Perspectives in Circulation Today

Fogarty Catheters


Dr. Thomas J. Fogarty introduced these catheters in the early 1960's for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. They have remained a leading choice for the rapid removal of arterial emboli and thrombi. With a recessed winding balloon attachment, uniform contact with vessel walls is achieved generally allowing successful clot removal. More adherent clot is approached with the Fogarty adherent clot catheters, which feature a spiral-shaped, latex-covered stainless steel cable designed to have a corkscrew shape when retracted to greatly expand the surface area entrapping fibrous material. The latter are effective in removing clot from native arteries and synthetic grafts.

The Fogarty Catheter, its Usage, Results and Complications


Authors (Years) Some Papers Describing Usage, Results and Complications
Hernandez-Richter T et al (2001)
Among 251 patients over 20 years, 283 thrombembolectomies performed on the upper extremity. Cardiac insufficiency, cerebral ischemia, etc. occurred in 18 patients (7.2%). Local complications, wound infection, persistence of ischemia, or hematoma were evident in 51 patients (20.3%). Re-occlusion was found in 21 patients (8.8%). The affected arm had to be amputated in five cases (2.0%). 14 patients (5.6%) died during the postoperative phase. With an average age of 73 years at the time of surgery, 40% of the patients had died by the time of follow-up while 111 patients of the 117 living patients showed no complaints or minor coldness and pain following heavy exercise.
Borioni et al (2001)
66 patients with acute thromboembolic limb ischemia retrospectively studied. Four groups: 1) upper limb embolism (12 patients), 2) lower limb embolism (54 patients), 3) thrombosis on atherosclerotic plaque or on a graft, 4) post-traumatic thrombosis. Atrial fibrillation was present in 57.5%. Procedures were successful in 89.4%. Further surgical procedures (bypass, arterioplasty, further embolectomy) were performed in 35.1% (19/54) of patients of groups 2 and 3. Results were very good in group 1 and 4. Limb amputation was performed in 12.9% of those with leg ischemia. Hospital mortality was 31.4 and 33.3% for lower and upper limb.
Wolosker et al (1996)
Arterial embolisms in lower limbs (159 cases) of patients with a mean age of 58 (ages 12 to 98)(80 male and 78 female). Atrial fibrillation was present in 78%. Occlusion was present in the femoral artery in 53.4 percent. All had severe lower limb ischemia, but not gangrene, on admission. Most patients (67.9 percent) were relieved of their ischemia from its onset in less than 24 hours. Fasciotomy was performed on 48 patients due to a compartimental syndrome. Nineteen patients died immediately after operation; 68.4 percent due to heart failure. Twenty-three (16.4 percent) of the 140 survivers had limb amputations after the occlusion of artery branches, which had undergone embolectomies. One hundred and twenty-seven limbs (84.6 percent) were preserved in 117 patients (83.5 percent). Eleven cases (7.3 percent) required repeated surgery with the Fogarty catheter. The patients with muscle tenderness, paralysis, or ischemia lasting longer than 24 hours had worse results in relation to the preservation of the limb (p < 0.05).
Kendrick and Thompson (1981)
Ninety patients with 121 arterial emboli from 1968 to 1978. In patients having their procedure within 6 hours of symptoms, the amputation rate was 4 percent and mortality rate 15 percent; for those operated on within 6 to 12 hours of onset of symptoms, the amputation rate was 27 percent and mortality 40 percent; for those operated on at 12-48 hours, mortality was 48 percent and amputation 52 percent. Immediate embolectomy was recommended for all potentially viable extremities in patients who present within 12 hours of symptoms, but that after 12 hours only for those limbs with obvious viability (not paralyzed or anesthetic). Alternatives for the remainder are high dose intravenous heparinization or expedient amputation. In patients who present greater than 60 hours after the onset of symptoms (with viable legs), embolectomy can be performed with low morbidity and mortality.
Canova CR et al (2001)
Eighty-eight procedures in 84 patients (46 men and 42 women with a mean age of 67.6 +/-14.4yrs) with acute embolic occlusions of the infrainguinal arteries. Indications for treatment were severe claudication (45 procedures) and limb threatening ischaemia (43 procedures). Local thrombolysis or balloon angioplasty was used as appropriate during the intervention. Two patients (2.3%) suffered major and two patients (2.3%) minor complications. One patient died within 30 days after the procedure. Mean follow-up was 3.7 +/- 2.9 years. Twelve patients (16%) were lost to follow-up. Initial technical success was 96.6%, primary clinical success rate at one year 88.4%, at two years 81.7% and declined to 76.5% at eight years. Ten of the 16 interval failures were due to recurrent embolism to the same leg and resulted in nine catheter reinterventions and one bypass graft. Six patients were treated conservatively. Cumulative mortality was 11.7% at one year and 29.5% at eight years.
Bowles CR et al (1988)
Five women 43 to 62 years of age--with progressive leg ischemia discovered 2 to 4 months after embolectomy. Angiography showed a characteristic pattern of severe, smooth narrowing of that portion of the artery in which balloon embolectomy was performed. Pathologic examination, available in two of the five patients, revealed marked intimal cellular proliferation, which narrowed the arteries severely without evidence of thrombosis, significant atheromatosis, or active arteritis. The cause appeared to be intimal damage by the balloon.
Gloor B et al (1994)
Arterial injuries caused by balloon embolectomy occur in up to 6%. Myointimal hyperplasia as a result of endothelial denudation a special problem. The authors conclude that after balloon-catheter thromboembolectomy an early angiographic control should be performed and repeated 3 months postoperatively.
Cronenwett et al (1988)
A case of multiple tibial artery pseudoaneurysms that appeared 4 years after embolectomy in a 42-year-old man with otherwise normal arteries. The patient was treated by internal aneurysmorrhaphy without sequelae. Literature review: 46 cases listed as arterial disruption (29), intimal injury (12), or catheter malfunction (5)... resulting in hemorrhage (13 cases), arteriovenous fistula (12), pseudoaneurysm (4), thrombosis (3), dissection (5), accelerated atherosclerosis (4), and catheter fragment embolism (5). Of these complications, 41% were recognized during the initial operation. Direct observation detected 32%, while 68% were shown only by completion arteriography. Complications recognized during initial operation were more frequently asymptomatic without further surgery (84%) than those detected postoperatively (30%)(p<0.001). Completion arteriography detected 87% of balloon catheter complications compared with only 23% of complications recognized intraoperatively without arteriography (p<0.001). The authors concluded that delicate technique, completion arteriography, prompt surgical treatment, and extended follow-up are important components of balloon catheter embolectomy.
Nevelsteen and Suy (1987)
The authors describe four cases of arterial damage secondary to the use of the Fogarty balloon catheter. After a review of the literature, they concluded that the number of complications after balloon catheter thrombectomy is generally underestimated and is associated with a high morbidity.

The Circulator Boot and the Acutely Ischemic Leg

Results for Legs Started on Boot within 14 Days of Onset of Problem

Table III from Dillon, R.S.: Fifteen years of experience in treating 2177 episodes of foot and leg lesions with the Circulator Boot. Results of treatments with the Circulator Boot. Angiology suppl 48:s17-s34, 1997

Result: Healed Improved Stable LTT No Change Blank AKA BKA
Males
63 34 6 2 1 1 2* 0
Females
33 27 2 3 - 3 4e 1**
*Sudden occlusion of bilateral aortofemoral bypasses
** Consulted but decides against boot therapy and never treated.
e One patient with Wagner 5 foot after 3 vascular procedures; two renal dialysis patients, one with a Wagner 2 and the other a Wagner 4 foot; one patient with rheumatoid vasculitis and an infected prothesis
LTT=Lost to Treatment

These 99 patients were referred largely after other treatment options had been exhausted. Among the 99 were 36 who presented within 5 days of the onset of their problems. And among the 36 were 13 whose ischemia made even a single step impossible. One of the latter died shortly after arrival. One soon had a BKA. Seven improved sufficiently to walk from the clinic. Three improved sufficiently to claim to be healed. The patient having the BKA had total blockage of her iliac and was not a good candidate for boot therapy.
While thromboembolism is commonly thought to precipitate the problems of the above patients, sudden thrombotic occlusions over pre-existing arteriosclerotic plaque is more common. Case #135 (www.Circulatorboot.com/casehistory/case135.html) is a good example of the latter. His acute occlusions, precipitated by a long trip in an airplane, were relieved and his clotting abnormalities improved.

Perspectives in Circulation Today

Volume 2, Number 8

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