- Email: [email protected]
Scientific Session 11: 1996 Selected Abstracts
Monday, March 4, 1996 Scientific Session 11 1996 Selected Abstracts Moderator: Robert 1. Vogelzang, MD, Chicago, IL Room 6B/C
61-1:30 pm The American College of Radiology Multicenter Trial to Evaluate Peripheral Vascular MR Angiography R.A. Baum, MD, Philadelphia, PA PURPOSE: To determine the relative sensitivity, specificity, and accuracy of contrast angiography (CA) and MR angiography (MRA) for detecting vascular segments in the lower leg and to investigate whether information gained from the MR examination aids in revascularization decision making. MATERIALS AND MElliODS: A multicenter trial under the auspices of the American College of Radiology was conducted in an 8-month period beginning in the fall of 1994. At six institutions, standardized MRA, CA, and intraoperative angiography of the lower extremity were performed, and the results were compared. RESULTS: One hundred fifty-five patients were registered in a 9-month period, with a data completion rate of 95%. Preliminary results showed strong agreement (81%) between CA and MRA. When compared with intraoperative angiography, MRA had an 85% sensitivity and 81% specificity rate; CA had 83% sensitivity and 81% specificity. In general, MRA showed more patent vessel segments than CA. Surgical plans were changed in 15% of patients because additional information was gained at the MR study. CONCLUSION Peripheral vascular MRA can serve as an efficacious alternative to CA for determination of runoff vessels used for revascularization.
62-1:45 pm Bronchial Artery Chemo- and Embolotherapy for Unreseetable Bronchogenic Carcinoma S. Sun, MD, Iowa City, 14 - E. V. Lang, MD PURPOSE: To evaluate chemotherapy of bronchial arteries for management of unresectable bronchogenic carcinoma. MATERIALS AND MElliODS: One hundred fifty patients with unresectable lung cancer were referred. Superselective catheterization of tumor
194
feeding arteries permitted chemoinfusion with cisplatin and/or mitomycin in 132 cases. Fortyfive of these patients with significant hemoptysis underwent additional embolization with 1-mm Gelfoam particles. Each patient had an average of three chemoinfusions at 28-day intervals. Response was measured monthly by means of chest radiography or CT scanning and clinical follow-up. RESULTS: Hemoptysis stopped in 42 of 45 patients. Fifteen patients (11%) had complete remission, 75 patients (57%) showed greater than 50% tumor reduction, 32 patients (24%) had 25o/cr-49% tumor reduction, and 11 patients (8%) did not respond to treatment « 25% reduction or progression). Eight of 12 patients with SVC syndrome and four patients with severe dyspnea experienced dramatic relief. Oneand 2-year survival rates were 65% and 32%, respectively. Most patients died of remote metastases. Major but transient complications were dysphagia (three cases) and transverse myelitis (one case). CONCLUSION Selective bronchial artery chemotherapy and embolotherapy are safe and effective methods of palliative treatment of unresectable bronchogenic carcinoma.
Take Home Points: 1. Bronchial embolotherapy is not limited to treatment of hemoptysis caused by inflammatory processes. 2. Bronchial chemotherapy is a promising, safe alternative for palliative therapy for unresectable bronchogenic carcinoma. 3. Value of superselective bronchial chemotherapy is largely underappreciated in the United States.
63-2:00 pm Percutaneous Varicocele Embolization versus Surgical Ligation for the Treatment of Infertility: Changes in Seminal Parameters RD. Shlansky-Goldberg, MD, Philadelphia, PA • K.N. Van Arsdalen, MD· M.e. Soulen, MDZj. Haskal, MD - R.A. Baum, MD· e. Cope, MD- et al PURPOSE: To compare the success of percutaneous varicocele embolization with the success of surgical ligation with regard to changes in semen characteristics and pregnancy outcome.
Monday, March 4, 1996 M4TERIALS AND METHODS: Infertility records of 178 men who had undergone correction of their varicocele for infertility were retrospectively reviewed. Surgical ligation was performed in 98 men from August 1979 to March 1986, and 80 underwent percutaneous gonadal vein embolization from September 1982 to July 1994. Pre- and postprocedural semen analyses and pregnancy outcomes were reviewed. The median follow-up period was 5 months (0-139 months).
M41ERlALS AND METHODS: Eighty patients with previous variceal bleeding were randomized to TIPS (n = 40) or ES (n = 40). Patients with portal thrombosis, hepatoma, chronic encephalopathy, or other contraindications were excluded. Sample size was determined to detect a difference of at least 75% in rate of rebleeding (alfa=.05, beta=.l). The groups were comparable for age, sex, cause of cirrhosis, Child class, and liver function tests.
RESULTS: The surgical and percutaneous technical failure rates were 15% and 2.6%, respectively. Postprocedural increases in seminal parameters (surgery versus embolization) were as follows: volume, 11.2% versus 4.7%; total, 249% versus 168%; morphology, 153% versus 65%; and progression, 14% versus 19%. There was no statistically significant difference between the techniques except for progression based on t tests comparing the means of the two groups. The pregnancy rate was nearly identical for the two groups with limited follow-up.
RESULTS: The mortality rate was not significantly lower in either group. Rebleeding rate was significantly lower in the TIPS group, but only when the treatment rendered is considered (8% vs 31%; P < .05), In the ES group severe esophageal stenosis occurred in three patients. Complications of TIPS were cardiac failure (one patient) and episodic hepatic encephalopathy (14 patients). Shunt stenosis or obstruction developed in 18 of 28 patients followed up by means of shunt venography (64%) and was treated with PTA (nine patients) or insertion of additional stents (eight patients). In one case, shunt recanalization failed.
CONCLUSION We did not find any statistically significant differences in seminal values or pregnancy outcomes except for mean sperm progression between surgical ligation and percutaneous embolization. The surgical failure rate was higher than that with embolization.
CONCLUSION Results of this trial show that the rebleeding rate tends to be lower in the group treated with TIPS. The difference, however, was not statistically significant. Shunt stenosis occurred frequently and required additional interventional treatment.
Tatke Home Points: 1. Seminal parameters and pregnancy rates improve with varicocele correction.
Take Home Points: Design of the trial. Criteria for randomization, and inclusion and exclusion of patients. Detailed analysis of results by life-table analysis.
2. Percutaneous embolization has a higher technical success rate than surgery. 3. Most seminal changes are not significantly different, and there is similar improvement in pregnancy rate when comparing the two techniques.
64-2:15 pm TIPS versus Endoscopic Sclerotherapy for the Prevention of Variceal Bleeding: Final Results of a Randomized Trial M Bezzi, MD, Rome, Italy· M Merli, MD· 0. R~ggio, MD· S. Abbondanza, MD • L. Capocaccia, MD • P. Rossi, MD PURPOSE: The efficacy of TIPS and endoscopic sclerotherapy (ES) in preventing rebleeding from esophageal varices was evaluated in a randomized controlled trial.
65-2:30 pm Preclinical and Clinical Evaluation of a Percutaneous Stainless-Steel Greenfield Filter Kj. Cho, MD, Ann Arbor, MI· Me. Proctor, MS· Lf. Greenfield, MD PURPOSE: To evaluate a new Greenfield filter with an alternating hook design and an overthe-wire delivery system. M41ERlALS AND METHODS: Preclinical testing of filter hook performance included mathematical modeling, in vitro testing, and animal studies. The superior filter design (SGF-AH) was selected to undergo clinical testing in a prospective clinical trial. Filters were placed in 75 patients, and follow-up with radiography and US was carried out at 30 days.
195
Monday, March 4, 1996 RESULTS: Preclinical evaluation demonstrated the SGF-AH to be comparable or superior to all prototypes (P < .05). Clinical trial results revealed successful placement in all patients. There were three cases (5%) with mild asymmetry. Sixty patients had 30-day follow-up. No significant migration was found. There were no clinically suspected pulmonary embolisms and one instance of CT-verified caval penetration. Caval patency was demonstrated in 95%. CONCLUSION: The SGF-AH provides the efficacy and patency associated with the titanium filter with the benefit of an over-the-wire delivery system to facilitate placement.
placement and angioplasty. Statistically significantly better 6-month results of stent placement are due to a lower incidence of intimal hyperplasia. Take Home Points: In the REFSA-trial higher 6-month success rates of stent placement.
Scientilic Session 12 Revascularization Moderator: Chet R. Rees, MD, Dallas, TX Room 608
67-3:30 pm Take Home Points: The SGF-AH maintains the high level of performance associated with the Greenfield filter plus the advantage of guide-wire delivery.
Carotid Angioplasty and Stent Placement for Severe Symptomatic Disease P.A. Gaines, MD, South Yorkshire, England· A. Sivaguru, MBChB • P. Birch, MBChB· G. Venables, MBChB • J.D. Beard, MD
66--2:45 pm First Report on Long-term Results of the Randomized European Femoral Stent versus Angioplasty Trial G.M. Richter, MD, PhD, Heidelberg, Germany· T.K. Roeren, MD, PhD· C. Simon, MD PURPOSE: To evaluate differences of morphologic and clinical efficacy of stent placement versus angioplasty of femoral stenosis and occlusion in a randomized, European, multicenter trial. MA TERlALS AND METHODS: Presently seven centers have recruited 90 patients with the following inclusion criteria: symptomatic lesions of the superficial femoral artery and proximal popliteal artery, lesion length less than 5 cm, and corrected upstream and downstream lesion. The midsize Palmaz stent is being used. Follow-up examinations include angiographic assessment at 6 and 12 months.
196
PURPOSE: The results of endovascular intervention for severe (stenosis > 70%) symptomatic carotid disease as part of a multicenter randomized trial (CAVATAS study) are presented. MATERIALS AND METHODS: We have treated 55 patients (17 women, 38 men, aged 47-78 years; mean, 64 years). Fifty patients had disease of the internal carotid artery (ICA); 41 had 700/0-95% stenosis, seven had greater than 95% stenosis, and three had 500/0-69% stenosis. Six patients were treated for common carotid artery (CCA) disease. All ICA disease was initially treated with balloon dilation with no cerebral protection. In four patients, a stent was placed to treat severe residual disease. Two patients with CCA disease were treated de novo with placement of a stent for an occluded contralateral CCA. All patients were pretreated with intraarterial atropine and heparin.
RESULTS: In the stent group (44 patients), the technical success rate has been 100%, and the primary clinical (1 month) success rate has been 97.3%. In the angioplasty group (46 patients), the technical success rate has been 94.3%, and the primary clinical success rate has been 91.3% (not statistically significant). Angiographic 6-month success rate has been 80.1% in the stent group and 63.3% in the angioplasty group (P = .012).
RESULTS: The stenosis was reduced to less than 50% in all but two patients, both of whom were treated before the introduction of stents. There have been three permanent cerebrovascular accidents at 30 days (5.4%). Three patients had a transient ischemic attack (5.4%), and five had an ischemic deficit that resolved within 30 days (9%). All patients remain asymptomatic at 1 month to 3 years, but eight patients have a stenosis of greater than 50% visible at duplex US.
CONCLUSION: Initial results of the trial show equal primary success rates of femoral stent
CONCLUSION: The procedure has an acceptable technical success rate, complication rate,
61-1:30 pm The American College of Radiology Multicenter Trial to Evaluate Peripheral Vascular MR Angiography R.A. Baum, MD, Philadelphia, PA PURPOSE: To determine the relative sensitivity, specificity, and accuracy of contrast angiography (CA) and MR angiography (MRA) for detecting vascular segments in the lower leg and to investigate whether information gained from the MR examination aids in revascularization decision making. MATERIALS AND MElliODS: A multicenter trial under the auspices of the American College of Radiology was conducted in an 8-month period beginning in the fall of 1994. At six institutions, standardized MRA, CA, and intraoperative angiography of the lower extremity were performed, and the results were compared. RESULTS: One hundred fifty-five patients were registered in a 9-month period, with a data completion rate of 95%. Preliminary results showed strong agreement (81%) between CA and MRA. When compared with intraoperative angiography, MRA had an 85% sensitivity and 81% specificity rate; CA had 83% sensitivity and 81% specificity. In general, MRA showed more patent vessel segments than CA. Surgical plans were changed in 15% of patients because additional information was gained at the MR study. CONCLUSION Peripheral vascular MRA can serve as an efficacious alternative to CA for determination of runoff vessels used for revascularization.
62-1:45 pm Bronchial Artery Chemo- and Embolotherapy for Unreseetable Bronchogenic Carcinoma S. Sun, MD, Iowa City, 14 - E. V. Lang, MD PURPOSE: To evaluate chemotherapy of bronchial arteries for management of unresectable bronchogenic carcinoma. MATERIALS AND MElliODS: One hundred fifty patients with unresectable lung cancer were referred. Superselective catheterization of tumor
194
feeding arteries permitted chemoinfusion with cisplatin and/or mitomycin in 132 cases. Fortyfive of these patients with significant hemoptysis underwent additional embolization with 1-mm Gelfoam particles. Each patient had an average of three chemoinfusions at 28-day intervals. Response was measured monthly by means of chest radiography or CT scanning and clinical follow-up. RESULTS: Hemoptysis stopped in 42 of 45 patients. Fifteen patients (11%) had complete remission, 75 patients (57%) showed greater than 50% tumor reduction, 32 patients (24%) had 25o/cr-49% tumor reduction, and 11 patients (8%) did not respond to treatment « 25% reduction or progression). Eight of 12 patients with SVC syndrome and four patients with severe dyspnea experienced dramatic relief. Oneand 2-year survival rates were 65% and 32%, respectively. Most patients died of remote metastases. Major but transient complications were dysphagia (three cases) and transverse myelitis (one case). CONCLUSION Selective bronchial artery chemotherapy and embolotherapy are safe and effective methods of palliative treatment of unresectable bronchogenic carcinoma.
Take Home Points: 1. Bronchial embolotherapy is not limited to treatment of hemoptysis caused by inflammatory processes. 2. Bronchial chemotherapy is a promising, safe alternative for palliative therapy for unresectable bronchogenic carcinoma. 3. Value of superselective bronchial chemotherapy is largely underappreciated in the United States.
63-2:00 pm Percutaneous Varicocele Embolization versus Surgical Ligation for the Treatment of Infertility: Changes in Seminal Parameters RD. Shlansky-Goldberg, MD, Philadelphia, PA • K.N. Van Arsdalen, MD· M.e. Soulen, MDZj. Haskal, MD - R.A. Baum, MD· e. Cope, MD- et al PURPOSE: To compare the success of percutaneous varicocele embolization with the success of surgical ligation with regard to changes in semen characteristics and pregnancy outcome.
Monday, March 4, 1996 M4TERIALS AND METHODS: Infertility records of 178 men who had undergone correction of their varicocele for infertility were retrospectively reviewed. Surgical ligation was performed in 98 men from August 1979 to March 1986, and 80 underwent percutaneous gonadal vein embolization from September 1982 to July 1994. Pre- and postprocedural semen analyses and pregnancy outcomes were reviewed. The median follow-up period was 5 months (0-139 months).
M41ERlALS AND METHODS: Eighty patients with previous variceal bleeding were randomized to TIPS (n = 40) or ES (n = 40). Patients with portal thrombosis, hepatoma, chronic encephalopathy, or other contraindications were excluded. Sample size was determined to detect a difference of at least 75% in rate of rebleeding (alfa=.05, beta=.l). The groups were comparable for age, sex, cause of cirrhosis, Child class, and liver function tests.
RESULTS: The surgical and percutaneous technical failure rates were 15% and 2.6%, respectively. Postprocedural increases in seminal parameters (surgery versus embolization) were as follows: volume, 11.2% versus 4.7%; total, 249% versus 168%; morphology, 153% versus 65%; and progression, 14% versus 19%. There was no statistically significant difference between the techniques except for progression based on t tests comparing the means of the two groups. The pregnancy rate was nearly identical for the two groups with limited follow-up.
RESULTS: The mortality rate was not significantly lower in either group. Rebleeding rate was significantly lower in the TIPS group, but only when the treatment rendered is considered (8% vs 31%; P < .05), In the ES group severe esophageal stenosis occurred in three patients. Complications of TIPS were cardiac failure (one patient) and episodic hepatic encephalopathy (14 patients). Shunt stenosis or obstruction developed in 18 of 28 patients followed up by means of shunt venography (64%) and was treated with PTA (nine patients) or insertion of additional stents (eight patients). In one case, shunt recanalization failed.
CONCLUSION We did not find any statistically significant differences in seminal values or pregnancy outcomes except for mean sperm progression between surgical ligation and percutaneous embolization. The surgical failure rate was higher than that with embolization.
CONCLUSION Results of this trial show that the rebleeding rate tends to be lower in the group treated with TIPS. The difference, however, was not statistically significant. Shunt stenosis occurred frequently and required additional interventional treatment.
Tatke Home Points: 1. Seminal parameters and pregnancy rates improve with varicocele correction.
Take Home Points: Design of the trial. Criteria for randomization, and inclusion and exclusion of patients. Detailed analysis of results by life-table analysis.
2. Percutaneous embolization has a higher technical success rate than surgery. 3. Most seminal changes are not significantly different, and there is similar improvement in pregnancy rate when comparing the two techniques.
64-2:15 pm TIPS versus Endoscopic Sclerotherapy for the Prevention of Variceal Bleeding: Final Results of a Randomized Trial M Bezzi, MD, Rome, Italy· M Merli, MD· 0. R~ggio, MD· S. Abbondanza, MD • L. Capocaccia, MD • P. Rossi, MD PURPOSE: The efficacy of TIPS and endoscopic sclerotherapy (ES) in preventing rebleeding from esophageal varices was evaluated in a randomized controlled trial.
65-2:30 pm Preclinical and Clinical Evaluation of a Percutaneous Stainless-Steel Greenfield Filter Kj. Cho, MD, Ann Arbor, MI· Me. Proctor, MS· Lf. Greenfield, MD PURPOSE: To evaluate a new Greenfield filter with an alternating hook design and an overthe-wire delivery system. M41ERlALS AND METHODS: Preclinical testing of filter hook performance included mathematical modeling, in vitro testing, and animal studies. The superior filter design (SGF-AH) was selected to undergo clinical testing in a prospective clinical trial. Filters were placed in 75 patients, and follow-up with radiography and US was carried out at 30 days.
195
Monday, March 4, 1996 RESULTS: Preclinical evaluation demonstrated the SGF-AH to be comparable or superior to all prototypes (P < .05). Clinical trial results revealed successful placement in all patients. There were three cases (5%) with mild asymmetry. Sixty patients had 30-day follow-up. No significant migration was found. There were no clinically suspected pulmonary embolisms and one instance of CT-verified caval penetration. Caval patency was demonstrated in 95%. CONCLUSION: The SGF-AH provides the efficacy and patency associated with the titanium filter with the benefit of an over-the-wire delivery system to facilitate placement.
placement and angioplasty. Statistically significantly better 6-month results of stent placement are due to a lower incidence of intimal hyperplasia. Take Home Points: In the REFSA-trial higher 6-month success rates of stent placement.
Scientilic Session 12 Revascularization Moderator: Chet R. Rees, MD, Dallas, TX Room 608
67-3:30 pm Take Home Points: The SGF-AH maintains the high level of performance associated with the Greenfield filter plus the advantage of guide-wire delivery.
Carotid Angioplasty and Stent Placement for Severe Symptomatic Disease P.A. Gaines, MD, South Yorkshire, England· A. Sivaguru, MBChB • P. Birch, MBChB· G. Venables, MBChB • J.D. Beard, MD
66--2:45 pm First Report on Long-term Results of the Randomized European Femoral Stent versus Angioplasty Trial G.M. Richter, MD, PhD, Heidelberg, Germany· T.K. Roeren, MD, PhD· C. Simon, MD PURPOSE: To evaluate differences of morphologic and clinical efficacy of stent placement versus angioplasty of femoral stenosis and occlusion in a randomized, European, multicenter trial. MA TERlALS AND METHODS: Presently seven centers have recruited 90 patients with the following inclusion criteria: symptomatic lesions of the superficial femoral artery and proximal popliteal artery, lesion length less than 5 cm, and corrected upstream and downstream lesion. The midsize Palmaz stent is being used. Follow-up examinations include angiographic assessment at 6 and 12 months.
196
PURPOSE: The results of endovascular intervention for severe (stenosis > 70%) symptomatic carotid disease as part of a multicenter randomized trial (CAVATAS study) are presented. MATERIALS AND METHODS: We have treated 55 patients (17 women, 38 men, aged 47-78 years; mean, 64 years). Fifty patients had disease of the internal carotid artery (ICA); 41 had 700/0-95% stenosis, seven had greater than 95% stenosis, and three had 500/0-69% stenosis. Six patients were treated for common carotid artery (CCA) disease. All ICA disease was initially treated with balloon dilation with no cerebral protection. In four patients, a stent was placed to treat severe residual disease. Two patients with CCA disease were treated de novo with placement of a stent for an occluded contralateral CCA. All patients were pretreated with intraarterial atropine and heparin.
RESULTS: In the stent group (44 patients), the technical success rate has been 100%, and the primary clinical (1 month) success rate has been 97.3%. In the angioplasty group (46 patients), the technical success rate has been 94.3%, and the primary clinical success rate has been 91.3% (not statistically significant). Angiographic 6-month success rate has been 80.1% in the stent group and 63.3% in the angioplasty group (P = .012).
RESULTS: The stenosis was reduced to less than 50% in all but two patients, both of whom were treated before the introduction of stents. There have been three permanent cerebrovascular accidents at 30 days (5.4%). Three patients had a transient ischemic attack (5.4%), and five had an ischemic deficit that resolved within 30 days (9%). All patients remain asymptomatic at 1 month to 3 years, but eight patients have a stenosis of greater than 50% visible at duplex US.
CONCLUSION: Initial results of the trial show equal primary success rates of femoral stent
CONCLUSION: The procedure has an acceptable technical success rate, complication rate,