The Laryngoscope C 2013 The American Laryngological, V
Rhinological and Otological Society, Inc.
Contemporary Review
Ethical Issues in Laryngology: Tracheal Stenting as Palliative Care Aasif A. Kazi, PharmD; W. Jeffrey Flowers, DMin, BCC; Jeanna M. Barrett, RN, BSN; Ashli K. O’Rourke, MD; Gregory N. Postma, MD; Paul M. Weinberger, MD Objectives/Hypothesis: To improve understanding of aspects of end-of-life care that may not be intuitive to the otolaryngology community. Data Sources and Review Methods: A comprehensive review of the literature was performed by searching Medline, Embase, and Google Scholar databases. Primary manuscripts’ bibliographies were reviewed to identify any nonindexed references. Prospective consultation by means of one-on-one interviews was sought from nonotolaryngology key stakeholders in the areas of hospice nursing care and patient advocacy in order to identify pertinent issues. Results: We identified over 1,000 articles published from 1965 to 2013 on the topic of tracheal stents, as well as over 40,000 on hospice/end-of-life care. Three articles focusing specifically on palliative care and airway stenting were identified, of which three were case reports and none were definitive reviews. There are a number of significant issues and concepts unique to hospice care. These are likely unfamiliar to all except for head and neck oncology-specialized otolaryngologists. An example is that hospice care focuses on quality of life rather than prolongation of life (such as curative surgery). Patients with nonoperable tracheal obstruction from malignancy face an unpleasant demise from suffocation. For those patients, stenting can relieve suffering by restoring airway patency. Conclusions: Airway stenting can be a valid palliative care option, even for terminal patients receiving hospice care, when performed to relieve airway obstruction and improve quality of life. End-of-life ethics is an underdeveloped area of otolaryngology that should be explored. Key Words: Stenting; hospice care; medical ethics; tracheal obstruction. Laryngoscope, 124:1663–1667, 2014
INTRODUCTION Lung cancer is the leading cause of cancer-related mortality among both genders in the United States and the most common cancer worldwide.1 Almost one-third of lung cancer patients at some point have obstruction of the trachea or mainstem bronchi resulting in respiratory distress, pulmonary insufficiency, hemoptysis, or postobstructive pneumonia.1,2 Obstruction can be caused by intraluminal tumor growth, malacia of tracheal, or bronchial walls or compression.1 Symptom burden is often
From the Department of Otolaryngology and Center for Voice, Airway and Swallowing, Medical College of Georgia at Georgia Regents University (A.A.K., G.N.P., P.M.W.); the Department of Pastoral Counseling, Georgia Regents Health System (W.J.F.); the Gentiva Hospice Corporation (J.M.B.), Augusta, Georgia; and the Department of Otolaryngology, Medical University of South Carolina (A.K.O’R.), Charleston South Carolina, U.S.A. This work presented as a Poster Presentation at the 2014 Combined Section Meetings of the Triological Society, Orlando, Florida, U.S.A., January 10–12, 2014. The authors have no funding, financial relationships, or conflicts of interest to disclose. Editor’s Note: This Manuscript was accepted for publication November 15, 2013. Send correspondence to Paul M. Weinberger M.D., Center for Voice, Airway and Swallowing, Department of Otolaryngology, Medical College of Georgia at Georgia Regent’s University, 1120 15th Street BP4109, Augusta, GA 30912. E-mail: [email protected] DOI: 10.1002/lary.24531
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significant with treatment strategy depending on comorbidities, pulmonary function, previous treatment, and life expectancy.1,3 Only one in five patients are amenable to surgical resection with curative intent; the remaining 80% eventually require palliative treatment using a variety of methods, including endoscopic surgical, radiotherapy, and endoscopic stenting.1,4 For those patients with extrinsic compression, stenting provides the most practical solution, with the main goal being relief of respiratory distress.5 However, there remain some unanswered questions regarding this issue. In a terminal patient, is stenting a valid palliative care treatment (as opposed to a life-prolonging therapy)? Is this considered a heroic effort? Is it ethical to pursue an expensive and invasive treatment plan with uncertain outcomes in a terminally ill patient? We present an exploration of this topic from multiple perspectives, including that of the hospital chaplain acting as the patient advocate and that of the surgeon— as well as a discussion of existing literature. While we would have liked to have included the perspective of the patients’ themselves, these issues are often faced after the patient has lost the ability to communicate, placing increased importance on advocates and the advanced directive. To facilitate the review, two example cases of palliation with tracheal stenting for patients with malignant compression of the trachea are discussed. Kazi et al.: Palliative Care Laryngology
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METHODS This study was approved by the Georgia Regents University Human Assurance Committee policy as an exempted report. A comprehensive review of the literature was performed by searching Medline, Embase, and Google Scholar databases. Primary manuscript’s bibliographies were reviewed to identify any nonindexed references. Prospective consultation by means of one-on-one interviews was sought from nonotolaryngology key stakeholders in the areas of hospice nursing care and patient advocacy in order to identify pertinent issues.
Example Case 1 A 48-year-old female presented to her primary care physician with chronic cough, mild dyspnea, and gradually worsening dysphagia. This progressed rapidly, and imaging demonstrated a 2.6-cm right upper lobe lung nodule. A tissue biopsy was obtained by bronchoscopy, consistent with nonsmall cell lung cancer. During this procedure, the patient required intubation and the otolaryngology service was consulted. On our evaluation, the patient was sedated on mechanical ventilator support with elevated peak pressures. Computed tomography of the chest demonstrated an infiltrative mediastinal soft tissue mass with encasement and narrowing of the distal trachea, carina, both mainstem bronchi, and involvement of the esophagus. After discussion with her next of kin (husband), a decision was made to take her to the operating room for endoscopic stent placement in an attempt to improve her quality of life. After overnight delivery of the appropriate sizes of stents, she underwent suspension microlaryngoscopy/bronchoscopy with tracheal tumor debulking by microdebrider and tracheal dilation using a controlled radial expansion balloon (Boston Scientific; Norwood, MS), placement of a dynamic-Y stent (13 mm, Boston Scientific), a covered Ultraflex left mainstem bronchial stent (12 3 40 mm, Boston Scientific), and a covered esophageal stent (18 mm 3 12cm WallFlex, Boston Scientific) with no complications. She was immediately started on external beam radiotherapy. Following stent deployment, her ventilator parameters improved dramatically and she regained alertness but was unable to be weaned from the ventilator. At 2 weeks postoperatively, she remained orally intubated and experienced acute decline in respiratory and mental status. Her husband made the decision to withdraw treatment and requested the endotracheal tube be removed. The patient was allowed to expire on postoperative day 15.
Example Case 2 A 60-year-old male presented to his internist with 1 month of progressive dyspnea, weight loss, and occasional
hemoptysis. He had a previous history of T2N0M0 supraglottic laryngeal squamous cell carcinoma, treated with external beam radiotherapy 6 years prior and with no recurrence. Computed tomography revealed a 3-cm compressive mass of the distal trachea. He was transferred to our facility for further evaluation and otolaryngology was consulted. He developed mild expiratory stridor and was taken to the operating room to secure his airway. Intraoperatively there was near complete tracheal obstruction secondary to the tumor. His airway was managed uneventfully by jet ventilation and immediate balloon dilation, followed by microdebridement and covered stent (60 3 20 mm and 40 3 20mm Aero Stents; Merit Medical Systems, South Jordan, UT) deployment (Fig. 1). The patient was extubated in the operating room, awakened and discharged home 2 days later. At last contact, he had no dyspnea, had completed a palliative course of external beam radiotherapy, and was enrolled in an outpatient/home visit hospice program in his hometown.
RESULTS Over 1000 articles were identified meeting the criteria of published from 1965 to 2013 on the topic of tracheal stents. Similarly, there were over 40,000 peerreviewed manuscripts on hospice / end-of-life care. Three manuscripts focusing specifically on palliative care and airway stenting were identified3,4,6 of which all 3 were case reports and none were definitive reviews. Following further investigations including one-to-one interviews with key stakeholders, a consensus opinion was formed, and is presented in the Discussion.
DISCUSSION Most patients with advanced malignancy die from metastases before central airway obstruction. Neck metastases with tracheal compression and direct spread from lung or tracheal cancer represent a unique exception. For these patients with airway obstruction, surgical resection is the treatment of choice. However, most of these patients are not candidates for surgical resection, and usually this mandates a shift in treatment goals toward palliation. In such cases, airway stent placement can offer a practical solution to maintain airway patency, either as palliation or as a temporizing measure to allow time for radiation therapy.2 Similar to performing a tracheostomy, bypassing an obstruction using stent
Fig. 1. Endoscopic views of the tracheal obstruction before (left) and after (right) tumor debulking and balloon dilation, but before stent deployment. Two interlocked stents were required to span the length of tumor compression. [Color figure can be viewed in the online issue, which is available at www. laryngoscope.com.]
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placement can allow the patient to awaken from sedation enough to participate in the decisions regarding their own care. However, tracheal or bronchial stents have a relatively high complication rate: migration or displacement, poor mucus clearance, restenosis, or mucous plugging can occur in up to 15% of patients.2,6 Nevertheless, Lemaire et al. found that patients with airway stents due to malignant airway compromise overall had less frequent repeat airway procedures poststent compared to prestent time course. Furthermore, patients in this study had a median survival of 3.4 months with a 15% 1-year survival (and presumably would have median survival measured in weeks if not stented).2 This must be balanced with findings from another study of patients who were given stents as a final treatment modality, which showed minimal improvements in performance and poor outcomes, with a mean survival of 1.6 months and 1-year survival of 5.1%.6 Given the invasive nature of stent placement, as well as the potential complications associated with such a procedure, judicious and carefully considered use is warranted. The surgeon must also consider technical factors associated with stent deployment, which can be extremely challenging even for the experienced airway surgeon. Further complicating the decision process is the fact that the determination of which patients are appropriate candidates for stent placement remains undefined. There are currently no trials comparing the outcomes of various options in this setting. Furthermore, while there are algorithms to guide management, individual preference usually drives treatment decisions in these cases due to the above factors.1 Often when presented with these patients, surgeons are left in unfamiliar territory—trying to determine (in a urgent or
emergent setting) whether to offer an expensive, invasive procedure with no guarantee of success to a patient with poor prognosis, regardless of treatment choice. The field of medical ethics offers significant assistance in making such decisions. Conventional medical ethics includes the principles of respecting patient’s right to determine their own care (autonomy), preventing harm to the patient (nonmaleficence), promoting well being (beneficence), and fairly allocating resources (justice),7 which would include respecting a patient’s desire to live out their final days in comfort (Fig. 2). But comfort measures traditionally involve pain relief without the use of invasive procedures. In fact, almost all hospice centers require that life-prolonging therapy be precluded from hospice care. Airway stenting is not widely recognized as being acceptable as comfort care only. As recently as 2011, Bandyopadhyay et al. reported that hospice care was discontinued for their two patients who underwent palliative airway stenting.8 The reality is that for patients with significant airway obstruction, stent placement can provide significant relief of respiratory discomfort. The tenets of hospice care support that, if an invasive procedure is being done to relieve suffering and improve comfort, this is compatible with hospice care and palliation. An additional issue to be considered is the cost of these interventions, especially in the setting of a patient with known short life expectancy. With current measures aimed at improving efficiency of healthcare, there is a significant emphasis placed on the cost benefit of any therapeutic measure. Recent research by Curtis et al. has shown that approximately 25% of all healthcare costs are spent in the last year of life, and that almost 20% of all deaths occur in the intensive care unit.9 The practical approach would involve improving efficiency in the ICU setting to curb overall healthcare costs. In fact, this same study found that most critical care physicians believe that the majority of resource intensive care provided in the ICU setting is inappropriate for end-of-life measures.9 They suggested that introducing palliation earlier in the stay could improve patient care while simultaneously reducing costs.9 Although airway stents are quite expensive (approximately $1,800–$2,400 per stent, plus direct and indirect costs of surgery, which can be in the $10,000–$20,000 range), the potential for reduction in ICU stay would potentially argue in favor of stenting. In addition to the previously described reduction in future airway procedures,2 there is potentially a substantial cost benefit even in terminal patients, although this has not been specifically studied. A thorough exploration of cost utility in palliative stenting has not been performed and would be an excellent direction for future research.
Hospice Nursing Perspective (Ms. Barrett, Hospice Nurse Administrator) Fig. 2. Commonly Accepted Principles of Medical Ethics. Adapted from Beauchamp PT, Childress JF. Principles of Biomedical Ethics. New York, NY: Oxford University Press, USA; 2009.
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The interventions and therapies covered under the concept of “palliation” are as unique and varied as the symptoms being treated. To provide aggressive symptom management in complex patients requires a Kazi et al.: Palliative Care Laryngology
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comprehensive evaluation and collaborative approach. The ultimate question that should be asked is, “What is in the best interest for the patient that will produce the desired outcome?” Some hospice professionals argue that true palliation includes only comfort medication/treatments, and that interventions should be nonaggressive and noninvasive in nature. In many instances, however, what would seem a therapeutic intervention can be contained under the umbrella of palliative care, when done to relieve undue suffering and improve comfort. Consider the case of a terminally ill patient who develops urinary obstruction. Would a bladder catheterization to relieve pain be therapeutic or palliative? Alternatively, open access hospice allows the patient and the family the possibility of receiving hospice care with their current treatment. Akin to the exit ramp on a highway, open access hospice does not require the patient to trade aggressive treatment (i.e., the highway) for hospice care (i.e., small roads) immediately. Instead, it allows the patient and the family to transition to hospice care until they feel comfortable driving at the speed of their desired choice.10 By upstreaming the palliative care, or bringing the option of palliative care to the patient earlier, physicians can help ease the transition while also preventing any unnecessary discomfort. Temel et al. has shown that early palliative care has resulted in improved mood and more frequent discussions about a less aggressive endof-life care, thus improving the quality of the remainder of the patient’s life with loved ones.11 Thus, our ultimate goals should be aligned with those of the patient and family. The route to those goals is entirely driven by patient choice. Investigating patient goals and wishes and physician disclosure thorough informed consent are both essential to bridge the gap between curative and palliative care. Understanding what options are available, the associated direct holistic costs, and the anticipated outcomes should be discussed when developing an individual plan of care.
Patient Advocate Perspective (Rev. Flowers, Hospital Chaplain) A continuing ethical issue for patients, such as the one described in this case study, is that of expressing their wishes concerning the care that they will receive at the end of life. Patient autonomy is an important principle that allows patients to guide their care, even beyond their ability to communicate. While a clear word from the next of kin is valuable, the directive from the patient is the gold standard for ethical decision making. In both clinical examples, there was no evidence of a formal advanced directive from the patient. Regarding the first patient, in prior discussions with the husband she had expressed a desire to not be kept alive if there was no chance of longterm viability. It was left to the health care team in accordance with the husband to decide how that would be carried out, and at what point such circumstances existed that would lead to the withdrawal of treatment. Family members often state in the aftermath of such decisions Laryngoscope 124: July 2014
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that they live with a sense of doubt as to whether or not they made the right decision. The patient/family advocate serves to remove the burden from the family, reminding them that the decision being made is not whether the patient will live, but rather the quality and dignity of life until they die. Advocacy may be provided by any number of professional services. Most institutions have social workers, family counselors, and chaplains who serve as advocates. Working in connection with the health care delivery team, the advocate can assist in any transitions that are introduced to the patient/family. Hospice and palliative care services often include their own advocates, providing excellent communication opportunities and seamless transitions if appropriate communication occurs. Pastoral care providers serve to help the family to find closure and to ensure that they have the necessary emotional support as the process unfolds. In such cases where the heavy burden of a clinical decision falls to a family member, the clinical team performs best when they interpret the advanced directive and consult with the family to define what will take place in accordance with the written wishes of the patient. By seeking an advanced directive from the patient, the family is relieved from making the decision; they simply affirm the choice made by their loved one. It is not uncommon for health care providers to also experience some reflective thought as to whether the right decisions were made. Surrogate decision making comes in different forms. The direct word from the patient is the clearest message. The advanced directive is the statement of the patient and should be viewed as such. The identified health care agent’s personal views often conflict with the advanced directive, leaving the health care delivery team in limbo. In such cases, the health care delivery team must decide if the agent is acting in the best interest of the patient. While the obligation is to carry out the advanced directive, the presence of a family member with a different opinion often delays and complicates the process. Every effort should be made to bring in consultants such as chaplains, social workers, and family counselors to seek a resolution. The absence of any family or individuals who know the patient creates a different issue. The clinician may find themselves in the position of being the surrogate decision maker under the “best interest standard” of medical ethics. In the absence of anyone who knows the patient, the team proceeds under the idea of what would a reasonable person do and what is in the best interest of the patient. The ethical standards of beneficence and nonmaleficence move to center stage. Again, the team is best served by bringing together a collective body of consultants to help discern this standard. The health care team should assist in this process by introducing the concept of palliation and hospice care at an early point in the relationship. The institution must also ensure that the information concerning the development of an advanced directive is given to the patient and that the desirability and implications that it can have on future decisions be discussed. These documents are designed to create a dialogue between the patient and the health care provider, and to insure that the patient’s wishes are known. While treatment is withdrawn, it is Kazi et al.: Palliative Care Laryngology
important to note that care for the patient is never withdrawn. Switching to comfort care should create a sense for all involved that the patient will not suffer, and that all of the needs of those affected will be addressed— including the need for emotional and spiritual support.
CONCLUSION Definitive parameters or guidelines for the stenting of patients with malignant airway obstruction would ideally allow identification of those patients who would benefit the most from aggressive intervention and be able to tolerate it and those who would represent an inappropriate allocation of scarce resources. Such parameters, however, do not exist. If the only goal is palliation and comfort care, than the answer should be “yes,” because any relief of discomfort could be significant. However, if the decision is entirely predicated on efficient use of resources, then this type of palliation should be reserved for patients who can tolerate aggressive support with a large expected improvement in functional quality of life. Regardless of these factors, airway stenting can be a valid palliative care option—even for terminal patients receiving hospice care— when performed to relieve airway obstruction and improve quality of life. Ultimately the decision to pursue endoscopic
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airway stenting for a terminally ill patient is shared by the patient, family, and surgeon.
BIBLIOGRAPHY 1. Santos RS, Raftopoulos Y, Keenan RJ, Halal A, Maley RH, Landreneau RJ. Bronchoscopic palliation of primary lung cancer: single or multimodality therapy? Surg Endosc 2004;18:931–936. 2. Lemaire A, Burfeind WR, Toloza E, et al. Outcomes of tracheobronchial stents in patients with malignant airway disease. Ann Thorac Surg 2005;80:434–437; discussion 437–438. 3. Davis MP. The emerging role of palliative medicine in the treatment of lung cancer patients. Cleve Clin J Med 2012;79(electronic suppl 1): eS51–55. doi: 10.3949/ccjm.79.s2.11. 4. Gaafar AH, Shaaban AY, Elhadidi MS. The use of metallic expandable tracheal stents in the management of inoperable malignant tracheal obstruction. Eur Arch Otorhinolaryngol 2012;269:247–253. 5. Shiraishi T, Kawahara K, Shirakusa T, Inada K, Okabayashi K, Iwasaki A. Stenting for airway obstruction in the carinal region. Ann Thorac Surg 1998;66:1925–1929. 6. Furukawa K, Ishida J, Yamaguchi G, et al. The role of airway stent placement in the management of tracheobronchial stenosis caused by inoperable advanced lung cancer. Surg Today 2010;40:315–320. 7. Beauchamp PT, Childress JF. Principles of Biomedical Ethics. New York, NY: Oxford University Press, USA; 2009. 8. Bandyopadhyay D, Induru RR. Role of palliative tracheobronchial stenting in hospice patients: boon or bane? Am J Hosp Palliat Care 2011;28:445–448. 9. Curtis JR, Engelberg RA, Bensink ME, Ramsey SD. End-of-life care in the intensive care unit: can we simultaneously increase quality and reduce costs? Am J Respir Crit Care Med 2012;186:587–592. 10. Wright AA, Katz IT. Letting go of the rope—aggressive treatment, hospice care, and open access. N Engl J Med 2007;357:324–327. 11. Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 2010;363:733–742.
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Rhinological and Otological Society, Inc.
Contemporary Review
Ethical Issues in Laryngology: Tracheal Stenting as Palliative Care Aasif A. Kazi, PharmD; W. Jeffrey Flowers, DMin, BCC; Jeanna M. Barrett, RN, BSN; Ashli K. O’Rourke, MD; Gregory N. Postma, MD; Paul M. Weinberger, MD Objectives/Hypothesis: To improve understanding of aspects of end-of-life care that may not be intuitive to the otolaryngology community. Data Sources and Review Methods: A comprehensive review of the literature was performed by searching Medline, Embase, and Google Scholar databases. Primary manuscripts’ bibliographies were reviewed to identify any nonindexed references. Prospective consultation by means of one-on-one interviews was sought from nonotolaryngology key stakeholders in the areas of hospice nursing care and patient advocacy in order to identify pertinent issues. Results: We identified over 1,000 articles published from 1965 to 2013 on the topic of tracheal stents, as well as over 40,000 on hospice/end-of-life care. Three articles focusing specifically on palliative care and airway stenting were identified, of which three were case reports and none were definitive reviews. There are a number of significant issues and concepts unique to hospice care. These are likely unfamiliar to all except for head and neck oncology-specialized otolaryngologists. An example is that hospice care focuses on quality of life rather than prolongation of life (such as curative surgery). Patients with nonoperable tracheal obstruction from malignancy face an unpleasant demise from suffocation. For those patients, stenting can relieve suffering by restoring airway patency. Conclusions: Airway stenting can be a valid palliative care option, even for terminal patients receiving hospice care, when performed to relieve airway obstruction and improve quality of life. End-of-life ethics is an underdeveloped area of otolaryngology that should be explored. Key Words: Stenting; hospice care; medical ethics; tracheal obstruction. Laryngoscope, 124:1663–1667, 2014
INTRODUCTION Lung cancer is the leading cause of cancer-related mortality among both genders in the United States and the most common cancer worldwide.1 Almost one-third of lung cancer patients at some point have obstruction of the trachea or mainstem bronchi resulting in respiratory distress, pulmonary insufficiency, hemoptysis, or postobstructive pneumonia.1,2 Obstruction can be caused by intraluminal tumor growth, malacia of tracheal, or bronchial walls or compression.1 Symptom burden is often
From the Department of Otolaryngology and Center for Voice, Airway and Swallowing, Medical College of Georgia at Georgia Regents University (A.A.K., G.N.P., P.M.W.); the Department of Pastoral Counseling, Georgia Regents Health System (W.J.F.); the Gentiva Hospice Corporation (J.M.B.), Augusta, Georgia; and the Department of Otolaryngology, Medical University of South Carolina (A.K.O’R.), Charleston South Carolina, U.S.A. This work presented as a Poster Presentation at the 2014 Combined Section Meetings of the Triological Society, Orlando, Florida, U.S.A., January 10–12, 2014. The authors have no funding, financial relationships, or conflicts of interest to disclose. Editor’s Note: This Manuscript was accepted for publication November 15, 2013. Send correspondence to Paul M. Weinberger M.D., Center for Voice, Airway and Swallowing, Department of Otolaryngology, Medical College of Georgia at Georgia Regent’s University, 1120 15th Street BP4109, Augusta, GA 30912. E-mail: [email protected] DOI: 10.1002/lary.24531
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significant with treatment strategy depending on comorbidities, pulmonary function, previous treatment, and life expectancy.1,3 Only one in five patients are amenable to surgical resection with curative intent; the remaining 80% eventually require palliative treatment using a variety of methods, including endoscopic surgical, radiotherapy, and endoscopic stenting.1,4 For those patients with extrinsic compression, stenting provides the most practical solution, with the main goal being relief of respiratory distress.5 However, there remain some unanswered questions regarding this issue. In a terminal patient, is stenting a valid palliative care treatment (as opposed to a life-prolonging therapy)? Is this considered a heroic effort? Is it ethical to pursue an expensive and invasive treatment plan with uncertain outcomes in a terminally ill patient? We present an exploration of this topic from multiple perspectives, including that of the hospital chaplain acting as the patient advocate and that of the surgeon— as well as a discussion of existing literature. While we would have liked to have included the perspective of the patients’ themselves, these issues are often faced after the patient has lost the ability to communicate, placing increased importance on advocates and the advanced directive. To facilitate the review, two example cases of palliation with tracheal stenting for patients with malignant compression of the trachea are discussed. Kazi et al.: Palliative Care Laryngology
1663
METHODS This study was approved by the Georgia Regents University Human Assurance Committee policy as an exempted report. A comprehensive review of the literature was performed by searching Medline, Embase, and Google Scholar databases. Primary manuscript’s bibliographies were reviewed to identify any nonindexed references. Prospective consultation by means of one-on-one interviews was sought from nonotolaryngology key stakeholders in the areas of hospice nursing care and patient advocacy in order to identify pertinent issues.
Example Case 1 A 48-year-old female presented to her primary care physician with chronic cough, mild dyspnea, and gradually worsening dysphagia. This progressed rapidly, and imaging demonstrated a 2.6-cm right upper lobe lung nodule. A tissue biopsy was obtained by bronchoscopy, consistent with nonsmall cell lung cancer. During this procedure, the patient required intubation and the otolaryngology service was consulted. On our evaluation, the patient was sedated on mechanical ventilator support with elevated peak pressures. Computed tomography of the chest demonstrated an infiltrative mediastinal soft tissue mass with encasement and narrowing of the distal trachea, carina, both mainstem bronchi, and involvement of the esophagus. After discussion with her next of kin (husband), a decision was made to take her to the operating room for endoscopic stent placement in an attempt to improve her quality of life. After overnight delivery of the appropriate sizes of stents, she underwent suspension microlaryngoscopy/bronchoscopy with tracheal tumor debulking by microdebrider and tracheal dilation using a controlled radial expansion balloon (Boston Scientific; Norwood, MS), placement of a dynamic-Y stent (13 mm, Boston Scientific), a covered Ultraflex left mainstem bronchial stent (12 3 40 mm, Boston Scientific), and a covered esophageal stent (18 mm 3 12cm WallFlex, Boston Scientific) with no complications. She was immediately started on external beam radiotherapy. Following stent deployment, her ventilator parameters improved dramatically and she regained alertness but was unable to be weaned from the ventilator. At 2 weeks postoperatively, she remained orally intubated and experienced acute decline in respiratory and mental status. Her husband made the decision to withdraw treatment and requested the endotracheal tube be removed. The patient was allowed to expire on postoperative day 15.
Example Case 2 A 60-year-old male presented to his internist with 1 month of progressive dyspnea, weight loss, and occasional
hemoptysis. He had a previous history of T2N0M0 supraglottic laryngeal squamous cell carcinoma, treated with external beam radiotherapy 6 years prior and with no recurrence. Computed tomography revealed a 3-cm compressive mass of the distal trachea. He was transferred to our facility for further evaluation and otolaryngology was consulted. He developed mild expiratory stridor and was taken to the operating room to secure his airway. Intraoperatively there was near complete tracheal obstruction secondary to the tumor. His airway was managed uneventfully by jet ventilation and immediate balloon dilation, followed by microdebridement and covered stent (60 3 20 mm and 40 3 20mm Aero Stents; Merit Medical Systems, South Jordan, UT) deployment (Fig. 1). The patient was extubated in the operating room, awakened and discharged home 2 days later. At last contact, he had no dyspnea, had completed a palliative course of external beam radiotherapy, and was enrolled in an outpatient/home visit hospice program in his hometown.
RESULTS Over 1000 articles were identified meeting the criteria of published from 1965 to 2013 on the topic of tracheal stents. Similarly, there were over 40,000 peerreviewed manuscripts on hospice / end-of-life care. Three manuscripts focusing specifically on palliative care and airway stenting were identified3,4,6 of which all 3 were case reports and none were definitive reviews. Following further investigations including one-to-one interviews with key stakeholders, a consensus opinion was formed, and is presented in the Discussion.
DISCUSSION Most patients with advanced malignancy die from metastases before central airway obstruction. Neck metastases with tracheal compression and direct spread from lung or tracheal cancer represent a unique exception. For these patients with airway obstruction, surgical resection is the treatment of choice. However, most of these patients are not candidates for surgical resection, and usually this mandates a shift in treatment goals toward palliation. In such cases, airway stent placement can offer a practical solution to maintain airway patency, either as palliation or as a temporizing measure to allow time for radiation therapy.2 Similar to performing a tracheostomy, bypassing an obstruction using stent
Fig. 1. Endoscopic views of the tracheal obstruction before (left) and after (right) tumor debulking and balloon dilation, but before stent deployment. Two interlocked stents were required to span the length of tumor compression. [Color figure can be viewed in the online issue, which is available at www. laryngoscope.com.]
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placement can allow the patient to awaken from sedation enough to participate in the decisions regarding their own care. However, tracheal or bronchial stents have a relatively high complication rate: migration or displacement, poor mucus clearance, restenosis, or mucous plugging can occur in up to 15% of patients.2,6 Nevertheless, Lemaire et al. found that patients with airway stents due to malignant airway compromise overall had less frequent repeat airway procedures poststent compared to prestent time course. Furthermore, patients in this study had a median survival of 3.4 months with a 15% 1-year survival (and presumably would have median survival measured in weeks if not stented).2 This must be balanced with findings from another study of patients who were given stents as a final treatment modality, which showed minimal improvements in performance and poor outcomes, with a mean survival of 1.6 months and 1-year survival of 5.1%.6 Given the invasive nature of stent placement, as well as the potential complications associated with such a procedure, judicious and carefully considered use is warranted. The surgeon must also consider technical factors associated with stent deployment, which can be extremely challenging even for the experienced airway surgeon. Further complicating the decision process is the fact that the determination of which patients are appropriate candidates for stent placement remains undefined. There are currently no trials comparing the outcomes of various options in this setting. Furthermore, while there are algorithms to guide management, individual preference usually drives treatment decisions in these cases due to the above factors.1 Often when presented with these patients, surgeons are left in unfamiliar territory—trying to determine (in a urgent or
emergent setting) whether to offer an expensive, invasive procedure with no guarantee of success to a patient with poor prognosis, regardless of treatment choice. The field of medical ethics offers significant assistance in making such decisions. Conventional medical ethics includes the principles of respecting patient’s right to determine their own care (autonomy), preventing harm to the patient (nonmaleficence), promoting well being (beneficence), and fairly allocating resources (justice),7 which would include respecting a patient’s desire to live out their final days in comfort (Fig. 2). But comfort measures traditionally involve pain relief without the use of invasive procedures. In fact, almost all hospice centers require that life-prolonging therapy be precluded from hospice care. Airway stenting is not widely recognized as being acceptable as comfort care only. As recently as 2011, Bandyopadhyay et al. reported that hospice care was discontinued for their two patients who underwent palliative airway stenting.8 The reality is that for patients with significant airway obstruction, stent placement can provide significant relief of respiratory discomfort. The tenets of hospice care support that, if an invasive procedure is being done to relieve suffering and improve comfort, this is compatible with hospice care and palliation. An additional issue to be considered is the cost of these interventions, especially in the setting of a patient with known short life expectancy. With current measures aimed at improving efficiency of healthcare, there is a significant emphasis placed on the cost benefit of any therapeutic measure. Recent research by Curtis et al. has shown that approximately 25% of all healthcare costs are spent in the last year of life, and that almost 20% of all deaths occur in the intensive care unit.9 The practical approach would involve improving efficiency in the ICU setting to curb overall healthcare costs. In fact, this same study found that most critical care physicians believe that the majority of resource intensive care provided in the ICU setting is inappropriate for end-of-life measures.9 They suggested that introducing palliation earlier in the stay could improve patient care while simultaneously reducing costs.9 Although airway stents are quite expensive (approximately $1,800–$2,400 per stent, plus direct and indirect costs of surgery, which can be in the $10,000–$20,000 range), the potential for reduction in ICU stay would potentially argue in favor of stenting. In addition to the previously described reduction in future airway procedures,2 there is potentially a substantial cost benefit even in terminal patients, although this has not been specifically studied. A thorough exploration of cost utility in palliative stenting has not been performed and would be an excellent direction for future research.
Hospice Nursing Perspective (Ms. Barrett, Hospice Nurse Administrator) Fig. 2. Commonly Accepted Principles of Medical Ethics. Adapted from Beauchamp PT, Childress JF. Principles of Biomedical Ethics. New York, NY: Oxford University Press, USA; 2009.
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The interventions and therapies covered under the concept of “palliation” are as unique and varied as the symptoms being treated. To provide aggressive symptom management in complex patients requires a Kazi et al.: Palliative Care Laryngology
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comprehensive evaluation and collaborative approach. The ultimate question that should be asked is, “What is in the best interest for the patient that will produce the desired outcome?” Some hospice professionals argue that true palliation includes only comfort medication/treatments, and that interventions should be nonaggressive and noninvasive in nature. In many instances, however, what would seem a therapeutic intervention can be contained under the umbrella of palliative care, when done to relieve undue suffering and improve comfort. Consider the case of a terminally ill patient who develops urinary obstruction. Would a bladder catheterization to relieve pain be therapeutic or palliative? Alternatively, open access hospice allows the patient and the family the possibility of receiving hospice care with their current treatment. Akin to the exit ramp on a highway, open access hospice does not require the patient to trade aggressive treatment (i.e., the highway) for hospice care (i.e., small roads) immediately. Instead, it allows the patient and the family to transition to hospice care until they feel comfortable driving at the speed of their desired choice.10 By upstreaming the palliative care, or bringing the option of palliative care to the patient earlier, physicians can help ease the transition while also preventing any unnecessary discomfort. Temel et al. has shown that early palliative care has resulted in improved mood and more frequent discussions about a less aggressive endof-life care, thus improving the quality of the remainder of the patient’s life with loved ones.11 Thus, our ultimate goals should be aligned with those of the patient and family. The route to those goals is entirely driven by patient choice. Investigating patient goals and wishes and physician disclosure thorough informed consent are both essential to bridge the gap between curative and palliative care. Understanding what options are available, the associated direct holistic costs, and the anticipated outcomes should be discussed when developing an individual plan of care.
Patient Advocate Perspective (Rev. Flowers, Hospital Chaplain) A continuing ethical issue for patients, such as the one described in this case study, is that of expressing their wishes concerning the care that they will receive at the end of life. Patient autonomy is an important principle that allows patients to guide their care, even beyond their ability to communicate. While a clear word from the next of kin is valuable, the directive from the patient is the gold standard for ethical decision making. In both clinical examples, there was no evidence of a formal advanced directive from the patient. Regarding the first patient, in prior discussions with the husband she had expressed a desire to not be kept alive if there was no chance of longterm viability. It was left to the health care team in accordance with the husband to decide how that would be carried out, and at what point such circumstances existed that would lead to the withdrawal of treatment. Family members often state in the aftermath of such decisions Laryngoscope 124: July 2014
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that they live with a sense of doubt as to whether or not they made the right decision. The patient/family advocate serves to remove the burden from the family, reminding them that the decision being made is not whether the patient will live, but rather the quality and dignity of life until they die. Advocacy may be provided by any number of professional services. Most institutions have social workers, family counselors, and chaplains who serve as advocates. Working in connection with the health care delivery team, the advocate can assist in any transitions that are introduced to the patient/family. Hospice and palliative care services often include their own advocates, providing excellent communication opportunities and seamless transitions if appropriate communication occurs. Pastoral care providers serve to help the family to find closure and to ensure that they have the necessary emotional support as the process unfolds. In such cases where the heavy burden of a clinical decision falls to a family member, the clinical team performs best when they interpret the advanced directive and consult with the family to define what will take place in accordance with the written wishes of the patient. By seeking an advanced directive from the patient, the family is relieved from making the decision; they simply affirm the choice made by their loved one. It is not uncommon for health care providers to also experience some reflective thought as to whether the right decisions were made. Surrogate decision making comes in different forms. The direct word from the patient is the clearest message. The advanced directive is the statement of the patient and should be viewed as such. The identified health care agent’s personal views often conflict with the advanced directive, leaving the health care delivery team in limbo. In such cases, the health care delivery team must decide if the agent is acting in the best interest of the patient. While the obligation is to carry out the advanced directive, the presence of a family member with a different opinion often delays and complicates the process. Every effort should be made to bring in consultants such as chaplains, social workers, and family counselors to seek a resolution. The absence of any family or individuals who know the patient creates a different issue. The clinician may find themselves in the position of being the surrogate decision maker under the “best interest standard” of medical ethics. In the absence of anyone who knows the patient, the team proceeds under the idea of what would a reasonable person do and what is in the best interest of the patient. The ethical standards of beneficence and nonmaleficence move to center stage. Again, the team is best served by bringing together a collective body of consultants to help discern this standard. The health care team should assist in this process by introducing the concept of palliation and hospice care at an early point in the relationship. The institution must also ensure that the information concerning the development of an advanced directive is given to the patient and that the desirability and implications that it can have on future decisions be discussed. These documents are designed to create a dialogue between the patient and the health care provider, and to insure that the patient’s wishes are known. While treatment is withdrawn, it is Kazi et al.: Palliative Care Laryngology
important to note that care for the patient is never withdrawn. Switching to comfort care should create a sense for all involved that the patient will not suffer, and that all of the needs of those affected will be addressed— including the need for emotional and spiritual support.
CONCLUSION Definitive parameters or guidelines for the stenting of patients with malignant airway obstruction would ideally allow identification of those patients who would benefit the most from aggressive intervention and be able to tolerate it and those who would represent an inappropriate allocation of scarce resources. Such parameters, however, do not exist. If the only goal is palliation and comfort care, than the answer should be “yes,” because any relief of discomfort could be significant. However, if the decision is entirely predicated on efficient use of resources, then this type of palliation should be reserved for patients who can tolerate aggressive support with a large expected improvement in functional quality of life. Regardless of these factors, airway stenting can be a valid palliative care option—even for terminal patients receiving hospice care— when performed to relieve airway obstruction and improve quality of life. Ultimately the decision to pursue endoscopic
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airway stenting for a terminally ill patient is shared by the patient, family, and surgeon.
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