Longitudinal micro-incision creation prior to balloon angioplasty for treatment of arteriovenous access dysfunction in a real-world patient population: 6-month cohort analysis.

INTRODUCTION: Routine hemodialysis depends on well-functioning vascular access. In the event of vascular access dysfunction, percutaneous transluminal balloon angioplasty (PTA) is conducted to restore patency. Although an angioplasty procedure can provide an excellent immediate result by opening the access to allow dialysis to continue, the long-term patency rates are less than satisfactory. The goal of this study was to assess the outcomes of patients who underwent a novel vessel preparation via longitudinal, controlled-depth micro-incisions prior to PTA. METHODS: This multicenter, prospective, observational registry enrolled hemodialysis patients scheduled to undergo PTA of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities. A primary endpoint was anatomic success, defined as angiographic confirmation of <30% residual stenosis post-procedure without an adverse event. Additional assessments included device technical success, clinical success, freedom from target lesion revascularization, target lesion primary patency, and circuit primary patency at 6 months. FINDINGS: A total of 148 lesions were treated with the FLEX Vessel Prep™ System (FLEX VP) prior to PTA in 114 subjects at eight clinical sites. Target lesions were 21 ± 25 mm in length with mean pre-procedure stenosis of 75.2% ± 4.7%. Five procedural complications were recorded without serious adverse events. Two subjects did not complete the follow-up evaluation. Target lesion primary patency across all subjects at 6-months was 62.2% with mean freedom from target lesion revascularization of 202.7 days. Target lesion primary patency and freedom from target lesion revascularization for AVF cases (n = 72) were 67.5% and 212.9 days, respectively. Target lesion primary patency and freedom from target lesion revascularization for AVGs (n = 42) were 52.4% and 183.3 days, respectively. In cases treating AVF cephalic arch stenosis (n = 25), 6-month target lesion primary patency was 70.6% and freedom from target lesion revascularization was 213.4 days. DISCUSSION: This FLEX-AV registry demonstrates safety and effectiveness, notably in the cephalic arch and AVGs, when FLEX VP is used prior to PTA for treatment of vascular access dysfunction in a population of end-stage renal disease subjects.

Safe and effective HeRO graft placement: Technique and results.

OBJECTIVES: Hemodialysis Reliable Outflow (HeRO) grafts are used when venous outflow is inadequate to support conventional access. These have been perceived as complex to implant and being associated with high risk. We have evolved a defined protocol for insertion that minimizes morbidity and maximizes efficiency. METHODS: Our protocol includes staged intravenous access versus HeRO graft placement, reverse Trendelenburg positioning, subcutaneous access of the deep portion of the existing catheter, use of a stiff wire placed within the inferior vena cava, dilation of the tract to 8 mm, device lubrication, all insertion procedures directly visualized, and use of immediate access conduits with SuperHeRO connector. RESULTS: From 7/1/18 to 8/13/19, 55 HeRO grafts were placed at our institution following this protocol, average age 58 ± 15 (26-86) years (mean ± SD, range). 53 (96%) had had prior ipsilateral central access (13 by means of "inside out" 2 weeks prior) the other two had on-table access. Mean procedure time was 70 ± 26 (38-148) min. Excluding seven "complex" cases, procedure time for our first 20 cases using this protocol was 72 ± 29 min, while that of the last 28 was 62 ± 18 min (p < 0.05). One patient suffered acute CHF after unclamping; despite reclamping and ligation he died on POD 3 (mortality rate 2%). 71% were done as outpatients, and 47 of 53 evaluable patients (89%) had their grafts used within 36 h for dialysis. Only one patient (2%) has had an infection within 30 days (cellulitis). At a mean followup of 95 ± 105 (maximum 383) days, three additional patients have had graft infections requiring excision, for a total infection rate of 5/53 (9%). CONCLUSIONS: Our results suggest that HeRO graft placement can be performed with minimal morbidity and mortality on an outpatient basis. Short-term infection rates are low and 89% of patients have their grafts immediately accessed and are discharged without a catheter.

The role of surgery for assisted maturation after endovascular and percutaneous arteriovenous fistula creation.

Even in the best of circumstances, a significant number of patients will require adjunctive endovascular and/or surgical revision prior to achieving functional patency after endovascular or percutaneous AVF creation, at least within the United States. This rate appears to be higher after percutaneous AVF than after endovascular AVF, although because published reports of the former are mostly derived from American experience and those of the latter derived from experience outside the United States, it is unclear whether these differences are due to the technique itself or cultural and/or anatomic differences in dialysis access practices and patient populations. If arterial inflow is poor, this should be corrected first. When flow is adequate (perhaps 900 cc/min) but no single vein is cannulatable, a dominant suitable vein can be superficialized or transposed. If no suitable vein is dominant (most accurately assessed by using an intraoperative flowmeter), the best vein can be used, with or without occlusion of the other veins or reimplantation into the brachial artery. Finally, if the original anastomosis remains the sole supply to the cannulated vein, the original fistula has achieved assisted primary maturation (and assisted primary patency continues), while if a new arteriovenous anastomosis has been constructed, the original fistula has failed. We point out that for this reason as well as to best utilize the upper arm for later access, endovascular and percutaneous AVFs should be constructed and maintained within an atmosphere where both surgeons and non-surgeons work together on the overall access plan.

Efficacy and safety associated with the use of the Surfacer® Inside-Out® Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

PURPOSE: Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The Surfacer System to Facilitate Access in Venous Occlusions Study was an Food and Drug Administration-approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction. METHODS: Thirty patients were enrolled in this prospective, multicenter, single-arm study between December 2017 and May 2019. Device performance and adverse events were collected peri-procedurally and at discharge. Enrollment included 15 female and 15 male subjects with a mean age of 55.5 ± 12.9 (range: 30-79) years. Twenty-eight patients (93.3%) required central venous access for hemodialysis access. Locations of thoracic central venous obstruction were graded from 1 to 4 based on severity and extension of venous occlusions. Seven patients (23.3%) had type 1, 6 (20.0%) type 2, 16 (53.3%) type 3, and 1 (3.3%) type 4 obstruction. RESULTS: Successful central venous catheter placement was achieved in 27 of 30 patients (90.0%). The procedure was discontinued in three (10.0%) due to tortuous anatomy discovered intraprocedurally. All 27 patients with successful CVC placement achieved adequate catheter patency and tip positioning with a mean overall procedural time and time to achieve central venous access with the Surfacer System being 44.1 ± 30.6 and 19.1 ± 25.1 min, respectively. There were no device-related adverse events or catheter malposition. CONCLUSION: The results of the SAVEUS Study confirm the safety and efficacy of the Surfacer System and the Inside-Out procedure when used for the placement of right-sided central venous access in patients with thoracic central venous obstruction.

One- versus two-stage transposed brachiobasilic arteriovenous fistulae: A review of the current state of the art.

In the absence of suitable cephalic vein, the brachiobasilic vein complex represents the best option for arteriovenous access. However, the basilic vein is too deep to cannulate and requires transposition to be accessible. Transposition can be performed during fistula creation (single-stage BBTx) or at a second operation after initial fistula creation (two-stage brachiobasilic transposition (BBTx)). The best approach is unknown. A PubMed search using "Basilic vein transposition" as the primary search term was performed to identify articles addressing this controversy. Meta-analysis was then performed using those papers that provided the inspected data points with student's t-test used to compare maturation and patency rates between the groups. A total of 37 manuscripts were judged of adequate quality for analysis. Based on the available data, overall maturation rates, 1-year primary patency rates, and overall complication rates seem to be equivalent between single- and two-stage BBTx, while 1-year secondary patency is greater in the two-stage group (79% vs 85%). A large prospective randomized clinical trial with clear definitions of maturity, patency, and complications is needed to definitively answer the question of whether one strategy is better than the other.

Costs and complications of endovascular inferior vena cava filter retrieval.

OBJECTIVE: Advanced endovascular techniques are frequently used for challenging inferior vena cava (IVC) filter retrieval. However, the costs of IVC filter retrieval have not been studied. This study compares IVC filter retrieval techniques and estimates procedural costs. METHODS: Consecutive IVC filter retrievals performed at a tertiary center between 2009 and 2014 were retrospectively reviewed. Procedures were classified as standard retrieval (SR) if they required only a vascular sheath and a snare device and as advanced endovascular retrieval (AER) if additional endovascular techniques were used for retrieval. Cost data were based on hospital bills for the procedures. Patients' characteristics, filter dwell time, retrieval procedure details, complications, and costs were compared between the groups. All statistical comparisons were performed using SAS 9.3 software. RESULTS: There were 191 IVC filter retrievals (SR, 157; AER, 34) in 183 patients (mean age, 55 years; 51% male). Fifteen filters (7.9%) were placed at an outside hospital. The indications for placement were mostly therapeutic (76% vs 24% for prophylaxis). All IVC filters were retrievable, with Bard Eclipse (Bard Peripheral Vascular, Tempe, Ariz; 34%) and Cook Günther Tulip (Cook Medical, Bloomington, Ind; 24%) the most common. Venous ultrasound examination of the lower extremities of 133 patients (70%) was performed before retrieval, whereas only 5 patients (2.6%) received a computed tomography scan of the abdomen. There was no difference in the mean filter dwell time in the two groups (SR, 147.9 ± 146.1 days; AER, 161.4 ± 91.3 days; P = .49). AERs were more likely to have had prior attempts at retrieval (23.5%) compared with SRs (1.9%; P < .001). The most common AER techniques used were the wire loop and snare sling (47.1%) and the stiff wire displacement (44.1%). Bronchoscopy forceps was used in four cases (11.8%); this was the only off-label device used. AERs were more likely to require more than one venous access site for the retrieval procedure (23.5% vs 0%; P < .001). AERs were significantly more likely to have longer fluoroscopy time (34.4 ± 18.3 vs 8.1 ± 7.9 minutes; P < .001) and longer total procedural time (102.8 ± 59.9 vs 41.1 ± 25.0 minutes; P < .001) compared with SRs. The complication rate was higher with AER (20.6%) than with SR (5.2%; P = .006). Most complications were abnormal radiologic findings that did not require additional intervention. The procedural cost of AER was significantly higher (AER, $14,565 ± $6354; SR, $7644 ± $2810; P < .001) than that of SR. This translated to an average increase in cost of $6921 ± $3544 per retrieval procedure for AER. CONCLUSIONS: Advanced endovascular techniques provide a feasible alternative when standard IVC filter retrieval techniques do not succeed. However, these procedures come with a higher cost and higher rate of complications.

Clinical and Economic Benefits of Stent Grafts in Dysfunctional and Thrombosed Hemodialysis Access Graft Circuits in the REVISE Randomized Trial.

PURPOSE: To compare reinterventions and associated costs to maintain arteriovenous graft hemodialysis access circuits after rescue with percutaneous transluminal angioplasty (PTA), with or without concurrent Viabahn stent grafts, over 24 months. MATERIALS AND METHODS: This multicenter (n = 30 sites) study evaluated reintervention number, type, and cost in 269 patients randomized to undergo placement of stent grafts or PTA alone. Outcomes were 24-month average cumulative number of reinterventions, associated costs, and total costs for all patients and in 4 groups based on index treatment and clinical presentation (thrombosed or dysfunctional). RESULTS: Over 24 months, the patients in the stent graft arm had a 27% significant reduction in the average number of reinterventions within the circuit compared to the PTA arm (3.7 stent graft vs 5.1 PTA; P = .005) and similar total costs ($27,483 vs $28,664; P = .49). In thrombosed grafts, stent grafts significantly reduced the number of reinterventions (3.7 stent graft vs 6.2 PTA; P = .022) and had significantly lower total costs compared to the PTA arm ($30,329 vs $37,206; P = .027). In dysfunctional grafts, no statistical difference was observed in the number of reinterventions or total costs (3.7 stent graft vs 4.4 PTA; P = .12, and $25,421 stent graft and $22,610 PTA; P = .14). CONCLUSIONS: Over 24 months, the use of stent grafts significantly reduced the number of reinterventions for all patients, driven by patients presenting with thrombosed grafts. Compared to PTA, stent grafts reduced overall treatment costs for patients presenting with thrombosed grafts and had similar costs for stenotic grafts.

Increased mortality in octogenarians treated for lifestyle limiting claudication.

OBJECTIVE: Treatment for lifestyle limiting claudication (LLC) that is due to infra-inguinal peripheral artery disease relies on either bypass, angioplasty, and/or stenting. Given the enthusiasm and shift toward more endovascular therapy for treatment of LLC, we sought to analyze whether octogenarians benefit from infra-inguinal interventions in the same manner as their younger counterparts. METHODS: We identified all patients admitted for elective treatment of LLC from the Nationwide Inpatient Sample from 2003 to 2012, who received open surgical or endovascular intervention for infra-inguinal peripheral arterial disease. These patients were divided into two groups including those between the ages 60-80 years (younger cohort) and those older than 80 years (octogenarians). Primary end-points included morbidity and mortality and the secondary end-points were length of hospital stay (LOS) and disposition after dismissal. RESULTS: Among 59,323 discharges identified in the dataset, 34,658 (58%) were males. There were 50,323 (85%) patients in the younger cohort and 9,000 (15%) octogenarians. The mean age was 69.9 ± 5.7 years and 84.2 ± 3.0 years for the younger cohort and octogenarians, respectively. The mean Charlson comorbidity index (CCI) was higher in our younger cohort (2.1 ± 1.1, P < 0.001). Octogenarians mainly treated with open surgery prior to 2004 are now treated endovascularly and this trend has remained stable. The younger cohort's treatment modality has fluctuated through the study period and most recently is treated mainly with open surgery. The rate of acute kidney injury, exacerbation of congestive heart failure and mortality was higher in octogenarians (P < 0.001). The rate of infectious wound complications was higher in the younger cohort (P < 0.05). Octogenarians have longer LOS and are dismissed in higher percentage to a skilled nursing facility (P < 0.001). On binary logistic regression analysis, age over 80 years, female sex, higher CCI and having an open as opposed to an endovascular procedure are independent predictors of in-hospital mortality. CONCLUSIONS: Although endovascular techniques seem to dominate the care for octogenarians with LLC, the overall morbidity and mortality rates are significantly higher in this patient population. Other options such as medical management and/or supervised exercise therapy should be explored in this patient group.

Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts.

OBJECTIVE: To compare the results of stent graft placement to balloon angioplasty for the treatment of stenosis at the venous anastomosis of failing and thrombosed prosthetic hemodialysis grafts. METHODS: This prospective, multicenter trial included 293 patients randomized (1:1) to the stent graft (n = 145) or balloon angioplasty (n = 148) group for treatment of stenosis at the venous anastomosis of dysfunctional (n = 164) or thrombosed (n = 129) hemodialysis grafts. The primary study end point was target lesion primary patency at 6 months; participants were followed for up to 24 months. Primary patency of the access circuit was a secondary end point. Statistical analysis of effectiveness was performed using both the intent-to-treat population and the effectiveness-per-protocol (EPP) populations for primary patency end points. Statistical analysis of additional effectiveness end points was performed using the EPP population. RESULTS: The 6-month target lesion primary patency was statistically greater in the stent graft group than the balloon angioplasty group (intent-to-treat, 51.6% vs 34.2% [P = .006]; EPP, 52.9% vs 35.5% [P = .008]). Compared with the angioplasty group, the stent graft group increased the median time from the index procedure to the next intervention on the target lesion by 95 days (203 vs 108 days). Patients with dysfunctional (stenotic) grafts had higher target lesion primary patency compared with patients with thrombosed grafts regardless of treatment (EPP, stent graft, 64.6% vs 36.1% and balloon angioplasty, 45.8% vs 23.5%). When compared with angioplasty, using a stent graft for treatment of a venous anastomotic stenosis of a thrombosed graft increased the 6-month target lesion primary patency by 53.6% (EPP, 36.1% vs 23.5%). CONCLUSIONS: When compared with balloon angioplasty, a stent graft provided superior target lesion primary patency at 6 months for treatment of venous anastomotic stenoses of dysfunctional and thrombosed prosthetic hemodialysis grafts.

Real-Time Super Selective Venous Sampling in Remedial Parathyroid Surgery.

BACKGROUND: Remedial cervical exploration for persistent or recurrent primary hyperparathyroidism can be technically difficult, but is expedited by accurate preoperative localization. We investigated the use of real-time super selective venous sampling (sSVS) in the setting of negative noninvasive imaging modalities. STUDY DESIGN: We performed a retrospective analysis of a prospective database incorporating real-time sSVS in a tertiary academic medical center. Between September 2001 and April 2014, 3,643 patients were referred for surgical treatment of primary hyperparathyroidism. Of these, 31 represented remedial patients who had undergone one (n=28) or more (n=3) earlier cervical explorations and had noninformative, noninvasive preoperative localization studies. RESULTS: We extended the use of the rapid parathyroid hormone assay in the interventional radiology suite, generating near real-time data facilitating onsite venous localization by a dedicated interventional radiologist. The predictive value of real-time sSVS localization was investigated. Overall, sSVS correctly predicted the localization of the affected gland in 89% of cases. Of 31 patients who underwent sSVS, a significant rapid parathyroid hormone gradient was identified in 28 (90%), localizing specific venous drainage of a culprit gland. All patients underwent subsequent surgery and were biochemically cured, with the exception of one who had metastatic parathyroid carcinoma. Three patients with negative sSVS were also explored and cured. CONCLUSIONS: Preoperative parathyroid localization is of paramount importance in remedial cervical explorations. Real-time sSVS is a sensitive localization technique for patients with persistent or recurrent primary hyperparathyroidism, when traditional noninvasive imaging studies fail. These results validate the utility and benefit of real-time sSVS in guiding remedial parathyroid surgery.

Successful treatment of a proximal type I endoleak with HeliFX EndoAnchors.

We report the use of Aptus HeliFX EndoAnchors for endovascular treatment of a proximal type I endoleak after previous endovascular aneurysm repair (EVAR) of a ruptured abdominal aortic aneurysm. An 81-year-old man had been treated with EVAR after a ruptured 12 × 11 cm abdominal aortic aneurysm. Standard computed tomographic angiography follow-up demonstrated a proximal type I endoleak. Because of the highly angulated neck and close position of the endograft to the renal arteries, placement of a proximal extension cuff was prohibited; therefore, the endoleak was treated with an alternative approach using the Aptus HeliFX EndoAnchors. Nine EndoAnchors were successfully placed circumferentially on the proximal site of the endograft. This successfully treated the endoleak by excluding the aneurysm sac from the circulation. Computed tomographic angiography follow-up after 3 months showed no residual type I endoleak. This case shows that placement of EndoAnchors can serve as a viable treatment option for proximal type I endoleaks after failed EVAR.

Tissue plasminogen activator via cross-collateralization for tandem internal carotid and middle cerebral artery occlusion.

Tandem internal carotid and middle cerebral artery occlusion after carotid dissection predicts poor outcome after systemic thrombolysis. Current treatments include the use of endovascular carotid stenting, which carries with it a high risk of propagating further embolic events and worsening the dissection. New strategies for avoiding the aforementioned side-effects include recanalization using cross-collaterals for delivery of intra-lesional tissue plasminogen activator (tPA). We present two cases that provide further support for this novel approach. Both patients presented with a National Institute of Health Stroke Scale of 20, received intra-arterial tPA via cross-collateralization, and made full recoveries without the need for stenting.

Subclavian aneurysm presenting with massive hemoptysis: a case report and review of the literature.

We present a case of a 70-year-old male with a past medical history of coronary artery bypass grafting and end stage renal disease who presented with massive hemoptysis. He had a history of methicillin-resistant Staphylococcus aureus endocarditis, with infection and removal of endocardial pacing leads. His work-up revealed a 2.9-cm proximal left subclavian artery aneurysm. Bronchoscopy confirmed bright red blood in the left upper lobe bronchus and coronary angiography confirmed a patent left internal mammary artery (LIMA) to left anterior descending bypass. Because of the consideration of maintaining coronary perfusion via the LIMA while excluding the subclavian aneurysm, he underwent a left carotid to left axillary artery bypass graft followed by deployment of an Amplatzer II vascular plug just distal to the aneurysm. A thoracic endograft was then deployed to exclude the origin of the subclavian. A review of the literature reveals hemoptysis as a rare presentation of a subclavian aneurysm. We discuss approaches to this challenging clinical problem, ranging from open repair to hybrid approaches.

Lower extremity limb salvage with cryoplasty: a single-center cohort study.

Endovascular techniques have been playing an increasing role in managing lower extremity chronic critical limb ischemia (CLI) in patients considered poor or non-candidates for surgical revascularization secondary to co-morbidities such as coronary artery disease, uncontrolled hypertension, diabetes mellitus or inadequate conduit. This study reviews our recent clinical experience in the treatment of peripheral artery disease solely using cryoplasty. A retrospective cohort study was performed. The cohort consisted of 88 patients who underwent lower extremity revascularization utilizing cryoplasty between December 2003 and August 2007. Indications for intervention included poor wound healing after forefoot amputation or persistent ulceration of the foot, disabling claudication and rest pain. Kaplan-Meier analysis was performed to assess salvage rates. One hundred twenty-six lesions were treated in 88 patients. Technical success rate was 97%. Limb salvage rates were 75 and 63% for patients with critical limbs ischemia after one and three years, respectively. A history of smoking was associated with a threefold increased risk of limb loss. In conclusion, endovascular management of lower extremity lesions with cryoplasty is an emerging and viable paradigm in the treatment of CLI in an attempt to preserve limbs and avoid major amputations.

The chimney procedure is an emergently available endovascular solution for visceral aortic aneurysm rupture.

A 79-year-old woman presented with a ruptured saccular thoracoabdominal aortic aneurysm involving the celiac and mesenteric artery. The patient was unfit for open surgical repair. A "chimney" procedure was performed, which involved placement of stents in the aortic side branches alongside the endograft. The patient underwent another chimney procedure 2 weeks later for a type I endoleak. Computed tomography angiography (CTA) at 1 and 6 months showed a good result with no endoleaks or graft migration. The chimney procedure provides an alternative for emergency patients unfit for open repair and has the advantage that stents can be used that are already available in most institutions.

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.

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 > or = 2.5 mm and < or = 5.0 mm and target lesion stenosis > or = 50%. The primary study endpoints were acute technical success (the ability to achieve < or = 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 (> or = 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.

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 < or =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 (> or =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.