Preclinical safety testing of percutaneous transatrial access to the normal pericardial space for local cardiac drug delivery and diagnostic sampling
The safety of a percutaneous method and streamlined catheter system to access the normal pericardial space via the right atrial appendage for drug delivery and diagnostic sampling was demonstrated in 20 anesthetized pigs. Access was successfully accomplished in all animals within 3 min of guide cath...
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Published in | Catheterization and cardiovascular interventions Vol. 49; no. 4; pp. 472 - 477 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
New York
John Wiley & Sons, Inc
01.04.2000
Wiley-Liss |
Subjects | |
Online Access | Get full text |
ISSN | 1522-1946 1522-726X |
DOI | 10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y |
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Abstract | The safety of a percutaneous method and streamlined catheter system to access the normal pericardial space via the right atrial appendage for drug delivery and diagnostic sampling was demonstrated in 20 anesthetized pigs. Access was successfully accomplished in all animals within 3 min of guide catheter positioning and was documented by fluoroscopic imaging and pericardial fluid sampling. The animals were sacrificed at 24 hr (n = 10) and 2 weeks (n = 10) for histopathologic analysis. Mean pericardial hematocrit was 1.1% ± 0.3% at initial sampling, 4.3% ± 1.4% at 24 hr (P = 0.005 vs. baseline), and 0.4% ± 0.2% at 2 weeks (P = 0.13 vs. baseline). At 24 hr, there was local inflammatory reaction in the atrial wall and a small thrombus at the site of puncture. At 2 weeks, no significant inflammatory changes or pericarditis were evident. The technique is well tolerated with no apparent adverse complications. Advances in intrapericardial therapeutics and diagnostics will direct the clinical application of this novel approach in human subjects. Cathet. Cardiovasc. Intervent. 49:472–477, 2000. © 2000 Wiley‐Liss, Inc. |
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AbstractList | The safety of a percutaneous method and streamlined catheter system to access the normal pericardial space via the right atrial appendage for drug delivery and diagnostic sampling was demonstrated in 20 anesthetized pigs. Access was successfully accomplished in all animals within 3 min of guide catheter positioning and was documented by fluoroscopic imaging and pericardial fluid sampling. The animals were sacrificed at 24 hr (n = 10) and 2 weeks (n = 10) for histopathologic analysis. Mean pericardial hematocrit was 1.1% ± 0.3% at initial sampling, 4.3% ± 1.4% at 24 hr (P = 0.005 vs. baseline), and 0.4% ± 0.2% at 2 weeks (P = 0.13 vs. baseline). At 24 hr, there was local inflammatory reaction in the atrial wall and a small thrombus at the site of puncture. At 2 weeks, no significant inflammatory changes or pericarditis were evident. The technique is well tolerated with no apparent adverse complications. Advances in intrapericardial therapeutics and diagnostics will direct the clinical application of this novel approach in human subjects. Cathet. Cardiovasc. Intervent. 49:472–477, 2000. © 2000 Wiley‐Liss, Inc. The safety of a percutaneous method and streamlined catheter system to access the normal pericardial space via the right atrial appendage for drug delivery and diagnostic sampling was demonstrated in 20 anesthetized pigs. Access was successfully accomplished in all animals within 3 min of guide catheter positioning and was documented by fluoroscopic imaging and pericardial fluid sampling. The animals were sacrificed at 24 hr (n = 10) and 2 weeks (n = 10) for histopathologic analysis. Mean pericardial hematocrit was 1.1% +/- 0.3% at initial sampling, 4.3% +/- 1.4% at 24 hr (P = 0.005 vs. baseline), and 0.4% +/- 0.2% at 2 weeks (P = 0.13 vs. baseline). At 24 hr, there was local inflammatory reaction in the atrial wall and a small thrombus at the site of puncture. At 2 weeks, no significant inflammatory changes or pericarditis were evident. The technique is well tolerated with no apparent adverse complications. Advances in intrapericardial therapeutics and diagnostics will direct the clinical application of this novel approach in human subjects.The safety of a percutaneous method and streamlined catheter system to access the normal pericardial space via the right atrial appendage for drug delivery and diagnostic sampling was demonstrated in 20 anesthetized pigs. Access was successfully accomplished in all animals within 3 min of guide catheter positioning and was documented by fluoroscopic imaging and pericardial fluid sampling. The animals were sacrificed at 24 hr (n = 10) and 2 weeks (n = 10) for histopathologic analysis. Mean pericardial hematocrit was 1.1% +/- 0.3% at initial sampling, 4.3% +/- 1.4% at 24 hr (P = 0.005 vs. baseline), and 0.4% +/- 0.2% at 2 weeks (P = 0.13 vs. baseline). At 24 hr, there was local inflammatory reaction in the atrial wall and a small thrombus at the site of puncture. At 2 weeks, no significant inflammatory changes or pericarditis were evident. The technique is well tolerated with no apparent adverse complications. Advances in intrapericardial therapeutics and diagnostics will direct the clinical application of this novel approach in human subjects. The safety of a percutaneous method and streamlined catheter system to access the normal pericardial space via the right atrial appendage for drug delivery and diagnostic sampling was demonstrated in 20 anesthetized pigs. Access was successfully accomplished in all animals within 3 min of guide catheter positioning and was documented by fluoroscopic imaging and pericardial fluid sampling. The animals were sacrificed at 24 hr (n = 10) and 2 weeks (n = 10) for histopathologic analysis. Mean pericardial hematocrit was 1.1% +/- 0.3% at initial sampling, 4.3% +/- 1.4% at 24 hr (P = 0.005 vs. baseline), and 0.4% +/- 0.2% at 2 weeks (P = 0.13 vs. baseline). At 24 hr, there was local inflammatory reaction in the atrial wall and a small thrombus at the site of puncture. At 2 weeks, no significant inflammatory changes or pericarditis were evident. The technique is well tolerated with no apparent adverse complications. Advances in intrapericardial therapeutics and diagnostics will direct the clinical application of this novel approach in human subjects. |
Author | Pulerwitz, Todd C. Verrier, Richard L. Waxman, Sergio Quist, William C. Rowe, Katharine A. |
Author_xml | – sequence: 1 givenname: Sergio surname: Waxman fullname: Waxman, Sergio organization: Institute for Prevention of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts – sequence: 2 givenname: Todd C. surname: Pulerwitz fullname: Pulerwitz, Todd C. organization: Harvard Medical School, Boston, Massachusetts – sequence: 3 givenname: Katharine A. surname: Rowe fullname: Rowe, Katharine A. organization: Institute for Prevention of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts – sequence: 4 givenname: William C. surname: Quist fullname: Quist, William C. organization: Institute for Prevention of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts – sequence: 5 givenname: Richard L. surname: Verrier fullname: Verrier, Richard L. email: rverrier@caregroup.harvard.edu organization: Institute for Prevention of Cardiovascular Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts |
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Cites_doi | 10.1161/01.CIR.98.21.2331 10.1002/clc.4960221308 10.1016/0002-8703(95)90113-2 10.1016/0002-8703(95)90140-X 10.1002/clc.4960221306 10.1016/S0735-1097(99)00131-X 10.1002/clc.4960221309 10.1111/j.1540-8167.1998.tb00907.x 10.1002/clc.4960221310 |
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Keywords | Space Exploration Pig Pericardium Percutaneous route Vertebrata Mammalia Animal Surgical approach Artiodactyla Technique Right atrium Ungulata |
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References | Landau C, Jacobs AK, Haudenschild CC. Intrapericardial basic fibroblast growth factor induces myocardial angiogenesis in a rabbit model of chronic ischemia. Am Heart J 1995; 129: 924-931. Spodick DH. The Pericardium: A Comprehensive Textbook. New York: Marcel Dekker; 1997. p 126-132. Waxman S, Moreno R, Rowe K, Verrier RL. Persistent primary coronary dilation induced by transatrial delivery of nitroglycerin into the pericardial space: a novel approach for local cardiac drug delivery. J Am Coll Cardiol 1999; 33: 2073-2077. Macris MP, Igo SR. Minimally invasive access of the normal pericardium: initial clinical experience with a novel device. Clin Cardiol 1999;22(Suppl I): I36-I39. March KL, Woody M, Mehdi K, Zipes DP, Brantly M, Trapnell BC. Efficient in vivo catheter-based pericardial gene transfer mediated by adenoviral vectors. Clin Cardiol 1999;22(Suppl I): I23-I29. Laham RJ, Rezaee M, Post M, Novicki D, Sellke FW, Pearlman JD, Simons M, Hung D. Intrapericardial delivery of fibroblast growth factor-2 induces neovascularization in a porcine model of chronic myocardial ischemia. J Pharmacol Exp Ther 2000; 292: 795-802. Spodick DH, editor. Intrapericardial therapeutics and diagnostics: potential advantages, recent advances, experimental direct therapy of cardiac diseases and arrhythmias. Clin Cardiol 1999;22(Suppl I). Uchida Y, Yanagisawa-Miwa A, Nakamura F, Yamada K, Tomaru T, Kimura K, Morita T. Angiogenic therapy of acute myocardial infarction by intrapericardial injection of basic fibroblast growth factor and heparin sulfate: an experimental study. Am Heart J 1995; 130: 1182-1188. Sosa E, Scanavacca M, d'Avila A, Piccioni J, Sanchez O, Velarde JL, Silva M, Reolao B. Endocardial and epicardial ablation guided by nonsurgical transthoracic epicardial mapping to treat recurrent ventricular tachycardia. J Cardiovasc Electrophysiol 1998; 9: 229-239. Verrier RL, Waxman S, Lovett EG, Moreno R. Transatrial access to the normal pericardial space: a novel approach for diagnostic sampling, pericardiocentesis, and therapeutic interventions. Circulation 1998; 98: 2331-2333. Seferovic PM, Ristic AD, Maksimovic R, Petrovic P, Ostojic M, Simeunovic S, Zamaklar D, Simeunovic D, Spodick DH. Initial clinical experience with PerDucer device: promising new tool in the diagnosis and treatment of pericardial disease. Clin Cardiol 1999;22(Suppl I): I30-I35. Stoll HP, Carlson K, Keefer LK, Hrabie JA, March KL. Pharmacokinetics and consistency of pericardial delivery directed to coronary arteries: direct comparison with endoluminal delivery. Clin Cardiol 1999;22(Suppl I): I10-I16. Pulerwitz T, Waxman S, Rowe KA, Quist WC, Lipinska I, Verrier RL. Preclinical safety of transatrial access to the normal pericardial space for local cardiac drug delivery during aspirin use and pulmonary hypertension (abstract). J Am Coll Cardiol 2000; 35: 79A. 2000; 292 1997 1995; 129 1999; 22 1999; 33 1998; 98 1995; 130 2000; 35 1998; 9 Sosa (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB6) 1998; 9 Verrier (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB3) 1998; 98 March (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB5) 1999; 22 Uchida (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB11) 1995; 130 Landau (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB10) 1995; 129 Spodick (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB1) 1999; 22 Seferovic (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB7) 1999; 22 Laham (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB12) 2000; 292 Waxman (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB4) 1999; 33 Stoll (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB9) 1999; 22 Spodick (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB2) 1997 Macris (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB8) 1999; 22 Pulerwitz (10.1002/(SICI)1522-726X(200004)49:4<472::AID-CCD28>3.0.CO;2-Y-BIB13) 2000; 35 |
References_xml | – reference: Sosa E, Scanavacca M, d'Avila A, Piccioni J, Sanchez O, Velarde JL, Silva M, Reolao B. Endocardial and epicardial ablation guided by nonsurgical transthoracic epicardial mapping to treat recurrent ventricular tachycardia. J Cardiovasc Electrophysiol 1998; 9: 229-239. – reference: Spodick DH, editor. Intrapericardial therapeutics and diagnostics: potential advantages, recent advances, experimental direct therapy of cardiac diseases and arrhythmias. Clin Cardiol 1999;22(Suppl I). – reference: Waxman S, Moreno R, Rowe K, Verrier RL. Persistent primary coronary dilation induced by transatrial delivery of nitroglycerin into the pericardial space: a novel approach for local cardiac drug delivery. J Am Coll Cardiol 1999; 33: 2073-2077. – reference: March KL, Woody M, Mehdi K, Zipes DP, Brantly M, Trapnell BC. Efficient in vivo catheter-based pericardial gene transfer mediated by adenoviral vectors. Clin Cardiol 1999;22(Suppl I): I23-I29. – reference: Pulerwitz T, Waxman S, Rowe KA, Quist WC, Lipinska I, Verrier RL. Preclinical safety of transatrial access to the normal pericardial space for local cardiac drug delivery during aspirin use and pulmonary hypertension (abstract). J Am Coll Cardiol 2000; 35: 79A. – reference: Stoll HP, Carlson K, Keefer LK, Hrabie JA, March KL. Pharmacokinetics and consistency of pericardial delivery directed to coronary arteries: direct comparison with endoluminal delivery. Clin Cardiol 1999;22(Suppl I): I10-I16. – reference: Uchida Y, Yanagisawa-Miwa A, Nakamura F, Yamada K, Tomaru T, Kimura K, Morita T. Angiogenic therapy of acute myocardial infarction by intrapericardial injection of basic fibroblast growth factor and heparin sulfate: an experimental study. Am Heart J 1995; 130: 1182-1188. – reference: Spodick DH. The Pericardium: A Comprehensive Textbook. New York: Marcel Dekker; 1997. p 126-132. – reference: Laham RJ, Rezaee M, Post M, Novicki D, Sellke FW, Pearlman JD, Simons M, Hung D. Intrapericardial delivery of fibroblast growth factor-2 induces neovascularization in a porcine model of chronic myocardial ischemia. J Pharmacol Exp Ther 2000; 292: 795-802. – reference: Macris MP, Igo SR. Minimally invasive access of the normal pericardium: initial clinical experience with a novel device. Clin Cardiol 1999;22(Suppl I): I36-I39. – reference: Seferovic PM, Ristic AD, Maksimovic R, Petrovic P, Ostojic M, Simeunovic S, Zamaklar D, Simeunovic D, Spodick DH. Initial clinical experience with PerDucer device: promising new tool in the diagnosis and treatment of pericardial disease. Clin Cardiol 1999;22(Suppl I): I30-I35. – reference: Landau C, Jacobs AK, Haudenschild CC. Intrapericardial basic fibroblast growth factor induces myocardial angiogenesis in a rabbit model of chronic ischemia. Am Heart J 1995; 129: 924-931. – reference: Verrier RL, Waxman S, Lovett EG, Moreno R. Transatrial access to the normal pericardial space: a novel approach for diagnostic sampling, pericardiocentesis, and therapeutic interventions. Circulation 1998; 98: 2331-2333. – volume: 98 start-page: 2331 year: 1998 end-page: 2333 article-title: Transatrial access to the normal pericardial space: a novel approach for diagnostic sampling, pericardiocentesis, and therapeutic interventions publication-title: Circulation – volume: 9 start-page: 229 year: 1998 end-page: 239 article-title: Endocardial and epicardial ablation guided by nonsurgical transthoracic epicardial mapping to treat recurrent ventricular tachycardia publication-title: J Cardiovasc Electrophysiol – volume: 292 start-page: 795 year: 2000 end-page: 802 article-title: Intrapericardial delivery of fibroblast growth factor‐2 induces neovascularization in a porcine model of chronic myocardial ischemia publication-title: J Pharmacol Exp Ther – volume: 22 start-page: I10 issue: Suppl I year: 1999 end-page: I16 article-title: Pharmacokinetics and consistency of pericardial delivery directed to coronary arteries: direct comparison with endoluminal delivery publication-title: Clin Cardiol – start-page: 126 year: 1997 end-page: 132 – volume: 22 issue: Suppl I year: 1999 article-title: Intrapericardial therapeutics and diagnostics: potential advantages, recent advances, experimental direct therapy of cardiac diseases and arrhythmias publication-title: Clin Cardiol – volume: 35 start-page: 79A year: 2000 article-title: Preclinical safety of transatrial access to the normal pericardial space for local cardiac drug delivery during aspirin use and pulmonary hypertension (abstract) publication-title: J Am Coll Cardiol – volume: 129 start-page: 924 year: 1995 end-page: 931 article-title: Intrapericardial basic fibroblast growth factor induces myocardial angiogenesis in a rabbit model of chronic ischemia publication-title: Am Heart J – volume: 130 start-page: 1182 year: 1995 end-page: 1188 article-title: Angiogenic therapy of acute myocardial infarction by intrapericardial injection of basic fibroblast growth factor and heparin sulfate: an experimental study publication-title: Am Heart J – volume: 22 start-page: I23 issue: Suppl I year: 1999 end-page: I29 article-title: Efficient in vivo catheter‐based pericardial gene transfer mediated by adenoviral vectors publication-title: Clin Cardiol – volume: 22 start-page: I30 issue: Suppl I year: 1999 end-page: I35 article-title: Initial clinical experience with PerDucer device: promising new tool in the diagnosis and treatment of pericardial disease publication-title: Clin Cardiol – volume: 33 start-page: 2073 year: 1999 end-page: 2077 article-title: Persistent primary coronary dilation induced by transatrial delivery of nitroglycerin into the pericardial space: a novel approach for local cardiac drug delivery publication-title: J Am Coll Cardiol – volume: 22 start-page: I36 issue: Suppl I year: 1999 end-page: I39 article-title: Minimally invasive access of the normal pericardium: initial clinical experience with a novel device publication-title: Clin Cardiol – volume: 35 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SubjectTerms | Animals atrial appendage Atrial Appendage - pathology Biological and medical sciences Cardiac Catheterization - instrumentation Cardiovascular system diagnostic sampling Drug Delivery Systems - instrumentation Equipment Design Equipment Safety Female Humans Investigative techniques, diagnostic techniques (general aspects) local drug delivery Male Medical sciences Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques Pericardial Effusion - chemistry pericardial space Pericardium - drug effects Pericardium - pathology Punctures - instrumentation Specimen Handling - instrumentation Swine |
Title | Preclinical safety testing of percutaneous transatrial access to the normal pericardial space for local cardiac drug delivery and diagnostic sampling |
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