title: Safety and efficacy of extracorporeal shock wave myocardial revascularization therapy for refractory angina pectoris.
abstract: OBJECTIVE
  To assess the safety and efficacy of extracorporeal shockwave myocardial revascularization (ESMR) therapy in treating patients with refractory angina pectoris.
  
  
  METHODS
  A single-arm multicenter prospective trial to assess safety and efficacy of the ESMR therapy in patients with refractory angina (class III/IV angina) was performed. Screening exercise treadmill tests and pharmacological single-photon emission computed tomography (SPECT) were performed for all patients to assess exercise capacity and ischemic burden. Patients were treated with 9 sessions of ESMR to ischemic areas over 9 weeks. Efficacy end points were exercise capacity by using treadmill test as well as ischemic burden on pharmacological SPECT at 4 months after the last ESMR treatment. Safety measures included electrocardiography, echocardiography, troponin, creatine kinase, and brain natriuretic peptide testing, and pain questionnaires.
  
  
  RESULTS
  Fifteen patients with medically refractory angina and no revascularization options were enrolled. There was a statistically significant mean increase of 122.3±156.9 seconds (38% increase compared with baseline; P=.01) in exercise treadmill time from baseline (319.8±157.2 seconds) to last follow-up after the ESMR treatment (422.1±183.3 seconds). There was no improvement in the summed stress perfusion scores after pharmacologically induced stress SPECT at 4 months after the last ESMR treatment in comparison to that at screening; however, SPECT summed stress score revealed that untreated areas had greater progression in ischemic burden vs treated areas (3.69±6.2 vs 0.31±4.5; P=.03). There was no significant change in the mean summed echo score from baseline to posttreatment (0.4±5.1; P=.70). The ESMR therapy was performed safely without any adverse events in electrocardiography, echocardiography, troponins, creatine kinase, or brain natriuretic peptide. Pain during the ESMR treatment was minimal (a score of 0.5±1.2 to 1.1±1.2 out of 10).
  
  
  CONCLUSIONS
  In this multicenter feasibility study, ESMR seems to be a safe and efficacious treatment for patients with refractory angina pectoris. However, larger sham-controlled trials will be required to confirm these findings.
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.
authors.forename: Andrew
authors.initials: A
authors.lastname: Cassar
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.
authors.forename: Megha
authors.initials: M
authors.lastname: Prasad
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.
authors.forename: Martin
authors.initials: M
authors.lastname: Rodriguez-Porcel
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.
authors.forename: Guy S
authors.initials: GS
authors.lastname: Reeder
authors.affiliation: Division of Cardiovascular Diseases, Albert Einstein Medical Center, Philadelphia, PA.
authors.forename: Darshak
authors.initials: D
authors.lastname: Karia
authors.affiliation: Division of Cardiovascular Diseases, University of California, San Diego, La Jolla.
authors.forename: Anthony N
authors.initials: AN
authors.lastname: DeMaria
authors.affiliation: Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN. Electronic address: lerman.amir@mayo.edu.
authors.forename: Amir
authors.initials: A
authors.lastname: Lerman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000175:diagnosis / Q000628:therapy*; D004452:Echocardiography; D005080:Exercise Test; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D019220:High-Energy Shock Waves / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods*; D010865:Pilot Projects; D011446:Prospective Studies; D015899:Tomography, Emission-Computed, Single-Photon; D016896:Treatment Outcome; D055815:Young Adult