The Research On The Effectiveness And Security Of Cardiac Shock Wave Therapy In Chronic Heart Failure

Purpose:To research the treatment effect and security of Cardiac Shock Wave Therapy (CSTW) and to provide some evidence to use in clinical medicine. Method:We enrolled patients with 36 reduced ejection fraction heart failure (LVEF<55%) under the Random principle and Blindness and 31 of them finished the program(18 in CSWT group,13 in placebo). All the patients complied with the management of Chinese Heart Failure Guideline in 2O12.The patients were treated by MODULITH R SLC machine with CSWT or Placebo in "6-point enlargement" criterion and then were conducted with 3 months,6 months,12 months follow-up. It includes soft end-point about symptom, echocardiography, BNP and quality in life and hard end-point like Major Adverse Cardio Event, hospitalization rate, and liability/mortality rate. We compared the First soft end-point and Second hard end-point and regard P<0.05 as meaningful differences in statistics.Result:In CSWT group, the SF-36 scores were much higher than the placebo (P<0.05).The distance in 6 minutes test expanded extraordinarily in CSWT group when comparing the placebo group (410.4±78.2 vs 365.2±116.3, P<0.001). The NYHA class (2.28±0.41与2.68±0.56, P=0.021) and LVEF (40.11±6.54和 37.12±6.24, P=0.032) also showed some difference between the two groups, whose data remained in a certain level but not deteriorated as placebo group. However, we failed to find any statistics differences in hard (second) end-point and BNP. No serious adverse event was found because of CSWT.Conclusion:1. CSWT, in medium/long term, can exert amelioration on the patients who suffered reduced ejection fraction heart failure with the improvement of symptom, quality of life and mental disorder. It should be considered as a complement method against heart failure.2. The LVEF and NYHA data did not improve but stayed in stable condition when the placebo group deteriorated sharply.3. Nevertheless, there is no evidence on the long-term prognosis, especially for hard end-point like MACE or mortality.4. The CSWT could be regarded as a safe method for heart failure treatment.