- Email: [email protected]
TCT-449: Intracoronary Paclitaxel Delivery with a Novel Mesh Catheter
http://www.aievolution.com/tct0901/
TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM
progressively degrades allowing for positive remodeling of the stented arterial segment. This leads to late lumen gain and restoration of the lumen size to nearly its post-implantation dimensions. It is thought that the polymer stents allow for regaining of elasticity of the arterial wall and that the intracoronary pressure remodels the vessel resulting in regained compliance. This hypothesis will be the subject of future studies.
data are separated in 10 groups according to their associated cardiac phase, and used for reconstruction of intermediate 3D images. The intermediate 3D images are registered to the reference 3D image and accumulated yielding a tomographic 3D image. Results: MC-3DR was performed in 20 patients: LCA: 14, RCA: 6, heart rate: 75±14 BPM. MC-3DR was feasible in 17 patients with a good imaging of the ZKROHFRURQDU\WUHH,QSDWLHQWV0&'5IDLOHG LQSDWLHQWVGXHWRWKHODFN RIDVXI¿FLHQW¿OOLQJRIWKHFRQWUDVWPHGLXPRYHUVHFRQGVLQRQHFDVHGXHWR the more complex motion of the RCA during heart beat. Conclusion: These data suggest, that motion corrected C-arm-CT reconstruction of coronary arteries is feasible. Due to the compensation of motion artefacts this method can support the physician during interventional procedures.
TCT-448 Two-year Results of the Vestasync I trial with a novel, thirdgeneration, hydroxyapatite polymer-free sirolimus-eluting stent José de Ribamar Costa, Jr., Alexandre Abizaid, Fausto Feres, Ricardo Costa, Dimytri Siqueira, Rodolfo Staico, Galo Maldonado, Luiz Fernado Tanajura, Amanda Sousa, J Eduardo Sousa Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
TCT-447
Background:'XUDEOHSRO\PHUVLQVWJHQHUDWLRQ'(6KDYHEHHQOLQNHGWR ORFDO LQÀDPPDWRU\ UHDFWLRQV 6WHQW WKURPERVLV 67 VHFRQGDU\ WR SRVLWLYH vessel remodeling and late-acquired incomplete stent apposition (ISA) is a possible clinical translation of this local adverse effect. We sought to assess WKH VDIHW\ DQG HI¿FDF\ RI WKH QRYHO 9(67$V\QF (OXWLQJ 6WHQW 9(6 combining a SS platform with a nanothin-microporous hydroxyapatite surface FRDWLQJLPSUHJQDWHGZLWKDSRO\PHUIUHHORZGRVHRI6LUROLPXV ȝJ $OO sirolimus is released within 3 months of the procedure. Methods: 15 pts with single de novo lesions in native coronary arteries with PPGLDPHWHUDQGPPLQOHQJWKZHUHHQUROOHGLQWKLV),0VWXG\ Primary endpoint was in-stent late lumen loss (LL) at 4 and 9 months. Results: Baseline characteristics included mean age of 63 years-old and 33% of diabetics. RVD and lesion length were 2.7 ± 0.3mm and 10 ± 2.0mm, respectively. Procedure success was obtained in all cases. Lifelong AAS and 6-month clopidogrel were prescribed to all pts. At 4 months, in-stent LL and RI1,+ZHUHPPDQGZLWKDQRQVLJQL¿FDQWLQFUHDVHDW 9 months (0.36 ± 0.23mm and 4.0 ± 2.2%). Serial IVUS did not show late ISA. The chart displays the variation of MLD and % of stenosis along the months. There was no MACE, including stent thrombosis in the 2 year FU period.
Late Positive Remodeling as a Mechanism of Late Lumen Gain in Bioresorbable Stents: Intravascular Ultrasound Study in a Normal Porcine Coronary Model Greg L. Kaluza1, Daryl G. Schulz2, Krzysztof P. Milewski1, Yanping Cheng1, Fred J. Clubb, Jr.3, Eric Schmid4, Robert K. Schultz4, Don Brandom4, Joan Zeltinger4 1 Cardiovascular Research Foundation, Orangeburg, NY;2The Methodist Hospital Research Institute, Houston, TX;3Texas A&M University, College Station, TX;4REVA Medical, Inc., San Diego, CA
Conclusion: The novel VES was effective in reducing LL and NIH at 4 and 9 months, with no evidence of late catch-up by QCA or IVUS. Studies in larger DQGPRUHFRPSOH[FRKRUWVRISDWLHQWVVKRXOGFRQ¿UPWKHVHLQLWLDOHQWKXVLDVWLF results.
Changes in lumen and stent areas over time in polymer vs metal stents Post5 days 30 days 90 days 180 days 365 days Implant Lumen Area: 8.42±1.05 7.74±1.02 3.65±1.70 5.92±1.34 7.05±1.34 8.28±2.09 Polymer (N=75) (N=9) (N=13) (N=24) (N=19) (N=10) Stent Lumen Area: 8.03±1.05 Express (N=33) Stent Outer Stent Area: 10.71±1.14 Polymer Stent Outer Stent Area: 9.89±1.27 Express Stent All data in mm2
7.51±0.85 5.84±1.30 (N=6) (N=7)
6.03±1.68 (N=7)
6.06±1.39 (N=9)
10.15±1.15 9.16±1.23
10.60±1.73 11.79±1.76 13.58±1.94
9.10±1.00 9.58±1.05
9.03±1.02
9.56±0.65
TCT-449 Intracoronary Paclitaxel Delivery with a Novel Mesh Catheter
6.28±1.08 (N=4)
Neal A. Scott, Scott Harris, Terry Burkoth, Nancy Powers, Jerome Segal Heart and Vascular Associates, Mountain View, CA Background: Drug eluting stents (DES) are associated with lower rates of restenosis and repeat revascularization when compared to bare metal stents. However, DES are costly and require prolonged dual anti-platelet therapy. Local delivery of paclitaxel with an angioplasty balloon has been shown WREHHI¿FDFLRXVIRUWKHWUHDWPHQWRIFRURQDU\LQVWHQWUHVWHQRVLV:HKDYH developed an improved method for intracoronary drug delivery that uses a catheter with a mechanically expanded wire mesh at its distal end. The mesh, ZKHQH[SDQGHGFDQGHOLYHURYHU$70RISUHVVXUH,QDGGLWLRQGLVWDOÀRZ and side-branch perfusion is preserved. The wires of the mesh were coated with a polymer containing highly concentrated paclitaxel.
9.22±1.29
Conclusion: In a normal porcine coronary model up to 365 days, the REVA bioabsorbable (tyrosine polycarbonate) polymer stent
The American Journal of Cardiology®
|
September 21-25, 2009
|
TCT Abstracts/POSTER
165D
P O S T E R A B S T R AC T S
Background: Bioabsorbable stents have shown preliminary evidence of feasibility and safety in clinical trials. However, the biological response to bioabsorbable stents is extremely complex; it involves traditional aspects such as mechanical injury and subsequent neointimal formation, but also the unique aspect of degradation of the entire device. These processes are highly individualized by the stent design, material and drug elution, and still require detailed characterization. Methods: REVA Medical tyrosine-derived polycarbonate polymer stents of DVOLGHDQGORFNGHVLJQZHUHLPSODQWHGLQDQG([SUHVVEDUHPHWDOVWHQWVLQ 33 porcine coronary arteries and analyzed by IVUS out to 1 year. Results: Both stents experience lumen loss due to neointimal proliferation at 30 days, but the bioabsorbable stent lumen recovers over time toward the baseline dimensions. This occurs via outward remodeling of the stented segment as the stent degrades, without angiographic or IVUS evidence of ectasia. In addition, the histopathology shows no signs of arterial wall thinning. Conversely, the lumen and stent areas of the metal stent remain relatively constant over time as expected (Table). Reference vessel dimensions remained unchanged; as such vessel growth did not appear to contribute to this remodeling.
http://www.aievolution.com/tct0901/
TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM
Methods: Catheter-based paclitaxel delivery was performed in 20 anesthetized pigs. Each delivery period was 10 minutes. There was no evidence of ischemia noted in any of the studies. Arterial levels of paclitaxel were measured at 1, 24, 48 and 72 hours after delivery in coronary, internal mammary and femoral artery segments. Another study was performed to determine if the same catheter could be used for two consecutive deliveries. In a separate safety study, paclitaxel was delivered to 23 coronaries in 8 pigs. In these animals, the coronaries were excised and underwent pathological H[DPLQDWLRQDIWHUZHHNV Results: Paclitaxel levels were highest one hour after delivery (total amount delivered: 1.4 ± 0.2 ug) and progressively decreased over time. Paclitaxel was detectable in the artery 72 hours after delivery. There was no difference in paclitaxel levels between the different arterial beds. When a catheter was used at two sites during the same procedure, 84 ± 2% of the amount initially delivered was present at the second site. The chronic safety study GHPRQVWUDWHG WKDW WKHUH ZDV QR HYLGHQFH RI VLJQL¿FDQW YDVFXODU SDWKRORJ\ associated with local delivery of paclitaxel. Conclusions: Intracoronary paclitaxel delivery can be easily and safely performed with a mechanically expandable mesh catheter. Since paclitaxel levels persist in the artery for several days, this technique may be useful when FRPELQHGZLWKEDUHPHWDOVWHQWSODFHPHQWDQGFRXOGUHVXOWLQVLJQL¿FDQWFRVW savings. TCT-450 Novel Sirolimus-Eluting Stent Coated with Bioabsorbable Salicylate-Based Polymer: Assesment of Imtramural Thrombus at 1 Month and 3 Month evaluated with Histology and Angioscopy in Pig Coronary model
P O S T E R A B S T R AC T S
Daisuke Matsumoto, Toshiro Shinke, Sarah Geva, Nicolas Chronos, Keith Robinson, Refat Jabara Saint Joseph’s Translational Research Institute, Norcross, GA Background &KURQLFLQÀDPPDWLRQDQGK\SHUVHQVLWLYLW\UHDFWLRQVLQGXFHG by permanent polymers used in current drug-eluting stent (DES) may contribute to late thrombosis and/or rebound restenosis.. We evaluated novel sirolimus-eluting stent coated with novel bioabsorbable salicylatebased polymer using histology and angioscopy at 1 month and 3 month after implantation. Methods: Bare metal stents (BMS, n=28), salicylic acid/adipic acid bioabsorbable polymer-only coated metal stents (SA/AA, n=29), durable polymeric sirolimus-eluting stents (Cypher®, n=26) and SA/AA containing sirolimus (SA/AA+S, n=32) were randomly implanted in pig coronary arteries using QCA to optimize stent apposition. Intramural thrombus was assessed E\KLVWRORJ\ K,7 $QGLQWUDPXUDOWKURPEXVDQGLQWLPDOWKLFNQHVVZDVDOVR assessed by angioscopy (aMT and aIT). Results: At 1 month, hMT and aMT in Cypher and SA/AA+S were VLJQL¿FDQWO\ KLJKHU WKDQ %06 DQG 6$$$ 3 )URP PRQWK WR month, aIT were increased and aMT were decreased in Cypher and SA/AA+S. While hMT in SA/AA+S were decreased at 3 month, hMT were still observed LQ&\SKHUZKLFKZDVVLJQL¿FDQWO\KLJKHUWKDQWKHRWKHUJURXSV 3
Conclusions: In Cypher, histological intramural thrombus was still observed at 3 months post implant .While, intramural thrombus in the sirolimus-eluting stent coated with novel bioabsorbable salicylate-based polymer was decreased up to the similar level with BMS at 3 month. TCT-451 In Vivo Validation of a Robotic System for Intracardiac Catheter Manipulation and Positioning Asim N Cheema1, Yusof Ganji2)DUURNK-DQDEL6KDUL¿3 1 St. Michael’s Hospital, Toronto, ON, Canada2University of Waterloo, Waterloo, ON, Canada3Ryerson University, Toronto, ON, Canada Background: Magnetic and steerable catheter manipulation systems have been developed to assist with catheter positioning. However, these systems rely on physician experience and dexterity for accurate results. In this study, we performed validation of a novel robotic catheter for precise intra cardiac SRVLWLRQLQJXVLQJUHPRWHFRQWUROMR\VWLFNLQDSRUFLQHPRGHO Methods: The automatic navigation platform (ANP) composed of a robotic V\VWHP DQG FXVWRP VRIWZDUH &DWK1DY IRU MR\VWLFN JXLGHG PDQLSXODWLRQ of a catheter using computer interface. Two Aurora sensors (catheter) were attached near the tip of 7F steerable ablation catheter and a third sensor UHI VHQVRU ZDV SRVLWLRQHG DW GHVLUHG ODQGPDUNV LQ WKH 5$ DV D WDUJHW RI navigation experiments. ANP utilized Aurora electromagnetic system to WUDFN FDWKHWHU PRYHPHQW LQ WKH SRUFLQH KHDUW $W DQ\ LQVWDQW WKH GLVWDQFH between the catheter tip and the ref sensor was reported by CathNav to assist WKHMR\VWLFNRSHUDWRUIRUFDWKHWHUSRVLWLRQLQJ7KHUHIVHQVRUZDVSRVLWLRQHGDW WKUHHODQGPDUNV ORZ5$KLJK5$DQGWULFXVSLGDQQXOXV LQWKUHHDQLPDOV 7KH FDWKHWHU ZDV SRVLWLRQHG ¿UVW XVLQJ ÀXRURVFRS\ DQG WKHQ ZLWK MR\VWLFN FRQWUROZLWKRXWÀXRURVFRS\E\DQH[SHULHQFHGSK\VLFLDQ7KHLQLWLDODQG¿QDO distance between the catheter tip and the reference sensor were recorded along ZLWKWKHGXUDWLRQRIWKHQDYLJDWLRQWDVN)RUHDFKODQGPDUNWKHQDYLJDWLRQ PDQHXYHUZDVUHSHDWHG¿YHWLPHV Results: The results of navigation performance are reported in the table. Landmark
ID
FD - M
FD - R
Duration - M
Duration - R
High RA
37±3
5±2
2±1
46±15
52±20
Low RA
31±3
7±3
1±0
46±18
50±10
TVA
34±2
9±1
1±1
37±17
42±15
5$ULJKWDWULXP79$WULFXVSLGYDOYHDQQXOXV,'LQLWLDOGLVWDQFH)'¿QDO distance, M-manual, R-robotic navigation using ANP. Distance in mm and duration in seconds.
Conclusion:$MR\VWLFNHQDEOHGURERWLFFDWKHWHUSRVLWLRQLQJXVLQJ$13LV feasible and achieves comparable results to manual catheter manipulation by an experienced physician. These experiments prove the feasibility of a remotely guided robotic manipulation of intra cardiac catheters. TCT-452 Patients with Diabetes Mellitus in the World-Wide e-HEALING Registry have Low Target Lesion Revascularization Rate at 12-months Follow up Robbert J De winter1, Sigmund Silber2, manfred Grisold3, Jaroslaw Wójcik4, Harry Suryapranata5, Expedito Ribeiro6, Kui Hian SIM7 1 Academic Medical Center, Amsterdam, Netherlands2Kardiologische Praxis und Praxisklinik, Munich, Germany3Medizinische Universitatsklinik, Graz, Austria4University Hospital No 4, Lublin, Poland5Isala Klinieken, Zwolle, Netherlands6Instituto do Coracao, Sao Paulo, Brazil7Sarawak General Hospital, Sarawak, Malaysia Background: Drug-eluting stents have reduced the incidence of clinical and angiographic in-stent-restenosis after percutaneous coronary intervention (PCI), particularly in patients with diabetes. However, the inhibition of intimal
166D
The American Journal of Cardiology® |
September 21-25, 2009
|
TCT Abstracts/POSTER
TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM
progressively degrades allowing for positive remodeling of the stented arterial segment. This leads to late lumen gain and restoration of the lumen size to nearly its post-implantation dimensions. It is thought that the polymer stents allow for regaining of elasticity of the arterial wall and that the intracoronary pressure remodels the vessel resulting in regained compliance. This hypothesis will be the subject of future studies.
data are separated in 10 groups according to their associated cardiac phase, and used for reconstruction of intermediate 3D images. The intermediate 3D images are registered to the reference 3D image and accumulated yielding a tomographic 3D image. Results: MC-3DR was performed in 20 patients: LCA: 14, RCA: 6, heart rate: 75±14 BPM. MC-3DR was feasible in 17 patients with a good imaging of the ZKROHFRURQDU\WUHH,QSDWLHQWV0&'5IDLOHG LQSDWLHQWVGXHWRWKHODFN RIDVXI¿FLHQW¿OOLQJRIWKHFRQWUDVWPHGLXPRYHUVHFRQGVLQRQHFDVHGXHWR the more complex motion of the RCA during heart beat. Conclusion: These data suggest, that motion corrected C-arm-CT reconstruction of coronary arteries is feasible. Due to the compensation of motion artefacts this method can support the physician during interventional procedures.
TCT-448 Two-year Results of the Vestasync I trial with a novel, thirdgeneration, hydroxyapatite polymer-free sirolimus-eluting stent José de Ribamar Costa, Jr., Alexandre Abizaid, Fausto Feres, Ricardo Costa, Dimytri Siqueira, Rodolfo Staico, Galo Maldonado, Luiz Fernado Tanajura, Amanda Sousa, J Eduardo Sousa Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
TCT-447
Background:'XUDEOHSRO\PHUVLQVWJHQHUDWLRQ'(6KDYHEHHQOLQNHGWR ORFDO LQÀDPPDWRU\ UHDFWLRQV 6WHQW WKURPERVLV 67 VHFRQGDU\ WR SRVLWLYH vessel remodeling and late-acquired incomplete stent apposition (ISA) is a possible clinical translation of this local adverse effect. We sought to assess WKH VDIHW\ DQG HI¿FDF\ RI WKH QRYHO 9(67$V\QF (OXWLQJ 6WHQW 9(6 combining a SS platform with a nanothin-microporous hydroxyapatite surface FRDWLQJLPSUHJQDWHGZLWKDSRO\PHUIUHHORZGRVHRI6LUROLPXV ȝJ $OO sirolimus is released within 3 months of the procedure. Methods: 15 pts with single de novo lesions in native coronary arteries with PPGLDPHWHUDQGPPLQOHQJWKZHUHHQUROOHGLQWKLV),0VWXG\ Primary endpoint was in-stent late lumen loss (LL) at 4 and 9 months. Results: Baseline characteristics included mean age of 63 years-old and 33% of diabetics. RVD and lesion length were 2.7 ± 0.3mm and 10 ± 2.0mm, respectively. Procedure success was obtained in all cases. Lifelong AAS and 6-month clopidogrel were prescribed to all pts. At 4 months, in-stent LL and RI1,+ZHUHPPDQGZLWKDQRQVLJQL¿FDQWLQFUHDVHDW 9 months (0.36 ± 0.23mm and 4.0 ± 2.2%). Serial IVUS did not show late ISA. The chart displays the variation of MLD and % of stenosis along the months. There was no MACE, including stent thrombosis in the 2 year FU period.
Late Positive Remodeling as a Mechanism of Late Lumen Gain in Bioresorbable Stents: Intravascular Ultrasound Study in a Normal Porcine Coronary Model Greg L. Kaluza1, Daryl G. Schulz2, Krzysztof P. Milewski1, Yanping Cheng1, Fred J. Clubb, Jr.3, Eric Schmid4, Robert K. Schultz4, Don Brandom4, Joan Zeltinger4 1 Cardiovascular Research Foundation, Orangeburg, NY;2The Methodist Hospital Research Institute, Houston, TX;3Texas A&M University, College Station, TX;4REVA Medical, Inc., San Diego, CA
Conclusion: The novel VES was effective in reducing LL and NIH at 4 and 9 months, with no evidence of late catch-up by QCA or IVUS. Studies in larger DQGPRUHFRPSOH[FRKRUWVRISDWLHQWVVKRXOGFRQ¿UPWKHVHLQLWLDOHQWKXVLDVWLF results.
Changes in lumen and stent areas over time in polymer vs metal stents Post5 days 30 days 90 days 180 days 365 days Implant Lumen Area: 8.42±1.05 7.74±1.02 3.65±1.70 5.92±1.34 7.05±1.34 8.28±2.09 Polymer (N=75) (N=9) (N=13) (N=24) (N=19) (N=10) Stent Lumen Area: 8.03±1.05 Express (N=33) Stent Outer Stent Area: 10.71±1.14 Polymer Stent Outer Stent Area: 9.89±1.27 Express Stent All data in mm2
7.51±0.85 5.84±1.30 (N=6) (N=7)
6.03±1.68 (N=7)
6.06±1.39 (N=9)
10.15±1.15 9.16±1.23
10.60±1.73 11.79±1.76 13.58±1.94
9.10±1.00 9.58±1.05
9.03±1.02
9.56±0.65
TCT-449 Intracoronary Paclitaxel Delivery with a Novel Mesh Catheter
6.28±1.08 (N=4)
Neal A. Scott, Scott Harris, Terry Burkoth, Nancy Powers, Jerome Segal Heart and Vascular Associates, Mountain View, CA Background: Drug eluting stents (DES) are associated with lower rates of restenosis and repeat revascularization when compared to bare metal stents. However, DES are costly and require prolonged dual anti-platelet therapy. Local delivery of paclitaxel with an angioplasty balloon has been shown WREHHI¿FDFLRXVIRUWKHWUHDWPHQWRIFRURQDU\LQVWHQWUHVWHQRVLV:HKDYH developed an improved method for intracoronary drug delivery that uses a catheter with a mechanically expanded wire mesh at its distal end. The mesh, ZKHQH[SDQGHGFDQGHOLYHURYHU$70RISUHVVXUH,QDGGLWLRQGLVWDOÀRZ and side-branch perfusion is preserved. The wires of the mesh were coated with a polymer containing highly concentrated paclitaxel.
9.22±1.29
Conclusion: In a normal porcine coronary model up to 365 days, the REVA bioabsorbable (tyrosine polycarbonate) polymer stent
The American Journal of Cardiology®
|
September 21-25, 2009
|
TCT Abstracts/POSTER
165D
P O S T E R A B S T R AC T S
Background: Bioabsorbable stents have shown preliminary evidence of feasibility and safety in clinical trials. However, the biological response to bioabsorbable stents is extremely complex; it involves traditional aspects such as mechanical injury and subsequent neointimal formation, but also the unique aspect of degradation of the entire device. These processes are highly individualized by the stent design, material and drug elution, and still require detailed characterization. Methods: REVA Medical tyrosine-derived polycarbonate polymer stents of DVOLGHDQGORFNGHVLJQZHUHLPSODQWHGLQDQG([SUHVVEDUHPHWDOVWHQWVLQ 33 porcine coronary arteries and analyzed by IVUS out to 1 year. Results: Both stents experience lumen loss due to neointimal proliferation at 30 days, but the bioabsorbable stent lumen recovers over time toward the baseline dimensions. This occurs via outward remodeling of the stented segment as the stent degrades, without angiographic or IVUS evidence of ectasia. In addition, the histopathology shows no signs of arterial wall thinning. Conversely, the lumen and stent areas of the metal stent remain relatively constant over time as expected (Table). Reference vessel dimensions remained unchanged; as such vessel growth did not appear to contribute to this remodeling.
http://www.aievolution.com/tct0901/
TUESDAY, SEPTEMBER 22, 2009, 8:00AM - 10:00AM
Methods: Catheter-based paclitaxel delivery was performed in 20 anesthetized pigs. Each delivery period was 10 minutes. There was no evidence of ischemia noted in any of the studies. Arterial levels of paclitaxel were measured at 1, 24, 48 and 72 hours after delivery in coronary, internal mammary and femoral artery segments. Another study was performed to determine if the same catheter could be used for two consecutive deliveries. In a separate safety study, paclitaxel was delivered to 23 coronaries in 8 pigs. In these animals, the coronaries were excised and underwent pathological H[DPLQDWLRQDIWHUZHHNV Results: Paclitaxel levels were highest one hour after delivery (total amount delivered: 1.4 ± 0.2 ug) and progressively decreased over time. Paclitaxel was detectable in the artery 72 hours after delivery. There was no difference in paclitaxel levels between the different arterial beds. When a catheter was used at two sites during the same procedure, 84 ± 2% of the amount initially delivered was present at the second site. The chronic safety study GHPRQVWUDWHG WKDW WKHUH ZDV QR HYLGHQFH RI VLJQL¿FDQW YDVFXODU SDWKRORJ\ associated with local delivery of paclitaxel. Conclusions: Intracoronary paclitaxel delivery can be easily and safely performed with a mechanically expandable mesh catheter. Since paclitaxel levels persist in the artery for several days, this technique may be useful when FRPELQHGZLWKEDUHPHWDOVWHQWSODFHPHQWDQGFRXOGUHVXOWLQVLJQL¿FDQWFRVW savings. TCT-450 Novel Sirolimus-Eluting Stent Coated with Bioabsorbable Salicylate-Based Polymer: Assesment of Imtramural Thrombus at 1 Month and 3 Month evaluated with Histology and Angioscopy in Pig Coronary model
P O S T E R A B S T R AC T S
Daisuke Matsumoto, Toshiro Shinke, Sarah Geva, Nicolas Chronos, Keith Robinson, Refat Jabara Saint Joseph’s Translational Research Institute, Norcross, GA Background &KURQLFLQÀDPPDWLRQDQGK\SHUVHQVLWLYLW\UHDFWLRQVLQGXFHG by permanent polymers used in current drug-eluting stent (DES) may contribute to late thrombosis and/or rebound restenosis.. We evaluated novel sirolimus-eluting stent coated with novel bioabsorbable salicylatebased polymer using histology and angioscopy at 1 month and 3 month after implantation. Methods: Bare metal stents (BMS, n=28), salicylic acid/adipic acid bioabsorbable polymer-only coated metal stents (SA/AA, n=29), durable polymeric sirolimus-eluting stents (Cypher®, n=26) and SA/AA containing sirolimus (SA/AA+S, n=32) were randomly implanted in pig coronary arteries using QCA to optimize stent apposition. Intramural thrombus was assessed E\KLVWRORJ\ K,7 $QGLQWUDPXUDOWKURPEXVDQGLQWLPDOWKLFNQHVVZDVDOVR assessed by angioscopy (aMT and aIT). Results: At 1 month, hMT and aMT in Cypher and SA/AA+S were VLJQL¿FDQWO\ KLJKHU WKDQ %06 DQG 6$$$ 3 )URP PRQWK WR month, aIT were increased and aMT were decreased in Cypher and SA/AA+S. While hMT in SA/AA+S were decreased at 3 month, hMT were still observed LQ&\SKHUZKLFKZDVVLJQL¿FDQWO\KLJKHUWKDQWKHRWKHUJURXSV 3
Conclusions: In Cypher, histological intramural thrombus was still observed at 3 months post implant .While, intramural thrombus in the sirolimus-eluting stent coated with novel bioabsorbable salicylate-based polymer was decreased up to the similar level with BMS at 3 month. TCT-451 In Vivo Validation of a Robotic System for Intracardiac Catheter Manipulation and Positioning Asim N Cheema1, Yusof Ganji2)DUURNK-DQDEL6KDUL¿3 1 St. Michael’s Hospital, Toronto, ON, Canada2University of Waterloo, Waterloo, ON, Canada3Ryerson University, Toronto, ON, Canada Background: Magnetic and steerable catheter manipulation systems have been developed to assist with catheter positioning. However, these systems rely on physician experience and dexterity for accurate results. In this study, we performed validation of a novel robotic catheter for precise intra cardiac SRVLWLRQLQJXVLQJUHPRWHFRQWUROMR\VWLFNLQDSRUFLQHPRGHO Methods: The automatic navigation platform (ANP) composed of a robotic V\VWHP DQG FXVWRP VRIWZDUH &DWK1DY IRU MR\VWLFN JXLGHG PDQLSXODWLRQ of a catheter using computer interface. Two Aurora sensors (catheter) were attached near the tip of 7F steerable ablation catheter and a third sensor UHI VHQVRU ZDV SRVLWLRQHG DW GHVLUHG ODQGPDUNV LQ WKH 5$ DV D WDUJHW RI navigation experiments. ANP utilized Aurora electromagnetic system to WUDFN FDWKHWHU PRYHPHQW LQ WKH SRUFLQH KHDUW $W DQ\ LQVWDQW WKH GLVWDQFH between the catheter tip and the ref sensor was reported by CathNav to assist WKHMR\VWLFNRSHUDWRUIRUFDWKHWHUSRVLWLRQLQJ7KHUHIVHQVRUZDVSRVLWLRQHGDW WKUHHODQGPDUNV ORZ5$KLJK5$DQGWULFXVSLGDQQXOXV LQWKUHHDQLPDOV 7KH FDWKHWHU ZDV SRVLWLRQHG ¿UVW XVLQJ ÀXRURVFRS\ DQG WKHQ ZLWK MR\VWLFN FRQWUROZLWKRXWÀXRURVFRS\E\DQH[SHULHQFHGSK\VLFLDQ7KHLQLWLDODQG¿QDO distance between the catheter tip and the reference sensor were recorded along ZLWKWKHGXUDWLRQRIWKHQDYLJDWLRQWDVN)RUHDFKODQGPDUNWKHQDYLJDWLRQ PDQHXYHUZDVUHSHDWHG¿YHWLPHV Results: The results of navigation performance are reported in the table. Landmark
ID
FD - M
FD - R
Duration - M
Duration - R
High RA
37±3
5±2
2±1
46±15
52±20
Low RA
31±3
7±3
1±0
46±18
50±10
TVA
34±2
9±1
1±1
37±17
42±15
5$ULJKWDWULXP79$WULFXVSLGYDOYHDQQXOXV,'LQLWLDOGLVWDQFH)'¿QDO distance, M-manual, R-robotic navigation using ANP. Distance in mm and duration in seconds.
Conclusion:$MR\VWLFNHQDEOHGURERWLFFDWKHWHUSRVLWLRQLQJXVLQJ$13LV feasible and achieves comparable results to manual catheter manipulation by an experienced physician. These experiments prove the feasibility of a remotely guided robotic manipulation of intra cardiac catheters. TCT-452 Patients with Diabetes Mellitus in the World-Wide e-HEALING Registry have Low Target Lesion Revascularization Rate at 12-months Follow up Robbert J De winter1, Sigmund Silber2, manfred Grisold3, Jaroslaw Wójcik4, Harry Suryapranata5, Expedito Ribeiro6, Kui Hian SIM7 1 Academic Medical Center, Amsterdam, Netherlands2Kardiologische Praxis und Praxisklinik, Munich, Germany3Medizinische Universitatsklinik, Graz, Austria4University Hospital No 4, Lublin, Poland5Isala Klinieken, Zwolle, Netherlands6Instituto do Coracao, Sao Paulo, Brazil7Sarawak General Hospital, Sarawak, Malaysia Background: Drug-eluting stents have reduced the incidence of clinical and angiographic in-stent-restenosis after percutaneous coronary intervention (PCI), particularly in patients with diabetes. However, the inhibition of intimal
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The American Journal of Cardiology® |
September 21-25, 2009
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TCT Abstracts/POSTER