American Geriatrics Society (AGS) 2012 Annual Meeting

May 2-5, 2012; Seattle, WA
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Product Theater

New Minimally Invasive Procedure Enables Treatment of Previously Inoperable Aortic Stenosis

Aortic stenosis, a narrowing of the aortic valve opening that impedes blood flow, is estimated to affect approximately five out of every 10,000 people in the United States, with approximately 250,000 new cases diagnosed annually. Initially, the disease may be asymptomatic, but once symptoms manifest, survival rates dramatically decrease, with only 50% of symptomatic patients being alive at 2 years and only 20% being alive at 5 years. There are no pharmaceutical options for aortic stenosis beyond those that alleviate its symptoms, and due to its high mortality rate, the American College of Cardiology recommends surgery once symptoms occur. Historically, the only treatment option has been an open-heart procedure, in which the damaged aortic valve is removed and replaced with an artificial one. Because of the complexity of the operation and the fragile state of many patients with aortic stenosis, a considerable number of patients have been deemed unsuitable candidates for this procedure, giving them a terminal diagnosis. However, in November 2011, the US Food and Drug Administration (FDA) approved the SAPIEN transcatheter aortic valve for use in patients who are not candidates for the open-heart procedure, providing new hope to previously inoperable patients.

Since SAPIEN’s approval, transcatheter aortic valve replacement (TAVR) has garnered a considerable amount of interest among cardiologists and cardiovascular surgeons, but knowledge of this treatment option is still lacking, especially among other specialties. As a result, the condition is undertreated and under-referred, with an estimated 40% of patients not being sent for therapy. During the AGS 2012 annual meeting, Edwards Lifesciences, the manufacturer of SAPIEN, held a product theater to educate attendees about TAVR. Clinical Geriatrics® (CG) had the opportunity to discuss TAVR with one of the product theater presenters, Todd Dewey, MD, cardiothoracic and transplantation surgeon, and director of structural heart disease, Medical City Dallas Hospital, TX.

CG: Please provide a brief overview of how TAVR works.
Dr. Dewey: TAVR is a minimally invasive procedure that generally takes 2 to 3 hours to perform with the patient under general anesthesia. During the procedure, a small incision is made in the leg and a sheath is advanced through the femoral artery to the aortic valve, where a balloon is deployed to open the narrowed valve. Once the balloon is deflated and removed, a 23-mm or 26-mm transcatheter aortic valve is delivered via the sheath to the aortic valve using a balloon delivery system guided by intraprocedural imaging. After the valve is positioned, the balloon on the delivery system is inflated with fluid, causing the valve to expand within the diseased aortic valve. The balloon is deflated and the delivery system is removed once the valve is determined to be functioning properly. In general, patients have a hospital stay of 5 to 7 days.

What are the indications for TAVR?
TAVR is indicated in patients with severe symptomatic native aortic valve stenosis, which is defined by the American College of Cardiology and the American Heart Association as an aortic valve area of <1.0 cm2. In addition, patients must be deemed inoperable for an open aortic valve replacement by a cardiac surgeon and be free from any comorbidities that would eliminate the expected benefit from aortic stenosis treatment; for example, advanced dementia.
 

Geriatric patients tend to have a lot of comorbidities, so can you talk a little bit about how a risk assessment is conducted and how comorbidities factor into the equation?
In the majority of patients, risk is determined using the STS [Society of Thoracic Surgeons’] score, which provides a reasonable preliminary estimate of a patient’s morbidity and mortality risks following TAVR. While the STS score weighs many important factors, such as age, sex, renal function, immunosuppression, and various comorbidities (eg, diabetes, arrhythmias, heart failure), there are other key factors that it does not account for or appropriately weigh, including some comorbidities that may be especially prevalent in geriatric patients, such as severely compromised respiratory function, severe liver disease, pulmonary hypertension, dementia, and frailty. Therefore, the STS score should serve as a starting point, and even when a contraindicative factor is observed that the STS risk assessment does not account for, further evaluations are generally warranted. For example, we had one case where a patient was in hospice due to his aortic stenosis. The patient appeared frail, but instead of precluding him from having the procedure, we sought to determine whether his frailty was caused by the aortic stenosis or by some other underlying pathology. After a comprehensive assessment, we determined that TAVR was feasible, and the patient successfully underwent the procedure and is now receiving rehabilitation. Cases like this reinforce the importance of considering the whole patient and not substituting one particular factor or finding for clinical judgment.

You note that age is one of the variables factored into the STS score. How does age impact a patient’s candidacy for TAVR?
Unfortunately, age is often a reason why patients are not deemed to be suitable candidates for TAVR. While age is a consideration, it is important not to place too much emphasis on the number alone. Although advanced age is generally associated with many comorbidities and more limited physical reserves, which may preclude treatment, there is great variability in the geriatric population. Therefore, it important to consider age as another part of the patient’s clinical picture, with the key objective being to determine possible life expectancy, which continues to increase. For instance, an 80-year-old person can live another 6 to 7 years, so age alone does not preclude these individuals from receiving TAVR. In fact, the average age of persons receiving valve replacements is currently 73 years, and every decade this number advances.

What are some of the risks of TAVR, and can you also briefly describe the study that led to the FDA’s approval of SAPIEN?
The safety and efficacy of TAVR was assessed in the PARTNER [Placement of Aortic Transcatheter Valves] trial, which included 358 patients who were deemed to have inoperable aortic stenosis. Of these patients, half received TAVR and the other half were treated with standard medical therapy, which included medications to control symptoms, aortic valvuloplasty, or both. Patients were evaluated at 30 days, 6 months, and 1 year following initiation of treatment. Some of the risks of TAVR that were identified included death, vascular complications, bleeding events, stroke, kidney failure, myocardial infarction, endocarditis, and new atrial fibrillation. Overall, patients in the TAVR group fared better than those receiving standard medical therapy, with investigators observing less death, fewer repeat hospitalizations, less need for new pacemaker implantation, and fewer cases of kidney failure, myocardial infarction, endocarditis, and new atrial fibrillation; however, the rate of bleeding events, stroke, and major vascular complications were more pronounced in the TAVR group. Patients in PARTNER will continue to be followed for 5 years to assess the long-term efficacy of TAVR.
 

What about patients who are operable and would prefer a minimally invasive approach?
Approval for certain operable patients may be on the horizon. An advisory panel for the FDA recently voted in favor of approving use of SAPIEN in high-risk aortic stenosis patients who are also eligible for surgery, but who have a >15% risk of mortality following surgical aortic valve replacement. While the FDA is not required to follow the panel’s recommendation, many expect that it will.

The product theater was sponsored by Edwards Lifesciences. For more information on SAPIEN and TAVR, visit www.edwards.com/products/transcathetervalve.
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Posters

Oral Healthcare Lacking in Older Adults With Dementia

Older adults with dementia have poor oral healthcare, which worsens with the stage of dementia, as compared with adults without dementia, according to Thulasiram Janardhanan, MD, MPH, and colleagues from the Department of Geriatric Psychiatry, SUNY Downstate Medical Center, Brooklyn, NY. In a poster session presented at the AGS annual meeting, Janardhanan and colleagues reported the findings of their retrospective chart review of 136 patients examined in a university-based dementia clinic and a geropsychiatry clinic in Brooklyn, NY, from December 2009 to July 2011. Because there is a lack of data concerning dental care in older adults with dementia, especially minorities, the study’s aim was to contrast various oral health measures of older adults with dementia with those of persons without dementia, but who have psychiatric diagnoses.

Of the study participants, 78% were black, 13% Hispanic, and 8% white; 70% were women. The participants were divided into two categories: dementia (n=59) and nondementia (n=77). They were also placed into two cognitive categories based on their Mini-Mental State Examination (MMSE) scores: >23 (n=51) and <23 (n=73). The following oral health measures were compared between the dementia and nondementia groups: daily brushings, annual dental visits, daily flossing, problems with teeth, dental pain, denture use, and problems with dentures. Of the measures, only two reached statistical significance (P<.05): annual dental visits (r=.18) and flossing teeth (r=.18). There were no significant correlations between the two MMSE groups and the dental variables.

The researchers noted that in the dementia group, having at least an annual visit to a dentist was significantly associated with the stage of dementia. Among persons with mild and moderate dementia, 71% had annual visits, whereas among persons with severe dementia, only 22% had annual visits. As poor oral health can lead to many negative outcomes in patients, Janardhanan and colleagues concluded that the study “confirms the need for education of caregivers and increased accessibility to oral healthcare in older adults with dementia.”—Allison Musante

The study was funded by a training grant from Health Resources and Services Administration (HRSA).
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Medication Adherence in Cognitively Impaired Adults Requires Frequent Human Interventions and Further Research

There are numerous barriers to medication adherence in cognitively impaired older adults, yet studies suggest frequent human communication interventions are more likely to improve medication adherence than non–human- reminder systems, reported Noll L. Campbell, PharmD, College of Pharmacy, Purdue University, West Lafayette, IN, and colleagues in a poster session presented at the AGS annual meeting. In a systematic evidence-based review, Campbell and colleagues conducted searches in MEDLINE/PubMed, EMBASE, PsycINFO, GoogleDocs, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) for studies including community-dwelling older adults with any degree of cognitive impairment. The authors reviewed observational studies to identify barriers to adherence, and also reviewed clinical trials targeting medication adherence to identify interventional studies. Case reports, reviews, and studies focusing on psychiatric disorders or infectious diseases were excluded from the review.

Campbell and colleagues identified three major categories of barriers: patient-reported, caregiver-reported, and those recognized by administrative databases. Patient-reported barriers included insufficient knowledge of directions and indications, difficulty understanding changes to the regimen, poor ability to remember doses, and taking more than four medications daily. Caregiver-reported barriers included difficulty scheduling medications into the care routine, difficulty keeping prescriptions filled, and cognitive impairment of the caregiver. Administrative databases also revealed common characteristics of persons less likely to adhere: female sex, age ≤75 years, minority ethnicity, and community-dwelling status.

In a summary of interventional studies, human communication systems were found to significantly improve adherence, as compared with non–human-based systems. Human-based systems included telephone and televideo monitoring at each dosing interval, as well as nurse-driven reminders and cueing. A study in which patients were reminded via mail to refill prescriptions, were provided with illustrated medication schedules, or both, showed no improvement in medication adherence. The authors acknowledged that their study was limited by the small sample sizes of the identified observational studies; thus, future research should include larger sample sizes. Additionally, they concluded that “moving beyond memory as the primary barrier to medication adherence should be the focus of future interventions within this population.”—Allison Musante

The study was supported by a grant from the Agency for Healthcare Research and Quality.