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 inCatheterization and cardiovascular interventions Vol. 49; no. 4; pp. 472 - 477
Main Authors Waxman, Sergio, Pulerwitz, Todd C., Rowe, Katharine A., Quist, William C., Verrier, Richard L.
Format Journal Article
LanguageEnglish
Published New York John Wiley & Sons, Inc 01.04.2000
Wiley-Liss
Subjects
Online AccessGet full text
ISSN1522-1946
1522-726X
DOI10.1002/(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.
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.
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Pericardium
Percutaneous route
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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.
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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
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Snippet 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...
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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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https://www.ncbi.nlm.nih.gov/pubmed/10751782
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