David S Seres Md Cnsp Contents

1

Introduction

2

Indications

3

Cost

4

Quality of Life

5

Incidence

6

Survival

7

Complications of HPEN

8

Infusion Considerations

9

Disease-Specific Considerations

10

Provision of artificial nutrition in the home is often necessary and has become a routine part of caring for patients with a variety of disorders. Indications for these therapies in the home do not differ from the hospital. The cost of these life-sustaining therapies, both economic and to quality of life, is substantial. Complications, while less often life-threatening, can be serious and include problems due both to the infusion or instillation of artificial nutrition, and to the techniques required to provide access. Lifespan is most often limited by the patient's underlying disease and not the nutrition support-related complications, but there are disease-specific considerations in applying these therapies. These issues are reviewed herein.

Key Words: Home parenteral nutrition, Enteral nutrition, Home care services, Economics of home parenteral nutrition, Economics of

From: Clinical Gastroenterology: Nutrition and Gastrointestinal Disease Edited by: M.H. DeLegge © Humana Press Inc., Totowa, NJ

enteral nutrition, Quality of life, Adverse effects of enteral nutrition, Adverse effects of parenteral nutrition

1. introduction

Outpatient parenteral nutrition (PN) has been available for more than 3 decades, while home tube feeding has been practiced for centuries [1]. These techniques for providing nutrients in the home setting have become a routine part of medical care for patients with chronic gastrointestinal dysfunction. With proper medical and social support, patients unable to meet nutritional needs due to problems of nutrient intake, nutrient absorption and nutrient excess losses may be managed with enteral nutrition (EN) or PN support at home for years [2, 3] with acceptable, albeit reduced, quality of life.

The incidence and prevalence of home parenteral and enteral nutrition (HPEN) support are not well documented. As with any technology, availability may lead to overuse. Complications of artificial nutrition support are not infrequent, but are usually manageable. The patients' primary and comorbid diseases are the usual determinant of longevity in patients receiving HPEN.

2. indications

Indications for home enteral nutrition (HEN) and home parenteral nutrition (HPN) have been continually reexamined [1]. We have developed a better understanding of the limitations of artificial nutrition and are better able to quantify intestinal failure (IF) [4]. Enteral nutrition is always preferred over PN. Parenteral nutrition should only be used in patients with intestinal failure for the purpose of treating or preventing starvation. Parenteral nutrition for less than 2 weeks has no proven value [5]. Indications for HPEN are no different than those in the hospital. Some disease-specific indications and considerations are discussed below.

3. cost

The cost of a complex therapy such as HPEN is very difficult to quantify. In addition to the obvious costs of tubing, pumps and nursing, there are always intangible costs such as transportation, out-of-pocket expenses and loss of income. It is clear that HPN is far more expensive than HEN, due to both the cost of the technology and the ancillary and hospital services required. In the period 1991-1995, HPN was

Table 13.1

Medicare Criteria for Coverage of Home TPN

• Permanent condition of at least 3 months duration and

• Significant impairment of absorption or motility o Massive small bowel resection leaving <5 feet of small bowel beyond ligament of Treitz and surgery within 3 months or o Short bowel syndrome with enteral losses > 50% of intake and intake

> 2.5-3l/day and urine output <1 liter/day or o Bowel rest required for > 3 months and patient receiving 20-35 kcal/kg/day IV and patient has one of the following

■ Symptomatic pancreatitis or

■ Severe exacerbation of regional enteritis or

■ High output enterocutaneous fistula and distal tube feeding not possible or o Complete mechanical bowel obstruction and surgery not an option or o 10% weight loss in < 3 months and serum albumin < 3.4 and fecal fat test demonstrates loss of > 50% of oral/enteral intake on

> 50g fat/day diet or o 10% weight loss in < 3 months and serum albumin < 3.4 and patient is taking maximum doses of prokinetic agent and patient has daily nausea/vomiting and has diagnostic test documenting motility disturbance and radioisotope, barium, or pellets fail to reach the right colon by 6 h and patient is not acutely ill or on any medication that would decrease motility or o Documented failure of a tube feed trial and 10% weight loss in < 3 months and serum albumin < 3.4 and altering the composition of an enteral diet or administering medications to treat the etiology of the malabsorption will not maintain the patient's health status and patient has moderate abnormality such as:

■ 72-h fecal fat test shows > 25% loss of > 50 g fat/day diet or

■ Confirmation of malabsorption by other test (sudan stain, d-xylose, etc.) or

■ Gastroparesis unresponsive to prokinetic agent demonstrated on study with failure of isotope or barium or pellets to reach right colon in 3-6 h or by manometric motility study or

■ Small bowel dysmotility unresponsive to prokinetic agent demonstrated with gastric to right colon transit time between 3-6 h or

(Continued)

Table 13.1 (Continued)

■ Small bowel resection that left > 5 feet of small bowel beyond the ligament of Treitz or

■ Less severe short bowel syndrome or

■ Mild to moderate exacerbation of regional enteritis or enterocuta-neous fistula or

■ Inoperable partial mechanical small bowel obstruction

Adapted from http://www.cignamedicare.com/dmerc/mr/pdfs/decisiontree.pdf accessed March 22, 2006.

estimated to cost $70,700 per patient per year, while HEN cost $18,000 per patient per year. This included clinic visits, medications, laboratory tests, nurse visits, hospitalizations, pump rental, intravenous or tube feeding solutions and other miscellaneous costs [6]. Adjusting for inflation, these costs likely now exceed $100,000 and $27,000 for HPN and HEN, respectively.

The cost of the HEN feeding product is frequently excluded from coverage by private health insurance companies. While standard feeding products may not cost more than normal groceries, specialized enteral formula products may place a significant financial burden on the patient. HPN is often covered by most insurers. The cost is rarely something a patient has the resources for if such coverage is lacking. Medicare has extremely stringent criteria for coverage of HPEN (Table 13.1).

4. quality of life

It is difficult to assess prospectively the effect of HPEN on quality of life (QOL) as randomization of patients deemed to require nutrition support and to receive none raises ethical questions. Nevertheless, there are standardized and validated QOL assessment instruments that have been used to compare QOL of patients on HPEN to well subjects and those receiving other complex medical technologies [7].

There is no question that QOL of patients receiving HPEN is significantly reduced relative to normal. HPEN patients are more likely to have significant medical problems, for example, high-output stomas or neurological disease, which negatively impact on QOL. Complications and tube-related problems such as poor ostomy closure with spillage of bowel contents onto clothing are not infrequently additional causes of decrements in QOL. In general, the QOL scores of patients on HPEN are comparable to those of patients on hemodialysis [6, 8]. While most HEN patients describe some improvement in QOL after initiation of nutrition support [9], half of all HEN patients in one series reported psychological intolerance to HEN [10].

HPEN patients are also at the mercy of a much less coordinated outpatient medical system once they are discharged from the hospital. Care of patients receiving HPEN at a dedicated HPEN expertise center may help ameliorate some of these problems. Additionally, a multidis-ciplinary team may be able to better anticipate problems with which the general gastroenterologist or other practitioner lacks familiarity [11, 12]. This team might consist of a pharmacist, a dietitian, a nurse and a social worker, often with physician oversight. Finally, improved nutrition support outcomes have been achieved when patients become affiliated with an organization such as the Oley Foundation, which provides ongoing educational and peer support for HPEN patients. HPN patients involved with the Oley Foundation have higher QOL scores, lower depression scores and a lower incidence of catheter-related infections [13]. Infection rates, depression rates and rehospi-talizations for sepsis have also been reduced using interactive video educational programs [14].

Shifting nutritional care to the home setting also shifts to patients and their caregivers a huge technical and logistic burden [15]. Patients and caregivers must become their own nurses, providing care that requires skills completely foreign to them. Discharge planning should address not only training on and the delivery of equipment and products, but the attendant anxiety about new skills and potential complications. The physician should also be aware of and be prepared to address problems that occur in the home environment that are usually handled by the infrastructure of the hospital.

The difficulty of self-administration of HPEN is compounded by inconsistent quality of care delivery by home care companies, including delay of delivery, difficulty coordinating scheduling of deliveries and equipment and supplies missing from delivery (Table 13.2). These types of problems have been reported to occur in as much as 50% of the HPEN population [16]. Periodic evaluations by the practitioner should include questions about satisfaction with services provided by the home care and/or nursing companies.

Patients on HPEN are also at the mercy of the limitations in technology. Incidents such as power outages [17] and mass transit

Table 13.2

Special Problems Seen Transitioning Between Hospital and Home

Clearance and coverage by insurance May delay discharge

Must be initiated ASAP prior to discharge Need to insure proper documentation sent to prevent denials Portions of therapy (e.g., enteral feeding product) often excluded from coverage Delivery of supplies Delay of arrival

Difficulty coordinating scheduling Equipment and supplies missing from delivery Training issues Hospital and home care nurse must do training Variable nurse knowledge and ability between hospital and home Patient's ability to learn skills

Need for a willing designated caregiver (or several) to provide care Emergencies Variable availability of urgent nurse visit

Primary physician lack of familiarity with HPEN-related problems Need designated physician and contact at home agency to answer calls related to HPEN

strikes may be deadly to patients on HPEN who lack means of access to hydration or those without the ability to recharge electrical pumps. Practitioners should familiarize themselves with hospital and home-care agency contingency plans for such events and insure patients have available alternatives to prevent short-term complications such as dehydration. Alternatives that may serve to bridge the patient through such a crisis include providing a back-up supply of IV fluid that may be kept out of refrigeration and infused via a flow regulator, or a supply of enteral feeding bags that may be used for slow gravity EN bolus feeds in patients unable to tolerate bolus feeding.

5. incidence

As there is no reporting requirement or centralized data collection regarding the incidence of HPEN use, there is no accurate assessment of its use in the U.S. There have not been any recent attempts to create reliable estimates. Estimates from the early 1990s of total HPN patients in the United States were performed by extrapolation from Medicare data bases. At that time, it was estimated that there were 40,000 HPN patients and 152,000 HEN patients, and the numbers were growing rapidly [18].

Life expectancy on HPEN is dependant mostly on surviving the underlying disease processes. While complications from HPEN techniques and technology are frequent, they are more commonly cause for hospi-talization and morbidity rather than mortality. It is difficult to interpret comparisons in efficacy between HEN and HPN because the indications for each are often very different. There is a small, but nonsignificant increase in mortality on HEN vs. HPN when the therapies are compared prospectively [19].

Survival in HEN patients is dependent on their underlying diseases. Survival in terminal cancer patients on HEN is 20% at 12 months, while survival in young patients with neuromuscular disease and malabsorption exceeds 80% for the same period of time [20] (Fig. 13.1). As would be expected, survival decreases with increasing age [21]. Survival is also better if patients on HEN can resume a normal diet [21]. However, this may be a reflection of generally better health in this cohort.

6.2. Survival on HPN

Survival on HPN is also dependant on underlying disease. While HEN complications are less severe and are an unusual cause of significant

6. survival

6.1. Survival on HEN

Terminal Cancer

Malabsorption Neuromuscular

Disease

Fig. 13.1. Percent 1-year survival on HEN by selected disease states (data from [20]).

Terminal Cancer

Malabsorption Neuromuscular

Disease

Fig. 13.1. Percent 1-year survival on HEN by selected disease states (data from [20]).

morbidity and even less often mortality, HPN complications are more frequent and may account for a significant proportion of the mortality (11% in one study). Survival at 1 year in non-cancer, non-HIV infected patients was 91% and 62% at 5 years [22]. In another series of 494 patients from nine European countries, the 6-12-month mortality rate was 4% in Crohn's disease, 13% in vascular diseases, 16% in others, 21% in radiation enteritis, 34% in AIDS and 74% in cancer for the year 1997 [23].

7. complications of hpen

7.1. Complications of HEN

Complications of HEN (Table 13.3) may include problems related to the tube, such as erosion or expansion of the stoma with leakage and excoriation of the skin, tube clogging and tube breakage, among others [24]. As discussed previously, these can be severely detrimental to QOL. Because feeding products are maximally 85% water by

Table 13.3 Complications of HEN

Metabolic Fluid and electrolyte imbalance

Fatty acid and fat soluble vitamin deficiencies in malabsorption Other vitamin/mineral deficiencies B12 if no terminal ileum

Iron if no remaining or bypassed proximal small bowel Mechanical Pain at stoma

Erosion of stoma with leaking Excoriation of skin around stoma Cellulitis around stoma Tube migration if no bolster Tube degradation Quality of life Leakage or discharge from stoma

Poor end closure of tube/poor connection to infusion tubing with leakage

Prolonged feeding times

Nocturia

Depression/altered self-image Other

Granulation at stoma with bleeding Tube obstruction content and may have limited electrolyte content, patients often require additional water supplementation and may develop fluid and electrolyte imbalances. Patients with abnormal fluid and electrolyte physiology (e.g., renal insufficiency, CHF, diarrhea) should be monitored closely.

Patients with malabsorption and IF may develop reductions in essential fatty acid and fat soluble vitamin levels. Frank essential fatty acid deficiency is unusual, but reduction in serum levels is common in patients with malabsorption. Cholesterol, a-tochopherol and fatty acid levels decrease in proportion to the degree of malabsorption. Retinol deficiency is less common [25]. In the absence of malabsorption or losses due to fistulae or diarrhea, other deficiencies are uncommon as most tube feedings provide 100% of the RDA if a reasonable quantity is delivered daily to the patient (usually 1,000 kcal in adults).

7.2. Complications of HPN

Patients receiving PN have alterations in physiology due to infusion of nutrients via an unnatural route. Despite the high frequency, complications from HPN are unlikely to cause mortality. Most patients who die do so as a result of their underlying illness [26]. Interestingly, HPN complications, especially infectious complications, are much less common in the home setting than the hospital [27]. This is unexplained, but may be due to factors such as the relative clinical stability of HPN patients. HPN complications accounted for 11% of deaths in a series of patients with IF and without malignancy in which the overall 5-year survival was 62% [22]. Catheter-related complications are far more common (2.4 fold) in patients with malignancy [28]. Complications (Table 13.4) may be mechanical, thrombotic, metabolic and infectious in nature [29].

Parenteral nutrition complications are far more likely to impact on hospitalization and survival than those related to HEN. In one series, HPN-related complications accounted for an average of $2,000 to $10,000 per year per patient, with one patient exceeding $150,000, while HEN patients in the series had no hospitalizations for EN-related complications in the same 5-year period. HPN patients suffered an average of 1 to 2 complications per year, 0.5-1.1 hospitalizations per year (depending on the year) and spent an average of 3-5 days per year hospitalized for HPN-related complications [6]. Survival rates vary from 20% at 1 year in cancer patients [30] to a range of 62% [22] to 70% [31] at 5-6 years in patients without malignancies.

Table 13.4 Complications of HPN

Metabolic Fluid imbalance Electrolyte imbalance Hepatic dysfunction/failure Vitamin deficiency or excess Manganese toxicity Aluminum toxicity Metabolic bone disease Progressive renal insufficiency Mechanical/thrombotic

Complications of initial insertion Bleeding Pneumothorax Venous thrombosis Catheter occlusion

Pulmonary embolization due to particulate contamination or precipitation of incompatible components Accidental removal of catheter Infectious Catheter sepsis Tunnel infection Entry-site infection Other Nocturia/insomnia Depression/altered self-image

7.3. Hepatic Dysfunction/Failure

One of the more daunting complications of PN, particularly long-term PN, is that of hepatic dysfunction and failure. PN-related hepatic failure often progresses to end-stage liver disease (ESLD) and is a not uncommon reason for referral for hepatic transplant. Incidence of biochemically evident cholestasis approached 65% after a median duration of 6 months in one study. Prevalence rose to 72% after 6 years on HPN. Clinically significant hepatic dysfunction, fibrosis or cirrhosis was seen in 26% of patients after 2 years, 50% of patients after 6 years and accounted for 22% of deaths. It should be noted that this study reported a 30% death rate over 6 years. Unlike most other studies, PN-related complications (sepsis = 26%, ESLD = 22%) accounted for a far greater proportion of deaths than underlying disease (15%) [31].

Overfeeding, especially of carbohydrates, has been implicated in the development of cholestasis and PN-related hepatic dysfunction. Elevation of markers of inflammation has also been correlated to the development of HPN-related hepatic failure. Administration of omega-6 fatty acids, the sole source of parenteral fat available in the United States, has been implicated in increasing systemic inflammation. However, only total PN calories and total carbohydrate calories have correlated with the incidence of abnormalities in liver enzymes. Interestingly, inflammatory markers increase in a linear fashion proportionate to total and carbohydrate calories [32, 33]. Shorter lengths of small bowel in patients with short bowel syndrome (SBS) have also been found to predispose to liver enzyme abnormalities [34].

Specific nutrient deficiencies have been implicated in the development of PN-related liver dysfunction. In one study, supplementation of patients on HPN with choline reversed CT-scan appearance of hepatic steatosis and normalized alkaline phosphatase and other liver enzymes [35].

7.4. Infectious Complications

Infections related to parenteral nutrition may occur at the point at which the catheter exits the skin (exit site infection), under the skin in tunneled catheters (tunnel infection) or in the bloodstream (catheter sepsis). The frequency of catheter-related sepsis is approximately 0.34 episodes per person per year [36] and comprises 80% of catheter-related infections [29]. Sixty percent are gram-positive organisms, mostly coagulase-negative staphylococci. However, 14% are fungal and 26% gramnegative organisms [29]. Infection rates may be inversely proportionate to the remaining small bowel in patients with SBS [37].

Infections may occur in clusters of patients [38]. These may not be readily noted without ongoing collection of quality improvement data. The origin may be difficult to identify, but may include such things as contamination of stock solutions or recurrent break in sterile technique by staff. These become all the more difficult to assess in patients dispersed in the home environment. Practitioners and home infusion companies must remain vigilant (Fig. 13.2).

Catheter choice may influence the frequency of catheter-related infections. A recent observational study compared the incidence of complications in patients on HPN through peripherally inserted central catheters (PICC) and other central access, either implantable ports or tunneled Hickman catheters. They found a nearly two-fold increase in catheter infections (0.458 episodes/100 days vs. 0.245/100 days, p < 0.01) in patients receiving HPN via PICC [39]. PICC catheters

Erythema of SQ tunnel tract i unn fecti

emo thet

Tunnel infection

Remove catheter

Fever (may be only during infusion Chills when flushing catheter or during infusion

1) Blood bacterial and fungal cultures from catheter + peripheral

2) CBC with smear (examine for bacteria/yeast

Treat for S. aureus with 1 wk IV antibiotics

May replace catheter in different site

IV antibiotics x 1-3 wks or Antiobiotic lock technique x 1 wk

Rx for coag. Neg. staph and Gram neg. organisms empirically: Adjust antibiotics based on C&S -H old TPN for 24 hrs

Tenderness, erythema, or purulence at exit site (or on dressing)

Exit site infection

Empiric treatment for S. aureus with 2 wks IV antibiotics; adjust antibiotics based on C&S >/ C&

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