David E. Allie

Midterm Outcomes from the TALON Registry: Treating Peripherals with SilverHawk: Outcomes Collection

Purpose: To determine midterm clinical outcomes among patients with lower extremity peripheral arterial disease who underwent revascularization with catheter-based plaque excision (PE). Methods: Between August 2003 and February 2005, 19 institutions participating in the observational, nonrandomized, multicenter TALON registry enrolled 601 consecutive patients (353 men; mean age 70±11, range 36–98) with 1258 symptomatic lower extremity atherosclerotic lesions (748 limbs) treated by plaque excision with the SilverHawk catheter. Approximately 50% of the patients had diabetes, and nearly one third of the procedures were indicated for Rutherford ischemia category ≥4. Mean lesion lengths above and below the knee, respectively, were 62.5±68.5 mm (interquartile range [IQR], 20.0–80.0) and 33.4±42.7 mm (IQR 15.0–37.5). The primary endpoints of the study were target lesion revascularization (TLR) at 6 and 12 months. Results: The device achieved ≤50% residual diameter stenosis in 94.7% of lesions; procedural success was 97.6%. Nearly half (41.9%) of the procedures involved PE of ≥2 lesions. Nearly three quarters (73.3%) of the lesions did not require adjunctive therapy, and stent placement following PE occurred in only 6.3% of lesions. The 6- and 12-month rates of survival free of TLR were 90% and 80%, respectively. Rates of TLR were similar among patients with diabetes (11%) and without diabetes (9%). In the multivariate analysis, significant predictors of TLR at 6 months were a history of MI or coronary revascularization (HR 5.49, 95% CI 1.87 to 16.10, p=0.0008), multiple (≥2) lesions (HR 1.37, 95% CI 1.11 to 1.70, p=0.0019), and increasing Rutherford category (HR 1.84, 95% CI 1.28 to 2.65, p=0.0003). Lesion length >50 mm was associated with a 2.9-fold increased risk for TLR (HR 2.88, 95% CI 1.18 to 7.01, p=0.012); lesion length >100 mm was associated with a 3.3-fold increase in TLR (HR 3.32, 95% CI 1.15 to 9.56, p=0.016). Conclusion: In patients undergoing revascularization for lower extremity atherosclerotic disease, catheter-based PE achieves favorable procedural success and avoids the need for repeat revascularization at midterm follow-up. These findings support PE as a primary endovascular therapy for patients undergoing lower extremity arterial revascularization.

Procedural and Clinical Outcomes with Catheter-Based Plaque Excision in Critical Limb Ischemia

Purpose: To examine the safety and efficacy of catheter-based plaque excision as an alternative therapy to surgery, conventional angioplasty, and/or stenting in high-risk patients with critical limb ischemia (CLI). Methods: Between August 2003 and August 2004, a prospective evaluation was conducted of consecutive patients with CLI (Rutherford category ≥5) who were treated with endovascular plaque excision at 7 institutions. This study enrolled 69 patients (37 women; mean age 70±12 years, range 43–93) with CLI involving 76 limbs. Clinical outcomes were prospectively followed for 6 months. The primary endpoint was major adverse events (death, myocardial infarction, unplanned amputation, or repeat target vessel revascularization) at 30 days. Visible healing of ulcerated tissue, avoidance of any amputation, and performance of less extensive amputation than initially planned were also assessed. Results: Procedural success was achieved in 99% of cases. Major adverse events occurred in 1% of patients at 30 days and 23% at 6 months. The target lesion revascularization rate was 4%, and there were no unplanned limb amputations. Amputation was less extensive than initially planned or avoided altogether in 92% of patients at 30 days and 82% at 6 months. Conclusion: Catheter-based plaque excision is a safe and effective revascularization method for patients with CLI. These findings support further study of this modality as a singular or adjunctive endovascular therapy for limb salvage in CLI.

Novel simultaneous combination chemical thrombolysis/rheolytic thrombectomy therapy for acute critical limb ischemia: The power‐pulse spray technique

The novel power‐pulse spray (P‐PS) technique maximizes and combines the advantages and minimizes the disadvantages of both chemical thrombolysis (CT) and rheolytic thrombectomy (RT). Forty‐nine consecutive patients with iliofemoral thrombotic occlusion were treated via P‐PS technique. Using a 6 Fr RT catheter, saline prime was exchanged for thrombolytic solution [group 1, 10–20 mg tenecteplase (TNK)/50 cc saline, n = 25; group 2, 1,000,000 urokinase (UK)/50 cc saline, n = 24]. The outflow port was closed, then the catheter was advanced at 1 mm increments while pulsing lytic agent. After 30‐min lysis time, RT and definitive treatment of the underlying stenosis were performed. Procedure success was 23/25 (92%) and 22/24 (91.6%) for group 1 and 2, respectively. The mean total procedure time was 72 and 75 min in group 1 and 2, respectively. Thirty‐day limb salvage was 91% in both groups. There were no major surgical complications. The P‐PS technique is safe and effective using either UK or TNK, offering several potential advantages over monotherapy, including more rapid revascularization, decreases systemic lytic exposure and bleeding complications while facilitating both CT and RT capacity and efficacy. Catheter Cardiovasc Interv 2004;63:512–522.

Intraoperative innominate and common carotid intervention combined with carotid endarterectomy: a "true" endovascular surgical approach.

Purpose: To report the technique of carotid endarterectomy (CEA) combined with retrograde balloon angioplasty and stenting of proximal “tandem” lesions in the supra-aortic trunk. Technique: Intraoperative techniques in 34 patients with 23 left common carotid artery (CCA) and 11 innominate artery lesions included general anesthesia, low-dose dextran, prosthetic patching, selective shunting, 8-F sheath entry into the native CCA before the CEA, manual CCA sizing, and balloon-expandable stent placement after predilation. The technique has a high procedural success rate (97%) and appears durable. Over a mean 34-month follow-up, 2 >70% ostial CCA restenoses were found at 24 months. Conclusions: Intraoperative innominate or left CCA balloon angioplasty/stenting combined with carotid endarterectomy is safe, effective, and durable.

Safety and Performance of Targeted Renal Therapy: The Be-RITe! Registry

Purpose: To evaluate the safety and patterns of use of targeted renal therapy (TRT) with the Benephit system. TRT, the delivery of therapeutic agents directly to the kidneys by renal arterial infusion, has the advantage of providing a higher local effective dose with potentially greater renal effects, while limiting systemic adverse effects due to renal first-pass elimination. Methods: The Benephit System Renal Infusion Therapy (Be-RITe!) Multicenter Registry was a post-market registry following patients treated using the Benephit systems for TRT. The registry enrolled 501 patients (332 men; mean age 72.2±9.5 years) at high risk for contrast-induced nephropathy (CIN) during coronary or peripheral angiography/intervention or cardiovascular surgery. The Mehran score was used to compare the actual to predicted incidence of CIN within 48 hours post procedure. Results: Bilateral renal artery cannulation was successful in 94.2%, with a mean cannulation time of 2.0 minutes. Either fenoldopam mesylate, sodium bicarbonate, alprostadil, or B-type natriuretic peptide (BNP) was infused for 184±212 minutes. Mean creatinine levels did not change significantly (baseline, 24, and 48 hours post procedure: 1.95, 1.99, and 1.98 mg/dL, respectively; p=NS). In 285 patients who received TRT with fenoldopam and were followed for at least 48 hours, the incidence of CIN was 71% lower than predicted (8.1% actual CIN versus 28.0% predicted; p<0.0001). Only 4 (1.4%) patients required dialysis (versus the 2.6% predicted rate, p=NS). Conclusion: The Benephit system and TRT during coronary and endovascular procedures in patients at high risk for renal failure is simple to use and safe. With the infusion of intrarenal fenoldopam, the incidence of CIN was significantly lower than predicted by risk score calculations.

Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study.

Mechanical closure of percutaneous femoral arteriotomies following catheter based procedures remains problematic.

Role of negative pressure wound therapy in treating peripheral vascular graft infections.

Wound complications involving large subcutaneous vessels can cause significant challenges for surgeons. Negative pressure wound therapy (NPWT) has been increasingly used for treating complex wounds in vascular surgery, including groin infections, either as a bridge to surgical closure or as a primary wound treatment modality. Although a growing body of evidence exists for managing various problematic wounds, such as diabetic foot ulcers and open abdominal wounds, the role of NPWT in wounds involving large blood vessels or wounds complicating infected vascular grafts has not been well defined. A multidisciplinary advisory panel reviewed the literature relevant to wounds related to vascular surgical procedures and complications, focusing on large subcutaneous or infected vascular conduits. The results supported by the literature and the clinical practice of the consensus panel suggested that NPWT can be a useful adjunct to the management of vascular groin infections and dehiscences but must be used with caution.

Targeted Renal Therapy and Contrast-Induced Nephropathy during Endovascular Abdominal Aortic Aneurysm Repair: Results of a Feasibility Pilot Trial

Purpose: To evaluate the feasibility of targeted renal therapy (TRT) to decrease the rate of contrast-induced nephropathy (CIN) during endovascular aortic aneurysm repair (EVAR) in patients at risk for CIN. Methods: A prospective nonrandomized analysis of TRT was performed in 10 high-risk patients (8 men; median age 66.5 years, range 56–80) with pre-existing renal insufficiency. TRT involved high-dose intrarenal artery infusions of fenoldopam (FEN), a short acting selective dopamine-1 agonist and renal arteriolar vasodilator, delivered percutaneously via a left brachial access using the 5-F Benephit PV Infusion System during EVAR. Results: There were no device-related complications. TRT infusion duration ranged from 3.5 to 6.0 hours (median 4.5). Median contrast dosage was 120 mL (range 50–200). At 24 and 72 hours after EVAR, creatinine clearance (CrCl) had improved in 7 (70%) patients, remained unchanged in 2 (20%), and declined >25% in 1 (10%); the latter returned to baseline on day 5. At 30 days, 7 (70%) patients had improved CrCl and 3 (30%) remained unchanged. Conclusion: TRT is feasible during EVAR in high-risk patients. Further investigation is warranted to determine the safety and efficacy of TRT in preserving renal function during EVAR.

24-Carat Gold, 14-Carat Gold, or Platinum Standards in the Treatment of Critical Limb Ischemia: Bypass Surgery or Endovascular Intervention?

Critical limb ischemia (CLI) remains a poorly understood, rarely reported, and inconsistently treated major global healthcare epidemic. The incidence in the US is estimated at 1% of the population aged 50 years and older and at approximately double that rate in the over-70 age group. These frequencies are expected to increase significantly with the aging population and the expected increase in diabetes. Within 1 year of being diagnosed with CLI, 40% to 50% of the now 20 million US diabetics will experience an amputation, and 20% to 25% will die. The estimate for treating CLI in the US alone is

Carotid body tumor

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