ORIGINAL ARTICLE: Clinical Endoscopy. Life after per-oral endoscopic myotomy: long-term outcomes of quality of life and their association with Eckardt scores.
ORIGINAL ARTICLE: Clinical Endoscopy
Life after per-oral endoscopic myotomy: long-term outcomes of quality of life and their association with Eckardt scores Yaseen B. Perbtani, DO,1 Lazarus K. Mramba, PhD,2 Dennis Yang, MD,1 Jorge Suarez, MD,1 Peter V. Draganov, MD1 Gainesville, Florida, USA
Background and Aims: The clinical efficacy of per-oral endoscopic myotomy (POEM) has been commonly established by reduction in the Eckardt score (12-months follow-up group. The mean Eckardt score significantly improved when compared with baseline (7.8 2.5) at both 1 to 3 month (0.9 0.18) and 6 to 9 month (1.3 0.25), and it remained low after 12 months Volume 87, No. 6 : 2018 GASTROINTESTINAL ENDOSCOPY 1417
Quality of life outcomes and their association with Eckardt scores after POEM
*
*
*
70
72
68
20 0
M hs hs s + OE ont ont nth P o e m m Pr 1-3 6-9 2 m 1
70
61 45
* 59
*
*
70
70
* 67
s s + EM nth nth ths O o o n o eP m m Pr 1-3 6-9 2 m 1
100 80 60 40 20 0
57
*
*
*
65
63
61
M ths hs s + OE on ont nth P o m m e Pr 1-3 -9 2 m 6 1
Figure 2. Physical component summary domains over time. * Z P < .05. QOL, quality of life; POEM, per-oral endoscopic myotomy.
Sum Physical and Mental Scores Over Time 100 QOL Score
80 60 40
55
5
4 3 0
General Health QOL Score
QOL Score
60
20 0
*
*
M ths ths s + OE on on nth P m o m e Pr 1-3 6-9 2 m 1
Pain 100 80 60 40 20 0
100 80 60 40
Mean eckardt scores
62
6
Role Physical QOL Score
QOL Score
Physical Function 100 80 60 40
Perbtani et al
62
* *
* *
71
69 73
66
* 64
* 71
75 50 25 Average HRQOL scores
100
Figure 4. Association between Eckardt8 and HRQOL scores. HRQOL, health-related quality of life.
component and physical component summary scores at baseline and at different intervals after POEM. Mental component summary scores were significantly improved when compared with baseline (61.5 2.2) at 1 to 3 months (71.4 1.9; P < .05), 6 to 9 months (72.6 2.7; P < .05), and 12þ months’ follow-up (71.2 3.6; P < .05). Physical component summary scores also were seen to significantly improve when compared with their baselines (55.8 2.2) at all interval clinical follow-ups including 1 to 3 months (66.6 1.9; P < .05), 6 to 9 months (69 2.5; P < .05), and 12þ months follow-up visits (63.6 3.3; P < .05). Eckardt versus HRQOL. The association between the Eckardt scores and HRQOL were examined through a mixed-model analysis. There was a significant correlation between postprocedural decrease of the Eckardt score and increase in all HRQOL domains and composite scores as seen in Figure 4 and Table 2 (P < .01).
20 0 Pre POEM
1-3 months 6-9 months 12 months +
DISCUSSION
(1.1 0.33) (P < .001). Overall, the clinical success rate for the POEM procedure was 97.2% (139/143). Four patients had an inadequate response after POEM based on highresolution manometry, and all subsequently underwent pneumatic dilation. Procedure impact on HRQOL. Figures 1 and 2 graphically depict the comparison between baseline and after-POEM changes in individual HRQOL domains. The mean scores of all HRQOL domains (Supplemental Table 1, available online at www.giejournal.org) improved significantly when compared with baseline at all followup visits (P < .05). Figure 3 shows the mental
In this study, we prospectively collected HRQOL beforeprocedure and after-procedure data on patients who underwent POEM for achalasia and esophageal spastic disorders. Overall, when compared with baseline, there was a significant improvement in all HRQOL domains at different after-POEM follow-up intervals. The mean physical and mental component summary scores also increased significantly after POEM and, even more importantly, were sustained at long-term follow-up. Our findings are congruent with a prior study reporting improvement of all HRQOL domains on short-term follow-up (6 months or less) after POEM.18 Although long-term outcomes (12 months and greater) of HRQOL after POEM are scarce, those available in the literature have not shown such a sustained global improvement in HRQOL domains as seen in our study.19-21 Notably, in most of these studies, POEM primarily improved HRQOL domains within the mental component score. These findings further allude to the
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Sum Physical
Sum Mental
Figure 3. Composite summary scores over time. * Z P < .05. QOL, quality of life; POEM, per-oral endoscopic myotomy.
Perbtani et al
Quality of life outcomes and their association with Eckardt scores after POEM
TABLE 2. Mixed-model analysis of the association between Eckardt scores8 and HRQOL Independent variable
Regression coefficient
Robust standard error
P value
-0.02
0.004
< .001
Physical function
-0.01
0.003
.008
Role limitation due to physical health
-0.01
0.002
< .001
Pain
-0.02
0.004
< .001
General health
-0.02
0.004
< .001
Physical composite summary
-0.03
0.004
< .001
Role limitations due to emotional problems
-.001
0.003
< .001
Energy/fatigue
-0.02
0.004
< .001
Emotional well-being
-0.03
0.005
< .001
Social functioning
-0.03
0.003
< .001
Mental composite summary
HRQOL, Health-related quality of life.
well-recognized social and economic burden that afflicts patients with esophageal dysmotility disorders and how it improves substantially after POEM.22 It is curious that the components of the physical component summary other than role limitation because of physical health did not sustain improvement at long-term follow-up in these studies because domains such as pain are directly asked when researchers are measuring clinical outcomes through the Eckardt score. Dissimilar patient populations may explain the discordance between our analyses and the aforementioned studies. In our study, nearly 22% of included patients underwent POEM for esophageal spastic disorders (jackhammer esophagus, esophagogastric outlet obstruction, and type III achalasia), in which pain may be the dominant symptom and the most notable to improve after the procedures. The relationship between the Eckardt score and a patient’s perception of the severity of their illness as determined by HRQOL scores has often been interrelated; however, it has not been thoroughly elucidated in past reports. Our study showed a significant inverse relationship between Eckardt scores and the HRQOL domains (improvement of the Eckardt score was related to an increase in HRQOL). Results from our mixed model’s analysis presented in Figure 4 and Table 2 indicate that Eckardt scores decrease as all HRQOL scores increase after POEM. The significance of this finding is that the Eckardt score can be used not only to measure treatment response after POEM but could potentially serve as a surrogate marker in the improvement of QOL after treatment of the disease. The validity of our findings is supported by a number of strengths of this study, including a prospective design with comprehensive and detailed assessment of all patients and a relatively large sample size of 143 patients. Furthermore, our study results on the positive effect of POEM in the treatment of achalasia as it pertains to the Eckardt score are in line with previously published reports, which gives www.giejournal.org
us reassurance that our findings on the HRQOL also have external validity. Also, we examined both the shortterm and long-term outcomes of HRQOL by using a validated instrument (SF-36). Finally, to our knowledge, this is the first study evaluating the association between the Eckardt score and HRQOL. Our study is not without limitations. All the procedures were performed by 1 endoscopist, which may limit the external validity of our findings. Our set-up, however, is typical because in most institutions a single provider performs all POEMs because achalasia is relatively uncommon, and there is a paucity of endoscopists trained to perform this technique.23 The SF-36 is a generic HRQOL survey that is applicable in an array of disease groups and is useful in comparison of the general population but may not be sensitive enough to measure the magnitude of outcomes associated with specific conditions such as achalasia. Therefore, an HRQOL that focuses on esophageal illness20 or is more specific for achalasia may provide more refined measures of the impact of POEM on patient QOL. Last, both the Eckardt score and HRQOL as measured by SF36 have the potential for recall and reporting bias. In summary, POEM is technically feasible and safe for the treatment of achalasia and esophageal spastic disorders. Our data support the rationale for using this minimally invasive approach because it improves symptoms of achalasia as measured by the Eckardt score. Importantly, we demonstrate that patients treated with POEM have improvement in quality of life as measured by the SF-36 and a significant negative correlation with the Eckardt score is maintained even at long-term follow-up. This study highlights that the Eckardt score and HRQOL are inversely correlated, and it is the first study to report improvement of all physical and mental domains as it pertains to the SF36 throughout their various follow-up visits. Our findings support the need for continued prospective studies in larger cohorts with longer follow-up, by using diseasespecific instruments. Volume 87, No. 6 : 2018 GASTROINTESTINAL ENDOSCOPY 1419
Quality of life outcomes and their association with Eckardt scores after POEM
REFERENCES 1. Park W, Vaezi MF. Etiology and pathogenesis of achalasia: the current understanding. Am J Gastroenterol 2005;100:1404-14. 2. Vaezi MF, Pandolfino JE, Vela MF. ACG clinical guideline: diagnosis and management of achalasia. Am J Gastroenterol 2013;108:1238-49; quiz 1250. 3. Inoue H, Minami H, Kobayashi Y, et al. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy 2010;42:265-71. 4. Inoue H, Sato H, Ikeda H, et al. Per-oral endoscopic myotomy: a series of 500 patients. J Am Coll Surg 2015;221:256-64. 5. Nabi Z, Ramchandani M, Chavan R, et al. Per-oral endoscopic myotomy for achalasia cardia: outcomes in over 400 consecutive patients. Endosc Int Open 2017;5:E331-9. 6. Haito-Chavez Y, Inoue H, Beard KW, et al. Comprehensive analysis of adverse events associated with per oral endoscopic myotomy in 1826 patients: an international multicenter study. Am J Gastroenterol 2017;112:1267-76. 7. Marano L, Pallabazzer G, Solito B, et al. Surgery or peroral esophageal myotomy for achalasia: a systematic review and meta-analysis. Medicine (Baltimore) 2016;95:e3001. 8. Eckardt VF. Clinical presentations and complications of achalasia. Gastrointest Endosc Clin N Am 2001;11:281-92, vi. 9. Meshkinpour H, Haghighat P, Meshkinpour A. Quality of life among patients treated for achalasia. Dig Dis Sci 1996;41:352-6. 10. Chrystoja CC, Darling GE, Diamant NE, et al. Achalasia-specific quality of life after pneumatic dilation or laparoscopic Heller myotomy with partial fundoplication: a multicenter, randomized clinical trial. Am J Gastroenterol 2016;111:1536-45. 11. Kahrilas PJ, Bredenoord AJ, Fox M, et al. The Chicago classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil 2015;27:160-74. 12. Yang D, Pannu D, Zhang Q, et al. Evaluation of anesthesia management, feasibility and efficacy of peroral endoscopic myotomy (POEM) for achalasia performed in the endoscopy unit. Endosc Int Open 2015;3:E289-95.
Perbtani et al 13. Acosta RD, Abraham NS, Chandrasekhara V, et al. The management of antithrombotic agents for patients undergoing GI endoscopy. Gastrointest Endosc 2016;83:3-16. 14. Pannu D, Yang D, Abbitt PL, et al. Prospective evaluation of CT esophagram findings after peroral endoscopic myotomy. Gastrointest Endosc 2016;84:408-15. 15. Manocchia M, Bayliss MS, Connor J, et al. SF-36 health survey annotated bibliography. In: The health assessment lab, 2nd ed. Boston (Mass): New England Medical Center; 1998. 16. Ware JE, Gandek B. Overview of the SF-36 health survey and the international quality of life assessment (IQOLA) project. J Clin Epidemiol 1998;51:903-12. 17. Cotton PB, Eisen GM, Aabakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71:446-54. 18. Liu XJ, Tan YY, Yang RQ, et al. The outcomes and quality of life of patients with achalasia after peroral endoscopic myotomy in the shortterm. Ann Thorac Cardiovasc Surg 2015;21:507-12. 19. Vigneswaran Y, Tanaka R, Gitelis M, et al. Quality of life assessment after peroral endoscopic myotomy. Surg Endosc 2015;29:1198-202. 20. Sharata AM, Dunst CM, Pescarus R, et al. Peroral endoscopic myotomy (POEM) for esophageal primary motility disorders: analysis of 100 consecutive patients. J Gastrointest Surg 2015;19:161-70; discussion 170. 21. Ward MA, Gitelis M, Patel L, et al. Outcomes in patients with over 1-year follow-up after peroral endoscopic myotomy (POEM). Surg Endosc 2017;31:1550-7. 22. Nenshi R, Takata J, Stegienko S, et al. The cost of achalasia: quantifying the effect of symptomatic disease on patient cost burden, treatment time, and work productivity. Surg Innov 2010;17:291-4. 23. Patti MG, Andolfi C, Bowers SP, et al. POEM vs laparoscopic Heller myotomy and fundoplication: Which is now the gold standard for treatment of achalasia? J Gastrointest Surg 2017;21:207-14.
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Quality of life outcomes and their association with Eckardt scores after POEM
SUPPLEMENTAL TABLE 1. HRQOL scores, short-term and long-term Variable, mean ± SEM
Baseline
1 Month
P value
6 Months
P value
12D Months
P value
Social functioning
67 2.5
76.7 2.6
< .05
82.4 3.3
< .05
78.8 4.3
< .05
Vitality
43.4 2
53.2 1.9
< .05
56.4 2.6
< .05
54.4 3.5
< .05
Role emotional
66.5 3.6
78.5 3.6
< .05
76.5 4.9
< .05
76 6.8
< .05
Emotional well-being
68.3 1.9
76.4 1.7
< .05
75 2.2
< .05
75.5 3
< .05
62 2.6
69.9 1.8
< .05
72.2 2.4
< .05
68 3.2
< .05
Role limitation due to physical health
44.5 3.8
61.3 4.1
< .05
69.9 5.4
< .05
58.7 7.3
< .05
Pain
59.5 2.3
70 2.2
< .05
69.6 2.8
< .05
66.5 3.5
< .05
56.6 2
65.3 1.6
< .05
63.2 2.1
< .05
61.3 2.5
< .05
Physical function
General health SEM, Standard error of the mean.
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