Impact of Frailty on Per Oral Endoscopic Myotomy (POEM) Outcomes: A National Database Analysis

doi:10.21203/rs.3.rs-5314787/v1

Introduction

Frailty remains an important risk factor for increased morbidity and mortality in patients undergoing various surgical interventions. The impact of frailty on clinical outcomes in patients undergoing Peroral Endoscopic Myotomy (POEM) is not well established. We aim to determine the association between frailty and clinical outcomes in patients hospitalized for POEM procedure.

Methods

We conducted a cohort study using data from the National Inpatient Sample (NIS) for the years 2017 to 2019. Adult patients who underwent POEM following hospitalization were identified using International Classification of Diseases (ICD) diagnostic codes. The Hospital Frailty Risk Score (HFRS) was used to classify patients as Frail or Non-Frail. Multivariate logistic regression analysis was performed to compare outcomes between study groups. Discharge weights were applied to provide national estimates for total hospital expenses.

Results

Among 1,735 POEM patients, 220 (12.68%) patients were frail. Frail patients had higher Charlson Comorbidity Index (CCI) compared to non-frail patients. In terms of systemic adverse events, frail patients had more cardiovascular (2.27% vs 0.00%, p < .01), thoracic (13.64% vs 2.97%, p < .01), and infectious (18.18% vs 2.64%, p < 0.01) adverse events compared to non-frail patients. The number of patients requiring TPN was higher in frail (13.64 vs 1.32, p < 0.01) compared to non-fail patients. After adjusting for confounders, frail patients were more likely to require TPN [OR 13.49 (95% CI 2.00-91.25)], had higher incidence of infectious [OR 17.38 (95% CI 5.22–57.91)] and thoracic [OR 5.75 (95% CI 1.75–18.92)] adverse events as well as increased LOS [OR 6.56 (95% CI 3.64–9.47)] when compared to non-frail patients.

Conclusion

Frailty in patients undergoing POEM is associated with a higher risk of systemic adverse events, need for TPN, longer hospital stays, higher healthcare cost, and increased in-hospital mortality. These findings emphasize the importance of frailty assessments in clinical decision-making for patients undergoing POEM.

Per Oral Endoscopic Myotomy

POEM

Frailty

systemic adverse events

Frailty is an important concept in the healthcare of aging populations, defined as a state of increased vulnerability to everyday acute stressors resulting from an age-associated decline in physiological reserves. It is a combination of multisystem pathophysiologic processes with complex multifactorial etiologies, including chronic inflammation, immune system activation and changes in endocrine system, that collectively lead to the frailty(1–3). The studies have shown that there might be a risk of decreased physical and cognitive functions in frail population. Also, frailty is associated with increased morbidity, longer duration of hospitalization, and increased mortality(3, 4). The prevalence of frailty ranges from 4.0–19.6% in community-dwelling older adults, and 60% in cancer patients, depending on the measurement criteria and population studied(5). The crude prevalence of achalasia in the United States is quite high (162.1 in 100,000 persons) and is even more prevalent in older population(6).

Peroral Endoscopic Myotomy (POEM), is a minimally invasive endoscopic treatment option for esophageal motility disorders like achalasia, diffuse esophageal spasm, and gastroparesis. POEM has revolutionized the field of third-space endoscopy since its introduction in humans by Inoue et al. in 2010(7). Compared to traditional treatments like pneumatic dilation or laparoscopic Heller myotomy, POEM offers comparable efficacy and relatively shorter recovery times(8). POEM was found to be more effective in comparison to pneumatic dilation and LHM in treating achalasia but carried a higher risk of gastroesophageal reflux and some other adverse events(9, 10).

Frailty is a crucial consideration in pre-surgical evaluation of various invasive surgical procedures and has been identified as an independent predictor of poorer clinical and financial outcomes after various invasive surgical procedures(11, 12). The current literature on POEM has primarily focused on the general population or those with standard risk profiles, leaving a gap in understanding its effects in frail patients. POEM may be an effective procedure in older populations who present with increased risk of frailty and comorbidities but POEM related complication rate was slightly higher in older age group in a study comparing POEM safety and efficacy in achalasia patients 60 years or older vs. younger population(12). Older patients undergoing POEM for esophageal achalasia had similar short-term success rates as younger patients, but they experienced significantly more perioperative adverse events, indicating the need for cautious application of POEM procedure in this age group(12, 13). Patients with esophageal motility disorder or gastroparesis may have rapid weight loss and malnutrition, which may contribute to frailty in even apparently overweight or obese patients(14). Guidelines for POEM do not specifically address frail subgroups, highlighting the necessity for targeted research to understand how frailty influences POEM outcomes.

The objective of this study was to bridge this knowledge gap by investigating the impact of frailty on the outcomes of patients undergoing POEM. By analyzing a comprehensive national database, we explored how frailty can impact outcomes such as mortality, duration of hospital stays, readmission rates, healthcare expenses, and other adverse events in patients undergoing Peroral Endoscopic Myotomy (POEM). We expect this study to aid us in enhancing outcomes of frail patients by helping refine decision-making processes, optimizing patient selection, and customizing perioperative care.

Study Design and Data Source

This is a population-based retrospective cohort study utilizing the National Inpatient Sample (NIS) for the years 2017 to 2019. NIS is an administrative claims database developed from the Healthcare Cost and Utilization Project by the Agency for Healthcare Research and Quality. It is the largest publicly available all-payer database for inpatient care in the US containing data on more than 7 million annual unweighted inpatient admissions(15). The NIS includes approximately a 20% stratified sample of all discharges from US community hospitals without the inclusion of rehabilitation and long-term acute care hospitals. The database contains both patient and hospital-level variables. Each patient has up to 40 discharge diagnoses and up to 25 procedures using the International Classification of Diseases, 10th revision, clinical modification (ICD-10-CM) coding system (16) .

Patient Population and Study Variables

We included adult patients (≥ 18 years old) who underwent POEM during their hospitalization dividing them into those who were frail (FrailPOEM) and those who were not (NonFrailPOEM). Variables considered included age, sex, race/ethnicity (Caucasian, African American, Hispanic, Asian or Pacific Islander, Native American, and other), median household income quartile, primary insurance provider (Medicare, Medicaid, private insurance and uninsured), and the Charlson comorbidity index.

Definition of frailty - Hospital Frailty Risk Score

We defined frailty using the Hospital Frailty Risk Score (HFRS) which is a score based on ICD-10 codes developed by Gilbert et al in 2018 (17) and was subsequently validated in multiple studies (18–22). The score is calculated from 109 ICD-10 codes representing the conditions that were found to be most associated with frailty. Each code is assigned a certain score/weight from 0.1 to 7.1 depending on the likelihood of being associated with frailty. Adding the corresponding scores in the set of ICD-10 codes each patient has, calculates the HFRS. Patients with HFRS < 5 were considered low risk for frailty (non-Frail) while those with HFRS ≥ 5 were considered moderate to high risk for frailty (Frail).

Outcomes

Outcomes included in-hospital all-cause mortality, having a diagnosis representing systemic adverse events (infectious, cardiovascular, thoracic, bleeding, accidental injuries), and requirement of artificial nutrition in the form of total parenteral nutrition (TPN) or enteral nutrition. We evaluated different healthcare utilization metrics including length of stay and total hospital charges. All ICD-10 codes used in this study are provided in (Supplementary Table 1).

Statistical Analysis

Categorical variables are presented as percentages while continuous variables are presented as means with standard deviations unless otherwise specified. We compared categorical variables using Chi-square and continuous variables using Student’s t-test. We conducted a multivariate regression analysis to assess the effect of frailty status on different outcomes after adjusting for age, sex, race, hospital location and teaching status, insurance, median household income, and Charlson comorbidity index. All statistical analyses were performed using Stata, version 17.0 (Stata Corp, College Station, Texas, USA). The Stata survey commands were used to account for clustering, stratification, and weighting of data in the NIS to provide national estimates. A p-value less than 0.05 was considered statistically significant.

Patients and Hospital Characteristics:

A total of 1,735 hospitalizations were identified with a mean age was 59.46 years and 50.72% were male. Of the entire population, 220 (12.68%) were FrailPOEM while 1,515 (87.32%) were NonFrailPOEM. When compared to NonFrailPOEM, FrailPOEM patients had a higher Charlson comorbidity index (mean index 1.89 vs. 1.22; p<0.001). There was no statistically significant difference in sex, race distribution, median household income, or primary insurance between both groups (Table 1).

Clinical Outcomes and Healthcare Utilization:

More FrailPOEM patients developed infections (18.18% vs. 2.64%; p<0.001), cardiovascular (<4.54% vs. 0.00%; p=0.007), and thoracic complications (13.64% vs. 2.97%; p=0.002) when compared to NonFrailPOEM. Additionally, more FrailPOEM required artificial nutrition but only TPN showed statistically significant difference (13.64% vs. 1.32%; p<0.001).

Less than 10 patients died during hospitalization in the FrailPOEM group, while none died among NonFrailPOEM patients (p=0.009).

In terms of healthcare resource utilization, FrailPOEM patients had significantly longer lengths of stay (mean 9.27 vs 2.69 days; p<0.001) and greater total hospital charges (mean 132,354$ vs. 58,776$; p=0.015) (Table 2).

Results of multivariate analysis:

Using a multivariate analysis and after adjusting for possible confounders, FrailPOEM patients had higher odds of having a diagnosis of infectious [OR: 17.38, 95% CI (5.22 – 57.91); p<0.001] and thoracic complications [OR: 5.75, 95% CI (1.75 – 18.92); p=0.004]. Furthermore, FrailPOEM patients were more likely to require TPN [OR: 13.49, 95% CI (2.00 – 91.25); p=0.008], had longer length of stay [Adjusted coefficient: 6.56, 95% CI (3.64 – 9.47); p<0.001] along with higher total charges [Adjusted coefficient: 78,788.54, 95% CI (10,651.66 – 146,925.4); p=0.023] compared with NonFrailPOEM. There was no difference in the odds of enteral nutrition, bleeding complications or accidental injuries (Table 3).

Frailty is being widely considered as a crucial pre-surgical evaluation for various invasive surgical procedures. As frailty has been reported as an independent predictor of poor clinical outcomes including more healthcare utilization and higher morbidity and mortality after various surgical procedures(11, 12). In this study, we aimed to study the impact of frailty on the clinical outcomes of patients undergoing POEM in terms of mortality, duration of hospital stays, readmission rates, healthcare expenses, and other adverse events rates. Utilizing a large national database study, our goal was to fill this gap to better understand impact of frailty with the aim of refining decision-making processes, optimizing patient selection, and customizing perioperative care to provide patient centered care.

In our study, 12.86% patients who underwent POEM were frail with mean age of 59.46 years, which is closer to calculated prevalence reported by other studies as high as 4.0–19.6% in community-dwelling older adults(5, 6). Frail POEM patients had higher Charlson comorbidity index (mean index 1.89 vs. 1.22; p < 0.001). Our data also reported that infections rate in frail POEM patients was higher than non-frail patients [OR: 17.38, 95% CI (5.22–57.91); p < 0.001]. Frailty is a combination of multisystem pathophysiologic processes with complex multifactorial etiologies, including chronic inflammation, immune system activation and changes in endocrine system, that collectively lead to the frailty(1–3). The addition of another stressor in the form of POEM in already compromised frail patients can predispose them to various infectious adverse events. Also, frail patients having a component of chronically active immune system and inflammation in the form of elevated white blood cell counts (neutrophils and monocytes)(23), elevated IL-6 levels(24) and higher CRP levels(25), and adding another invasive procedure can be associated with higher rate of infections in these individuals.

Frail POEM patients had higher rate of thoracic adverse events [OR: 5.75, 95% CI (1.75–18.92); p = 0.004] than non-frail POEM patients. Also, our data concluded that frail POEM patients were more likely to require TPN [OR: 13.49, 95% CI (2.00–91.25); p = 0.008] than non-frail POEM patients. Higher thoracic complications rate and need for TPN in frail patients can be due to complex multifactorial etiologies, including sarcopenia, decreased levels of albumin, and overall malnutrition in frail patients(26, 27). Sarcopenia traditionally defined by skeletal muscle loss and decreased skeletal muscle strength, have been associated with higher rate of various surgical adverse events and need for total parenteral nutrition after major surgeries(27, 28). As POEM procedure involves creating a submucosal tunnel and submucosal circular muscle dissection, frailty with sarcopenia may have less muscle mass, and submucosal fat/tissue thickness, which may contribute to the higher risk of thoracic complications post-procedure(26). In a study of patients undergoing colorectal surgery, patients with sarcopenia were more likely to develop anastomotic leak, and Clavein-Dindo grade IV complications. Also, patients with sarcopenia were three times more likely to require TPN than non-sarcopenia patients(27).

Additionally, frail POEM patients in our study had more inpatient mortality risk than non-frail POEM patients as less than 10 patients died during hospitalization in the frail POEM group, while none died among non-frail POEM group (p = 0.009). Poor functional and nutritional status associated with sarcopenia, and frailty is linked with significantly increased mortality in surgical patients as in another study frail patients with sarcopenia had shown significantly lower survival rates at 1, 3, and 5 years after major surgery(28).Our data aligns with their findings and concludes that frail POEM patients had higher risk of clinical complications and the need for TPN than non-frail POEM patients.

Lastly, our data showed that frail POEM patients had more healthcare resource utilization in terms of total length of hospital stays, and higher total hospital expenses than non-frail POEM patients. Frail POEM patients had significantly longer lengths of stay (mean 9.27 vs. 2.69 days; p < 0.001) and greater total hospital charges (mean 132,354$ vs. 58,776$; p = 0.015) than non-frail POEM patients. Longer total length of hospital stays and thus, greater total hospital charges could be partially explained by high probability of frail POEM patients having more clinical complications, and need for TPN than non-frail POEM patients and this has been supported by existing literature(6).

Our data concludes, frailty in patients undergoing POEM is associated with a higher risk of systemic adverse events, need for TPN, longer hospital stay, higher healthcare cost, and increased in-hospital mortality. These findings emphasize the importance of frailty assessments in clinical decision-making for patients undergoing POEM. Patients undergoing POEM procedure should be screened for frailty using standardized frailty tools to optimize patient experience, clinical outcomes, and healthcare utilization. It may be beneficial to have a multidisciplinary approach involving nutritionist, gastroenterologist, anesthetist, and advanced interventional endoscopist for cautious screening for frailty in targeted POEM population, careful patient selection, and prior pre-medical optimization prior to POEM procedure to deliver patient centered and customized perioperative care.

POEM Peroral Endoscopic Myotomy

CCI Charlson Comorbidity Index

ICD International Classification of Diseases

HFRS Hospital Frailty Risk Score

LOS Length of hospital Stay

CRP C-reactive protein
TPN Total Parenteral Nutrition

LHM Laparoscopic Heller myotomy

NIS National Inpatient Sample

Authors Contribution

Ahmad Nawaz, MD- conception and design; analysis and interpretation of the data; drafting of the article; critical revision of the article for important intellectual content.

Azhar Hussain, MD- drafting of the article
Aisha Khaliq, MD- drafting of the article
Abdelkader Chaar, MD- analysis and interpretation of the data

Vishnu Charan Suresh Kumar, MD- drafting of the article

Ganesh Aswath, MD- critical revision of the article for important intellectual content

Kelita Singh, MD- critical revision of the article for important intellectual content

Savio John, MD- critical revision of the article for important intellectual content

Dennis Yang, MD- critical revision of the article for important intellectual content

Muhammad Khalid Hasan, MD- critical revision of the article for important intellectual content; final approval of the article

Hafiz Muzaffar Akbar Khan, MD- conception and design, critical revision of the article for important intellectual content; final approval of the article

Funding/Grant Sources: None

Financial Disclosures/Conflicts of Interest:

Dennis Yang, MD (Consultant for Olympus, Fujifilm, Apollo Endosurgery, 3D- Matrix, Medtronic, Micro tech)

Muhammad Khalid Hasan, MD (Consultant for Olympus America, Boston Scientific, Micro Tech Endoscopy)

All other authors have no disclosures

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Table 1: Baseline characteristics

Variable	NonFrailPOEM n=1,515	FrailPOEM n= 220	p-value
Female, %	740 (48.84)	115 (52.27)	0.678
Age (years), mean ± SD	58.83 ± 17.64	63.82 ± 16.52	0.069
Race/Ethnicity, %			0.057
White	1015 (68.81)	115 (53.49)
Black	180 (12.20)	65 (30.23)
Hispanic	140 (9.49)	20 (9.30)
Asian or Pacific Islander	50 (3.39)	≤10 (4.54%) ^a
Native American	5 (0.34)	0 (0.00)
Other	85 (5.76)	10 (4.65)
Median household income, %			0.223
0-25th percentile	320 (21.48)	65 (30.23)
26th to 50th percentile	410 (27.52)	60 (27.91)
51st to 75th percentile	335 (22.48)	20 (9.30)
76th to 100th percentile	425 (28.52)	70 (32.56)
Primary Payer, %			0.056
Medicare	655 (43.23)	120 (54.55)
Medicaid	150 (9.90)	25 (11.36)
Private insurance	615 (40.59)	55 (25.00)
Self-pay	35 (2.31)	20 (9.09)
No charge	≤10 (0.66%) ^a	0 (0.00)
Other	55 (3.63)	0 (0.00)
Charlson comorbidity index, mean ± SD	0.72 ± 1.22	1.89 ± 2.16	*<0.001*
Hospital Frailty Risk Score, mean ± SD	1.64 ± 1.39	7.59 ± 3.45	*<0.001*

^a Indicates ≤10 outcomes, thus, exact estimates not permitted for reporting due to HCUP regulations.

Table 2: Outcomes and healthcare utilization of frail and non-frail group in patients who underwent POEM (bivariate analysis)

Variable	NonFrailPOEM n=1,515	FrailPOEM n= 220	p-value
Enteral nutrition, n (%)	15 (0.99)	≤10 (4.54%) ^a	0.057
Total parenteral nutrition, n (%)	20 (1.32)	30 (13.64)	*<0.001*
In-hospital all-cause mortality, n (%)	0 (0.00)	≤10 (4.54%) ^a	*0.009*
Length of Stay (Days), mean ± SD	2.69 ± 2.78	9.27 ± 8.42	*<0.001*
Total Charges ($), mean ± SD	58,775.67 ± 49,643.95	132,353.9 ± 201,555.6	*0.015*
Adverse events, n (%)
Infectious complications	40 (2.64)	40 (18.18)	*<0.001*
Cardiovascular complications	0 (0.00)	≤10 (4.54%) ^a	*0.007*
Bleeding complications	50 (3.30)	20 (9.09)	0.064
Accidental injuries	25 (1.65)	≤10 (4.54%) ^a	0.766
Thoracic complications	45 (2.97)	30 (13.64)	0.002

^a Indicates ≤10 outcomes, thus, exact estimates not permitted for reporting due to HCUP regulations.

Table 3: Multivariate regression for the outcomes of FrailPOEM patients compared to NonFrailPOEM patients. Analysis adjusted for age, sex, race, hospital location and teaching status, insurance, median household income and Charlson comorbidity index.

Multivariate Regression for the Outcomes
Outcome	Adjusted Odds Ratio (FrailPOEM vs NonFrailPOEM)	95% CI	p-value
Length of Stay (Days)	6.56*	[3.64 - 9.47]	*<0.001*
Total Charges ($)	78788.54*	[10651.66 - 146925.4]	*0.023*
Enteral nutrition	3.26	[0.12 - 87.83]	0.481
Total parenteral nutrition	13.49	[2.00 - 91.25]	*0.008*
Infectious complications	17.38	[5.22 - 57.91]	*<0.001*
Bleeding complications	3.84	[0.46 - 32.37]	0.216
Accidental injuries	2.61	[0.09 - 72.61]	0.571
Thoracic complications	5.75	[1.75 - 18.92]	*0.004*

* Adjusted coefficient representing the average difference in this outcome between Frail and NonFrail

No competing interests reported.

SupplementaryTable1FRAILPOEM.docx
Supplementary Table 1 ICD-10 codes utilized in this study.

Impact of Frailty on Per Oral Endoscopic Myotomy (POEM) Outcomes: A National Database Analysis

Status:

Version 1

Abstract

Introduction

Methods

Study Design and Data Source

Patient Population and Study Variables

Definition of frailty - Hospital Frailty Risk Score

Outcomes

Statistical Analysis

Results

Discussion

Abbreviations

Declarations

References

Tables

Additional Declarations

Supplementary Files

Status:

Version 1