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研究生：	郭德輝 Kuo, Te-Hui
論文名稱：	血液透析血管通路應該在早期或晚期建立？從其醫療風險或益處分析 Should the vascular access for hemodialysis be created early or late? Analysis of healthcare risks and benefits
指導教授：	李中一 Li, Chung-Yi
學位類別：	博士 Doctor
系所名稱：	醫學院 - 公共衛生學系 Department of Public Health
論文出版年：	2022
畢業學年度：	110
語文別：	英文
論文頁數：	127
中文關鍵詞：	血管通路、時機、血液透析、死亡率、花費成本
外文關鍵詞：	Vascular access, Timing, Hemodialysis, Mortality, Cost
相關次數：	點閱：108 下載：4
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透析血管通路是接受血液透析的終末期腎病病人的生命線，而血液透析病人又因晚期慢性腎病相關因素容易有著高死亡率、高疾病共病症和高醫療保健支出。過去研究指出及時轉診並建立透析血管通路可以降低血液透析病人透析之後的死亡率，但這些虛弱的晚期慢性腎病病人又常常在開始血液透析前就面臨死亡，導致可能事先做了沒使用到的透析血管通路。因此，各個透析相關臨床指引中，主要基於專家意見去衡量建立透析血管通路的益處和風險，不同的指引建議了不同的透析血管通路手術轉介時間。鑑於目前仍缺乏藉由實際醫療保健資料及花費來評估不同建立透析血管通路時機的研究，因此本研究欲從其醫療風險或益處來分析血液透析血管通路是應該及早還是較晚才來建立。本研究有兩個目的，第一個目的是比較早期或較晚建立透析血管通路時的風險或益處，藉由健保資料庫資料分析不同血管通路建立時間的死亡率、醫療保健利用率和醫療花費；第二個目的是找出導致透析前早亡（定義為晚期慢性腎病病人建立透析血管通路後，未開始接受透析就已死亡）的風險因素。
研究第一部分納入於2003年1月1日至2013年12月31日期間首次接受血液透析的終末期腎病病人，這些病人會於首次透析日期後追蹤兩年，並根據建立透析血管通路的時間進行分層：血管通路建立在初次透析前超過 180 天、91~180 天、31~90 天、前30天內，以及在初次透析開始後30天內五組。在兩年的追蹤期間，計算並比較了這五組病人的死亡率、醫療保健利用率和醫療花費。研究期間有 77,205名病人首次接受血液透析：4,919名病人在初次透析180天前，4,180名在91~180天內，8,767名在31~90天內，47,115名在前30天內建立血管通路，以及12,224名在初次透析後30天內建立血管通路。在初次透析開始前30天內建立血管通路的病人死亡率最高（每100人年15.92），較其他四組病人門診醫療利用率低（每人年43.14）、門診醫療費用低（每人年593,100點數）、住院次數高（每人年1.86）、住院費用高（每人年24.96萬點數）、總醫療保健費用高（每人年84.27萬點數）。死亡率和總醫療保健費用第二高的是血管通路建立在初次透析後30天內的病人：死亡率為每100人年13.82，住院和門診總費用為每人年804,800點數。
本研究的第二部分的研究對象為提前準備好透析血管通路的晚期慢性腎病病人。於2003年1月1日至2013年12月31日期間，有38,673名病人在初次血液透析開始前或者是在死亡前有接受了第一次透析血管通路手術。第一次透析血管通路手術後2年內有922名病人未接受透析就死亡（2.38%），死亡率為每1000人月5.88。透析前早亡的危險因子包括血管通路類型為永久性導管（每1000人月25.56）、男性（每1000人月6.56）和年紀為75 歲以上（每1000人月10.80）。另外透過Cox存活分析(以初次血液透析開始作為設限[censor])找出晚期慢性腎病病人透析前早亡的危險因子為：年齡（75歲以上與45歲以下相比，調整後風險比 [adjusted hazard ratio, aHR] 3.11 [95%信賴區間(confidence interval, CI) 2.10-4.58），男性（aHR 1.36 [95% CI 1.17-1.57]），血管通路類型為永久性導管（aHR 5.38 [95% CI 4.39-6.60]，與動靜脈瘻管相比），較低健保保險費用投保級距（aHR 1.54 [95% CI 1.27-1.88]，級距<15,000，與>25,000相比），台灣東部和離島的地理區域（aHR 1.41 [95% CI 0.97-2.05]，與北部地理區域相比），以及大多數心血管相關共病症。
總結，較晚建立透析血管通路會增加透析病人在初次透析開始後兩年內的死亡率、住院率和總體醫療費用。雖然有些病人在未透析前建立血管通路會面臨透析前早亡的情形，但其比例其實不高，因此仍建議預先提早建立透析血管通路。儘管如此，在為病人計畫建立透析血管通路的同時，我們仍然需要考量各個透析前早亡的風險因子，如：年齡、性別、各種共病症和病人特徵，為每個晚期慢性腎病病人找出其建立透析血管通路的適當時機。

Vascular access (VA) is considered a lifeline for patients with end-stage kidney disease (ESKD) receiving hemodialysis (HD), who are noted for their high mortality, morbidity, and healthcare expenditure related to their advanced chronic kidney disease (CKD). Timely referral for VA creation can affect HD patients’ outcome to reduce mortality, but unnecessary VA may be created if death competes for HD initiation in these frail CKD patients. Therefore, different timings of referral for VA creation are suggested in the clinical practice guidelines, mostly based on expert opinions, to balance benefits and risks of VA creation in advance. Given the lack of studies evaluating real world healthcare outcomes for different timings of VA creation, the present study has two goals to clarify whether VA for HD should be created early or late. The first goal is to explore risks and benefits, including mortality, healthcare utilization and costs, when VA is created either early or late, and the second one is to find out risk factors contributing to premature death, defined as death after VA creation but without HD initiation in advanced CKD patients, by analyzing the National Health Insurance administrative data.
The cohort in the first part of the study consisted of incident ESKD patients who received their first HD from January 1, 2003 to December 31, 2013. These patients were followed up for two years after their first reported date of dialysis. These patients were stratified according to the time of VA creation: over 180 days, 91~180 days, 31~90 days, within 30 days before HD initiation and within 30 days after HD initiation. During the 2-year follow-up period, mortality, health service utilization and costs were calculated and compared for these five groups of patients. There were 77,205 patients initiating HD during the study period: 4,919 having VA creation over 180 days, 4,180 within 91~180 days, 8,767 within 31~90 days, 47,115 within 30 days prior to HD initiation, and 12,224 within 30 days post the first HD. Those who received VA creation within 30 days before HD initiation had the highest mortality density (15.92 per 100-person-years), less ambulatory care utilization (43.14 per person-year) and less ambulatory care cost (593,100 reimbursement points per person-year), more hospital admission (1.86 per person-year) and more hospitalization cost (249,600 reimbursement points per person-year), and more total expenditure (842,700 reimbursement points per person-year) than the other four groups of patients. Those receiving VA creation within 30 days after HD initiation had the second highest mortality and total health care costs: 13.82 per 100-person-years in mortality and 804,800 reimbursement points per person-year in total inpatient plus outpatient costs.
The study population of the second part of this study was from advanced CKD patients who prepared their VAs in advance. There were 38,673 patients receiving their first VA operation either before HD initiation or before their deaths in the period from January 1, 2003 to December 31, 2013. Nine hundred and twenty-two patients died without HD initiation within 2 years after their first VA (2.38%) and the mortality density was 5.88 per 1,000 person-months. Risk factors for premature death after VA creation included VA type of permanent catheter (25.56 per 1,000 person-months), male gender (6.56 per 1,000 person-months), and age of 75 years or above (10.80 per 1,000 person-months). Survival analysis by Cox regression, with HD initiation as a censor, revealed that age (adjusted hazard ratio [aHR] 3.11 [95% confidence interval (CI) 2.10-4.58] in aged 75 or more, compared with aged less than 45), male gender (aHR 1.36 [95% CI 1.17-1.57]), VA type of permanent catheter (aHR 5.38 [95% CI 4.39-6.60], compared with arteriovenous fistula), low income-based insurance premium (aHR 1.54 [95% CI 1.27-1.88] in <NT$15,000 compared with >NT$25,000) and geographic region in eastern and outlying island of Taiwan (aHR 1.41 [95% CI 0.97-2.05], compared with the northern geographic region), and most cardiovascular-related comorbidities, were risk factors of premature death in patients with advanced CKD after their VA creations.
In conclusion, late VA creation for HD can increase the mortality rate, hospitalization rate, and healthcare costs within two years after HD initiation. Although some patients experience premature deaths after VA creation, the proportion is not high enough to argue against early VA creation. Nevertheless, we still have to keep premature death in mind and consider age, sex, underlying comorbidities, and other patient characteristics to determine a proper timing for VA creation.

Abstract III
Acknowledgement VII
Introduction 1
Study aims and research questions 3
Timing of VA creation with better post-HD outcomes 3
Identifying patients who cannot benefit from early VA creation: clinical application in decision making 3
Literature review 5
Timing of VA creation 5
Pre-emptive VA creation but without HD initiation (competing risks of death—premature death, survival without requiring HD, or VA failure to mature) 7
Cost-effectiveness of the timing of VA creation 8
Materials and methods 13
Study data source 13
Patient selection 13
Study design 15
Statistical analysis 22
Results 23
Part 1. Mortality, health care utilization, and expenditure within 2 years after hemodialysis initiation according to VA operation timings. 23
1.1 Baseline characteristics and descriptive epidemiology 23
1.2 Mortality 26
1.3 Healthcare utilization and costs 27
Part 2. Patients experiencing premature death after VA creation (i.e. death before HD initiation but with an existing VA). 29
2.1 Baseline characteristics and descriptive epidemiology 29
2.2 All-cause mortality 30
2.3 Cox proportional hazard model 31
Discussion 34
Early creation of VA, at least one month before HD initiation, can reduce post-HD mortality, hospitalization and healthcare costs 35
How to explain the findings-- the earlier of VA creation, the better? 37
Premature death after VA creation cannot change our results a lot 40
Cost saving after HD initiation if VA prepare at least one month earlier before HD 41
Patients cannot be well categorized into CKD stage 5 and non-CKD stage 5 by whether ESA use or not in the NHI database 43
To categorize patients according to the first or the last VA type before HD is not a concern to change the study results 45
Characteristics of patients who had VA in advance but cannot survive long enough to receive HD (premature death after VA creation) 46
Socioeconomic state and geographic region in Taiwan affecting premature death after VA creation 51
Limitations 53
Conclusion 57
References 103
Appendix 113
 
List of Tables
Table 1-1-1. Characteristics of patients (according to the first vascular access type before hemodialysis by date*) 58
Table 1-1-2. Type of HD vascular access (according to the first vascular access type before hemodialysis by dates*) 61
Table 1-1-3. Type of HD vascular access (according to the last vascular access type before hemodialysis by dates*) 62
Table 1-1-4. Characteristics of patients (according to the first vascular access type before hemodialysis by whether ESA use*) 63
Table 1-1-5. Type of HD vascular access (according to the first vascular access type before hemodialysis by whether ESA use*) 66
Table 1-1-6. Type of HD vascular access (according to the last vascular access type before hemodialysis by whether ESA use*) 67
Table 1-2-1. Mortality density within 2 years after hemodialysis according to the first vascular access type before hemodialysis by dates* 68
Table 1-2-2. Mortality density within 2 years after hemodialysis according to the last vascular access type before hemodialysis by dates* 70
Table 1-2-3. Mortality density within 2 years after hemodialysis according to the first vascular access type before hemodialysis by whether ESA use* 72
Table 1-2-4. Mortality density within 2 years after hemodialysis according to the last vascular access type before hemodialysis by whether ESA use* 75
Table 1-3-1. Ambulatory care utilization and expenditure according to the first vascular access type before hemodialysis by dates* 78
Table 1-3-2. Ambulatory care utilization and expenditure according to the last vascular access type before hemodialysis by dates* 79
Table 1-3-3. Hospital admission utilization and expenditure according to the first vascular access type before hemodialysis by dates* 80
Table 1-3-4. Hospital admission utilization and expenditure according to the last vascular access type before hemodialysis by dates* 81
Table 1-3-5. Ambulatory care utilization and expenditure according to the first vascular access type before hemodialysis by whether ESA use* 82
Table 1-3-6. Ambulatory care utilization and expenditure according to the last vascular access type before hemodialysis by whether ESA use* 84
Table 1-3-7. Hospital admission utilization and expenditure according to the first vascular access type before hemodialysis by whether ESA use* 86
Table 1-3-8. Hospital admission utilization and expenditure according to the last vascular access type before hemodialysis by whether ESA use* 88
Table 1-3-9. Total expenditure according to the first vascular access type before hemodialysis by dates* 90
Table 1-3-10. Total expenditure according to the first vascular access type before hemodialysis by whether ESA use* 91
Table 2-1. Characteristics of patients with the first vascular access created in the period of 2003~2013 (n=38,673). 93
Table 2-2. All-cause mortality in the following 2 years after the first vascular access creation in the period of 2003~2013 (n=38,673). 96
Table 2-3. Risk of mortality by Cox model and Fine & Gray model with hemodialysis as a competing risk within 2 years after the first vascular access creation in the period of 2003~2013 (n=38,673). 99
Supplementary Table 1. National Health Insurance (NHI) procedure codes related to vascular access 109
Supplementary Table 2. National Health Insurance (NHI) codes for ESA 110
Supplementary Table 3. Types of vascular access at hemodialysis initiation 111
Supplementary Table 4. ICD-9-CM codes for clinical conditions 112

 
List of Figures
Figure 1. Study design of VA creation classified by time period before HD initiation and post-HD outcome follow-up 17
Figure 2. Study design of VA creation classified by ESA use as a proxy of CKD stage 5 (eGFR<15) before HD initiation and post-HD outcome follow-up 17
Figure 3. Examples of rationale behind “intention to treat”-like or “per protocol”-like VA grouping for patients in our study 19
Figure 4. Study design to identify patient characteristics and risk factors for premature death after VA creation 20
Figure 5. Comparisons of Kaplan-Meier failure estimates of mortality among the VA types (n=38,673). 98
Figure 6. A log–log survival curve for evaluating the proportional hazard assumption (n=38,673). 102
                                    

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