John E. Aruny

Quality Improvement Guidelines for Percutaneous Management of the Thrombosed or Dysfunctional Dialysis Access

John E. Aruny, MD, Curtis A. Lewis, MD, John F. Cardella, MD, Patricia E. Cole, PhD, MD, Andrew Davis, MD, Alain T. Drooz, MD, Clement J. Grassi, MD, Richard J. Gray, MD, James W. Husted, MD, Michael Todd Jones, MD, Timothy C. McCowan, MD, Steven G. Meranze, MD, A. Van Moore, MD, Calvin D. Neithamer, MD, Steven B. Oglevie, MD, Reed A. Omary, MD, Nilesh H. Patel, MD, Kenneth S. Rholl, MD, Anne C. Roberts, MD, David Sacks, MD, Orestes Sanchez, MD, Mark I. Silverstein, MD, Harjit Singh, MD, Timothy L. Swan, MD, Richard B. Towbin, MD, Scott O. Trerotola, MD, Curtis W. Bakal, MD, MPH, for the Society of Interventional Radiology Standards of Practice Committee

Risks and benefits of femoropopliteal percutaneous balloon angioplasty

PURPOSE The purpose of this study was to evaluate the efficacy of angioplasty in the treatment of femoropopliteal arterial disease. METHODS From 1980 to 1991, 126 angioplasty procedures were performed in 131 limbs of 106 patients with 175 femoropopliteal lesions (26 common femoral, 118 superficial femoral, and 31 popliteal). Critical ischemia was present in 55 limbs (42%), and claudication was present in 76 (58%). Angioplasty was performed for a single lesion in 87 limbs (66%) and for multiple lesions in 44 (34%). In 13 limbs (10%) the most severe lesion was an occlusion; in 118 (90%) all lesions were stenoses. Distal runoff was good (2 or 3 vessels patent) in 72 limbs (55%) and poor (0 or 1 vessel patent) in 59 (45%). RESULTS Death within 30 days occurred in 0.8%, nonfatal systemic morbidity in 7.1%, and local morbidity in 1.6% of procedures. Multivariate analysis revealed that indication and age were predictive of increased morbidity and mortality rates. Immediate success was achieved in 95% of limbs treated. Mean follow-up time was 2.0 years. The overall 5-year cumulative primary patency rate was 45% (+/- 5%). In a proportional hazards model indication and lesion type were predictive (p < 0.01) of long-term failure, with relative risks of 2.0 (1.2 to 3.3) and 2.7 (1.3 to 5.6), respectively. The 5-year primary patency rate after angioplasty for stenoses and claudication was 55% (+/- 7%), for stenoses and critical ischemia it was 29% (+/- 11%), and for occlusions it was 36% (+/- 14%). CONCLUSION These results suggest that femoropopliteal angioplasty is a low-risk procedure with acceptable long-term results in patients with claudication and stenoses.

Management of Type II Endoleaks: Preoperative versus Postoperative versus Expectant Management

Type II endoleak is a common phenomenon after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA). Most type II endoleaks are innocuous and transient and therefore do not require intervention. However, particularly persistent endoleaks could lead to aneurysm enlargement and delayed aortic rupture. Decreasing the occurrence rates of type II endoleaks can be attempted with prophylactic occlusion of the inferior mesenteric, hypogastric, and lumbar arteries. Although the efficacy and clinical benefit of prophylactic occlusion of aortic branches prior to EVAR or during the endovascular repair remain controversial, we anticipate an increased use of intraoperative embolization techniques. A reasonable treatment strategy in patients with type II endoleak may be to intervene in cases of increasing aneurysm size or if the endoleak does not resolve spontaneously within 6 months. Translumbar embolization has been shown to be more effective than transarterial embolization. An alternative embolization technique is transcaval embolization, which has shown success rates comparable to translumbar embolization. Type II endoleaks can also be treated during laparoscopy or laparotomy, but these techniques are more invasive and should be used only after failure of embolization techniques.

Rapid Parathyroid Hormone Analysis During Venous Localization

ObjectiveTo determine the usefulness of the rapid parathyroid hormone (PTH) assay during venous localization for primary hyperparathyroidism (1° HPTH). Summary Background DataRemedial exploration for persistent 1° HPTH poses a significant challenge when noninvasive preoperative localization studies are negative. Based on experience with the intraoperative rapid PTH assay, this technique was extrapolated to the interventional radiology suite and generated near real-time data for the interventional radiologist employing on-site hormone analysis, with a 12-minute turnaround time from blood sampling to assay result. MethodsBetween November 1997 and July 2002, 446 patients with 1° HPTH were referred for treatment. Of these, 56 (12.5%) represented remedial patients who had each undergone one or more previous cervical explorations. Noninvasive imaging studies were positive for or suggestive of localized disease in 49/56 (87.5%) of these patients, who therefore proceeded directly to surgical exploration. Seven patients with persistent 1° HPTH and negative noninvasive studies underwent selective venous sampling employing a rapid PTH assay in the interventional suite. ResultsVenous localization demonstrated an apparent PTH gradient in six of the seven patients. In three, a subtle gradient demonstrated in near real-time prompted additional sampling, which confirmed an unequivocal hormone gradient. In an additional case, the absence of a gradient on initial sampling prompted further sampling, which was positive. All of the patients were explored, and in five of the six patients with a positive PTH gradient, a parathyroid adenoma (mean weight 636 ± 196 mg) was resected from a location predicted by venous localization. In the sixth patient with a positive gradient, parathyroid tissue was not identified; however, there was a significant fall in the intraoperative PTH values, and immediate postoperative and follow-up laboratory data at 1 month are indicative of a cure. In the one patient with negative localization, abnormal parathyroid tissue could not be located during surgical exploration. ConclusionsThe rapid PTH assay is a major adjunct for obtaining informative venous localization in patients with persistent 1° HPTH. This information is extremely helpful to the surgeon in this challenging group of patients and resulted in a 100% cure rate when a venous gradient was demonstrated. The authors now employ this technique routinely in remedial patients with negative noninvasive imaging studies.

Right Atrial Migration and Percutaneous Retrieval of a Günther Tulip Inferior Vena Cava Filter

This report describes a 67-year-old trauma victim in whom a retrievable Günther Tulip (Cook, Bloomington, IN) inferior vena cava filter was placed. The filter migrated to the right atrium immediately after placement. Initial attempts to retrieve the filter with Amplatz Goose Neck snares (Microvena, White Bear Lake, MN) were unsuccessful. A second attempt performed a week later with the addition of the new EnSnare (MDTech, Gainesville, FL) was successful. Possible causes of the migration are discussed and the difficulties encountered while removing this retrievable filter are described.

Cryoplasty Therapy for Limb Salvage in Patients with Critical Limb Ischemia

Purpose: To report the 6-month outcomes from a prospective multicenter study investigating the use of cryoplasty (cold balloon angioplasty) to treat below-knee occlusive disease in patients with critical limb ischemia (CLI). Methods: Between August 2004 and October 2005, 108 patients (77 men; mean age 73±12 years, range 41–101) with CLI involving 111 limbs were enrolled in a prospective multicenter trial (Below-the-Knee Chill Study), which was conducted at 16 institutions. The primary study endpoints were acute technical success, defined as the ability to achieve ≤50% residual stenosis and continuous inline flow to the foot, and absence of major (above or below-knee) amputation of the target limb 180 days post procedure. Results: Acute technical success was achieved in 108 (97.3%) of the 111 limbs treated, with only 1 (0.9%) clinically significant dissection (≥type C) and 2 residual stenoses >50%. During the 180-day follow-up, 15 (13.9%) of the initial 108 patients either withdrew or were lost to follow-up. Five (4.6%) deaths occurred, leaving 88 (81.5%) patients with 91 (82.0%) treated limbs available for 180-day assessment. The rate of freedom from major amputation at 180 days was 93.4%. Amputation-free survival was 89.3% at 180 days (5 deaths, 6 major amputations). Stratifying data by diabetics (n=71) versus non-diabetics (n=34), the 180-day death and amputation rates were 4.9% and 10.0%, respectively, for diabetics versus 6.7% and 0.0%, respectively, for non-diabetics. Conclusion: Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent acute outcomes and a high rate of limb salvage in patients with CLI. Study outcomes support the use of cryoplasty therapy as a primary treatment option for patients with CLI secondary to below- knee disease.

Evaluation of various maneuvers for prevention of air embolism during central venous catheter placement.

This study is designed to evaluate the various physiologic maneuvers (Valsalva, humming, breath-hold) for the potential prevention of air embolism during central venous catheter placement. Central venous pressure measurements were prospectively obtained in 40 patients undergoing central venous catheter placement. The average central venous pressure at baseline was 3.275 mm Hg (range = -4 to 16, SD = 5.99). The average central venous pressure during breath hold was 6.1 mm Hg (range = -6 to 24, SD = 7.99). The average central venous pressure during humming was 5.1 mm Hg (range = -4 to 20, SD = 6.4) The average central venous pressure during the Valsalva maneuver was 18.43 (range = -3 to 48, SD = 14.73). Forty percent of patients (16 of 40) had negative central venous pressures at rest, 25% (10 of 40) had negative pressures during breath hold, 20% (8 of 40) had negative pressures during humming, and 2.5% (1 of 40) had negative pressures during Valsalva maneuver. The average increases in central venous pressure during breath hold, humming, and Valsalva were 2.85, 1.82, and 15.2 mm Hg, respectively. The difference between pressures during Valsalva and other maneuvers was statistically significant (P <.05). The conclusion is that the Valsalva maneuver is superior to breath-hold and humming for increasing central venous pressure during central venous catheter placement and, therefore, it is more likely to prevent air embolism in cooperative patients.

Primary Cryoplasty Therapy Provides Durable Support for Limb Salvage in Critical Limb Ischemia Patients with Infrapopliteal Lesions: 12-Month Follow-up Results from the BTK Chill Trial

Purpose: To report the 12-month follow-up data from the prospective 16-center Below-the-Knee (BTK) Chill Trial, which examined the use of primary cryoplasty for BTK occlusive disease in patients with critical limb ischemia (CLI). Methods: The trial included 108 patients (77 men; mean age 73±11 years, range 41–101) with CLI (Rutherford categories 4–6) involving 111 limbs with 115 target infrapopliteal lesions. Angiographic inclusion criteria were reference vessel diameter ≥2.5 mm and ≤5.0 mm and target lesion stenosis ≥50%. The primary study endpoints were acute technical success (the ability to achieve ≤50% residual stenosis and continuous inline flow to the foot) and absence of major amputation of the target limb at 6 months. Secondary endpoints were serious adverse events specifically related to use of primary cryoplasty and absence of major amputation of the target limb at 1, 3, and 12 months. Results: Acute technical success was achieved in 108 (97.3%) of treated limbs, with only 1 clinically significant dissection (≥type C) and 2 residual stenoses >50%; stent placement was required following cryoplasty in only 3 (2.7%) procedures. At 6 months and 1 year, major amputation was avoided in 93.4% (85/91) and 85.2% (69/81) of patients, respectively. Through 1 year, 21% (17/81) of patients underwent target limb revascularization. Rates of major amputation and death at 1 year were 0% for limbs of patients with initial Rutherford category 4; 11.4% and 0%, respectively, for initial category 5; and 40.0% and 31.8% for initial category 6. One-year rates of major amputation and death were 20.4% and 8.8%, respectively, for diabetics, versus 4.0% and 10.7% for non-diabetics. At 1 year, major amputation occurred in 16.7% (2/12) of limbs that were expected to be amputated at the time of treatment. Conclusion: Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent results and a high rate of limb salvage in patients with CLI. Study outcomes through 1 year support the use of cryoplasty as a primary treatment option for patients with CLI secondary to BTK occlusive disease.

Comparative efficacy of pulse-spray thrombolysis and angioplasty versus surgical salvage procedures for treatment of recurrent occlusion of PTFE dialysis access grafts.

Purpose: To compare the efficacy of surgery versus pulse-spray thrombolysis and angioplasty in patients with recurrent thrombosis of polytetrafluoroethylene (PTFE) dialysis access grafts. Methods: We analyzed 96 consecutive interventions for thrombosed PTFE dialysis access grafts in 18 patients. Primary patency after thrombolysis and angioplasty (n= 25) was compared with primary patency following thrombectomy alone (n= 50) or thrombectomy followed by graft revision (n= 21) using life-table analysis. A Cox proportional hazards model that accounted for graft age and number of previous interventions was used to generate the relative risk for recurrent occlusion following therapy. Results: Life-table analysis showed that patency after thrombolysis and angioplasty was greater than that following thrombectomy alone (p= 0.02). After accounting for the age of the graft and the number of previous interventions (average six per patient), the relative risk for recurrent occlusion [3.0; 95% confidence intervals (CI): 1.5, 6.4] was greater for thrombectomy alone than for thrombolysis/angioplasty [0.6; CI = 0.3, 1.3]. The relative risks of repeat occlusion following thrombolysis/angioplasty [0.6; CI = 0.3, 1.3] and thrombectomy/surgical revision [1.0; CI = 0.5, 1.7] were similar. Conclusion: Outcome data from our retrospective study on recurrent thrombosis of PTFE dialysis access grafts suggest that thrombolysis/angioplasty is superior to thrombectomy alone, and equivalent to thrombectomy/surgical revision.

Recurrent Thrombosis of Polytetrafluoroethylene Dialysis Fistulas after Recent Surgical Thrombectomy: Salvage by Means of Thrombolysis and Angioplasty

PURPOSE To test the hypothesis that thrombolysis followed by angioplasty for salvage of thrombosed polytetrafluoroethylene (PTFE) dialysis fistulas is safe and effective even after recent surgical thrombectomy. MATERIALS AND METHODS Thrombolysis and balloon angioplasty were performed on 12 fistulas in which thrombosis had recurred within 30 days after thrombectomy (n = 10) or thrombectomy/revision (n = 2). All patients underwent pulse-spray pharmacomechanical thrombolysis with urokinase and use of a crossed-catheter technique. A total of 250,000-1,000,000 IU of urokinase and 2,500 IU of heparin were injected throughout the clot in 17-33 minutes. A bolus of 2,500 IU of heparin was simultaneously administered intravenously. RESULTS Thrombolysis was successful in restoring flow in all grafts, but thrombosis recurred in three grafts before they could be used for dialysis. The clinical success rate was thus 75%. There were no major complications. Mean primary patency after thrombolysis in this small select group of patients was 94 days (median, 68.5 days), comparing favorably with the mean patency of 44 days (median, 23 days) achieved by the prior 23 surgical revisions in the same grafts. CONCLUSION Percutaneous fistula salvage appears to be a safe and effective means of treating recurrent thrombosis in PTFE dialysis fistulas when recent surgical thrombectomy has failed.