Andrew Cassar1, Megha Prasad1, Martin Rodriguez-Porcel1, Guy S Reeder1, Darshak Karia2, Anthony N DeMaria3, Amir Lerman4. 1. Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN. 2. Division of Cardiovascular Diseases, Albert Einstein Medical Center, Philadelphia, PA. 3. Division of Cardiovascular Diseases, University of California, San Diego, La Jolla. 4. Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN. Electronic address: lerman.amir@mayo.edu.
Abstract
OBJECTIVE: To assess the safety and efficacy of extracorporeal shockwave myocardial revascularization (ESMR) therapy in treating patients with refractory angina pectoris. PATIENTS AND 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). CONCLUSION: 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.
OBJECTIVE: To assess the safety and efficacy of extracorporeal shockwave myocardial revascularization (ESMR) therapy in treating patients with refractory angina pectoris. PATIENTS AND 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). CONCLUSION: 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: Manuel D Cerqueira; Neil J Weissman; Vasken Dilsizian; Alice K Jacobs; Sanjiv Kaul; Warren K Laskey; Dudley J Pennell; John A Rumberger; Thomas Ryan; Mario S Verani Journal: Circulation Date: 2002-01-29 Impact factor: 29.690
Authors: Ahmed A Khattab; Broder Brodersen; Daniela Schuermann-Kuchenbrandt; Hans Beurich; Ralph Tölg; Volker Geist; Torsten Schäfer; Gert Richardt Journal: Int J Cardiol Date: 2006-11-09 Impact factor: 4.164
Authors: Douglas W Losordo; Timothy D Henry; Charles Davidson; Joon Sup Lee; Marco A Costa; Theodore Bass; Farrell Mendelsohn; F David Fortuin; Carl J Pepine; Jay H Traverse; David Amrani; Bruce M Ewenstein; Norbert Riedel; Kenneth Story; Kerry Barker; Thomas J Povsic; Robert A Harrington; Richard A Schatz Journal: Circ Res Date: 2011-07-07 Impact factor: 17.367
Authors: Alexandra Aicher; Christopher Heeschen; Ken-ichiro Sasaki; Carmen Urbich; Andreas M Zeiher; Stefanie Dimmeler Journal: Circulation Date: 2006-12-04 Impact factor: 29.690
Authors: Timothy D Henry; Brian H Annex; George R McKendall; Michael A Azrin; John J Lopez; Frank J Giordano; P K Shah; James T Willerson; Raymond L Benza; Daniel S Berman; C Michael Gibson; Alex Bajamonde; Amy Chen Rundle; Jennifer Fine; Edward R McCluskey Journal: Circulation Date: 2003-03-18 Impact factor: 29.690
Authors: Xin Zhang; James D Krier; Carolina Amador Carrascal; James F Greenleaf; Behzad Ebrahimi; Ahmad F Hedayat; Stephen C Textor; Amir Lerman; Lilach O Lerman Journal: J Am Soc Nephrol Date: 2016-06-13 Impact factor: 10.121
Authors: Megha Prasad; Wan Azman Wan Ahmad; Renan Sukmawan; Edward-Bengie L Magsombol; Andrew Cassar; Yuri Vinshtok; Muhammad Dzafir Ismail; Ahmad Syadi Mahmood Zuhdi; Sue Ann Locnen; Rodney Jimenez; Homobono Callleja; Amir Lerman Journal: Coron Artery Dis Date: 2015-05 Impact factor: 1.439
Authors: Greta Burneikaitė; Evgeny Shkolnik; Jelena Čelutkienė; Gitana Zuozienė; Irena Butkuvienė; Birutė Petrauskienė; Pranas Šerpytis; Aleksandras Laucevičius; Amir Lerman Journal: Cardiovasc Ultrasound Date: 2017-04-12 Impact factor: 2.062
Authors: J Vainer; J H M Habets; S Schalla; A H P Lousberg; C D J M de Pont; S A Vöö; B T Brans; J C A Hoorntje; J Waltenberger Journal: Neth Heart J Date: 2016-05 Impact factor: 2.380