts, as well as those in clinical trials, are presented.