A blinded trial of local recombinant tissue factor pathway inhibitor versus either local or systemic heparin in a vein bypass model.

PURPOSE: Tissue factor pathway inhibitor (TFPI), an endogenous protease, is a potent inhibitor of the extrinsic pathway of coagulation. To determine whether TFPI could be used as an alternative to systemic heparin and dextran in vein bypass grafting procedures, we compared the efficacy of these agents in a blinded trial using a pig model of lower extremity vein bypass grafting. METHODS: Yorkshire pigs (60 to 75 kg) were divided into four groups of five each: systemic heparin (5 ml 10(3) U heparin, 50 ml intravenous dextran, and 10 U heparin/ml flush), local heparin (5 ml saline solution, 50 ml intravenous dextran, and 10 U heparin/ml flush), recombinant TFPI (rTFPI) (5 ml saline solution, 50 ml intravenous saline, and rTFPI 90 micrograms/ml flush), and control (5 ml and 50 ml intravenous saline and intravenous phosphate-buffered saline solution flush). The pigs were anesthetized and the lesser saphenous vein was harvested and reversed to construct a bypass from the common femoral artery to the saphenous artery at the hock. Each pig received two intravenous infusions before cross-clamping, and the artery and vein were flushed locally according to the protocol for each treatment group. Coagulation parameters were drawn 30 minutes after cross-clamping. The surgical team was blinded as to the pigs' treatment group throughout the protocol. RESULTS: The time from initial infusion until bypass completion averaged 80 minutes. Conduit patency rates at 7 days were as follows: four of five in the rTFPI group, three of five in the systemic heparin group, one of five in the local heparin group, and zero of five in the control group. The activated partial thromboplastin time was elevated (50.1 +/- 13.8 seconds) with systemic heparin but not in the other groups. CONCLUSIONS: Local administration of TFPI prevents thrombosis as effectively as systemic heparin and dextran and is superior to local heparin flush plus dextran (p = 0.02). Thus local TFPI offers an excellent alternative to systemic heparin plus dextran and avoids the risks of systemic anticoagulation.

Importance of adequate staging and of hormone receptors in women older than age 70 with breast cancer.

This report includes 479 women older than 70 years of age who were operated on between January 1980 and January 1988 and who were followed for 2.5 to 10.5 years (mean, 4.6 years). There were no operative deaths. Staging was available on 90.8%. Eighty-one per cent of patients were estrogen receptor positive (ER+), and 64% had negative lymph nodes (LN-). There were 50 deaths from breast cancer (10.4%), and 56 (11.6%) from other causes (mostly cardiovascular). Estrogen receptor negativity was significant by both univariate and multivariate analysis for increased risk of death from breast cancer (by factors of 3 and 1.4). Only four of 152 (2.6%) women who were node negative and estrogen receptor positive died during the follow-up of 4.9 years. The results of this study suggest that elderly women should be fully staged with axillary node dissections, and the hormone receptor assay should be performed because these are important indicators of prognosis. Because only 2.6% of the LN- and ER+ women in this study died of breast cancer, and only 3% in this group were treated with adjuvant systemic therapy (tamoxifen), the authors conclude that this therapy is unnecessary, although a prospective randomized study of elderly women would be required to state this definitively.

Outpatient and short-stay thyroid surgery.

With the realization that simple thyroid procedures had a very low rate of complication and that patients often seemed well enough to go home from the recovery room, we began performing them in an ambulatory surgery setting. We review here 134 consecutive thyroid procedures performed at Columbia Presbyterian Medical Center between July 1987 and July 1989. Patients undergoing reoperation, neck dissection, sternal splits, or other concomitant procedures were excluded. There were 105 women and 29 men with an average age of 47 years. Fifty percent of the operations were performed for benign disease, although the most common diagnosis was papillary cancer (44%). Twenty-one operations (16%) were performed under local anesthesia. Most patients underwent surgery in our ambulatory surgery unit and 76 were discharged the day of surgery. Of these patients, 21 underwent total thyroidectomy, 13 subtotal thyroidectomy, and 42 simple thyroid lobectomy. Of the 58 patients who were admitted, 53 were discharged on the day following surgery. The average length of stay was 0.49 days. Extensive pre- and postoperative teaching was given regarding the signs and symptoms associated with the complications of thyroid surgery. All patients were felt to be reliable and capable of understanding the procedure and of complying with the postoperative plans. Postoperative complications included 8 patients (6%) with transient hypocalcemia and 1 patient (0.75%) with permanent unilateral recurrent laryngeal nerve paralysis. All complications occurred in patients who underwent total thyroidectomies. No patient had a postoperative complication requiring reoperation or readmission. We conclude that by using specific selection criteria, thyroid lobectomies and subtotal thyroidectomies can be performed safely in an ambulatory surgery setting without increase in morbidity or mortality.

The intraoperative incidence of detectable bilateral and multicentric disease in papillary cancer of the thyroid.

This is a prospective study to determine the incidence of grossly detectable multicentric and bilateral cancer at operation in patients who, before surgery, were believed to have a unilateral lesion. The opposite lobe was inspected at the time of operation and the surgeon made a determination as to whether there was bilateral and/or multicentric disease present. A total thyroidectomy was then carried out and the accuracy of the surgeon's judgment was established by permanent-section pathologic examination. Fifteen of the 44 patients were assessed to have gross bilateral disease. Thirteen of these were confirmed by pathologic examination. One case of microscopic bilateral disease was not recognized by the surgeon. Seventeen patients were thought to have unilateral multicentric disease. Fifteen of these cases were confirmed by microscopy and an additional seven cases were documented to have secondary foci. It is obvious from this study that most disease that is called microscopic disease is actually palpable. A review of the literature confirms this. It was very unlikely for a patient who did not have unilateral multicentric disease to have a contralateral focus of carcinoma. The incidence of bilateral disease was 32%, and the incidence of multicentric disease was 50%; the surgeon was very accurate in assessing this. We believe that surgeons who advocate lobectomy as the primary treatment for thyroid cancer are recognizing grossly detectable disease in a significant number of patients and thus are doing total thyroidectomies in most patients with bilateral disease.