Heparin Fails to Cut Rate of DVT/PE After Prostatectomy

PARIS — Prophylactic use of heparin made no difference in the incidence of symptomatic deep vein thrombosis and/or pulmonary embolism after 4,609 laparoscopic radical prostatectomies reviewed by the International Laparoscopy Prostate Cancer Working Group.

Eleven centers in seven countries contributed patients to the ongoing study. Dr. Fernando P. Secin presented an interim analysis of the study data at the annual congress of the European Association of Urology.

The overall rate of deep vein thrombosis and/or pulmonary embolism (DVT/PE) was low: 0.6%, according to Dr. Secin, a urology fellow at Memorial Sloan-Kettering Cancer Center in New York.

Dr. Secin speculated that most patients undergoing laparoscopic radical prostatectomies are probably at low risk for thromboembolic events.

“Most prostate cancers [that] are operated [on] are early prostate cancers, so the impact of the cancer itself on the thrombotic mechanism may not be that serious,” he said in an interview at the meeting.

Although heparin use was not a statistically significant factor in univariate or multivariate analyses, the latter did identify the following risk factors as being significant for DVT/PE in patients undergoing laparoscopic radical prostatectomy:

▸ Patients undergoing a reexploration were 20 times more likely to have a thromboembolic event.

▸ The odds were 13 times greater for those with a prior history of DVT.

▸ Every 10-g increase in prostate size raised the odds ratio by 1.2.

The investigators concluded that the data do not support heparin prophylaxis in patients who do not have these risk factors. Randomized trials are needed to establish its utility, they said.

Centers in France, Belgium, Austria, the United Kingdom, Spain, Sweden, and the United States contributed patients to the analysis. Dr. Secin said he hopes to accumulate another 1,000 patients before completing the study.

Prophylaxis protocols ranged from no heparin use to both preoperative and postoperative use of heparin, with no discernible relationship to the rate of DVT/PE at each hospital. All the institutions used mechanical prophylaxis: either a pneumatic compression device or a gradual compression stocking.

The lowest and highest DVT/PE rates (0% and 1.4%, respectively) were both found at centers that administered heparin before and after surgery. At the Cleveland Clinic, where heparin prophylaxis was not used, the rate was 0.5%.

Patients receiving preoperative heparin had significantly higher intraoperative mean blood loss, compared with those given postoperative heparin or no heparin: 444 mL vs. 332 mL.

This difference in blood loss did not translate into longer hospital stays or higher transfusion or reoperation rates, according to Dr. Secin.

Estimating the cost of heparin at $80 per dose, the investigators calculated the total cost as $2,955,057 for the 11 centers that contributed data.

“You spend so much money and there isn't any use for that,” said Dr. Bertrand D. Guillonneau, the study's senior author and section head of minimally invasive surgery, department of urology, Memorial Sloan-Kettering.

PARIS — Prophylactic use of heparin made no difference in the incidence of symptomatic deep vein thrombosis and/or pulmonary embolism after 4,609 laparoscopic radical prostatectomies reviewed by the International Laparoscopy Prostate Cancer Working Group.

Eleven centers in seven countries contributed patients to the ongoing study. Dr. Fernando P. Secin presented an interim analysis of the study data at the annual congress of the European Association of Urology.

The overall rate of deep vein thrombosis and/or pulmonary embolism (DVT/PE) was low: 0.6%, according to Dr. Secin, a urology fellow at Memorial Sloan-Kettering Cancer Center in New York.

Dr. Secin speculated that most patients undergoing laparoscopic radical prostatectomies are probably at low risk for thromboembolic events.

“Most prostate cancers [that] are operated [on] are early prostate cancers, so the impact of the cancer itself on the thrombotic mechanism may not be that serious,” he said in an interview at the meeting.

Although heparin use was not a statistically significant factor in univariate or multivariate analyses, the latter did identify the following risk factors as being significant for DVT/PE in patients undergoing laparoscopic radical prostatectomy:

▸ Patients undergoing a reexploration were 20 times more likely to have a thromboembolic event.

▸ The odds were 13 times greater for those with a prior history of DVT.

▸ Every 10-g increase in prostate size raised the odds ratio by 1.2.

The investigators concluded that the data do not support heparin prophylaxis in patients who do not have these risk factors. Randomized trials are needed to establish its utility, they said.

Centers in France, Belgium, Austria, the United Kingdom, Spain, Sweden, and the United States contributed patients to the analysis. Dr. Secin said he hopes to accumulate another 1,000 patients before completing the study.

Prophylaxis protocols ranged from no heparin use to both preoperative and postoperative use of heparin, with no discernible relationship to the rate of DVT/PE at each hospital. All the institutions used mechanical prophylaxis: either a pneumatic compression device or a gradual compression stocking.

The lowest and highest DVT/PE rates (0% and 1.4%, respectively) were both found at centers that administered heparin before and after surgery. At the Cleveland Clinic, where heparin prophylaxis was not used, the rate was 0.5%.

Patients receiving preoperative heparin had significantly higher intraoperative mean blood loss, compared with those given postoperative heparin or no heparin: 444 mL vs. 332 mL.

This difference in blood loss did not translate into longer hospital stays or higher transfusion or reoperation rates, according to Dr. Secin.

Estimating the cost of heparin at $80 per dose, the investigators calculated the total cost as $2,955,057 for the 11 centers that contributed data.

“You spend so much money and there isn't any use for that,” said Dr. Bertrand D. Guillonneau, the study's senior author and section head of minimally invasive surgery, department of urology, Memorial Sloan-Kettering.

PARIS — Prophylactic use of heparin made no difference in the incidence of symptomatic deep vein thrombosis and/or pulmonary embolism after 4,609 laparoscopic radical prostatectomies reviewed by the International Laparoscopy Prostate Cancer Working Group.

Eleven centers in seven countries contributed patients to the ongoing study. Dr. Fernando P. Secin presented an interim analysis of the study data at the annual congress of the European Association of Urology.

The overall rate of deep vein thrombosis and/or pulmonary embolism (DVT/PE) was low: 0.6%, according to Dr. Secin, a urology fellow at Memorial Sloan-Kettering Cancer Center in New York.

Dr. Secin speculated that most patients undergoing laparoscopic radical prostatectomies are probably at low risk for thromboembolic events.

“Most prostate cancers [that] are operated [on] are early prostate cancers, so the impact of the cancer itself on the thrombotic mechanism may not be that serious,” he said in an interview at the meeting.

Although heparin use was not a statistically significant factor in univariate or multivariate analyses, the latter did identify the following risk factors as being significant for DVT/PE in patients undergoing laparoscopic radical prostatectomy:

▸ Patients undergoing a reexploration were 20 times more likely to have a thromboembolic event.

▸ The odds were 13 times greater for those with a prior history of DVT.

▸ Every 10-g increase in prostate size raised the odds ratio by 1.2.

The investigators concluded that the data do not support heparin prophylaxis in patients who do not have these risk factors. Randomized trials are needed to establish its utility, they said.

Centers in France, Belgium, Austria, the United Kingdom, Spain, Sweden, and the United States contributed patients to the analysis. Dr. Secin said he hopes to accumulate another 1,000 patients before completing the study.

Prophylaxis protocols ranged from no heparin use to both preoperative and postoperative use of heparin, with no discernible relationship to the rate of DVT/PE at each hospital. All the institutions used mechanical prophylaxis: either a pneumatic compression device or a gradual compression stocking.

The lowest and highest DVT/PE rates (0% and 1.4%, respectively) were both found at centers that administered heparin before and after surgery. At the Cleveland Clinic, where heparin prophylaxis was not used, the rate was 0.5%.

Patients receiving preoperative heparin had significantly higher intraoperative mean blood loss, compared with those given postoperative heparin or no heparin: 444 mL vs. 332 mL.

This difference in blood loss did not translate into longer hospital stays or higher transfusion or reoperation rates, according to Dr. Secin.

Estimating the cost of heparin at $80 per dose, the investigators calculated the total cost as $2,955,057 for the 11 centers that contributed data.

“You spend so much money and there isn't any use for that,” said Dr. Bertrand D. Guillonneau, the study's senior author and section head of minimally invasive surgery, department of urology, Memorial Sloan-Kettering.