The China Heart Valve Center and National Transcatheter Valve Therapeutics Registry database : Cardiology Plus

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The China Heart Valve Center and National Transcatheter Valve Therapeutics Registry database

Hong, Nanchao1,2; Pan, Wenzhi1,2; Zhou, Daxin1,2,*; Ge, Junbo1,2,*

Author Information
doi: 10.1097/CP9.0000000000000024
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Abstract

Introduction

The concept of Heart Valve Center (HVC) was developed from heart valve clinic, a specialist outpatient clinic linked with multidisciplinary inpatient care for patients with valvular heart disease (VHD)[1,2]. International guidelines extend this specialist concept to a “Heart Valve Center”[2] or a “Heart Valve Center of Excellence”[3] in 2017. A HVC harbors a multidisciplinary team consisting specialists of a variety of expertise for coordinated care of patients with VHD[2,3]. The first HVC in China was established in June 2019, and since has become a major regional center for patient management as well as a national center for training of management team and specialists. Moreover, the HVC headquarter also established the National Transcatheter Valve Therapeutics Registry (NTCVR) database which was in accord with the situation of transcatheter valve replacement in China. This review summarizes the history, certification process, and current status of HVCs in China, as well as the NTCVR database.

Urgent need for HVC in China

VHD is the third most common cardiovascular disease (after coronary heart disease and hypertension) in China[4]. With the aging population, the incidence rate of VHD is increasing. Traditionally, VHD was treated mainly with surgery in addition to medications. Interventional therapy has revolutionized the treatment of VHD, and is increasingly used. Randomized controlled trials have demonstrated the safety and efficacy of interventional therapy for VHD, first in inoperable, and then in high-risk, intermediate, and most recently low-risk patients[5–9].

Interventional therapy for VHD in China started relatively late. However, the number of medical centers that provide interventional therapy for VHD on routine basis has been increasing rapidly. With the rapid growth, many challenges emerge: a lack of standardized diagnosis and treatment process, along with high rates of missed and misdiagnosis cases; a lack of standardized management of VHD patients and secondary prevention measures. The first HVC in China was established in 2019 to address the emerging needs, and specifically, to serve as a regional center to provide patient management as well as a national center for training of management team and specialists.

Certification standards of the China HVC

Certification standards for HVC were formulated by the HVC headquarter, and include 4 elements: basic conditions, standardized diagnosis and treatment of VHD, training and education, and continuous improvement mechanism.

The first consideration of the certification is the quality of the multidisciplinary team in the management of VHD, including clinical and interventional cardiologists, cardiac surgeons, imaging specialists with expertise in interventional imaging, cardiovascular anesthesiologists, and other specialists if necessary (eg, heart failure specialists, electrophysiologists, dietitian)[10–12]. Dedicated nursing personnel with expertise in the care of patients with VHD are also important. Heart Valve Clinics are an important component of the HVCs, aiming to provide standardized organization of care based on the guidelines. Access to Heart Valve Clinics improves outcomes[13]. Expertise in relevant areas outside strictly-defined VHD, including coronary artery disease, is also considered.

Techniques with a steep learning curve may be performed with better results at hospitals with high procedural volume and experience. The relationship between case volume and outcomes for surgery and transcatheter interventions is complex and must be fully recognized[14–16]. However, the precise number of procedures per individual hospital required to provide high-quality care remains controversial[17]. The current standard is a minimum of 150 transcatheter aortic valve implantation (TAVI) operations in 3 years for HVC certified centers, and a minimum of 30 TAVI operations in 3 years for HVC construction centers. Basic requirements for HVC certified centers and HVC construction centers are summarized in Table 1.

Table 1 - Basic conditions of HVC in China
Certified centers Construction centers
Hospital documents Official document to establish the HVC The same
Outpatient and emergency Heart Valve Clinics and first aid equipment available The same
Inpatient department Intensive care unit and operating rooms available The same
Staffing Interventional cardiologists, cardiac surgeons, imaging
specialists, anesthesiologists, etc.
The same
PCI operation volume/year >800 >500
Echocardiography volume/year >3000 >2000
Volume of valve intervention in recent 3 years >150 >30
HVC: Heart Valve Center; PCI: Percutaneous coronary intervention.

All HVCs must implement structured training programs for interventionalists, cardiac surgeons, and imaging specialists[10,15,18]. The programs must be led by competent mentors.

Continuous improvement is the core value of HVC certification. The HVC headquarter set 11 key performance indicators (KPIs) for the quality control of each HVC: in-hospital mortality, 30-day mortality, 1-year mortality, 30-day stroke, 1-year stroke, conversion to surgery, coronary artery obstruction, pericardial tamponade, moderate/severe paravalvular leak, major vascular complications, and life-threatening or major bleeding. HVC is required to complete, update, and improve these KPIs. HVCs should provide services at the community level, and promote networking with other medical departments, referring cardiologists and primary care physicians.

Upon application by candidate centers at www.valvecenter.org.cn, the HVC headquarter in charge of the region will organize on-site audit. Certification is voted by the member of the China HVC accreditation committee.

The NTCVR database

The NTCVR was launched in April 2021. The NTCVR uses a Case Report Form (CRF) table modified from that used by HVCs in developed countries for use in Chinese patients. All valve intervention cases of HVCs must be reported using this CRF.

The NTCVR has six features: (1) All case data are from patients who received treatment for a confirmed diagnosis; (2) Management process is recorded in sufficient details; (3) All data shall be consistent with the original medical records and documents, and thus ensure data accuracy; (4) Demographic information, preoperative evaluation, image evaluation, intraoperative records, perioperative event records, discharge medication and post discharge follow-up can be verified through case records and original examination documents; (5) Data entry is conducted within 30 days after patient discharge; data archiving was conducted within 60 days after patient discharge. If a third-party database is used, the data docking time is within 30 days after patient discharge; (6) All data in the NTCVR database are shared among all HVCs. To safeguard data security, document of data use and publication of HVCs are formulated by the HVC headquarter. Individual HVC centers may apply to use the NTCVR data for research purpose, but must follow the rules.

The HVC headquarter publishes data quality report regularly, and appoints administrators to audit the data collected from individual centers. The goal of NTCVR is to establish a national database and to promote the interventional treatment of VHD in China.

Current status of HVCs in China

The first China HVC was established in June 2019; the first China HVC headquarter was established under the auspices of the China Cardiovascular Health Alliance (CCA) in Suzhou. The headquarter is responsible for coordination of resources, training, and education and the accreditation office maintains full responsibility for accreditation. The construction of the HVC requires multidisciplinary cooperation at the hospital level. The hospital issues official documents to establish HVC and Heart Valve Center committee, and the committee should include a panel of interventional cardiologists, cardiac surgeons, imaging specialists, cardiovascular anesthesiologists, and experts in critical care medicine and emergency medicine. The medical director at the participating center may appoint a secretary to coordinate the daily work.

Up to April 2022, there are 83 registered HVCs in China, covering 25 provinces. Fifty-seven HVCs have started data entry (Figure 1). The NTCVR now includes a total of 5062 cases, 4787 cases (94%) involving the aortic valve and 275 cases (6%) involving other valves (Figure 2). A number of hospitals are planning or in the process of establishing HVCs and are expected to apply for accreditation over the next 1 to 2 years.

F1
Figure 1.:
Trend of registered Heart Valve Centers in China after the launch of National Transcatheter Valve Therapeutics Registry from 2021 to 2022.
F2
Figure 2.:
Valve type distribution of National Transcatheter Valve Therapeutics Registry.

The NTCVR database faces a variety of challenges: (1) Most centers have not initiated consistent reporting to the NTCVR database. Since the first case in China by Ge et al in 2010[19], TAVI has been increasingly common in a variety of hospitals in China. There is substantial back-log since majority of the HVCs are in the process of logging in past TAVI cases; (2) Data quality, and particularly follow-up, requires substantial improvement. As for now, the follow-up rate is 20% at 1 month, 9% at 3 months, and 8% at 12 months. (3) The workload of data entry is heavy. For each case, data in the following six categories are needed: demographic and baseline clinical characteristics, preoperative evaluation (including preoperative echocardiography and computed tomograph scan), intraoperative record, perioperative events, discharge medication, and follow-up (including 1, 3, 6, and 12 months). To ensure the accuracy and timeliness of data entry, full-time employees are needed at each HVC. Tasks of the HVC headquarter in the immediate future included: (1) To publish monthly data quality report, and to organize periodic training sessions; (2) Appoint regional administrators and set up routine data audit at all participating HVCs.

In summary, HVCs in China are relatively new but have entered an era of rapid development. Management standardization and continuing education are expected to improve routine patient care and narrow the regional gap in the diagnosis and treatment of VHD.

FUNDING

This study is supported by the National Key R&D Program of China (2020YFC2008100).

AUTHOR CONTRIBUTIONS

NH participated in data analysis and the writing of the paper; WP participated in data analysis and the revising of the paper; DZ and JG participated in study design and supervision.

CONFLICTS OF INTEREST STATEMENT

Junbo Ge is the Editor-in-Chief of Cardiology Plus. The article was subject to the journal’s standard procedures, with peer review handled independently of these Editorial Board members and their research groups.

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Keywords:

Heart valve diseases; Accreditation; Transcatheter aortic valve replacement; Registry

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