28th Great Wall International Congress of Cardiology (GW-ICC), 2017, News: RVOT CARE Study curative effect evaluation of right ventricular septum pacing in preventing cardiac functional insufficiency
On October 13th, 2017 at a press conference at the 28th GW-ICC, Beijing, China, a prospective, randomized, double-blind, multicenter, parallel controled, postmarket clinical study released their results for “RVOT CARE Study curative effect evaluation of right ventricular septum pacing in preventing cardiac functional insufficiency”. Trial results showed that compared with right ventricular apex (RVA) pacing, right ventricular outflow tract septum (RVOTs) pacing can prevent ventricular dyssynchrony, reducing the incidence of paroxysmal and persistent trembling.
Professor Wu Shulin, Professor Yan Ji, Professor Dong Yugang, Dr. Liang Yuanhong attending the press conference.
Professor Wu Shulin from the principal investigation institution Guangdong General Hospital, and from cooperative units, Professor Yan Ji of the First Affiliated Hospital of Anhui Medical University, Professor Dong Yugang of the First Affiliated Hospital of Zhongshan University, and Dr. Liang Yuanhong of Guangdong General Hospital, attended the press conference.
This trial was jointly completed by the leading facility, Guangdong General Hospital, and 25 National Centers (see list below) as cooperative units, in collaboration with the St. Jude Medical (Shanghai) Limited company. The trial enrolled 380 patients in total, who were randomly divided into AAI group, RVOTs group and RVA group, with follow-up in 1 month, 6 months, 12 months and 18 months after implantation, collecting the echocardiographic data for heart function evaluation, 6 minutes walking distance and SF-36 quality of life score.
Professor Wu Shulin speaks at the press conference
Professor Wu Shulin said that pacemaker technology has become a radical treatment technology for bradycardic arrhythmia, which is the merit of wisdom and exploration of many experts. The “idea” of this trial comes from many previous clinical and research experience in the field of pacemaker, and the release of the trial results is also inseparable from the joint efforts of Chinese experts. Five years have passed from the initial formation of concept to the implementation of the trial, and finally to the result release, RVOT CARE Study. The release of results is a new starting point, how can RVOTs pacing be more widely used in clinical practice in the future?
Professor Yan ji speaks at the press conference
Professor Yan Ji said in his speech that in the clinical exploration of pacing treatment, RVOTs pacing is both the difficult part and the hot spot. Is RVOTs pacing superior to RVA pacing in cardiac synchrony, ventricular remodeling and cardiac function in patients with bradycardia but normal left ventricular function? Clinical results vary a lot. From patient selection, standardized treatment, to long-term follow-up, RVOT CARE Study has gone through a long and rigorous process, and finally come to a useful conclusion. Further follow-up and observation of the trial will provide clarification on some outstanding questions. This is good news for pacemaker electrophysiology physicians, further enhancing clinical practice and improving treatment approaches.
Professor Dong Yugang speaks at the press conference
Professor Dong Yugang noted that RVOTs pacing faces many problems such as RVOT dissection and definition, and inconsistence of early clinical research results, due to the lack of multi center, large-scale clinical research. Compared with RVA pacing, the duration of QRS wave was significantly shortened during RVOTs pacing. The study was carried out at the right time, the results of which is consistent with our clinical observations, further validating clinical practice. It is of great significance for clinical work of cardiac pacing and electrophysiology. If the work can be carried out in the primary hospital, we believe that it will bring greater benefits for our clinical patients.
Subsequently, Dr. Liang Yuanhong introduced the background, end point, statistics and baseline data of the study in detail. Three groups of DAVID Trial, MOST Trial, DANISH II Study showed the common results that: unnecessary right ventricular apical pacing can lead to decline of left ventricular systolic function, resulting in undesired consequences. RVOT CARE Study results showed that (1) after eighteenth months of follow-up, no difference in LVEF change was observed among the three groups; (2) the interval to posterior wall motion delay in RVA group was significantly delayed, but there was no difference between RVOT group and AAI group; (3) incidence of intermittent AF significantly increased in RVA group, but there was no difference between RVOTs group and AAI group.
Professor Wu Shulin concluded that randomized controlled trials have specific inclusion criteria. In practice, we should guide the clinical work with the concept of precise and individualized treatment. We hope that after further publication in international journals, the trial results will garner more attention, benefiting many arrhythmia patients internationally.
RVOT CARE Study: curative effect evaluation of right ventricular septum pacing in preventing cardiac functional insufficiency - 26 participating national centers:
Lead facility: Guangdong General Hospital
Collaboration units: (in no particular order)
The Third Xiangya Hospital of Central South University
The First Affiliated Hospital of Zhongshan University
The First Affiliated Hospital of Guangxi Medical University
People’s Hospital of Liaoning Province
People’s Hospital of Anhui Province
Xijing Hospital of An Zhen Hospital
Cardiovascular Hospital of Guizhou Province
The Second Affiliated Hospital of Nanchang University
The First Affiliated Hospital of Nanchang University
People’s Hospital of Jiangxi Province
Guangzhou Military General Hospital of Guangzhou Military Area Command
Fujian provincial hospital
People’s Hospital of Zhongshan City
People’s Hospital of Huai Hua City
Affiliated Hospital of Guangdong Medical University
Dalian Central Hospital
The second people’s Hospital of Foshan
People’s Hospital of Shaanxi Province
Nanfang Hospital of Southern Medical University
The First Affiliated Hospital of Anhui Medical University
Sir Run Run Shaw Hospital affiliated to Zhejiang University
Xiamen Heart Center
Xiangtan Central Hospital
Changsha Central Hospital