Herbert Dardik

A decade of experience with the glutaraldehyde-tanned human umbilical cord vein graft for revascularization of the lower limb

Between October 1975 and November 1985, 907 lower limb bypasses were constructed in 715 patients (799 limbs) with glutaraldehyde-stabilized umbilical veins (UV-G) used as the predominant, or sole, graft material. Each reconstruction was classified in one of eight categories depending on the site of the distal anastomosis: above- and below-knee popliteal, anterior and posterior tibial, peroneal, trifurcation, sequential, and crural (tibial or peroneal) bypasses with adjunctive distal arteriovenous fistulas. Primary and secondary cumulative graft patency rates were determined for each category as well as cumulative actual palliation that combines end points of graft failure, amputation, and death. Half-life patencies for popliteal, tibial, and peroneal bypasses were 6.5, 2.3, and 1.7 years, respectively. Perioperative graft thrombosis occurred in 11% of popliteal reconstructions compared with 22% for the crural group. Nonocclusive graft failure caused by infection, aneurysm, or progressive foot gangrene occurred in 87 grafts (8%). The overall infection rate was 4.3%. Anastomotic aneurysms (1.4%) and strictures (2.1%) occurred infrequently as isolated phenomena. The incidence of graft dilatation and aneurysms assumed significant proportion after 5 years (36% aneurysms and 21% dilation); the diagnosis was particularly facilitated by B-mode imaging. Nevertheless, the overall clinical impact of graft degradation remained minimal (6% after 5 years). Twenty-two of 26 graft aneurysms were excised with successful graft replacement achieved in 10. During this 10-year period, our attitudes did change with regard to the indication for UV-Gs in relation to the maturation of infrapopliteal reconstructive surgery, appreciation of the superior results attainable with in situ saphenous vein, recognition of morphologic changes in long-term UV-G implants, and the growing documentation of poor results with polytetrafluorethylene in the crural position. We believe that UV-G is an acceptable alternative to the absent or deficient autologous vein, particularly in patients with limited life expectancy and where expediency may be a critical factor.

Autologous platelet-rich fibrin matrix as cell therapy in the healing of chronic lower-extremity ulcers

A novel autologous platelet‐rich fibrin matrix membrane (PRFM) was assessed for the ability to facilitate healing in patients with chronic lower‐extremity ulcers. Preliminary data are presented from a prospective trial (n=21). Twelve patients were identified with 17 venous leg ulcers (VLU) and nine bearing 13 nonvenous lower‐extremity ulcers. Before enrollment, the patients were evaluated for vascular status and received appropriate surgical intervention to optimize arterial and venous circulatory status. None of the ulcers had responded to a variety of standard treatments from 4 months to 53 years. Initial ulcer size ranged from 0.7 to 65 cm2 (mean, 11.2 cm2). Each PRFM‐treated patient received up to three applications of either a 35 or 50 mm fenestrated membrane, depending on initial ulcer size. The primary endpoints were percent and rate of complete closure as measured by digital photography, computerized planimetery, and clinical examination. Patients were followed weekly for 12 weeks with a follow‐up visit at 16 weeks. At each 4‐week interval, the extent of healing was assessed, and those patients with >50% reduction in wound area were allowed to continue to complete closure. Patients with <50% closure received repeated applications. Complete closure was achieved in 66.7% of the VLU patients (64.7% of treated ulcers) in 7.1 weeks (median, 6 weeks) with an average of two applications per patient. Forty‐four percent complete closure was seen with non‐VLU patients (31% of treated ulcers). From the results of this small‐scale pilot study, PRFM shows significant potential for closing of chronic leg ulcers.

Revisiting the Appropriateness of Carotid Endarterectomy

Background and Purpose— In the 1980s, carotid endarterectomy was controversial because proof of efficacy was lacking, complication rates were high, and one third of cases were reported to be inappropriate. Since publication of several randomized controlled trials (RCTs), rates of carotid endarterectomy have doubled nationwide. This study assesses the appropriateness and use of carotid endarterectomy since publication of the RCTs. Methods— Using the literature, we developed a list of 1557 mutually exclusive indications for carotid endarterectomy and asked a panel of national experts to rate the appropriateness of each indication using the RAND methodology. We used these ratings to assess appropriateness in a sample of 2124 patients who underwent the procedure in 1997 to 1998 in 6 hospitals. We also analyzed the reasons for the procedure and rates of death, stroke, and myocardial infarction within 30 days of surgery. Results— Overall, 84.9% of operations were done for appropriate reasons, 4.5% for uncertain reasons, and 10.6% for inappropriate reasons. Among procedures considered inappropriate, the most common reasons were high comorbidity (46.6%) and minimal stenosis (27.1%). Overall, 72.5% were asymptomatic, 17.4% had a carotid transient ischemic attack, and 10.1% had a stroke. The 30-day rate of death or stroke was 5.47% for symptomatic patients and 2.26% for asymptomatic patients. Among patients having combined carotid and coronary artery bypass graft surgery, the rate was 10.32%. The complication rate in asymptomatic patients with high comorbidity was 5.56%. Conclusions— Since the RCTs, rates of overuse appear to have fallen considerably, although they are still significant. A major shift has occurred toward operating on asymptomatic patients. Although overall complication rates were low, rates among asymptomatic patients with high comorbidity exceeded recommended thresholds.

Successful arterial substitution with modified human umbilical vein.

Human umbilical veins were prepared as vascular grafts by tanning with dialdehyde starch or gluteraldehyde and by structural re-inforcement with an outer polyester fiber mesh. These grafts were implanted in baboons in the aortoiliac position for periods of 3 days to 9 months. There was no aneurysm formation and there was an excellent maintenance of patency as well as function. Histologic evaluation of the graft materials showed a dense collagen layer within the encircling polyester fiber mesh. A multicellular subintimal layer formed a discrete inner capsule. The inflammatory response within the umbilical component was insignificant. There was no evidence of rejection. This study suggests that the modified umbilical vein can serve as a satisfactory blood conduit. Experience with three short-term clinical implants supports the applicability and potential for this new vascular graft.

Biodegradation and aneurysm formation in umbilical vein grafts. Observations and a realistic strategy.

In a series of 756 glutaraldehyde-stabilized umbilical vein grafts implanted over a 7 1/2-year period, aneurysms were identified in seven cases. The earliest aneurysm was seen at 31 months after implantation and the remainder between 43 and 79 months after surgery. Corrective surgery was performed in five cases and succeeded in four. Although definite mechanisms have not been identified, mechanical fatigue, reversal of aldehyde crosslinks, and immunologic factors may be operative. The pathologic changes include: (1) actual dilation of both graft and mesh with or without intraluminal thrombus and, (2) maintenance of graft diameter with erosion of the umbilical vein and polyester mesh rupture leading to perigraft hematoma and false aneurysm formation. Microscopic examination and infrared spectral analysis confirmed the presence of host-contributed lipid in some specimens. Although this is a low incidence of aneurysm formation, umbilical vein grafts should be selected primarily for patients with limited life expectancy or for whom alternative materials with comparable or superior patency rates are not available or acceptable. Periodic angiography, particularly after 3 or 4 years, is recommended as a routine part of follow-up examinations. Improved graft materials and control of host environmental factors are potential means to reduce the noted degradation.

Patches for carotid artery endarterectomy: Current materials and prospects

Patch angioplasty is commonly performed after carotid endarterectomy. Randomized prospective trials and meta-analyses have documented improved rates of perioperative and long-term stroke prevention as well as reduced rates of restenosis for patches compared with primary closure of the arteriotomy. Although use of vein patches is considered to be the gold standard for patch closure, newer generations of synthetic and biologic materials rival outcomes associated with vein patches. Future bioengineered patches are likely to optimize patch performance, both by achieving minimal stroke risk and long-term rates of restenosis as well as by minimizing the risk of unusual complications of prosthetic patches such as infection and pseudoaneurysm formation. In addition, lessons from bioengineered patches will likely enable construction of bioengineered and tissue-engineered bypass grafts.

Adventitial cystic disease of the popliteal artery: Failure of percutaneous transluminal angioplasty as a therapeutic modality

Adventitial cystic disease of the popliteal artery is an important cause of peripheral vascular insufficiency in the young and middle-aged man. The pathologic feature is a mucinous cyst located within the adventitia of the artery that expands and secondarily compromises the vessel lumen. Although physiologically quite different, this process is easily mistaken for arteriosclerosis. The clinical history of sudden claudication in a young nonsmoking man, combined with characteristic angiographic features, are important clues to the correct underlying pathology. Treatment generally consists of cyst evacuation or local bypass. This article was prompted by the failure of percutaneous transluminal angioplasty to achieve durable success in controlling this unique type of arterial disease. Subsequent surgical intervention proved satisfactory, lending support to this modality as the treatment of choice.

Adjunctive arteriovenous fistula with tibial and peroneal reconstruction for limb salvage

Arteriovenous fistulas were constructed as an adjunct to femoral peroneal and tibial bypasses in 13 patients threatened by imminent limb amputation. Previous attempts at conventional vascular reconstructive procedures had failed in nine patients. Deficient or absent pedal arches were noted in all patients, as were poor quality or small crural arteries. Graft patency was achieved in 11 cases and limb salvage in 10. There was no mortality. A steal phenomenon occurred in one patient and was successfully treated by secondary popliteal vein ligation. These preliminary results clearly indicate that an adjunctive arteriovenous fistula can maintain patency in a femoral tibial or peroneal bypass graft while preserving flow into the markedly diseased distal circulation.

Transmetatarsal amputation: The role of adjunctive revascularization

Over a 12-year period, 160 transmetatarsal amputations were performed in patients with peripheral vascular occlusive disease. The following groups were defined: group 1 - nonreconstructable disease (n = 40); group 2 - transmetatarsal amputation in conjunction with distal revascularization (n = 99); group 3 - reconstructable disease but transmetatarsal amputation performed without simultaneous revascularization (n = 21). There were nine early deaths in the entire series, for an operative mortality rate of 5.6%. The lowest rate of transmetatarsal amputation healing (24%) occurred in group 1. An 86% healing rate was achieved in group 3, but in seven cases (33%) some type of revascularization was required within 3 months of the amputation. In group 2 the healing rate was 62% but reached 83% where the bypass remained patent for at least 3 months after the amputation. Long-term patency rates also affected healing. Healing was not influenced by the number of local procedures (single vs multiple). The presence of severe infection or extensive necrosis necessitated open transmetatarsal amputation in 89 cases; the remaining 71 amputations involved primary closure. Since many patients were treated at a time when diagnostic modalities as well as the operative indications and techniques differed somewhat from the current practice, much of the information regarding group I patients in particular should be considered as a negative historical control and any conclusion from our data should be adjusted accordingly. Healing after amputation at the transmetatarsal level can be expected in the majority of instances in which revascularization can be performed with predictable patency, even when the standard criteria for performing such amputations are liberalized.(ABSTRACT TRUNCATED AT 250 WORDS)

The role of the peroneal artery for limb salvage.

Peroneal artery revascularization was performed in 61 cases for limb salvage and compared to a comparable group of 89 tibial artery reconstructions. Preoperative arteriography is essential to define runoff quality and pedal arch integrity. Intraoperative arteriography and flow determinations minimize failures due to technical error and provide some indication of the prognosis for graft patency. Failure to augment flow by at least 50% suggests pedal arch deficiency and is predictive for early graft closure. Cumulative patency for peroneal bypass was 55 ± 8% at 1 year and 38 ± 10% at 30 months compared to 63 ± 6 and 59 ± 7% for tibial reconstructions at the same time intervals. Most graft failures occurred within the first six months. Nineteen peroneals have been followed for more than one year with only three failures occurring. Improved criteria for case selection resulted in an 80% decrease in the number of failed grafts for the second half of this series. A similar reduction was noted for secondary operations. Results obtained with good quality saphenous veins (37 ± 13% at 30 months) and glutaraldehyde tanned umbilical veins (53 ± 11%) depend more on technical, pathologic and biologic factors than on the particular graft material employed. The mortality rate at 30 days was 3.3% and compared favorably with other limb salvage procedures and with primary amputations. Cumulative patient survival with functional limbs was 79 ± 9% at 30 months and was distinctly superior to reported data on survival of amputees. A cumulative limb salvage rate of 79 ± 6% at 30 months for the peroneal group makes such reconstructions definitely favorable to uniform limb ablation.