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      Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial

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          Abstract

          Pharmacological antiarrhythmic therapy such as beta-blockers in patients with frequent premature ventricular contractions (PVCs) and concomitant bradycardia is challenging. A traditional Chinese medicine, Shensong Yangxin (SSYX), has been effective in treatment of frequent PVCs and sinus bradycardia (SB) in separate patient cohorts. This double-blind, placebo-controlled, multicentre, randomized clinical trial investigates the acute efficacy of SSYX in reducing PVCs burden in patients with concomitant SB. Patients with symptomatic, frequent PVCs, and SB, defined as mean heart rate (MHR) of 45 to 59 beats per min (bpm), were recruited at 33 medical centres in mainland China and randomly assigned by computer to either SSYX or matching placebo for eight weeks. Patients, investigators, and trial personnel were masked to treatment allocation. Primary endpoints were changes in PVCs burden and MHR as assessed by 24-hour Holter monitoring relative to baseline. Secondary efficacy endpoints were subjective symptom score, ECG, and biochemical parameters. Analysis was based on intention-to-treat principles. 333 patients were randomized, of which 166 received SSYX and 167 placebo. Baseline characteristics did not differ. SSYX reduced PVCs burden by 68.2% ( p < 0.001) and increased MHR by 10.9% ( p < 0.001) compared to 32.2% and 4.7%, respectively, in the placebo group. SSYX group experienced greater symptomatic improvement ( p < 0.001). No differences in reported adverse events were seen (20 versus 23). SSYX is an effective antiarrhythmic therapy for symptomatic, frequent PVCs uniquely suited patients with concomitant SB. Clinical trial number was NCT01750775.

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          2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC).

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            Radiofrequency ablation of frequent, idiopathic premature ventricular complexes: comparison with a control group without intervention.

            Idiopathic premature ventricular complexes (PVCs) usually are considered benign, even when frequent. However, case reports have demonstrated a possible link between frequent PVCs and left ventricular (LV) dysfunction. In addition, frequent PVCs recently were demonstrated to be associated with increased LV dimensions and cardiomyopathy. Among 60 consecutive patients with idiopathic, frequent PVCs (>10/hour), a reduced LV ejection fraction (EF; mean 34% +/- 13%) was present in 22 (37%) patients. Patients with decreased LV function had a greater PVC burden on a 24-hour Holter monitor than patients with normal EF (37% +/- 13% vs. 11% +/- 10% of all QRS complexes; P <.0001). There was a significant inverse correlation between the PVC burden and the EF before ablation (r = 0.73, P <.0001). The PVCs originated in the right ventricular outflow tract in 31 (52%) of 60 patients, the LV outflow tract in 9 (15%) of 60 patients, and in other sites in 13 (22%) of 60 patients. The site of PVC origin could not be determined in seven patients. Ablation was completely successful in 48 (80%) patients. In patients with an abnormal EF before ablation, LV function normalized in 18 (82%) of 22 patients from a baseline of 34% to 59% +/- 7% (P <.0001) within 6 months. In the four patients in whom ablation was ineffective, the EF further declined from 34% +/- 10% to 25% +/- 7% (P = .06) during follow-up. In a control group of 11 patients with a similar PVC burden (30% +/- 8%) and a reduced EF (28% +/- 13%) who did not undergo ablation, the EF remained unchanged in 10/11 patients over 19 +/- 17 months of follow-up and one patient underwent heart transplantation. LV dysfunction in the setting of frequent, idiopathic PVCs may represent a form of cardiomyopathy that can be reversed by catheter ablation of the PVCs.
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              Radiofrequency catheter ablation of premature ventricular complexes from right ventricular outflow tract improves left ventricular dilation and clinical status in patients without structural heart disease.

              The present study evaluated clinical benefits of radiofrequency catheter ablation (RFA) for premature ventricular complexes from right ventricular outflow tract (RVOT-PVC) in patients without structural heart disease. It is unknown whether PVC causes left ventricular (LV) dilation, which is a well-recognized precursor of LV dysfunction and heart failure, and whether eliminating PVC by RFA produces clinical benefits in patients with RVOT-PVC. Frequency of PVC per total heart beats by 24-h Holter monitoring, left ventricular ejection fraction (LVEF), left ventricular end-diastolic internal dimension (LVDd), mitral regurgitation (MR) by echocardiogram, cardiothoracic ratio (CTR) by chest radiogram, and New York Heart Association (NYHA) functional class of 40 patients with RVOT-PVC without structural heart disease were evaluated before and 6 to 12 months after RFA. Before RFA, a subgroup of patients with frequent (>20%) PVC demonstrated significantly enlarged LVDd and CTR, reduced LVEF, increased MR, and deteriorated NYHA functional class as compared to the subgroup with rare ( 20%) RVOT-PVC may be a possible cause of LV dysfunction and/or heart failure, and RFA produces clinical benefits in these patients.
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                Author and article information

                Contributors
                Journal
                Evid Based Complement Alternat Med
                Evid Based Complement Alternat Med
                ECAM
                Evidence-based Complementary and Alternative Medicine : eCAM
                Hindawi
                1741-427X
                1741-4288
                2019
                4 March 2019
                4 March 2019
                : 2019
                : 3917282
                Affiliations
                1Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China
                2Department of Statistics of Nanjing Medical University, Nanjing, China
                3National University Heart Centre, National University Hospital, Singapore
                4Department of Cardiology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China
                5Department of Cardiology, Chinese Academy of Medical Sciences Fuwai Cardiovascular Hospital, Beijing, China
                6Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China
                7Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China
                8Department of Cardiology, The First Affiliated Hospital of China Medical University, Shenyang, China
                9Department of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin, China
                10Department of Cardiology, First Affiliated Hospital of Chongqing Medical University, Chongqing, China
                11Department of Cardiology, Xiangya No. 2 Hospital Central South University, Changsha, China
                12Department of Cardiology, No. 1 Hospital of Jilin University, Changchun, China
                13Department of Cardiology, First People's Hospital of Yunnan Province, Kunming, China
                14Department of Cardiology, The 252 nd Hospital of Chinese People's Liberation Army, Beijing, China
                15Department of Cardiology, First Affiliated of Liaoning Medical University, Shenyang, China
                16Department of Cardiology, Jiangxi Provincial People's Hospital, Nanchang, China
                17Department of Cardiology, The Department of Cardiology, People's Hospital of Baoji City, Baoji, China
                18Department of Cardiology, Jinzhou Central Hospital, Jinzhou, China
                Author notes

                Academic Editor: Laura De Martino

                Author information
                http://orcid.org/0000-0003-0125-3926
                http://orcid.org/0000-0003-2121-2873
                http://orcid.org/0000-0002-4542-3811
                Article
                10.1155/2019/3917282
                6425419
                3c2bdc24-b3f0-466b-90c2-2d1de8b2d1e9
                Copyright © 2019 Fengxiang Zhang et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 18 August 2018
                : 15 February 2019
                Funding
                Funded by: National Basic Research Program of China
                Award ID: 2012CB518606
                Funded by: National Natural Science Foundation of China
                Award ID: 81470456
                Award ID: 81871113
                Funded by: National key R&D projects
                Award ID: 2016YFE0117000
                Funded by: Jiangsu Higher Education Institutions
                Categories
                Research Article

                Complementary & Alternative medicine
                Complementary & Alternative medicine

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