Inoperable?-A Status Not Written in Stone
I recently encountered a previously functional and independent 80-year-old woman who slipped and broke her hip. Surgery was required to repair the injury and was her only hope of returning to her premorbid state. She lived alone and was still able to shop, clean, and cook for herself, despite being on several medications for congestive heart failure. She had a long-standing history of aortic stenosis, and reported having been told more than 10 years ago that it was inoperable. An echocardiogram revealed a current aortic valve surface area of 0.4 cm2, placing her in the significant risk category and giving her a 40% risk of developing further complications within the next year. We had no way of knowing at that time if her congestive heart failure was due solely to her significant aortic stenosis or if other cardiac pathology was affecting her cardiac function.
The cardiology consultant doing a preoperative assessment stated that she was a “high-risk candidate for an intermediate-risk surgery.” It was mentioned that her aortic stenosis was deemed inoperable based on her history of it being considered as such, and no further assessment was undertaken. Although the patient initially expressed interest in having everything done to repair her hip, as her hope was that this would enable her to return to her baseline status, she quickly developed a delirium and lost her capacity to make an informed decision. At a family meeting, it was decided that surgery would not be performed and that she would be given “comfort measures” only.
Clearly, the patient’s aortic valve pathology and her congestive heart failure were influencing this decision. I knew that no one had discussed the relatively new method of transcatheter aortic-valve implantation with her or even thought about it as an option to improve her chances of surviving the hip surgery. The label of inoperable had followed her as a final decree for the past 10 years, despite the availability of a new technology that permits aortic valve repair in patients who were previously deemed to be poor candidates for open-heart surgery. Clearly, this new technology is not for everyone and it has its own set of complications to consider, but it must first be identified as an option if there is to be any hope of an altered outcome.
In various dictionaries, the term inoperable has been defined as “incapable of being implemented or operated; unworkable,” “surgery not suitable for operation without risk,” and “pertaining to a medical condition that would not benefit from surgical intervention or for which the risk outweighs the benefits.”1 However, as new advances in medicine become a reality and gain more universal acceptance, it is imperative that clinicians re-evaluate conditions that were previously labeled as being inoperable or untreatable. In the case of aortic valve repair, we are now able to refer select patients to repair who were previously denied this operation because they were judged to be inoperable at a time when an open-heart approach was the only one available.
In 2002, the first transcatheter insertion of an aortic-valve prosthesis was performed by Cribier and colleagues.2 Since then, transcatheter aortic-valve implantation has become a viable option for those in whom an open-heart approach is considered too risky. Although perioperative rates of death were judged to be low for these relatively high-risk patients, and most studies report noninferiority in terms of 30-day and 1-year mortality rates, complications appear to be more common with the transcatheter approach, particularly paravalvular leakage and risk of stroke. In fact, Smith and colleagues3 reported a 5.5% risk of stroke or transient ischemic attack within 30 days after transcatheter aortic-valve replacement, increasing to 8.3% after 1 year. This is in contrast to rates of 2.4% and 4.3%, respectively, for surgical valve replacement.3
When discussing new treatment options with our patients, we must continually evaluate the data and attempt to present a fair picture of the risks, but how does one determine what percentage of risk is acceptable? The end result of an unwanted complication is 100% if it will occur regardless of the data presented. In the case of transcatheter aortic-valve repair, the increased risk of a stroke or a valve leak must be weighed against the expected outcome if no repair is undertaken. We know that individuals with symptomatic aortic stenosis have a reduced survival rate, with sudden death being the end result. Although survival is nearly normal until the classic symptoms of angina, syncope, or dyspnea manifest, only 50% of patients survive 5 years once they present with angina, 3 years once they present with syncope, and 2 years once dyspnea or other manifestations of congestive heart failure are noted.
No choice is without risk for the high-risk surgical patient with significant aortic stenosis. Clearly, some patients will seek their physician’s advice to help them decide what to do, whereas others will attempt to make a decision based on their personal choice and values as well as their assessment of the data presented. When advising patients, clinicians must carefully consider whether a potential treatment has the propensity to have a better outcome than doing nothing, but they must also recognize that everyone is ultimately forced to play the odds. With regard to aortic stenosis, at least we now have one more option to help patients who previously had no options to potentially beat the odds. In the case of the aforementioned patient, the decision to “do nothing” regarding her aortic valve also resulted in her being considered too high-risk for hip repair surgery, placing her remaining quality of life at double jeopardy and making any chance of return to her premorbid status impossible.
References
1. The Free Dictionary. Inoperable. http://medical-dictionary.thefreedictionary.com/inoperable.
Accessed June 5, 2012.
2. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aorticvalve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106(24):3006-3008.
3. Smith Cr, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187-2198.