Federal medical tort reform: Has its time come?

Article Type
Changed
Thu, 03/28/2019 - 14:48

 

Question: Congressional proposals on medical tort reform can be expected to include the following, except:

A. A no-fault system akin to automobile no-fault insurance.

B. A cap on noneconomic damages.

C. “Safe-harbor” immunity against medical negligence.

D. Health courts in place of the judge/jury system to adjudicate claims.

E. Promotion of laws that encourage apologies and error disclosures.

Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.1

Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.2 Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.

The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.

Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.

California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.3 The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”

On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.4 The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.5

Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
 

Health courts

Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.

In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.

As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
 

 

 

Apology law

Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.

For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.6 Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.

However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.7 And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
 

Safe harbors

A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”

There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.

Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.

Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.8 The outlook in the U.S. Senate, however, is anything but certain.
 

Dr. S.Y. Tan
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at [email protected].

References

1. N Engl J Med. 2017 May 11;376(19):1806-8.

2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.

3. Chan v. Curran, 237 CA 4th 601 (2015).

4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).

5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).

6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).

7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.

8. Protecting Access to Care Act of 2017 (H.R. 1215).

Publications
Topics
Sections

 

Question: Congressional proposals on medical tort reform can be expected to include the following, except:

A. A no-fault system akin to automobile no-fault insurance.

B. A cap on noneconomic damages.

C. “Safe-harbor” immunity against medical negligence.

D. Health courts in place of the judge/jury system to adjudicate claims.

E. Promotion of laws that encourage apologies and error disclosures.

Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.1

Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.2 Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.

The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.

Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.

California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.3 The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”

On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.4 The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.5

Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
 

Health courts

Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.

In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.

As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
 

 

 

Apology law

Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.

For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.6 Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.

However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.7 And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
 

Safe harbors

A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”

There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.

Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.

Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.8 The outlook in the U.S. Senate, however, is anything but certain.
 

Dr. S.Y. Tan
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at [email protected].

References

1. N Engl J Med. 2017 May 11;376(19):1806-8.

2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.

3. Chan v. Curran, 237 CA 4th 601 (2015).

4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).

5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).

6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).

7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.

8. Protecting Access to Care Act of 2017 (H.R. 1215).

 

Question: Congressional proposals on medical tort reform can be expected to include the following, except:

A. A no-fault system akin to automobile no-fault insurance.

B. A cap on noneconomic damages.

C. “Safe-harbor” immunity against medical negligence.

D. Health courts in place of the judge/jury system to adjudicate claims.

E. Promotion of laws that encourage apologies and error disclosures.

Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.1

Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.2 Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.

The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.

Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.

California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.3 The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”

On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.4 The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.5

Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
 

Health courts

Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.

In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.

As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
 

 

 

Apology law

Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.

For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.6 Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.

However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.7 And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
 

Safe harbors

A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”

There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.

Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.

Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.8 The outlook in the U.S. Senate, however, is anything but certain.
 

Dr. S.Y. Tan
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the materials have been taken from earlier columns in Internal Medicine News. For additional information, readers may contact the author at [email protected].

References

1. N Engl J Med. 2017 May 11;376(19):1806-8.

2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.

3. Chan v. Curran, 237 CA 4th 601 (2015).

4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).

5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).

6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).

7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.

8. Protecting Access to Care Act of 2017 (H.R. 1215).

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Screening MRI misses Sturge-Weber in babies with port-wine stain

Article Type
Changed
Fri, 01/18/2019 - 16:57

 

CHICAGO– Screening infants with a port-wine stain for Sturge-Weber syndrome (SWS) with a magnetic resonance imaging brain scan had a 23% false-negative rate and actually delayed seizure detection, according to a recent study.

When infants with port-wine stains receive a dermatology consult, they may also be screened for SWS by means of MRI and by electroencephalography, particularly if their lesion phenotype puts them at higher risk for SWS. But the accuracy and benefit of the screenings has not been well established, said Michaela Zallmann, MD, the study’s first author. Hemifacial lesions that involve both the forehead and cheek and median lesions that are centered around the facial midline are both considered high-risk lesions.

Dr. Zallmann, a dermatologist at Monash University and the Royal Children’s Hospital, Melbourne, and her coinvestigators examined data on 126 patients with facial port-wine stains who came to a laser clinic over a 12-month period. Of these, 32 (25.4%) had a high-risk port-wine stain, and 9 of those 32 (28.1%) had a capillary-venous malformation characteristic of SWS. Of the high-risk patients, 14 received a screening MRI or EEG before having had a first seizure. Of those 14 scans, 1 resulted in a diagnosis of SWS; of the 13 patients with a negative MRI screen, 3 (23.1%) were later found to have SWS when their parents or caregivers detected seizures. Thus, a total of four of the high-risk infants who were screened eventually were diagnosed with SWS.

Of the 18 high-risk patients who did not receive a screening MRI, 3 (16.7%) developed seizures, while 2 (11.1%) were seizure free but developed glaucoma severe enough to require treatment. One patient who was also seizure free developed an autism spectrum disorder.

Two patients who were in the high-risk group received screening EEGs that detected abnormalities that were not yet clinically evident. These included sub-clinical seizures and posterior-quadrant focal slowing. Both of these patients had initial negative screening MRIs.

Scanning early in life, using inappropriate imaging protocols, and having an inexperienced radiologist were all factors associated with a higher probability of false negative screening MRI, according to the researchers’ analysis, which was presented in a poster session at the World Congress of Pediatric Dermatology.

All of the false negative MRIs in the study cohort were conducted in infants younger than 9 weeks old. But whether it is useful to reserve imaging for later in infancy is debatable. “While later imaging may have improved sensitivity, 75% of infants with SWS will have already had their first seizure by 12 months of age,” wrote Dr. Zallmann and her colleagues.

Of the infants involved in the study, two of the three patients with false negative scans did not receive a referral to a neurologist, nor did their parents receive seizure education. “False reassurance may delay seizure detection,” Dr. Zallmann said.

For infants with positive MRIs who went on to develop seizures, the mean age of when they experienced their first documented seizure was 10 weeks. For those who did not receive an MRI, the mean age was 14 months, compared with 28 months for patients who had received a false negative MRI.

In discussing the findings, Dr. Zallmann and her colleagues made the point that early referral to a pediatric neurologist is important, especially for infants with the higher-risk port-wine stain patterns of hemifacial and median lesions. Seizure education can help parents detect the often subtle signs of seizures in infants with SWS, which can include staring spells, subtle limb twitching, and lip smacking.

The fact that seizures were detected an average of 14 months later in patients with negative screening MRIs may mean that such subtle signs were missed. “False reassurance may delay the recognition and treatment of seizures and impact neurodevelopmental outcomes,” Dr. Zallmann and her colleagues wrote in the abstract that accompanied the poster.

The study, while small, helps fill in some knowledge gaps, the researchers pointed out; they noted that there is no consensus on what level or type of facial involvement warrants screening, which protocols are best for MRI and EEG, or even whether the screening will improve seizure detection or outcomes.

“Currently there is no evidence that screening improves neurodevelopmental outcomes,” they said. “Conversely, there is a role for early neurological referral, symptom education, and potentially of EEGs in the prevention of complications related to SWS.”

Dr. Zallmann reported no conflicts of interest.
 

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event

 

CHICAGO– Screening infants with a port-wine stain for Sturge-Weber syndrome (SWS) with a magnetic resonance imaging brain scan had a 23% false-negative rate and actually delayed seizure detection, according to a recent study.

When infants with port-wine stains receive a dermatology consult, they may also be screened for SWS by means of MRI and by electroencephalography, particularly if their lesion phenotype puts them at higher risk for SWS. But the accuracy and benefit of the screenings has not been well established, said Michaela Zallmann, MD, the study’s first author. Hemifacial lesions that involve both the forehead and cheek and median lesions that are centered around the facial midline are both considered high-risk lesions.

Dr. Zallmann, a dermatologist at Monash University and the Royal Children’s Hospital, Melbourne, and her coinvestigators examined data on 126 patients with facial port-wine stains who came to a laser clinic over a 12-month period. Of these, 32 (25.4%) had a high-risk port-wine stain, and 9 of those 32 (28.1%) had a capillary-venous malformation characteristic of SWS. Of the high-risk patients, 14 received a screening MRI or EEG before having had a first seizure. Of those 14 scans, 1 resulted in a diagnosis of SWS; of the 13 patients with a negative MRI screen, 3 (23.1%) were later found to have SWS when their parents or caregivers detected seizures. Thus, a total of four of the high-risk infants who were screened eventually were diagnosed with SWS.

Of the 18 high-risk patients who did not receive a screening MRI, 3 (16.7%) developed seizures, while 2 (11.1%) were seizure free but developed glaucoma severe enough to require treatment. One patient who was also seizure free developed an autism spectrum disorder.

Two patients who were in the high-risk group received screening EEGs that detected abnormalities that were not yet clinically evident. These included sub-clinical seizures and posterior-quadrant focal slowing. Both of these patients had initial negative screening MRIs.

Scanning early in life, using inappropriate imaging protocols, and having an inexperienced radiologist were all factors associated with a higher probability of false negative screening MRI, according to the researchers’ analysis, which was presented in a poster session at the World Congress of Pediatric Dermatology.

All of the false negative MRIs in the study cohort were conducted in infants younger than 9 weeks old. But whether it is useful to reserve imaging for later in infancy is debatable. “While later imaging may have improved sensitivity, 75% of infants with SWS will have already had their first seizure by 12 months of age,” wrote Dr. Zallmann and her colleagues.

Of the infants involved in the study, two of the three patients with false negative scans did not receive a referral to a neurologist, nor did their parents receive seizure education. “False reassurance may delay seizure detection,” Dr. Zallmann said.

For infants with positive MRIs who went on to develop seizures, the mean age of when they experienced their first documented seizure was 10 weeks. For those who did not receive an MRI, the mean age was 14 months, compared with 28 months for patients who had received a false negative MRI.

In discussing the findings, Dr. Zallmann and her colleagues made the point that early referral to a pediatric neurologist is important, especially for infants with the higher-risk port-wine stain patterns of hemifacial and median lesions. Seizure education can help parents detect the often subtle signs of seizures in infants with SWS, which can include staring spells, subtle limb twitching, and lip smacking.

The fact that seizures were detected an average of 14 months later in patients with negative screening MRIs may mean that such subtle signs were missed. “False reassurance may delay the recognition and treatment of seizures and impact neurodevelopmental outcomes,” Dr. Zallmann and her colleagues wrote in the abstract that accompanied the poster.

The study, while small, helps fill in some knowledge gaps, the researchers pointed out; they noted that there is no consensus on what level or type of facial involvement warrants screening, which protocols are best for MRI and EEG, or even whether the screening will improve seizure detection or outcomes.

“Currently there is no evidence that screening improves neurodevelopmental outcomes,” they said. “Conversely, there is a role for early neurological referral, symptom education, and potentially of EEGs in the prevention of complications related to SWS.”

Dr. Zallmann reported no conflicts of interest.
 

 

CHICAGO– Screening infants with a port-wine stain for Sturge-Weber syndrome (SWS) with a magnetic resonance imaging brain scan had a 23% false-negative rate and actually delayed seizure detection, according to a recent study.

When infants with port-wine stains receive a dermatology consult, they may also be screened for SWS by means of MRI and by electroencephalography, particularly if their lesion phenotype puts them at higher risk for SWS. But the accuracy and benefit of the screenings has not been well established, said Michaela Zallmann, MD, the study’s first author. Hemifacial lesions that involve both the forehead and cheek and median lesions that are centered around the facial midline are both considered high-risk lesions.

Dr. Zallmann, a dermatologist at Monash University and the Royal Children’s Hospital, Melbourne, and her coinvestigators examined data on 126 patients with facial port-wine stains who came to a laser clinic over a 12-month period. Of these, 32 (25.4%) had a high-risk port-wine stain, and 9 of those 32 (28.1%) had a capillary-venous malformation characteristic of SWS. Of the high-risk patients, 14 received a screening MRI or EEG before having had a first seizure. Of those 14 scans, 1 resulted in a diagnosis of SWS; of the 13 patients with a negative MRI screen, 3 (23.1%) were later found to have SWS when their parents or caregivers detected seizures. Thus, a total of four of the high-risk infants who were screened eventually were diagnosed with SWS.

Of the 18 high-risk patients who did not receive a screening MRI, 3 (16.7%) developed seizures, while 2 (11.1%) were seizure free but developed glaucoma severe enough to require treatment. One patient who was also seizure free developed an autism spectrum disorder.

Two patients who were in the high-risk group received screening EEGs that detected abnormalities that were not yet clinically evident. These included sub-clinical seizures and posterior-quadrant focal slowing. Both of these patients had initial negative screening MRIs.

Scanning early in life, using inappropriate imaging protocols, and having an inexperienced radiologist were all factors associated with a higher probability of false negative screening MRI, according to the researchers’ analysis, which was presented in a poster session at the World Congress of Pediatric Dermatology.

All of the false negative MRIs in the study cohort were conducted in infants younger than 9 weeks old. But whether it is useful to reserve imaging for later in infancy is debatable. “While later imaging may have improved sensitivity, 75% of infants with SWS will have already had their first seizure by 12 months of age,” wrote Dr. Zallmann and her colleagues.

Of the infants involved in the study, two of the three patients with false negative scans did not receive a referral to a neurologist, nor did their parents receive seizure education. “False reassurance may delay seizure detection,” Dr. Zallmann said.

For infants with positive MRIs who went on to develop seizures, the mean age of when they experienced their first documented seizure was 10 weeks. For those who did not receive an MRI, the mean age was 14 months, compared with 28 months for patients who had received a false negative MRI.

In discussing the findings, Dr. Zallmann and her colleagues made the point that early referral to a pediatric neurologist is important, especially for infants with the higher-risk port-wine stain patterns of hemifacial and median lesions. Seizure education can help parents detect the often subtle signs of seizures in infants with SWS, which can include staring spells, subtle limb twitching, and lip smacking.

The fact that seizures were detected an average of 14 months later in patients with negative screening MRIs may mean that such subtle signs were missed. “False reassurance may delay the recognition and treatment of seizures and impact neurodevelopmental outcomes,” Dr. Zallmann and her colleagues wrote in the abstract that accompanied the poster.

The study, while small, helps fill in some knowledge gaps, the researchers pointed out; they noted that there is no consensus on what level or type of facial involvement warrants screening, which protocols are best for MRI and EEG, or even whether the screening will improve seizure detection or outcomes.

“Currently there is no evidence that screening improves neurodevelopmental outcomes,” they said. “Conversely, there is a role for early neurological referral, symptom education, and potentially of EEGs in the prevention of complications related to SWS.”

Dr. Zallmann reported no conflicts of interest.
 

Publications
Publications
Topics
Article Type
Click for Credit Status
Ready
Sections
Article Source

AT WCPD 2017

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Brain imaging screening often failed to detect Sturge-Weber syndrome and delayed seizure detection in infants with port-wine stain.

Major finding: Magnetic resonance imaging screening for Sturge-Weber syndrome resulted in a 23.2% false negative rate in babies with port-wine stain.

Data source: A review of screening and outcomes for 126 infants with port-wine stain seen in a laser clinic over a 12-month period. Disclosures: The lead author reported no disclosures.

Disqus Comments
Default

Wide variability found in invasive mediastinal staging rates for lung cancer

Article Type
Changed
Fri, 01/04/2019 - 13:39

 

– Significant variability exists between hospitals in Washington state in their rates of invasive mediastinal staging for lung cancer, Farhood Farjah, MD, reported at the annual meeting of the Western Thoracic Surgical Association.

“We found evidence of a fivefold variation in hospital-level rates of invasive mediastinal staging not explained by chance or case mix,” according to Dr. Farjah of the University of Washington, Seattle.

Dr. Farood Farjah
Prior studies from across the country have documented widespread underutilization of invasive mediastinal staging in situations where the staging is recommended in major guidelines such as those published by the National Comprehensive Cancer Network.

“This has led to substantial concerns about quality of thoracic surgical care in the community at large,” he noted.

The Washington study is the first to show hospital-by-hospital variation in rates of invasive mediastinal staging.

Invasive mediastinal staging for lung cancer is considered important because imaging is known to have a substantial false-negative rate, and staging results have a profound impact on treatment recommendations, which can range from surgery alone to additional chemoradiation therapy.

Yet the meaning of the hospital-level huge variability in practice observed in the Washington study remains unclear.

“Our understanding of the underutilization of invasive mediastinal staging is further complicated by the fact that patterns of invasive mediastinal staging are highly variable across hospitals staffed by at least one board-certified thoracic surgeon with a noncardiac practice,” Dr. Farjah explained. “This variability could be a marker of poor-quality care. However, because the guidelines are not supported by level 1 evidence, it’s equally plausible that this variability might represent uncertainty or even disagreement with the practice guidelines – and specifically about the appropriate indication for invasive staging.”

He presented a retrospective cohort study of 406 patients whose non–small cell lung cancer was resected during July 2011–December 2013 at one of five Washington hospitals, each with at least one board-certified thoracic surgeon with a noncardiac practice on staff. The four participating community hospitals and one academic medical center were involved in a National Cancer Institute–funded, physician-led quality improvement initiative.

Overall, 66% of the 406 patients underwent any form of invasive mediastinal staging: 85% by mediastinoscopy only; 12% by mediastinoscopy plus endobronchial ultrasound-guided nodal aspiration (EBUS); 3% by EBUS only; and the remaining handful by mediastinoscopy, EBUS, and esophageal ultrasound-guided nodal aspiration. The invasive staging was performed at the time of resection in 64% of cases. A median of three nodal stations were sampled.

After statistical adjustment for random variation and between-hospital differences in clinical stage, rates of invasive staging were all over the map. While an overall mean of 66% of the lung cancer patients underwent invasive mediastinal staging, the rates at the five hospitals were 94%, 84%, 31%, 80%, and 17%.

Dr. Farjah and his coinvestigators are now conducting provider interviews and focus groups in an effort to understand what drove the participating surgeons’ wide variability in performing invasive mediastinal staging.

Discussant Jane Yanagawa, MD, of the University of California, Los Angeles, commented, “I think this is a really interesting study because, historically, lower rates of mediastinoscopy are assumed to be a reflection of low-quality care – and you suggest that might not be the case, that it might be more complicated than that.”

Dr. Yanagawa sketched one fairly common scenario that might represent a surgeon’s reasonable avoidance of guideline-recommended invasive mediastinal staging: a patient who by all preoperative imaging appears to have stage IA lung cancer and wishes to avoid the morbidity, time, and cost of needle biopsy, instead choosing to go straight to the operating room for a diagnosis by wedge resection, followed by a completion lobectomy based upon the frozen section results. Could such a pathway account for the variability seen in the Washington study?

“I think it could have,” Dr. Farjah replied. “I would say that’s probably one driver of variability.”

As for the generalizability of the findings of a five-hospital study carried out in a single state, Dr. Farjah said he thinks the results are applicable to any academic or community hospital with at least one board-certified thoracic surgeon with a noncardiac practice.

He reported having no financial conflicts of interest regarding the study.

Body

M. Patricia Rivera, MD, FCCP, comments: Staging of lung cancer is essential to select the best treatment strategy for a given patient. However, despite multiple guideline recommendations

Dr. M. Patricia Rivera
for mediastinal staging, a significant number of stage IIIA NSCLC do not receive guideline-adherent mediastinal staging. This study highlights the marked variability in mediastinal staging that persists across clinical centers. Lower rates of mediastinal staging have been blamed on lack of board-certified thoracic surgeons with training in mediastinoscopy, but in this study, each center involved had at least one board-certified thoracic surgeon. Striking is that only a small percentage (15%) of patients in this study underwent staging with bronchoscopic ultrasound-guided needle aspiration. Given the high sensitivity and low invasiveness, ultrasound-guided staging modalities should be considered before surgical techniques for hilar and mediastinal staging. The “gold standard” of mediastinoscopy for invasive staging is challenged by ultrasound-guided techniques, which guidelines recommend to be the initial invasive test in most instances for which lymph node staging is required. This study underscores the importance of continual education and training of pulmonologists and thoracic surgeons in ultrasound-guided techniques in order to improve mediastinal staging application and accuracy.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event
Related Articles
Body

M. Patricia Rivera, MD, FCCP, comments: Staging of lung cancer is essential to select the best treatment strategy for a given patient. However, despite multiple guideline recommendations

Dr. M. Patricia Rivera
for mediastinal staging, a significant number of stage IIIA NSCLC do not receive guideline-adherent mediastinal staging. This study highlights the marked variability in mediastinal staging that persists across clinical centers. Lower rates of mediastinal staging have been blamed on lack of board-certified thoracic surgeons with training in mediastinoscopy, but in this study, each center involved had at least one board-certified thoracic surgeon. Striking is that only a small percentage (15%) of patients in this study underwent staging with bronchoscopic ultrasound-guided needle aspiration. Given the high sensitivity and low invasiveness, ultrasound-guided staging modalities should be considered before surgical techniques for hilar and mediastinal staging. The “gold standard” of mediastinoscopy for invasive staging is challenged by ultrasound-guided techniques, which guidelines recommend to be the initial invasive test in most instances for which lymph node staging is required. This study underscores the importance of continual education and training of pulmonologists and thoracic surgeons in ultrasound-guided techniques in order to improve mediastinal staging application and accuracy.

Body

M. Patricia Rivera, MD, FCCP, comments: Staging of lung cancer is essential to select the best treatment strategy for a given patient. However, despite multiple guideline recommendations

Dr. M. Patricia Rivera
for mediastinal staging, a significant number of stage IIIA NSCLC do not receive guideline-adherent mediastinal staging. This study highlights the marked variability in mediastinal staging that persists across clinical centers. Lower rates of mediastinal staging have been blamed on lack of board-certified thoracic surgeons with training in mediastinoscopy, but in this study, each center involved had at least one board-certified thoracic surgeon. Striking is that only a small percentage (15%) of patients in this study underwent staging with bronchoscopic ultrasound-guided needle aspiration. Given the high sensitivity and low invasiveness, ultrasound-guided staging modalities should be considered before surgical techniques for hilar and mediastinal staging. The “gold standard” of mediastinoscopy for invasive staging is challenged by ultrasound-guided techniques, which guidelines recommend to be the initial invasive test in most instances for which lymph node staging is required. This study underscores the importance of continual education and training of pulmonologists and thoracic surgeons in ultrasound-guided techniques in order to improve mediastinal staging application and accuracy.

 

– Significant variability exists between hospitals in Washington state in their rates of invasive mediastinal staging for lung cancer, Farhood Farjah, MD, reported at the annual meeting of the Western Thoracic Surgical Association.

“We found evidence of a fivefold variation in hospital-level rates of invasive mediastinal staging not explained by chance or case mix,” according to Dr. Farjah of the University of Washington, Seattle.

Dr. Farood Farjah
Prior studies from across the country have documented widespread underutilization of invasive mediastinal staging in situations where the staging is recommended in major guidelines such as those published by the National Comprehensive Cancer Network.

“This has led to substantial concerns about quality of thoracic surgical care in the community at large,” he noted.

The Washington study is the first to show hospital-by-hospital variation in rates of invasive mediastinal staging.

Invasive mediastinal staging for lung cancer is considered important because imaging is known to have a substantial false-negative rate, and staging results have a profound impact on treatment recommendations, which can range from surgery alone to additional chemoradiation therapy.

Yet the meaning of the hospital-level huge variability in practice observed in the Washington study remains unclear.

“Our understanding of the underutilization of invasive mediastinal staging is further complicated by the fact that patterns of invasive mediastinal staging are highly variable across hospitals staffed by at least one board-certified thoracic surgeon with a noncardiac practice,” Dr. Farjah explained. “This variability could be a marker of poor-quality care. However, because the guidelines are not supported by level 1 evidence, it’s equally plausible that this variability might represent uncertainty or even disagreement with the practice guidelines – and specifically about the appropriate indication for invasive staging.”

He presented a retrospective cohort study of 406 patients whose non–small cell lung cancer was resected during July 2011–December 2013 at one of five Washington hospitals, each with at least one board-certified thoracic surgeon with a noncardiac practice on staff. The four participating community hospitals and one academic medical center were involved in a National Cancer Institute–funded, physician-led quality improvement initiative.

Overall, 66% of the 406 patients underwent any form of invasive mediastinal staging: 85% by mediastinoscopy only; 12% by mediastinoscopy plus endobronchial ultrasound-guided nodal aspiration (EBUS); 3% by EBUS only; and the remaining handful by mediastinoscopy, EBUS, and esophageal ultrasound-guided nodal aspiration. The invasive staging was performed at the time of resection in 64% of cases. A median of three nodal stations were sampled.

After statistical adjustment for random variation and between-hospital differences in clinical stage, rates of invasive staging were all over the map. While an overall mean of 66% of the lung cancer patients underwent invasive mediastinal staging, the rates at the five hospitals were 94%, 84%, 31%, 80%, and 17%.

Dr. Farjah and his coinvestigators are now conducting provider interviews and focus groups in an effort to understand what drove the participating surgeons’ wide variability in performing invasive mediastinal staging.

Discussant Jane Yanagawa, MD, of the University of California, Los Angeles, commented, “I think this is a really interesting study because, historically, lower rates of mediastinoscopy are assumed to be a reflection of low-quality care – and you suggest that might not be the case, that it might be more complicated than that.”

Dr. Yanagawa sketched one fairly common scenario that might represent a surgeon’s reasonable avoidance of guideline-recommended invasive mediastinal staging: a patient who by all preoperative imaging appears to have stage IA lung cancer and wishes to avoid the morbidity, time, and cost of needle biopsy, instead choosing to go straight to the operating room for a diagnosis by wedge resection, followed by a completion lobectomy based upon the frozen section results. Could such a pathway account for the variability seen in the Washington study?

“I think it could have,” Dr. Farjah replied. “I would say that’s probably one driver of variability.”

As for the generalizability of the findings of a five-hospital study carried out in a single state, Dr. Farjah said he thinks the results are applicable to any academic or community hospital with at least one board-certified thoracic surgeon with a noncardiac practice.

He reported having no financial conflicts of interest regarding the study.

 

– Significant variability exists between hospitals in Washington state in their rates of invasive mediastinal staging for lung cancer, Farhood Farjah, MD, reported at the annual meeting of the Western Thoracic Surgical Association.

“We found evidence of a fivefold variation in hospital-level rates of invasive mediastinal staging not explained by chance or case mix,” according to Dr. Farjah of the University of Washington, Seattle.

Dr. Farood Farjah
Prior studies from across the country have documented widespread underutilization of invasive mediastinal staging in situations where the staging is recommended in major guidelines such as those published by the National Comprehensive Cancer Network.

“This has led to substantial concerns about quality of thoracic surgical care in the community at large,” he noted.

The Washington study is the first to show hospital-by-hospital variation in rates of invasive mediastinal staging.

Invasive mediastinal staging for lung cancer is considered important because imaging is known to have a substantial false-negative rate, and staging results have a profound impact on treatment recommendations, which can range from surgery alone to additional chemoradiation therapy.

Yet the meaning of the hospital-level huge variability in practice observed in the Washington study remains unclear.

“Our understanding of the underutilization of invasive mediastinal staging is further complicated by the fact that patterns of invasive mediastinal staging are highly variable across hospitals staffed by at least one board-certified thoracic surgeon with a noncardiac practice,” Dr. Farjah explained. “This variability could be a marker of poor-quality care. However, because the guidelines are not supported by level 1 evidence, it’s equally plausible that this variability might represent uncertainty or even disagreement with the practice guidelines – and specifically about the appropriate indication for invasive staging.”

He presented a retrospective cohort study of 406 patients whose non–small cell lung cancer was resected during July 2011–December 2013 at one of five Washington hospitals, each with at least one board-certified thoracic surgeon with a noncardiac practice on staff. The four participating community hospitals and one academic medical center were involved in a National Cancer Institute–funded, physician-led quality improvement initiative.

Overall, 66% of the 406 patients underwent any form of invasive mediastinal staging: 85% by mediastinoscopy only; 12% by mediastinoscopy plus endobronchial ultrasound-guided nodal aspiration (EBUS); 3% by EBUS only; and the remaining handful by mediastinoscopy, EBUS, and esophageal ultrasound-guided nodal aspiration. The invasive staging was performed at the time of resection in 64% of cases. A median of three nodal stations were sampled.

After statistical adjustment for random variation and between-hospital differences in clinical stage, rates of invasive staging were all over the map. While an overall mean of 66% of the lung cancer patients underwent invasive mediastinal staging, the rates at the five hospitals were 94%, 84%, 31%, 80%, and 17%.

Dr. Farjah and his coinvestigators are now conducting provider interviews and focus groups in an effort to understand what drove the participating surgeons’ wide variability in performing invasive mediastinal staging.

Discussant Jane Yanagawa, MD, of the University of California, Los Angeles, commented, “I think this is a really interesting study because, historically, lower rates of mediastinoscopy are assumed to be a reflection of low-quality care – and you suggest that might not be the case, that it might be more complicated than that.”

Dr. Yanagawa sketched one fairly common scenario that might represent a surgeon’s reasonable avoidance of guideline-recommended invasive mediastinal staging: a patient who by all preoperative imaging appears to have stage IA lung cancer and wishes to avoid the morbidity, time, and cost of needle biopsy, instead choosing to go straight to the operating room for a diagnosis by wedge resection, followed by a completion lobectomy based upon the frozen section results. Could such a pathway account for the variability seen in the Washington study?

“I think it could have,” Dr. Farjah replied. “I would say that’s probably one driver of variability.”

As for the generalizability of the findings of a five-hospital study carried out in a single state, Dr. Farjah said he thinks the results are applicable to any academic or community hospital with at least one board-certified thoracic surgeon with a noncardiac practice.

He reported having no financial conflicts of interest regarding the study.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT THE WTSA ANNUAL MEETING

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Hospital-level rates of invasive mediastinal staging for lung cancer varied more than fivefold in a Washington state study.

Major finding: Rates of invasive mediastinal staging after adjustment for clinical stage ranged from a low of 17% at one hospital to as high as 94% at another.

Data source: This retrospective cohort study included 406 patients.

Disclosures: Dr. Farjah reported having no financial conflicts of interest.

Disqus Comments
Default

TAVR for failed surgical valves: the VIVA study

Article Type
Changed
Tue, 12/04/2018 - 11:30

 

– Transcatheter aortic valve replacement using the self-expanding Evolut R device in high-surgical-risk patients with failing surgical aortic bioprostheses showed promising 30-day safety and effectiveness results in the ongoing VIVA study, Ran Kornowski, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“We had a lot of patients with small, failing valves in this study. Despite this, our valve gradients postprocedure were very, very low. This means to me that this platform is very well suited to deal with valve-in-valve procedures in general and with small bioprosthetic valves in particular,” observed Dr. Kornowski, chairman of the department of cardiology at Rabin Medical Center in Petah Tikva, Israel, and president of the Israel Heart Society.

Bruce Jancin/Frontline Medical News
Dr. Ran Kornowski
The ongoing VIVA (Valve In Valve) study is a formal prospective observational study of the less invasive valve-in-valve transcatheter procedure as an emerging alternative in the growing number of patients whose surgical bioprosthetic aortic valves are degenerating over time but who are not reasonable candidates for redo open surgery. VIVA is a 23-site, four-nation study of 202 such patients at high surgical risk as evidenced by a Society of Thoracic Surgeons predicted risk of mortality score of at least 10% or a logistic EuroSCORE greater than 20%. Of them, 183 underwent transcatheter aortic valve replacement (TAVR) with the FDA-approved repositionable Evolut R valve and, early on, 19 others received the device’s predecessor, the CoreValve.

The participants’ last surgical aortic valve replacement had been a mean of 9.3 years earlier. Seventy-one percent of subjects were New York Heart Association class III or IV. The mode of bioprosthetic failure was stenosis in 56% of cases, regurgitation in 23%, and both in the remainder. Ninety-three percent of their failing biosprothetic valves were stented devices. Forty-one percent of the devices were up to 21 mm and another 33% were more than 21 but less than 25 mm.

TAVR procedural access was by the iliofemoral route in 97% of cases. Local anesthesia was used in 42% of cases and conscious sedation in 35%. Fourteen percent of patients underwent preimplantation valvuloplasty; 21% postimplantation valvuloplasty. The procedural success rate was 98.5%.

The primary safety endpoint was 30-day cardiovascular mortality. The 2.0% rate was far lower than the prespecified cutoff which defined a positive outcome as less than a 10% rate in this high-surgical-risk population.

Other key 30-day outcomes:

• All-cause mortality occurred in 2.5% of patients.

• The 30-day stroke rate was 3%, with no disabling strokes.

• Major vascular complications occurred in 6.5% of the VIVA patients.

• Major bleeding occurred in 7%, minor bleeding in 7.9%. There were no cases of life-threatening bleeding.

• The incidence of Stage I acute kidney injury was rare, at 0.5%.

• Seven percent of patients received a permanent pacemaker.

• Eighty-seven percent of patients had no postprocedure paravalvular regurgitation (PVR), 11.4 had mild PVR, and 1.5% had moderate PVR.

• NYHA classification improved from baseline to 30 days in 81% of patients. At 30 days, 93% of participants were NYHA class I or II.

Turning to echocardiographic findings, the mean gradient improved from a mean baseline of 31.8 mm Hg to 12.6 mm Hg, while the effective orifice area rose from 1.0 to 1.5 cm2. The magnitude of both improvements was greater for patients with stenosis as their mode of valve failure.

“With the Evolut R, we aim for higher implantations – not more than about 4 mm below the ring – because going deeper could bring about higher gradients and functional deterioration later on,” the cardiologist explained.

The 1-year primary efficacy endpoint – lack of significant aortic stenosis as defined by a mean gradient less than 40 mm Hg – will be reported soon. The VIVA study is sponsored by Medtronic. Dr. Kornowski reported serving as a consultant to the company.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event
Related Articles

 

– Transcatheter aortic valve replacement using the self-expanding Evolut R device in high-surgical-risk patients with failing surgical aortic bioprostheses showed promising 30-day safety and effectiveness results in the ongoing VIVA study, Ran Kornowski, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“We had a lot of patients with small, failing valves in this study. Despite this, our valve gradients postprocedure were very, very low. This means to me that this platform is very well suited to deal with valve-in-valve procedures in general and with small bioprosthetic valves in particular,” observed Dr. Kornowski, chairman of the department of cardiology at Rabin Medical Center in Petah Tikva, Israel, and president of the Israel Heart Society.

Bruce Jancin/Frontline Medical News
Dr. Ran Kornowski
The ongoing VIVA (Valve In Valve) study is a formal prospective observational study of the less invasive valve-in-valve transcatheter procedure as an emerging alternative in the growing number of patients whose surgical bioprosthetic aortic valves are degenerating over time but who are not reasonable candidates for redo open surgery. VIVA is a 23-site, four-nation study of 202 such patients at high surgical risk as evidenced by a Society of Thoracic Surgeons predicted risk of mortality score of at least 10% or a logistic EuroSCORE greater than 20%. Of them, 183 underwent transcatheter aortic valve replacement (TAVR) with the FDA-approved repositionable Evolut R valve and, early on, 19 others received the device’s predecessor, the CoreValve.

The participants’ last surgical aortic valve replacement had been a mean of 9.3 years earlier. Seventy-one percent of subjects were New York Heart Association class III or IV. The mode of bioprosthetic failure was stenosis in 56% of cases, regurgitation in 23%, and both in the remainder. Ninety-three percent of their failing biosprothetic valves were stented devices. Forty-one percent of the devices were up to 21 mm and another 33% were more than 21 but less than 25 mm.

TAVR procedural access was by the iliofemoral route in 97% of cases. Local anesthesia was used in 42% of cases and conscious sedation in 35%. Fourteen percent of patients underwent preimplantation valvuloplasty; 21% postimplantation valvuloplasty. The procedural success rate was 98.5%.

The primary safety endpoint was 30-day cardiovascular mortality. The 2.0% rate was far lower than the prespecified cutoff which defined a positive outcome as less than a 10% rate in this high-surgical-risk population.

Other key 30-day outcomes:

• All-cause mortality occurred in 2.5% of patients.

• The 30-day stroke rate was 3%, with no disabling strokes.

• Major vascular complications occurred in 6.5% of the VIVA patients.

• Major bleeding occurred in 7%, minor bleeding in 7.9%. There were no cases of life-threatening bleeding.

• The incidence of Stage I acute kidney injury was rare, at 0.5%.

• Seven percent of patients received a permanent pacemaker.

• Eighty-seven percent of patients had no postprocedure paravalvular regurgitation (PVR), 11.4 had mild PVR, and 1.5% had moderate PVR.

• NYHA classification improved from baseline to 30 days in 81% of patients. At 30 days, 93% of participants were NYHA class I or II.

Turning to echocardiographic findings, the mean gradient improved from a mean baseline of 31.8 mm Hg to 12.6 mm Hg, while the effective orifice area rose from 1.0 to 1.5 cm2. The magnitude of both improvements was greater for patients with stenosis as their mode of valve failure.

“With the Evolut R, we aim for higher implantations – not more than about 4 mm below the ring – because going deeper could bring about higher gradients and functional deterioration later on,” the cardiologist explained.

The 1-year primary efficacy endpoint – lack of significant aortic stenosis as defined by a mean gradient less than 40 mm Hg – will be reported soon. The VIVA study is sponsored by Medtronic. Dr. Kornowski reported serving as a consultant to the company.

 

– Transcatheter aortic valve replacement using the self-expanding Evolut R device in high-surgical-risk patients with failing surgical aortic bioprostheses showed promising 30-day safety and effectiveness results in the ongoing VIVA study, Ran Kornowski, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“We had a lot of patients with small, failing valves in this study. Despite this, our valve gradients postprocedure were very, very low. This means to me that this platform is very well suited to deal with valve-in-valve procedures in general and with small bioprosthetic valves in particular,” observed Dr. Kornowski, chairman of the department of cardiology at Rabin Medical Center in Petah Tikva, Israel, and president of the Israel Heart Society.

Bruce Jancin/Frontline Medical News
Dr. Ran Kornowski
The ongoing VIVA (Valve In Valve) study is a formal prospective observational study of the less invasive valve-in-valve transcatheter procedure as an emerging alternative in the growing number of patients whose surgical bioprosthetic aortic valves are degenerating over time but who are not reasonable candidates for redo open surgery. VIVA is a 23-site, four-nation study of 202 such patients at high surgical risk as evidenced by a Society of Thoracic Surgeons predicted risk of mortality score of at least 10% or a logistic EuroSCORE greater than 20%. Of them, 183 underwent transcatheter aortic valve replacement (TAVR) with the FDA-approved repositionable Evolut R valve and, early on, 19 others received the device’s predecessor, the CoreValve.

The participants’ last surgical aortic valve replacement had been a mean of 9.3 years earlier. Seventy-one percent of subjects were New York Heart Association class III or IV. The mode of bioprosthetic failure was stenosis in 56% of cases, regurgitation in 23%, and both in the remainder. Ninety-three percent of their failing biosprothetic valves were stented devices. Forty-one percent of the devices were up to 21 mm and another 33% were more than 21 but less than 25 mm.

TAVR procedural access was by the iliofemoral route in 97% of cases. Local anesthesia was used in 42% of cases and conscious sedation in 35%. Fourteen percent of patients underwent preimplantation valvuloplasty; 21% postimplantation valvuloplasty. The procedural success rate was 98.5%.

The primary safety endpoint was 30-day cardiovascular mortality. The 2.0% rate was far lower than the prespecified cutoff which defined a positive outcome as less than a 10% rate in this high-surgical-risk population.

Other key 30-day outcomes:

• All-cause mortality occurred in 2.5% of patients.

• The 30-day stroke rate was 3%, with no disabling strokes.

• Major vascular complications occurred in 6.5% of the VIVA patients.

• Major bleeding occurred in 7%, minor bleeding in 7.9%. There were no cases of life-threatening bleeding.

• The incidence of Stage I acute kidney injury was rare, at 0.5%.

• Seven percent of patients received a permanent pacemaker.

• Eighty-seven percent of patients had no postprocedure paravalvular regurgitation (PVR), 11.4 had mild PVR, and 1.5% had moderate PVR.

• NYHA classification improved from baseline to 30 days in 81% of patients. At 30 days, 93% of participants were NYHA class I or II.

Turning to echocardiographic findings, the mean gradient improved from a mean baseline of 31.8 mm Hg to 12.6 mm Hg, while the effective orifice area rose from 1.0 to 1.5 cm2. The magnitude of both improvements was greater for patients with stenosis as their mode of valve failure.

“With the Evolut R, we aim for higher implantations – not more than about 4 mm below the ring – because going deeper could bring about higher gradients and functional deterioration later on,” the cardiologist explained.

The 1-year primary efficacy endpoint – lack of significant aortic stenosis as defined by a mean gradient less than 40 mm Hg – will be reported soon. The VIVA study is sponsored by Medtronic. Dr. Kornowski reported serving as a consultant to the company.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT EuroPCR

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Transcatheter valve-in-valve implantation of the Evolut R valve in high-surgical-risk patients with a failing aortic bioprosthesis was safe and effective in preliminary analysis of an ongoing study.

Major finding: The 30-day cardiovascular mortality rate after transcatheter aortic valve replacement via a valve-in-valve procedure in patients with a failing surgically implanted bioprosthesis was 2%, compared with a projected rate of at least 10% with redo surgery.

Data source: VIVA, a prospective observational registry of 202 high-surgical-risk patients at 23 centers in four countries who underwent valve-in-valve transcatheter aortic valve replacement because of a failing surgically implanted aortic bioprosthesis.

Disclosures: VIVA is sponsored by Medtronic. The presenter reported serving as a consultant to the company.

Disqus Comments
Default

Now boarding: How we can skip coach and bump our patients up to first class

Article Type
Changed
Fri, 01/18/2019 - 16:57

 

Cruising above the earth at 37,000 feet on the way back from vacation, my mind starts wandering. The impending reality of returning to work is setting in, and I can’t help but reflect on how the experience of a weary traveler trying to get home is like that of a weary patient trying to navigate modern health care. As it turns out, there are more than a few similarities, and that is not necessarily a good thing.

The modern airline industry is often cited by experts as a model for safety, efficiency, and innovation, though just a few decades ago this wasn’t the case. Several factors (for example, catastrophic crashes; the events of September 11th, 2001; the economic downturn) forced airlines to make radical improvements in how they operated – many of which I am quite thankful for as I gaze down upon America’s heartland from my window seat. Still, there are many who would say that in spite of (and sometimes because of) these improvements, air travel is the worst it’s ever been; airport lines are longer than ever, costs have steadily increased, and customer service has become little more than a quaint idea from a bygone era.

Dr. Chris Notte and Dr. Neil Skolnik
It occurs to me that these very same complaints could be leveled at the health care industry as well. We’ve focused on collecting data and improving outcomes. But costs continue to rise while patients are more frustrated and dissatisfied. It’s high time we examine our own industry through the eyes of a health care “traveler,” and consider how we can use technology to help navigate through the uncertainty and improve the patient experience.

Most people deride the frustrations of air travel yet accept them as normal. The same expectations have unfortunately been set in health care. Patients wait, though waiting only contributes to anxiety and leads them to question the quality of their care. They also expect their journey to have many layover stops, though these involve even more waiting and often unnecessary redundancy. We need to streamline the care delivery process, and this is where technology can help.

First of all, we need to address the waiting. In health care, we tend to call this “access,” an ever-present problem for patients and providers. Thankfully, some recent innovations have helped significantly. The first of these innovations is online scheduling, which allows patients to find openings and schedule visits without the need to pick up the phone. Much like the ability to book a dinner reservation online, this is becoming an expectation for health care consumers. Participating practices and health systems can also use it as a marketing advantage; it is a fantastic way to recruit new patients as they search for a new provider online (that is, seeing that a physician has immediate openings may make the decision easier).

There are several companies providing third-party online scheduling services, and many of these can interface directly with electronic health records. EHR vendors themselves also provide this functionality to existing patients through an online web portal or mobile app. Either way, if you haven’t considered it yet, you should. It’s a great way to fill last-minute schedule openings and increase your patient base, all while improving access and patient satisfaction.

Another way to improve access is through telemedicine. We’ve written about this in prior columns, but it has certainly become more prevalent and available since then. Now more insurers are reimbursing for telemedicine services, and consumers are starting to embrace it as well. Consider some advantages: it’s more convenient for patients and often less expensive for those without insurance – cash prices tend to be in the $50-$75 range. It can also be more convenient for providers, as the typical telemedicine visit lasts only about 10 minutes and can be easily fit in last-minute. Better still, telemedicine can be a way for providers to now be paid for services they might have previously provided for free by telephone. It is critical to choose patients and conditions appropriate for these “virtual visits.” Medication checks, lab follow-ups, or rash evaluations are just a few examples, but with a little bit of thought it is easy to find dozens of other opportunities to use telemedicine to improve access.

In addition to access, we need to look for ways to improve efficiency and decrease redundancy when sending patients for testing and consultations. Recently, I had the experience of visiting a specialist for a minor medical issue. In spite of the fact that the specialist was a member of the same health system as my PCP, I still spent the first 15 minutes of my visit filling out paperwork that requested information easily available from my health record. There must be a better way.

Patients are beginning to question why, in the world of ubiquitous social media and connectivity, our computerized medical records can’t communicate. This is especially true when they are seeing physicians who are part of the same health system (as in my case). Thankfully, vendors have gotten the message and have begun allowing providers to collaborate, not only with physicians using the same software, but also with those using other EHRs through Health Information Exchanges (HIEs). Unfortunately, this alone won’t be enough. We must continue to promote the notion of patient-owned medical records, as that will be the only way to ensure true patient-centered care. In a future column, we’ll explore this concept in greater detail, but for now we’ll confirm our belief that universal interoperability is reasonable and possible.

As we are getting ready to land, I reflect on the wonderful vacation I just had and the tasks ahead at home, most of which I enjoy. Patients aren’t always as lucky; they are accessing medical care because they have to, not because they want to. Their “destination” is all too often an unfortunate diagnosis, unexpected surgical procedure, or lifetime of chronic discomfort. It is therefore incumbent on us, their care providers, to use the tools at our disposal to offer them the most efficient, most comfortable, and most connected journey possible.

 

 

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.

Publications
Topics
Sections

 

Cruising above the earth at 37,000 feet on the way back from vacation, my mind starts wandering. The impending reality of returning to work is setting in, and I can’t help but reflect on how the experience of a weary traveler trying to get home is like that of a weary patient trying to navigate modern health care. As it turns out, there are more than a few similarities, and that is not necessarily a good thing.

The modern airline industry is often cited by experts as a model for safety, efficiency, and innovation, though just a few decades ago this wasn’t the case. Several factors (for example, catastrophic crashes; the events of September 11th, 2001; the economic downturn) forced airlines to make radical improvements in how they operated – many of which I am quite thankful for as I gaze down upon America’s heartland from my window seat. Still, there are many who would say that in spite of (and sometimes because of) these improvements, air travel is the worst it’s ever been; airport lines are longer than ever, costs have steadily increased, and customer service has become little more than a quaint idea from a bygone era.

Dr. Chris Notte and Dr. Neil Skolnik
It occurs to me that these very same complaints could be leveled at the health care industry as well. We’ve focused on collecting data and improving outcomes. But costs continue to rise while patients are more frustrated and dissatisfied. It’s high time we examine our own industry through the eyes of a health care “traveler,” and consider how we can use technology to help navigate through the uncertainty and improve the patient experience.

Most people deride the frustrations of air travel yet accept them as normal. The same expectations have unfortunately been set in health care. Patients wait, though waiting only contributes to anxiety and leads them to question the quality of their care. They also expect their journey to have many layover stops, though these involve even more waiting and often unnecessary redundancy. We need to streamline the care delivery process, and this is where technology can help.

First of all, we need to address the waiting. In health care, we tend to call this “access,” an ever-present problem for patients and providers. Thankfully, some recent innovations have helped significantly. The first of these innovations is online scheduling, which allows patients to find openings and schedule visits without the need to pick up the phone. Much like the ability to book a dinner reservation online, this is becoming an expectation for health care consumers. Participating practices and health systems can also use it as a marketing advantage; it is a fantastic way to recruit new patients as they search for a new provider online (that is, seeing that a physician has immediate openings may make the decision easier).

There are several companies providing third-party online scheduling services, and many of these can interface directly with electronic health records. EHR vendors themselves also provide this functionality to existing patients through an online web portal or mobile app. Either way, if you haven’t considered it yet, you should. It’s a great way to fill last-minute schedule openings and increase your patient base, all while improving access and patient satisfaction.

Another way to improve access is through telemedicine. We’ve written about this in prior columns, but it has certainly become more prevalent and available since then. Now more insurers are reimbursing for telemedicine services, and consumers are starting to embrace it as well. Consider some advantages: it’s more convenient for patients and often less expensive for those without insurance – cash prices tend to be in the $50-$75 range. It can also be more convenient for providers, as the typical telemedicine visit lasts only about 10 minutes and can be easily fit in last-minute. Better still, telemedicine can be a way for providers to now be paid for services they might have previously provided for free by telephone. It is critical to choose patients and conditions appropriate for these “virtual visits.” Medication checks, lab follow-ups, or rash evaluations are just a few examples, but with a little bit of thought it is easy to find dozens of other opportunities to use telemedicine to improve access.

In addition to access, we need to look for ways to improve efficiency and decrease redundancy when sending patients for testing and consultations. Recently, I had the experience of visiting a specialist for a minor medical issue. In spite of the fact that the specialist was a member of the same health system as my PCP, I still spent the first 15 minutes of my visit filling out paperwork that requested information easily available from my health record. There must be a better way.

Patients are beginning to question why, in the world of ubiquitous social media and connectivity, our computerized medical records can’t communicate. This is especially true when they are seeing physicians who are part of the same health system (as in my case). Thankfully, vendors have gotten the message and have begun allowing providers to collaborate, not only with physicians using the same software, but also with those using other EHRs through Health Information Exchanges (HIEs). Unfortunately, this alone won’t be enough. We must continue to promote the notion of patient-owned medical records, as that will be the only way to ensure true patient-centered care. In a future column, we’ll explore this concept in greater detail, but for now we’ll confirm our belief that universal interoperability is reasonable and possible.

As we are getting ready to land, I reflect on the wonderful vacation I just had and the tasks ahead at home, most of which I enjoy. Patients aren’t always as lucky; they are accessing medical care because they have to, not because they want to. Their “destination” is all too often an unfortunate diagnosis, unexpected surgical procedure, or lifetime of chronic discomfort. It is therefore incumbent on us, their care providers, to use the tools at our disposal to offer them the most efficient, most comfortable, and most connected journey possible.

 

 

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.

 

Cruising above the earth at 37,000 feet on the way back from vacation, my mind starts wandering. The impending reality of returning to work is setting in, and I can’t help but reflect on how the experience of a weary traveler trying to get home is like that of a weary patient trying to navigate modern health care. As it turns out, there are more than a few similarities, and that is not necessarily a good thing.

The modern airline industry is often cited by experts as a model for safety, efficiency, and innovation, though just a few decades ago this wasn’t the case. Several factors (for example, catastrophic crashes; the events of September 11th, 2001; the economic downturn) forced airlines to make radical improvements in how they operated – many of which I am quite thankful for as I gaze down upon America’s heartland from my window seat. Still, there are many who would say that in spite of (and sometimes because of) these improvements, air travel is the worst it’s ever been; airport lines are longer than ever, costs have steadily increased, and customer service has become little more than a quaint idea from a bygone era.

Dr. Chris Notte and Dr. Neil Skolnik
It occurs to me that these very same complaints could be leveled at the health care industry as well. We’ve focused on collecting data and improving outcomes. But costs continue to rise while patients are more frustrated and dissatisfied. It’s high time we examine our own industry through the eyes of a health care “traveler,” and consider how we can use technology to help navigate through the uncertainty and improve the patient experience.

Most people deride the frustrations of air travel yet accept them as normal. The same expectations have unfortunately been set in health care. Patients wait, though waiting only contributes to anxiety and leads them to question the quality of their care. They also expect their journey to have many layover stops, though these involve even more waiting and often unnecessary redundancy. We need to streamline the care delivery process, and this is where technology can help.

First of all, we need to address the waiting. In health care, we tend to call this “access,” an ever-present problem for patients and providers. Thankfully, some recent innovations have helped significantly. The first of these innovations is online scheduling, which allows patients to find openings and schedule visits without the need to pick up the phone. Much like the ability to book a dinner reservation online, this is becoming an expectation for health care consumers. Participating practices and health systems can also use it as a marketing advantage; it is a fantastic way to recruit new patients as they search for a new provider online (that is, seeing that a physician has immediate openings may make the decision easier).

There are several companies providing third-party online scheduling services, and many of these can interface directly with electronic health records. EHR vendors themselves also provide this functionality to existing patients through an online web portal or mobile app. Either way, if you haven’t considered it yet, you should. It’s a great way to fill last-minute schedule openings and increase your patient base, all while improving access and patient satisfaction.

Another way to improve access is through telemedicine. We’ve written about this in prior columns, but it has certainly become more prevalent and available since then. Now more insurers are reimbursing for telemedicine services, and consumers are starting to embrace it as well. Consider some advantages: it’s more convenient for patients and often less expensive for those without insurance – cash prices tend to be in the $50-$75 range. It can also be more convenient for providers, as the typical telemedicine visit lasts only about 10 minutes and can be easily fit in last-minute. Better still, telemedicine can be a way for providers to now be paid for services they might have previously provided for free by telephone. It is critical to choose patients and conditions appropriate for these “virtual visits.” Medication checks, lab follow-ups, or rash evaluations are just a few examples, but with a little bit of thought it is easy to find dozens of other opportunities to use telemedicine to improve access.

In addition to access, we need to look for ways to improve efficiency and decrease redundancy when sending patients for testing and consultations. Recently, I had the experience of visiting a specialist for a minor medical issue. In spite of the fact that the specialist was a member of the same health system as my PCP, I still spent the first 15 minutes of my visit filling out paperwork that requested information easily available from my health record. There must be a better way.

Patients are beginning to question why, in the world of ubiquitous social media and connectivity, our computerized medical records can’t communicate. This is especially true when they are seeing physicians who are part of the same health system (as in my case). Thankfully, vendors have gotten the message and have begun allowing providers to collaborate, not only with physicians using the same software, but also with those using other EHRs through Health Information Exchanges (HIEs). Unfortunately, this alone won’t be enough. We must continue to promote the notion of patient-owned medical records, as that will be the only way to ensure true patient-centered care. In a future column, we’ll explore this concept in greater detail, but for now we’ll confirm our belief that universal interoperability is reasonable and possible.

As we are getting ready to land, I reflect on the wonderful vacation I just had and the tasks ahead at home, most of which I enjoy. Patients aren’t always as lucky; they are accessing medical care because they have to, not because they want to. Their “destination” is all too often an unfortunate diagnosis, unexpected surgical procedure, or lifetime of chronic discomfort. It is therefore incumbent on us, their care providers, to use the tools at our disposal to offer them the most efficient, most comfortable, and most connected journey possible.

 

 

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Solitary Nodule With White Hairs

Article Type
Changed
Thu, 01/10/2019 - 13:44
Display Headline
Solitary Nodule With White Hairs

The Diagnosis: Trichofolliculoma

Microscopic examination revealed a dilated cystic follicle that communicated with the skin surface (Figure). The follicle was lined with squamous epithelium and surrounded by numerous secondary follicles, many of which contained a hair shaft. A diagnosis of trichofolliculoma was made.

Microscopic examination revealed a dilated cystic follicle that communicated with the skin surface (H&E, original magnification ×40).

Clinically, the differential diagnosis of a flesh-colored papule on the scalp with prominent follicle includes dilated pore of Winer, epidermoid cyst, pilar sheath acanthoma, and trichoepithelioma.1,2 Multiple hair shafts present in a single follicle may be seen in pili multigemini, tufted folliculitis, trichostasis spinulosa, and trichofolliculoma. On histopathologic examination, a dilated central follicle surrounded with smaller secondary follicles was identified, consistent with trichofolliculoma.

Trichofolliculoma is a rare follicular hamartoma typically occurring on the face, scalp, or trunk as a solitary papule or nodule due to the proliferation of abnormal hair follicle stem cells.3,4 It may present as a flesh-colored nodule with a central pore that may drain sebum or contain white vellus hairs. Trichofolliculoma is considered a benign entity, despite one case report of malignant transformation.5 Biopsy is diagnostic and no further treatment is needed. Recurrence rarely occurs at the primary site after surgical excision, which may be performed for cosmetic purposes or to alleviate functional impairment.

References
  1. Ghosh SK, Bandyopadhyay D, Barma KD. Perifollicular nodule on the face of a young man. Indian J Dermatol Venereol Leprol. 2011;77:531-533.  
  2. Gokalp H, Gurer MA, Alan S. Trichofolliculoma: a rare variant of hair follicle hamartoma. Dermatol Online J. 2013;19:19264.
  3. Choi CM, Lew BL, Sim WY. Multiple trichofolliculomas on unusual sites: a case report and review of the literature. Int J Dermatol. 2013;52:87-89.  
  4. Misago N, Kimura T, Toda S, et al. A revaluation of trichofolliculoma: the histopathological and immunohistochemical features. Am J Dermatopathol. 2010;32:35-43.
  5. Stem JB, Stout DA. Trichofolliculoma showing perineural invasion. trichofolliculocarcinoma? Arch Dermatol. 1979;115:1003-1004.
Article PDF
Author and Disclosure Information

Dr. Wetzel was from the University of Vermont, Burlington, and currently is from the Division of Dermatology, Department of Internal Medicine, University of Louisville School of Medicine, Kentucky. Drs. Gagnon and McDermott were from the University of Virginia, Charlottesville. Dr. Gagnon currently is from Dermatology PLC, Charlottesville and Orange, Virginia. Dr. McDermott currently is from the Department of Pathology and Laboratory Services, David Grant Medical Center, Fairfield, California.

The authors report no conflict of interest.

The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Air Force or the Department of Defense.

Correspondence: Megan Wetzel, MD, MPH, 3810 Springhurst Blvd, Louisville, KY 40241 ([email protected]). 

Issue
Cutis - 100(2)
Publications
Topics
Page Number
E1-E2
Sections
Author and Disclosure Information

Dr. Wetzel was from the University of Vermont, Burlington, and currently is from the Division of Dermatology, Department of Internal Medicine, University of Louisville School of Medicine, Kentucky. Drs. Gagnon and McDermott were from the University of Virginia, Charlottesville. Dr. Gagnon currently is from Dermatology PLC, Charlottesville and Orange, Virginia. Dr. McDermott currently is from the Department of Pathology and Laboratory Services, David Grant Medical Center, Fairfield, California.

The authors report no conflict of interest.

The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Air Force or the Department of Defense.

Correspondence: Megan Wetzel, MD, MPH, 3810 Springhurst Blvd, Louisville, KY 40241 ([email protected]). 

Author and Disclosure Information

Dr. Wetzel was from the University of Vermont, Burlington, and currently is from the Division of Dermatology, Department of Internal Medicine, University of Louisville School of Medicine, Kentucky. Drs. Gagnon and McDermott were from the University of Virginia, Charlottesville. Dr. Gagnon currently is from Dermatology PLC, Charlottesville and Orange, Virginia. Dr. McDermott currently is from the Department of Pathology and Laboratory Services, David Grant Medical Center, Fairfield, California.

The authors report no conflict of interest.

The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Air Force or the Department of Defense.

Correspondence: Megan Wetzel, MD, MPH, 3810 Springhurst Blvd, Louisville, KY 40241 ([email protected]). 

Article PDF
Article PDF
Related Articles

The Diagnosis: Trichofolliculoma

Microscopic examination revealed a dilated cystic follicle that communicated with the skin surface (Figure). The follicle was lined with squamous epithelium and surrounded by numerous secondary follicles, many of which contained a hair shaft. A diagnosis of trichofolliculoma was made.

Microscopic examination revealed a dilated cystic follicle that communicated with the skin surface (H&E, original magnification ×40).

Clinically, the differential diagnosis of a flesh-colored papule on the scalp with prominent follicle includes dilated pore of Winer, epidermoid cyst, pilar sheath acanthoma, and trichoepithelioma.1,2 Multiple hair shafts present in a single follicle may be seen in pili multigemini, tufted folliculitis, trichostasis spinulosa, and trichofolliculoma. On histopathologic examination, a dilated central follicle surrounded with smaller secondary follicles was identified, consistent with trichofolliculoma.

Trichofolliculoma is a rare follicular hamartoma typically occurring on the face, scalp, or trunk as a solitary papule or nodule due to the proliferation of abnormal hair follicle stem cells.3,4 It may present as a flesh-colored nodule with a central pore that may drain sebum or contain white vellus hairs. Trichofolliculoma is considered a benign entity, despite one case report of malignant transformation.5 Biopsy is diagnostic and no further treatment is needed. Recurrence rarely occurs at the primary site after surgical excision, which may be performed for cosmetic purposes or to alleviate functional impairment.

The Diagnosis: Trichofolliculoma

Microscopic examination revealed a dilated cystic follicle that communicated with the skin surface (Figure). The follicle was lined with squamous epithelium and surrounded by numerous secondary follicles, many of which contained a hair shaft. A diagnosis of trichofolliculoma was made.

Microscopic examination revealed a dilated cystic follicle that communicated with the skin surface (H&E, original magnification ×40).

Clinically, the differential diagnosis of a flesh-colored papule on the scalp with prominent follicle includes dilated pore of Winer, epidermoid cyst, pilar sheath acanthoma, and trichoepithelioma.1,2 Multiple hair shafts present in a single follicle may be seen in pili multigemini, tufted folliculitis, trichostasis spinulosa, and trichofolliculoma. On histopathologic examination, a dilated central follicle surrounded with smaller secondary follicles was identified, consistent with trichofolliculoma.

Trichofolliculoma is a rare follicular hamartoma typically occurring on the face, scalp, or trunk as a solitary papule or nodule due to the proliferation of abnormal hair follicle stem cells.3,4 It may present as a flesh-colored nodule with a central pore that may drain sebum or contain white vellus hairs. Trichofolliculoma is considered a benign entity, despite one case report of malignant transformation.5 Biopsy is diagnostic and no further treatment is needed. Recurrence rarely occurs at the primary site after surgical excision, which may be performed for cosmetic purposes or to alleviate functional impairment.

References
  1. Ghosh SK, Bandyopadhyay D, Barma KD. Perifollicular nodule on the face of a young man. Indian J Dermatol Venereol Leprol. 2011;77:531-533.  
  2. Gokalp H, Gurer MA, Alan S. Trichofolliculoma: a rare variant of hair follicle hamartoma. Dermatol Online J. 2013;19:19264.
  3. Choi CM, Lew BL, Sim WY. Multiple trichofolliculomas on unusual sites: a case report and review of the literature. Int J Dermatol. 2013;52:87-89.  
  4. Misago N, Kimura T, Toda S, et al. A revaluation of trichofolliculoma: the histopathological and immunohistochemical features. Am J Dermatopathol. 2010;32:35-43.
  5. Stem JB, Stout DA. Trichofolliculoma showing perineural invasion. trichofolliculocarcinoma? Arch Dermatol. 1979;115:1003-1004.
References
  1. Ghosh SK, Bandyopadhyay D, Barma KD. Perifollicular nodule on the face of a young man. Indian J Dermatol Venereol Leprol. 2011;77:531-533.  
  2. Gokalp H, Gurer MA, Alan S. Trichofolliculoma: a rare variant of hair follicle hamartoma. Dermatol Online J. 2013;19:19264.
  3. Choi CM, Lew BL, Sim WY. Multiple trichofolliculomas on unusual sites: a case report and review of the literature. Int J Dermatol. 2013;52:87-89.  
  4. Misago N, Kimura T, Toda S, et al. A revaluation of trichofolliculoma: the histopathological and immunohistochemical features. Am J Dermatopathol. 2010;32:35-43.
  5. Stem JB, Stout DA. Trichofolliculoma showing perineural invasion. trichofolliculocarcinoma? Arch Dermatol. 1979;115:1003-1004.
Issue
Cutis - 100(2)
Issue
Cutis - 100(2)
Page Number
E1-E2
Page Number
E1-E2
Publications
Publications
Topics
Article Type
Display Headline
Solitary Nodule With White Hairs
Display Headline
Solitary Nodule With White Hairs
Sections
Questionnaire Body

A 72-year-old man presented with a new asymptomatic 0.7-cm flesh-colored papule with a central tuft of white hairs on the posterior scalp. The remainder of the physical examination was unremarkable. Biopsy for histopathologic examination was performed to confirm diagnosis.

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
PubMed ID
28961295
Disqus Comments
Default
Article PDF Media

Campylobacteriosis incidence rises in U.S. from 2004 to 2012

Article Type
Changed
Fri, 01/18/2019 - 16:57

 

Incidence of campylobacteriosis increased significantly in the United States from 2004 to 2012, according to Aimee Geissler, PhD, and her associates.

A total of 303,520 cases of campylobacteriosis were reported during the study period, with the average incidence rate growing from 10.5 cases per 100,000 persons during 2004-2006 to 12.7 cases per 100,000 persons during 2010-2012, an increase of 21%. The median number of Camplyobacter outbreaks doubled from 28 during 2004-2006 to 56 during 2010-2012; in total, 347 outbreaks were reported. Campylobacteriosis is the nation’s most common bacterial diarrheal illness.

De Wood, Pooley, USDA, ARS, EMU/Wikimedia Commons/Public domain
Campylobacteriosis incidence rates were lowest in the South, and highest in the West, and increased in all regions, with the greatest increase seen in the South. Louisiana had the lowest average incidence rate, at 3.1 cases per 100,000 persons, and Hawaii had the highest, at 47.6 cases per 100,000 persons.

The study findings “underscore the importance of standardizing national surveillance for campylobacteriosis, which is important in understanding the burden of infection, better describing geographic variations and differences among species, elucidating risk factors, and targeting prevention and control measures,” the investigators concluded.

Find the full study in Clinical Infectious Diseases (2017 Jul 20. doi: 10.1093/cid/cix624).

Publications
Topics
Sections

 

Incidence of campylobacteriosis increased significantly in the United States from 2004 to 2012, according to Aimee Geissler, PhD, and her associates.

A total of 303,520 cases of campylobacteriosis were reported during the study period, with the average incidence rate growing from 10.5 cases per 100,000 persons during 2004-2006 to 12.7 cases per 100,000 persons during 2010-2012, an increase of 21%. The median number of Camplyobacter outbreaks doubled from 28 during 2004-2006 to 56 during 2010-2012; in total, 347 outbreaks were reported. Campylobacteriosis is the nation’s most common bacterial diarrheal illness.

De Wood, Pooley, USDA, ARS, EMU/Wikimedia Commons/Public domain
Campylobacteriosis incidence rates were lowest in the South, and highest in the West, and increased in all regions, with the greatest increase seen in the South. Louisiana had the lowest average incidence rate, at 3.1 cases per 100,000 persons, and Hawaii had the highest, at 47.6 cases per 100,000 persons.

The study findings “underscore the importance of standardizing national surveillance for campylobacteriosis, which is important in understanding the burden of infection, better describing geographic variations and differences among species, elucidating risk factors, and targeting prevention and control measures,” the investigators concluded.

Find the full study in Clinical Infectious Diseases (2017 Jul 20. doi: 10.1093/cid/cix624).

 

Incidence of campylobacteriosis increased significantly in the United States from 2004 to 2012, according to Aimee Geissler, PhD, and her associates.

A total of 303,520 cases of campylobacteriosis were reported during the study period, with the average incidence rate growing from 10.5 cases per 100,000 persons during 2004-2006 to 12.7 cases per 100,000 persons during 2010-2012, an increase of 21%. The median number of Camplyobacter outbreaks doubled from 28 during 2004-2006 to 56 during 2010-2012; in total, 347 outbreaks were reported. Campylobacteriosis is the nation’s most common bacterial diarrheal illness.

De Wood, Pooley, USDA, ARS, EMU/Wikimedia Commons/Public domain
Campylobacteriosis incidence rates were lowest in the South, and highest in the West, and increased in all regions, with the greatest increase seen in the South. Louisiana had the lowest average incidence rate, at 3.1 cases per 100,000 persons, and Hawaii had the highest, at 47.6 cases per 100,000 persons.

The study findings “underscore the importance of standardizing national surveillance for campylobacteriosis, which is important in understanding the burden of infection, better describing geographic variations and differences among species, elucidating risk factors, and targeting prevention and control measures,” the investigators concluded.

Find the full study in Clinical Infectious Diseases (2017 Jul 20. doi: 10.1093/cid/cix624).

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM CLINICAL INFECTIOUS DISEASES

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Crisis in psychiatry: Top 5 problems, many solutions

Article Type
Changed
Thu, 03/28/2019 - 14:48

 

Lack of access to psychiatric services has been a challenge for decades, resulting in significant delays to treatment with associated consequences in reduced quality of care, low patient satisfaction, poor patient outcomes, and higher costs.

The problem is exacerbated by a growing shortage of psychiatrists, an increased demand for psychiatric services, and inadequate payment rates. The result is a crisis that is resonating throughout the U.S. health care system.

As many know, a few months ago, the Medical Director Institute of the National Council for Behavioral Health, in partnership with the American Psychiatric Association, convened an expert panel to develop a report responding to this evolving quandary. The findings of our 60-page report, “The Psychiatric Shortage: Causes and Solutions,” suggest that psychiatry is uniquely positioned to address the issues that face our specialty.


The institute identified five areas of critical concern: workforce development, improved efficiency of service delivery, reducing burdensome regulations and confidentiality restrictions, broader implementation of innovative models, and adoption of novel reimbursement methods.

1. Workforce development

Psychiatrists come out of residency training without the skills they need to practice in today’s rapidly evolving health care environment. We need better preparation in measurement-based care, telepsychiatry, collaborative care, and other methods of efficient team collaboration with primary care.

Funding for graduate medical education and training programs must be expanded with an infusion of new funding – not only for psychiatrists – but also for psychiatric nurse practitioners and psychiatric physician assistants.

2. Improved efficiency of service delivery

Providers of psychiatric services in outpatient psychiatric programs face a cramped daily routine with increasingly briefer appointments scheduled back-to-back that limit in-depth clinical assessment, collaboration with other members of the treatment team, and consultation with primary care providers outside of the program. Such a schedule leads to lower-quality care.

Psychiatrists must have the same level of nurse and paraprofessional assistance and support provided to other medical specialties. In addition, regulations that prevent the broader use of telepsychiatry must be revised. All behavioral health providers should implement open access scheduling, a proven modality for reducing missed appointments.

3. Reducing burdensome regulations and confidentiality restrictions

Excessive documentation requirements, especially necessarily detailed, lengthy assessments and treatment must be revised and 42 CFR Part 2 must be made consistent with HIPAA requirements.

4. Broader implementation of innovative models

The shortage of psychiatrists will only worsen with the integration of primary care and behavioral health, and the shift to Accountable Care Organizations as part of health care reform (which, as of this writing, faces much uncertainty). Thanks to more efficient screening for mental health and substance use disorders now occurring in primary care, there will be growing demand for access to psychiatric services.

The collaborative care model for providing psychiatric services should be implemented throughout primary care. Behavioral health organizations must develop their own version of collaborative care that targets the limited psychiatric resource where it is most needed by using measurement-based care and collaborating more effectively with other team members.

5. Adoption of novel reimbursement methods

Inappropriately low rates limit access to care. Today, 40% of psychiatrists choose cash-only private practices, the second-highest among medical specialties after dermatologists, and 75% of provider organizations employing psychiatrists report that they lose money on their psychiatric services. At the same time, the shrinking number of inpatient psychiatric services has become a significant obstacle to improved access. Beds have been eliminated because of lower rates of reimbursement, compared with other medical-surgical procedures and difficulty in recruiting psychiatrists to staff inpatient units.

Psychiatric service rates must be reset to be consistent with the actual cost of providing care. Prospective payment models like Certified Community Behavioral Health Clinics should be expanded, and bundled payments for services like collaborative care and complex care should be covered by payers.

The Medical Director Institute recommends these solutions so that access to psychiatric services does not remain a barrier to the overall success of health care reform and service delivery improving the health of Americans. Multiple stakeholders – federal and state governments, payers, providers, provider trade associations, and advocates – must take action within their spheres of influence in the design, funding, regulation, and delivery of behavioral health care to improve access to psychiatric services. Such broad collaboration is imperative for our patients to get the care they need.

Dr. Parks is the medical director for the National Council for Behavioral Health. He practices psychiatry on an outpatient basis at Family Health Center, a federally funded community health center established to expand services to uninsured and underinsured patients in central Missouri. He also holds the position of Distinguished Research Professor of Science at the University of Missouri–St. Louis and is a clinical assistant professor of psychiatry at the University of Missouri–Columbia.

Publications
Topics
Sections

 

Lack of access to psychiatric services has been a challenge for decades, resulting in significant delays to treatment with associated consequences in reduced quality of care, low patient satisfaction, poor patient outcomes, and higher costs.

The problem is exacerbated by a growing shortage of psychiatrists, an increased demand for psychiatric services, and inadequate payment rates. The result is a crisis that is resonating throughout the U.S. health care system.

As many know, a few months ago, the Medical Director Institute of the National Council for Behavioral Health, in partnership with the American Psychiatric Association, convened an expert panel to develop a report responding to this evolving quandary. The findings of our 60-page report, “The Psychiatric Shortage: Causes and Solutions,” suggest that psychiatry is uniquely positioned to address the issues that face our specialty.


The institute identified five areas of critical concern: workforce development, improved efficiency of service delivery, reducing burdensome regulations and confidentiality restrictions, broader implementation of innovative models, and adoption of novel reimbursement methods.

1. Workforce development

Psychiatrists come out of residency training without the skills they need to practice in today’s rapidly evolving health care environment. We need better preparation in measurement-based care, telepsychiatry, collaborative care, and other methods of efficient team collaboration with primary care.

Funding for graduate medical education and training programs must be expanded with an infusion of new funding – not only for psychiatrists – but also for psychiatric nurse practitioners and psychiatric physician assistants.

2. Improved efficiency of service delivery

Providers of psychiatric services in outpatient psychiatric programs face a cramped daily routine with increasingly briefer appointments scheduled back-to-back that limit in-depth clinical assessment, collaboration with other members of the treatment team, and consultation with primary care providers outside of the program. Such a schedule leads to lower-quality care.

Psychiatrists must have the same level of nurse and paraprofessional assistance and support provided to other medical specialties. In addition, regulations that prevent the broader use of telepsychiatry must be revised. All behavioral health providers should implement open access scheduling, a proven modality for reducing missed appointments.

3. Reducing burdensome regulations and confidentiality restrictions

Excessive documentation requirements, especially necessarily detailed, lengthy assessments and treatment must be revised and 42 CFR Part 2 must be made consistent with HIPAA requirements.

4. Broader implementation of innovative models

The shortage of psychiatrists will only worsen with the integration of primary care and behavioral health, and the shift to Accountable Care Organizations as part of health care reform (which, as of this writing, faces much uncertainty). Thanks to more efficient screening for mental health and substance use disorders now occurring in primary care, there will be growing demand for access to psychiatric services.

The collaborative care model for providing psychiatric services should be implemented throughout primary care. Behavioral health organizations must develop their own version of collaborative care that targets the limited psychiatric resource where it is most needed by using measurement-based care and collaborating more effectively with other team members.

5. Adoption of novel reimbursement methods

Inappropriately low rates limit access to care. Today, 40% of psychiatrists choose cash-only private practices, the second-highest among medical specialties after dermatologists, and 75% of provider organizations employing psychiatrists report that they lose money on their psychiatric services. At the same time, the shrinking number of inpatient psychiatric services has become a significant obstacle to improved access. Beds have been eliminated because of lower rates of reimbursement, compared with other medical-surgical procedures and difficulty in recruiting psychiatrists to staff inpatient units.

Psychiatric service rates must be reset to be consistent with the actual cost of providing care. Prospective payment models like Certified Community Behavioral Health Clinics should be expanded, and bundled payments for services like collaborative care and complex care should be covered by payers.

The Medical Director Institute recommends these solutions so that access to psychiatric services does not remain a barrier to the overall success of health care reform and service delivery improving the health of Americans. Multiple stakeholders – federal and state governments, payers, providers, provider trade associations, and advocates – must take action within their spheres of influence in the design, funding, regulation, and delivery of behavioral health care to improve access to psychiatric services. Such broad collaboration is imperative for our patients to get the care they need.

Dr. Parks is the medical director for the National Council for Behavioral Health. He practices psychiatry on an outpatient basis at Family Health Center, a federally funded community health center established to expand services to uninsured and underinsured patients in central Missouri. He also holds the position of Distinguished Research Professor of Science at the University of Missouri–St. Louis and is a clinical assistant professor of psychiatry at the University of Missouri–Columbia.

 

Lack of access to psychiatric services has been a challenge for decades, resulting in significant delays to treatment with associated consequences in reduced quality of care, low patient satisfaction, poor patient outcomes, and higher costs.

The problem is exacerbated by a growing shortage of psychiatrists, an increased demand for psychiatric services, and inadequate payment rates. The result is a crisis that is resonating throughout the U.S. health care system.

As many know, a few months ago, the Medical Director Institute of the National Council for Behavioral Health, in partnership with the American Psychiatric Association, convened an expert panel to develop a report responding to this evolving quandary. The findings of our 60-page report, “The Psychiatric Shortage: Causes and Solutions,” suggest that psychiatry is uniquely positioned to address the issues that face our specialty.


The institute identified five areas of critical concern: workforce development, improved efficiency of service delivery, reducing burdensome regulations and confidentiality restrictions, broader implementation of innovative models, and adoption of novel reimbursement methods.

1. Workforce development

Psychiatrists come out of residency training without the skills they need to practice in today’s rapidly evolving health care environment. We need better preparation in measurement-based care, telepsychiatry, collaborative care, and other methods of efficient team collaboration with primary care.

Funding for graduate medical education and training programs must be expanded with an infusion of new funding – not only for psychiatrists – but also for psychiatric nurse practitioners and psychiatric physician assistants.

2. Improved efficiency of service delivery

Providers of psychiatric services in outpatient psychiatric programs face a cramped daily routine with increasingly briefer appointments scheduled back-to-back that limit in-depth clinical assessment, collaboration with other members of the treatment team, and consultation with primary care providers outside of the program. Such a schedule leads to lower-quality care.

Psychiatrists must have the same level of nurse and paraprofessional assistance and support provided to other medical specialties. In addition, regulations that prevent the broader use of telepsychiatry must be revised. All behavioral health providers should implement open access scheduling, a proven modality for reducing missed appointments.

3. Reducing burdensome regulations and confidentiality restrictions

Excessive documentation requirements, especially necessarily detailed, lengthy assessments and treatment must be revised and 42 CFR Part 2 must be made consistent with HIPAA requirements.

4. Broader implementation of innovative models

The shortage of psychiatrists will only worsen with the integration of primary care and behavioral health, and the shift to Accountable Care Organizations as part of health care reform (which, as of this writing, faces much uncertainty). Thanks to more efficient screening for mental health and substance use disorders now occurring in primary care, there will be growing demand for access to psychiatric services.

The collaborative care model for providing psychiatric services should be implemented throughout primary care. Behavioral health organizations must develop their own version of collaborative care that targets the limited psychiatric resource where it is most needed by using measurement-based care and collaborating more effectively with other team members.

5. Adoption of novel reimbursement methods

Inappropriately low rates limit access to care. Today, 40% of psychiatrists choose cash-only private practices, the second-highest among medical specialties after dermatologists, and 75% of provider organizations employing psychiatrists report that they lose money on their psychiatric services. At the same time, the shrinking number of inpatient psychiatric services has become a significant obstacle to improved access. Beds have been eliminated because of lower rates of reimbursement, compared with other medical-surgical procedures and difficulty in recruiting psychiatrists to staff inpatient units.

Psychiatric service rates must be reset to be consistent with the actual cost of providing care. Prospective payment models like Certified Community Behavioral Health Clinics should be expanded, and bundled payments for services like collaborative care and complex care should be covered by payers.

The Medical Director Institute recommends these solutions so that access to psychiatric services does not remain a barrier to the overall success of health care reform and service delivery improving the health of Americans. Multiple stakeholders – federal and state governments, payers, providers, provider trade associations, and advocates – must take action within their spheres of influence in the design, funding, regulation, and delivery of behavioral health care to improve access to psychiatric services. Such broad collaboration is imperative for our patients to get the care they need.

Dr. Parks is the medical director for the National Council for Behavioral Health. He practices psychiatry on an outpatient basis at Family Health Center, a federally funded community health center established to expand services to uninsured and underinsured patients in central Missouri. He also holds the position of Distinguished Research Professor of Science at the University of Missouri–St. Louis and is a clinical assistant professor of psychiatry at the University of Missouri–Columbia.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default

Bailout stenting for coronary bifurcations brings ‘unacceptable’ hazards

Comment by G. Hossein Almassi, MD, FCCP
Article Type
Changed
Wed, 01/02/2019 - 09:56

 

– Bailout stenting during percutaneous coronary intervention for coronary bifurcations doubled the risk of major adverse cardiovascular events in the world’s largest registry of patients with these often-challenging lesions treated using bioactive stents, Marco Zimarino, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Indeed, resort to bailout stenting stood out as the major potentially modifiable risk factor for adverse outcomes among the 4,306 participants in the P2BiTO registry, an international collaboration supported by members of the EuroBifurcation Club. Most of the other independent risk factors identified in a multivariate regression analysis of the P2BiTO database were beyond operator control, including diabetes, advanced age, and presentation with an acute coronary syndrome, according to Dr. Zimarino of the University of Chieti (Italy).

Dr. Marco Zimarino
“The message is that the relevant player in determining adverse outcomes is bailout stenting, meaning any stent deployed beyond the planned strategy of either single or double stenting,” he said.

Bailout stenting is largely avoidable through meticulous procedural planning, the interventional cardiologist added.

“Careful planning is always mandatory because bailout stenting is associated with an unacceptably higher risk of both in-hospital and 1-year adverse outcomes,” Dr. Zimarino emphasized. “It’s much better to leave a degraded side branch instead of using bailout stenting to get an excellent angiographic outcome that’s a predictor of a worse clinical outcome.”

Conventional wisdom holds that single stenting of either the main artery or a side branch in a patient with coronary bifurcation is safer than double stenting of both. However, that wasn’t really borne out in the P2BiTO registry provided the operator’s plan was for double stenting. The difference in 1-year major adverse cardiovascular events (MACE) between patients treated using a single- or double-stenting strategy wasn’t statistically significant, provided bailout stenting wasn’t utilized. If bailout stenting was employed, though, the risk of MACE was 2.2-fold greater than if the cardiologist stuck with the plan.

Ninety-eight percent of patients in the P2BiTO registry received drug-eluting stents. The other 2% got the Absorb bioabsorbable vascular scaffold. The percutaneous coronary intervention access site, treatment strategy, choice of stent, and duration of dual-antiplatelet therapy were left up to the operator’s discretion.

The 1-year MACE rate was 10%, including a 5.1% incidence of all-cause mortality, 3.2% cardiovascular mortality, 1.7% stroke, 3.4% acute MI excluding periprocedural MI, 2.5% stent thrombosis, and 1.7% Bleeding Academic Research Consortium type 3-5 bleeding. Bailout stenting was utilized in 8.8% of patients who experienced MACE and 4% of those who didn’t.

The risk of MACE was reduced by 39% in patients on dual-antiplatelet therapy for 6-12 months, compared with less than 6 months.

Discussant Graham Cassel, MD, director of the heart transplant unit at Milpark Hospital in Johannesburg, commented, “The message comes through very clearly that, if you plan your procedure well, the chance of bailout is far less – and if you do have to bail out, the results are uniformly bad. If you can avoid putting in two or three stents, that’s beneficial.”

Dr. Zimarino reported having no financial conflicts of interest regarding his presentation.

Body

Dr. Hossein Almassi
Dr. Hossein Almassi
The findings of this study suggest that a careful preplanning and adherence to the planned procedure is in the best interest of the patient.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event
Related Articles
Body

Dr. Hossein Almassi
Dr. Hossein Almassi
The findings of this study suggest that a careful preplanning and adherence to the planned procedure is in the best interest of the patient.

Body

Dr. Hossein Almassi
Dr. Hossein Almassi
The findings of this study suggest that a careful preplanning and adherence to the planned procedure is in the best interest of the patient.

Title
Comment by G. Hossein Almassi, MD, FCCP
Comment by G. Hossein Almassi, MD, FCCP

 

– Bailout stenting during percutaneous coronary intervention for coronary bifurcations doubled the risk of major adverse cardiovascular events in the world’s largest registry of patients with these often-challenging lesions treated using bioactive stents, Marco Zimarino, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Indeed, resort to bailout stenting stood out as the major potentially modifiable risk factor for adverse outcomes among the 4,306 participants in the P2BiTO registry, an international collaboration supported by members of the EuroBifurcation Club. Most of the other independent risk factors identified in a multivariate regression analysis of the P2BiTO database were beyond operator control, including diabetes, advanced age, and presentation with an acute coronary syndrome, according to Dr. Zimarino of the University of Chieti (Italy).

Dr. Marco Zimarino
“The message is that the relevant player in determining adverse outcomes is bailout stenting, meaning any stent deployed beyond the planned strategy of either single or double stenting,” he said.

Bailout stenting is largely avoidable through meticulous procedural planning, the interventional cardiologist added.

“Careful planning is always mandatory because bailout stenting is associated with an unacceptably higher risk of both in-hospital and 1-year adverse outcomes,” Dr. Zimarino emphasized. “It’s much better to leave a degraded side branch instead of using bailout stenting to get an excellent angiographic outcome that’s a predictor of a worse clinical outcome.”

Conventional wisdom holds that single stenting of either the main artery or a side branch in a patient with coronary bifurcation is safer than double stenting of both. However, that wasn’t really borne out in the P2BiTO registry provided the operator’s plan was for double stenting. The difference in 1-year major adverse cardiovascular events (MACE) between patients treated using a single- or double-stenting strategy wasn’t statistically significant, provided bailout stenting wasn’t utilized. If bailout stenting was employed, though, the risk of MACE was 2.2-fold greater than if the cardiologist stuck with the plan.

Ninety-eight percent of patients in the P2BiTO registry received drug-eluting stents. The other 2% got the Absorb bioabsorbable vascular scaffold. The percutaneous coronary intervention access site, treatment strategy, choice of stent, and duration of dual-antiplatelet therapy were left up to the operator’s discretion.

The 1-year MACE rate was 10%, including a 5.1% incidence of all-cause mortality, 3.2% cardiovascular mortality, 1.7% stroke, 3.4% acute MI excluding periprocedural MI, 2.5% stent thrombosis, and 1.7% Bleeding Academic Research Consortium type 3-5 bleeding. Bailout stenting was utilized in 8.8% of patients who experienced MACE and 4% of those who didn’t.

The risk of MACE was reduced by 39% in patients on dual-antiplatelet therapy for 6-12 months, compared with less than 6 months.

Discussant Graham Cassel, MD, director of the heart transplant unit at Milpark Hospital in Johannesburg, commented, “The message comes through very clearly that, if you plan your procedure well, the chance of bailout is far less – and if you do have to bail out, the results are uniformly bad. If you can avoid putting in two or three stents, that’s beneficial.”

Dr. Zimarino reported having no financial conflicts of interest regarding his presentation.

 

– Bailout stenting during percutaneous coronary intervention for coronary bifurcations doubled the risk of major adverse cardiovascular events in the world’s largest registry of patients with these often-challenging lesions treated using bioactive stents, Marco Zimarino, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

Indeed, resort to bailout stenting stood out as the major potentially modifiable risk factor for adverse outcomes among the 4,306 participants in the P2BiTO registry, an international collaboration supported by members of the EuroBifurcation Club. Most of the other independent risk factors identified in a multivariate regression analysis of the P2BiTO database were beyond operator control, including diabetes, advanced age, and presentation with an acute coronary syndrome, according to Dr. Zimarino of the University of Chieti (Italy).

Dr. Marco Zimarino
“The message is that the relevant player in determining adverse outcomes is bailout stenting, meaning any stent deployed beyond the planned strategy of either single or double stenting,” he said.

Bailout stenting is largely avoidable through meticulous procedural planning, the interventional cardiologist added.

“Careful planning is always mandatory because bailout stenting is associated with an unacceptably higher risk of both in-hospital and 1-year adverse outcomes,” Dr. Zimarino emphasized. “It’s much better to leave a degraded side branch instead of using bailout stenting to get an excellent angiographic outcome that’s a predictor of a worse clinical outcome.”

Conventional wisdom holds that single stenting of either the main artery or a side branch in a patient with coronary bifurcation is safer than double stenting of both. However, that wasn’t really borne out in the P2BiTO registry provided the operator’s plan was for double stenting. The difference in 1-year major adverse cardiovascular events (MACE) between patients treated using a single- or double-stenting strategy wasn’t statistically significant, provided bailout stenting wasn’t utilized. If bailout stenting was employed, though, the risk of MACE was 2.2-fold greater than if the cardiologist stuck with the plan.

Ninety-eight percent of patients in the P2BiTO registry received drug-eluting stents. The other 2% got the Absorb bioabsorbable vascular scaffold. The percutaneous coronary intervention access site, treatment strategy, choice of stent, and duration of dual-antiplatelet therapy were left up to the operator’s discretion.

The 1-year MACE rate was 10%, including a 5.1% incidence of all-cause mortality, 3.2% cardiovascular mortality, 1.7% stroke, 3.4% acute MI excluding periprocedural MI, 2.5% stent thrombosis, and 1.7% Bleeding Academic Research Consortium type 3-5 bleeding. Bailout stenting was utilized in 8.8% of patients who experienced MACE and 4% of those who didn’t.

The risk of MACE was reduced by 39% in patients on dual-antiplatelet therapy for 6-12 months, compared with less than 6 months.

Discussant Graham Cassel, MD, director of the heart transplant unit at Milpark Hospital in Johannesburg, commented, “The message comes through very clearly that, if you plan your procedure well, the chance of bailout is far less – and if you do have to bail out, the results are uniformly bad. If you can avoid putting in two or three stents, that’s beneficial.”

Dr. Zimarino reported having no financial conflicts of interest regarding his presentation.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT EUROPCR

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Avoid bailout stenting during PCI for coronary bifurcation lesions.

Major finding: Bailout stenting during PCI for coronary bifurcations doubles the risk of major adverse cardiovascular events.

Data source: The P2BiTO registry includes 4,306 patients who received one or more drug-eluting stents or bioabsorbable vascular scaffolds for treatment of coronary bifurcations.

Disclosures: The study presenter reported having no financial conflicts of interest.

Disqus Comments
Default

Revascularization of CTOs improves health status more than medical therapy

Article Type
Changed
Tue, 12/04/2018 - 11:30

 

– The first randomized clinical trial to evaluate quality of life and clinical symptoms as the primary efficacy outcome in patients with coronary chronic total occlusion (CTO) showed a clear advantage for percutaneous revascularization over optimal medical therapy.

At 12 months’ follow-up in the 26-site, 396-patient EuroCTO trial, patients randomized to PCI with drug-eluting stents had significantly less angina and physical limitations coupled with greater improvement in quality of life than the optimal medical therapy (OMT) group on subscales of the Seattle Angina Questionnaire. On the angina frequency subscale, for example, the PCI group improved from a mean baseline score of 77.2 to 91.4 at 12 months, a significantly better result than the OMT group improvement from 80.6 to 87.5.

The PCI group also experienced greater mobility, better activity status, and less pain and discomfort as assessed by the EuroQOL five dimensions questionnaire (EQ-5D), Gerald S. Werner, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“PCI of a CTO should be considered as a primary option in symptomatic patients. It is a safe and effective treatment option in expert hands,” said Dr. Werner, director of cardiology and nonsurgical intensive care at the Darmstadt (Ger.) Clinic.

He emphasized the point about “expert hands,” drawing attention to the stellar 86.3% successful revascularization rate in the EuroCTO trial, even though these were often complex procedures. Indeed, in 36% of the CTO PCIs, a retrograde approach was used.

“CTO is a special field. Just like not everybody in every hospital will do a transcatheter aortic valve replacement, not everybody should do a CTO. It can be done safely and to the benefit of the patient, but it needs to be done by someone with expertise,” the cardiologist said.

Study participants were evenly split between those with single- and multivessel disease. Patients with additional nonocclusive disease had those lesions treated by PCI before the 2:1 randomization to CTO PCI or OMT.

The periprocedural complication rate was low at 2.9%, a figure that included a 1.5% incidence of pericardial tamponade as well as vascular repairs. There were no periprocedural MIs or deaths. The 1-year major adverse cardiac event rate was roughly 6% in both study arms.

The PCI group received 6-12 months of dual-antiplatelet therapy with clopidogrel and aspirin. So did roughly 40% of the OMT group because of prior PCI.

Both study arms had comparably high rates of guideline-directed medical therapy, including statins, beta-blockers, and ACE inhibitors. However, the PCI group made significantly less use of nitrates than the OMT group during follow-up, reflecting their greater reduction in angina frequency. The crossover rate from OMT to PCI because of ongoing angina was 7.3%.

The long-term safety and durability of the two treatment strategies will be assessed at 3 years of follow-up.

The EuroCTO trial was originally planned for 600 patients. The investigators eventually settled for less because of slow enrollment. Many interventionalists who are skilled in treating CTOs proved reluctant to randomize the patients.

Dr. Werner contrasted the positive EuroCTO findings regarding clinical symptoms and quality of life to the negative results of the Korean DECISION CTO trial presented at the 2017 meeting of the American College of Cardiology. DECISION CTO found that PCI plus OMT wasn’t superior to OMT alone in reducing MI and other major adverse cardiac events in patients with at least one CTO. In Dr. Werner’s view, the Korean investigators chose the wrong endpoint.

“The quality of life improvement we’ve shown after PCI in EuroCTO is a valid clinical goal in treating stable coronary artery disease. I don’t think we can aim at improving prognosis,” according to Dr. Werner.

The impetus for EuroCTO was a recognition that CTOs are common and seriously undertreated. CTOs account for 16%-18% of all coronary lesions in patients with stable coronary artery disease, yet U.S. national data indicate only 5% of PCIs are performed to treat CTOs.

The EuroCTO trial was sponsored by the Euro CTO Club and supported by research grants from Biosensors and Asahi.

Meeting/Event
Publications
Topics
Sections
Meeting/Event
Meeting/Event
Related Articles

 

– The first randomized clinical trial to evaluate quality of life and clinical symptoms as the primary efficacy outcome in patients with coronary chronic total occlusion (CTO) showed a clear advantage for percutaneous revascularization over optimal medical therapy.

At 12 months’ follow-up in the 26-site, 396-patient EuroCTO trial, patients randomized to PCI with drug-eluting stents had significantly less angina and physical limitations coupled with greater improvement in quality of life than the optimal medical therapy (OMT) group on subscales of the Seattle Angina Questionnaire. On the angina frequency subscale, for example, the PCI group improved from a mean baseline score of 77.2 to 91.4 at 12 months, a significantly better result than the OMT group improvement from 80.6 to 87.5.

The PCI group also experienced greater mobility, better activity status, and less pain and discomfort as assessed by the EuroQOL five dimensions questionnaire (EQ-5D), Gerald S. Werner, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“PCI of a CTO should be considered as a primary option in symptomatic patients. It is a safe and effective treatment option in expert hands,” said Dr. Werner, director of cardiology and nonsurgical intensive care at the Darmstadt (Ger.) Clinic.

He emphasized the point about “expert hands,” drawing attention to the stellar 86.3% successful revascularization rate in the EuroCTO trial, even though these were often complex procedures. Indeed, in 36% of the CTO PCIs, a retrograde approach was used.

“CTO is a special field. Just like not everybody in every hospital will do a transcatheter aortic valve replacement, not everybody should do a CTO. It can be done safely and to the benefit of the patient, but it needs to be done by someone with expertise,” the cardiologist said.

Study participants were evenly split between those with single- and multivessel disease. Patients with additional nonocclusive disease had those lesions treated by PCI before the 2:1 randomization to CTO PCI or OMT.

The periprocedural complication rate was low at 2.9%, a figure that included a 1.5% incidence of pericardial tamponade as well as vascular repairs. There were no periprocedural MIs or deaths. The 1-year major adverse cardiac event rate was roughly 6% in both study arms.

The PCI group received 6-12 months of dual-antiplatelet therapy with clopidogrel and aspirin. So did roughly 40% of the OMT group because of prior PCI.

Both study arms had comparably high rates of guideline-directed medical therapy, including statins, beta-blockers, and ACE inhibitors. However, the PCI group made significantly less use of nitrates than the OMT group during follow-up, reflecting their greater reduction in angina frequency. The crossover rate from OMT to PCI because of ongoing angina was 7.3%.

The long-term safety and durability of the two treatment strategies will be assessed at 3 years of follow-up.

The EuroCTO trial was originally planned for 600 patients. The investigators eventually settled for less because of slow enrollment. Many interventionalists who are skilled in treating CTOs proved reluctant to randomize the patients.

Dr. Werner contrasted the positive EuroCTO findings regarding clinical symptoms and quality of life to the negative results of the Korean DECISION CTO trial presented at the 2017 meeting of the American College of Cardiology. DECISION CTO found that PCI plus OMT wasn’t superior to OMT alone in reducing MI and other major adverse cardiac events in patients with at least one CTO. In Dr. Werner’s view, the Korean investigators chose the wrong endpoint.

“The quality of life improvement we’ve shown after PCI in EuroCTO is a valid clinical goal in treating stable coronary artery disease. I don’t think we can aim at improving prognosis,” according to Dr. Werner.

The impetus for EuroCTO was a recognition that CTOs are common and seriously undertreated. CTOs account for 16%-18% of all coronary lesions in patients with stable coronary artery disease, yet U.S. national data indicate only 5% of PCIs are performed to treat CTOs.

The EuroCTO trial was sponsored by the Euro CTO Club and supported by research grants from Biosensors and Asahi.

 

– The first randomized clinical trial to evaluate quality of life and clinical symptoms as the primary efficacy outcome in patients with coronary chronic total occlusion (CTO) showed a clear advantage for percutaneous revascularization over optimal medical therapy.

At 12 months’ follow-up in the 26-site, 396-patient EuroCTO trial, patients randomized to PCI with drug-eluting stents had significantly less angina and physical limitations coupled with greater improvement in quality of life than the optimal medical therapy (OMT) group on subscales of the Seattle Angina Questionnaire. On the angina frequency subscale, for example, the PCI group improved from a mean baseline score of 77.2 to 91.4 at 12 months, a significantly better result than the OMT group improvement from 80.6 to 87.5.

The PCI group also experienced greater mobility, better activity status, and less pain and discomfort as assessed by the EuroQOL five dimensions questionnaire (EQ-5D), Gerald S. Werner, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“PCI of a CTO should be considered as a primary option in symptomatic patients. It is a safe and effective treatment option in expert hands,” said Dr. Werner, director of cardiology and nonsurgical intensive care at the Darmstadt (Ger.) Clinic.

He emphasized the point about “expert hands,” drawing attention to the stellar 86.3% successful revascularization rate in the EuroCTO trial, even though these were often complex procedures. Indeed, in 36% of the CTO PCIs, a retrograde approach was used.

“CTO is a special field. Just like not everybody in every hospital will do a transcatheter aortic valve replacement, not everybody should do a CTO. It can be done safely and to the benefit of the patient, but it needs to be done by someone with expertise,” the cardiologist said.

Study participants were evenly split between those with single- and multivessel disease. Patients with additional nonocclusive disease had those lesions treated by PCI before the 2:1 randomization to CTO PCI or OMT.

The periprocedural complication rate was low at 2.9%, a figure that included a 1.5% incidence of pericardial tamponade as well as vascular repairs. There were no periprocedural MIs or deaths. The 1-year major adverse cardiac event rate was roughly 6% in both study arms.

The PCI group received 6-12 months of dual-antiplatelet therapy with clopidogrel and aspirin. So did roughly 40% of the OMT group because of prior PCI.

Both study arms had comparably high rates of guideline-directed medical therapy, including statins, beta-blockers, and ACE inhibitors. However, the PCI group made significantly less use of nitrates than the OMT group during follow-up, reflecting their greater reduction in angina frequency. The crossover rate from OMT to PCI because of ongoing angina was 7.3%.

The long-term safety and durability of the two treatment strategies will be assessed at 3 years of follow-up.

The EuroCTO trial was originally planned for 600 patients. The investigators eventually settled for less because of slow enrollment. Many interventionalists who are skilled in treating CTOs proved reluctant to randomize the patients.

Dr. Werner contrasted the positive EuroCTO findings regarding clinical symptoms and quality of life to the negative results of the Korean DECISION CTO trial presented at the 2017 meeting of the American College of Cardiology. DECISION CTO found that PCI plus OMT wasn’t superior to OMT alone in reducing MI and other major adverse cardiac events in patients with at least one CTO. In Dr. Werner’s view, the Korean investigators chose the wrong endpoint.

“The quality of life improvement we’ve shown after PCI in EuroCTO is a valid clinical goal in treating stable coronary artery disease. I don’t think we can aim at improving prognosis,” according to Dr. Werner.

The impetus for EuroCTO was a recognition that CTOs are common and seriously undertreated. CTOs account for 16%-18% of all coronary lesions in patients with stable coronary artery disease, yet U.S. national data indicate only 5% of PCIs are performed to treat CTOs.

The EuroCTO trial was sponsored by the Euro CTO Club and supported by research grants from Biosensors and Asahi.

Publications
Publications
Topics
Article Type
Sections
Article Source

AT EUROPCR

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Vitals

 

Key clinical point: Percutaneous revascularization of coronary chronic total occlusions provided superior quality of life improvement, compared with optimal medical therapy.

Major finding: Patients whose chronic total occlusions were treated by PCI rather than optimal medical therapy experienced significantly less angina and greater improvement in quality of life during 12 months of follow-up.

Data source: EuroCTO, a prospective, 26-site study in which 396 patients with coronary chronic total occlusions were randomized 2:1 to PCI or optimal medical therapy.

Disclosures: EuroCTO was sponsored by the Euro CTO Club and supported by research grants from Biosensors and Asahi.

Disqus Comments
Default