Document Detail

A first-in-man study of percutaneous myocardial cryotreatment in nonrevascularizable patients with refractory angina.
MedLine Citation:
PMID:  19496148     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: To evaluate the safety and feasibility of myocardial cryotreatment for patients with coronary artery disease (CAD) and severe angina refractory to standard treatment. BACKGROUND: Innovative myocardial revascularization strategies are needed for patients with CAD and severe angina uncontrolled by conventional methods. Preclinical data have demonstrated that cryotherapy can induce myocardial neovascularization through arteriogenesis. METHODS: This was a two center, nonrandomized, study that enrolled 20 patients. All patients had CAD and severe angina (CCS Angina Class III or IV). Safety was the primary endpoint. Treatment involved 8-10 intramyocardial cryoapplications (at < or = -50 degrees C), for 2 min by a specially designed percutaneous catheter at an identified ischemic area of the myocardium. Primary endpoint was safety, with secondary endpoints of angina severity, exercise tolerance, quality of life, and myocardial perfusion assessed by radionuclide scintigraphy. RESULTS: The procedure was successful in 19 patients. There were three device-related events, a pericardial tamponade requiring pericardiocenetesis, a clinically nonsignificant pericardial effusion, and an episode of ventricular tachycardia requiring cardioversion in one patient. Complete 12-month follow-up was obtained in 16 patients. Significant reduction in CCS angina scores and significant improvements in both exercise tolerance and quality of life (P < 0.05) were seen at 6 and 12-month follow-up. Although no significant differences were observed in myocardial perfusion in the overall group, marked improvement was detected in 8 (42%) patients. CONCLUSION: Cryotreatment is feasible and safe in patients with severe angina refractory to standard management. Early efficacy results are encouraging and further clinical study is warranted.
Richard Gallo; Paul Fefer; Michael Freeman; Peter Andrew; Duncan J Stewart; Pierre Theroux; Bradley H Strauss
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  74     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2009 Sep 
Date Detail:
Created Date:  2009-08-19     Completed Date:  2009-10-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  387-94     Citation Subset:  IM    
Copyright Information:
2009 Wiley-Liss, Inc.
Interventional Cardiology Service, Institut de Cardiologie de Montréal, Université de Montréal, Québec, Canada.
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MeSH Terms
Angina Pectoris / etiology,  physiopathology,  radionuclide imaging,  surgery*
Coronary Artery Disease / complications,  physiopathology,  radionuclide imaging,  surgery*
Coronary Circulation
Cryosurgery* / adverse effects,  instrumentation
Equipment Design
Exercise Tolerance
Feasibility Studies
Heart Catheterization* / adverse effects,  instrumentation
Middle Aged
Myocardial Perfusion Imaging / methods
Myocardial Revascularization / adverse effects,  instrumentation,  methods*
Neovascularization, Physiologic
Quality of Life
Severity of Illness Index
Time Factors
Treatment Failure
Comment In:
Catheter Cardiovasc Interv. 2009 Sep 1;74(3):395-7   [PMID:  19681118 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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