A first-in-man study of percutaneous myocardial cryotreatment in nonrevascularizable patients with refractory angina

Catheterization and Cardiovascular Interventions

Volumn 74, Issue 3, 2009, Pages 387-394

  Gallo, Richard ^a   Fefer, Paul ^b   Freeman, Michael ^c   Andrew, Peter ^d   Stewart, Duncan J ^c   Theroux, Pierre ^a   Strauss, Bradley H ^c,e  

^a MONTREAL HEART INSTITUTE   (Canada)

^b UNIVERSITY OF TORONTO   (Canada)

^c ST MICHAEL'S HOSPITAL   (Canada)

^d aATLAS Medical Research Inc   (Canada)

^e Roy and Ann Foss Interventional Cardiology Research Program   (Canada)

Author keywords

Angina; Angiogenesis; Arteriogenesis; Catheter; Coronary artery disease; Cryotherapy; Myocardial; Revascularization

Indexed keywords

METHOXY ISOBUTYL ISONITRILE TECHNETIUM TC 99M;

ADULT; ANGINA PECTORIS; ARTICLE; CARDIOVERSION; CLINICAL ARTICLE; CLINICAL TRIAL; CORONARY ARTERY DISEASE; CRYOTHERAPY; DISEASE SEVERITY; EXERCISE TOLERANCE; FEASIBILITY STUDY; FEMALE; FOLLOW UP; HEART MUSCLE PERFUSION; HEART MUSCLE REVASCULARIZATION; HEART SCINTISCANNING; HEART TAMPONADE; HEART VENTRICLE TACHYCARDIA; HUMAN; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT SAFETY; PERCUTANEOUS CORONARY INTERVENTION; PERICARDIAL EFFUSION; PERICARDIOCENTESIS; QUALITY OF LIFE; AGED; ANGIOGENESIS; CANADA; CORONARY ARTERY BLOOD FLOW; CRYOSURGERY; EQUIPMENT DESIGN; HEART CATHETERIZATION; HOSPITALIZATION; INSTRUMENTATION; METHODOLOGY; MIDDLE AGED; PATHOPHYSIOLOGY; SCINTISCANNING; TIME; TREATMENT FAILURE;

AGED; ANGINA PECTORIS; CANADA; CORONARY ARTERY DISEASE; CORONARY CIRCULATION; CRYOSURGERY; EQUIPMENT DESIGN; EXERCISE TOLERANCE; FEASIBILITY STUDIES; FEMALE; HEART CATHETERIZATION; HUMANS; MALE; MIDDLE AGED; MYOCARDIAL PERFUSION IMAGING; MYOCARDIAL REVASCULARIZATION; NEOVASCULARIZATION, PHYSIOLOGIC; QUALITY OF LIFE; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT FAILURE;

EID: 70350492828     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.22138     Document Type: Article

References (45)

1. Svorkdal N. Treatment of inoperable coronary disease and refractory angina: Spinal stimulators, epidurals, gene therapy, transmyocardial laser, and counterpulsation. Semin Cardiothorac Vasc Anesth 2004;8:43-58. (Pubitemid 38419209)
2. Goldberg RF, Fass AE, Frishman WH. Transmyocardial revascularization: Defining its role. Cardiol Rev 2005;13:52-55.
3. Mukherjee D, Ellis SG. New options for untreatable coronary artery disease: Angiogenesis and laser revascularization. Cleve Clin J Med 2000;67:577-583. (Pubitemid 30618550)
4. Perin EC, Dohmann HF, Borojevic R, Silva SA, Sousa AL, Mesquita CT, Rossi MI, Carvalho AC, Dutra HS, Dohmann HJ, Silva GV, Belém L, Vivacqua R, Rangel FO, Esporcatte R, Geng YJ, Vaughn WK, Assad JA, Mesquita ET, Willerson JT. Transendocardial, autologous bone marrow cell transplantation for severe, chronic ischemic heart failure. Circulation 2003;107:2294-2302. (Pubitemid 36578498)
5. Fuchs S, Satler LF, Kornowski R, Okubagzi P, Weisz G, Baffour R, Waksman R, Weissman NJ, Cerqueira M, Leon MB, Epstein SE. Catheter-based autologous bone marrow myocardial injection in no-option patients with advanced coronary artery disease: A feasibility study. J Am Coll Cardiol 2003;41:1721-1724. (Pubitemid 36584242)
6. Dimmeler S, Zeiher AM, Schneider MD. Unchain my heart: The scientific foundations of cardiac repair. J Clin Invest 2005;115:572-583. (Pubitemid 40322227)
7. Wollert KC, Drexler H. Clinical applications of stem cells for the heart. Circ Res 2005;96:151-163. (Pubitemid 40209362)
8. Fuchs S, Kornowski R, Weisz G, Satler LF, Smits PC, Okubagzi P, Baffour R, Aggarwal A, Weissman NJ, Cerqueira M, Waksman R, Serrruys P, Battler A, Moses JW, Leon MB, Epstein SE. Safety and feasibility of transendocardial autologous bone marrow cell transplantation in patients with advanced heart disease. Am J Cardiol 2006;97:823-829. (Pubitemid 43313253)
9. Kang HJ, Kim HS, Zhang SY, Park KW, Cho HJ, Koo BK, Kim YJ, Lee DS, Sohn DW, Han KS, Oh BH, Lee MM, Park YB. Effects of intracoronary infusion of peripheral blood stem-cells mobilised with granulocyte-colony stimulating factor on left ventricular systolic function and restenosis after coronary stenting in myocardial infarction: The MAGIC cell randomised clinical trial. Lancet 2004;363:751-756.
10. Janssens S, Dubois C, Bogaert J, Theunissen K, Deroose C, Desmet W, Kalantzi M, Herbots L, Sinnaeve P, Dens J, Maertens J, Rademakers F, Dymarkowski S, Gheysens O, Van Cleemput J, Bormans G, Nuyts J, Belmans A, Mortelmans L, Boogaerts M, Van de Werf F. Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: Double-blind, randomised controlled trial. Lancet 2006;367:113-121. (Pubitemid 43077127)
11. Menasche P, Hagege AA, Vilquin JT, Desnos M, Abergel E, Pouzet B, Bel A, Sarateanu S, Scorsin M, Schwartz K, Bruneval P, Benbunan M, Marolleau JP, Duboc D. Autologous skeletal myoblast transplantation for severe postinfarction left ventricular dysfunction. J Am Coll Cardiol 2003;41:1078-1083. (Pubitemid 36384891)
12. Menasché P, Alfieri O, Janssens S, McKenna W, Reichenspurner H, Trinquart L, Vilquin JT, Marolleau JP, Seymour B, Larghero J, Lake S, Chatellier G, Solomon S, Desnos M, Hagège AA. The Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) trial: First randomized placebo-controlled study of myoblast transplantation. Circulation 2008;117:1189-1200.
13. Horvath KA. The art and science of transmyocardial laser revascularization. J Am Coll Cardiol 2003;41:2298.
14. Horvath KA. Mechanisms and results of transmyocardial laser revascularization. Cardiology 2004;101:37-47. (Pubitemid 38339705)
15. Leon MB, Kornowski R, Downey WE, Weisz G, Baim DS, Bonow RO, Hendel RC, Cohen DJ, Gervino E, Laham R, Lembo NJ, Moses JW, Kuntz RE. A blinded, randomized, placebo-controlled trial of percutaneous laser myocardial revascularization to improve angina symptoms in patients with severe coronary disease. J Am Coll Cardiol 2005;46:1812-1819. (Pubitemid 41579801)
16. Huikeshoven M, Beek JF, van der Sloot JA, Tukkie R, van der Meulen J, van Gemert MJ. 35 years of experimental research in transmyocardial revascularization: What have we learned? Ann Thorac Surg 2002;74:956-970.
17. Khan SN, McNab DC, Sharples LD, Freeman CJ, Hardy I, Stone DL, Schofield PM. A study to assess changes in myocardial perfusion after treatment with spinal cord stimulation and percutaneous myocardial laser revascularisation; data from a randomised trial. Trials 2008;28:9.
18. Rimoldi O, Burns SM, Rosen SD, Wistow TE, Schofield PM, Taylor G, Camici PG. Measurement of myocardial blood flow with positron emission tomography before and after transmyocardial laser revascularization. Circulation 1999;100:134-138. (Pubitemid 29523523)
19. Dubuc M, Talajic M, Roy D, Thibault B, Leung TK, Friedman PL. Feasibility of cardiac cryoablation using a transvenous steerable electrode catheter. J Interv Cardiovasc Electrophysiol 1998;2:285-292. (Pubitemid 128510965)
20. Gaita F, Haissaguerre M, Giustetto C, Grossi S, Caruzzo E, Bianchi F, Richiardi E, Riccardi R, Hocini M, Jais P. Safety and efficacy of cryoablation of accessory pathways adjacent to the normal conduction system. J Cardiovasc Electrophysiol 2003;14:825-829. (Pubitemid 36994101)
21. Lanzotti ME, De Ponti R, Tritto M, Spadacini G, Salerno-Uriarte JA. Successful treatment of anteroseptal accessory pathways by transvenous cryomapping and cryoablation. Ital Heart J 2002;3:128-132. (Pubitemid 34591556)
22. Friedman PL, Dubuc M, Green MS, Jackman WM, Keane DT, Marinchak RA, Nazari J, Packer DL, Skanes A, Steinberg JS, Stevenson WG, Tchou PJ, Wilber DJ, Worley SJ. Catheter cryoablation of supraventricular tachycardia: Results of the multicenter prospective "frosty" trial. Heart Rhythm 2004;1:129-138.
23. Skanes AC, Yee R, Krahn AD, Klein GJ. Cryoablation of atrial arrhythmias. Card Electrophysiol Rev 2002;6:383-388.
24. Khairy P, Dubuc M. Transcatheter cryoablation, Part I: Preclinical experience. Pacing Clin Electrophysiol 2008;31:112-120.
25. Lemola K, Dubuc M, Khairy P. Transcatheter cryoablation, Part II: Clinical utility. Pacing Clin Electrophysiol 2008;31:235-244.
26. Campeau L. Grading of angina pectoris (Letter). Circulation 1976;54:522-523.
27. Chaitman BR, Stone PH, Knatterud GL, Forman SA, Sopko G, Bourassa MG, Pratt C, Rogers WJ, Pepine CJ, Conti CR. Asymptomatic Cardiac Ischemia Pilot (ACIP) study: Impact of anti-ischemia therapy on 12-week rest electrocardiogram and exercise test outcomes. The ACIP Investigators. J Am Coll Cardiol 1995;26:585-593.
28. Tamesis B, Stelken A, Byers S, Shaw L, Younis L, Miller DD, Chaitman BR. Comparison of the asymptomatic cardiac ischemia pilot and modified asymptomatic cardiac ischemia pilot versus Bruce and Cornell exercise protocols. Am J Cardiol 1993;72:715-720. (Pubitemid 23273564)
29. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Fihn SD. Monitoring the quality of life in patients with coronary artery disease. Am J Cardiol 1994;74:1240-1244. (Pubitemid 24375015)
30. Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD. Development and evaluation of the Seattle Angina Questionnaire: A new functional status measure for coronary artery disease. J Am Coll Cardiol 1995;25:333-341.
31. Berman DS, Kiat H, Friedman JD, Wang FP, van Train K, Matzer L, Maddahi J, Germano G. Separate acquisition rest thallium-201/stress technetium-99m sestamibi dual-isotope myocardial perfusion single-photon emission computed tomography: A clinical validation study. J Am Coll Cardiol 1993;22:1455-1464. (Pubitemid 23316373)
32. Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Comparison of the short-term survival benefit associated with revascularization compared with medical therapy in patients with no prior coronary artery disease undergoing stress myocardial perfusion single photon emission computed tomography. Circulation 2003;107:2900-2907. (Pubitemid 36736630)
33. Berman DS, Kang X, Schisterman EF, Gerlach J, Kavanagh PB, Areeda JS, Sharir T, Hayes SW, Shaw LJ, Lewin HC, Friedman JD, Miranda R, Germano G. Serial changes on quantitative myocardial perfusion SPECT in patients undergoing revascularization or conservative therapy. J Nucl Cardiol 2001;8:428-437. (Pubitemid 32737367)
34. Dakik HA, Kleiman NS, Farmer JA, He ZX, Wendt JA, Pratt CM, Verani MS, Mahmarian JJ. Intensive medical therapy versus coronary angioplasty for suppression of myocardial ischemia in survivors of acute myocardial infarction: A prospective, randomized pilot study. Circulation 1998;98:2017-2023.
35. Laham RJ, Sellke FW, Edelman ER, Pearlman JD, Ware JA, Brown DL, Gold JP, Simons M. Local perivascular delivery of basic fibroblast growth factor in patients undergoing coronary bypass surgery: Results of a phase I randomized, double-blind, placebo-controlled trial. Circulation 1999;100:1865-1871. (Pubitemid 29511139)
36. Lee CH, Smits PC. Vascular growth factors for coronary angiogenesis. J Interv Cardiol 2002;15:511-518. (Pubitemid 35387393)
37. Lee LY, O'Hara MF, Finnin EB, Hachamovitch R, Szulc M, Kligfield PD, Okin PM, Isom OW, Rosengart TK. Transmyocardial laser revascularization with excimer laser: Clinical results at 1 year. Ann Thorac Surg 2000;70:498-503. (Pubitemid 30650979)
38. Gray TJ, Burns SM, Clarke SC, Tait S, Sharples LD, Caine N, Schofield PM. Percutaneous myocardial laser revascularization in patients with refractory angina pectoris. Am J Cardiol 2003;91:661-666. (Pubitemid 36287454)
39. Spertus JA, Jones PG, Coen M, Garg M, Bliven B, O'Keefe J, March RJ, Horvath K. Transmyocardial CO2 laser revascularization improves symptoms, function, and quality of life: 12-month results from a randomized controlled trial. Am J Med 2001;111:341-348. (Pubitemid 32913665)
40. Allen KB, Dowling RD, Angell WW, Gangahar DM, Fudge TL, Richenbacher W, Selinger SL, Petracek MR, Murphy D. Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial. Ann Thorac Surg 2004;77:1228-1234. (Pubitemid 38452353)
41. Bridges CR, Horvath KA, Nugent WC, Shahian DM, Haan CK, Shemin RJ, Allen KB, Edwards FH; Society of Thoracic Surgeons. The Society of Thoracic Surgeons practice guideline series: Transmyocardial laser revascularization. Ann Thorac Surg 2004;77:1494-1502.
42. Kaptchuk TJ, Goldman P, Stone DA, Stason WB. Do medical devices have enhanced placebo effects? J Clin Epidemiol 2000;53:786-792.
43. Spertus J. Selecting end points in clinical trials: What evidence do we really need to evaluate a new treatment? Am Heart J 2001;142:745-747.
44. Segev A, Strauss BH, Coates G, Freeman MR, Gallo R. Endocardial cryotherapy as a novel strategy of improving myocardial perfusion in a patient with severe coronary artery disease. Cathet Cardiovasc Interv 2003;60:229-232. (Pubitemid 37204003)
45. Sandstede JJ. Assessment of myocardial viability by MR imaging. Eur Radiol 2003;13:52-61.