遠距監測於台灣心臟電子儀器置入病人醫療照護之研究

Impact of Remote Monitoring in Patients with Cardiovascular Implantable Electronic Devices (CIEDs) on Health Care in Taiwan: The Clinical Experience from National Taiwan University Hospital

劉言彬(Yen-Bin Liu)

指導教授 ： 翁崇雄

國立臺灣大學/管理學院/資訊管理組/碩士(2018年)

https://doi.org/10.6342/NTU201800177

摘要

「遠距醫療」泛指應用媒體科技系統、突破時間與空間的控制、以從事互動式的醫療專業顧問與諮詢。遠距醫療的優點在於「打破時空限制」和「資源分享，節省成本」。臺大醫院遠距照護中心設立於2009年，採用互動式資料蒐集與分析系統，且即時反應的遠距照護模式，提供病患遠距式的持續性醫療照護。
植入式電子儀器旨在植入在病人體內多年，可間歇地、長時間地監測追蹤關於可植入系統的性能或病人的健康的信息。現今置入式心臟電子儀器的技術發展，心臟電子儀器已可記錄許多和儀器本身功能及病人心律不整或心臟功能變化指標的資訊，並可藉由遠距監測自動取得且通知病人及醫師，遠距監測心臟電子儀器的發展，將使心臟電子儀器置入病人其臨床照護及追蹤產生結構性的改變。關於心血管疾病之遠距醫療照護之臨床實證，在隨機分派的大型臨床試驗中並未證實對於「沒有植入式心臟電子儀器」之病人可以顯著減少有關病人之死亡率和心臟衰竭相關住院率。
就台大醫院本身而言，期望藉由遠距醫療照護的特點，克服龐大的臨床服務量壓力，在人力、空間、就醫流程的困境上，改善醫療品質，也利用植入式電子儀器遠距監測突破台大醫院遠距照護中心的發展瓶頸。植入式電子儀器遠距監測的導入，在病人端、醫療從業人員以及機構端三方面均有可預期的障礙與困難，我們透過必要的措施盡力消除克服，期能在醫療照護、臨床研究及產學合作構面上為組織帶來優勢與競爭力。
為此，我們建立了台大醫院心臟電子儀器置入病人之遠距監測的營運模式，透過心臟電子儀器之記錄電子化，將心臟電子儀器之記錄自動無線傳輸至雲端，雲端記錄可跨平台讀取，並導入台大醫院電子病歷，可電子簽章認證，永久儲存。未來將整合不同廠家的心臟電子儀器記錄之 HL7 database，建立屬於台大醫療體系之心臟電子儀器病人資料庫。我們進行了一項病例對照研究，發現植入式心臟電子儀器病人在台灣之環境下，無線傳輸的可靠性高達99％。因臨床事件或儀器異常所產生的警訊傳輸約佔27.8％；臨床事件中又以心房心律不整(主要是心房顫動)居多，發生比率佔研究人群50％以上。此外，遠距監測對心房顫動事件臨床決策時間平均可提前14天，有助於心房顫動的即早治療及中風預防，惟遠距監測組有較多的診間隨訪次數，且最後影響臨床決策的比例與傳統診間隨訪組並無差異。植入式心臟電子儀器病人的生活品質方面，兩組無顯著不同，這可能是追蹤時間過短、植入式心臟電子儀器病人遠距監測照護初建立或台灣地區傳統診間就診十分方便等因素所造成。但因遠距監測無線傳輸造成的植入式心臟電子儀器電池壽命減少，則是技術上待克服的課題。
根據臺大醫院對於植入式心臟電子儀器病人的遠距照護經驗，遠距照護的確可改善植入式心臟電子儀器病人的就醫可近性及可負擔性，提升醫療照護品質。植入式心臟電子儀器病人的遠距照護是一種以「不一樣的遠距監測方式」、對「特定醫療需求的病人族群」，進行「長時間、連續性的監測」。國外經由隨機分派的臨床試驗以及大型世代觀察型研究，發現接受遠距監測可有效降低植入式心臟電子儀器病人的全因總死亡率，改善病人預後。台灣的遠距監測尚屬建置初期，臨床經驗有限，雖有初步成效，但尚未觀察到病人預後的改變。期能透過克服法律與監管、科技技術及財務層面上的障礙與挑戰，結合政府與民間的力量，將台灣作為植入式心臟電子儀器置入病人遠距醫療照護研發基地，建立有競爭力的商業模式，藉由中國市場的經濟規模，開創植入式心臟電子儀器置入病人遠距醫療照護中國市場的藍海策略；並以此照護模式為借鏡，提供台灣資訊科技產業及生技醫療產業轉型的可能方向。

關鍵字

遠距醫療照護 ； 植入式心臟電子儀器置 ； 醫療品質 ； 發展策略

並列摘要

Telemedicine refers to the application of media technology, breaking the limitation of time and space to engage in interactive medical professional consultants. The Telemedicine Center of National Taiwan University was established in 2009 to provide remote, continuous medical care to patients using an interactive data collecting and analyzing system that responds instantaneously.
Implanted electronic devices are intended to be implanted in a patient for many years to monitor intermittently or continuously tracking information regarding the performance of the implantable system or the patient's health status. Clinical evidence of telemedicine for cardiovascular disease has not been shown in large randomized clinical trials to significantly reduce heart failure-related hospitalizations and/or mortality for patients without implanted devices.
For National Taiwan University Hospital (NTUH), the introduction of remote monitoring of CIEDs has predictable obstacles and difficulties in terms of patient end, medical practitioner and hospital organization.
We have established a remote monitoring operating system in patients with CIEDs at NTUH. The recording of the CIEDs were wirelessly transmitted to the cloud and integrated with the NTU's electronic medical records, which can be electronically signed and certified for permanent storage. A prospective, case-control study was conducted at NTUH. During a one-year and four-month follow-up period, the reliability of wireless data transmission of CIEDs in Taiwan is high (99%). Alter- initiated transmission accounts for about 27.8% of all transmission and 57% of alter transmission are arrhythmia-related warning. Although there were more follow-up visits in the remote monitoring group, there was no difference in medication adjustment between the remote monitoring group and the control group. The clinical time to decision for atrial fibrillation was 14 days earlier in patients with remote monitoring, which is helpful for the early treatment of atrial fibrillation and stroke prevention. We also surveyed patients in the remote monitoring group, their quality of life before and after 6-12 months being monitored remotely, and the results showed no significant change.
We believe that telemedicine can indeed improve the accessibility and affordability of patients with CIEDs compared to traditional medical care and also improve the quality of medical care. Remote monitoring for CIEDs is a "long-term, continuous monitoring “ in a patient population with “specific medical needs" using a "different remote monitoring methods". Taiwan is still at an initial stage of establishment, and our clinical experience is limited. Although preliminary results have been obtained, the prognosis of patients has not been observed yet. We look forward to establishing Taiwan as a place of the R&D center for remote medical care for CIED patients by overcoming legal and regulatory, technological and financial barriers.

並列關鍵字

Remote monitoring ； Telemedicine ； Implantable cardiac electronic device ； Quality of

參考文獻

1. 陸哲駒、陳恆順、鄭伯壎、賴金鑫，2004，遠距醫療的發展與落實，台灣醫學，8(6)：826-831。

4. Children’s Health Insurance Progam (CHIP): https://www.medicaid.gov/chip/index.html

6. Bazaka K, Jacob MV. Implantable Devices: Issues and Challenges. Electronics 2013, 2, 1-34; doi:10.3390/electronics2010001.

7. Heidbüchel H, Lioen P, Foulon S, Huybrechts W, Ector J, Willems R, Ector H. Potential of remote monitoring for scheduled and unscheduled evaluations of patients with an implantable defibrillator. Europace 2008; 10: 351–357.

9. Hanlon P, Daines L, Campbell C, McKinstry B, Weller D, Pinnock H. Telehealth Interventions to Support Self-Management of Long-Term Conditions: A Systematic Metareview of Diabetes, Heart Failure, Asthma, Chronic Obstructive Pulmonary Disease, and Cancer. J Med Internet Res. 2017; 19(5): e172.