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High Risk Surgery
What is Best for the Patient?
Hypothetical Scenario
The following is a hypothetical scenario for discussion purposes only and does not
represent any real persons, places, dates or events.
Mr. Smith, 78, was seen by his orthopedic surgeon, Dr. White,
because of knee pain. He was diagnosed with severe osteoarthritis
and a total knee replacement was recommended to relieve the pain
and improve his functional status. In addition to suffering from his
afflicted joint, Mr. Smith is also morbidly obese.
Dr. White subsequently met with Mr. Smith and his wife to discuss
the surgery at length. He laid out all the risks involved, going over
details of the knee replacement, as well as the anesthesia and
surgery in general. The doctor also advised his patient that there were
other, non-surgical options available. In the end, however, Mr. Smith
signed the consent form and underwent a total knee replacement.
The surgery itself was without complication. There was minimal
blood loss and Mr. Smith was taken to the recovery room in stable
condition. However, it became very difficult to extubate him, so
he was taken to the ICU to be closely monitored. Once extubated,
Mr. Smith was moved to the regular floor until he was stable enough
to be discharged to an extended care facility. He remained at this
facility for several weeks, but had to be readmitted to the hospital
because of post-operative complications.
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Mrs. Smith wondered why her husband’s hospital course was so
much different than her brother Bill’s, who is also 78 and underwent
the exact surgery. Bill did not have to go to the ICU and had no
difficulty with his breathing. In fact, his breathing tube was removed
before he left the recovery room. Her brother was in the hospital
for a much shorter time, was discharged home and is now walking
without any pain. One other key difference is that Mrs. Smith’s
brother is not obese.
Although the couple was told of the risk, benefits and alternatives
to knee replacement surgery, they weren’t told of the risks individualized to Mr. Smith’s medical condition. In all likelihood, he still
would have undergone the surgery, but now the two face medical
bills they had never anticipated. Moreover, they would have made
different arrangements to bring him home and to support Mrs. Smith
while her husband was hospitalized. They were never told that Mr.
Smith’s obesity placed him in a different category than brother Bill’s.
“The good physician treats the disease; the great physician
treats the patient who has the disease.” Sir William Osler
Audience
This white paper is designed not only for physicians, but also for other stakeholders within
a healthcare organization. Those individuals are affected by the decision process surrounding
high-risk surgeries and realize the need to change the culture to deal with this important
issue with an eye toward overall patient care goals. Specifically, healthcare providers, healthcare
educators, organizational leaders, ethics committees, risk managers and patient financial
advocates can use the ideas and tools presented in this paper to help better deliver safe, effective
and comprehensive care by recognizing the importance of a team approach that includes
the patient and family when deciding on high risk surgery.
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This paper recognizes that healthcare is delivered under different structures, including but
not limited to: private practice, county clinics, academic facilities, long term care facilities,
military institutions and physician employment models. Each delivery system will need to
tailor the recommendations to fit its specific needs, similar to the healthcare team who must
individualize the approach to each patient.
Basic Definitions
The first step in defining high risk or heroic surgery, as it is sometimes referred to, is defining
what it is not. It is not futile surgery. Futile surgery can be differentiated from high risk surgery
based on the idea that futile surgery is of no benefit to the patient. It is medically ineffective.
There is no obligation to offer or continue interventions that are medically ineffective, even if
the patient or surrogate decision maker demands it. High risk surgery is also not any heroic
measure such as a code blue.
High risk surgery may best be considered on a spectrum of procedures that MAY make a
difference and intend to improve the quality of life/decrease pain in a frail or terminal patient.
Therefore, families, patients and healthcare providers may push for the procedure without
full evaluation of the value to the patient from a physical, emotional or financial standpoint.
Additionally, the cost to the organization in terms of hard dollars as well as ICU beds needs
to be taken into consideration, as resources are limited.
From a practical standpoint, high risk surgery can be defined in two ways: the first is relevant
to the patient and suggests that the risk to him or her is higher than for a population; the second
compares the risk of the proposed surgery to the risk of surgical procedures in general.1
High Risk Patient
The first category to be considered is the high risk patient having a routine procedure.
While not typically thought of as undergoing high risk surgery, this group of patients should
be approached from a collaborative standpoint when making decisions for surgery. High risk
patients can include: (1) the elderly; (2) the disabled; (3) the morbidly obese; (4) transplant
patients; (5) multiple co-morbidities; (6) chronically ill children; (7) patients admitted from
nursing homes, institutionalized or so-called “hand-off” patients; (8) cancer patients in general;
(9) those dealing with substance abuse including tobacco; and (10) patients without a clear
primary admitting provider.
To simplify the discussion, this paper will use obesity as an example since the epidemic of
obesity in America continues to increase, and now extends to the elderly population.2 A study
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by Silber et al. suggests that the condition may require an increase in general and orthopedic
surgery in the obese elderly but, unfortunately, administrative claims do not collect Body
Mass Index (BMI) information, making it somewhat difficult to study. Furthermore, since BMI
information is not collected, it is not used for severity adjustments in Medicare payment
algorithms. This suggests that doctors and hospitals are not being reimbursed appropriately
for taking care of such high risk patients. Medicare payments from 2002-2006 were 3% greater
for the obese than the non-obese, but it cost almost 10% more to care for these patients.2
More significant was the medical outcomes in this group of patients. While there was no
significant difference in mortality for obese patients, complications such as wound infection,
sepsis, respiratory system complication, cardiac events and longer lengths of stay were
observed, as compared to their matched non-obese counterparts.2 Additionally, the odds of
being re-admitted were between 40% and 50% greater in the obese than the non-obese.
This paper does not suggest that an obese patient should not undergo surgery. Instead, this
individual needs to be informed that in addition to the risk of the surgery itself, he or she has
a higher likelihood of certain complications, including a longer length of stay and increased
rates of readmission. Arming our patients with this information and properly educating them
will allow the healthcare team to better manage the individual patient’s overall expectations.
High Risk Surgical Procedures
In 2011, the New England Journal of Medicine (NEJM) listed eight cancer and cardiovascular
surgeries to be considered high risk. They include: (1) cancer resection of the lung, esophagus,
pancreas and bladder; (2) repair of an abdominal aortic aneurysm; (3) A-V valve replacement;
(4) carotid artery bypass graft (CABG); (5) carotid endarterectomy; and (6) previous gastric
bypass.3 In an effort to reduce mortality in these procedures, minimum volume standards
were established in 2000 for several of the procedures as part of a broader, value-based
purchasing initiative.3,4 Operative mortality is defined by the Medicare eligibility file as death
before discharge or within 30 days after the operation.3 Additionally, professional organizations
such as the American College of Surgeons have established minimum volumes as part of
Centers of Excellence accreditation programs.3,5 While these efforts have improved the mortality
when a few of the aforementioned procedures are done in high volume hospitals, the studies
tend to focus on mortality as the end outcome.3 Minimal focus has been placed on quality
of life following the procedures. One could argue that as improvement in mortality improves
in high risk procedures, does that necessarily correlate to improved quality of life? If the World
Health Organization (WHO) in 1948 defined health as “a state of complete physical, mental
and social well-being, not merely the absence of disease or infirmary,” are we taking this
comprehensive definition into account when we counsel our patients facing high risk surgery?6
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Health Literacy and Decision Making
Studies on patients with colon cancer, the third highest cause of cancer-related morality,
have demonstrated that optimal oncologic outcomes and long-term survival requires a
multidisciplinary approach.7 In addition to the multidisciplinary approach, advances in
chemotherapy agents have led to significant improvements in colorectal cancer outcomes
in recent years.7–9 In the same study, emphasis was placed on the health literacy of patients
and how adequate health literacy enables them to be informed and make appropriate treatment
decisions.7,10 The U.S. Department of Health and Human Services defined health literacy as:
“The degree to which individuals have the capacity to obtain, process, and understand basic
health information and services needed to make appropriate health decisions.”11 Included in
this definition is the ability to understand doctors’ directions and consent forms, as well as
the ability to negotiate complex health care systems. Health literacy is not merely the ability
to read the instructions, but the ability to listen, analyze and apply decision-making skills to
healthcare situations.12
Numerically, health literacy can be characterized as Level 1, which is less than a grade 4
education. Patients with a Level 1 understanding can’t read signs, medication bottles, poison
warnings or the city bus schedule. Approximately 40-44 million Americans are categorized
as Level 1.13 An additional 50 million fall under the Level 2 category, with a reading comprehension of grade 4-8. They have difficulties with executive functions such as simple forms
and reading USA Today. For reference, the average reading level is 8th grade. Medicaid patients
and the elderly typically read at 5th grade levels. These are our patients, but do they really
understand what we are telling them? People with limited literacy skills not only have problems
with reading, they are more likely to have difficulties with oral communication, short term
memory, carrying out medical instructions or learning new skills.11
Health Literacy and Understanding Quality of Life
The requirement for adequate health literacy can be demonstrated in the evaluation of Quality
of Life (QOL) measures. When patients and family members are trying to make difficult decisions
on whether to proceed with a treatment, in addition to the inherent and immediate risks of
surgery, also included in the discussion must be an evaluation of quality of life. QOL is a
multifaceted ideal that incorporates physical, mental, social and emotional health as well as
pre and post levels of functioning.14 It can be an abstract idea that depends on the individual’s
circumstances. Measuring QOL is both a subjective and objective task based on the underlying
disease, previous level of function and planned treatment.14 This paper is not meant to evaluate
the numerous QOL measurement tools available, but instead to emphasize the need for a
discussion regarding QOL prior to undertaking a treatment, in a proactive manner, rather than
waiting until after the treatment. Assessing how treatments affect patients’ health from their
understanding/viewpoint is one way to provide a more complete understanding of a proposed
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intervention and is a useful supplement to traditional endpoints such as survival rates.15
Physicians take an oath to “first do no harm,” but how is that harm quantified? What may be
considered harm to one patient may be an acceptable outcome to another. Unless we are
having complete discussions with our patients, healthcare providers will not be able to optimize
treatment choices and manage expectations.
When discussing high risk surgery with a patient and his/her family, it becomes the duty
of the healthcare team to understand the health literacy level of the individual making the
decision. When evaluating whether to proceed with surgery, the patient will be hopeful that
the planned procedure will confer a range of benefits including improved survival, symptom
improvement and improvements in quality of life.16 We know from the principles of informed
consent that the risks must also be discussed, and the prospect that the proposed surgery may
result in post-operative mortality, morbidity, worsening quality of life and financial burden.
Advanced surgical techniques, coupled with the greater focus on patient centered care, requires
a completed discussion at the patient’s level of understanding. For most high risk surgery,
survival is the primary endpoint when treatment is curative, potentially curative or when long-term
survival is expected.16,17 However, when considering high risk surgery with a focus on palliative
intent, the healthcare team should also discuss the challenges faced during the postoperative
period that can result in both long term and short term problems. Therefore, any survival
benefits must be considered in the context of the patient’s quality of life, as this may be the
actual endpoint of concern.16,18,19
A less discussed or considered factor when deciding on high risk surgery is the financial
implication to the patient, his/her family and the institution. For example, in cardiac surgery,
studies have been done that demonstrate the difference in outcomes of patients with identified
pre-operative risks related to length of intensive care unit (ICU) and hospital stay, and minimizing
cost without compromising a patient’s clinical outcomes.20 In Rajakaruna, et al., the direct
burden on hospital resources of patients requiring a prolonged ICU stay was recognized,
demonstrating 12.2% of bed occupancy costs used to care for only 2.6% of patients, with
indirect implications such as cancellations of surgery because of lack of ICU beds.20 The study
concluded that there may be a benefit in optimizing the patient’s risk factors preoperatively
and that predicting the likelihood of complications would optimize the preoperative patient
information and consent process. The study could also prompt the question, if the patient
could not be optimized and the risk of a lengthy stay in the ICU were known, would that
information help the patient? A slippery slope to be avoided would be that of basing the decision
on the cost to the institution, but is there a point where the financial impact to the organization,
including lack of ICU beds, should be considered in the discussion with the patient?
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Conclusion
In order to optimize healthcare decision making, a complete evaluation of all aspects of care
must be done, including the less often talked about financial implications. High risk surgery
needs to be approached from the procedural standpoint, individualizing each surgery to a
complex portrait of all the factors a patient brings to the operating suite. Surgeons must be
aware of the importance the patient places on the desired outcome, not just survival alone.
Patients are not a “one size fits all” and it becomes incumbent on the healthcare team to
evaluate the patient’s level of understanding before attempting any discussion related to
surgical outcomes.
Any surgery carries an inherent amount of risk. Being able to appropriately evaluate our
patient’s level of understanding, his/her co-morbid conditions prior to surgery and focus on
post-op quality of life, will improve overall communication and ultimately align the goals of
the surgeon and the high risk patient.
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Bibliography
1
Boyd O, Jackson N. How is risk defined in high-risk surgical patient management? Crit Care. 2005;9(4):390–396.
doi:10.1186/cc3057.
2
Silber JH, Rosenbaum PR, Kelz RR, et al. Medical and financial risks associated with surgery in the elderly obese.
Ann. Surg. 2012;256(1):79–86. doi:10.1097/SLA.0b013e31825375ef.
3
Finks JF, Osborne NH, Birkmeyer JD. Trends in Hospital Volume and Operative Mortality for High-Risk Surgery.
New England Journal of Medicine. 2011;364(22):2128–2137. doi:10.1056/NEJMsa1010705.
Milstein A, Galvin RS, Delbanco SF, Salber P, Buck CR Jr. Improving the safety of health care: the leapfrog initiative.
Eff Clin Pract. 2000;3(6):313–316.
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The American College of Surgeons. Bariatric Surgery Center Network Accreditation Program. 2010.
Available at: http://www.acsbscn.org/Public/index.jsp. Accessed January 10, 2013.
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World Health Organization. Preamble to the Constitution of the World Health Organization as adopted by the
International Health Conference, New York, 19-22 June, 1946; signed on 22 July 1946 by the representatives of 61
States (Official Records of the World Health Organization, no. 2, p. 100) and entered into force on 7 April 1948.
Retrieved March. 1948;16:2011.
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Pendlimari R, Holubar SD, Hassinger JP, Cima RR. Assessment of Colon Cancer Literacy in screening colonoscopy
patients: a validation study. J. Surg. Res. 2012;175(2):221–226. doi:10.1016/j.jss.2011.04.036.
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Tsikitis VL, Holubar SD, Dozois EJ, Cima RR, Pemberton JH, Larson DW. Advantages of fast-track recovery after laparoscopic
right hemicolectomy for colon cancer. Surg Endosc. 2010;24(8):1911–1916. doi:10.1007/s00464-009-0871-y.
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Boostrom SY, Nagorney DM, Donohue JH, et al. Impact of neoadjuvant chemotherapy with FOLFOX/FOLFIRI on
disease-free and overall survival of patients with colorectal metastases. J. Gastrointest. Surg. 2009;13(11):2003–2009;
discussion 2009–2010. doi:10.1007/s11605-009-1007-3.
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Human Services NAS Newsletter. 2000;15(3).
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Lynn Nielsen-Bohlman, Allison M. Panzer, David A. Kindig, Editors, Committee on Health Literacy.
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National Network of Libraries of Medicine. Health Literacy. 2012. Available at: http://nnlm.gov/outreach/consumer/hlthlit.html.
Accessed January 10, 2013.
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Institute of Education Sciences National Center for Education Statistics. National Assessment of Adult Literacy (NAAL).
2013. Available at: http://nces.ed.gov/naal/. Accessed January 10, 2013.
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Kasparek MS, Hassan I, Cima RR, Larson DR, Gullerud RE, Wolff BG. Long-term quality of life and sexual and urinary
function after abdominoperineal resection for distal rectal cancer. Dis. Colon Rectum. 2012;55(2):147–154.
doi:10.1097/DCR.0b013e31823d2606.
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McNair AG, Blazeby JM. Health-related quality-of-life assessment in GI cancer randomized trials: improving the impact
on clinical practice. Expert Rev Pharmacoecon Outcomes Res. 2009;9(6):559–567. doi:10.1586/erp.09.68.
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Fitzsimmons D, Wheelwright S, Johnson CD. Quality of life in pulmonary surgery: choosing, using, and developing
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Davis K, Yount S, Wagner L, Cella D. Measurement and management of health-related quality of life in lung cancer.
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Yusen RD. Technology and outcomes assessment in lung transplantation. Proc Am Thorac Soc. 2009;6(1):128–136.
doi:10.1513/pats.200809-102GO.
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Brunelli A. Risk Assessment for Pulmonary Resection. Seminars in Thoracic and Cardiovascular Surgery.
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About the Authors
Dr. Dana Welle has more than 16 years of clinical experience as an
obstetrician-gynecologist. After completing her residency in a large tertiary
academic medical center, she began private practice, where she continued
to manage high risk obstetric cases as well as perform complicated gynecological surgery. She is a fellow in the American College of Obstetrics
and Gynecology (ACOG) and also a fellow in the American College of
Surgeons (ACS). Although she is no longer directly involved in patient
care, she continues her pursuit of medical knowledge and remains active
in both ACOG and ACS.
Dr. Welle currently serves as the physician risk consultant for Stanford Hospital & Clinics and
Lucile Packard Children’s Hospital. Her responsibilities include conducting risk assessments,
consulting with and educating healthcare providers and staff, and investigating potential claims
at both facilities. She serves on the Committee for Professionalism and the Physician Wellness
Committee at Stanford Hospital & Clinics, as well as on the Care Improvement Committee for
both hospitals, and the Patient Safety Oversight Committee for Lucile Packard Children’s Hospital.
Dr. Welle’s combined educational degrees, coupled with her clinical background, places her
in a unique position. She is able to use both her medical and legal insight to strengthen the
relationship between the medical staff and the risk management team and bring a different
perspective to addressing risk management issues.
Dr. Welle received her BS in Kinesiology from the University of California at Los Angeles,
her DO degree from the Western University of Health Sciences and her JD degree from Santa
Clara University School of Law. She is a member of the state bar of California.
This white paper is not intended to be and should not be taken as legal advice. It is for educational purposes only, and
does not provide all available information on the subject, nor establish the statutory, legal or medical standard of care
on any particular subject. Federal and State law may have different standards on the subject matter; any question on a
particular jurisdiction’s legal standards/requirements should be presented to legal counsel familiar with that jurisdiction.
The opinions expressed, discussions undertaken, and materials provided do not represent any official position of Stanford
University or any of its affiliates including Stanford University Medical Center, its faculty, staff or employees.
The Risk Authority of The Stanford University Medical Network / January 2013
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Learn more about The Risk Authority of The Stanford University
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