Intravenous solid tip lead placement in telemetry implanted dogs. Part 1: Surgical methods, signal quality, and pathological endpoints

Journal of Pharmacological and Toxicological Methods

Volumn 68, Issue 1, 2013, Pages 52-61

  Walisser, Jacqueline A ^a   Mitchell, Andrea Z ^a   Bills, Andrew J ^a   Sharma, Alok K ^a   Latimer, Kenneth ^a   Taschwer, Michael ^a   Osinski, Mark A ^a  

^a 206 Carnegie Center   (United States)

Author keywords

Cardiovascular safety; Dogs; ECG; Intravenous; Pathology; Preclinical; Signal quality; Surgical methods; Telemetry

Indexed keywords

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; AUTOPSY; BIOCOMPATIBILITY; COMPUTER PROGRAM; CONTROLLED STUDY; DATA PROCESSING; DIAPHRAGM; DOG; ELECTROCARDIOGRAM; ELECTRODE IMPLANT; FEMALE; HISTOPATHOLOGY; INTERMETHOD COMPARISON; MALE; NONHUMAN; OPERATION DURATION; PARAMETERS; POSTOPERATIVE PERIOD; SIGNAL QUALITY; SURGICAL TECHNIQUE; TELEMETRY; VASCULAR EQUIPMENT;

CARDIOVASCULAR SAFETY; DOGS; ECG; INTRAVENOUS; PATHOLOGY; PRECLINICAL; SIGNAL QUALITY; SURGICAL METHODS; TELEMETRY;

ANIMALS; DOGS; ELECTROCARDIOGRAPHY; ELECTRODES, IMPLANTED; FEMALE; MALE; OPERATIVE TIME; TELEMETRY; TIME FACTORS;

ANIMALIA; CANIS FAMILIARIS;

EID: 84880038963     PISSN: 10568719     EISSN: 1873488X     Source Type: Journal    
DOI: 10.1016/j.vascn.2013.04.001     Document Type: Article

References (27)

1. Authier S., Moon L.B., Stonerook M., Fournier S., Gervais J., Maghezzi S., et al. Evaluation of a novel ECG lead placement method in telemetered freely moving cynomolgus monkeys: Assessment of an intravascular biopotential lead. Journal of Pharmacological and Toxicological Methods 2011, 64:145-150.
2. Chaves A.A., Keller W.J., O'Sullivan S., Williams M.A., Fitzgerald L.E., McPherson H.E., et al. Cardiovascular monkey telemetry: Sensitivity to detect QT interval prolongation. Journal of Pharmacological and Toxicological Methods 2006, 54(2):150-158.
3. Chaves A.A., Zingaro G.J., Yordy M.A., Bustard K.A., O'Sullivan S., Galijatovic-Idrizbegovic A., et al. A highly sensitive canine telemetry model for detection of QT interval prolongation: Studies with moxifloxacin, haloperidol and MK-499. Journal of Pharmacological and Toxicological Methods 2007, 56(2):103-114.
4. Fermini B., Fossa A.A. The impact of drug-induced QT interval prolongations on drug discovery and development. Nature Reviews. Drug Discovery 2003, 2:439-447.
5. Gauvin D.V., Tilley L.P., Smith F.W.K., Baird T.J. Electrocardiogram, hemodynamics, and core body temperatures of the normal free moving laboratory beagle dog by remote radiotelemetry. Journal of Pharmacological and Toxicological Methods 2006, 53:128-139.
6. Gauvin D.V., Tilley L.P., Smith F.W.K., Baird T.J. Electrocardiogram, hemodynamics, and core body temperatures of the normal free moving cynomolgus monkey by remote radiotelemetry. Journal of Pharmacological and Toxicological Methods 2006, 53:140-151.
7. Guth B. Preclinical cardiovascular risk assessment in modern drug development. Toxicological Sciences 2007, 97(1):4-20.
8. Henriques T.A., Beck T.W., Douglas C.L., Jones H.M., Kremer J.J., Kruzich P.J., et al. Left thoracotomy surgical approach for chronic instrumentation in dogs and monkeys providing high-quality electrocardiogram signals. Journal of Pharmacological and Toxicological Methods 2010, 62:136-142.
9. Holzgrefe H.H., Cavero I., Buchanan L.V., Gill M.W., Durham S.K. Application of a probabilistic method for the determination of drug-induced QT prolongation in telemeterized cynomolgus monkeys: Effects of moxifloxacin. Journal of Pharmacological and Toxicological Methods 2007, 55:227-237.
10. ICH (International Conference on Harmonisation) S7A Guidance. Safety pharmacology studies for human pharmaceuticals 2001, July.
11. ICH (International Conference on Harmonisation) S7B Guidance 2005, October.
12. Kannankeril P., Roden D.M., Darbar D. Drug-induced long QT syndrome. Pharmacological Reviews 2010, 62:760-781.
13. Kurtz T.W., Grifflin K.A., Bidani A.K., Davisson R.L., Hall J.E. Recommendations for blood pressure measurement in humans and experimental animals. Part 2: Blood pressure measurement in experimental animals: a statement for professionals from the subcommittee of professional and public education of the American Heart Association council on high blood pressure research. Hypertension 2005, 45:299-310.
14. Leishman D.J., Beck T.W., Dybdal N., Gallacher D.J., Guth B.D., Holbrook M., et al. Best practice in the conduct of key nonclinical cardiovascular assessments in drug development: Current recommendations from the Safety Pharmacology Society. Journal of Pharmacological and Toxicological Methods 2012, 65(3):93-101.
15. Lewington S., Clarke R., Qizilbash N., Peto R., Collins R. Prospective Studies Collaboration: Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002, 366:1903-1913.
16. Luft J., Bode G. Integration of safety pharmacology endpoints into toxicology studies. Fundamentals of Clinical Pharmacology 2002, 16(2):91-103.
17. McMahon C., Mitchell A.Z., Klein J.L., Jenkins A.C., Sarazan R.D. Evaluation of blood pressure measurement using a miniature blood pressure transmitter with jacketed external telemetry in cynomolgus monkeys. Journal of Pharmacological and Toxicological Methods 2010, 62(2):127-135.
18. Mitchell A.Z., Bills A.J., Wittwer G.T., Foley C.M., Kremer J.J., Chen H., et al. Intravenous solid tip ECG lead placement in telemetry implanted dogs. Part 2: High quality telemetry signals yield high sensitivity to drug-induced changes. Journal of Pharmacological and Toxicological Methods 2013, 68:62-73.
19. Pugsley M.K., Authier S., Curtis J. Principles of safety pharmacology. British Journal of Pharmacology 2008, 154(7):1382-1399.
20. Rey M., Weber E.W., Hess P.D. Simultaneous pulmonary and systemic blood pressure and ECG interval measurement in conscious, freely moving rats. Journal of the American Association for Laboratory Animal Science 2012, 51(2):231-238.
21. Russell W.M.S., Burch R.L. The principles of humane experimental technique 1959, Methuen & Co. Ltd., London.
22. Sarazan R.D., Mittelstadt S., Guth B., Koerner J., Zhang J., Pettit S. Cardiovascular function in nonclinical drug safety assessment: Current issues and opportunities. International Journal of Toxicology 2011, 30(3):272-286.
23. Singer D., Stonerook M., Vinci T., Hassler C., Vadnal A. Telemetric intracardiac ECG dramatically improve internal detection and reduces artifact when compared to a subcutaneous lead placement in freely moving dogs. The FASEB Journal 2006, 20:A232.
24. Stubhan M., Markert M., Mayer K., Trautmann T., Klumpp A., Henke J., et al. Evaluation of cardiovascular and ECG parameters in the normal, freely moving Göttingen Minipig. Journal of Pharmacological and Toxicological Methods 2008, 57:202-211.
25. Vargas H.M., Amouzadeh H.R., Engwall M.J. Nonclinical strategy considerations for safety pharmacology: Evaluation of biopharmaceuticals. Expert Opinion on Drug Safety 2013, 12(1):91-102.
26. Vargas H.M., Bass A.S., Breidenbach A., Feldman H.S., Gintant G.A., Harmer A.R., et al. Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics. Journal of Pharmacological and Toxicological Methods 2008, 58(2):72-76.
27. Yao J.A., Feldman H.S., Illenberger A., Littell T., Schnee L., Yates D. Evaluation of electrocardiograms recorded in cynomolgus monkeys with short- and long-term intracardiac lead implantations. Journal of Pharmacological and Toxicological Methods 2009, 60:185-192.