Heart Transplantation Performance in China: Five-Year Experience After Transplantation System Reform
China’s heart transplantation system underwent significant reforms between 2005 and 2015 to address systemic challenges, including organ shortages, lack of transparent allocation mechanisms, and inconsistent quality control. This article synthesizes findings from a nationwide analysis of heart transplantation outcomes between 2015 and 2019, evaluating the impact of these reforms on organ donation, allocation, and clinical outcomes. Comparisons with contemporary U.S. data provide context for understanding China’s progress and remaining gaps.
Evolution of China’s Heart Transplantation System
The reform era (2005–2015) established a legal and ethical framework for organ donation and transplantation. Key milestones included the creation of the China Organ Donation and Transplantation Committee (2007), the introduction of brain death criteria (2013–2014), and the implementation of the China Organ Transplant Response System (COTRS) for organ allocation. By 2015, three categories of deceased organ donation were standardized:
- Category I: Organ donation after brain death.
- Category II: Organ donation after circulatory death.
- Category III: Organ donation after brain death followed by circulatory death.
These categories aimed to balance medical feasibility with cultural acceptance, particularly through Category III, which facilitated public understanding of brain death. A national promotion strategy further encouraged organ donation, leveraging China’s socioeconomic diversity.
Organ Allocation and Quality Control Mechanisms
The COTRS prioritized organ allocation based on urgency scores, geographic proximity, age, and blood type compatibility. This system emphasized rescuing critically ill patients while optimizing transplant survival rates. Concurrently, the China Heart Transplant Registry (CHTR) mandated comprehensive data reporting from all qualified centers, covering donor-recipient demographics, surgical details, postoperative care, and outcomes. Quality control metrics included six process measures (e.g., timely reporting of complications), three outcome measures (e.g., in-hospital mortality), and three data quality benchmarks. Annual reports enabled hospitals to benchmark performance and implement improvements.
Five-Year Outcomes (2015–2019)
A total of 2,262 heart transplants were performed across 57 centers during this period. Annual transplant volume increased steadily, from 279 in 2015 to 557 in 2020. Key findings included:
Organ Donation Trends
The organ donation rate per million population (PMP) rose from 2.01 in 2015 to 4.16 in 2019, reflecting improved public engagement and institutional efficiency. However, this rate remained below that of the U.S., which reported a PMP of 11.3 in 2019.
Waiting List Mortality
In 2019, the mortality rate among patients awaiting transplantation was 6.0% (75 of 1,248), lower than the U.S. rate of 9.1% for the same year. This difference was attributed to China’s prioritization of critically ill patients in allocation policies.
In-Hospital and Post-Transplant Mortality
In-hospital mortality averaged 7.6% (171 of 2,262) across all centers, with no significant annual trend (6.3% in 2015 vs. 6.8% in 2019). However, stratification by center volume revealed divergent outcomes:
- High-volume centers (≥20 transplants/year): Adjusted in-hospital mortality declined significantly (5.9% in 2015 to 3.1% in 2019; P for trend = 0.036).
- Low-volume centers (<20 transplants/year): Mortality rates fluctuated between 7.1% and 11.7%, with no improvement trend (P = 0.856).
One-year post-transplant mortality was 16.6% overall, with significant disparities between high-volume (13.7%) and low-volume (22.8%) centers (P <0.001). In the U.S., one-year mortality was lower (9.4%), highlighting areas for improvement in China’s long-term post-transplant care.
Comparative Analysis: China vs. the United States
While China’s reforms narrowed gaps in acute outcomes, differences persisted in donor availability and long-term survival:
- Donor Availability: The U.S. PMP (11.3) far exceeded China’s 4.16, underscoring the need for continued public awareness campaigns.
- Waiting List Management: China’s lower waiting list mortality (6.0% vs. 9.1%) suggested effective prioritization of high-risk patients.
- Clinical Outcomes: Comparable in-hospital mortality (China: 6.8% vs. U.S.: 7.4%) indicated procedural parity, but higher one-year mortality in China (16.6% vs. 9.4%) pointed to challenges in immunosuppression management, infection control, and follow-up care.
Challenges and Future Directions
The study identified several areas for improvement:
- Expanding Organ Donation: Despite progress, donation rates remain insufficient. Targeted campaigns and simplified donation processes could enhance participation.
- Standardizing Care Across Centers: The mortality gap between high- and low-volume centers calls for centralized training programs and regional referral networks.
- Strengthening Post-Transplant Care: Investments in outpatient monitoring, patient education, and access to immunosuppressive therapies may improve long-term survival.
- Data Transparency and Collaboration: Open access to CHTR and COTRS data could foster international collaborations and accelerate quality improvement.
Conclusion
China’s heart transplantation system achieved measurable progress in donation rates, allocation equity, and surgical safety following the 2005–2015 reforms. The establishment of COTRS and CHTR provided a foundation for data-driven quality control, while culturally adapted donation policies enhanced public trust. However, persistent challenges in donor shortages and post-transplant care necessitate ongoing reforms. By addressing these gaps, China can further align its transplantation outcomes with global benchmarks, offering a model for other nations navigating similar challenges in organ transplantation.
doi.org/10.1097/CM9.0000000000003488
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