User login
Medicare at 50: Or, the end of fee-for-service
Few of my readers were around when Medicare was signed into law in 1965 by President Lyndon Johnson. Mr. Johnson was into his first elected term as president, having first taken the oath of office with the assassination of John F. Kennedy in November 1963.
Hardly a darling of the liberal left, he was maligned as the perpetrator, if not for the expansion, of the Vietnam War. He was elected with the largest presidential plurality in history, receiving 61% of the votes, and he carried with him a solid Democratic Congress bolstered by a large block of solid Southern Democrats, a firmament from which he had emerged. He can be credited for the most far-reaching social legislation of the 20th century, second only to Franklin Delano Roosevelt of the 1930s. Johnson was able to move the Civil Rights Act of 1964 and the Voting Rights Act and Medicare Act through Congress in 1965, the latter of which we celebrate this year.
At the time of passage of Medicare, 35% of Americans over 65 had no health insurance, either because they found insurance unaffordable or because of preexisting illness. Health insurance premiums for the elderly cost roughly three times more than did those for younger individuals. With many of the elderly living on Social Security alone, health insurance was an impossibility. If they needed care, they might find it at the emergency department of their local hospitals.
The battle for the passage of Medicare was formidable. In contrast to the passive role of the American Medical Association in the passage of the Affordable Care Act, Medicare was, to put it mildly, vigorously opposed by most doctors and by the AMA, which viewed it as the harbinger of long-anticipated socialized medicine. It ended up being far from it.
Medicare provided a pathway to an economic bonanza for the practicing physician and to hospitals that they could never have imagined. It immediately expanded the patient population and allowed enterprising and not-so-enterprising doctors and hospitals to run up the costs of health care by strengthening the fee-for-service style of medical care. Doctors, hospitals, and patients had no concern for cost: Medicare paid for everything.
Hospitals found Medicare a ready source of income. Doctor and hospital bills were based on the usual cost to each in their respective communities. Medical educators as well as house staff also saw their income lifted as a result of the federal government’s paying for a large part if not all of the cost of house staff education. Even the small number of physicians who opted out of Medicare, because of the red tape or to preserve their independence from the federal government, benefited. Their fees increased as the payment schedules of Medicare increased in their communities.
One of the by-products of Medicare was the end of hospital segregation. For those of you who were not around then, you can imagine what an impact that had on hospitals and doctors in both the North and the South.
Over time, Medicare expanded its footprint to include treatment of chronic kidney disease at any age, as well as drug coverage. I would guess that most Americans over 65 (this writer included) love Medicare. And doctors? Well, they still grumble about it.
With the recent readjustment of physicians’ Medicare reimbursement rates, the door has been opened to new initiatives based on quality of care. No matter what your political persuasion, it is clear that Americans cannot afford Medicare as we know it. Physicians undoubtedly will find their fee-for-service style of reimbursement curtailed as we learn the definition of “quality care standards.” Quality standards will not only define clinical performance, but will also include cost of rendering that care. So long to the world of fee-for-service reimbursement.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Few of my readers were around when Medicare was signed into law in 1965 by President Lyndon Johnson. Mr. Johnson was into his first elected term as president, having first taken the oath of office with the assassination of John F. Kennedy in November 1963.
Hardly a darling of the liberal left, he was maligned as the perpetrator, if not for the expansion, of the Vietnam War. He was elected with the largest presidential plurality in history, receiving 61% of the votes, and he carried with him a solid Democratic Congress bolstered by a large block of solid Southern Democrats, a firmament from which he had emerged. He can be credited for the most far-reaching social legislation of the 20th century, second only to Franklin Delano Roosevelt of the 1930s. Johnson was able to move the Civil Rights Act of 1964 and the Voting Rights Act and Medicare Act through Congress in 1965, the latter of which we celebrate this year.
At the time of passage of Medicare, 35% of Americans over 65 had no health insurance, either because they found insurance unaffordable or because of preexisting illness. Health insurance premiums for the elderly cost roughly three times more than did those for younger individuals. With many of the elderly living on Social Security alone, health insurance was an impossibility. If they needed care, they might find it at the emergency department of their local hospitals.
The battle for the passage of Medicare was formidable. In contrast to the passive role of the American Medical Association in the passage of the Affordable Care Act, Medicare was, to put it mildly, vigorously opposed by most doctors and by the AMA, which viewed it as the harbinger of long-anticipated socialized medicine. It ended up being far from it.
Medicare provided a pathway to an economic bonanza for the practicing physician and to hospitals that they could never have imagined. It immediately expanded the patient population and allowed enterprising and not-so-enterprising doctors and hospitals to run up the costs of health care by strengthening the fee-for-service style of medical care. Doctors, hospitals, and patients had no concern for cost: Medicare paid for everything.
Hospitals found Medicare a ready source of income. Doctor and hospital bills were based on the usual cost to each in their respective communities. Medical educators as well as house staff also saw their income lifted as a result of the federal government’s paying for a large part if not all of the cost of house staff education. Even the small number of physicians who opted out of Medicare, because of the red tape or to preserve their independence from the federal government, benefited. Their fees increased as the payment schedules of Medicare increased in their communities.
One of the by-products of Medicare was the end of hospital segregation. For those of you who were not around then, you can imagine what an impact that had on hospitals and doctors in both the North and the South.
Over time, Medicare expanded its footprint to include treatment of chronic kidney disease at any age, as well as drug coverage. I would guess that most Americans over 65 (this writer included) love Medicare. And doctors? Well, they still grumble about it.
With the recent readjustment of physicians’ Medicare reimbursement rates, the door has been opened to new initiatives based on quality of care. No matter what your political persuasion, it is clear that Americans cannot afford Medicare as we know it. Physicians undoubtedly will find their fee-for-service style of reimbursement curtailed as we learn the definition of “quality care standards.” Quality standards will not only define clinical performance, but will also include cost of rendering that care. So long to the world of fee-for-service reimbursement.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Few of my readers were around when Medicare was signed into law in 1965 by President Lyndon Johnson. Mr. Johnson was into his first elected term as president, having first taken the oath of office with the assassination of John F. Kennedy in November 1963.
Hardly a darling of the liberal left, he was maligned as the perpetrator, if not for the expansion, of the Vietnam War. He was elected with the largest presidential plurality in history, receiving 61% of the votes, and he carried with him a solid Democratic Congress bolstered by a large block of solid Southern Democrats, a firmament from which he had emerged. He can be credited for the most far-reaching social legislation of the 20th century, second only to Franklin Delano Roosevelt of the 1930s. Johnson was able to move the Civil Rights Act of 1964 and the Voting Rights Act and Medicare Act through Congress in 1965, the latter of which we celebrate this year.
At the time of passage of Medicare, 35% of Americans over 65 had no health insurance, either because they found insurance unaffordable or because of preexisting illness. Health insurance premiums for the elderly cost roughly three times more than did those for younger individuals. With many of the elderly living on Social Security alone, health insurance was an impossibility. If they needed care, they might find it at the emergency department of their local hospitals.
The battle for the passage of Medicare was formidable. In contrast to the passive role of the American Medical Association in the passage of the Affordable Care Act, Medicare was, to put it mildly, vigorously opposed by most doctors and by the AMA, which viewed it as the harbinger of long-anticipated socialized medicine. It ended up being far from it.
Medicare provided a pathway to an economic bonanza for the practicing physician and to hospitals that they could never have imagined. It immediately expanded the patient population and allowed enterprising and not-so-enterprising doctors and hospitals to run up the costs of health care by strengthening the fee-for-service style of medical care. Doctors, hospitals, and patients had no concern for cost: Medicare paid for everything.
Hospitals found Medicare a ready source of income. Doctor and hospital bills were based on the usual cost to each in their respective communities. Medical educators as well as house staff also saw their income lifted as a result of the federal government’s paying for a large part if not all of the cost of house staff education. Even the small number of physicians who opted out of Medicare, because of the red tape or to preserve their independence from the federal government, benefited. Their fees increased as the payment schedules of Medicare increased in their communities.
One of the by-products of Medicare was the end of hospital segregation. For those of you who were not around then, you can imagine what an impact that had on hospitals and doctors in both the North and the South.
Over time, Medicare expanded its footprint to include treatment of chronic kidney disease at any age, as well as drug coverage. I would guess that most Americans over 65 (this writer included) love Medicare. And doctors? Well, they still grumble about it.
With the recent readjustment of physicians’ Medicare reimbursement rates, the door has been opened to new initiatives based on quality of care. No matter what your political persuasion, it is clear that Americans cannot afford Medicare as we know it. Physicians undoubtedly will find their fee-for-service style of reimbursement curtailed as we learn the definition of “quality care standards.” Quality standards will not only define clinical performance, but will also include cost of rendering that care. So long to the world of fee-for-service reimbursement.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Advanced practice registered nurses in cardiology
In case you didn’t notice, our clinical practice has been reinforced by a entirely new class of performers who have become essential to our daily activities.
They are Advanced Practice Registered Nurses, whose role has evolved over the last 50 years from the Coronary Care Unit nurse with special training in coronary care to an array of well-trained women and men who have received both Bachelor’s and Master’s degrees in Nursing.
As a further extension of their training, many are now going on to achieve a further doctorate degree in nursing after 90 hours of postgraduate classes at certified academic centers and additional clinical experience in a variety of fields, including cardiology. The nurses completing those programs will be certified and licensed as APRNs. They come to our practice with remarkable experience and expertise in arrhythmia and heart failure management, as well as interventional skills, on top of wide experience in the management of patients in critical care units. Their integration into comprehensive and collaborative cardiac care raises challenges to and opportunities for the cardiologist.
A recent survey of large cardiology clinics initiated by the Summit Medical Group assessed the role of the APRN in the care of patients both in hospitals and in clinics. It reported that in many of cardiology clinics surveyed, APRNs provide an expanding role in patient care leading to variable relationships between the patient and the cardiologist. In some settings, the APRNs often function independent of physician interaction, initiating the patients’ entrance into the clinic and managing their follow-up. In other situations, they may be supervised by a cardiologist and their future laboratory studies and therapy are completely managed by the APRN, who functions as a professional associate of a physician. However, in many situations the cardiologist may have little or no contact with the patient.
While the APRN is seeing the patient, the cardiologists often are seeing their own patients or, more likely, are involved with maintaining the electronic medical record or performing or interpreting tests that are usually reimbursed at a fee that is a multiple of that received for a patient visit alone. Much of this is carried out under the heading of “coordinated care” and is managed in a multidisciplinary matrix in which many specialists and APRNs play a role in the care of the patient. In this setting, the doctor has become manager of a diverse group of support staff, including APRNs, and may be increasingly remote from direct patient care. My medical colleagues find the process as a way to increase the patient “pass through.” Many patients presume that the APRN is a reasonable alternative to a busy cardiologist or are interacting with their cardiologist.
As doctors, we are divesting ourselves from the one thing that sets us apart and makes us unique in the health care system; the ability to interact with patients in a comprehensive way. We seem to be on the slippery slope to medical obsolescence, soon to be replaced by staff who can triage our patients to the next appropriate test. Both the patient and doctor seem to have slipped into a Walmart-like world where expedience dominates over skill and shortcuts are the alternative to thoughtful personal physician-patient interaction.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
In case you didn’t notice, our clinical practice has been reinforced by a entirely new class of performers who have become essential to our daily activities.
They are Advanced Practice Registered Nurses, whose role has evolved over the last 50 years from the Coronary Care Unit nurse with special training in coronary care to an array of well-trained women and men who have received both Bachelor’s and Master’s degrees in Nursing.
As a further extension of their training, many are now going on to achieve a further doctorate degree in nursing after 90 hours of postgraduate classes at certified academic centers and additional clinical experience in a variety of fields, including cardiology. The nurses completing those programs will be certified and licensed as APRNs. They come to our practice with remarkable experience and expertise in arrhythmia and heart failure management, as well as interventional skills, on top of wide experience in the management of patients in critical care units. Their integration into comprehensive and collaborative cardiac care raises challenges to and opportunities for the cardiologist.
A recent survey of large cardiology clinics initiated by the Summit Medical Group assessed the role of the APRN in the care of patients both in hospitals and in clinics. It reported that in many of cardiology clinics surveyed, APRNs provide an expanding role in patient care leading to variable relationships between the patient and the cardiologist. In some settings, the APRNs often function independent of physician interaction, initiating the patients’ entrance into the clinic and managing their follow-up. In other situations, they may be supervised by a cardiologist and their future laboratory studies and therapy are completely managed by the APRN, who functions as a professional associate of a physician. However, in many situations the cardiologist may have little or no contact with the patient.
While the APRN is seeing the patient, the cardiologists often are seeing their own patients or, more likely, are involved with maintaining the electronic medical record or performing or interpreting tests that are usually reimbursed at a fee that is a multiple of that received for a patient visit alone. Much of this is carried out under the heading of “coordinated care” and is managed in a multidisciplinary matrix in which many specialists and APRNs play a role in the care of the patient. In this setting, the doctor has become manager of a diverse group of support staff, including APRNs, and may be increasingly remote from direct patient care. My medical colleagues find the process as a way to increase the patient “pass through.” Many patients presume that the APRN is a reasonable alternative to a busy cardiologist or are interacting with their cardiologist.
As doctors, we are divesting ourselves from the one thing that sets us apart and makes us unique in the health care system; the ability to interact with patients in a comprehensive way. We seem to be on the slippery slope to medical obsolescence, soon to be replaced by staff who can triage our patients to the next appropriate test. Both the patient and doctor seem to have slipped into a Walmart-like world where expedience dominates over skill and shortcuts are the alternative to thoughtful personal physician-patient interaction.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
In case you didn’t notice, our clinical practice has been reinforced by a entirely new class of performers who have become essential to our daily activities.
They are Advanced Practice Registered Nurses, whose role has evolved over the last 50 years from the Coronary Care Unit nurse with special training in coronary care to an array of well-trained women and men who have received both Bachelor’s and Master’s degrees in Nursing.
As a further extension of their training, many are now going on to achieve a further doctorate degree in nursing after 90 hours of postgraduate classes at certified academic centers and additional clinical experience in a variety of fields, including cardiology. The nurses completing those programs will be certified and licensed as APRNs. They come to our practice with remarkable experience and expertise in arrhythmia and heart failure management, as well as interventional skills, on top of wide experience in the management of patients in critical care units. Their integration into comprehensive and collaborative cardiac care raises challenges to and opportunities for the cardiologist.
A recent survey of large cardiology clinics initiated by the Summit Medical Group assessed the role of the APRN in the care of patients both in hospitals and in clinics. It reported that in many of cardiology clinics surveyed, APRNs provide an expanding role in patient care leading to variable relationships between the patient and the cardiologist. In some settings, the APRNs often function independent of physician interaction, initiating the patients’ entrance into the clinic and managing their follow-up. In other situations, they may be supervised by a cardiologist and their future laboratory studies and therapy are completely managed by the APRN, who functions as a professional associate of a physician. However, in many situations the cardiologist may have little or no contact with the patient.
While the APRN is seeing the patient, the cardiologists often are seeing their own patients or, more likely, are involved with maintaining the electronic medical record or performing or interpreting tests that are usually reimbursed at a fee that is a multiple of that received for a patient visit alone. Much of this is carried out under the heading of “coordinated care” and is managed in a multidisciplinary matrix in which many specialists and APRNs play a role in the care of the patient. In this setting, the doctor has become manager of a diverse group of support staff, including APRNs, and may be increasingly remote from direct patient care. My medical colleagues find the process as a way to increase the patient “pass through.” Many patients presume that the APRN is a reasonable alternative to a busy cardiologist or are interacting with their cardiologist.
As doctors, we are divesting ourselves from the one thing that sets us apart and makes us unique in the health care system; the ability to interact with patients in a comprehensive way. We seem to be on the slippery slope to medical obsolescence, soon to be replaced by staff who can triage our patients to the next appropriate test. Both the patient and doctor seem to have slipped into a Walmart-like world where expedience dominates over skill and shortcuts are the alternative to thoughtful personal physician-patient interaction.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
The end of the cardiology boom
Twenty years ago Dr. Joseph Alpert and I published an editorial suggesting that we were training too many cardiologists and that we should begin to decrease the existing training programs. It was written in anticipation of the expansion of health maintenance organizations and the Clinton health care initiatives, neither of which occurred (Am. J. Cardiol. 1994;74:394-5). Our opinions were met with universal disdain among our cardiology colleagues.
However, what did take place over the next 15 years was the creation of a cardiology "boom," inflated by an expansion of cardiology services with coronary stents and multiple imaging techniques, which succeeded in making work for newly trained cardiologists. Most of these procedures, with few exceptions, had little or no impact on the quality of care but did generate a significant increase in cost. From 1995 to 2012, an additional 7,000 cardiologists became members of the American College of Cardiology, swelling its ranks from 21,000 to 28,000 members. Workforce projection in the early 21st century suggested that there would be a continuing need for cardiology specialists well into 2025. These projections were based on the aging of the population and gave little attention to the potential future change in health care financing.
But in fact, changes did occur, and the cardiology boom has been deflated, not like the 2008 deflation of the housing boom, but it is clear that some of the gas has been let out, and the boom will continue to deflate in the future. A recent editorial (J. Am. Coll. Cardiol. 2014,63;1927-8) authored by the ACC leaders suggests that major adjustments in career goals of graduating trainees will have to be made in order to deal with the change in the marketplace. The major change in the reimbursement for outpatient procedures that favored hospital services created a flight of practicing physicians from private to hospital-based practice. The federal government and private insurers can now monitor practice patterns and the utilizations of services more closely, and this has led to a significant decrease in these procedures. At the same time, the conversion of your friendly local hospital to a corporate conglomerate has opened the door for hospital administrators to squeeze cost centers like cardiology in order to improve the bottom line.
The new emphasis on physician participation in cost control, as manifested by the move to medical homes and accountable care organizations, emphasizes quality improvement over quantity billing, where doctors can benefit financially from cost savings. Patients are also becoming more concerned about their own role in medical costs as they begin to face increases in deductible costs. The age of fee-for-service payment is fast coming to an end. We are moving away from high-cost care that led to the boom to efficient care based on value payment models.
As medicine, and particularly cardiology, moves further into the 21st century it is clear that we are victims of our own technology. It is difficult to predict the future when so many countercurrents are in effect in our profession. Joe Alpert and I missed the target by about 20 years, but we could never have anticipated the magnitude of ebb and flow of workforce tides. Many of us presumed that the medical profession would be free of the changes in economy and technology. We are learning now that we are not immune to those changes.
To my readers: After writing this column for almost 18 years, I have decided to take a long summer vacation. I plan to be back in the fall but writing less frequently and sharing this wonderful platform with others. I thank you all for the many comments that I have received through the years, both positive and negative. I also want to thank my editor, Catherine Hackett, who has always encouraged me to speak out without any constraint.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Twenty years ago Dr. Joseph Alpert and I published an editorial suggesting that we were training too many cardiologists and that we should begin to decrease the existing training programs. It was written in anticipation of the expansion of health maintenance organizations and the Clinton health care initiatives, neither of which occurred (Am. J. Cardiol. 1994;74:394-5). Our opinions were met with universal disdain among our cardiology colleagues.
However, what did take place over the next 15 years was the creation of a cardiology "boom," inflated by an expansion of cardiology services with coronary stents and multiple imaging techniques, which succeeded in making work for newly trained cardiologists. Most of these procedures, with few exceptions, had little or no impact on the quality of care but did generate a significant increase in cost. From 1995 to 2012, an additional 7,000 cardiologists became members of the American College of Cardiology, swelling its ranks from 21,000 to 28,000 members. Workforce projection in the early 21st century suggested that there would be a continuing need for cardiology specialists well into 2025. These projections were based on the aging of the population and gave little attention to the potential future change in health care financing.
But in fact, changes did occur, and the cardiology boom has been deflated, not like the 2008 deflation of the housing boom, but it is clear that some of the gas has been let out, and the boom will continue to deflate in the future. A recent editorial (J. Am. Coll. Cardiol. 2014,63;1927-8) authored by the ACC leaders suggests that major adjustments in career goals of graduating trainees will have to be made in order to deal with the change in the marketplace. The major change in the reimbursement for outpatient procedures that favored hospital services created a flight of practicing physicians from private to hospital-based practice. The federal government and private insurers can now monitor practice patterns and the utilizations of services more closely, and this has led to a significant decrease in these procedures. At the same time, the conversion of your friendly local hospital to a corporate conglomerate has opened the door for hospital administrators to squeeze cost centers like cardiology in order to improve the bottom line.
The new emphasis on physician participation in cost control, as manifested by the move to medical homes and accountable care organizations, emphasizes quality improvement over quantity billing, where doctors can benefit financially from cost savings. Patients are also becoming more concerned about their own role in medical costs as they begin to face increases in deductible costs. The age of fee-for-service payment is fast coming to an end. We are moving away from high-cost care that led to the boom to efficient care based on value payment models.
As medicine, and particularly cardiology, moves further into the 21st century it is clear that we are victims of our own technology. It is difficult to predict the future when so many countercurrents are in effect in our profession. Joe Alpert and I missed the target by about 20 years, but we could never have anticipated the magnitude of ebb and flow of workforce tides. Many of us presumed that the medical profession would be free of the changes in economy and technology. We are learning now that we are not immune to those changes.
To my readers: After writing this column for almost 18 years, I have decided to take a long summer vacation. I plan to be back in the fall but writing less frequently and sharing this wonderful platform with others. I thank you all for the many comments that I have received through the years, both positive and negative. I also want to thank my editor, Catherine Hackett, who has always encouraged me to speak out without any constraint.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Twenty years ago Dr. Joseph Alpert and I published an editorial suggesting that we were training too many cardiologists and that we should begin to decrease the existing training programs. It was written in anticipation of the expansion of health maintenance organizations and the Clinton health care initiatives, neither of which occurred (Am. J. Cardiol. 1994;74:394-5). Our opinions were met with universal disdain among our cardiology colleagues.
However, what did take place over the next 15 years was the creation of a cardiology "boom," inflated by an expansion of cardiology services with coronary stents and multiple imaging techniques, which succeeded in making work for newly trained cardiologists. Most of these procedures, with few exceptions, had little or no impact on the quality of care but did generate a significant increase in cost. From 1995 to 2012, an additional 7,000 cardiologists became members of the American College of Cardiology, swelling its ranks from 21,000 to 28,000 members. Workforce projection in the early 21st century suggested that there would be a continuing need for cardiology specialists well into 2025. These projections were based on the aging of the population and gave little attention to the potential future change in health care financing.
But in fact, changes did occur, and the cardiology boom has been deflated, not like the 2008 deflation of the housing boom, but it is clear that some of the gas has been let out, and the boom will continue to deflate in the future. A recent editorial (J. Am. Coll. Cardiol. 2014,63;1927-8) authored by the ACC leaders suggests that major adjustments in career goals of graduating trainees will have to be made in order to deal with the change in the marketplace. The major change in the reimbursement for outpatient procedures that favored hospital services created a flight of practicing physicians from private to hospital-based practice. The federal government and private insurers can now monitor practice patterns and the utilizations of services more closely, and this has led to a significant decrease in these procedures. At the same time, the conversion of your friendly local hospital to a corporate conglomerate has opened the door for hospital administrators to squeeze cost centers like cardiology in order to improve the bottom line.
The new emphasis on physician participation in cost control, as manifested by the move to medical homes and accountable care organizations, emphasizes quality improvement over quantity billing, where doctors can benefit financially from cost savings. Patients are also becoming more concerned about their own role in medical costs as they begin to face increases in deductible costs. The age of fee-for-service payment is fast coming to an end. We are moving away from high-cost care that led to the boom to efficient care based on value payment models.
As medicine, and particularly cardiology, moves further into the 21st century it is clear that we are victims of our own technology. It is difficult to predict the future when so many countercurrents are in effect in our profession. Joe Alpert and I missed the target by about 20 years, but we could never have anticipated the magnitude of ebb and flow of workforce tides. Many of us presumed that the medical profession would be free of the changes in economy and technology. We are learning now that we are not immune to those changes.
To my readers: After writing this column for almost 18 years, I have decided to take a long summer vacation. I plan to be back in the fall but writing less frequently and sharing this wonderful platform with others. I thank you all for the many comments that I have received through the years, both positive and negative. I also want to thank my editor, Catherine Hackett, who has always encouraged me to speak out without any constraint.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Bariatric surgery/Preventive medicine
Until recently, bariatric surgery was considered a cosmetic operation with little physiologic importance. A series of preliminary randomized clinical trials, however, have suggested that bariatric surgery may have importance in mitigating the adverse pathophysiology associated with obesity, including type 2 diabetes and some cardiovascular risk factors.
The finding of a surgical method of modifying this disease, which has occupied research for the last century, is somewhat unexpected after the many false starts associated with medical interventions. The two most popular surgical procedures, the gastric bypass and the sleeve gastrectomy performed using laparoscopic techniques, are currently being performed in obese patients with BMIs of greater than 35 with very low morbidly and rare mortality events. Several nonrandomized and prospective trials have examined the effect of bariatric surgery and reported beneficial effects on diabetes regression and significant reduction in major cardiovascular disease ( JAMA 2012;307:56-65).
The recent report of the 3-year follow-up of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial ( N. Engl. J. Med. 2014;370:2002-13) provides additional physiologic information on the benefits of bariatric surgery in 150 obese diabetic patients aged 20-60 years with BMIs of 27-43, compared with intensive medical therapy. Patients were randomized to three arms: intensive medical therapy, gastric bypass, or sleeve gastrectomy. Most of the patients were white women with a history of diabetes for 8.3 years; the mean hemoglobin A1c was 9.3%. At baseline, 43% of the patients required insulin therapy. The primary endpoint was the achievement of HbA1c of 6% or less, which was achieved in 5% of the medically treated patients, compared with 38% in the gastric bypass group and 24% in the sleeve gastrectomy group. Decrease in BMI was the only measure that predicted the achievement of the HbA1c endpoint. Body weight decreased by 4.5% in the intensive medical group, 24.5% in the gastric bypass group, and 21.1% in the sleeve gastrectomy group. Significant decreases in low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were achieved in both surgical intervention groups, compared with the intensive medical care group. In addition, medical control of diabetes was improved and 69% and 43% of the gastrectomy and sleeve bypass group, respectively, were no longer requiring insulin therapy. There was, however, no significant difference in the change in blood pressure in the three groups. There were no life-threatening complications or deaths in the groups, but there were a number of complications associated with the procedure.
The metabolic changes associated with bariatric surgery reported in STAMPEDE open the door for future randomized studies examining long-term morbidity and mortality benefits that may be attributed to this therapy. Bariatric surgery is being performed widely in the United States with very low mortality and morbidity. Previous short-term studies have reported the benefit of bariatric surgery, compared with intensive medical therapy. The longer duration of follow-up in STAMPEDE emphasizes the need for larger randomized trials of this method of therapy. The study of the surgical patients may also provide new insight into the relationship of body fat to the expression of type 2 diabetes.
The prevention of medical disease using surgical techniques in clinical medicine has not been a particularly fertile road of investigation. Intervention in the treatment of coronary artery disease with bypass surgery although associated with symptomatic benefit and with some exceptions, has not been overwhelmingly successful in affecting the long-term mortality of that disease. Bariatric surgery may be the first surgical intervention that can arrest or even reverse type 2 diabetes and its many sequelae.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Until recently, bariatric surgery was considered a cosmetic operation with little physiologic importance. A series of preliminary randomized clinical trials, however, have suggested that bariatric surgery may have importance in mitigating the adverse pathophysiology associated with obesity, including type 2 diabetes and some cardiovascular risk factors.
The finding of a surgical method of modifying this disease, which has occupied research for the last century, is somewhat unexpected after the many false starts associated with medical interventions. The two most popular surgical procedures, the gastric bypass and the sleeve gastrectomy performed using laparoscopic techniques, are currently being performed in obese patients with BMIs of greater than 35 with very low morbidly and rare mortality events. Several nonrandomized and prospective trials have examined the effect of bariatric surgery and reported beneficial effects on diabetes regression and significant reduction in major cardiovascular disease ( JAMA 2012;307:56-65).
The recent report of the 3-year follow-up of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial ( N. Engl. J. Med. 2014;370:2002-13) provides additional physiologic information on the benefits of bariatric surgery in 150 obese diabetic patients aged 20-60 years with BMIs of 27-43, compared with intensive medical therapy. Patients were randomized to three arms: intensive medical therapy, gastric bypass, or sleeve gastrectomy. Most of the patients were white women with a history of diabetes for 8.3 years; the mean hemoglobin A1c was 9.3%. At baseline, 43% of the patients required insulin therapy. The primary endpoint was the achievement of HbA1c of 6% or less, which was achieved in 5% of the medically treated patients, compared with 38% in the gastric bypass group and 24% in the sleeve gastrectomy group. Decrease in BMI was the only measure that predicted the achievement of the HbA1c endpoint. Body weight decreased by 4.5% in the intensive medical group, 24.5% in the gastric bypass group, and 21.1% in the sleeve gastrectomy group. Significant decreases in low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were achieved in both surgical intervention groups, compared with the intensive medical care group. In addition, medical control of diabetes was improved and 69% and 43% of the gastrectomy and sleeve bypass group, respectively, were no longer requiring insulin therapy. There was, however, no significant difference in the change in blood pressure in the three groups. There were no life-threatening complications or deaths in the groups, but there were a number of complications associated with the procedure.
The metabolic changes associated with bariatric surgery reported in STAMPEDE open the door for future randomized studies examining long-term morbidity and mortality benefits that may be attributed to this therapy. Bariatric surgery is being performed widely in the United States with very low mortality and morbidity. Previous short-term studies have reported the benefit of bariatric surgery, compared with intensive medical therapy. The longer duration of follow-up in STAMPEDE emphasizes the need for larger randomized trials of this method of therapy. The study of the surgical patients may also provide new insight into the relationship of body fat to the expression of type 2 diabetes.
The prevention of medical disease using surgical techniques in clinical medicine has not been a particularly fertile road of investigation. Intervention in the treatment of coronary artery disease with bypass surgery although associated with symptomatic benefit and with some exceptions, has not been overwhelmingly successful in affecting the long-term mortality of that disease. Bariatric surgery may be the first surgical intervention that can arrest or even reverse type 2 diabetes and its many sequelae.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Until recently, bariatric surgery was considered a cosmetic operation with little physiologic importance. A series of preliminary randomized clinical trials, however, have suggested that bariatric surgery may have importance in mitigating the adverse pathophysiology associated with obesity, including type 2 diabetes and some cardiovascular risk factors.
The finding of a surgical method of modifying this disease, which has occupied research for the last century, is somewhat unexpected after the many false starts associated with medical interventions. The two most popular surgical procedures, the gastric bypass and the sleeve gastrectomy performed using laparoscopic techniques, are currently being performed in obese patients with BMIs of greater than 35 with very low morbidly and rare mortality events. Several nonrandomized and prospective trials have examined the effect of bariatric surgery and reported beneficial effects on diabetes regression and significant reduction in major cardiovascular disease ( JAMA 2012;307:56-65).
The recent report of the 3-year follow-up of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) trial ( N. Engl. J. Med. 2014;370:2002-13) provides additional physiologic information on the benefits of bariatric surgery in 150 obese diabetic patients aged 20-60 years with BMIs of 27-43, compared with intensive medical therapy. Patients were randomized to three arms: intensive medical therapy, gastric bypass, or sleeve gastrectomy. Most of the patients were white women with a history of diabetes for 8.3 years; the mean hemoglobin A1c was 9.3%. At baseline, 43% of the patients required insulin therapy. The primary endpoint was the achievement of HbA1c of 6% or less, which was achieved in 5% of the medically treated patients, compared with 38% in the gastric bypass group and 24% in the sleeve gastrectomy group. Decrease in BMI was the only measure that predicted the achievement of the HbA1c endpoint. Body weight decreased by 4.5% in the intensive medical group, 24.5% in the gastric bypass group, and 21.1% in the sleeve gastrectomy group. Significant decreases in low-density lipoprotein cholesterol and increases in high-density lipoprotein cholesterol were achieved in both surgical intervention groups, compared with the intensive medical care group. In addition, medical control of diabetes was improved and 69% and 43% of the gastrectomy and sleeve bypass group, respectively, were no longer requiring insulin therapy. There was, however, no significant difference in the change in blood pressure in the three groups. There were no life-threatening complications or deaths in the groups, but there were a number of complications associated with the procedure.
The metabolic changes associated with bariatric surgery reported in STAMPEDE open the door for future randomized studies examining long-term morbidity and mortality benefits that may be attributed to this therapy. Bariatric surgery is being performed widely in the United States with very low mortality and morbidity. Previous short-term studies have reported the benefit of bariatric surgery, compared with intensive medical therapy. The longer duration of follow-up in STAMPEDE emphasizes the need for larger randomized trials of this method of therapy. The study of the surgical patients may also provide new insight into the relationship of body fat to the expression of type 2 diabetes.
The prevention of medical disease using surgical techniques in clinical medicine has not been a particularly fertile road of investigation. Intervention in the treatment of coronary artery disease with bypass surgery although associated with symptomatic benefit and with some exceptions, has not been overwhelmingly successful in affecting the long-term mortality of that disease. Bariatric surgery may be the first surgical intervention that can arrest or even reverse type 2 diabetes and its many sequelae.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Atrial fibrillation: The unknown known
For a problem that has been on the back burner for decades, the treatment of atrial fibrillation has suddenly become a "marquis" diagnosis.
Age and technology have led to an explosion of interest in this arcane cardiac problem. Advertisements for new anticoagulants and thrombin inhibitors for "A Fib" have become almost as common as those for male impotency. The aging of the world population certainly has been a major factor in its increased incidence. New technology and pharmacology has driven the increase in clinical interest and has advanced our knowledge about the disease. Epidemiology data have provided important information about the natural history of paroxysmal atrial fibrillation (AF), and its relationship to chronic AF and its adverse effects on long-term mortality.
The importance of anticoagulant therapy for the prevention of systemic emboli and stroke has been the mainstay of therapy for almost 50 years. Although we have struggled with a variety of antiarrhythmic drugs, their shortcomings have been more than apparent. Most of us now use a rate-control strategy to control the tachycardia inherent in AF. The development of new factor Xa and direct thrombin inhibitor drugs have made the logistics of providing adequate thrombus prevention much simpler, if somewhat more expensive.
The elephant in the room is the increasing use of radiofrequency catheter ablation technology that has had some success in the prevention of AF arising from the tissue in the pulmonary vein–atrial interface. Numerous small studies have reported that this technology surpasses rhythm control with antiarrhythmic agents, a hurdle not too difficult to beat. The best results have been observed in patients with recurrent paroxysmal AF where maintenance of regular sinus rhythm has been the primary outcome measurement (JAMA 2014;311:692-700). Even here, recurrence after ablation has been common. The benefit of ablation therapy in patients with initial paroxysmal AF (N. Engl. J. Med. 2012;367:1587-95) or chronic persistent AF has been uncertain at best. As a result, the AHA/ACC/HRS (American Heart Association/American College of Cardiology/Heart Rhythm Society) guidelines have given a class I (evidence level A) recommendation for ablation therapy for symptomatic paroxysmal AF and class IIa (evidence level A) and IIb (evidence level B) for symptomatic recurrent paroxysmal and longstanding persistent AF when balanced against drug tolerability, respectively (J. Am. Coll. Cardiol. 2014 [doi:10.1016/j.jacc.2014.03.021]).
All of these clinical data are exciting and have led to enthusiasm for ablation technology despite the potential for nonfatal and rare fatal complication, based almost entirely on its ability to improve upon the dismal benefits of antiarrhythmic rhythm control. Even as we consider the benefit of ablation therapy, new techniques are being developed. The lack of mortality and morbidity data is a result of the short follow-up, usually limited to a year or two, and small sample size. This lack of long-term outcome data for ablation therapy should be of some concern to clinicians who have lived through the last few years. Many of my readers had not been born when we embarked on the ineffective and dangerous pharmacologic prevention of sudden death by pharmacologic suppression of ambient ventricular premature beats. Numerous surrogate measures of clinical benefit of a variety of therapeutic interventions have been disproven and disposed of in the subsequent years. The use of surrogate measures like the partial suppression of AF rather than morbidity and mortality outcomes to establish clinical benefit, have been largely discarded as a dead end.
The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA), which is beginning to recruit more than 2,000 patients with new-onset or undertreated paroxysmal, persistent, or longstanding AF to be followed for over 4 years may answer the question of whether radiofrequency ablation therapy, rate control, or rhythm control provides the best clinical treatment of atrial fibrillation. The primary outcome will be the composite endpoint of total mortality, disabling stroke or serious bleeding, or cardiac arrest. An important secondary endpoint will be total mortality. Until its conclusion, we should proceed cautiously with expanding radiofrequency ablation therapy for the treatment of AF.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
For a problem that has been on the back burner for decades, the treatment of atrial fibrillation has suddenly become a "marquis" diagnosis.
Age and technology have led to an explosion of interest in this arcane cardiac problem. Advertisements for new anticoagulants and thrombin inhibitors for "A Fib" have become almost as common as those for male impotency. The aging of the world population certainly has been a major factor in its increased incidence. New technology and pharmacology has driven the increase in clinical interest and has advanced our knowledge about the disease. Epidemiology data have provided important information about the natural history of paroxysmal atrial fibrillation (AF), and its relationship to chronic AF and its adverse effects on long-term mortality.
The importance of anticoagulant therapy for the prevention of systemic emboli and stroke has been the mainstay of therapy for almost 50 years. Although we have struggled with a variety of antiarrhythmic drugs, their shortcomings have been more than apparent. Most of us now use a rate-control strategy to control the tachycardia inherent in AF. The development of new factor Xa and direct thrombin inhibitor drugs have made the logistics of providing adequate thrombus prevention much simpler, if somewhat more expensive.
The elephant in the room is the increasing use of radiofrequency catheter ablation technology that has had some success in the prevention of AF arising from the tissue in the pulmonary vein–atrial interface. Numerous small studies have reported that this technology surpasses rhythm control with antiarrhythmic agents, a hurdle not too difficult to beat. The best results have been observed in patients with recurrent paroxysmal AF where maintenance of regular sinus rhythm has been the primary outcome measurement (JAMA 2014;311:692-700). Even here, recurrence after ablation has been common. The benefit of ablation therapy in patients with initial paroxysmal AF (N. Engl. J. Med. 2012;367:1587-95) or chronic persistent AF has been uncertain at best. As a result, the AHA/ACC/HRS (American Heart Association/American College of Cardiology/Heart Rhythm Society) guidelines have given a class I (evidence level A) recommendation for ablation therapy for symptomatic paroxysmal AF and class IIa (evidence level A) and IIb (evidence level B) for symptomatic recurrent paroxysmal and longstanding persistent AF when balanced against drug tolerability, respectively (J. Am. Coll. Cardiol. 2014 [doi:10.1016/j.jacc.2014.03.021]).
All of these clinical data are exciting and have led to enthusiasm for ablation technology despite the potential for nonfatal and rare fatal complication, based almost entirely on its ability to improve upon the dismal benefits of antiarrhythmic rhythm control. Even as we consider the benefit of ablation therapy, new techniques are being developed. The lack of mortality and morbidity data is a result of the short follow-up, usually limited to a year or two, and small sample size. This lack of long-term outcome data for ablation therapy should be of some concern to clinicians who have lived through the last few years. Many of my readers had not been born when we embarked on the ineffective and dangerous pharmacologic prevention of sudden death by pharmacologic suppression of ambient ventricular premature beats. Numerous surrogate measures of clinical benefit of a variety of therapeutic interventions have been disproven and disposed of in the subsequent years. The use of surrogate measures like the partial suppression of AF rather than morbidity and mortality outcomes to establish clinical benefit, have been largely discarded as a dead end.
The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA), which is beginning to recruit more than 2,000 patients with new-onset or undertreated paroxysmal, persistent, or longstanding AF to be followed for over 4 years may answer the question of whether radiofrequency ablation therapy, rate control, or rhythm control provides the best clinical treatment of atrial fibrillation. The primary outcome will be the composite endpoint of total mortality, disabling stroke or serious bleeding, or cardiac arrest. An important secondary endpoint will be total mortality. Until its conclusion, we should proceed cautiously with expanding radiofrequency ablation therapy for the treatment of AF.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
For a problem that has been on the back burner for decades, the treatment of atrial fibrillation has suddenly become a "marquis" diagnosis.
Age and technology have led to an explosion of interest in this arcane cardiac problem. Advertisements for new anticoagulants and thrombin inhibitors for "A Fib" have become almost as common as those for male impotency. The aging of the world population certainly has been a major factor in its increased incidence. New technology and pharmacology has driven the increase in clinical interest and has advanced our knowledge about the disease. Epidemiology data have provided important information about the natural history of paroxysmal atrial fibrillation (AF), and its relationship to chronic AF and its adverse effects on long-term mortality.
The importance of anticoagulant therapy for the prevention of systemic emboli and stroke has been the mainstay of therapy for almost 50 years. Although we have struggled with a variety of antiarrhythmic drugs, their shortcomings have been more than apparent. Most of us now use a rate-control strategy to control the tachycardia inherent in AF. The development of new factor Xa and direct thrombin inhibitor drugs have made the logistics of providing adequate thrombus prevention much simpler, if somewhat more expensive.
The elephant in the room is the increasing use of radiofrequency catheter ablation technology that has had some success in the prevention of AF arising from the tissue in the pulmonary vein–atrial interface. Numerous small studies have reported that this technology surpasses rhythm control with antiarrhythmic agents, a hurdle not too difficult to beat. The best results have been observed in patients with recurrent paroxysmal AF where maintenance of regular sinus rhythm has been the primary outcome measurement (JAMA 2014;311:692-700). Even here, recurrence after ablation has been common. The benefit of ablation therapy in patients with initial paroxysmal AF (N. Engl. J. Med. 2012;367:1587-95) or chronic persistent AF has been uncertain at best. As a result, the AHA/ACC/HRS (American Heart Association/American College of Cardiology/Heart Rhythm Society) guidelines have given a class I (evidence level A) recommendation for ablation therapy for symptomatic paroxysmal AF and class IIa (evidence level A) and IIb (evidence level B) for symptomatic recurrent paroxysmal and longstanding persistent AF when balanced against drug tolerability, respectively (J. Am. Coll. Cardiol. 2014 [doi:10.1016/j.jacc.2014.03.021]).
All of these clinical data are exciting and have led to enthusiasm for ablation technology despite the potential for nonfatal and rare fatal complication, based almost entirely on its ability to improve upon the dismal benefits of antiarrhythmic rhythm control. Even as we consider the benefit of ablation therapy, new techniques are being developed. The lack of mortality and morbidity data is a result of the short follow-up, usually limited to a year or two, and small sample size. This lack of long-term outcome data for ablation therapy should be of some concern to clinicians who have lived through the last few years. Many of my readers had not been born when we embarked on the ineffective and dangerous pharmacologic prevention of sudden death by pharmacologic suppression of ambient ventricular premature beats. Numerous surrogate measures of clinical benefit of a variety of therapeutic interventions have been disproven and disposed of in the subsequent years. The use of surrogate measures like the partial suppression of AF rather than morbidity and mortality outcomes to establish clinical benefit, have been largely discarded as a dead end.
The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA), which is beginning to recruit more than 2,000 patients with new-onset or undertreated paroxysmal, persistent, or longstanding AF to be followed for over 4 years may answer the question of whether radiofrequency ablation therapy, rate control, or rhythm control provides the best clinical treatment of atrial fibrillation. The primary outcome will be the composite endpoint of total mortality, disabling stroke or serious bleeding, or cardiac arrest. An important secondary endpoint will be total mortality. Until its conclusion, we should proceed cautiously with expanding radiofrequency ablation therapy for the treatment of AF.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
The ICU: From bed to bedside
I recently came to the realization that one doesn’t usually end up in an ICU unless the odds of making it out are not in one’s favor.
Now, I want to make it clear from the very first that my wife and I survived life-threatening medical experiences as a result of the superb care provided to both of us. Nevertheless, the experience made me aware of how ICU and hospital care has changed in the last 50 years. I have spent most of my life in ICUs from the "invention" of the Coronary Care Unit in the mid-1960s to its current iteration of an intensely monitored hospital room where emergency surgery could be performed if need be. Much of that change is a result of the variety of medical specialists who are players in the ICU drama. The other major changes have been the time restraints of house staff rotation to meet certification criteria and rotation of the senior staff in order to provide continuing on-site coverage of the ICU. As the acuteness of hospital admissions has increased, the ICU and its management have assumed a larger role in the care and the finances of major hospitals.
Some years ago, we hosted a distinguished European physician who spent 2 months with us as a visiting professor. It was at a time when we felt a need to begin to develop subspecialties in angiography, electrophysiology, and echocardiography in order to provide a research and training atmosphere for our fellowship program. Later, he wrote an editorial in his local medical journal criticizing cardiac care in the United States because of the lack of continuity. He was of the tradition that mandated that he would see the patient in the clinic, perform a cardiac catheterization himself, and follow his patient through surgery and manage their postoperative care, as was standard practice in the mid-20th century. He believed that the concept of delegating diagnostic and care responsibilities to specialty trained colleagues that he observed here was a major disaster. He should see the system now. Nevertheless, his plea for continuity in care resonates in my mind.
That need for continuity came back to me as I experienced the dizzying rotation of house staff and senior staff that takes place in the ICU today. Any semblance of continuity of care was lacking at a time when there was a need to provide information to anxious patients and their families. In the environment of medical uncertainty, when you would like to find a familiar physician to ask "How are we doing," the attending physician or medical resident in charge was either on another rotation or being covered by a colleague. No training or adherence to "sign-off" rounds can replace the need for that professional continuity. As competent and well meaning the covering doctor was, answers to questions seemed shallow. It was difficult even to express gratitude to "a" physician who had tipped the scales in my favor. One had to direct it to an amorphous team of doctors, nurses, and technicians who had participated in care. That is a reality that describes the methodology of ICU and its success. It is a reality that to a similar degree characterizes the current management of inpatient care.
It seemed that in the setting of a life-threatening experience, the link between the treating physicians and the patients or family has almost disappeared in the ICU. The challenge to us as we play our role in the ICU, and the CCU, is to establish and maintain a personal relationship with the patients and their family.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
I recently came to the realization that one doesn’t usually end up in an ICU unless the odds of making it out are not in one’s favor.
Now, I want to make it clear from the very first that my wife and I survived life-threatening medical experiences as a result of the superb care provided to both of us. Nevertheless, the experience made me aware of how ICU and hospital care has changed in the last 50 years. I have spent most of my life in ICUs from the "invention" of the Coronary Care Unit in the mid-1960s to its current iteration of an intensely monitored hospital room where emergency surgery could be performed if need be. Much of that change is a result of the variety of medical specialists who are players in the ICU drama. The other major changes have been the time restraints of house staff rotation to meet certification criteria and rotation of the senior staff in order to provide continuing on-site coverage of the ICU. As the acuteness of hospital admissions has increased, the ICU and its management have assumed a larger role in the care and the finances of major hospitals.
Some years ago, we hosted a distinguished European physician who spent 2 months with us as a visiting professor. It was at a time when we felt a need to begin to develop subspecialties in angiography, electrophysiology, and echocardiography in order to provide a research and training atmosphere for our fellowship program. Later, he wrote an editorial in his local medical journal criticizing cardiac care in the United States because of the lack of continuity. He was of the tradition that mandated that he would see the patient in the clinic, perform a cardiac catheterization himself, and follow his patient through surgery and manage their postoperative care, as was standard practice in the mid-20th century. He believed that the concept of delegating diagnostic and care responsibilities to specialty trained colleagues that he observed here was a major disaster. He should see the system now. Nevertheless, his plea for continuity in care resonates in my mind.
That need for continuity came back to me as I experienced the dizzying rotation of house staff and senior staff that takes place in the ICU today. Any semblance of continuity of care was lacking at a time when there was a need to provide information to anxious patients and their families. In the environment of medical uncertainty, when you would like to find a familiar physician to ask "How are we doing," the attending physician or medical resident in charge was either on another rotation or being covered by a colleague. No training or adherence to "sign-off" rounds can replace the need for that professional continuity. As competent and well meaning the covering doctor was, answers to questions seemed shallow. It was difficult even to express gratitude to "a" physician who had tipped the scales in my favor. One had to direct it to an amorphous team of doctors, nurses, and technicians who had participated in care. That is a reality that describes the methodology of ICU and its success. It is a reality that to a similar degree characterizes the current management of inpatient care.
It seemed that in the setting of a life-threatening experience, the link between the treating physicians and the patients or family has almost disappeared in the ICU. The challenge to us as we play our role in the ICU, and the CCU, is to establish and maintain a personal relationship with the patients and their family.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
I recently came to the realization that one doesn’t usually end up in an ICU unless the odds of making it out are not in one’s favor.
Now, I want to make it clear from the very first that my wife and I survived life-threatening medical experiences as a result of the superb care provided to both of us. Nevertheless, the experience made me aware of how ICU and hospital care has changed in the last 50 years. I have spent most of my life in ICUs from the "invention" of the Coronary Care Unit in the mid-1960s to its current iteration of an intensely monitored hospital room where emergency surgery could be performed if need be. Much of that change is a result of the variety of medical specialists who are players in the ICU drama. The other major changes have been the time restraints of house staff rotation to meet certification criteria and rotation of the senior staff in order to provide continuing on-site coverage of the ICU. As the acuteness of hospital admissions has increased, the ICU and its management have assumed a larger role in the care and the finances of major hospitals.
Some years ago, we hosted a distinguished European physician who spent 2 months with us as a visiting professor. It was at a time when we felt a need to begin to develop subspecialties in angiography, electrophysiology, and echocardiography in order to provide a research and training atmosphere for our fellowship program. Later, he wrote an editorial in his local medical journal criticizing cardiac care in the United States because of the lack of continuity. He was of the tradition that mandated that he would see the patient in the clinic, perform a cardiac catheterization himself, and follow his patient through surgery and manage their postoperative care, as was standard practice in the mid-20th century. He believed that the concept of delegating diagnostic and care responsibilities to specialty trained colleagues that he observed here was a major disaster. He should see the system now. Nevertheless, his plea for continuity in care resonates in my mind.
That need for continuity came back to me as I experienced the dizzying rotation of house staff and senior staff that takes place in the ICU today. Any semblance of continuity of care was lacking at a time when there was a need to provide information to anxious patients and their families. In the environment of medical uncertainty, when you would like to find a familiar physician to ask "How are we doing," the attending physician or medical resident in charge was either on another rotation or being covered by a colleague. No training or adherence to "sign-off" rounds can replace the need for that professional continuity. As competent and well meaning the covering doctor was, answers to questions seemed shallow. It was difficult even to express gratitude to "a" physician who had tipped the scales in my favor. One had to direct it to an amorphous team of doctors, nurses, and technicians who had participated in care. That is a reality that describes the methodology of ICU and its success. It is a reality that to a similar degree characterizes the current management of inpatient care.
It seemed that in the setting of a life-threatening experience, the link between the treating physicians and the patients or family has almost disappeared in the ICU. The challenge to us as we play our role in the ICU, and the CCU, is to establish and maintain a personal relationship with the patients and their family.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Corporate health care is here
Hospital mergers have been accelerating in the last few years, and doctors and other health care workers have been swept up in the process.
The last time merger mania took place in the 1990s, seemingly to provide efficiencies and savings, costs went up. At that time some doctors became interested in joining their local hospitals and became salaried employees. This time around multiple incentives are playing out, and the exodus from private practice has accelerated. Between 2007 and 2012 the number of cardiologists employed by hospitals has increased from 11% to 35% (N. Engl. J. Med. 2014;370;198-9).
The increased need for investment in financial infrastructure has led many private practitioners to seek the umbrella of the local hospital. Cardiology has seen a shift in federal reimbursement rates for imaging favoring hospital-based testing. At the same time, local hospitals have sought out mergers and acquisitions of varying sorts in order to become more competitive in the marketplace and to acquire more development capital. The number of hospital mergers increased almost twofold from 2009 to 2012 (N.Y. Times, Aug. 12, 2013, p. B1). Local hospitals have been anxious to solidify relationships within their local communities by creating referral networks. Others have looked nationally for the "quality branding" for their institution.
Merger mania has also moved from local to national control by both profit and nonprofit corporations. Entrepreneurism has driven financial incentives in order to develop large networks that have the potential to improve quality and efficiency. An unwritten motivation is the potential to generate large profits that have the potential of increasing health care costs in the pre-Medicare population that we saw in the last merger go-around. Several large medical groups, like the Mayo Clinic or the Cleveland Clinic, have expanded their network and instituted franchiselike arrangements with hospitals thousands of miles distant from their headquarters, to create referral networks for highly specialized and high-cost procedures.
Much of this is hardly news to any of us. This trend is a result of multiple forces that include the changes in imaging fees, which provided the potential for expanding sources of revenue to hospitals and hospital networks. Many physicians found that merging their practice with their local hospital, where they had been practicing, was not too wrenching. That is, until they woke up the next morning to learn that their local hospital had just merged with another system. They now found that they had to deal with unfamiliar administrators with different views on health care. The system was no longer sensitive to local health care but to the corporate bottom line. Suddenly, the familiarity with the local hospital administrator, whom they knew, had been replaced by a "corporate vice president for physician relations."
Recent press coverage has recounted tales of corporate initiatives that have driven up expenses in order to improve the bottom line. One recent report recounts the story of emergency department physicians who were financially rewarded or penalized based upon the statistics of their hospital admission rate (N.Y. Times, Jan. 23, 2014, p. A1).
According to the attorney who represented the doctors, "It’s not a doctor in there watching those statistics – it’s the finance people." The economics of cardiology provide many targets for finance people to improve the bottom line. Some examples are biannual or annual stress tests, multiple imaging procedures, and "tack-on" procedures during angiography, to name just a few. The most recent story (Bloomberg News, March 6, 2014) of how one of America’s most prestigious hospitals manipulated admissions for coronary angiography and trolled local communities with stress tests to increase the number of angiograms, raised shudders in this reader. In 2010, seven of the hospital-based cardiologists each averaged 301 referrals to the cath lab, which was "15 times the average by all 546 doctors who sent patients to the lab that year."
These events were not driven by "finance people" alone, but had complicity by doctors. They suggest that the process is endemic in cardiology today. It has been said before; the enemy is US.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Hospital mergers have been accelerating in the last few years, and doctors and other health care workers have been swept up in the process.
The last time merger mania took place in the 1990s, seemingly to provide efficiencies and savings, costs went up. At that time some doctors became interested in joining their local hospitals and became salaried employees. This time around multiple incentives are playing out, and the exodus from private practice has accelerated. Between 2007 and 2012 the number of cardiologists employed by hospitals has increased from 11% to 35% (N. Engl. J. Med. 2014;370;198-9).
The increased need for investment in financial infrastructure has led many private practitioners to seek the umbrella of the local hospital. Cardiology has seen a shift in federal reimbursement rates for imaging favoring hospital-based testing. At the same time, local hospitals have sought out mergers and acquisitions of varying sorts in order to become more competitive in the marketplace and to acquire more development capital. The number of hospital mergers increased almost twofold from 2009 to 2012 (N.Y. Times, Aug. 12, 2013, p. B1). Local hospitals have been anxious to solidify relationships within their local communities by creating referral networks. Others have looked nationally for the "quality branding" for their institution.
Merger mania has also moved from local to national control by both profit and nonprofit corporations. Entrepreneurism has driven financial incentives in order to develop large networks that have the potential to improve quality and efficiency. An unwritten motivation is the potential to generate large profits that have the potential of increasing health care costs in the pre-Medicare population that we saw in the last merger go-around. Several large medical groups, like the Mayo Clinic or the Cleveland Clinic, have expanded their network and instituted franchiselike arrangements with hospitals thousands of miles distant from their headquarters, to create referral networks for highly specialized and high-cost procedures.
Much of this is hardly news to any of us. This trend is a result of multiple forces that include the changes in imaging fees, which provided the potential for expanding sources of revenue to hospitals and hospital networks. Many physicians found that merging their practice with their local hospital, where they had been practicing, was not too wrenching. That is, until they woke up the next morning to learn that their local hospital had just merged with another system. They now found that they had to deal with unfamiliar administrators with different views on health care. The system was no longer sensitive to local health care but to the corporate bottom line. Suddenly, the familiarity with the local hospital administrator, whom they knew, had been replaced by a "corporate vice president for physician relations."
Recent press coverage has recounted tales of corporate initiatives that have driven up expenses in order to improve the bottom line. One recent report recounts the story of emergency department physicians who were financially rewarded or penalized based upon the statistics of their hospital admission rate (N.Y. Times, Jan. 23, 2014, p. A1).
According to the attorney who represented the doctors, "It’s not a doctor in there watching those statistics – it’s the finance people." The economics of cardiology provide many targets for finance people to improve the bottom line. Some examples are biannual or annual stress tests, multiple imaging procedures, and "tack-on" procedures during angiography, to name just a few. The most recent story (Bloomberg News, March 6, 2014) of how one of America’s most prestigious hospitals manipulated admissions for coronary angiography and trolled local communities with stress tests to increase the number of angiograms, raised shudders in this reader. In 2010, seven of the hospital-based cardiologists each averaged 301 referrals to the cath lab, which was "15 times the average by all 546 doctors who sent patients to the lab that year."
These events were not driven by "finance people" alone, but had complicity by doctors. They suggest that the process is endemic in cardiology today. It has been said before; the enemy is US.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Hospital mergers have been accelerating in the last few years, and doctors and other health care workers have been swept up in the process.
The last time merger mania took place in the 1990s, seemingly to provide efficiencies and savings, costs went up. At that time some doctors became interested in joining their local hospitals and became salaried employees. This time around multiple incentives are playing out, and the exodus from private practice has accelerated. Between 2007 and 2012 the number of cardiologists employed by hospitals has increased from 11% to 35% (N. Engl. J. Med. 2014;370;198-9).
The increased need for investment in financial infrastructure has led many private practitioners to seek the umbrella of the local hospital. Cardiology has seen a shift in federal reimbursement rates for imaging favoring hospital-based testing. At the same time, local hospitals have sought out mergers and acquisitions of varying sorts in order to become more competitive in the marketplace and to acquire more development capital. The number of hospital mergers increased almost twofold from 2009 to 2012 (N.Y. Times, Aug. 12, 2013, p. B1). Local hospitals have been anxious to solidify relationships within their local communities by creating referral networks. Others have looked nationally for the "quality branding" for their institution.
Merger mania has also moved from local to national control by both profit and nonprofit corporations. Entrepreneurism has driven financial incentives in order to develop large networks that have the potential to improve quality and efficiency. An unwritten motivation is the potential to generate large profits that have the potential of increasing health care costs in the pre-Medicare population that we saw in the last merger go-around. Several large medical groups, like the Mayo Clinic or the Cleveland Clinic, have expanded their network and instituted franchiselike arrangements with hospitals thousands of miles distant from their headquarters, to create referral networks for highly specialized and high-cost procedures.
Much of this is hardly news to any of us. This trend is a result of multiple forces that include the changes in imaging fees, which provided the potential for expanding sources of revenue to hospitals and hospital networks. Many physicians found that merging their practice with their local hospital, where they had been practicing, was not too wrenching. That is, until they woke up the next morning to learn that their local hospital had just merged with another system. They now found that they had to deal with unfamiliar administrators with different views on health care. The system was no longer sensitive to local health care but to the corporate bottom line. Suddenly, the familiarity with the local hospital administrator, whom they knew, had been replaced by a "corporate vice president for physician relations."
Recent press coverage has recounted tales of corporate initiatives that have driven up expenses in order to improve the bottom line. One recent report recounts the story of emergency department physicians who were financially rewarded or penalized based upon the statistics of their hospital admission rate (N.Y. Times, Jan. 23, 2014, p. A1).
According to the attorney who represented the doctors, "It’s not a doctor in there watching those statistics – it’s the finance people." The economics of cardiology provide many targets for finance people to improve the bottom line. Some examples are biannual or annual stress tests, multiple imaging procedures, and "tack-on" procedures during angiography, to name just a few. The most recent story (Bloomberg News, March 6, 2014) of how one of America’s most prestigious hospitals manipulated admissions for coronary angiography and trolled local communities with stress tests to increase the number of angiograms, raised shudders in this reader. In 2010, seven of the hospital-based cardiologists each averaged 301 referrals to the cath lab, which was "15 times the average by all 546 doctors who sent patients to the lab that year."
These events were not driven by "finance people" alone, but had complicity by doctors. They suggest that the process is endemic in cardiology today. It has been said before; the enemy is US.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
The demise of renal artery stenting
The announcement from Medtronic in January has apparently brought down the curtain on the much-heralded approach to the treatment of refractory hypertension using radio-frequency renal artery sympathetic nerve ablation (RASNA) applied through the tip of the Symplicity catheter.
This technology is being used widely around the world for the treatment of refractory hypertensive patients. The enthusiasm for RASNA was generated by a series of reports suggesting that an amazing decrease in systolic blood pressure of more than 30 mm Hg can be obtained in patients with resistant hypertension taking three or more antihypertensive drugs. However, the SYMPLICITY HTN-3 trial (Clin. Cardiol. 2012;35:528-35), which enrolled 535 patients with refractory hypertension, failed to achieve the primary endpoint of a significant decrease in systolic pressure in the radio-frequency (RF)-treated patients compared with the sham-operated patients. In the study, blinding was rigorously managed by renal artery catheterization of all 535 patients, with RF ablation instituted in two-thirds of the patients, and a sham operation conducted in one-third.
As a result of the observations in SYMPLICITY HTN-3, Medtronic is suspending enrollment in current trials using the Symplicity device throughout the world, and will "continue to ensure patients access to the Symplicity technology at the discretion of their physicians in countries where the device is approved," according to its statement.
Enthusiasm for RF ablation of the sympathetic nerves accompanying the renal artery was generated by a series of publications describing the physiologic and therapeutic effects. The first publications in this series described the metabolic changes that occurred after RF ablation carried out in one patient who experienced a decrease in systolic pressure of 20 mm Hg associated with modulation of sympathetic activity 30 days and 12 months after the procedure (N. Engl. J. Med. 2009;361:932-4). This study was followed by two subsequent reports of patients in whom RASNA was carried out. A proof-of-concept trial (SYMPLICITY HTN-1) in 153 patients reported a substantial decrease in blood pressure over a 2-year period (Hypertension 2011;57:911-7). A second trial (SYMPLICITY HTN-2) randomized 106 patients to either RASNA or standard therapy. That trial reported that 84% of the patients receiving RASNA had a reduction of blood pressure greater than 10 mm Hg within 6 months, compared with 35% of the control group (Lancet 2010;376:1903-9). Both studies reported a profound decrease in blood pressure that ensued over a 6-month period in 80%-90% of patients undergoing the therapy. In light of these reports, it is difficult to explain the fact that SYMPLICITY HTN-3 was a negative study.
Modulation of the sympathetic nervous system for the treatment of hypertension is not new. More than 60 years ago, Smithwick and colleagues carried out both surgical lumbar and sympathetic splanchnicectomy for its treatment with uncertain results (JAMA 1952;153:1501-4). In an era when all that we could offer hypertensive patients was a low-salt diet, the procedure became rather popular. However, the surgical risks, adverse side effects, and uncertainty of benefit led to both procedures being discontinued. Recently, there have been studies of the effect of stimulation of the carotid sinus nerve for the treatment of hypertension.
The potential benefit of modulation of the arterial sympathetic nerves, and particularly those located in the renal artery, became the focus of this recent interest. Nevertheless, a number of questions have arisen in regard to the mechanism of RASNA. And why does it take 6 months to achieve the blood pressure response? In addition, there is very little published data in regard to the changes in the renal artery and its adjacent tissue as a result of the RF ablation.
At the present, Medtronic has not provided any information beyond its indicating the lack of benefit. Further information will be reported at the upcoming American College of Cardiology scientific sessions. In the meantime, speculation is rampant as to whether the initial reports were purely placebo effects or if there is something intrinsically flawed in the SYMPLICITY HTN -3 trial.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
The announcement from Medtronic in January has apparently brought down the curtain on the much-heralded approach to the treatment of refractory hypertension using radio-frequency renal artery sympathetic nerve ablation (RASNA) applied through the tip of the Symplicity catheter.
This technology is being used widely around the world for the treatment of refractory hypertensive patients. The enthusiasm for RASNA was generated by a series of reports suggesting that an amazing decrease in systolic blood pressure of more than 30 mm Hg can be obtained in patients with resistant hypertension taking three or more antihypertensive drugs. However, the SYMPLICITY HTN-3 trial (Clin. Cardiol. 2012;35:528-35), which enrolled 535 patients with refractory hypertension, failed to achieve the primary endpoint of a significant decrease in systolic pressure in the radio-frequency (RF)-treated patients compared with the sham-operated patients. In the study, blinding was rigorously managed by renal artery catheterization of all 535 patients, with RF ablation instituted in two-thirds of the patients, and a sham operation conducted in one-third.
As a result of the observations in SYMPLICITY HTN-3, Medtronic is suspending enrollment in current trials using the Symplicity device throughout the world, and will "continue to ensure patients access to the Symplicity technology at the discretion of their physicians in countries where the device is approved," according to its statement.
Enthusiasm for RF ablation of the sympathetic nerves accompanying the renal artery was generated by a series of publications describing the physiologic and therapeutic effects. The first publications in this series described the metabolic changes that occurred after RF ablation carried out in one patient who experienced a decrease in systolic pressure of 20 mm Hg associated with modulation of sympathetic activity 30 days and 12 months after the procedure (N. Engl. J. Med. 2009;361:932-4). This study was followed by two subsequent reports of patients in whom RASNA was carried out. A proof-of-concept trial (SYMPLICITY HTN-1) in 153 patients reported a substantial decrease in blood pressure over a 2-year period (Hypertension 2011;57:911-7). A second trial (SYMPLICITY HTN-2) randomized 106 patients to either RASNA or standard therapy. That trial reported that 84% of the patients receiving RASNA had a reduction of blood pressure greater than 10 mm Hg within 6 months, compared with 35% of the control group (Lancet 2010;376:1903-9). Both studies reported a profound decrease in blood pressure that ensued over a 6-month period in 80%-90% of patients undergoing the therapy. In light of these reports, it is difficult to explain the fact that SYMPLICITY HTN-3 was a negative study.
Modulation of the sympathetic nervous system for the treatment of hypertension is not new. More than 60 years ago, Smithwick and colleagues carried out both surgical lumbar and sympathetic splanchnicectomy for its treatment with uncertain results (JAMA 1952;153:1501-4). In an era when all that we could offer hypertensive patients was a low-salt diet, the procedure became rather popular. However, the surgical risks, adverse side effects, and uncertainty of benefit led to both procedures being discontinued. Recently, there have been studies of the effect of stimulation of the carotid sinus nerve for the treatment of hypertension.
The potential benefit of modulation of the arterial sympathetic nerves, and particularly those located in the renal artery, became the focus of this recent interest. Nevertheless, a number of questions have arisen in regard to the mechanism of RASNA. And why does it take 6 months to achieve the blood pressure response? In addition, there is very little published data in regard to the changes in the renal artery and its adjacent tissue as a result of the RF ablation.
At the present, Medtronic has not provided any information beyond its indicating the lack of benefit. Further information will be reported at the upcoming American College of Cardiology scientific sessions. In the meantime, speculation is rampant as to whether the initial reports were purely placebo effects or if there is something intrinsically flawed in the SYMPLICITY HTN -3 trial.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
The announcement from Medtronic in January has apparently brought down the curtain on the much-heralded approach to the treatment of refractory hypertension using radio-frequency renal artery sympathetic nerve ablation (RASNA) applied through the tip of the Symplicity catheter.
This technology is being used widely around the world for the treatment of refractory hypertensive patients. The enthusiasm for RASNA was generated by a series of reports suggesting that an amazing decrease in systolic blood pressure of more than 30 mm Hg can be obtained in patients with resistant hypertension taking three or more antihypertensive drugs. However, the SYMPLICITY HTN-3 trial (Clin. Cardiol. 2012;35:528-35), which enrolled 535 patients with refractory hypertension, failed to achieve the primary endpoint of a significant decrease in systolic pressure in the radio-frequency (RF)-treated patients compared with the sham-operated patients. In the study, blinding was rigorously managed by renal artery catheterization of all 535 patients, with RF ablation instituted in two-thirds of the patients, and a sham operation conducted in one-third.
As a result of the observations in SYMPLICITY HTN-3, Medtronic is suspending enrollment in current trials using the Symplicity device throughout the world, and will "continue to ensure patients access to the Symplicity technology at the discretion of their physicians in countries where the device is approved," according to its statement.
Enthusiasm for RF ablation of the sympathetic nerves accompanying the renal artery was generated by a series of publications describing the physiologic and therapeutic effects. The first publications in this series described the metabolic changes that occurred after RF ablation carried out in one patient who experienced a decrease in systolic pressure of 20 mm Hg associated with modulation of sympathetic activity 30 days and 12 months after the procedure (N. Engl. J. Med. 2009;361:932-4). This study was followed by two subsequent reports of patients in whom RASNA was carried out. A proof-of-concept trial (SYMPLICITY HTN-1) in 153 patients reported a substantial decrease in blood pressure over a 2-year period (Hypertension 2011;57:911-7). A second trial (SYMPLICITY HTN-2) randomized 106 patients to either RASNA or standard therapy. That trial reported that 84% of the patients receiving RASNA had a reduction of blood pressure greater than 10 mm Hg within 6 months, compared with 35% of the control group (Lancet 2010;376:1903-9). Both studies reported a profound decrease in blood pressure that ensued over a 6-month period in 80%-90% of patients undergoing the therapy. In light of these reports, it is difficult to explain the fact that SYMPLICITY HTN-3 was a negative study.
Modulation of the sympathetic nervous system for the treatment of hypertension is not new. More than 60 years ago, Smithwick and colleagues carried out both surgical lumbar and sympathetic splanchnicectomy for its treatment with uncertain results (JAMA 1952;153:1501-4). In an era when all that we could offer hypertensive patients was a low-salt diet, the procedure became rather popular. However, the surgical risks, adverse side effects, and uncertainty of benefit led to both procedures being discontinued. Recently, there have been studies of the effect of stimulation of the carotid sinus nerve for the treatment of hypertension.
The potential benefit of modulation of the arterial sympathetic nerves, and particularly those located in the renal artery, became the focus of this recent interest. Nevertheless, a number of questions have arisen in regard to the mechanism of RASNA. And why does it take 6 months to achieve the blood pressure response? In addition, there is very little published data in regard to the changes in the renal artery and its adjacent tissue as a result of the RF ablation.
At the present, Medtronic has not provided any information beyond its indicating the lack of benefit. Further information will be reported at the upcoming American College of Cardiology scientific sessions. In the meantime, speculation is rampant as to whether the initial reports were purely placebo effects or if there is something intrinsically flawed in the SYMPLICITY HTN -3 trial.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Cooling the resuscitated sudden dead
In the last 30 years, there have been immense advances in the treatment and prevention of sudden cardiac arrest, including beta-blocker therapy and automatic implantable cardiac defibrillators.
In addition, communities have organized emergency medical systems (EMS) designed to provide early cardiac care for the prevention and treatment of cardiac arrest occurring outside the hospital (OHCA). One of the great frustrations of physicians working in the EMS environment is the successful cardiac resuscitation for the patient who is left with severe neurological impairment or brain death. It is clear that resuscitation of the brain is very time dependent. Complete interruption of blood flow to the brain leads to the loss of consciousness within seconds and death of vulnerable neurons in several brain regions occurs within minutes, whereas 20-40 minutes of ischemia is required to kill cardiac myocytes.
To improve survival and prevent the neurological sequelae of OHCA, total body hypothermia is advised based on animal laboratory experiments and a few small clinical studies carried out in a total of 179 OHCA patients (N. Engl. J. Med. 2002;346:557-63 and 549-56).
Both studies show both a neurological and survival benefit – particularly in patients resuscitated from ventricular fibrillation – in comatose patients in whom resuscitation was achieved within 5-10 minutes after witnessed cardiac arrest when cooled to 32-34 degrees Celsius within 60 minutes of collapse. These studies led to the recommendation by the International Liaison Committee on Resuscitation (Circulation 2004;110;3385-97) that cooling to 32-34 degrees Celsius for 12-24 hours should be used in unconscious patients with OHCA with VF and possibly non-VF arrests.
These recommendations were supported by the AHA Guideline Committee (Circulation 2010;122:S768-86) As a result, cooling comatose OHCA patients after resuscitation is widely used in emergency departments in the United States and Europe with the use of a variety of devices and techniques including large volume saline, external cooling devices, intravenous catheter devices, and intranasal devices. When hypothermia was initially recommended, a number of questions were unanswered and remain unanswered despite multiple publications and wide clinical experience in the succeeding 12 years. Some of those questions include the timing, duration, and intensity of cooling, the preferable technique of cooling, and risk and benefits of the different cooling techniques.
In the United States, pressure infusion of 2 liters of ice cold saline is the usual initial method of cooling to 32-34 degrees Celsius followed by 12-36 hours with surface cooling.
Investigators in Seattle randomized OHCA patients prior to hypothermia or standard therapy with both VF and non-VF rhythms before hospitalization to improve the previous reported benefit when initiated in hospital (JAMA 2014;311;45-52).
The initiation of prehospital therapy achieved cooling 1 hour earlier than in previous hospitalization studies. The result in 1,359 OHCAs over a 5-year period raises important questions about the benefit of hypothermia. The researchers failed to find any benefit in regard to neurological outcomes or mortality. In VF OHCA, they observed a survival rate to hospital discharge of 62.7 % (intervention group) and 64.3% (controls). In the patients without VF, those rates were 19.2 and 16.3, respectively.
Neurological outcomes were also similar for patients with VF at 57.5% (intervention group) and 61.9% (controls), respectively. The non-VF rates were 14.4% (intervention) and 13.4 % (controls). Hypothermia was associated with significant adverse events, including pulmonary edema and increased use of diuretics.
These observations are contrary to previous observations and should provide an opportunity to reevaluate hypothermia for OHCA. These patients represent a series of complex metabolic issues that deserve careful research to provide answers to some of the outstanding issues. The recent studies provide an environment of equipoise where we can step back and revaluate this complex procedure in randomized control trials.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
In the last 30 years, there have been immense advances in the treatment and prevention of sudden cardiac arrest, including beta-blocker therapy and automatic implantable cardiac defibrillators.
In addition, communities have organized emergency medical systems (EMS) designed to provide early cardiac care for the prevention and treatment of cardiac arrest occurring outside the hospital (OHCA). One of the great frustrations of physicians working in the EMS environment is the successful cardiac resuscitation for the patient who is left with severe neurological impairment or brain death. It is clear that resuscitation of the brain is very time dependent. Complete interruption of blood flow to the brain leads to the loss of consciousness within seconds and death of vulnerable neurons in several brain regions occurs within minutes, whereas 20-40 minutes of ischemia is required to kill cardiac myocytes.
To improve survival and prevent the neurological sequelae of OHCA, total body hypothermia is advised based on animal laboratory experiments and a few small clinical studies carried out in a total of 179 OHCA patients (N. Engl. J. Med. 2002;346:557-63 and 549-56).
Both studies show both a neurological and survival benefit – particularly in patients resuscitated from ventricular fibrillation – in comatose patients in whom resuscitation was achieved within 5-10 minutes after witnessed cardiac arrest when cooled to 32-34 degrees Celsius within 60 minutes of collapse. These studies led to the recommendation by the International Liaison Committee on Resuscitation (Circulation 2004;110;3385-97) that cooling to 32-34 degrees Celsius for 12-24 hours should be used in unconscious patients with OHCA with VF and possibly non-VF arrests.
These recommendations were supported by the AHA Guideline Committee (Circulation 2010;122:S768-86) As a result, cooling comatose OHCA patients after resuscitation is widely used in emergency departments in the United States and Europe with the use of a variety of devices and techniques including large volume saline, external cooling devices, intravenous catheter devices, and intranasal devices. When hypothermia was initially recommended, a number of questions were unanswered and remain unanswered despite multiple publications and wide clinical experience in the succeeding 12 years. Some of those questions include the timing, duration, and intensity of cooling, the preferable technique of cooling, and risk and benefits of the different cooling techniques.
In the United States, pressure infusion of 2 liters of ice cold saline is the usual initial method of cooling to 32-34 degrees Celsius followed by 12-36 hours with surface cooling.
Investigators in Seattle randomized OHCA patients prior to hypothermia or standard therapy with both VF and non-VF rhythms before hospitalization to improve the previous reported benefit when initiated in hospital (JAMA 2014;311;45-52).
The initiation of prehospital therapy achieved cooling 1 hour earlier than in previous hospitalization studies. The result in 1,359 OHCAs over a 5-year period raises important questions about the benefit of hypothermia. The researchers failed to find any benefit in regard to neurological outcomes or mortality. In VF OHCA, they observed a survival rate to hospital discharge of 62.7 % (intervention group) and 64.3% (controls). In the patients without VF, those rates were 19.2 and 16.3, respectively.
Neurological outcomes were also similar for patients with VF at 57.5% (intervention group) and 61.9% (controls), respectively. The non-VF rates were 14.4% (intervention) and 13.4 % (controls). Hypothermia was associated with significant adverse events, including pulmonary edema and increased use of diuretics.
These observations are contrary to previous observations and should provide an opportunity to reevaluate hypothermia for OHCA. These patients represent a series of complex metabolic issues that deserve careful research to provide answers to some of the outstanding issues. The recent studies provide an environment of equipoise where we can step back and revaluate this complex procedure in randomized control trials.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
In the last 30 years, there have been immense advances in the treatment and prevention of sudden cardiac arrest, including beta-blocker therapy and automatic implantable cardiac defibrillators.
In addition, communities have organized emergency medical systems (EMS) designed to provide early cardiac care for the prevention and treatment of cardiac arrest occurring outside the hospital (OHCA). One of the great frustrations of physicians working in the EMS environment is the successful cardiac resuscitation for the patient who is left with severe neurological impairment or brain death. It is clear that resuscitation of the brain is very time dependent. Complete interruption of blood flow to the brain leads to the loss of consciousness within seconds and death of vulnerable neurons in several brain regions occurs within minutes, whereas 20-40 minutes of ischemia is required to kill cardiac myocytes.
To improve survival and prevent the neurological sequelae of OHCA, total body hypothermia is advised based on animal laboratory experiments and a few small clinical studies carried out in a total of 179 OHCA patients (N. Engl. J. Med. 2002;346:557-63 and 549-56).
Both studies show both a neurological and survival benefit – particularly in patients resuscitated from ventricular fibrillation – in comatose patients in whom resuscitation was achieved within 5-10 minutes after witnessed cardiac arrest when cooled to 32-34 degrees Celsius within 60 minutes of collapse. These studies led to the recommendation by the International Liaison Committee on Resuscitation (Circulation 2004;110;3385-97) that cooling to 32-34 degrees Celsius for 12-24 hours should be used in unconscious patients with OHCA with VF and possibly non-VF arrests.
These recommendations were supported by the AHA Guideline Committee (Circulation 2010;122:S768-86) As a result, cooling comatose OHCA patients after resuscitation is widely used in emergency departments in the United States and Europe with the use of a variety of devices and techniques including large volume saline, external cooling devices, intravenous catheter devices, and intranasal devices. When hypothermia was initially recommended, a number of questions were unanswered and remain unanswered despite multiple publications and wide clinical experience in the succeeding 12 years. Some of those questions include the timing, duration, and intensity of cooling, the preferable technique of cooling, and risk and benefits of the different cooling techniques.
In the United States, pressure infusion of 2 liters of ice cold saline is the usual initial method of cooling to 32-34 degrees Celsius followed by 12-36 hours with surface cooling.
Investigators in Seattle randomized OHCA patients prior to hypothermia or standard therapy with both VF and non-VF rhythms before hospitalization to improve the previous reported benefit when initiated in hospital (JAMA 2014;311;45-52).
The initiation of prehospital therapy achieved cooling 1 hour earlier than in previous hospitalization studies. The result in 1,359 OHCAs over a 5-year period raises important questions about the benefit of hypothermia. The researchers failed to find any benefit in regard to neurological outcomes or mortality. In VF OHCA, they observed a survival rate to hospital discharge of 62.7 % (intervention group) and 64.3% (controls). In the patients without VF, those rates were 19.2 and 16.3, respectively.
Neurological outcomes were also similar for patients with VF at 57.5% (intervention group) and 61.9% (controls), respectively. The non-VF rates were 14.4% (intervention) and 13.4 % (controls). Hypothermia was associated with significant adverse events, including pulmonary edema and increased use of diuretics.
These observations are contrary to previous observations and should provide an opportunity to reevaluate hypothermia for OHCA. These patients represent a series of complex metabolic issues that deserve careful research to provide answers to some of the outstanding issues. The recent studies provide an environment of equipoise where we can step back and revaluate this complex procedure in randomized control trials.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Focusing on statins
I have been thinking about the recent cholesterol management guidelines offered by the American Heart Association and American College of Cardiology experts (J. Am. Coll. Cardiol. 2013;doi:10.1016/j.jacc.2013.11.002) and how they affect my approach to my patients. I am quick to agree to the first three points and the end of LDL targeted therapy in the guidelines, which focus now on the intensity of statins therapy in patients who have already expressed the complications of atherosclerotic cardiovascular disease (ASCVD).
However, I do question a cardiovascular prevention program that, for low-risk individuals with an LDL cholesterol level above 190 mg/dL, is largely driven by statin therapy based on a risk prediction model using age, sex, hypertension, smoking, HDL, and LDL cholesterol elevation. Of all risk factors, smoking and LDL are the only ones that we can modify. Although we have made a major attack on smoking, it would seem that the key to survival is that all of us should take a statin.
There is an abundant source of data on the benefit of statin therapy in patients who have already expressed ASCVD. Although data are limited in regard to very-low-risk groups without evidence of ASCVD, a meta-analysis by the Cholesterol Treatment Trialist Collaborators indicates that the lowering of LDL cholesterol by 40 mg/dL results in an approximate 12% decrease in vascular mortality and 20% decrease in cardiac deaths, regardless of regardless of risk category (Lancet 2012;380;581-90). This benefit was observed even in low-risk individuals despite the slight excess risk of hemorrhagic strokes and diabetes.
The prediction model appears to be the major point of controversy. Along with thousands other Americans, I went to the AHA website to see what my risk score was. I found that by modifying a few factors I could move from less than a 7.5% risk of a stroke or a heart attack in the next 10 years to a risk of well over that. I was not reassured that I was in the company of more than 45 million fellow Americans. Critics of the risk model suggest that based on a number of epidemiologic surveys, the risk model may double the number of individuals to whom the prevention guidelines apply (Lancet 2013;382:1762-5). If we expand the population so broadly, are we going to be a society of statin pill poppers?
Our attempts in the last half-century to develop prevention therapy for hypertension and diabetes have only been marginally successful. The cardiorenal scourge of hypertension remains, despite a plethora of effective drugs that have had little effect on chronic renal disease. Although therapy for diabetes has been supremely effective in treating the acute and chronic metabolic aspects of diabetes, insulin therapy has not been successful in preventing the long-term expression of the cardiovascular, ophthalmic, and renal events. And now we are trying to assess the role of statins for the prevention of cardiovascular events.
In comparison to hypertension and diabetes, statin therapy has the potential to be a sea change in the prevention of ASCVD by lowering serum cholesterol and thereby limiting the growth of the atherosclerotic plaque. A number of clinical trials support the cardiovascular benefit of statin therapy and its effect on lowering serum cholesterol. Although it is clear that we need to reflect on the reliability of the current risk factor model, the current guidelines are an important step forward in the integration of statin therapy into the prevention of cardiovascular disease.
However, talking to patients and telling them that they have greater than a 7.5% risk of having a stroke or a heart attack in the next 10 years remains an abstract concept. The guideline committee now urges me to sit down with my patients and have a heart-to-heart talk about risk and how to decrease it by changing their dangerous lifestyles rather than taking statins for the rest of their lives. When it comes down to it, lifestyle change loses and statins win.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
I have been thinking about the recent cholesterol management guidelines offered by the American Heart Association and American College of Cardiology experts (J. Am. Coll. Cardiol. 2013;doi:10.1016/j.jacc.2013.11.002) and how they affect my approach to my patients. I am quick to agree to the first three points and the end of LDL targeted therapy in the guidelines, which focus now on the intensity of statins therapy in patients who have already expressed the complications of atherosclerotic cardiovascular disease (ASCVD).
However, I do question a cardiovascular prevention program that, for low-risk individuals with an LDL cholesterol level above 190 mg/dL, is largely driven by statin therapy based on a risk prediction model using age, sex, hypertension, smoking, HDL, and LDL cholesterol elevation. Of all risk factors, smoking and LDL are the only ones that we can modify. Although we have made a major attack on smoking, it would seem that the key to survival is that all of us should take a statin.
There is an abundant source of data on the benefit of statin therapy in patients who have already expressed ASCVD. Although data are limited in regard to very-low-risk groups without evidence of ASCVD, a meta-analysis by the Cholesterol Treatment Trialist Collaborators indicates that the lowering of LDL cholesterol by 40 mg/dL results in an approximate 12% decrease in vascular mortality and 20% decrease in cardiac deaths, regardless of regardless of risk category (Lancet 2012;380;581-90). This benefit was observed even in low-risk individuals despite the slight excess risk of hemorrhagic strokes and diabetes.
The prediction model appears to be the major point of controversy. Along with thousands other Americans, I went to the AHA website to see what my risk score was. I found that by modifying a few factors I could move from less than a 7.5% risk of a stroke or a heart attack in the next 10 years to a risk of well over that. I was not reassured that I was in the company of more than 45 million fellow Americans. Critics of the risk model suggest that based on a number of epidemiologic surveys, the risk model may double the number of individuals to whom the prevention guidelines apply (Lancet 2013;382:1762-5). If we expand the population so broadly, are we going to be a society of statin pill poppers?
Our attempts in the last half-century to develop prevention therapy for hypertension and diabetes have only been marginally successful. The cardiorenal scourge of hypertension remains, despite a plethora of effective drugs that have had little effect on chronic renal disease. Although therapy for diabetes has been supremely effective in treating the acute and chronic metabolic aspects of diabetes, insulin therapy has not been successful in preventing the long-term expression of the cardiovascular, ophthalmic, and renal events. And now we are trying to assess the role of statins for the prevention of cardiovascular events.
In comparison to hypertension and diabetes, statin therapy has the potential to be a sea change in the prevention of ASCVD by lowering serum cholesterol and thereby limiting the growth of the atherosclerotic plaque. A number of clinical trials support the cardiovascular benefit of statin therapy and its effect on lowering serum cholesterol. Although it is clear that we need to reflect on the reliability of the current risk factor model, the current guidelines are an important step forward in the integration of statin therapy into the prevention of cardiovascular disease.
However, talking to patients and telling them that they have greater than a 7.5% risk of having a stroke or a heart attack in the next 10 years remains an abstract concept. The guideline committee now urges me to sit down with my patients and have a heart-to-heart talk about risk and how to decrease it by changing their dangerous lifestyles rather than taking statins for the rest of their lives. When it comes down to it, lifestyle change loses and statins win.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
I have been thinking about the recent cholesterol management guidelines offered by the American Heart Association and American College of Cardiology experts (J. Am. Coll. Cardiol. 2013;doi:10.1016/j.jacc.2013.11.002) and how they affect my approach to my patients. I am quick to agree to the first three points and the end of LDL targeted therapy in the guidelines, which focus now on the intensity of statins therapy in patients who have already expressed the complications of atherosclerotic cardiovascular disease (ASCVD).
However, I do question a cardiovascular prevention program that, for low-risk individuals with an LDL cholesterol level above 190 mg/dL, is largely driven by statin therapy based on a risk prediction model using age, sex, hypertension, smoking, HDL, and LDL cholesterol elevation. Of all risk factors, smoking and LDL are the only ones that we can modify. Although we have made a major attack on smoking, it would seem that the key to survival is that all of us should take a statin.
There is an abundant source of data on the benefit of statin therapy in patients who have already expressed ASCVD. Although data are limited in regard to very-low-risk groups without evidence of ASCVD, a meta-analysis by the Cholesterol Treatment Trialist Collaborators indicates that the lowering of LDL cholesterol by 40 mg/dL results in an approximate 12% decrease in vascular mortality and 20% decrease in cardiac deaths, regardless of regardless of risk category (Lancet 2012;380;581-90). This benefit was observed even in low-risk individuals despite the slight excess risk of hemorrhagic strokes and diabetes.
The prediction model appears to be the major point of controversy. Along with thousands other Americans, I went to the AHA website to see what my risk score was. I found that by modifying a few factors I could move from less than a 7.5% risk of a stroke or a heart attack in the next 10 years to a risk of well over that. I was not reassured that I was in the company of more than 45 million fellow Americans. Critics of the risk model suggest that based on a number of epidemiologic surveys, the risk model may double the number of individuals to whom the prevention guidelines apply (Lancet 2013;382:1762-5). If we expand the population so broadly, are we going to be a society of statin pill poppers?
Our attempts in the last half-century to develop prevention therapy for hypertension and diabetes have only been marginally successful. The cardiorenal scourge of hypertension remains, despite a plethora of effective drugs that have had little effect on chronic renal disease. Although therapy for diabetes has been supremely effective in treating the acute and chronic metabolic aspects of diabetes, insulin therapy has not been successful in preventing the long-term expression of the cardiovascular, ophthalmic, and renal events. And now we are trying to assess the role of statins for the prevention of cardiovascular events.
In comparison to hypertension and diabetes, statin therapy has the potential to be a sea change in the prevention of ASCVD by lowering serum cholesterol and thereby limiting the growth of the atherosclerotic plaque. A number of clinical trials support the cardiovascular benefit of statin therapy and its effect on lowering serum cholesterol. Although it is clear that we need to reflect on the reliability of the current risk factor model, the current guidelines are an important step forward in the integration of statin therapy into the prevention of cardiovascular disease.
However, talking to patients and telling them that they have greater than a 7.5% risk of having a stroke or a heart attack in the next 10 years remains an abstract concept. The guideline committee now urges me to sit down with my patients and have a heart-to-heart talk about risk and how to decrease it by changing their dangerous lifestyles rather than taking statins for the rest of their lives. When it comes down to it, lifestyle change loses and statins win.
Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.