What is the evidence for the efficacy of cryoplasty?

Cryoplasty is a technique for treating vascular stenosis which combines balloon angioplasty with cold injury. The combination is proposed to reduce the incidence of restenosis by inhibition of neointimal hyperplasia. There have been several clinical studies which purport to show improved patency compared to conventional angioplasty. Unfortunately, these are not comparative or controlled studies and have not been performed, analyzed or reported in accordance with recognized reporting standards for peripheral vascular intervention. The studies on femoropopliteal disease have selected favourable patients. Of greatest concern is the use of surrogate endpoints in lieu of objective demonstration of vessel patency. Critical interpretation of the results fails to demonstrate any convincing superiority of cryoplasty compared to conventional balloon angioplasty. Where little difference in outcome exists between two techniques, a trial comparing them will require hundreds of patients to be sufficiently powered to demonstrate a benefit of one technique over the other. As cryoplasty is significantly more expensive than conventional angioplasty, the cost benefit ratio is unfavourable and such a trial is unlikely to occur. This article is a critical review of the technique of cryoplasty. The reader will be able to: describe expected outcomes from balloon angioplasty; describe the theoretical role for cold injury as a component of angioplasty; recognize the need to adhere to well defined standards when reporting the results of new techniques for treating vascular disease; critically review the results of cryoplasty; understand the limitations and relevance of the published clinical results of cryoplasty.

Femoropopliteal bypass is not a generic procedure: a survey of the practice patterns of the Florida Vascular Society.

The purpose of this study was to evaluate whether surgeons perform femoropopliteal bypass using standard or dissimilar methods. A questionnaire was mailed to all members of the Florida Vascular Society, which consists of 83 board-certified vascular surgeons. Fifty-three responded (62%). Eighty-one questions covered aspects of the intraoperative and postoperative technical details usually involved in performing femoropopliteal bypass. Surgeons performed between 10 and 80 (mean 38) femoropopliteal bypasses per year. Only seven (13%) surgeons were aware of their patency rates. The results of this study showed that surgeons are largely unaware of their patency rates. When the variables used in this study were considered, no two surgeons performed the procedure in an identical manner. This variation in practice pattern may account for the discrepancy in reported patency rates for femoropopliteal bypass.

Hemodynamically significant early recurrent carotid stenosis: an often self-limiting and self-reversing condition.

PURPOSE: The natural history of hemodynamically significant (internal carotid systolic velocity more than 125 cm/s) early recurrent carotid stenosis was studied. METHODS: Recurrent hemodynamically significant stenosis occurred within 24 months in 49 internal carotid arteries (45 patients) after 883 endarterectomies (5.4%). These patients were then examined with serial scans. Subsequent redo endarterectomy and neurological events were recorded. RESULTS: Patients were observed for 9 to 84 months (mean, 53 months). Arteries with recurrent stenosis were grouped according to the maximal velocity recorded: group I, systolic velocity more than 125 cm/s and less than 280 cm/s (12); group II, systolic velocity more than 280 cm/s or diastolic velocity more than 80 cm/s (21); group III, systolic velocity more than 280 cm/s and diastolic velocity more than 120 cm/s (14); group IV, internal carotid artery occlusion (2). The mean time to a velocity of more than 125 cm/s was 11 months. The mean time to peak velocity was 16 months. During The Follow-UP Period, Five Stenoses Remained Stable. Nineteen Continued To Increase, With Two Eventual Asymptomatic Occlusions (4%). Six Recurrences Ultimately Had Redo Endarterectomy, Two For Symptoms. Three Of These Developed New Secondary Recurrent Lesions. However, In 25 Arteries (53%), The Velocity Profile Decreased By At Least One Group Classification. The Mean Time To The Lowest Velocity (TTL) Was 50 Months. Systolic Velocity Ultimately Fell Below 125 Cm/S In 13 Stenoses (SIX In Group I; Five In Group II; Two In Group III). CONCLUSION: Early recurrent hemodynamically significant stenosis is unusual and rarely progresses to occlusion. Even critical stenosis can regress to within normal limits. Redo endarterectomy is seldom necessary. The challenge remains to define which patients are at risk for symptoms and occlusion.

Color flow scan diagnosis of the carotid string may prevent unnecessary surgery.

Can the color flow scanner assist in the diagnosis and management of patients with preocclusive lesions of the carotid bifurcation (so-called 'string sign')? Twenty-three patients were identified as having a 'string' by duplex criteria. Seventeen patients underwent angiography, which confirmed the duplex findings in 14 patients. In three, the angiogram was originally misread as showing an occluded internal carotid Artery. Six patients were managed solely on the basis of the duplex findings. Based on arteriography and/or duplex criteria, 12 involved internal carotid arteries were not explored. One artery went on to occlude asymptomatically. The remaining 11 have remained patent and asymptomatic (follow-up 6-72 months). Five arteries were predicted operable and underwent successful endarterectomy. Six were predicted inoperable yet underwent exploration. All were ultimately treated by ligation +/- external carotid endarterectomy without subsequent neurological deficit. Duplex scans can identify internal carotid artery string signs, determine operability and may predict the functionally occluded artery that can be safely observed.

Isolated femoropopliteal bypass graft for limb salvage after failed tibial reconstruction: a viable alternative to amputation.

PURPOSE: Femoropopliteal bypass grafting procedures performed to isolated popliteal arteries after failure of a previous tibial reconstruction were studied. The results were compared with those of a study of primary isolated femoropopliteal bypass grafts (IFPBs). METHODS: IFPBs were only constructed if the uninvolved or patent popliteal segment measured at least 7 cm in length and had at least one major collateral supplying the calf. When IFPB was performed for ischemic lesions, these lesions were usually limited to the digits or small portions of the foot. Forty-seven polytetrafluoroethylene grafts and three autogenous reversed saphenous vein grafts were used. RESULTS: Ankle brachial pressure index (ABI) increased after bypass grafting by a mean of 0.46. Three-year primary life table patency and limb-salvage rates for primary IFPBs were 73% and 86%, respectively. All eight IFPBs performed after failed tibial bypass grafts remained patent for 2 to 44 months, with patients having viable, healed feet. CONCLUSION: In the presence of a suitable popliteal artery and limited tissue necrosis, IFPB can have acceptable patency and limb-salvage rates, even when a polytetrafluoroethylene graft is used. Secondary IFPB can be used to achieve limb salvage after failed tibial bypass grafting.

Routine carotid endarterectomy without a shunt, even in the presence of a contralateral occlusion.

UNLABELLED: A 10-year prospective experience with routine non-shunting, even in the presence of a contralateral internal carotid artery occlusion, is reviewed. METHOD AND RESULTS: Carotid endarterectomy was performed without a shunt in 654 consecutive patients: group 1, 513 patients with contralateral stenosis of less than 79%: group 11, 74 patients with a greater than 80% contralateral stenosis; and group 111, 67 patients with a contralateral occlusion. Average cross-clamp time was 23 min. Neurological complications occurred within 30 days in 20 (3.0%) patients (10 strokes, seven transient ischemic attacks in group I, one transient ischemic attack in group II, and one stroke and one transient ischemic attack in group III). Immediate postoperative strokes, i.e. those five cases that could be implicated as caused by lack of a shunt, were rare (0.76%). There were five perioperative deaths (0.76%). CONCLUSION: Carotid endarterectomy may be performed safely without a shunt even in the presence of a contralateral occlusion. Age, sex, preoperative indication, anesthetic agent and contralateral stenosis were not associated with an increased risk of postoperative neurological deficit.

Is thigh saphenectomy a necessary adjunct to high ligation and stab avulsion phlebectomy?

BACKGROUND: Controversy still exists as to whether the thigh saphenous vein should be stripped concomitant with high ligation and phlebectomy. METHOD: A total of 218 procedures were retrospectively grouped into three groups: group 1, 10 limbs with visible, duplex scan-confirmed varicose veins of the thigh saphenous vein; group 2, 13 saphenous veins with varices that were not clinically evident; group 3, 195 limbs with incompetent saphenous veins without thigh saphenous varices. RESULTS: Five limbs in group 1 were treated by high ligation, phlebectomy, and thigh saphenectomy. All did well. Five had high ligation and phlebectomy only. Two developed painful phlebitis, and two had residual varices in the saphenous vein. Group 2 and group 3 were treated by high ligation and phlebectomy. One group 2 limb developed saphenous phlebitis. Five limbs in group 3 developed recurrent veins that were removed in the office. CONCLUSION: Thigh saphenectomy is only required when there are visible, duplex scan-confirmed varices of the thigh saphenous itself, or when the procedure is performed for severely symptomatic patients or those with advanced stasis changes.

Stockings and the prevention of recurrent venous ulcers.

BACKGROUND: Cost-effective therapy that heals ulcers rapidly and prevents recurrence would significantly impact patient care and the health system. OBJECTIVE: To evaluate compression stockings for treatment of venous ulcerations and prevention of recurrent ulceration; to analyze patient compliance; and to evaluate cost of compression stocking therapy. METHODS: Stocking therapy healed venous ulcers in 53 patients. The effect of continued stocking use on ulcer recurrence rate and treatment costs was evaluated. RESULTS: Twenty-five patients had good stocking usage; one developed recurrence (4%). Twenty-eight patients had bad or none usage; 22 had at least one recurrence (79%). Bad/none usage was associated with 31 of 32 (97%) recurrent ulcerations; good usage was associated with 52 of 58 (90%) nonrecurrent ulcers. Cost was a major reason for noncompliance. CONCLUSIONS: Continued stocking use after ulcer healing will prevent most recurrences and will provide a significant cost saving to the nation's health care budget.

Compression stockings and non-continuous use of polyurethane foam dressings for the treatment of venous ulceration. A pilot study.

BACKGROUND: Venous ulceration is usually treated with Unna's boot. Recently another product, Ulcer-care, has been developed to treat these ulcers. OBJECTIVE: To evaluate the therapeutic value of Ulcer-care. METHODS: Over 24 months, 20 ambulatory patients with 30 lower extremity stasis ulcers were treated with a product consisting of: 1) a hydrophilic polyurethane sponge covered by a hydrophobic membrane changed daily or every other day; 2) an inner liner stocking that applies 10 mmHg pressure and is worn 24 hours a day; and 3) a surgical stocking with a posterior zipper that applies 30 mmHg graduated pressure and is removed at night. RESULTS: All ulcers healed after 2 to 30 weeks (mean 8.3 weeks) including 15 previously treated by Unna's boot or hydrocolloid dressings and 3 infected ulcers. CONCLUSION: The Ulcer care treatment for stasis ulcers is highly successful, easy to use, and well accepted by patients.

High ligation of the greater saphenous vein for treatment of lower extremity varicosities: the fate of the vein and therapeutic results.

This study was carried out to determine the subsequent fate of the greater saphenous vein and the efficacy of its high ligation along with surgical excision or sclerotherapy of varicosities. From 1988 to 1990, 22 patients underwent high ligation and sclerotherapy, 22 underwent high ligation and varicose vein excision, and four underwent high ligation alone. There were 36 women and 12 men patients. The average patient age was 48. Sixty limbs were scanned by duplex ultrasound pre- and postoperatively to determine the status of the greater saphenous vein. Average follow-up time was 10 months. Patients and surgeons rated the results of therapy for ablation of varicosities and alleviation of symptoms. Surgical complications were evaluated. At postoperative scan, 47 greater saphenous veins (78%) were found to be completely patent, nine (15%) were thrombosed for a short segment (less than 10 cm) and four (7%) were more significantly thrombosed. Those limbs in which high ligation and sclerotherapy were performed had the highest complete patency rate (96%). Patient and surgeon satisfaction was good to excellent in every case. The only complications were three symptomatic greater saphenous vein thromboses. Although follow-up is relatively brief, complete patency of the ligated greater saphenous vein was found in most cases. High ligation allows preservation of a patent greater saphenous vein, which can be used as an arterial conduit at a later date and gives therapeutic results comparable to stripping without the additional morbidity.

Popliteal artery occlusion caused by cystic adventitial disease: successful treatment by urokinase followed by nonresectional cystotomy.

Preoperative diagnosis of an occluded popliteal artery caused by cystic adventitial disease allowed use of urokinase to successfully dissolve secondary thrombosis. Subsequent non-resectional adventitial cystotomy and evacuation of cyst contents allowed lasting restoration of a patent arterial lumen and return of normal distal pulses. This nongrafting technique may serve as a model for future patients with occluded arteries caused by this condition.

A modified classification and approach to the management of infections involving peripheral arterial prosthetic grafts.

During the past 15 years, we have employed a modified classification and management plan to treat infections involving nonaortic peripheral arterial prosthetic grafts (PAPGs) without graft removal whenever possible. Sixty-eight infected wounds potentially involving PAPGs were initially treated by excision of necrotic and infected wound tissue in the operating room (wound excision). This was sufficient for all 34 minor infections that did not directly involve the graft. In the 34 remaining infected wounds with graft involvement (major infections), partial removal of a PAPG in 13 cases allowed preservation for up to 15 years of a functioning arterial segment and its collaterals. Ten other grafts were entirely saved. Only 11 of 34 major graft infections ultimately required total graft removal. This approach to infection complicating PAPGs resulted in only two deaths (6%) and directly led to limb loss or amputation at a higher level in eight patients (24%). Total removal of an infected PAPG is often unnecessary and may increase mortality and morbidity.

Peripheral vascular injuries associated with falls from heights.

Peripheral vascular injuries associated with falls from heights are uncommon. We report our 15-year experience with ten such injuries in 230 patients who jumped or fell from heights of at least 3 stories. These injuries occurred in seven patients and included four popliteal artery thromboses or disruptions, two popliteal vein disruptions, one traumatic tibial arteriovenous fistula, one subclavian artery pseudoaneurysm, one radial artery transection, and one lacerated medial circumflex artery. Although the mechanism of injury is multifactorial, all were associated with significant orthopedic trauma. Early recognition of vascular injuries, minimization of ischemic time, completion arteriography, venous repair, and liberal use of fasciotomy are emphasized to maximize limb salvage.

Prevention and management of ischemic complications of vein harvest incisions in cardiac surgery--case reports.

Leg wound complications following saphenous vein harvest for coronary revascularization are uncommon. We have encountered five patients in whom unrecognized arterial occlusive disease contributed to wound necrosis. All required vascular reconstruction in addition to local wound care to achieve healing. Careful preoperative attention to symptoms of arterial insufficiency is recommended and appropriate modification of lower extremity incisions may reduce the frequency of this complication. Prompt recognition and appropriate arterial revascularization should avoid prolonged morbidity if ischemic necrosis of leg wounds does occur. If arterial reconstruction is required, PTFE is an acceptable graft material if the remaining saphenous vein is inadequate for use.

Limb salvage in octogenarians and nonagenarians.

Although advanced age has often been a relative contraindication to attempts at limb salvage, we have not regarded it as an important deterrent to arterial reconstruction. Our 6-year experience with 168 consecutive patients over 80 years of age who underwent arterial reconstruction or percutaneous transluminal angioplasty represented 18% of all patients treated with limb-threatening ischemia during this period. The average age was 84 years, with 14 patients over 90 years of age. Sixty-eight patients were men (41%) and 100 were women (59%). Indications for treatment in 189 limbs were restricted to limb salvage. One hundred eighty-two operative procedures were performed consisting of 84 femoropopliteal, 72 femorotibial, 12 axillofemoral, 11 femorofemoral, two axillopopliteal and one iliofemoral bypass. Percutaneous transluminal angioplasty was performed in 12 iliac and 14 femoral or popliteal arteries as an alternative (seven) or adjunct (19) to vascular reconstruction. The 30-day procedural mortality rate was 6%. The cumulative life table survival rate of all patients who underwent an attempt at limb salvage was 78% at 1 year, 65% at 2 years, and 54% at 3 years. Cumulative life table limb salvage rates were 84% at 1 year, 74% at 2 years, and 71% at 3 years. Overall graft patency for 182 arterial reconstructive operations was 80% at 1 year and 62% at 3 years. Of patients in whom limb salvage was attempted, 65% lived more than 1 year and 51% more than 2 years with a functional limb. Of patients who died within 5 years of treatment, 76% did so with their previously threatened limb intact. These data support an aggressive approach to arterial reconstruction in elderly patients and indicate that advanced age alone should not be considered a contraindication to attempts at limb salvage.

Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstructions.

Autologous saphenous vein (ASV) and polytetrafluoroethylene (PTFE) grafts were compared in 845 infrainguinal bypass operations, 485 to the popliteal artery and 360 to infrapopliteal arteries. Life-table primary patency rates for randomized PTFE grafts to the popliteal artery paralleled those for randomized ASV grafts to the same level for 2 years and then became significantly different (4-year patency rate of 68% +/- 8% [SE] for ASV vs. 47% +/- 9% for PTFE, p less than 0.025). Four-year patency differences for randomized above-knee grafts were not statistically significant (61% +/- 12% for ASV vs. 38% +/- 13% for PTFE, p greater than 0.25) but were for randomized below-knee grafts (76% +/- 9% for ASV vs. 54% +/- 11% for PTFE, p less than 0.05). Four-year limb salvage rates after bypasses to the popliteal artery to control critical ischemia did not differ for the two types of randomized grafts (75% +/- 10% for ASV vs. 70% +/- 10% for PTFE, p greater than 0.25). Although primary patency rates for randomized and obligatory PTFE grafts to the popliteal artery were significantly different (p less than 0.025), 4-year limb salvage rates were not (70% +/- 10% vs. 68% +/- 20%, p greater than 0.25). Primary patency rates at 4 years for infrapopliteal bypasses with randomized ASV were significantly better than those with randomized PTFE (49% +/- 10% vs. 12% +/- 7%, p less than 0.001). Limb salvage rates at 3 1/2 years for infrapopliteal bypasses with both randomized grafts (57% +/- 10% for ASV and 61% +/- 10% for PTFE) were better than those for obligatory infrapopliteal PTFE grafts (38% +/- 11%, p less than 0.01). These results fail to support the routine preferential use of PTFE grafts for either femoropopliteal or more distal bypasses. However, this graft may be used preferentially in selected poor-risk patients for femoropopliteal bypasses, particularly those that do not cross the knee. Although every effort should be made to use ASV for infrapopliteal bypasses, a PTFE distal bypass is a better option than a primary major amputation.