The relative importance of graft surveillance and warfarin therapy in infrainguinal prosthetic bypass failure

BackgroundWe sought to describe modes of failure and associated limb loss after infrainguinal polytetrafluoroethylene bypass grafting in patients lacking a saphenous venous conduit and to define specific clinical or hemodynamic factors prognostic for bypass failure.MethodsWe identified 121 patients (mean age, 67 years; 90 men and 31 women) with determinable outcomes (minimum follow-up, 2 months; mean, 17 months) after 130 prosthetic infrainguinal bypasses between 1997 and 2005. Ischemic presentation was rest pain in 52%, tissue loss in 34%, and disabling claudication and/or popliteal aneurysm in 14%, with 24% of patients requiring a redo bypass. Distal targets were the above-knee (n = 44), distal popliteal (n = 27), or tibial/pedal (n = 59) arteries. Sixty-six (77%) of the below-knee (BK) target (distal popliteal or tibial) bypasses had distal anastomotic adjuncts (vein cuff or patch). Duplex graft surveillance was performed at 1, 4, and 7 months after surgery and twice yearly thereafter, with recording of midgraft velocities and imaging encompassing inflow and outflow vessels. Arteriography and open/endovascular intervention was performed for stenoses identified by duplex scanning (peak systolic velocity >300 cm/s; velocity ratio >3.5). An attempt was made to salvage occluded grafts by using catheter-directed thrombolysis or open techniques. Eighty-six patients (74% of BK bypasses) were placed on chronic warfarin therapy with a target international normalized ratio range between 2 and 3. Prognostic factors were identified by using univariate statistics and multivariate logistic regression analysis.ResultsThree-year primary, assisted, and secondary patency rates were 39%, 43%, and 59%, respectively, for all bypasses, with no difference noted between above-knee and BK grafts (P = .5). At 3 years, freedom from limb loss was 75%, and patient survival was only 70%, with no adverse effect on survival imparted by amputation. Sixty-nine total adverse events occurred as a result of thrombotic occlusion (n = 51), duplex scan–detected stenosis (n = 13), or graft infection (n = 5). Forty-nine percent of all initial graft occlusions eventually led to amputation. Twenty-three grafts (27% of 86 patients) in patients maintained on chronic warfarin were subtherapeutic at the time of occlusion. Use of a distal anastomotic adjunct with BK bypasses reduced graft thrombosis (35% with vs 60% without) but did not impart a significant patency advantage (P = .07). Multivariate analysis revealed low graft flow (midgraft velocity ≤45 cm/s; odds ratio [OR], 6.1; 95% confidence interval [CI], 1.9-19.2), use of warfarin (OR, 8.4; 95% CI, 2.1-34.5), and therapeutic warfarin (OR, 24.6; 95% CI, 5.7-106) to be independently predictive for bypass patency. Graft patency was maintained in 89% of grafts remaining therapeutic on warfarin compared with only 55% of subtherapeutic or nonanticoagulated grafts (P < .001). Low-flow grafts (n = 61) occluded more frequently than higher-flow grafts (46% vs 13%; P < .001). Therapeutic warfarin augmented the patency of low-flow (P < .001) but not high-flow (P = .15) grafts.ConclusionsLow graft flow was a more common mode of prosthetic bypass failure than development of duplex scan–detected stenotic lesions during follow-up. Early duplex scanning may be more important for characterizing midgraft velocity and related thrombotic potential and selecting patients for chronic anticoagulation. Maintenance of therapeutic warfarin is paramount in optimizing prosthetic bypass patency and limb preservation

Plaque excision with the Silverhawk catheter: Early results in patients with claudication or critical limb ischemia

ObjectiveThis study was conducted to detail the early experience after infrainguinal atherectomy using the Silverhawk plaque excision catheter for the treatment of symptomatic peripheral vascular disease.MethodsA prospective database was established in August 2004 in which data for operations, outcomes, and follow-up were recorded for patients undergoing percutaneous plaque excision for peripheral arterial occlusive disease. Society for Vascular Surgery (SVS) ischemia scores and femoropopliteal TransAtlantic Inter-Society Consensus (TASC) criteria were assigned. A follow-up protocol included duplex ultrasound surveillance at 1, 3, and 6 months and then yearly thereafter. Standard statistical analyses were performed.ResultsDuring a 17-month period, 66 limbs of 60 patients (37 men [61.7%]) underwent 70 plaque excisions (four repeat procedures). Indications included tissue loss based on SVS ischemia at grades 5 and 6 (25/70), rest pain at grade 4 (22/70), and claudication at grades 2 to 3 (23/70). The mean lesion length was 8.8 ± 0.7 cm. The technical success rate was 87.1% (61/70). Adjunctive treatment was required in 17 procedures (24.3%), consisting of 14 balloon angioplasties and three stents. Femoropopliteal TASC criteria included 5 TASC A lesions, 14 TASC B lesions, 32 TASC C lesions, and 19 TASC D lesions. Although 17 plaque excisions included a tibial vessel, no patient underwent isolated tibial atherectomy. The mean increase in ankle-brachial index was 0.27 ± 0.04 and in toe pressure, 20.3 ± 6.9 mm Hg. Mean duplex ultrasound follow-up was 5.2 months (range, 1 to 17 months). One-year primary, primary assisted, and secondary patency was 61.7%, 64.1%, and 76.4%, respectively. Restenosis or occlusion developed in 12 patients (16.7%) and was detected at a mean of 2.8 ± 0.7 months. Restenosis or occlusion was significantly more common (P < .05) in patients with TASC C and D lesions compared with patients with TASC A and B lesions. Six (8.3%) of 12 patients underwent reintervention on the basis of duplex ultrasound surveillance results. Four (33.3%) of 12 patients experienced reocclusion during the same hospitalization, and amputation and open revascularization were required in two patients each.ConclusionsPercutaneous plaque excision is a viable treatment option for lower extremity revascularization. Outcomes are related to ischemia and lesion severity. Patency and limb salvage rates are equivalent to other endovascular modalities

Outcome of carotid stent-assisted angioplasty versus open surgical repair of recurrent carotid stenosis

AbstractPurposeWe compared outcome and durability of carotid stent-assisted angioplasty (CAS) with open surgical repair (ie, repeat carotid endarterectomy [CEA]) to treat recurrent carotid stenosis (RCS).MethodsA retrospective review of anatomic and neurologic outcomes was carried out after 27 repeat CEA procedures (1993-2002) and 52 CAS procedures (1997-2002) performed to treat high-grade internal carotid artery (ICA) RCS after CEA. The incidence of intervention because of symptomatic RCS was similar (repeat CEA, 63%; CAS, 60%), but the interval from primary CEA to repeat intervention was greater (P < .05) in the repeat CEA group (83 ± 15 months) compared with the CAS group (50 ± 8 months). In the CAS group, 17 of 52 arteries (33%) were judged not to be surgical candidates because of surgically inaccessible high lesions (n = 8), medical comorbid conditions (n = 4), neck irradiation (n = 3), or previous surgery with cranial nerve deficit or stroke (n = 2). Three patients who underwent repeat CEA had lesions not appropriate for treatment with CAS.ResultsOverall 30-day morbidity was similar after CAS (12%; death due to ipsilateral intracranial hemorrhage, 1; nondisabling stroke, 1; reversible neurologic deficits or transient ischemic attack, 2; access site complication, 2) and repeat CEA (11%; no death; nondisabling stroke, 1; reversible cranial nerve injury, 1; cervical hematoma, 1). Combined stroke and death rate was 3.7% for repeat CEA and 5.7% for CAS (P > .1). All duplex ultrasound scans obtained within 3 months after CEA and CAS demonstrated patent ICA and velocity spectra of less than 50% stenosis. During follow-up, no repeat CEA (mean, 39 months) or CAS (mean, 26 months) repair demonstrated ICA occlusion, but two patients (8%) who underwent repeat CEA and 4 patients (8%) who underwent CAS required balloon or stent angioplasty because of 80% RCS. At last follow-up, no patient had ipsilateral stroke and all ICA remain patent. At duplex scanning, stenosis-free (<50% diameter reduction) ICA patency at 36 months was 75% after repeat CEA and 57% after CAS (P = .26, log-rank test).ConclusionsCarotid angioplasty for treatment of high-grade stenotic ICA after CEA resulted in similar anatomic and neurologic outcomes compared with open surgical repair. Most lesions are amenable to endovascular therapy, and CAS enabled treatment in patients judged not to be suitable surgical candidates. Duplex scanning surveillance after repeat CEA or CAS is recommended, because stenosis can recur after either secondary procedure

Early results and lessons learned from a multicenter, randomized, double-blind trial of bone marrow aspirate concentrate in critical limb ischemia

ObjectivesDespite advances in endovascular therapies, critical limb ischemia (CLI) continues to be associated with high morbidity and mortality. Patients without direct revascularization options have the worst outcomes. We sought to explore the feasibility of conducting a definitive trial of a bone marrow-derived cellular therapy for CLI in this “no option” population.MethodsA pilot, multicenter, prospective, randomized, double-blind, placebo-controlled trial for “no option” CLI patients was performed. The therapy consisted of bone marrow aspirate concentrate (BMAC), prepared using a point of service centrifugation technique and injected percutaneously in 40 injections to the affected limb. Patients were randomized to BMAC or sham injections (dilute blood). We are reporting the 12-week data.ResultsForty-eight patients were enrolled. The mean age was 69.5 years (range, 42-93 years). Males predominated (68%). Diabetes was present in 50%. Tissue loss (Rutherford 5) was present in 30 patients (62.5%), and 18 (37.5%) had rest pain without tissue loss (Rutherford 4). Patients were deemed unsuitable for conventional revascularization based on multiple prior failed revascularization efforts (24 [50%]), poor distal targets (43 [89.6%]), and medical risk (six [12.5%]). Thirty-four patients were treated with BMAC and 14 with sham injections. There were no adverse events attributed to the injections. Renal function was not affected. Effective blinding was confirmed; blinding index of 61% to 85%. Subjective and objective outcome measures were effectively obtained with the exception of treadmill walking times, which could only be obtained at baseline and follow-up in 15 of 48 subjects. This pilot study was not powered to demonstrate statistical significance but did demonstrate favorable trends for BMAC versus control in major amputations (17.6% vs 28.6%), improved pain (44% vs 25%), improved ankle brachial index (ABI; 32.4% vs 7.1%), improved Rutherford classification (35.3% vs 14.3%), and quality-of-life scoring better for BMAC in six of eight domains.ConclusionsIn this multicenter, randomized, double-blind, placebo-controlled trial of autologous bone marrow cell therapy for CLI, the therapy was well tolerated without significant adverse events. The BMAC group demonstrated trends toward improvement in amputation, pain, quality of life, Rutherford classification, and ABI when compared with controls. This pilot allowed us to identify several areas for improvement for future trials and CLI studies. These recommendations include elimination of treadmill testing, stratification by Rutherford class, and more liberal inclusion of patients with renal insufficiency. Our strongest recommendation is that CLI studies that include Rutherford 4 patients should incorporate a composite endpoint reflecting pain and quality of life

Relationship of age, gender, race, and body size to infrarenal aortic diameter

AbstractPurpose: To assess the effects of age, gender, race, and body size on infrarenal aortic diameter (IAD) and to determine expected values for IAD on the basis of these factors.Methods: Veterans aged 50 to 79 years at 15 Department of Veterans Affairs medical centers were invited to undergo ultrasound measurement of IAD and complete a prescreening questionnaire. We report here on 69,905 subjects who had no previous history of abdominal aortic aneurysm (AAA) and no ultrasound evidence of AAA (defined as IAD ≥ 3.0 cm).Results: Although age, gender, black race, height, weight, body mass index, and body surface area were associated with IAD by multivariate linear regression (all p < 0.001), the effects were small. Female sex was associated with a 0.14 cm reduction in IAD and black race with a 0.01 cm increase in IAD. A 0.1 cm change in IAD was associated with large changes in the independent variables: 29 years in age, 19 cm or 40 cm in height, 35 kg in weight, 11 kg/m2 in body mass index, and 0.35 m2 in body surface area. Nearly all height-weight groups were within 0.1 cm of the gender means, and the unadjusted gender means differed by only 0.23 cm. The variation among medical centers had more influence on IAD than did the combination of age, gender, race, and body size.Conclusions: Age, gender, race, and body size have statistically significant but small effects on IAD. Use of these parameters to define AAA may not offer sufficient advantage over simpler definitions (such as an IAD ≥3.0 cm) to be warranted. (J Vasc Surg 1997;26:595-601.

The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design

<p>Abstract</p> <p>Background</p> <p>Autologous bone marrow-derived stem cells have been ascribed an important therapeutic role in No-Option Critical limb Ischemia (NO-CLI). One primary endpoint for evaluating NO-CLI therapy is major amputation (AMP), which is usually combined with mortality for AMP-free survival (AFS). Only a trial which is double blinded can eliminate physician and patient bias as to the timing and reason for AMP. We examined factors influencing AMP in a prospective double-blinded pilot RCT (2:1 therapy to control) of 48 patients treated with site of service obtained bone marrow cells (BMAC) as well as a systematic review of the literature.</p> <p>Methods</p> <p>Cells were injected intramuscularly in the CLI limbs as either BMAC or placebo (peripheral blood). Six month AMP rates were compared between the two arms. Both patient and treating team were blinded of the assignment in follow-up examinations. A search of the literature identified 9 NO-CLI trials, the control arms of which were used to determine 6 month AMP rates and the influence of tissue loss.</p> <p>Results</p> <p>Fifteen amputations occurred during the 6 month period, 86.7% of these during the first 4 months. One amputation occurred in a Rutherford 4 patient. The difference in amputation rate between patients with rest pain (5.6%) and those with tissue loss (46.7%), irrespective of treatment group, was significant (p = 0.0029). In patients with tissue loss, treatment with BMAC demonstrated a lower amputation rate than placebo (39.1% vs. 71.4%, p = 0.1337). The Kaplan-Meier time to amputation was longer in the BMAC group than in the placebo group (p = 0.067). Projecting these results to a pivotal trial, a bootstrap simulation model showed significant difference in AFS between BMAC and placebo with a power of 95% for a sample size of 210 patients. Meta-analysis of the literature confirmed a difference in amputation rate between patients with tissue loss and rest pain.</p> <p>Conclusions</p> <p>BMAC shows promise in improving AMP-free survival if the trends in this pilot study are validated in a larger pivotal trial. The difference in amp rate between Rutherford 4 & 5 patients suggests that these patients should be stratified in future RCTs.</p

Noninvasive Vascular DiagnosisA Practical Guide to Therapy /

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