Satisfaction of Patients Treated Surgically for Intractable Aspiration

Satisfaction of Patients Treated Surgically for Intractable Aspiration* Yoshihisa Takano, MD; Moritaka Suga, MD, PhD; Osamu Sakamoto, MD, PhD; Keizo Sato, MD, PhD; Yasuhiro Samejima, MD, PhD; and Masayuki Ando, MD, PhD, FCCP

Study objective: Impaired laryngeal protective function can result in intractable aspiration requiring surgical treatment. There are, however, few reports evaluating the satisfaction of patients and the efficacy of surgical therapy. The purpose of this study is to determine whether surgery for intractable aspiration is beneficial for alleviating depression and improving the mood of patients who have undergone surgical treatment and whether patients and their families are satisfied with the therapy. Patients and study design: Seven patients with recurrent aspiration pneumonia that could not be controlled by appropriate medical therapies participated in the study. These patients had no hope of recovering laryngeal function. Six underwent laryngectomy and one underwent laryngotracheal separation. After surgery, we evaluated the efficacy of the therapy and the patients’ satisfaction with the therapy. Methods: The following clinical variables concerning surgical procedure were examined: operation time, time until oral intake, videofluorographic study, and surgical complications. The treatment methods including feeding status were also examined before and after surgery. In addition, the following markers were examined to evaluate the efficacy of the surgery: score of aspiration pneumonia, body mass index, total protein, albumin, hematocrit, WBC count, C-reactive protein, erythrocyte sedimentation rate, and the Barthel Index, an indicator of daily activity. Furthermore, the grade of depression and mood, and satisfaction of patients and their caretakers among family members were scored by the Zung self-rating depression scale, a 20-picture face scale, and the visual analog scale. Results: After surgical therapy, we confirmed by videofluorography that aspiration was completely prevented. No surgical complications occurred. By 18 6 6 days, all seven patients were able to ingest a meal orally. The need for extensive medical care and repeated hospitalizations became unnecessary after surgery. The control of pneumonia and albumin improved significantly. The grade of depression and mood of patients and their families also improved significantly. Satisfaction scores of patients receiving therapy were very high. Conclusions: Our study shows that surgical therapy to prevent aspiration improves the depression and mood of patients and their families as well as feeding status and clinical outlook. Surgical therapy for patients with intractable aspiration is effective and beneficial. (CHEST 1999; 116:1251–1256) Key words: feeding status; intractable aspiration; patient’s satisfaction; surgical therapy Abbreviations: BMI 5 body mass index; CRP 5 C-reactive protein; ESR 5 erythrocyte sedimentation rate; IVH 5 IV hyperalimentation; NTF 5 nasogastric tube feeding; PEG 5 percutaneous endoscopic gastrostomy; SDS 5 Zung self-rating depression scale; VAS 5 visual analog scale

is a major cause of pulmonary infecA spiration tions, and recurrent aspiration can cause life1,2

threatening pulmonary diseases.3,4 Swallowing diffi*From the First Department of Internal Medicine (Drs. Takano, Suga, Sakamoto, Sato, and Ando) and Department of Otorhinolaryngology (Dr. Samejima), Kumamoto University School of Medicine, Kumamoto, Japan. Manuscript received October 6, 1998; revision accepted June 15, 1999. Correspondence to: Moritaka Suga, MD, First Department of Internal Medicine, Kumamoto University School of Medicine, 1–1-1 Honjo, Kumamoto 860-0811, Japan; e-mail: suga@gpo. kumamoto-u.ac.jp

culties resulting in aspiration occur in a variety of swallowing and laryngeal dysfunctions associated with neuromuscular, esophageal, and laryngeal disorders.5,6 Management of patients with aspiration initially requires discontinuation of oral intake.5 In some instances, pulmonary lavage may be indicated. Next, alimentary routes are changed to enteral routes requiring nasogastric tube feeding (NTF) and gastrostomy, or IV hyperalimentation (IVH).5,7 In addition, antimicrobial therapy may be necessary to counteract bacterial infections.3 These medical managements are ordinarily effective; however, in some CHEST / 116 / 5 / NOVEMBER, 1999

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patients, intractable aspiration and aspiration pneumonia necessitate surgical procedures,5,8,9 mainly laryngectomy or laryngotracheal separation. Although these procedures separate the airway and digestive systems and can effectively eliminate intractable aspiration, patients who undergo these therapies lose the ability to speak after surgery.8,9 To determine the efficacy of surgical therapy, we examined changes in medical management, including feeding conditions, and clinical data of patients who underwent surgery. Moreover, because it is unclear whether such patients and their families are truly satisfied with surgical therapy, we also investigated whether depression levels and mood of patients and families changed after surgery. In this article, we show that the surgical therapy for intractable aspiration improves at least some variables of quality of life including feeding conditions and clinical data. In addition, we show that this therapy also improves the depression and mood of both patients and families. Materials and Methods Subjects Seven patients with intractable aspiration and recurrent aspiration pneumonia participated in this study. We confirmed the aspirations by videofluorography and clinical evaluation in all patients. The indications for surgical therapy for intractable aspiration are as follows: (1) aspiration cannot be controlled by medical treatments; (2) there is an irreversible laryngeal dysfunction; (3) phonation disturbance is aphonia or unintelligible speech; (4) there are no other diseases with a poor prognosis, such as end-stage malignancies; (5) prognosis would improve if aspiration was completely prevented; (6) informed consent is provided agreeing to loss of speech; (7) there is a desire to be able to eat orally and taste food; and (8) there is no contraindication for general anesthesia. All of our patients fulfilled these criteria. These studies were approved by the Institutional Review Board of Kumamoto University. Each subject was informed of the purpose of the study and gave written consent. As surgical therapy, six patients underwent laryngectomy and one underwent laryngotracheal separation. The laryngotracheal separation procedure was performed by dividing the trachea horizontally at the level of the tracheostomy. Then proximal end-to-side tracheoesophageal anastomosis and distal tracheostomy were performed.10 Clinical Data Scores of aspiration pneumonia reflect the frequency of occurrence and are defined as follows: 0, no occurrence; 1, one or two times per year; 2, three to five times per year; 3, every month or two. Conditions of phonation were defined as follows: 0, fully understood by others; 1, mostly understood by others; 2, slightly understood by others; 3, not understood by others. Body mass index (BMI) was measured as a marker of nutritional state. Among laboratory data, total protein, albumin, and hematocrit were measured as nutritional markers. In addition, WBC count, C-reactive protein (CRP), and erythrocyte sedimentation rate 1252

(ESR) were measured as inflammatory markers. Daily activity was evaluated by the Barthel Index. (0 to 100).11 Mental status was evaluated by the following tests: depression was scored by the Zung self-rating depression scale (SDS) (20 to 80),12 nonverbal mood was scored by the face scale (1 to 20),13 and satisfaction was scored by the visual analog scale (VAS). In the SDS, patients were asked to rate each of 20 items as to how it applied to them at the time of testing in terms of four quantitative levels: a little of the time, some of the time, a good part of the time, or most of the time. The SDS is constructed so that a less-depressed patient will have a low score on the scale and a more-depressed patient will have a high score. The face scale contains 20 drawings of a single face, arranged in serial order by rows with each face depicting a slightly different mood state. They are arranged in decreasing order of mood and numbered from 1 to 20, with 1 representing the most-positive mood and 20 representing the most-negative mood. The VAS is a 20-cm horizontal line with opposite descriptions such as “not satisfied with surgical therapy at all” (lower end 0%) and “extremely satisfied” (upper end 100%). The validity and reliability of these scales have been confirmed by previous reports.13–15 Data Collection The following clinical data concerning the surgical procedure were examined: operation time, time until oral intake, videofluorographic study, and surgical complications. The medical management for aspiration including feeding condition was also examined before and after surgery. Scores of aspiration pneumonia, BMI, laboratory data, the Barthel Index, the SDS, the face scale, and the VAS were determined 1 month before surgery and again 14.5 6 6.7 months (range, 8 to 25 months) after surgery. All patients were clinically stable 1 month before surgery and did not suffer from respiratory failure caused by pneumonia. In addition, the SDS, the face scale, and the VAS of families were evaluated before and after surgery. Statistical Analysis Data are shown as means 6 SD. The differences before and after surgical therapy were compared using the Wilcoxon signedrank test. A value of p , 0.05 was considered significant. Further multiple tests of clinical data were determined using Bonferroni/ Dunn test.

Results Table 1 summarizes the characteristics before surgical therapy of patients participating in this study. The BMI of all patients was very low (16.9 6 3.5 kg/m2), and control of aspiration pneumonia was also very poor. All patients had intractable aspiration and suffered from recurrent aspiration pneumonia. Phonation was poor in all patients; therefore, they could not communicate well with others by speech. Preoperative feeding conditions of patients were as follows: NTF in five, IVH in four, and percutaneous endoscopic gastrostomy (PEG) in three. We discontinued PEG before surgery in all three because of aspiration and peristomal wound infection. Clinical data of surgical procedures are shown in Table 2. Mean operation time was 201 6 47 min. Clinical Investigations

Table 1—Characteristics of Study Population* Age, yr

Sex

BMI Before Operation, kg/m2

1 2 3 4

73 62 53 77

M M M M

23.3 18.1 16.0 12.0

5 6 7

52 63 64

M M M

17.2 14.8 16.8

Patient No.

Mean SD

63.4 9.3

Score of Aspiration Pneumonia†

Underlying Disease Cerebrovascular disease Oropharyngeal dysynchrony, bedridden Cerebrovascular disease Oropharyngeal dysynchrony, laryngeal cancer after laser surgery and irradiation Cerebrovascular disease Amyotrophic lateral sclerosis Muscular dystrophy, oropharyngeal muscle atrophy

16.9 3.5

Phonation Condition‡

Preoperative Feeding Condition

3 3 2 3

2 2 3 3

PEG, IVH NTF, IVH NTF NTF

3 3 2

3 3 2

PEG, NTF, IVH PEG, IVH NTF

2.7 0.5

2.6 0.5

*M 5 male. †Scores of aspiration pneumonia are defined as follows: 0 5 no occurrence; 1 5 one or two times per year; 2 5 three to five times per year; 3 5 every month or two. ‡Phonation conditions are defined as follows: 0 5 fully understood by others; 1 5 mostly understood by others; 2 5 slightly understood by others; 3 5 not understood by others.

The time until oral intake was 18 6 6 days. Videofluorography revealed that no patient suffered from aspiration after surgery. There were no surgical complications in any patient. Table 3 shows the types and rates of medical procedures required before and after surgery. Medical care such as the elimination of thin liquids, education about optimal feeding techniques, and repeated hospitalization became unnecessary after surgery. The number of patients who needed frequent suctioning of oral secretions, and general rehabilitation was reduced after surgery, and six of the seven patients were able to satisfy their nutritional needs solely by oral intake. One patient required a supplemental tube feeding because he could not chew well. Clinical data before and after surgical therapy are given in Table 4. After surgery, the scores of aspira-

tion pneumonia, BMI, total protein, albumin, hematocrit, CRP, and ESR were significantly better than the scores before surgery (p , 0.05). Postsurgery satisfaction scores, as determined by the VAS, were very high in both patients (95.4 6 6.7 points) and families (96.7 6 5.2 points). As shown in Figure 1, significant improvements in depression were observed in the patients (p , 0.05) and their families (p , 0.05) after surgery. Before surgery, six of seven patients and three of the families were depressed according to their scores on the SDS, which defines depression as a score of . 40 points. After surgery, six of seven patients and all families showed a decrease in depression score. Furthermore, as shown in Figure 2, significant improvements in the face scale were also observed in both patients (p , 0.05) and families (p , 0.05). Moreover, these clinical data were evaluated by

Table 2—Clinical Data for the Surgical Procedure*

Patient No. 1 2 3 4 5 6 7 Mean SD

Operation Time, min

Time Until Oral Intake, d

170 180 230 230 240 115 240 201 47

24 20 11 19 14 18 13 18 6

Aspiration Evaluated by Videofluorography Before Surgery

After Surgery

1 1 1 1 1 1 1

2 2 2 2 2 2 2

*There were no surgical complications. 1 5 present; 2 5 absent.

Table 3—Medical Care for Aspiration Before and After Surgical Therapy* Surgery Care

Before

After

Elimination of thin liquids Education about optimal feeding techniques Need for frequent suctioning of oral secretions General rehabilitation Repeated hospitalization Artificial feeding NTF IVH PEG Oral intake

7 7 7 7 7

0 0 1 2 0

5 4 3 0

1 0 0 7

*Values given as No. of patients. CHEST / 116 / 5 / NOVEMBER, 1999

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Table 4 —Clinical Data Before and After Surgical Therapy* Surgery Variable

Before

After

p Value

Aspiration pneumonia score BMI, kg/m2 Total protein, g/dL Albumin, g/dL Hematocrit, % WBC count, per mL CRP, mg/dL ESR, mm/h Barthel Index Satisfaction score of patients by the VAS Satisfaction score of families by the VAS

2.7 6 0.5 16.9 6 3.5 6.4 6 0.8 3.3 6 0.1 35.0 6 3.9 7,271 6 3,007 1.8 6 2.0 53.9 6 24.5 21.4 6 35.0

0.1 6 0.4 19.0 6 3.5 7.0 6 0.6 3.8 6 0.3 38.1 6 4.4 5,723 6 2,721 0.7 6 1.2 32.3 6 24.5 38.6 6 40.8 95.4 6 6.7 96.7 6 5.2

, 0.05 , 0.05 , 0.05 , 0.05 , 0.05 NS , 0.05 , 0.05 NS

*Values are presented as mean 6 SD. NS 5 not significant.

multiple tests. After surgery, scores of aspiration pneumonia (p , 0.0001), albumin (p 5 0.002), the SDS of patients (p 5 0.0006) and their families (p 5 0.04), and the face scale of patients (p , 0.0001) and their families (p , 0.0001) were significantly better than scores before surgery. Discussion Laryngectomy and laryngotracheal separation are therapies used to treat intractable aspiration.5,8,9 These procedures separate the airway and digestive

systems and can eliminate aspiration completely. However, such procedures have both advantages and disadvantages: for example, patients recover the ability to eat, which is a significant sensual pleasure, but they lose the ability to speak. The latter condition can make it difficult to assess patients’ satisfaction with such treatment. As far as we could determine, no study has evaluated the satisfaction of patients with such therapy. Here, we have attempted to evaluate the benefits of surgical intervention for both patients and their families. Patients who continue to have aspiration and

Figure 1. Depression scale of patients (left, A) and their families (right, B) before and after the surgical therapy. The grade of depression significantly improved in both patients and their families after the surgical therapy (p , 0.05). In the SDS, a depressive state is defined by a score . 40 points (a broken line). 1254

Clinical Investigations

Figure 2. The face scale of patients (left, A) and their families (right, B) before and after the surgical therapy. The nonverbal mood improved significantly in both patients and their families after the surgical therapy (p , 0.05).

pneumonia despite appropriate medical therapies and skilled nursing care exhibit malnutrition and cachexia because of recurrent pneumonia and parenteral feeding.8 When aspiration is completely eliminated after surgery and aspiration pneumonia is controlled, patients can eat orally, which results in a gradual improvement in their nutritional status.5,8,9 In our patients, aspiration was completely eliminated after surgical therapy and the change of feeding conditions to oral intake from NTF, IVH, or PEG. In addition, a number of medical treatments including repeated hospitalization became unnecessary after surgery. Furthermore, the score for aspiration pneumonia and albumin significantly improved after surgery. These results indicate that surgery prevented recurrent aspiration pneumonia in our patients and that change to enteral feeding from parenteral feeding improved their nutritional status. Eibling et al16 reviewed 34 patients who underwent laryngotracheal separation for intractable aspiration. In their series, 14 patients were able to resume a regular or liquid diet and sustain their weight without supplemental feedings postoperatively. Although more than half of their patients required permanent nasogastric or gastrostomy tube feedings because of neurologic impairment, their results also show that surgical treatment for intractable aspiration enables patients to resume an oral diet. Compared with parenteral nutrition, enteral nutrition is superior in respect to host immune responses

or host defense systems.17,18 The gut mucosa is an important barrier to microbial translocation from the gut to the mesenteric lymph nodes, the spleen, and the liver. Therefore, intestinal atrophy associated with parenteral nutrition leads to increasing passage of bacteria and other toxins from the gut. Translocation of these products has been implicated as a cause of infection and organ failure. Thus, the option of enteral rather than parenteral feeding after surgery is very important not only for nutrition but also for host defense mechanisms. PEG and NTF are useful and effective methods using the enteral route for intractable aspiration. However, a number of complications of PEG and NTF have also become apparent.19,20 The most significant complication in both is aspiration and the resultant aspiration pneumonia. In our study, although PEG was applied to three of seven patients before surgery, it was stopped because of aspiration and peristomal wound infection. In general, patients cannot resume an oral diet or taste food during artificial enteral feeding. Therefore, we consider that laryngectomy and laryngotracheal separation are superior to artificial enteral feeding for patients who continue to have intractable aspiration and who wish to resume oral intake and to be able to taste their food. Inasmuch as both feeding and overall well-being improved after surgery, our patients were satisfied with the therapy. Mental status as evaluated by the SDS and the face scale significantly improved in CHEST / 116 / 5 / NOVEMBER, 1999

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parallel with improvements in the patients’ health. The mental status of patients’ family members also significantly improved, demonstrating that surgical intervention benefits not only those suffering from intractable aspiration but their caregivers as well. Moreover, satisfaction scores, as determined by the VAS, were very high in both patients and families. These results suggest that patients who undergo surgical therapy are satisfied with the therapy in spite of their loss of speech. We consider the indications for surgical therapy for intractable aspiration to be as follows: aspiration that cannot be controlled by medical treatments; irreversible laryngeal dysfunction; phonation impairment manifesting as aphonia or unintelligible speech; improvement in prognosis if aspiration is completely prevented; willingness to completely give up being able to speak; and the desire for oral intake and tasting of food. Among these criteria, we think that the patient’s desire for oral intake and the ability to taste food is the most important factor. In one of our seven patients, we could not sustain the patient’s weight without supplemental feedings because the patient could not chew well. We consider a surgical procedure to be suitable for patients who retain the ability to chew and have a sense of taste. Because laryngotracheal separation is a procedure that can recover phonation, it is suitable for patients who want to retain the possibility of phonation. In summary, the results from our indexes evaluating patient satisfaction, mental health, nutritional state, overall health, and patients’ family outlook argue in favor of surgical intervention to treat intractable aspiration. However, because our evaluation is based on data gathered from a small group of patients, larger studies are required to confirm the efficacy of such therapy. References 1 Kikuchi R, Watabe N, Konno T, et al. High incidence of silent aspiration in elderly patients with community-acquired pneumonia. Am J Respir Crit Care Med 1994; 150:251–253

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2 Nakagawa T, Sekizawa K, Arai H, et al. High incidence of pneumonia in elderly patients with basal ganglia infarction. Arch Intern Med 1997; 157:321–324 3 Bartlett JG. Aspiration disease and anaerobic infection. In: Fishman AP, ed. Pulmonary diseases and disorders. 3rd ed. New York, NY: McGraw-Hill, 1998; 2011–2019 4 Ribaudo CA, Grace WJ. Pulmonary aspiration. Am J Med 1971; 50:510 –520 5 Eisele DW. Surgical approaches to aspiration. Dysphagia 1991; 6:71–78 6 Chan ED, Welsh CH. Geriatric respiratory medicine. Chest 1998; 114:1704 –1733 7 Finucane TE, Bynum JP. Use of tube feeding to prevent aspiration pneumonia. Lancet 1996; 348:1421–1424 8 Blitzer A. Approaches to the patient with aspiration and swallowing disabilities. Dysphagia 1990; 5:129 –137 9 Cannon CR, McLean WC. Laryngectomy for chronic aspiration. Am J Otolaryngol 1982; 3:145–149 10 Lindeman RC. Diverting the paralyzed larynx: a reversible procedure for intractable aspiration. Laryngoscope 1975; 85:157–180 11 Mahoney FT, Barthel DW. Functional evaluation: Barthel index. MD State Med J 1965; 14:61– 65 12 Zung WWK. A self-rating depression scale. Arch Gen Psychiatry 1965; 12:63–70 13 Lorish CD, Maisiak R. The face scale: a brief, nonverbal method for assessing patient mood. Arthritis Rheum 1986; 29:906 –909 14 Naughton MJ, Shumaker SA, Anderson RT, et al. Psychological aspects of health-related quality of life measurement: test and scales. In: Spilker B, ed. Quality of life and pharmacoeconomics in clinical trials. 2nd ed. Philadelphia, PA: Lippincott-Raven, 1996; 117–131 15 Miller MD, Ferris DG. Measurement of subjective phenomena in primary care research: the visual analogue scale. Fam Pract Res J 1993; 13:15–24 16 Eibling DE, Snyderman CH, Eibling C. Laryngotracheal separation for intractable aspiration: a retrospective review of 34 patients. Laryngoscope 1995; 105:83– 85 17 Alverdy J, Chi HS, Sheldon GF. The effect of parenteral nutrition on gastrointestinal immunity: the importance of enteral stimulation. Ann Surg 1985; 202:681– 684 18 Lo CW, Walker WA. Changes in the gastrointestinal tract during enteral or parenteral feeding. Nutr Rev 1989; 47:193– 198 19 Schapiro GD, Edmundowicz SA. Complications of percutaneous endoscopic gastrostomy. Gastrointest Endosc Clin N Am 1996; 6:409 – 422 20 Eisenberg P. Pulmonary complications from enteral nutrition. Crit Care Nurs Clin North Am 1991; 3:641– 649

Clinical Investigations