- Email: [email protected]
Thrombectomy
Tuesday, March 5, 1996 Scientific Session 20 Thrombolysis/Thrombectomy Moderator: Karen O. Ehrman, MD, Indianapolis, IN Room 611
118-2:30 pm Long-term Patency after Thrombolysis of O,:cluded Lower Extremity Arterial Bypass Grafts: Results from the STAR Registry R.I. Patel, MD, Philadelphia, PA· K.L. Sullivan, MD· S. Misra, MD· GA. Gardiner, jr, MD
PURPOSE The initial outcome and long-term patency of thrombolysis of lower extremity arterial bypass grafts were analyzed from a multicenter registry. MATERIALS AND METHODS: A total of 12] lower extremity arterial bypass graft thrombolysis procedures in 118 patients were analyzed from the STAR registry. Initial technical success, defined as at least 95% graft recanalization, was calculated. The effect of graft material and location on patency was evaluated with life-table analysis and the log-rank test. RESULTS: The initial technical success was 59%. Patency (± standard error) at 6 months and 1 year for all grafts, including technical successes and failures, was 43% (± 9) and 36% (± 14). There was no significant difference in patency raltes for vein versus synthetic grafts (P = .8). There was a trend toward improved patency for aortoiliac/aortofemoral over femoropopliteal over femorodistal (P = .054), which had 6month patencies of 55% (± 14), 43% (± 13), and 36% (± 22), respectively. CONCLUSION Inability to recanalize the graft during attempted thrombolysis was the most important factor determining patency at 1 year. As long-term follow-up data continue to accrue in the STAR registry, it should be possible to determine the durability of patency in successfully thrombolysed grafts. T~Lke
Home Points: 1. The initial technical success associated with thrombolysis of lower extremity bypass grafts was 59%.
2. One-year patency of all grafts treated with thrombolysis was 36%. 3. There were no significant differences in patency rates based on graft material and graft location.
119-2:45 pm Pharmacomechanical Thrombolysis in Peripheral Arterial Occlusions: Prospective Evaluation T.K. Roeren, MD, PhD, Heidelberg, Germany· B. Lachenicbt, BS· M. Duex, MD· V. Hoffmann, MD· G.M. Richter, MD, PhD· G. W Kauffmann, MD, PhD
PURPOSE: To prospectively determine technical and clinical efficacy, time requirements, and prognostic factors associated with pharrnacomechanical thrombolysis (PMT). MATERIALS AND METHODS: Twenty-eight consecutive patients with acute arterial (n = 14) or bypass (n = 14) occlusions of the lower limb were treated with PMT; 82% had a limb at risk. PMT was started with 2.5 mg of r-tPA diluted in 20 mL of saline. The dose was then changed to 1.5 mg of r-tPA over 20 minutes until the occluded segment showed pulsatile perfusion. Technical and clinical success, time requirements for the intervention, and complications were noted. To obtain midterm results, patients were followed up at 3-month intervals with nonvasive examinations and intraarterial angiography after 6 and 12 months. Data were evaluated with life-table analysis and nonparametric tests. RESULTS: Technical success was 89%, and clinical success was 68%. Mean duration of PMT alone was 110 minutes. The mean duration of the intervention, however, was 17 hours (0.554.5 hours) due to additional lysis or intraarterial heparinization for residual thrombi. Ten patients underwent additional interventions. Two (7.1%) significant complications occurred (groin hematomas). Primary assisted patency for native arteries was Significantly higher than for bypasses (82% vs 48% at 6 months, P = .012). Salvage of threatened limbs was 75% at 6 months. Presence of bypasses (P = .009) and poor runoff (P = .025) significantly decreased mid-term patency. CONCLUSION: PMT accelerates return of pulsatile flow in occluded segments, while the overall time requirement for the intervention remains comparable to that of infusion lysis. With low mortality (0%) and complication rates (7.1%) the method is safe and successful (75% limbs salvaged). Bypasses and poor runoff are significant prognostic factors for midterm clinical failure.
243
Tuesday, March 5, 1996 Take Home Points: PMT accelerates reperfusion of arterial occlusions, but total time for intervention remains unchanged. Bypasses have a significantly worse prognosis than native arteries despite a higher technical success rate. 120-3:00 pm Amplatz Thrombectomy Device in the Treatment of Acute Lower Limb Occlusions: Preliminary Experience with 40 Patients N. Rilinger, MD, Ulm, Germany·]. Goerich, MD· R. Scharrer-Pamler, MD • R. Sokiranski, MD .]. Vogel, MD· H. Brambs, MD, PhD PURPOSE: To elucidate the therapeutic effect of the Amplatz thrombectomy device (AID) in the treatment of acute peripheral thromboembolic occlusions. MA1ERlALS AND METHODS: Mechanical thrombectomy with use of the ATD was carried out in 40 patients with acutely threatened lower limbs. Estimated occlusion time was 3 hours up to 8 days, 0 2 days. Occlusions were embolic in 32 patients and thrombotic in eight. At the start of the procedure, 5,000 IV of heparin was given followed by 25,000 IV per day for 2 days. Localization of acute occlusions was as follows: superficial and deep femoral arteries in four cases, superficial femoral and infrapopliteal arteries in 17, and popliteal and infrapopliteal arteries in 19. RESULTS: Total limb salvage rate was 92.5%. Successful recanalization was achieved without adjunctive procedure in 65% of cases. Average treatment time was 75 seconds ± 15. Successful recanalization was achieved with adjunctive procedures in 27.5%. Average treatment time was 24 hours ± 4. Failures occurred in 7.5%. In three cases, a breakage of the drive shaft of the ATD was observed without sequelae.
CONCLUSION: The ATD is an effective and safe procedure for quick restoration of vascular patency. Take Home Points: Mechanical thrombectomy with the AID quickly restores vascular patency in patients with acute peripheral occlusions.
244
121-3:15 pm Multicenter Trial of a Rheolytic Thrombectomy Device for Treatment of Acute Occlusions of Native Leg Arteries, Bypass Grafts, and Hemodialysis Access: Interim Report H. Wagner, MD, Marburg, Germany· S. Mueller-Huelsbeck, MD PURPOSE: Prospective evaluation of a rheolytic thrombectomy device (Angiojet) for treatment of acutely thrombosed native leg arteries, bypass grafts, and hemodialysis fistulas. MATERIALS AND METHODS: From March 1995 through September 1995, 29 patients (mean age, 70 years ± 12) entered the study at six different centers. Patients had acute occlusions of native lower limb arteries (n = 20), bypass grafts (n = 7), or hemodialysis access (n = 2). Estimated thrombus age was 6 days ± 5, and mean thrombus length was 17 cm ± 11. RESULTS: Technical success (residual luminal narrowing < 50%) of the thrombectomy device alone was 56%. As adjunctive therapy, balloon dilation was carried out in 66%, fibrinolysis in 31%, and stent implantation in 10%. Clinical improvement was + 3 in 43%, + 2 in 35%, + 1 in 15%, and 0 in 7% (with Rutherford criteria). Limb salvage rate was 93%. Two patients underwent vascular surgery. Complications related to the rheolytic thrombectomy were embolization (n = 1) and arterial dissection (n = 2). None of these were clinically significant. Blood parameters revealed signs of mild hemolysis after thrombectomy, but no clinical sequelae were noted. Cumulative primary patency rates (follow-up with duplex sonography) were 93% after 1 month and 93% after 3 months.
CONCLUSION: Preliminary results for the rheolytic thrombectomy device are promising with regard to initial success, complication rate, and patency during short-term follow-up. Take Home Points: The rheolytic thrombectomy device for acute occlusions of native arteries and bypass grafts is safe and efficacious and can reduce the need for fibrinolysis. Stand alone procedures are possible.
Tuesday, March 5, 1996 122-3:30 pm
123-3:45 pm
Percutaneous Hydrodynamic Thrombectomy with Use of the Hydrolyser System M. Hemy, MD, Essey Les Nancy, France' M. Amor, MD' 1. Hemy, MD' O. Tricoche, MD' M. Allaoui, MD
Pharmacologic Thrombolysis and Mechanical Fragmentation in Massive Pulmonary Embolism M. Fava, MD, Santiago, Chile' M.S. Loyola, MD • P. Flores, MD • 1. Huete, MD
PURPOSE: To present our clinical experience with a new mechanical hydrodynamic thrombectomy system (Hydrolyser) that uses the venturi effect. This device was used for thrombus removal in native arteries, arterial grafts, the venous system, and pulmonary arteries.
PURPOSE: To evaluate the usefulness of intrapulmonary thrombolysis associated with mechanical fragmentation in acute massive pulmonary embolism (PE).
M4TERJALS AND METHODS: The Hydrolyser is a recently developed 7-F, double-lumen, overthe-wire catheter. The device has been used in 28 patients (15 men, 13 women), aged 40-88 years (mean, 68.1 years ± 13), with recent thromboses. Occlusion time ranged from 1 to 30 days (mean, 8.7 days ± 8.5), and thrombus length ranged from 4 to 35 cm (mean, 17.7 cm ± 9.5). Location of thrombus included native arteries (n = 19), arterial grafts (n = 5), the SVC (n = 2), and the pulmonary artery (n = 2). Femoral antegrade (n = 15), femoral retrograde (n = 4), and femoral contralateral (n = 9) approaches were used. RESULTS: Thrombectomy was technically successful in 22 patients in native arteries (14 of 18), arterial grafts (four of five), pulmonary arteries (two of two), and SVC (two of two). The pcTcentage of thrombus estimated angiographically to be removed by the Hydrolyser was 72.5% ± 22. Adjunctive therapy included angioplasty (n = 16, with six immediate stent implantations), thromboaspiration (n = 16), and reduced time fibrinolysis (n = 6). Distal embolism cured by thromboaspiration was the only complication. In six patients, the procedure failed and surgery was required (bypass or Fogarty). CONCLUSION The Hydrolyser system seems a promising concept for percutaneous thrombectomy. It is a quick, reliable, efficient device, which can be combined with other techniques, such as thromboaspiration, and completed by reduced time fibrinolysis. This technique may also offer an alternative to thrombolysis and surgical thrombectomy.
M4TER1ALS AND METHODS: Twenty-two cases of massive acute PE treated with pharmacologic thrombolysis (14 with mechanical fragmentation) between 1987 and 1995 were retrospectively studied. RESULTS: Eighteen patients underwent direct intrathrombus infusion with 50,000-100,000 VI hr of urokinase, and four patients were treated with 30,000-50,000 Vlh of streptokinase. Infusion time was 4---24 hours. In 14 patients, mechanical fragmentation of emboli was performed. Severity of PE was assessed with the angiographic severity index according to the Urokinase Pulmonary Embolism Trial. The preand postinfusion mean values (±SD) were 16 ± 1 and 9 ± 3, respectively (P < .01) (maximum value of 18). The mean pre- and postinfusion pulmonary artery pressures (PAP) were 65/35 rom Hg and 35/15 rom Hg, respectively (P < .01). Pa0 2 increased from 67 rom Hg ± 17 to 132 mm Hg ± 38 after therapy. Oxygen requirement decreased by one-half on average (P < .01). Seventeen patients (77%) completely recovered from the massive acute PE episode and continued with oral anticoagulant therapy. Three patients died during thrombolysis despite improvement in PAP and Pa0 2 parameters; one death was due to intracerebral hemorrhage. CONCLUSION Our data support the efficacy of pharmacologic thrombolysis with mechanical fragmentation in the treatment of acute massive PE, resulting in improved hemodynamics and blood oxygenation and a decrease in PAP.
Take Home Points: Pharmacologic intrapulmonary thrombolysis with mechanical fragmentation results in a rapid decrease in PAP and improved hemodynamic status and blood oxygenation. PE thrombolysis showed important benefits with a low complication rate.
245
118-2:30 pm Long-term Patency after Thrombolysis of O,:cluded Lower Extremity Arterial Bypass Grafts: Results from the STAR Registry R.I. Patel, MD, Philadelphia, PA· K.L. Sullivan, MD· S. Misra, MD· GA. Gardiner, jr, MD
PURPOSE The initial outcome and long-term patency of thrombolysis of lower extremity arterial bypass grafts were analyzed from a multicenter registry. MATERIALS AND METHODS: A total of 12] lower extremity arterial bypass graft thrombolysis procedures in 118 patients were analyzed from the STAR registry. Initial technical success, defined as at least 95% graft recanalization, was calculated. The effect of graft material and location on patency was evaluated with life-table analysis and the log-rank test. RESULTS: The initial technical success was 59%. Patency (± standard error) at 6 months and 1 year for all grafts, including technical successes and failures, was 43% (± 9) and 36% (± 14). There was no significant difference in patency raltes for vein versus synthetic grafts (P = .8). There was a trend toward improved patency for aortoiliac/aortofemoral over femoropopliteal over femorodistal (P = .054), which had 6month patencies of 55% (± 14), 43% (± 13), and 36% (± 22), respectively. CONCLUSION Inability to recanalize the graft during attempted thrombolysis was the most important factor determining patency at 1 year. As long-term follow-up data continue to accrue in the STAR registry, it should be possible to determine the durability of patency in successfully thrombolysed grafts. T~Lke
Home Points: 1. The initial technical success associated with thrombolysis of lower extremity bypass grafts was 59%.
2. One-year patency of all grafts treated with thrombolysis was 36%. 3. There were no significant differences in patency rates based on graft material and graft location.
119-2:45 pm Pharmacomechanical Thrombolysis in Peripheral Arterial Occlusions: Prospective Evaluation T.K. Roeren, MD, PhD, Heidelberg, Germany· B. Lachenicbt, BS· M. Duex, MD· V. Hoffmann, MD· G.M. Richter, MD, PhD· G. W Kauffmann, MD, PhD
PURPOSE: To prospectively determine technical and clinical efficacy, time requirements, and prognostic factors associated with pharrnacomechanical thrombolysis (PMT). MATERIALS AND METHODS: Twenty-eight consecutive patients with acute arterial (n = 14) or bypass (n = 14) occlusions of the lower limb were treated with PMT; 82% had a limb at risk. PMT was started with 2.5 mg of r-tPA diluted in 20 mL of saline. The dose was then changed to 1.5 mg of r-tPA over 20 minutes until the occluded segment showed pulsatile perfusion. Technical and clinical success, time requirements for the intervention, and complications were noted. To obtain midterm results, patients were followed up at 3-month intervals with nonvasive examinations and intraarterial angiography after 6 and 12 months. Data were evaluated with life-table analysis and nonparametric tests. RESULTS: Technical success was 89%, and clinical success was 68%. Mean duration of PMT alone was 110 minutes. The mean duration of the intervention, however, was 17 hours (0.554.5 hours) due to additional lysis or intraarterial heparinization for residual thrombi. Ten patients underwent additional interventions. Two (7.1%) significant complications occurred (groin hematomas). Primary assisted patency for native arteries was Significantly higher than for bypasses (82% vs 48% at 6 months, P = .012). Salvage of threatened limbs was 75% at 6 months. Presence of bypasses (P = .009) and poor runoff (P = .025) significantly decreased mid-term patency. CONCLUSION: PMT accelerates return of pulsatile flow in occluded segments, while the overall time requirement for the intervention remains comparable to that of infusion lysis. With low mortality (0%) and complication rates (7.1%) the method is safe and successful (75% limbs salvaged). Bypasses and poor runoff are significant prognostic factors for midterm clinical failure.
243
Tuesday, March 5, 1996 Take Home Points: PMT accelerates reperfusion of arterial occlusions, but total time for intervention remains unchanged. Bypasses have a significantly worse prognosis than native arteries despite a higher technical success rate. 120-3:00 pm Amplatz Thrombectomy Device in the Treatment of Acute Lower Limb Occlusions: Preliminary Experience with 40 Patients N. Rilinger, MD, Ulm, Germany·]. Goerich, MD· R. Scharrer-Pamler, MD • R. Sokiranski, MD .]. Vogel, MD· H. Brambs, MD, PhD PURPOSE: To elucidate the therapeutic effect of the Amplatz thrombectomy device (AID) in the treatment of acute peripheral thromboembolic occlusions. MA1ERlALS AND METHODS: Mechanical thrombectomy with use of the ATD was carried out in 40 patients with acutely threatened lower limbs. Estimated occlusion time was 3 hours up to 8 days, 0 2 days. Occlusions were embolic in 32 patients and thrombotic in eight. At the start of the procedure, 5,000 IV of heparin was given followed by 25,000 IV per day for 2 days. Localization of acute occlusions was as follows: superficial and deep femoral arteries in four cases, superficial femoral and infrapopliteal arteries in 17, and popliteal and infrapopliteal arteries in 19. RESULTS: Total limb salvage rate was 92.5%. Successful recanalization was achieved without adjunctive procedure in 65% of cases. Average treatment time was 75 seconds ± 15. Successful recanalization was achieved with adjunctive procedures in 27.5%. Average treatment time was 24 hours ± 4. Failures occurred in 7.5%. In three cases, a breakage of the drive shaft of the ATD was observed without sequelae.
CONCLUSION: The ATD is an effective and safe procedure for quick restoration of vascular patency. Take Home Points: Mechanical thrombectomy with the AID quickly restores vascular patency in patients with acute peripheral occlusions.
244
121-3:15 pm Multicenter Trial of a Rheolytic Thrombectomy Device for Treatment of Acute Occlusions of Native Leg Arteries, Bypass Grafts, and Hemodialysis Access: Interim Report H. Wagner, MD, Marburg, Germany· S. Mueller-Huelsbeck, MD PURPOSE: Prospective evaluation of a rheolytic thrombectomy device (Angiojet) for treatment of acutely thrombosed native leg arteries, bypass grafts, and hemodialysis fistulas. MATERIALS AND METHODS: From March 1995 through September 1995, 29 patients (mean age, 70 years ± 12) entered the study at six different centers. Patients had acute occlusions of native lower limb arteries (n = 20), bypass grafts (n = 7), or hemodialysis access (n = 2). Estimated thrombus age was 6 days ± 5, and mean thrombus length was 17 cm ± 11. RESULTS: Technical success (residual luminal narrowing < 50%) of the thrombectomy device alone was 56%. As adjunctive therapy, balloon dilation was carried out in 66%, fibrinolysis in 31%, and stent implantation in 10%. Clinical improvement was + 3 in 43%, + 2 in 35%, + 1 in 15%, and 0 in 7% (with Rutherford criteria). Limb salvage rate was 93%. Two patients underwent vascular surgery. Complications related to the rheolytic thrombectomy were embolization (n = 1) and arterial dissection (n = 2). None of these were clinically significant. Blood parameters revealed signs of mild hemolysis after thrombectomy, but no clinical sequelae were noted. Cumulative primary patency rates (follow-up with duplex sonography) were 93% after 1 month and 93% after 3 months.
CONCLUSION: Preliminary results for the rheolytic thrombectomy device are promising with regard to initial success, complication rate, and patency during short-term follow-up. Take Home Points: The rheolytic thrombectomy device for acute occlusions of native arteries and bypass grafts is safe and efficacious and can reduce the need for fibrinolysis. Stand alone procedures are possible.
Tuesday, March 5, 1996 122-3:30 pm
123-3:45 pm
Percutaneous Hydrodynamic Thrombectomy with Use of the Hydrolyser System M. Hemy, MD, Essey Les Nancy, France' M. Amor, MD' 1. Hemy, MD' O. Tricoche, MD' M. Allaoui, MD
Pharmacologic Thrombolysis and Mechanical Fragmentation in Massive Pulmonary Embolism M. Fava, MD, Santiago, Chile' M.S. Loyola, MD • P. Flores, MD • 1. Huete, MD
PURPOSE: To present our clinical experience with a new mechanical hydrodynamic thrombectomy system (Hydrolyser) that uses the venturi effect. This device was used for thrombus removal in native arteries, arterial grafts, the venous system, and pulmonary arteries.
PURPOSE: To evaluate the usefulness of intrapulmonary thrombolysis associated with mechanical fragmentation in acute massive pulmonary embolism (PE).
M4TERJALS AND METHODS: The Hydrolyser is a recently developed 7-F, double-lumen, overthe-wire catheter. The device has been used in 28 patients (15 men, 13 women), aged 40-88 years (mean, 68.1 years ± 13), with recent thromboses. Occlusion time ranged from 1 to 30 days (mean, 8.7 days ± 8.5), and thrombus length ranged from 4 to 35 cm (mean, 17.7 cm ± 9.5). Location of thrombus included native arteries (n = 19), arterial grafts (n = 5), the SVC (n = 2), and the pulmonary artery (n = 2). Femoral antegrade (n = 15), femoral retrograde (n = 4), and femoral contralateral (n = 9) approaches were used. RESULTS: Thrombectomy was technically successful in 22 patients in native arteries (14 of 18), arterial grafts (four of five), pulmonary arteries (two of two), and SVC (two of two). The pcTcentage of thrombus estimated angiographically to be removed by the Hydrolyser was 72.5% ± 22. Adjunctive therapy included angioplasty (n = 16, with six immediate stent implantations), thromboaspiration (n = 16), and reduced time fibrinolysis (n = 6). Distal embolism cured by thromboaspiration was the only complication. In six patients, the procedure failed and surgery was required (bypass or Fogarty). CONCLUSION The Hydrolyser system seems a promising concept for percutaneous thrombectomy. It is a quick, reliable, efficient device, which can be combined with other techniques, such as thromboaspiration, and completed by reduced time fibrinolysis. This technique may also offer an alternative to thrombolysis and surgical thrombectomy.
M4TER1ALS AND METHODS: Twenty-two cases of massive acute PE treated with pharmacologic thrombolysis (14 with mechanical fragmentation) between 1987 and 1995 were retrospectively studied. RESULTS: Eighteen patients underwent direct intrathrombus infusion with 50,000-100,000 VI hr of urokinase, and four patients were treated with 30,000-50,000 Vlh of streptokinase. Infusion time was 4---24 hours. In 14 patients, mechanical fragmentation of emboli was performed. Severity of PE was assessed with the angiographic severity index according to the Urokinase Pulmonary Embolism Trial. The preand postinfusion mean values (±SD) were 16 ± 1 and 9 ± 3, respectively (P < .01) (maximum value of 18). The mean pre- and postinfusion pulmonary artery pressures (PAP) were 65/35 rom Hg and 35/15 rom Hg, respectively (P < .01). Pa0 2 increased from 67 rom Hg ± 17 to 132 mm Hg ± 38 after therapy. Oxygen requirement decreased by one-half on average (P < .01). Seventeen patients (77%) completely recovered from the massive acute PE episode and continued with oral anticoagulant therapy. Three patients died during thrombolysis despite improvement in PAP and Pa0 2 parameters; one death was due to intracerebral hemorrhage. CONCLUSION Our data support the efficacy of pharmacologic thrombolysis with mechanical fragmentation in the treatment of acute massive PE, resulting in improved hemodynamics and blood oxygenation and a decrease in PAP.
Take Home Points: Pharmacologic intrapulmonary thrombolysis with mechanical fragmentation results in a rapid decrease in PAP and improved hemodynamic status and blood oxygenation. PE thrombolysis showed important benefits with a low complication rate.
245