This week I'm posting a podcast I did for GeriPal about my forthcoming book, "Old and Sick in America: the Journey through the Health Care System."
Showing posts with label medical devices. Show all posts
Showing posts with label medical devices. Show all posts
March 31, 2017
November 15, 2015
The Sound of Music
From a mathematical
perspective, adding and subtracting are equivalent: with addition, you
perform an operation on two positive numbers; with substraction, you perform the
same operation on one positive and one negative number. In medicine, by
contrast, addition and subtraction couldn’t be more different. Introducing
another drug or another procedure is considerably easier than discontinuing a
long-standing practice, even when there is mounting evidence that the practice
is not beneficial, perhaps even harmful. One way to wean patients and doctors
from an established treatment is to substitute a different, more effective or
safer treatment. It’s a lot easier to change behavior if you can offer a new,
improved treatment rather than just asking people to forgo something that they
believe must be helping them. So clinicians ought to be very enthusiastic about
the strong evidence supporting the use of music to aid in postoperative
recovery, as shown in a systematic review and meta-analysis recent published in
the British journal, the Lancet.
Taking all available studies
of the utility of music into consideration, the authors conclude that playing
music before and/or after an operation decreases the amount of pain medication
patients take, it decreases their degree of pain, and it lessens their anxiety.
That means opioid medications, currently in the news because of the epidemic of
overdose deaths from these drugs, can be given in lower doses, for shorter
periods of time, or potentially not at all. Ditto for anti-anxiety medications,
which have been associated with increased confusion, increased falls, and other
problems in older people.
This is a rare instance where we should go ahead and change the way we practice medicine without demanding additional studies, better studies, or more definitive studies. Here's an intervention that has no disadvantages that I can think of, it's cheap, and there's even moderately persuasive evidence that it is effective. Not only that, but playing music for patients doesn't mean we have to stop doing what we're currently doing, only that we should do a little less of it.
If we don't introduce music into surgical units and recovery rooms (parenthetically, I'd like to see a study of the effect of classical music on surgical performance in the operating room--my guess is that it would calm the doctors as well as the patients), that will say a great deal about what we value in medicine today. It will suggest that what drives the diffusion of medical care is not so much evidence as advertising. There are, after all, no medical device manufacturers or pharmaceutical companies that will promote and market classical CDs and portable CD players to hospitals. I can't say I'm very optimistic, but I hope we will do the right thing.
September 30, 2014
To Cover or Not to Cover
April 01, 2014
Lotsa Lumps
Geriatrics would be a good deal easier if every older person suffered from just one medical condition. But most elderly people have more than one chronic disease and the older they are, the more chronic conditions they are likely to have. Since “multiple chronic conditions” is a mouthful, researchers coined the term “multimorbidity,” an only slightly less awkward way of expressing what is probably one of the most critical features of geriatric existence. It’s so critical because the best medical treatment, known as “evidence-based medicine,” is founded on studies of patients who don’t have multimorbidity at all. They are generally perfectly healthy except for the single disease being studied. So when we tell a patient that “studies show’ that blood pressure should be below 140 and that the best medication to take if the blood pressure is elevated is a diuretic, we mean that if the only problem is high blood pressure, then taking the diuretic is the best way to lower the risk of bad outcomes such as strokes and heart attacks. But if the patient also has another chronic condition, say Parkinson’s disease, which is being treated with the medication L-dopa (Sinemet), then giving that patient a diuretic to lower blood pressure could backfire—long before any heart attacks or strokes were prevented, the patient might fall down (both L-dopa and diuretics contribute to sudden falls in blood pressure when a person stands up) and break a hip. Simply assuming it makes sense to apply multiple guidelines to a patient with multiple problems can result in medication lists a mile long that cost a fortune and that cause more problems than they solve. So multimorbidity is a big deal in geriatrics. Now, for the first time, multimorbidity is getting the attention it deserves.
A couple of years ago, the American Geriatrics Society set up a task force to develop an approach to multimorbidity for physicians. This group generated a report that lays out the basic principles that should underlie care for a patient with multiple chronic conditions. And a recent symposium brought together physicians and researchers from a variety of backgrounds to come up with strategies for generating a better evidence base, for designing new guidelines, and for carrying out appropriate systematic reviews for patients with multimorbidity. The results of the symposium are published as 3 articles along with an editorial in the April issue of the Journal of General Internal Medicine.
I wish I could report that these new guidelines-for-producing- guidelines came up with the solution to the problem of multimorbidity. I wish I could summarize the gist of these papers. They constitute a valiant attempt to find an answer to a vexing problem. They go far in enumerating the many obstacles to a solution. They provide an exhaustive list of all the issues that must be addressed in the future. But in the end, they advocate a technical solution to a dilemma that can only be addressed by eliciting patient preferences and by use of clinical judgment.
There are just too many different clusters of chronic diseases for physicians to come up with recommendations that clearly and unambiguously apply to a given patient. Consider just the 10 most common chronic diseases. For any group of 10 diseases, there are 45 pairs of diseases and 120 groups of 3 diseases and 210 groups of 4 diseases—and that doesn’t include clusters of greater than 4, even though plenty of older people have, say, arthritis, diabetes, heart disease, emphysema, and kidney problems. Even if it were practical to design a guideline for all the most common groupings, which it isn’t, that wouldn’t be good enough. What matters is not just how many diseases you have, but how sick you are and how well you can go about your day to day business (what geriatricians call your functional status). Someone who lives independently and shops and cooks for herself is in far better shape—and able to withstand a new medication or a brief hospitalization—than her counterpart with the same underlying chronic conditions who lives in a nursing home and needs help with all her daily activities.
I tend to agree with an article in the British Medical Journal that argues that “multimorbidity introduces clinical uncertainty in a way that is unlikely to be resolved by ever more sophisticated guidelines.” The authors advocate listening to patients to find out what matters to them and using clinical judgment to try to achieve their ends. A similar recommendation came from the American Geriatrics Society task force, which even created a pocket card summarizing their key conclusions: consider patient preferences, consider prognosis, consider interactions among treatments, review the entire care plan, and communicate and decide on treatment together with patient and family.
More research that measures quality of life outcomes as well as survival outcomes is of course important. But empirical studies alone will not solve the multimorbidity problem. Talking to patients about their overall health status and their goals of care, and figuring out together what tests and treatments make most sense in light of their status and their goals, just might.
A couple of years ago, the American Geriatrics Society set up a task force to develop an approach to multimorbidity for physicians. This group generated a report that lays out the basic principles that should underlie care for a patient with multiple chronic conditions. And a recent symposium brought together physicians and researchers from a variety of backgrounds to come up with strategies for generating a better evidence base, for designing new guidelines, and for carrying out appropriate systematic reviews for patients with multimorbidity. The results of the symposium are published as 3 articles along with an editorial in the April issue of the Journal of General Internal Medicine.
I wish I could report that these new guidelines-for-producing- guidelines came up with the solution to the problem of multimorbidity. I wish I could summarize the gist of these papers. They constitute a valiant attempt to find an answer to a vexing problem. They go far in enumerating the many obstacles to a solution. They provide an exhaustive list of all the issues that must be addressed in the future. But in the end, they advocate a technical solution to a dilemma that can only be addressed by eliciting patient preferences and by use of clinical judgment.
There are just too many different clusters of chronic diseases for physicians to come up with recommendations that clearly and unambiguously apply to a given patient. Consider just the 10 most common chronic diseases. For any group of 10 diseases, there are 45 pairs of diseases and 120 groups of 3 diseases and 210 groups of 4 diseases—and that doesn’t include clusters of greater than 4, even though plenty of older people have, say, arthritis, diabetes, heart disease, emphysema, and kidney problems. Even if it were practical to design a guideline for all the most common groupings, which it isn’t, that wouldn’t be good enough. What matters is not just how many diseases you have, but how sick you are and how well you can go about your day to day business (what geriatricians call your functional status). Someone who lives independently and shops and cooks for herself is in far better shape—and able to withstand a new medication or a brief hospitalization—than her counterpart with the same underlying chronic conditions who lives in a nursing home and needs help with all her daily activities.
I tend to agree with an article in the British Medical Journal that argues that “multimorbidity introduces clinical uncertainty in a way that is unlikely to be resolved by ever more sophisticated guidelines.” The authors advocate listening to patients to find out what matters to them and using clinical judgment to try to achieve their ends. A similar recommendation came from the American Geriatrics Society task force, which even created a pocket card summarizing their key conclusions: consider patient preferences, consider prognosis, consider interactions among treatments, review the entire care plan, and communicate and decide on treatment together with patient and family.
More research that measures quality of life outcomes as well as survival outcomes is of course important. But empirical studies alone will not solve the multimorbidity problem. Talking to patients about their overall health status and their goals of care, and figuring out together what tests and treatments make most sense in light of their status and their goals, just might.
January 06, 2012
Is Heavy Metal Hip?
Type “metal-on-metal hip replacement” into your favorite search engine, and you will bring up dozens of hits from personal injury lawyers. These devices, initially touted as being more durable than conventional metal and plastic or metal and ceramic versions, have proved to be considerably less reliable. A substantial proportion produce problems within a few years after insertion: either the device fails, causing pain and disability, and needs to be replaced (necessitating another operation) or it sheds tiny metal flakes into the circulation, triggering both local inflammation and systemic illness. The British Orthopedic Association reported in 2011 that metal-on-metal (MoM) devices had a shocking 21% failure rate within 4 years and a 49% failure rate at 6 years. Several products have been taken off the market. The cost of replacing the joints is expected to reach billions of dollars in the coming years, and that doesn’t include the human suffering or lost productivity. What happened?
In discussing the perils of metal-on-metal hips, it’s critical to recognize that hip replacement surgery has been an enormous boon to aging Americans. Osteoarthritis, or wear and tear arthritis, is found in 50% of people over age 65, making it one of the most common chronic diseases of older people. It can cause pain and difficulty walking, debilitating symptoms that are often completely alleviated by replacing the worn out joint. And while hip replacement surgery has been around for decades, it has been plagued by the risk of hip dislocation or the artificial joint itself wearing out. Hence the holy grail of hip replacement surgery has been a hip made of better materials and with a better design. Metal-on-metal hip prostheses were once thought to be the answer to the orthopedist’s prayers.
Something else stimulated development of metal-on-metal hip joints as well as the desire for an improved device. With the benefits of surgery well established, the number of hip replacement operations remained fairly stable in the 1990s (adjusting for the aging of the population). Device manufacturers realized that if they could make a joint that lasted longer than the 15 years expected with conventional devices, they could increase sales by marketing to a younger population. Metal-on-metal hip prostheses, in which both the ball (femoral head) and the socket (acetabulum) are removed and replaced with metal parts, seemed to fit the bill; mechanical stimulation studies in the laboratory suggested they would last longer than existing devices.
The new MoM hips were rapidly introduced into practice and the total number of operations performed each year soared. Estimates from Kaiser Permanente, a large multi-specialty group practice that decided to keep track of all joint replacements in their patients, are that 35-40% of all joint replacements are now done in people under 65. Then anecdotal reports of early device failure began appearing. Device manufacturers initially denied any problems associated with MoM hips but in 2007, the Australian National Joint Replacement Registry reported a higher rate of hip revision surgery with MoM devices. Finally, in August, 2010, DePuy Orthopedics, a subsidiary of the giant Johnson & Johnson, recalled its MoM total hip implant system. A total of 90,000 people had had the device inserted, just about half of them in the US.
What is striking in this saga is that no randomized controlled trials comparing MoM hip joints to existing models were required for Food and Drug Administration (FDA) approval. Since the FDA considered these devices only “moderate risk” and since they regarded them as “substantially equivalent” to existing devices, only the most cursory approval process was necessary to bring them to market. High risk or radically new devices, by contrast, undergo rigorous pre-market testing, often involving sophisticated—and expensive—randomized clinical trials. To demonstrate “substantial equivalence,” all that’s required is to show that the new device has the same intended use as an existing device and the same technological characteristics. The FDA uses this expedited “510(k)” review process for an estimated 90% of the devices it approves. (A related surgical approach, but which did require a full premarket review, involves hip “resurfacing” rather than total hip replacement. This technique has also met with difficulties when the head of the femur is capped with metal rather than plastic, but it is not the subject of this article.)
In light of several well-publicized recalls of devices that entered clinical use via the 510(k) route, the FDA requested a review of the expedited review process. The review was conducted by the Institute of Medicine (IOM), a widely respected, not-for-profit, independent organization dedicated to providing advice to government policymakers. The IOM report was released last summer. Its conclusions were clear: “The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life.” Would this kind of approach, transparent and based on sound science, have avoided the MoM fiasco? \
If MoM artificial hips had been compared to existing products in a randomized controlled trial, flaws would likely have emerged early. While most of the device failures take five years to develop, much longer than the duration of a typical clinical trial, data from the British National Joint Registry suggest there are signs of trouble much earlier. For women aged 60-69, the Registry the revision rate for cemented hips one year after initial insertion is .65%; the revision rate for metal on metal hips in this population is 1.42%, or more than double. By year three, the gap is even more impressive: 1.32% of cemented hips require revision compared to 4.11% of MoM joints, a near tripling of the rate.
Adequate pre-market testing would have raised red flags; systematic post-market surveillance, which is non-existent in the US, would have revealed any problems that had escaped early detection. The Australians, who maintain a Registry of all the artificial joints inserted in their population, observed a spike in surgical revisions after hip replacement in 2007, with the highest revision rates in MoM joints, and the British reported a similar finding based on their Registry soon afterwards. A US database, which would have been far larger, might have detected problems even more quickly.
Any rational observer would conclude that our story will have a happy ending: the recommendations of the IOM committee will be implemented by Congress, we will have a new improved regulatory process for medical devices. Tales such as the metal-on- metal hip fiasco will provide fodder for future historians who will write of the bad old days when corporate greed and medical wishful thinking led to needless suffering in hundreds of thousands of patients, at a cost of billions. But the reality is strikingly different. The IOM report was dead on arrival. In a shocking development, the report was viciously attacked even before it was released. As the NY Times put it in a July 27, 2011 article: “Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups.” The article continued that business groups took “the highly unusual step of making a pre-emptive strike,” claiming that better regulation would “slow innovation, harm patients and cost jobs.” Industry does not want to modify the 510(k) process, substituting more thorough, time-consuming, and costly studies of potentially risky devices. Their lobbyists responded to the IOM report by barraging the media, Congress, and other thought-leaders with a blistering counter-attack. The result? Deafening silence in the halls of Congress, which would need to pass legislation to further amend the Food and Drug Administration Act.
The metal on metal hip story is not unique. A recent article in the Archives of Internal Medicine reviewing all FDA device recalls between 2005 and 2009 found that 71% of the devices recalled because they were felt to cause serious health problems or death had been approved by the 510(k) expedited review process. Patients who have been harmed by dangerous devices are busily trying to salvage their own health and are relying on the courts for monetary compensation for their injuries. But it is consumers who put pressure on government back in 1976 to demand regulatory protection from dangerous devices. It was consumers, reacting to dramatic examples such as deaths related to the Dalkon Shield, an intrauterine contraceptive device, who demanded and finally prevailed upon Congress to pass the Medical Device Amendments of 1976, for the first time giving the FDA jurisdiction over devices. How many more disasters will we need before we act again?
In discussing the perils of metal-on-metal hips, it’s critical to recognize that hip replacement surgery has been an enormous boon to aging Americans. Osteoarthritis, or wear and tear arthritis, is found in 50% of people over age 65, making it one of the most common chronic diseases of older people. It can cause pain and difficulty walking, debilitating symptoms that are often completely alleviated by replacing the worn out joint. And while hip replacement surgery has been around for decades, it has been plagued by the risk of hip dislocation or the artificial joint itself wearing out. Hence the holy grail of hip replacement surgery has been a hip made of better materials and with a better design. Metal-on-metal hip prostheses were once thought to be the answer to the orthopedist’s prayers.
Something else stimulated development of metal-on-metal hip joints as well as the desire for an improved device. With the benefits of surgery well established, the number of hip replacement operations remained fairly stable in the 1990s (adjusting for the aging of the population). Device manufacturers realized that if they could make a joint that lasted longer than the 15 years expected with conventional devices, they could increase sales by marketing to a younger population. Metal-on-metal hip prostheses, in which both the ball (femoral head) and the socket (acetabulum) are removed and replaced with metal parts, seemed to fit the bill; mechanical stimulation studies in the laboratory suggested they would last longer than existing devices.
The new MoM hips were rapidly introduced into practice and the total number of operations performed each year soared. Estimates from Kaiser Permanente, a large multi-specialty group practice that decided to keep track of all joint replacements in their patients, are that 35-40% of all joint replacements are now done in people under 65. Then anecdotal reports of early device failure began appearing. Device manufacturers initially denied any problems associated with MoM hips but in 2007, the Australian National Joint Replacement Registry reported a higher rate of hip revision surgery with MoM devices. Finally, in August, 2010, DePuy Orthopedics, a subsidiary of the giant Johnson & Johnson, recalled its MoM total hip implant system. A total of 90,000 people had had the device inserted, just about half of them in the US.
What is striking in this saga is that no randomized controlled trials comparing MoM hip joints to existing models were required for Food and Drug Administration (FDA) approval. Since the FDA considered these devices only “moderate risk” and since they regarded them as “substantially equivalent” to existing devices, only the most cursory approval process was necessary to bring them to market. High risk or radically new devices, by contrast, undergo rigorous pre-market testing, often involving sophisticated—and expensive—randomized clinical trials. To demonstrate “substantial equivalence,” all that’s required is to show that the new device has the same intended use as an existing device and the same technological characteristics. The FDA uses this expedited “510(k)” review process for an estimated 90% of the devices it approves. (A related surgical approach, but which did require a full premarket review, involves hip “resurfacing” rather than total hip replacement. This technique has also met with difficulties when the head of the femur is capped with metal rather than plastic, but it is not the subject of this article.)
In light of several well-publicized recalls of devices that entered clinical use via the 510(k) route, the FDA requested a review of the expedited review process. The review was conducted by the Institute of Medicine (IOM), a widely respected, not-for-profit, independent organization dedicated to providing advice to government policymakers. The IOM report was released last summer. Its conclusions were clear: “The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life.” Would this kind of approach, transparent and based on sound science, have avoided the MoM fiasco? \
If MoM artificial hips had been compared to existing products in a randomized controlled trial, flaws would likely have emerged early. While most of the device failures take five years to develop, much longer than the duration of a typical clinical trial, data from the British National Joint Registry suggest there are signs of trouble much earlier. For women aged 60-69, the Registry the revision rate for cemented hips one year after initial insertion is .65%; the revision rate for metal on metal hips in this population is 1.42%, or more than double. By year three, the gap is even more impressive: 1.32% of cemented hips require revision compared to 4.11% of MoM joints, a near tripling of the rate.
Adequate pre-market testing would have raised red flags; systematic post-market surveillance, which is non-existent in the US, would have revealed any problems that had escaped early detection. The Australians, who maintain a Registry of all the artificial joints inserted in their population, observed a spike in surgical revisions after hip replacement in 2007, with the highest revision rates in MoM joints, and the British reported a similar finding based on their Registry soon afterwards. A US database, which would have been far larger, might have detected problems even more quickly.
Any rational observer would conclude that our story will have a happy ending: the recommendations of the IOM committee will be implemented by Congress, we will have a new improved regulatory process for medical devices. Tales such as the metal-on- metal hip fiasco will provide fodder for future historians who will write of the bad old days when corporate greed and medical wishful thinking led to needless suffering in hundreds of thousands of patients, at a cost of billions. But the reality is strikingly different. The IOM report was dead on arrival. In a shocking development, the report was viciously attacked even before it was released. As the NY Times put it in a July 27, 2011 article: “Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups.” The article continued that business groups took “the highly unusual step of making a pre-emptive strike,” claiming that better regulation would “slow innovation, harm patients and cost jobs.” Industry does not want to modify the 510(k) process, substituting more thorough, time-consuming, and costly studies of potentially risky devices. Their lobbyists responded to the IOM report by barraging the media, Congress, and other thought-leaders with a blistering counter-attack. The result? Deafening silence in the halls of Congress, which would need to pass legislation to further amend the Food and Drug Administration Act.
The metal on metal hip story is not unique. A recent article in the Archives of Internal Medicine reviewing all FDA device recalls between 2005 and 2009 found that 71% of the devices recalled because they were felt to cause serious health problems or death had been approved by the 510(k) expedited review process. Patients who have been harmed by dangerous devices are busily trying to salvage their own health and are relying on the courts for monetary compensation for their injuries. But it is consumers who put pressure on government back in 1976 to demand regulatory protection from dangerous devices. It was consumers, reacting to dramatic examples such as deaths related to the Dalkon Shield, an intrauterine contraceptive device, who demanded and finally prevailed upon Congress to pass the Medical Device Amendments of 1976, for the first time giving the FDA jurisdiction over devices. How many more disasters will we need before we act again?
November 30, 2009
The Heart of the Matter
Just before the annual deluge of holiday visitors began inundating the Magic Kingdom, over 20,000 people gathered in Orlando, Florida to attend the American Heart Association annual meeting. At one late-breaking scientific session, Dr. Joseph Rogers, a Duke University cardiologist, presented the results of a study of a nifty new cardiac device, the HeartMate II (to distinguish it from its predecessor, HeartMate I, also known as HeartMate XVE). This remarkable 390-gram contraption is the next best thing to a heart transplant for patients with severe heart failure. It is a “ventricular assist device,” (VAD) implanted in the abdomen, hooked up to the heart to propel blood through a failing ventricle, and powered by an external generator. The study, published the very same day in the online version of the New England Journal of Medicine, showed that patients with the new device lived longer and better, with fewer complications, than those who got the earlier variety.
Just six years ago, the Centers for Medicare and Medicaid Services (CMS) approved use of the HeartMate I in Medicare patients as “destination” or definitive treatment of severe heart failure. Based on the results of a 2001 study, the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial, CMS concluded that the device was “reasonable and necessary” for the treatment of advanced heart failure and therefore, as required by its 1965 Congressional mandate, agreed to pay for implantation of the device.
Physicians, however, were not convinced the device was reasonable or necessary. In fact, the number of patients receiving a ventricular assist device has fallen every year since CMS approved its use. Between March, 2006 and June, 2009, a total of only 1664 HeartMate I’s were implanted (just under 500 per year) and 90% of them were used as “bridge to transplant,” that is to tide patients over until a heart became available for transplant, rather than as “destination therapy,” or permanent treatment. Physicians evidently were not impressed by the data that patients who had a ventricular assist device lived longer than those receiving “maximal medical therapy.” Even with the device, one-year mortality remained high at 48% and two-year mortality at 77%. Moreover, HeartMate I recipients were at risk of stroke, infection, and device malfunction.
Will physicians be more enthusiastic about the new HeartMate II? It is smaller—small enough to fit into a woman, unlike the earlier version. It uses a continuous rotary system rather than a pulsatile mechanism, which means it’s quieter and more durable. And the new device is clearly superior to the old one—the randomized study reported in Orlando found that 46% of those with the new device were alive after 2 years without having sustained a debilitating stroke or required replacement of the device, compared to 11% of those who got the original model. Quality of life was also improved, with recipients of the new HeartMate able to walk further and do more for themselves.
Are these results good enough? They will almost surely be good enough for the Food and Drug Administration to approve use of the device as destination therapy and for Medicare to follow suit by approving reimbursement in Medicare patients—currently Medicare pays an average of $177,000 for a hospitalization in which a ventricular assist device is inserted. Whether physicians will regard the new pump as ready for prime time remains to be seen.
The deeper question is whether we should be putting more and more resources into shoring up failing hearts in patients near the end of life or whether, instead, we should concentrate on palliative care for patients dying of heart failure and on prevention to avoid the development of heart failure in the first place.
Palliative care is an effective, well-regarded approach to end stage heart failure. It focuses on comfort and on supporting patients and their families as the end draws near and may involve enrollment in hospice. Individuals whose heart cannot pump properly repeatedly suffer from fluid backing up into their lungs, swelling their legs, and filling their abdomen, causing shortness of breath, difficulty walking, and fatigue. Instead of hospitalizing these patients, often transferring them to the Intensive Care Unit where they may be attached to a ventilator that forces oxygen into their lungs and put on an intravenous drip to try to stimulate the heart to contract more forcefully, palliative care strives to keep them home. At home they use oxygen and medication such as morphine to help them breathe. Interestingly, the studies of the left ventricular assist device compare patients receiving one particular device to those getting another type (the new study) or patients receiving a device to patients receiving “maximal medical therapy” (the earlier study), but never compare patients receiving a device to those getting palliative care.
Prevention makes a lot of sense in the case of heart failure. Heart failure is the leading cause of hospitalization in individuals over age 65. Americans have a 20% life time risk of developing the condition and treatment costs the US upwards of $30 billion per year. But we know what causes the heart to fail: it is high blood pressure, diabetes, or coronary artery disease (which in turn is caused by some combination of high blood pressure, diabetes, high cholesterol and smoking). And every one of these predisposing conditions is treatable or preventable. While there are few good studies of what it would cost to institute a comprehensive set of measures to prevent heart failure, we do know that 82% of the cardiac events in one observational study, the Nurses Health Study, were attributable to diet and lifestyle issues. An Australian analysis suggests that the best way to prevent heart failure is by a combination of medical preventive strategies (proceeding patient by patient to assess risk factors and intervene to treat high blood pressure, diabetes, and high cholesterol) and public health strategies (using legislative and environmental approaches to promote a healthy lifestyle).
America has its heart set on the technological fix—the HeartMate II is the latest in a series of ingenious approaches to treating the chronic diseases afflicting older people. But its time to get to the heart of the matter, trying to prevent the major scourges that we have the knowhow to avoid, and palliating those who, despite our best efforts, are dying.
Just six years ago, the Centers for Medicare and Medicaid Services (CMS) approved use of the HeartMate I in Medicare patients as “destination” or definitive treatment of severe heart failure. Based on the results of a 2001 study, the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial, CMS concluded that the device was “reasonable and necessary” for the treatment of advanced heart failure and therefore, as required by its 1965 Congressional mandate, agreed to pay for implantation of the device.
Physicians, however, were not convinced the device was reasonable or necessary. In fact, the number of patients receiving a ventricular assist device has fallen every year since CMS approved its use. Between March, 2006 and June, 2009, a total of only 1664 HeartMate I’s were implanted (just under 500 per year) and 90% of them were used as “bridge to transplant,” that is to tide patients over until a heart became available for transplant, rather than as “destination therapy,” or permanent treatment. Physicians evidently were not impressed by the data that patients who had a ventricular assist device lived longer than those receiving “maximal medical therapy.” Even with the device, one-year mortality remained high at 48% and two-year mortality at 77%. Moreover, HeartMate I recipients were at risk of stroke, infection, and device malfunction.
Will physicians be more enthusiastic about the new HeartMate II? It is smaller—small enough to fit into a woman, unlike the earlier version. It uses a continuous rotary system rather than a pulsatile mechanism, which means it’s quieter and more durable. And the new device is clearly superior to the old one—the randomized study reported in Orlando found that 46% of those with the new device were alive after 2 years without having sustained a debilitating stroke or required replacement of the device, compared to 11% of those who got the original model. Quality of life was also improved, with recipients of the new HeartMate able to walk further and do more for themselves.
Are these results good enough? They will almost surely be good enough for the Food and Drug Administration to approve use of the device as destination therapy and for Medicare to follow suit by approving reimbursement in Medicare patients—currently Medicare pays an average of $177,000 for a hospitalization in which a ventricular assist device is inserted. Whether physicians will regard the new pump as ready for prime time remains to be seen.
The deeper question is whether we should be putting more and more resources into shoring up failing hearts in patients near the end of life or whether, instead, we should concentrate on palliative care for patients dying of heart failure and on prevention to avoid the development of heart failure in the first place.
Palliative care is an effective, well-regarded approach to end stage heart failure. It focuses on comfort and on supporting patients and their families as the end draws near and may involve enrollment in hospice. Individuals whose heart cannot pump properly repeatedly suffer from fluid backing up into their lungs, swelling their legs, and filling their abdomen, causing shortness of breath, difficulty walking, and fatigue. Instead of hospitalizing these patients, often transferring them to the Intensive Care Unit where they may be attached to a ventilator that forces oxygen into their lungs and put on an intravenous drip to try to stimulate the heart to contract more forcefully, palliative care strives to keep them home. At home they use oxygen and medication such as morphine to help them breathe. Interestingly, the studies of the left ventricular assist device compare patients receiving one particular device to those getting another type (the new study) or patients receiving a device to patients receiving “maximal medical therapy” (the earlier study), but never compare patients receiving a device to those getting palliative care.
Prevention makes a lot of sense in the case of heart failure. Heart failure is the leading cause of hospitalization in individuals over age 65. Americans have a 20% life time risk of developing the condition and treatment costs the US upwards of $30 billion per year. But we know what causes the heart to fail: it is high blood pressure, diabetes, or coronary artery disease (which in turn is caused by some combination of high blood pressure, diabetes, high cholesterol and smoking). And every one of these predisposing conditions is treatable or preventable. While there are few good studies of what it would cost to institute a comprehensive set of measures to prevent heart failure, we do know that 82% of the cardiac events in one observational study, the Nurses Health Study, were attributable to diet and lifestyle issues. An Australian analysis suggests that the best way to prevent heart failure is by a combination of medical preventive strategies (proceeding patient by patient to assess risk factors and intervene to treat high blood pressure, diabetes, and high cholesterol) and public health strategies (using legislative and environmental approaches to promote a healthy lifestyle).
America has its heart set on the technological fix—the HeartMate II is the latest in a series of ingenious approaches to treating the chronic diseases afflicting older people. But its time to get to the heart of the matter, trying to prevent the major scourges that we have the knowhow to avoid, and palliating those who, despite our best efforts, are dying.
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