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Reduced stent utilization with Silverhawk atherectomy vs balloon angioplasty in patients undergoing peripheral vascular interventions: a randomized trial
Abstracts / Cardiovascular Revascularization Medicine 9 (2008) 101–129 susceptible to high rates of restenosis due to clinical factors independent of the stent characteristics studied. doi:10.1016/j.carrev.2008.02.045
Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry NW Shammas, EJ Dippel, D Coiner, GA Shammas, M Jerin, A Kumar Midwest Cardiovascular Research Foundation, Davenport, IA, USA Background: Atheroembolization has been frequently noted during endovascular interventions. In this prospective registry, we evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during lower extremity peripheral percutaneous intervention. Methods: In this single-center prospective registry, patients were included if they were able to provide informed consent and had an infrainguinal lesion that met one or more of the following angiographic criteria: (a) moderate or severe calcification of any length, (b) total occlusions of any length, (c) presence of a filling defect, (d) irregular appearing lesions at least 30 mm in length, and (e) smooth lesion at least 50 mm in length. The primary angiographic outcome was to evaluate the EFP ability in capturing macrodebris in the lower extremities and prevent visible embolization, slow flow, and loss of a distal tibial runoff. Clinically significant macrodebris was defined as more or equal 2 mm in its longest axis. Results: Forty patients were enrolled in the Preventing Lower Extremity Distal Embolization using Embolic Filter Protection (PROTECT) registry. One filter was used per patient. The total number of vessels treated with EFP is 57 (denovo 43, restenotic 14). The Spider Filter (ev3, Inc, Plymouth, MN) (n=35) and the EmboShield (Abbott Vascular, Abbott Park, IL) (n=15) were used. Forty-four vessels (group A) were treated with percutaneous angioplasty with (n=33) and without stenting (n=11) and the remainder 13 vessels (group B) were treated with the SilverHawk (Foxhollow, Redwood City, CA) atherectomy and adjunctive balloon angioplasty. Macroembolization occurred in 53% of treated vessels (44% clinically significant), 39% in group A, and 100% in group B. All filters were retrieved successfully with no complications. One patient had side branch embolization. In another patient, the filter was overfilled resulting in no distal flow and had to be retrieved with subsequent distal tibial embolization when the procedure was continued without EFP. Conclusion: Macroembolization is very frequent in patients undergoing peripheral percutaneous intervention of the lower extremity particularly with SilverHawk atherectomy. Embolic filter protection appears to be very effective in capturing macrodebris and its use is associated with good angiographic outcome. Problems with filter retrieval were not encountered. doi:10.1016/j.carrev.2008.02.046
Reduced stent utilization with Silverhawk atherectomy vs balloon angioplasty in patients undergoing peripheral vascular interventions: a randomized trial NW Shammas, D Coiner, GA Shammas, EJ Dippel Midwest cardiovascular Research Foundation, Davenport, IA, USA Background: There are no data on bail out stent utilization rate with percutaneous transluminal angioplasty (PTA) vs Silverhawk (Foxhollow, Redwood City, CA) atherectomy (SA) in the treatment of de novo peripheral arterial disease. In this open-label, 2-center, randomized trial, we tested the hypothesis that SA of infrainguinal denovo arterial lesions leads to significantly less bail out stenting rate than balloon angioplasty alone. Methods: The primary end point of the trial is the rate of bail out stenting because of suboptimal acute procedural results defined as a residual of 30% or greater and/or a 20-mm Hg gradient across the treated segment. Secondary end point is target lesion revascularization at 6 months and 1 year. Patients were included if they were older than 18 years and referred for peripheral angioplasty of the femoral, popliteal, and/or infrapopliteal vessels
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with symptoms of claudication or limb ischemia. Exclusion criteria included heavy vessel calcification, occlusions longer than 10 cm, creatinine above 2.5, and inability to give consent. Ninety seconds of balloon inflation at the required pressure to yield full balloon inflation was performed twice before declaring failure of PTA in achieving optimal results. Adjunctive balloon angioplasty of the treated segment with SA was also allowed at low pressure (6-8 atm) for 2 inflations, 90 seconds each. Clinical, demographics and detailed angiographic variables were documented on electronic case report forms. Results: A total of 58 patients were included in the study. Of these, 29 (36 vessels) were included in the SA arm, and 29 (48 vessels), in the PTA arm. Bail out stenting was needed in 50% (24/48 ) of vessels in the PTA arm, and 22.2% (8/36), in the SA arm (P=.009). Balloon mean pressure required to yield optimal balloon inflation for PTA was 10.17±1.88 mm Hg vs 7.89±1.88 mm Hg for SA (Pb.001). Conclusion: Silverhawk atherectomy with adjunctive balloon angioplasty reduces stent utilization significantly compared to PTA alone. Furthermore, optimal balloon inflation after atherectomy can be achieved at lower pressures than PTA, which might reflect on a better compliance of the treated segment after SA. doi:10.1016/j.carrev.2008.02.047
Intermediate-term outcomes with bifurcating coronary lesions stenting using the paclitaxel drug-eluting stent: a single-center experience NW Shammas, EJ Dippel, P Sharis, J Robken, L Farland, S Brosius, M Jerin, A Avila, L Gehbauer, M Winter, G Shammas, P Stoakes Midwest Cardiovascular Research Foundation, Davenport, IA, USA Background: Percutaneous treatment of bifurcating coronary artery disease (BCAD) is complex and, in the era of bare metal stents (BMS) was reported to have a high rate of repeat target lesion revascularization (TLR). Drugeluting stents (DES) have been used in the treatment of BCAD with overall better outcomes than BMS. Short- and long-term acute stent thrombosis (AST) ranging from 1.7% to 4.3% has been reported with bifurcating DES and remains a concern in treating these patients. In this report, we present intermediate term outcomes with BCAD stenting using the Taxus (Boston Scientific, Natick, MA) paclitaxel-DES from our own center. Methods: Five hundred eighteen consecutive de novo bifurcating stenting procedures were performed in 2005 at our institution using the Taxus DES. Follow-up data on 312 patients (60.2%) was achieved using phone interviews and review of medical records at a mean of 6.7 months. Patients were treated with aspirin and clopidogrel for at least 6 months. The primary end point of the study was the combined end points of cardiac death, nonfatal myocardial infarction (MI) (ST-elevation MI [STEMI] and non–STelevation MI [NSTEMI]) and target lesion revascularization (TLR). Secondary outcomes included the individual end points of death, cardiac death, AST, target vessel revascularization (TVR), TLR, STEMI and NSTEMI on intermediate-term follow-up. Results: The following bifurcating stenting techniques were used: T stenting, 43.9%; v-stenting, 30.1%; crush, 0.4%; culotte, 0.2%; Y stenting, 3.9%; and 1-branch stenting, 16.7%. Kissing balloon was performed in 76% of patients. The mean age of the patients was 66±12 years. Acute procedural success was 95% (main branch, 99%; side branch, 95.9%). The bifurcation lesions were located in the left anterior descending coronary artery/diagonal coronary artery (LAD/D) (50.7%), left circumflex/obtuse marginal (LCX/ OM) (26.7%), LAD/LCX (13.5%), posterolateral/posterior descending coronary artery (PL/PDA) (6.6%), and others (2.5%). The following Intermediate-term outcomes with bifurcating drug-eluting stent were TLR (6.7%), TVR (12.2%), AST (1.3%), death (6.1%), cardiac death (2.9%), NSTEMI (0.7%), STEMI (2%), and combined primary end point (9.9%). Conclusion: The Taxus DES carries good intermediate-term outcomes in the treatment of bifurcating coronary lesions compared to historic controls with BMS with low TLR, TVR, and overall primary combined end point. doi:10.1016/j.carrev.2008.02.048
Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry NW Shammas, EJ Dippel, D Coiner, GA Shammas, M Jerin, A Kumar Midwest Cardiovascular Research Foundation, Davenport, IA, USA Background: Atheroembolization has been frequently noted during endovascular interventions. In this prospective registry, we evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during lower extremity peripheral percutaneous intervention. Methods: In this single-center prospective registry, patients were included if they were able to provide informed consent and had an infrainguinal lesion that met one or more of the following angiographic criteria: (a) moderate or severe calcification of any length, (b) total occlusions of any length, (c) presence of a filling defect, (d) irregular appearing lesions at least 30 mm in length, and (e) smooth lesion at least 50 mm in length. The primary angiographic outcome was to evaluate the EFP ability in capturing macrodebris in the lower extremities and prevent visible embolization, slow flow, and loss of a distal tibial runoff. Clinically significant macrodebris was defined as more or equal 2 mm in its longest axis. Results: Forty patients were enrolled in the Preventing Lower Extremity Distal Embolization using Embolic Filter Protection (PROTECT) registry. One filter was used per patient. The total number of vessels treated with EFP is 57 (denovo 43, restenotic 14). The Spider Filter (ev3, Inc, Plymouth, MN) (n=35) and the EmboShield (Abbott Vascular, Abbott Park, IL) (n=15) were used. Forty-four vessels (group A) were treated with percutaneous angioplasty with (n=33) and without stenting (n=11) and the remainder 13 vessels (group B) were treated with the SilverHawk (Foxhollow, Redwood City, CA) atherectomy and adjunctive balloon angioplasty. Macroembolization occurred in 53% of treated vessels (44% clinically significant), 39% in group A, and 100% in group B. All filters were retrieved successfully with no complications. One patient had side branch embolization. In another patient, the filter was overfilled resulting in no distal flow and had to be retrieved with subsequent distal tibial embolization when the procedure was continued without EFP. Conclusion: Macroembolization is very frequent in patients undergoing peripheral percutaneous intervention of the lower extremity particularly with SilverHawk atherectomy. Embolic filter protection appears to be very effective in capturing macrodebris and its use is associated with good angiographic outcome. Problems with filter retrieval were not encountered. doi:10.1016/j.carrev.2008.02.046
Reduced stent utilization with Silverhawk atherectomy vs balloon angioplasty in patients undergoing peripheral vascular interventions: a randomized trial NW Shammas, D Coiner, GA Shammas, EJ Dippel Midwest cardiovascular Research Foundation, Davenport, IA, USA Background: There are no data on bail out stent utilization rate with percutaneous transluminal angioplasty (PTA) vs Silverhawk (Foxhollow, Redwood City, CA) atherectomy (SA) in the treatment of de novo peripheral arterial disease. In this open-label, 2-center, randomized trial, we tested the hypothesis that SA of infrainguinal denovo arterial lesions leads to significantly less bail out stenting rate than balloon angioplasty alone. Methods: The primary end point of the trial is the rate of bail out stenting because of suboptimal acute procedural results defined as a residual of 30% or greater and/or a 20-mm Hg gradient across the treated segment. Secondary end point is target lesion revascularization at 6 months and 1 year. Patients were included if they were older than 18 years and referred for peripheral angioplasty of the femoral, popliteal, and/or infrapopliteal vessels
115
with symptoms of claudication or limb ischemia. Exclusion criteria included heavy vessel calcification, occlusions longer than 10 cm, creatinine above 2.5, and inability to give consent. Ninety seconds of balloon inflation at the required pressure to yield full balloon inflation was performed twice before declaring failure of PTA in achieving optimal results. Adjunctive balloon angioplasty of the treated segment with SA was also allowed at low pressure (6-8 atm) for 2 inflations, 90 seconds each. Clinical, demographics and detailed angiographic variables were documented on electronic case report forms. Results: A total of 58 patients were included in the study. Of these, 29 (36 vessels) were included in the SA arm, and 29 (48 vessels), in the PTA arm. Bail out stenting was needed in 50% (24/48 ) of vessels in the PTA arm, and 22.2% (8/36), in the SA arm (P=.009). Balloon mean pressure required to yield optimal balloon inflation for PTA was 10.17±1.88 mm Hg vs 7.89±1.88 mm Hg for SA (Pb.001). Conclusion: Silverhawk atherectomy with adjunctive balloon angioplasty reduces stent utilization significantly compared to PTA alone. Furthermore, optimal balloon inflation after atherectomy can be achieved at lower pressures than PTA, which might reflect on a better compliance of the treated segment after SA. doi:10.1016/j.carrev.2008.02.047
Intermediate-term outcomes with bifurcating coronary lesions stenting using the paclitaxel drug-eluting stent: a single-center experience NW Shammas, EJ Dippel, P Sharis, J Robken, L Farland, S Brosius, M Jerin, A Avila, L Gehbauer, M Winter, G Shammas, P Stoakes Midwest Cardiovascular Research Foundation, Davenport, IA, USA Background: Percutaneous treatment of bifurcating coronary artery disease (BCAD) is complex and, in the era of bare metal stents (BMS) was reported to have a high rate of repeat target lesion revascularization (TLR). Drugeluting stents (DES) have been used in the treatment of BCAD with overall better outcomes than BMS. Short- and long-term acute stent thrombosis (AST) ranging from 1.7% to 4.3% has been reported with bifurcating DES and remains a concern in treating these patients. In this report, we present intermediate term outcomes with BCAD stenting using the Taxus (Boston Scientific, Natick, MA) paclitaxel-DES from our own center. Methods: Five hundred eighteen consecutive de novo bifurcating stenting procedures were performed in 2005 at our institution using the Taxus DES. Follow-up data on 312 patients (60.2%) was achieved using phone interviews and review of medical records at a mean of 6.7 months. Patients were treated with aspirin and clopidogrel for at least 6 months. The primary end point of the study was the combined end points of cardiac death, nonfatal myocardial infarction (MI) (ST-elevation MI [STEMI] and non–STelevation MI [NSTEMI]) and target lesion revascularization (TLR). Secondary outcomes included the individual end points of death, cardiac death, AST, target vessel revascularization (TVR), TLR, STEMI and NSTEMI on intermediate-term follow-up. Results: The following bifurcating stenting techniques were used: T stenting, 43.9%; v-stenting, 30.1%; crush, 0.4%; culotte, 0.2%; Y stenting, 3.9%; and 1-branch stenting, 16.7%. Kissing balloon was performed in 76% of patients. The mean age of the patients was 66±12 years. Acute procedural success was 95% (main branch, 99%; side branch, 95.9%). The bifurcation lesions were located in the left anterior descending coronary artery/diagonal coronary artery (LAD/D) (50.7%), left circumflex/obtuse marginal (LCX/ OM) (26.7%), LAD/LCX (13.5%), posterolateral/posterior descending coronary artery (PL/PDA) (6.6%), and others (2.5%). The following Intermediate-term outcomes with bifurcating drug-eluting stent were TLR (6.7%), TVR (12.2%), AST (1.3%), death (6.1%), cardiac death (2.9%), NSTEMI (0.7%), STEMI (2%), and combined primary end point (9.9%). Conclusion: The Taxus DES carries good intermediate-term outcomes in the treatment of bifurcating coronary lesions compared to historic controls with BMS with low TLR, TVR, and overall primary combined end point. doi:10.1016/j.carrev.2008.02.048