User login
Neurologists Must Chart a New Course in EHR Era
SAN DIEGO — A consulting group enlisted by the American Academy of Neurology evaluated more than 100 different vendors of electronic health records for their suitability for neurology practices and has provided detailed ratings of the strengths and weaknesses of the top eight performers.
“By 2009, if you don't install [an] EHR [system], you might be out of business,” warned consultant Mark R. Anderson of the AC Group Inc. of Montgomery, Tex. Anderson cited several reasons for this prediction, including government and health plan pay-for-performance subsidization of EHR use, the expectation that providing quality medicine according to standards of care will depend upon information generated through EHRs, and reduced malpractice rates for clinicians who use the systems.
Mr. Anderson's group provides third-party independent evaluations of EHR systems and has done so for other medical associations.
For the current evaluation, Mr. Anderson collaborated with the academy's EHR Search and Selection Committee, a group of eight neurologists experienced with EHRs. The first step in the evaluation process was asking approximately 100 EHR vendors to answer 2,700 questions about the capabilities of their systems, and these claims were validated by the committee. To allow head-to-head comparisons, eight of the top-performing companies were then asked to follow a predetermined series of challenges, which was broadcast via Webcasts to the judges.
The EHR systems were assessed on a spectrum of neurology-related practice needs, ranging from first contact to billing. The criteria included the following capabilities:
▸ E-prescribing. The systems should be capable of handling prescription requests and pharmacy orders.
▸ Incorporating laboratory and test data. This should include radiology reports and images, and the system should assure that the data are collected, alerts responded to, and patients informed. Consideration must be given to who will input the data and how.
▸ Charting. Ideally, a system should accept handwritten, typed, or dictated input.
▸ Data access. Each physician should be able to readily access his daily schedule and individual patient records, including summary sheets and compilations.
▸ Document management. This should include both current data and old records, which must be quickly and easily accessible and must adhere to legal guidelines.
▸ Security. The system needs to adhere to HIPAA requirements and provide confidentiality, privacy, and audit trails.
▸ Networking. The ability to communicate both within and outside the practice should be available.
▸ Reporting. Systems should be capable of reporting to insurance providers and government agencies.
▸ Information access. The ability to access practice guidelines, clinical alerts, published materials, and Internet sources of information should be available.
The neurologists' ranking of the selected EHR vendors is shown below. For more information, see www.acgroup.org
One of the biggest mistakes a physician can make when choosing an EHR system, Mr. Anderson said, is to allow the vendor to demonstrate the product, showing you what they can do—and omitting what they can't do. Another mistake is failing to insist that the vendor configure the system for your practice, train your personnel adequately, and follow up on how well the system is working for you. But the biggest mistake, said Mr. Anderson, is purchasing the cheapest system. “You will not get the clinical and financial return that some more expensive systems have,” he said.
Neurologists have been slow to adopt EHR systems, according to Mr. Anderson. The top eight vendors reported that they have supplied systems to 100 neurology practices, representing about 200 neurologists. He estimates that due to shortages in skilled labor, vendors will be able to add only about 8% more practices per year in the next few years, so physicians may experience delays in obtaining systems once they are ordered, and the delays may worsen temporarily as demand grows.
At a symposium held at the AAN annual meeting, Dr. Michael A. Lobatz and Dr. Jack D. Schim of The Neurology Center, Oceanside, Calif., shared their experiences of having an electronic, paperless office for the past 4 years. They found that EHRs increased the quality of services, increased efficiency, contained costs, improved continuity of care, and increased the complexity of medical care that could be provided to patients.
For instance, Dr. Lobatz said that having an EHR system saves an average of $9 to $30 in costs just to retrieve, replace, and locate misplaced charts. Transcription costs are reduced by typing consultation notes into a laptop computer during the patient visit, and off-site access to patient records is available through a PDA.
Dr. Lobatz and Dr. Schim offered the following advice for physicians making the transition to electronic health record keeping:
▸ Avoid systems that rely on “point-and-click” data entry, because this is cumbersome for physicians who prefer to dictate notes more in prose.
▸ Make sure the system can interface with the outside laboratory or testing facilities you work with.
▸ Select a strong in-house advocate for the system.
▸ Avoid being the first neurology customer of a vendor.
▸ Visit two or more sites where the system is used, without the presence of the vendor's representative.
▸ Begin by inputting data from current patients.
▸ Use outside help to input data, lab results, and scans.
▸ Proofread data after entry.
▸ Create a real-time, reliable backup system located at least 100 miles from the office.
▸ Anticipate that initial costs will be higher than expected and unanticipated issues will arise.
▸ Consider implementing changes in phases (e-prescribing is a good place to start).
▸ Start planning early.
Eight EHR Systems That Are Worth a Look for Neurologists
▸ eClinicalWorks (
▸ e-MDs Inc. (
▸ GE Healthcare (
▸ Greenway Medical Technologies (
▸ Medical Communication Systems Inc. (
▸ Misys Healthcare Systems (
▸ NextGen Healthcare Information Systems Inc. (
▸ Practice Partner (
Source: AC Group Inc.
SAN DIEGO — A consulting group enlisted by the American Academy of Neurology evaluated more than 100 different vendors of electronic health records for their suitability for neurology practices and has provided detailed ratings of the strengths and weaknesses of the top eight performers.
“By 2009, if you don't install [an] EHR [system], you might be out of business,” warned consultant Mark R. Anderson of the AC Group Inc. of Montgomery, Tex. Anderson cited several reasons for this prediction, including government and health plan pay-for-performance subsidization of EHR use, the expectation that providing quality medicine according to standards of care will depend upon information generated through EHRs, and reduced malpractice rates for clinicians who use the systems.
Mr. Anderson's group provides third-party independent evaluations of EHR systems and has done so for other medical associations.
For the current evaluation, Mr. Anderson collaborated with the academy's EHR Search and Selection Committee, a group of eight neurologists experienced with EHRs. The first step in the evaluation process was asking approximately 100 EHR vendors to answer 2,700 questions about the capabilities of their systems, and these claims were validated by the committee. To allow head-to-head comparisons, eight of the top-performing companies were then asked to follow a predetermined series of challenges, which was broadcast via Webcasts to the judges.
The EHR systems were assessed on a spectrum of neurology-related practice needs, ranging from first contact to billing. The criteria included the following capabilities:
▸ E-prescribing. The systems should be capable of handling prescription requests and pharmacy orders.
▸ Incorporating laboratory and test data. This should include radiology reports and images, and the system should assure that the data are collected, alerts responded to, and patients informed. Consideration must be given to who will input the data and how.
▸ Charting. Ideally, a system should accept handwritten, typed, or dictated input.
▸ Data access. Each physician should be able to readily access his daily schedule and individual patient records, including summary sheets and compilations.
▸ Document management. This should include both current data and old records, which must be quickly and easily accessible and must adhere to legal guidelines.
▸ Security. The system needs to adhere to HIPAA requirements and provide confidentiality, privacy, and audit trails.
▸ Networking. The ability to communicate both within and outside the practice should be available.
▸ Reporting. Systems should be capable of reporting to insurance providers and government agencies.
▸ Information access. The ability to access practice guidelines, clinical alerts, published materials, and Internet sources of information should be available.
The neurologists' ranking of the selected EHR vendors is shown below. For more information, see www.acgroup.org
One of the biggest mistakes a physician can make when choosing an EHR system, Mr. Anderson said, is to allow the vendor to demonstrate the product, showing you what they can do—and omitting what they can't do. Another mistake is failing to insist that the vendor configure the system for your practice, train your personnel adequately, and follow up on how well the system is working for you. But the biggest mistake, said Mr. Anderson, is purchasing the cheapest system. “You will not get the clinical and financial return that some more expensive systems have,” he said.
Neurologists have been slow to adopt EHR systems, according to Mr. Anderson. The top eight vendors reported that they have supplied systems to 100 neurology practices, representing about 200 neurologists. He estimates that due to shortages in skilled labor, vendors will be able to add only about 8% more practices per year in the next few years, so physicians may experience delays in obtaining systems once they are ordered, and the delays may worsen temporarily as demand grows.
At a symposium held at the AAN annual meeting, Dr. Michael A. Lobatz and Dr. Jack D. Schim of The Neurology Center, Oceanside, Calif., shared their experiences of having an electronic, paperless office for the past 4 years. They found that EHRs increased the quality of services, increased efficiency, contained costs, improved continuity of care, and increased the complexity of medical care that could be provided to patients.
For instance, Dr. Lobatz said that having an EHR system saves an average of $9 to $30 in costs just to retrieve, replace, and locate misplaced charts. Transcription costs are reduced by typing consultation notes into a laptop computer during the patient visit, and off-site access to patient records is available through a PDA.
Dr. Lobatz and Dr. Schim offered the following advice for physicians making the transition to electronic health record keeping:
▸ Avoid systems that rely on “point-and-click” data entry, because this is cumbersome for physicians who prefer to dictate notes more in prose.
▸ Make sure the system can interface with the outside laboratory or testing facilities you work with.
▸ Select a strong in-house advocate for the system.
▸ Avoid being the first neurology customer of a vendor.
▸ Visit two or more sites where the system is used, without the presence of the vendor's representative.
▸ Begin by inputting data from current patients.
▸ Use outside help to input data, lab results, and scans.
▸ Proofread data after entry.
▸ Create a real-time, reliable backup system located at least 100 miles from the office.
▸ Anticipate that initial costs will be higher than expected and unanticipated issues will arise.
▸ Consider implementing changes in phases (e-prescribing is a good place to start).
▸ Start planning early.
Eight EHR Systems That Are Worth a Look for Neurologists
▸ eClinicalWorks (
▸ e-MDs Inc. (
▸ GE Healthcare (
▸ Greenway Medical Technologies (
▸ Medical Communication Systems Inc. (
▸ Misys Healthcare Systems (
▸ NextGen Healthcare Information Systems Inc. (
▸ Practice Partner (
Source: AC Group Inc.
SAN DIEGO — A consulting group enlisted by the American Academy of Neurology evaluated more than 100 different vendors of electronic health records for their suitability for neurology practices and has provided detailed ratings of the strengths and weaknesses of the top eight performers.
“By 2009, if you don't install [an] EHR [system], you might be out of business,” warned consultant Mark R. Anderson of the AC Group Inc. of Montgomery, Tex. Anderson cited several reasons for this prediction, including government and health plan pay-for-performance subsidization of EHR use, the expectation that providing quality medicine according to standards of care will depend upon information generated through EHRs, and reduced malpractice rates for clinicians who use the systems.
Mr. Anderson's group provides third-party independent evaluations of EHR systems and has done so for other medical associations.
For the current evaluation, Mr. Anderson collaborated with the academy's EHR Search and Selection Committee, a group of eight neurologists experienced with EHRs. The first step in the evaluation process was asking approximately 100 EHR vendors to answer 2,700 questions about the capabilities of their systems, and these claims were validated by the committee. To allow head-to-head comparisons, eight of the top-performing companies were then asked to follow a predetermined series of challenges, which was broadcast via Webcasts to the judges.
The EHR systems were assessed on a spectrum of neurology-related practice needs, ranging from first contact to billing. The criteria included the following capabilities:
▸ E-prescribing. The systems should be capable of handling prescription requests and pharmacy orders.
▸ Incorporating laboratory and test data. This should include radiology reports and images, and the system should assure that the data are collected, alerts responded to, and patients informed. Consideration must be given to who will input the data and how.
▸ Charting. Ideally, a system should accept handwritten, typed, or dictated input.
▸ Data access. Each physician should be able to readily access his daily schedule and individual patient records, including summary sheets and compilations.
▸ Document management. This should include both current data and old records, which must be quickly and easily accessible and must adhere to legal guidelines.
▸ Security. The system needs to adhere to HIPAA requirements and provide confidentiality, privacy, and audit trails.
▸ Networking. The ability to communicate both within and outside the practice should be available.
▸ Reporting. Systems should be capable of reporting to insurance providers and government agencies.
▸ Information access. The ability to access practice guidelines, clinical alerts, published materials, and Internet sources of information should be available.
The neurologists' ranking of the selected EHR vendors is shown below. For more information, see www.acgroup.org
One of the biggest mistakes a physician can make when choosing an EHR system, Mr. Anderson said, is to allow the vendor to demonstrate the product, showing you what they can do—and omitting what they can't do. Another mistake is failing to insist that the vendor configure the system for your practice, train your personnel adequately, and follow up on how well the system is working for you. But the biggest mistake, said Mr. Anderson, is purchasing the cheapest system. “You will not get the clinical and financial return that some more expensive systems have,” he said.
Neurologists have been slow to adopt EHR systems, according to Mr. Anderson. The top eight vendors reported that they have supplied systems to 100 neurology practices, representing about 200 neurologists. He estimates that due to shortages in skilled labor, vendors will be able to add only about 8% more practices per year in the next few years, so physicians may experience delays in obtaining systems once they are ordered, and the delays may worsen temporarily as demand grows.
At a symposium held at the AAN annual meeting, Dr. Michael A. Lobatz and Dr. Jack D. Schim of The Neurology Center, Oceanside, Calif., shared their experiences of having an electronic, paperless office for the past 4 years. They found that EHRs increased the quality of services, increased efficiency, contained costs, improved continuity of care, and increased the complexity of medical care that could be provided to patients.
For instance, Dr. Lobatz said that having an EHR system saves an average of $9 to $30 in costs just to retrieve, replace, and locate misplaced charts. Transcription costs are reduced by typing consultation notes into a laptop computer during the patient visit, and off-site access to patient records is available through a PDA.
Dr. Lobatz and Dr. Schim offered the following advice for physicians making the transition to electronic health record keeping:
▸ Avoid systems that rely on “point-and-click” data entry, because this is cumbersome for physicians who prefer to dictate notes more in prose.
▸ Make sure the system can interface with the outside laboratory or testing facilities you work with.
▸ Select a strong in-house advocate for the system.
▸ Avoid being the first neurology customer of a vendor.
▸ Visit two or more sites where the system is used, without the presence of the vendor's representative.
▸ Begin by inputting data from current patients.
▸ Use outside help to input data, lab results, and scans.
▸ Proofread data after entry.
▸ Create a real-time, reliable backup system located at least 100 miles from the office.
▸ Anticipate that initial costs will be higher than expected and unanticipated issues will arise.
▸ Consider implementing changes in phases (e-prescribing is a good place to start).
▸ Start planning early.
Eight EHR Systems That Are Worth a Look for Neurologists
▸ eClinicalWorks (
▸ e-MDs Inc. (
▸ GE Healthcare (
▸ Greenway Medical Technologies (
▸ Medical Communication Systems Inc. (
▸ Misys Healthcare Systems (
▸ NextGen Healthcare Information Systems Inc. (
▸ Practice Partner (
Source: AC Group Inc.
Dire Prognosis Unjustified in Retarded Kids
MONTREAL — Children with epilepsy who are also mentally retarded can become seizure free, and more than half can eventually discontinue seizure medication, although repeated efforts may be required to reach those goals, reported Dr. Carol Camfield at the 10th International Child Neurology Congress.
Because children with epilepsy and mental retardation have a poor prognosis for seizure control, physicians and parents may be reluctant to discontinue antiepileptic drugs (AEDs), noted Dr. Camfield, of Dalhousie University and the IWK Health Center, Halifax, Nova Scotia. The result is that these patients may unnecessarily remain on AEDs.
Dr. Camfield—working in collaboration with her husband Dr. Peter Camfield, of the same affiliation—for more than 20 years followed 692 children in Nova Scotia aged 1 month to 16 years who were diagnosed with epilepsy between 1977 and 1985. Children with a mental handicap (IQ less than 70) were studied to establish whether they could become seizure free long enough to discontinue AEDs, and were then followed to see how long they could remain seizure free without AEDs.
Twenty-one percent of the children with epilepsy had an IQ of less than 70 at the time of diagnosis. Of these patients, 117 children with epilepsy and mental retardation were still alive at the end of the follow-up period, Dr. Camfield reported.
Of this group, 45% were deemed to be severely mentally disabled, 26% moderately disabled, and 28% mildly disabled. Epilepsy started earlier in children with a low IQ, compared with children of normal intelligence (3.3 years vs. 7.0 years), with 40% having a seizure within the first year of life.
Sixty-nine (59%) of the epilepsy/low IQ subgroup became seizure free and attempted to end AED therapy. Of these, 35 (51%) were able to discontinue AEDs on the first attempt without seizure recurrence. Eleven others achieved the goal after two tries, and four were able to discontinue AEDs after three tries. Overall, 61% of the children with epilepsy and low IQ were able to discontinue the medications successfully, compared with 73% of children with epilepsy of normal intelligence. However, it took an average of more than 5 years to make the initial try.
Those children with more severe mental retardation, status epilepticus, neurologic deficits, and poor mobility were less likely to discontinue AEDs. Those with symptomatic partial epilepsies were more likely to attempt discontinuation than were those with secondary generalized epilepsies.
“The practice had been to keep any child on AEDs for 2–4 years once they became seizure free—these children were clearly kept on longer,” commented Dr. Camfield.
MONTREAL — Children with epilepsy who are also mentally retarded can become seizure free, and more than half can eventually discontinue seizure medication, although repeated efforts may be required to reach those goals, reported Dr. Carol Camfield at the 10th International Child Neurology Congress.
Because children with epilepsy and mental retardation have a poor prognosis for seizure control, physicians and parents may be reluctant to discontinue antiepileptic drugs (AEDs), noted Dr. Camfield, of Dalhousie University and the IWK Health Center, Halifax, Nova Scotia. The result is that these patients may unnecessarily remain on AEDs.
Dr. Camfield—working in collaboration with her husband Dr. Peter Camfield, of the same affiliation—for more than 20 years followed 692 children in Nova Scotia aged 1 month to 16 years who were diagnosed with epilepsy between 1977 and 1985. Children with a mental handicap (IQ less than 70) were studied to establish whether they could become seizure free long enough to discontinue AEDs, and were then followed to see how long they could remain seizure free without AEDs.
Twenty-one percent of the children with epilepsy had an IQ of less than 70 at the time of diagnosis. Of these patients, 117 children with epilepsy and mental retardation were still alive at the end of the follow-up period, Dr. Camfield reported.
Of this group, 45% were deemed to be severely mentally disabled, 26% moderately disabled, and 28% mildly disabled. Epilepsy started earlier in children with a low IQ, compared with children of normal intelligence (3.3 years vs. 7.0 years), with 40% having a seizure within the first year of life.
Sixty-nine (59%) of the epilepsy/low IQ subgroup became seizure free and attempted to end AED therapy. Of these, 35 (51%) were able to discontinue AEDs on the first attempt without seizure recurrence. Eleven others achieved the goal after two tries, and four were able to discontinue AEDs after three tries. Overall, 61% of the children with epilepsy and low IQ were able to discontinue the medications successfully, compared with 73% of children with epilepsy of normal intelligence. However, it took an average of more than 5 years to make the initial try.
Those children with more severe mental retardation, status epilepticus, neurologic deficits, and poor mobility were less likely to discontinue AEDs. Those with symptomatic partial epilepsies were more likely to attempt discontinuation than were those with secondary generalized epilepsies.
“The practice had been to keep any child on AEDs for 2–4 years once they became seizure free—these children were clearly kept on longer,” commented Dr. Camfield.
MONTREAL — Children with epilepsy who are also mentally retarded can become seizure free, and more than half can eventually discontinue seizure medication, although repeated efforts may be required to reach those goals, reported Dr. Carol Camfield at the 10th International Child Neurology Congress.
Because children with epilepsy and mental retardation have a poor prognosis for seizure control, physicians and parents may be reluctant to discontinue antiepileptic drugs (AEDs), noted Dr. Camfield, of Dalhousie University and the IWK Health Center, Halifax, Nova Scotia. The result is that these patients may unnecessarily remain on AEDs.
Dr. Camfield—working in collaboration with her husband Dr. Peter Camfield, of the same affiliation—for more than 20 years followed 692 children in Nova Scotia aged 1 month to 16 years who were diagnosed with epilepsy between 1977 and 1985. Children with a mental handicap (IQ less than 70) were studied to establish whether they could become seizure free long enough to discontinue AEDs, and were then followed to see how long they could remain seizure free without AEDs.
Twenty-one percent of the children with epilepsy had an IQ of less than 70 at the time of diagnosis. Of these patients, 117 children with epilepsy and mental retardation were still alive at the end of the follow-up period, Dr. Camfield reported.
Of this group, 45% were deemed to be severely mentally disabled, 26% moderately disabled, and 28% mildly disabled. Epilepsy started earlier in children with a low IQ, compared with children of normal intelligence (3.3 years vs. 7.0 years), with 40% having a seizure within the first year of life.
Sixty-nine (59%) of the epilepsy/low IQ subgroup became seizure free and attempted to end AED therapy. Of these, 35 (51%) were able to discontinue AEDs on the first attempt without seizure recurrence. Eleven others achieved the goal after two tries, and four were able to discontinue AEDs after three tries. Overall, 61% of the children with epilepsy and low IQ were able to discontinue the medications successfully, compared with 73% of children with epilepsy of normal intelligence. However, it took an average of more than 5 years to make the initial try.
Those children with more severe mental retardation, status epilepticus, neurologic deficits, and poor mobility were less likely to discontinue AEDs. Those with symptomatic partial epilepsies were more likely to attempt discontinuation than were those with secondary generalized epilepsies.
“The practice had been to keep any child on AEDs for 2–4 years once they became seizure free—these children were clearly kept on longer,” commented Dr. Camfield.
Four New Parkinson's Disease Guidelines Hailed : Review finds insufficient evidence to show that alternative therapies benefit Parkinson's patients.
SAN DIEGO – Use of alternative therapies in the management of Parkinson's disease is supported only by weak data, according to one of four new practice parameters issued by the American Academy of Neurology at its annual meeting.
Considering that 60%–70% of PD patients turn to alternative therapies, the parameter provides the evidence a clinician needs to answer patient inquiries about their use.
AAN's review also found only weak evidence that exercise or speech therapy improves motor function. There was insufficient evidence to show that patients with PD derive any benefit from acupuncture, biofeedback, chiropractic, Mucuna pruriens (a nutritional supplement derived from a tropical legume, also known as velvet bean, that contains levodopa), or the Alexander technique (a form of movement therapy emphasizing correct posture and the proper positioning of the head with regard to the spine), according to the parameters, the 100th set to be issued by the AAN, which is known for the rigor of its guidelines.
An estimated 80% of the AAN membership uses the academy's various practice parameters in their clinical practice. The goals of the parameters are not to dictate decision making but rather to provide neurologists with the information they need to make evidence-based judgments.
The four new guidelines address the diagnosis and prognosis of new onset PD, neuroprotective strategies and alternative therapies, treatment of PD with motor fluctuations and dyskinesia, and evaluation and treatment of depression, psychosis, and dementia in PD. The guidelines tackle previously unexplored issues, and also revisit questions addressed by previous parameters.
For each parameter, the Quality Standards Subcommittee selected a committee composed of movement disorder specialists, a general neurologist, and, in the case of the nonmotor-symptom parameter, psychiatrists. Each committee surveyed the literature published from 1996 to January 2005, and scientifically rigorous studies were selected.
For the treatment of PD with motor fluctuations and dyskinesia parameter, 730 articles were initially identified but only 29 met criteria for inclusion, explained coauthor Dr. Rajesh Pahwa of the University of Kansas, Kansas City.
The use of selegiline, levodopa, or a dopamine agonist for the initiation of treatment for PD is supported by the highest level of data.
For neuroprotection, the panel found that levodopa may be considered for the initial treatment of PD because it does not accelerate disease progression and is safe. However, the neuroprotective value of other medications–including amantadine, coenzyme Q, pramipexole, rasagiline, riluzole, ropinirole, and selegiline–is unproven. Good evidence is available to discount any protective effects from vitamin E (2,000 U).
For motor fluctuations, the panel recommended that entacapone and rasagiline be offered, while pergolide, pramipexole, ropinirole, and tolcapone may be considered to reduce “off time” in PD. Only weak evidence is available to support the use of subcutaneous apomorphine, cabergoline, or selegiline, and the panel disregarded the use of sustained-release carbidopa/levodopa or bromocriptine.
The panel also updated the evidence on deep brain stimulation (DBS) for motor fluctuations, a matter that it last addressed 7 years ago. Level C evidence (possibly effective) was found for DBS of the subthalamic nucleus, while there was insufficient evidence to make any recommendations about DBS of the globus pallidus interna or ventral intermediate nucleus of the thalamus.
For the first time, the AAN established a practice parameter for nonmotor PD symptoms, reflecting current thought that almost all PD patients are affected with one or more of these problems and that they have serious consequences. For instance, psychosis is the strongest marker for placement of a PD patient in a nursing home and, if untreated, leads to 100% mortality within a year, said coauthor Dr. Jill M. Miyasaki of the University of Toronto. With treatment, mortality falls to 28%. The panel examined whether effective screening tools and treatments were available for these conditions. While these parameters looked only at depression, psychosis, and dementia, new guidelines in preparation will address other nonmotor features of PD, including other behavioral issues, constipation, lightheadedness, and bladder problems.
The guidelines also will help investigators identify gaps in knowledge that may guide future research. For instance, more evidence is needed to determine whether DBS of areas other than the subthalamic nucleus is effective for treating motor fluctuations. There is also a need for head-to-head comparisons of medications.
The parameters are available in the April 11 issue of Neurology (2006;66:968–1002) and on the AAN's Web site (www.aan.com/professionals/practice/guideline/index.cfm
The guidelines “scored an 'A,' ” commented Robin A. Elliott, executive director of the Parkinson's Disease Foundation. Mr. Elliott was particularly appreciative of the patient summary sheets, which he felt provided information to patients and their families that was understandable but not patronizing. Noting that only one-third of PD patients are treated by a movement disorders specialist, Mr. Elliott said the parameters “will empower larger groups of doctors to become expert in PD.”
SAN DIEGO – Use of alternative therapies in the management of Parkinson's disease is supported only by weak data, according to one of four new practice parameters issued by the American Academy of Neurology at its annual meeting.
Considering that 60%–70% of PD patients turn to alternative therapies, the parameter provides the evidence a clinician needs to answer patient inquiries about their use.
AAN's review also found only weak evidence that exercise or speech therapy improves motor function. There was insufficient evidence to show that patients with PD derive any benefit from acupuncture, biofeedback, chiropractic, Mucuna pruriens (a nutritional supplement derived from a tropical legume, also known as velvet bean, that contains levodopa), or the Alexander technique (a form of movement therapy emphasizing correct posture and the proper positioning of the head with regard to the spine), according to the parameters, the 100th set to be issued by the AAN, which is known for the rigor of its guidelines.
An estimated 80% of the AAN membership uses the academy's various practice parameters in their clinical practice. The goals of the parameters are not to dictate decision making but rather to provide neurologists with the information they need to make evidence-based judgments.
The four new guidelines address the diagnosis and prognosis of new onset PD, neuroprotective strategies and alternative therapies, treatment of PD with motor fluctuations and dyskinesia, and evaluation and treatment of depression, psychosis, and dementia in PD. The guidelines tackle previously unexplored issues, and also revisit questions addressed by previous parameters.
For each parameter, the Quality Standards Subcommittee selected a committee composed of movement disorder specialists, a general neurologist, and, in the case of the nonmotor-symptom parameter, psychiatrists. Each committee surveyed the literature published from 1996 to January 2005, and scientifically rigorous studies were selected.
For the treatment of PD with motor fluctuations and dyskinesia parameter, 730 articles were initially identified but only 29 met criteria for inclusion, explained coauthor Dr. Rajesh Pahwa of the University of Kansas, Kansas City.
The use of selegiline, levodopa, or a dopamine agonist for the initiation of treatment for PD is supported by the highest level of data.
For neuroprotection, the panel found that levodopa may be considered for the initial treatment of PD because it does not accelerate disease progression and is safe. However, the neuroprotective value of other medications–including amantadine, coenzyme Q, pramipexole, rasagiline, riluzole, ropinirole, and selegiline–is unproven. Good evidence is available to discount any protective effects from vitamin E (2,000 U).
For motor fluctuations, the panel recommended that entacapone and rasagiline be offered, while pergolide, pramipexole, ropinirole, and tolcapone may be considered to reduce “off time” in PD. Only weak evidence is available to support the use of subcutaneous apomorphine, cabergoline, or selegiline, and the panel disregarded the use of sustained-release carbidopa/levodopa or bromocriptine.
The panel also updated the evidence on deep brain stimulation (DBS) for motor fluctuations, a matter that it last addressed 7 years ago. Level C evidence (possibly effective) was found for DBS of the subthalamic nucleus, while there was insufficient evidence to make any recommendations about DBS of the globus pallidus interna or ventral intermediate nucleus of the thalamus.
For the first time, the AAN established a practice parameter for nonmotor PD symptoms, reflecting current thought that almost all PD patients are affected with one or more of these problems and that they have serious consequences. For instance, psychosis is the strongest marker for placement of a PD patient in a nursing home and, if untreated, leads to 100% mortality within a year, said coauthor Dr. Jill M. Miyasaki of the University of Toronto. With treatment, mortality falls to 28%. The panel examined whether effective screening tools and treatments were available for these conditions. While these parameters looked only at depression, psychosis, and dementia, new guidelines in preparation will address other nonmotor features of PD, including other behavioral issues, constipation, lightheadedness, and bladder problems.
The guidelines also will help investigators identify gaps in knowledge that may guide future research. For instance, more evidence is needed to determine whether DBS of areas other than the subthalamic nucleus is effective for treating motor fluctuations. There is also a need for head-to-head comparisons of medications.
The parameters are available in the April 11 issue of Neurology (2006;66:968–1002) and on the AAN's Web site (www.aan.com/professionals/practice/guideline/index.cfm
The guidelines “scored an 'A,' ” commented Robin A. Elliott, executive director of the Parkinson's Disease Foundation. Mr. Elliott was particularly appreciative of the patient summary sheets, which he felt provided information to patients and their families that was understandable but not patronizing. Noting that only one-third of PD patients are treated by a movement disorders specialist, Mr. Elliott said the parameters “will empower larger groups of doctors to become expert in PD.”
SAN DIEGO – Use of alternative therapies in the management of Parkinson's disease is supported only by weak data, according to one of four new practice parameters issued by the American Academy of Neurology at its annual meeting.
Considering that 60%–70% of PD patients turn to alternative therapies, the parameter provides the evidence a clinician needs to answer patient inquiries about their use.
AAN's review also found only weak evidence that exercise or speech therapy improves motor function. There was insufficient evidence to show that patients with PD derive any benefit from acupuncture, biofeedback, chiropractic, Mucuna pruriens (a nutritional supplement derived from a tropical legume, also known as velvet bean, that contains levodopa), or the Alexander technique (a form of movement therapy emphasizing correct posture and the proper positioning of the head with regard to the spine), according to the parameters, the 100th set to be issued by the AAN, which is known for the rigor of its guidelines.
An estimated 80% of the AAN membership uses the academy's various practice parameters in their clinical practice. The goals of the parameters are not to dictate decision making but rather to provide neurologists with the information they need to make evidence-based judgments.
The four new guidelines address the diagnosis and prognosis of new onset PD, neuroprotective strategies and alternative therapies, treatment of PD with motor fluctuations and dyskinesia, and evaluation and treatment of depression, psychosis, and dementia in PD. The guidelines tackle previously unexplored issues, and also revisit questions addressed by previous parameters.
For each parameter, the Quality Standards Subcommittee selected a committee composed of movement disorder specialists, a general neurologist, and, in the case of the nonmotor-symptom parameter, psychiatrists. Each committee surveyed the literature published from 1996 to January 2005, and scientifically rigorous studies were selected.
For the treatment of PD with motor fluctuations and dyskinesia parameter, 730 articles were initially identified but only 29 met criteria for inclusion, explained coauthor Dr. Rajesh Pahwa of the University of Kansas, Kansas City.
The use of selegiline, levodopa, or a dopamine agonist for the initiation of treatment for PD is supported by the highest level of data.
For neuroprotection, the panel found that levodopa may be considered for the initial treatment of PD because it does not accelerate disease progression and is safe. However, the neuroprotective value of other medications–including amantadine, coenzyme Q, pramipexole, rasagiline, riluzole, ropinirole, and selegiline–is unproven. Good evidence is available to discount any protective effects from vitamin E (2,000 U).
For motor fluctuations, the panel recommended that entacapone and rasagiline be offered, while pergolide, pramipexole, ropinirole, and tolcapone may be considered to reduce “off time” in PD. Only weak evidence is available to support the use of subcutaneous apomorphine, cabergoline, or selegiline, and the panel disregarded the use of sustained-release carbidopa/levodopa or bromocriptine.
The panel also updated the evidence on deep brain stimulation (DBS) for motor fluctuations, a matter that it last addressed 7 years ago. Level C evidence (possibly effective) was found for DBS of the subthalamic nucleus, while there was insufficient evidence to make any recommendations about DBS of the globus pallidus interna or ventral intermediate nucleus of the thalamus.
For the first time, the AAN established a practice parameter for nonmotor PD symptoms, reflecting current thought that almost all PD patients are affected with one or more of these problems and that they have serious consequences. For instance, psychosis is the strongest marker for placement of a PD patient in a nursing home and, if untreated, leads to 100% mortality within a year, said coauthor Dr. Jill M. Miyasaki of the University of Toronto. With treatment, mortality falls to 28%. The panel examined whether effective screening tools and treatments were available for these conditions. While these parameters looked only at depression, psychosis, and dementia, new guidelines in preparation will address other nonmotor features of PD, including other behavioral issues, constipation, lightheadedness, and bladder problems.
The guidelines also will help investigators identify gaps in knowledge that may guide future research. For instance, more evidence is needed to determine whether DBS of areas other than the subthalamic nucleus is effective for treating motor fluctuations. There is also a need for head-to-head comparisons of medications.
The parameters are available in the April 11 issue of Neurology (2006;66:968–1002) and on the AAN's Web site (www.aan.com/professionals/practice/guideline/index.cfm
The guidelines “scored an 'A,' ” commented Robin A. Elliott, executive director of the Parkinson's Disease Foundation. Mr. Elliott was particularly appreciative of the patient summary sheets, which he felt provided information to patients and their families that was understandable but not patronizing. Noting that only one-third of PD patients are treated by a movement disorders specialist, Mr. Elliott said the parameters “will empower larger groups of doctors to become expert in PD.”
Late-Life AD Risk Linked to Midlife Fat Distribution
SAN DIEGO – The increased risk of Alzheimer's disease may be more closely related to midlife distribution of adiposity rather than to being overweight or obese, according to the results of a large-scale study presented at the annual meeting of the American Academy of Neurology.
Researchers were able to use data from almost 9,000 members of the Kaiser Permanente Health Plan who underwent a series of tests between 1964 and 1973 when they were aged 40–45 years. One evaluation included measurement of skinfold thickness using calipers in the subscapular and triceps regions. Between 1994 and 2003, investigators checked medical records for diagnoses of Alzheimer's disease.
The findings showed that people in the upper 20% of adiposity in the subscapular region were almost four times more likely to develop Alzheimer's disease than were those in the lowest 20%. The risk for developing Alzheimer's disease for individuals in the upper 20% of adiposity on triceps measurements was about three and a half times greater than that of people in the lowest quintile, according to lead researcher Dr. Rachel A. Whitmer, a research scientist at the Kaiser Permanente division of research, in Oakland, Calif.
Previous research by Dr. Whitmer (BMJ 2005;330:1360) and others (Arch. Intern. Med. 2003;163:1524–8) has shown that overweight and obesity in middle age increase the future risk of dementia and Alzheimer's disease. However, these studies relied on measurement of body mass index. The data from the current study, in which calipers were used to measure skinfold, were adjusted for body mass index.
SAN DIEGO – The increased risk of Alzheimer's disease may be more closely related to midlife distribution of adiposity rather than to being overweight or obese, according to the results of a large-scale study presented at the annual meeting of the American Academy of Neurology.
Researchers were able to use data from almost 9,000 members of the Kaiser Permanente Health Plan who underwent a series of tests between 1964 and 1973 when they were aged 40–45 years. One evaluation included measurement of skinfold thickness using calipers in the subscapular and triceps regions. Between 1994 and 2003, investigators checked medical records for diagnoses of Alzheimer's disease.
The findings showed that people in the upper 20% of adiposity in the subscapular region were almost four times more likely to develop Alzheimer's disease than were those in the lowest 20%. The risk for developing Alzheimer's disease for individuals in the upper 20% of adiposity on triceps measurements was about three and a half times greater than that of people in the lowest quintile, according to lead researcher Dr. Rachel A. Whitmer, a research scientist at the Kaiser Permanente division of research, in Oakland, Calif.
Previous research by Dr. Whitmer (BMJ 2005;330:1360) and others (Arch. Intern. Med. 2003;163:1524–8) has shown that overweight and obesity in middle age increase the future risk of dementia and Alzheimer's disease. However, these studies relied on measurement of body mass index. The data from the current study, in which calipers were used to measure skinfold, were adjusted for body mass index.
SAN DIEGO – The increased risk of Alzheimer's disease may be more closely related to midlife distribution of adiposity rather than to being overweight or obese, according to the results of a large-scale study presented at the annual meeting of the American Academy of Neurology.
Researchers were able to use data from almost 9,000 members of the Kaiser Permanente Health Plan who underwent a series of tests between 1964 and 1973 when they were aged 40–45 years. One evaluation included measurement of skinfold thickness using calipers in the subscapular and triceps regions. Between 1994 and 2003, investigators checked medical records for diagnoses of Alzheimer's disease.
The findings showed that people in the upper 20% of adiposity in the subscapular region were almost four times more likely to develop Alzheimer's disease than were those in the lowest 20%. The risk for developing Alzheimer's disease for individuals in the upper 20% of adiposity on triceps measurements was about three and a half times greater than that of people in the lowest quintile, according to lead researcher Dr. Rachel A. Whitmer, a research scientist at the Kaiser Permanente division of research, in Oakland, Calif.
Previous research by Dr. Whitmer (BMJ 2005;330:1360) and others (Arch. Intern. Med. 2003;163:1524–8) has shown that overweight and obesity in middle age increase the future risk of dementia and Alzheimer's disease. However, these studies relied on measurement of body mass index. The data from the current study, in which calipers were used to measure skinfold, were adjusted for body mass index.
PD Guidelines: Therapy Do's and Don't Bother's
SAN DIEGO — Use of alternative therapies in the management of Parkinson's disease is supported only by weak data, according to one of four new practice parameters issued by the American Academy of Neurology at its annual meeting.
Considering that 60%–70% of PD patients turn to alternative therapies, the parameter provides the evidence a clinician needs to answer patient inquiries about their use.
AAN's review also found only weak evidence that exercise or speech therapy improves motor function. There was insufficient evidence to show that patients with PD derive any benefit from acupuncture, biofeedback, chiropractic, Mucuna pruriens (a nutritional supplement derived from a tropical legume, also known as velvet bean, that contains levodopa), or the Alexander technique (a form of movement therapy emphasizing correct posture and the proper positioning of the head with regard to the spine), according to the parameters, the 100th set to be issued by the AAN, which is known for the rigor of its guidelines. An estimated 80% of the AAN membership uses the academy's various practice parameters in their clinical practice. The goals of the parameters are not to dictate decision making but rather to provide neurologists with the information they need to make evidence-based judgments.
The four new guidelines address the diagnosis and prognosis of new-onset PD, neuroprotective strategies and alternative therapies, treatment of PD with motor fluctuations and dyskinesia, and evaluation and treatment of depression, psychosis, and dementia in PD.
For each parameter, the Quality Standards Subcommittee selected a committee composed of movement disorder specialists, a general neurologist, and, in the case of the nonmotor-symptom parameter, psychiatrists. Each committee surveyed the literature published from 1996 to January 2005, and scientifically rigorous studies were selected. For the treatment of PD with motor fluctuations and dyskinesia parameter, 730 articles were initially identified but only 29 met criteria for inclusion, explained coauthor Dr. Rajesh Pahwa of the University of Kansas, Kansas City.
The use of selegiline, levodopa, or a dopamine agonist for the initiation of treatment for PD is supported by the highest level of data.
For neuroprotection, the panel found that levodopa may be considered for the initial treatment of PD because it does not accelerate disease progression and is safe. However, the neuroprotective value of other medications is unproven. Good evidence is available to discount any protective effects from vitamin E (2,000 U).
For motor fluctuations, the panel recommended that entacapone and rasagiline should be offered, while pergolide, pramipexole, ropinirole, and tolcapone may be considered to reduce “off time” in PD. Only weak evidence is available to support the use of subcutaneous apomorphine, cabergoline, or selegiline, and the panel disregarded the use of sustained-release carbidopa/levodopa or bromocriptine.
The panel also updated the evidence on deep brain stimulation (DBS) for motor fluctuations, a matter that it last addressed 7 years ago. Level C evidence was found for DBS of the subthalamic nucleus, while there is insufficient evidence to make any recommendations about DBS of the globus pallidus interna or ventral intermediate nucleus of the thalamus.
For the first time, the AAN established a practice parameter for nonmotor PD symptoms, reflecting current thought that almost all PD patients are affected with one or more of these problems and that they have serious consequences. For instance, psychosis is the strongest marker for placement of a PD patient in a nursing home and, if untreated, leads to 100% mortality within a year, said coauthor Dr. Jill M. Miyasaki of the University of Toronto. With treatment, mortality falls to 28%. The panel examined whether effective screening tools and treatments were available for these conditions. While these parameters looked only at depression, psychosis, and dementia, new guidelines in preparation will address other nonmotor features of PD, including other behavioral issues, constipation, lightheadedness, and bladder problems.
The guidelines also will help investigators identify gaps in knowledge that may guide future research. For instance, more evidence is needed to determine whether DBS of areas other than the subthalamic nucleus is effective for treating motor fluctuations. There is also a need for head-to-head comparisons of medications.
The parameters are available in the April 11 issue of Neurology (2006;66:968–1002) and on the AAN's Web site (www.aan.com/professionals/practice/guideline/index.cfm
The guidelines “scored an 'A,'” commented Robin A. Elliott, executive director of the Parkinson's Disease Foundation. Mr. Elliott was particularly appreciative of the patient summary sheets. Noting that only one-third of PD patients are treated by a movement disorders specialist, Mr. Elliott said the parameters “will empower larger groups of doctors to become expert in PD.”
SAN DIEGO — Use of alternative therapies in the management of Parkinson's disease is supported only by weak data, according to one of four new practice parameters issued by the American Academy of Neurology at its annual meeting.
Considering that 60%–70% of PD patients turn to alternative therapies, the parameter provides the evidence a clinician needs to answer patient inquiries about their use.
AAN's review also found only weak evidence that exercise or speech therapy improves motor function. There was insufficient evidence to show that patients with PD derive any benefit from acupuncture, biofeedback, chiropractic, Mucuna pruriens (a nutritional supplement derived from a tropical legume, also known as velvet bean, that contains levodopa), or the Alexander technique (a form of movement therapy emphasizing correct posture and the proper positioning of the head with regard to the spine), according to the parameters, the 100th set to be issued by the AAN, which is known for the rigor of its guidelines. An estimated 80% of the AAN membership uses the academy's various practice parameters in their clinical practice. The goals of the parameters are not to dictate decision making but rather to provide neurologists with the information they need to make evidence-based judgments.
The four new guidelines address the diagnosis and prognosis of new-onset PD, neuroprotective strategies and alternative therapies, treatment of PD with motor fluctuations and dyskinesia, and evaluation and treatment of depression, psychosis, and dementia in PD.
For each parameter, the Quality Standards Subcommittee selected a committee composed of movement disorder specialists, a general neurologist, and, in the case of the nonmotor-symptom parameter, psychiatrists. Each committee surveyed the literature published from 1996 to January 2005, and scientifically rigorous studies were selected. For the treatment of PD with motor fluctuations and dyskinesia parameter, 730 articles were initially identified but only 29 met criteria for inclusion, explained coauthor Dr. Rajesh Pahwa of the University of Kansas, Kansas City.
The use of selegiline, levodopa, or a dopamine agonist for the initiation of treatment for PD is supported by the highest level of data.
For neuroprotection, the panel found that levodopa may be considered for the initial treatment of PD because it does not accelerate disease progression and is safe. However, the neuroprotective value of other medications is unproven. Good evidence is available to discount any protective effects from vitamin E (2,000 U).
For motor fluctuations, the panel recommended that entacapone and rasagiline should be offered, while pergolide, pramipexole, ropinirole, and tolcapone may be considered to reduce “off time” in PD. Only weak evidence is available to support the use of subcutaneous apomorphine, cabergoline, or selegiline, and the panel disregarded the use of sustained-release carbidopa/levodopa or bromocriptine.
The panel also updated the evidence on deep brain stimulation (DBS) for motor fluctuations, a matter that it last addressed 7 years ago. Level C evidence was found for DBS of the subthalamic nucleus, while there is insufficient evidence to make any recommendations about DBS of the globus pallidus interna or ventral intermediate nucleus of the thalamus.
For the first time, the AAN established a practice parameter for nonmotor PD symptoms, reflecting current thought that almost all PD patients are affected with one or more of these problems and that they have serious consequences. For instance, psychosis is the strongest marker for placement of a PD patient in a nursing home and, if untreated, leads to 100% mortality within a year, said coauthor Dr. Jill M. Miyasaki of the University of Toronto. With treatment, mortality falls to 28%. The panel examined whether effective screening tools and treatments were available for these conditions. While these parameters looked only at depression, psychosis, and dementia, new guidelines in preparation will address other nonmotor features of PD, including other behavioral issues, constipation, lightheadedness, and bladder problems.
The guidelines also will help investigators identify gaps in knowledge that may guide future research. For instance, more evidence is needed to determine whether DBS of areas other than the subthalamic nucleus is effective for treating motor fluctuations. There is also a need for head-to-head comparisons of medications.
The parameters are available in the April 11 issue of Neurology (2006;66:968–1002) and on the AAN's Web site (www.aan.com/professionals/practice/guideline/index.cfm
The guidelines “scored an 'A,'” commented Robin A. Elliott, executive director of the Parkinson's Disease Foundation. Mr. Elliott was particularly appreciative of the patient summary sheets. Noting that only one-third of PD patients are treated by a movement disorders specialist, Mr. Elliott said the parameters “will empower larger groups of doctors to become expert in PD.”
SAN DIEGO — Use of alternative therapies in the management of Parkinson's disease is supported only by weak data, according to one of four new practice parameters issued by the American Academy of Neurology at its annual meeting.
Considering that 60%–70% of PD patients turn to alternative therapies, the parameter provides the evidence a clinician needs to answer patient inquiries about their use.
AAN's review also found only weak evidence that exercise or speech therapy improves motor function. There was insufficient evidence to show that patients with PD derive any benefit from acupuncture, biofeedback, chiropractic, Mucuna pruriens (a nutritional supplement derived from a tropical legume, also known as velvet bean, that contains levodopa), or the Alexander technique (a form of movement therapy emphasizing correct posture and the proper positioning of the head with regard to the spine), according to the parameters, the 100th set to be issued by the AAN, which is known for the rigor of its guidelines. An estimated 80% of the AAN membership uses the academy's various practice parameters in their clinical practice. The goals of the parameters are not to dictate decision making but rather to provide neurologists with the information they need to make evidence-based judgments.
The four new guidelines address the diagnosis and prognosis of new-onset PD, neuroprotective strategies and alternative therapies, treatment of PD with motor fluctuations and dyskinesia, and evaluation and treatment of depression, psychosis, and dementia in PD.
For each parameter, the Quality Standards Subcommittee selected a committee composed of movement disorder specialists, a general neurologist, and, in the case of the nonmotor-symptom parameter, psychiatrists. Each committee surveyed the literature published from 1996 to January 2005, and scientifically rigorous studies were selected. For the treatment of PD with motor fluctuations and dyskinesia parameter, 730 articles were initially identified but only 29 met criteria for inclusion, explained coauthor Dr. Rajesh Pahwa of the University of Kansas, Kansas City.
The use of selegiline, levodopa, or a dopamine agonist for the initiation of treatment for PD is supported by the highest level of data.
For neuroprotection, the panel found that levodopa may be considered for the initial treatment of PD because it does not accelerate disease progression and is safe. However, the neuroprotective value of other medications is unproven. Good evidence is available to discount any protective effects from vitamin E (2,000 U).
For motor fluctuations, the panel recommended that entacapone and rasagiline should be offered, while pergolide, pramipexole, ropinirole, and tolcapone may be considered to reduce “off time” in PD. Only weak evidence is available to support the use of subcutaneous apomorphine, cabergoline, or selegiline, and the panel disregarded the use of sustained-release carbidopa/levodopa or bromocriptine.
The panel also updated the evidence on deep brain stimulation (DBS) for motor fluctuations, a matter that it last addressed 7 years ago. Level C evidence was found for DBS of the subthalamic nucleus, while there is insufficient evidence to make any recommendations about DBS of the globus pallidus interna or ventral intermediate nucleus of the thalamus.
For the first time, the AAN established a practice parameter for nonmotor PD symptoms, reflecting current thought that almost all PD patients are affected with one or more of these problems and that they have serious consequences. For instance, psychosis is the strongest marker for placement of a PD patient in a nursing home and, if untreated, leads to 100% mortality within a year, said coauthor Dr. Jill M. Miyasaki of the University of Toronto. With treatment, mortality falls to 28%. The panel examined whether effective screening tools and treatments were available for these conditions. While these parameters looked only at depression, psychosis, and dementia, new guidelines in preparation will address other nonmotor features of PD, including other behavioral issues, constipation, lightheadedness, and bladder problems.
The guidelines also will help investigators identify gaps in knowledge that may guide future research. For instance, more evidence is needed to determine whether DBS of areas other than the subthalamic nucleus is effective for treating motor fluctuations. There is also a need for head-to-head comparisons of medications.
The parameters are available in the April 11 issue of Neurology (2006;66:968–1002) and on the AAN's Web site (www.aan.com/professionals/practice/guideline/index.cfm
The guidelines “scored an 'A,'” commented Robin A. Elliott, executive director of the Parkinson's Disease Foundation. Mr. Elliott was particularly appreciative of the patient summary sheets. Noting that only one-third of PD patients are treated by a movement disorders specialist, Mr. Elliott said the parameters “will empower larger groups of doctors to become expert in PD.”
Dopamine Agonist/Levodopa Combo Linked to Compulsions
SAN DIEGO — The specific drug combination of a dopamine agonist and levodopa may trigger the onset of pathological behaviors, including compulsive gambling, hypersexuality, and compulsive shopping in a subset of patients with Parkinson's disease, according to the results of two independent investigations on a total of 485 patients presented at the annual meeting of the American Academy of Neurology.
“Although since 2000 there have been case reports [of pathologic behaviors], these are the first systematic detailed evaluations of these patients,” said Dr. Oksana Suchowersky of the University of Calgary, Alberta, Canada. In her study, 188 patients with Parkinson's disease (PD) were surveyed for difficulties with gambling. Twelve patients met DSM IV criteria for pathological gambling, equivalent to a lifetime prevalence rate of 6%, compared with 1.5% in the general population.
All patients who developed pathological gambling had been recreational gamblers before starting PD medications, and all had been treated with levodopa plus a dopamine agonist, rather than with levodopa (0 of 93 patients) or bromocriptine (0 of 14 patients) monotherapy. The risk of developing pathological gambling appeared to be a class effect of the dopamine agonists, with no significant differences among those treated with pramipexole (10%), pergolide (17%), or ropinirole (17%).
Dr. Valerie Voon, a psychiatrist who conducted research at the Toronto Western Hospital Movement Disorders Centre, investigated pathological gambling, hypersexuality, and compulsive shopping in 297 patients with PD. She found that overall lifetime prevalence (which includes both past and current behaviors) for the group was 6%, which increased to 16% in patients taking levodopa and dopamine agonist in combination. The lifetime prevalence was 3.4% for pathologic gambling, 2.4% for hypersexuality, and 0.7% for compulsive shopping; 10%–20% of patients exhibited more than one disorder.
One hypothesis is that these obsessive behaviors reflect excessive stimulation of the limbic reward system in susceptible individuals. Risk factors that may increase susceptibility to compulsive behaviors include younger age of PD onset, novelty-seeking personality traits, and history of alcohol abuse. Stage of disease was ruled out as a risk factor.
These findings suggest that clinicians should regularly query patients with PD and family members about excessive behaviors, which may take the form of hobbies, collections, sexual behavior, or shopping. Early identification can help physicians make adjustments that may rectify the problematic behaviors, including switching dopaminergic agonists, discontinuing therapy if possible, or even substituting deep brain stimulation for long-term dopaminergic therapy. The latter option should be used with caution, since Suchowersky found that 5% of 39 deep brain stimulation patients actually developed pathologic gambling after surgery.
Left unchecked, serious psychosocial consequences may result from these behaviors, including isolation, shame, depression, marital discord, and suicidal thoughts. Among Dr. Voon's patients, pathologic gambling led to a mean loss of $125,000, while some of Dr. Suchowersky's patients “literally lost the farm.”
SAN DIEGO — The specific drug combination of a dopamine agonist and levodopa may trigger the onset of pathological behaviors, including compulsive gambling, hypersexuality, and compulsive shopping in a subset of patients with Parkinson's disease, according to the results of two independent investigations on a total of 485 patients presented at the annual meeting of the American Academy of Neurology.
“Although since 2000 there have been case reports [of pathologic behaviors], these are the first systematic detailed evaluations of these patients,” said Dr. Oksana Suchowersky of the University of Calgary, Alberta, Canada. In her study, 188 patients with Parkinson's disease (PD) were surveyed for difficulties with gambling. Twelve patients met DSM IV criteria for pathological gambling, equivalent to a lifetime prevalence rate of 6%, compared with 1.5% in the general population.
All patients who developed pathological gambling had been recreational gamblers before starting PD medications, and all had been treated with levodopa plus a dopamine agonist, rather than with levodopa (0 of 93 patients) or bromocriptine (0 of 14 patients) monotherapy. The risk of developing pathological gambling appeared to be a class effect of the dopamine agonists, with no significant differences among those treated with pramipexole (10%), pergolide (17%), or ropinirole (17%).
Dr. Valerie Voon, a psychiatrist who conducted research at the Toronto Western Hospital Movement Disorders Centre, investigated pathological gambling, hypersexuality, and compulsive shopping in 297 patients with PD. She found that overall lifetime prevalence (which includes both past and current behaviors) for the group was 6%, which increased to 16% in patients taking levodopa and dopamine agonist in combination. The lifetime prevalence was 3.4% for pathologic gambling, 2.4% for hypersexuality, and 0.7% for compulsive shopping; 10%–20% of patients exhibited more than one disorder.
One hypothesis is that these obsessive behaviors reflect excessive stimulation of the limbic reward system in susceptible individuals. Risk factors that may increase susceptibility to compulsive behaviors include younger age of PD onset, novelty-seeking personality traits, and history of alcohol abuse. Stage of disease was ruled out as a risk factor.
These findings suggest that clinicians should regularly query patients with PD and family members about excessive behaviors, which may take the form of hobbies, collections, sexual behavior, or shopping. Early identification can help physicians make adjustments that may rectify the problematic behaviors, including switching dopaminergic agonists, discontinuing therapy if possible, or even substituting deep brain stimulation for long-term dopaminergic therapy. The latter option should be used with caution, since Suchowersky found that 5% of 39 deep brain stimulation patients actually developed pathologic gambling after surgery.
Left unchecked, serious psychosocial consequences may result from these behaviors, including isolation, shame, depression, marital discord, and suicidal thoughts. Among Dr. Voon's patients, pathologic gambling led to a mean loss of $125,000, while some of Dr. Suchowersky's patients “literally lost the farm.”
SAN DIEGO — The specific drug combination of a dopamine agonist and levodopa may trigger the onset of pathological behaviors, including compulsive gambling, hypersexuality, and compulsive shopping in a subset of patients with Parkinson's disease, according to the results of two independent investigations on a total of 485 patients presented at the annual meeting of the American Academy of Neurology.
“Although since 2000 there have been case reports [of pathologic behaviors], these are the first systematic detailed evaluations of these patients,” said Dr. Oksana Suchowersky of the University of Calgary, Alberta, Canada. In her study, 188 patients with Parkinson's disease (PD) were surveyed for difficulties with gambling. Twelve patients met DSM IV criteria for pathological gambling, equivalent to a lifetime prevalence rate of 6%, compared with 1.5% in the general population.
All patients who developed pathological gambling had been recreational gamblers before starting PD medications, and all had been treated with levodopa plus a dopamine agonist, rather than with levodopa (0 of 93 patients) or bromocriptine (0 of 14 patients) monotherapy. The risk of developing pathological gambling appeared to be a class effect of the dopamine agonists, with no significant differences among those treated with pramipexole (10%), pergolide (17%), or ropinirole (17%).
Dr. Valerie Voon, a psychiatrist who conducted research at the Toronto Western Hospital Movement Disorders Centre, investigated pathological gambling, hypersexuality, and compulsive shopping in 297 patients with PD. She found that overall lifetime prevalence (which includes both past and current behaviors) for the group was 6%, which increased to 16% in patients taking levodopa and dopamine agonist in combination. The lifetime prevalence was 3.4% for pathologic gambling, 2.4% for hypersexuality, and 0.7% for compulsive shopping; 10%–20% of patients exhibited more than one disorder.
One hypothesis is that these obsessive behaviors reflect excessive stimulation of the limbic reward system in susceptible individuals. Risk factors that may increase susceptibility to compulsive behaviors include younger age of PD onset, novelty-seeking personality traits, and history of alcohol abuse. Stage of disease was ruled out as a risk factor.
These findings suggest that clinicians should regularly query patients with PD and family members about excessive behaviors, which may take the form of hobbies, collections, sexual behavior, or shopping. Early identification can help physicians make adjustments that may rectify the problematic behaviors, including switching dopaminergic agonists, discontinuing therapy if possible, or even substituting deep brain stimulation for long-term dopaminergic therapy. The latter option should be used with caution, since Suchowersky found that 5% of 39 deep brain stimulation patients actually developed pathologic gambling after surgery.
Left unchecked, serious psychosocial consequences may result from these behaviors, including isolation, shame, depression, marital discord, and suicidal thoughts. Among Dr. Voon's patients, pathologic gambling led to a mean loss of $125,000, while some of Dr. Suchowersky's patients “literally lost the farm.”
Too Much Intraarterial TPA Impedes Clot Lysis
OAHU, HAWAII — Inadvertent overdosing of ischemic stroke patients with tissue plasminogen activator can significantly undermine the drug's effectiveness, Buddy Connors, M.D., said at a meeting sponsored by the American Society of Interventional and Therapeutic Neuroradiology.
When tissue plasminogen activator (TPA) is administered for treatment of an acute ischemic stroke, the dose used for catheter-directed intraarterial fibrinolysis might be inadvertently 100–1,000 times the optimal dose.
Few interventionalists or stroke neurologists realize that when these relatively “massive” doses are given intraarterially by catheter-directed therapy, thrombolytic activity may actually be decreased by up to 90%, according to Dr. Connors, medical director of interventional neuroradiology at Baptist Cardiac and Vascular Institute in Miami.
Although intravenous alteplase initiated within 3 hours after the onset of stroke symptoms is the only TPA treatment approved by the Food and Drug Administration for acute ischemic stroke, recombinant TPA, such as alteplase and reteplase, are being used off label for intraarterial lysis in ischemic stroke.
To gain more accurate clinical information about dosing of intraarterial thrombolytic agents and stroke outcomes, Dr. Connors urged the audience members to contribute data to the Interventional Stroke Therapy Outcomes Registry (INSTOR) at www.strokeregistry.org
In addition to TPA's direct neurotoxic effects, serious adverse events may result from overshooting the optimal dose. These can include increasing the risk of bleeding in the brain as well as remote areas such as the gums, gastrointestinal tract, retroperitoneum, or elsewhere, as well as direct interference with clot lysis.
This unintentional intraarterial overdosing has arisen because no dose-ranging studies have been done specifically for intraarterial TPA stroke therapy, Dr. Connors said.
Doses for TPA that are typically used for intraarterial stroke therapy were arbitrarily chosen to be “one-third” of the total dose that was proved effective for intravenous stroke therapy by the National Institute of Neurological Disorders and Stroke IV TPA stroke trials. This decision resulted in the very high intraarterial dose used in the later intraarterial trials.
The data proving this paradox in dosing were obtained from direct pharmacokinetic testing as well as in vivo testing, Dr. Connors noted. Both alteplase and reteplase demonstrate well-defined bell-shaped curves of fibrinolytic activity. At twofold higher or lower concentration, activity is reduced by 25%. At eightfold higher or lower concentration, activity is reduced by 50%, compared with the optimal dose. At 100 times the optimal dose, activity might be cut by as much as 90%.
Dr. Connors suggested the lytic capability for intraarterial thrombolysis with reteplase and alteplase are about equal and the optimal infusion concentrations should be about 1 U reteplase/100 cc normal saline infused at 0.1–1 U/hr and 1 mg/100 cc for alteplase infused at 0.1–1 mg/hr.
The optimal dosing for urokinase might be 250,000–500,000 U/hr for urokinase (mixed in 100 cc of normal saline). These concentrations are typically infused into stagnant blood, thus preserving the high concentrations of even these extremely low doses.
As explanation of these recommendations, first it is important to remember that TPA itself does not dissolve clot—plasmin does, Dr. Connors said. TPAs are catalysts for the reaction that turns plasminogen into plasmin. Fibrinolysis occurs when plasmin binds to a receptor on fibrin and then causes lysis of fibrin. High doses of TPA flood these receptors and block plasmin's ability to bind with these receptors on fibrin, thus interfering with fibrinolysis.
“Don't oversaturate the receptors on fibrin with TPA. You want to optimally catalyze plasminogen into plasmin and allow the plasmin to then reach these receptors on fibrin in order to cause lysis,” Dr. Connors said.
Besides dose conservation, he said that intraarterial thrombolytic outcomes improve if therapy is started before the 3-hour mark but rarely beyond 7 hours (except in basilar artery thrombosis—a distinct entity of its own).
OAHU, HAWAII — Inadvertent overdosing of ischemic stroke patients with tissue plasminogen activator can significantly undermine the drug's effectiveness, Buddy Connors, M.D., said at a meeting sponsored by the American Society of Interventional and Therapeutic Neuroradiology.
When tissue plasminogen activator (TPA) is administered for treatment of an acute ischemic stroke, the dose used for catheter-directed intraarterial fibrinolysis might be inadvertently 100–1,000 times the optimal dose.
Few interventionalists or stroke neurologists realize that when these relatively “massive” doses are given intraarterially by catheter-directed therapy, thrombolytic activity may actually be decreased by up to 90%, according to Dr. Connors, medical director of interventional neuroradiology at Baptist Cardiac and Vascular Institute in Miami.
Although intravenous alteplase initiated within 3 hours after the onset of stroke symptoms is the only TPA treatment approved by the Food and Drug Administration for acute ischemic stroke, recombinant TPA, such as alteplase and reteplase, are being used off label for intraarterial lysis in ischemic stroke.
To gain more accurate clinical information about dosing of intraarterial thrombolytic agents and stroke outcomes, Dr. Connors urged the audience members to contribute data to the Interventional Stroke Therapy Outcomes Registry (INSTOR) at www.strokeregistry.org
In addition to TPA's direct neurotoxic effects, serious adverse events may result from overshooting the optimal dose. These can include increasing the risk of bleeding in the brain as well as remote areas such as the gums, gastrointestinal tract, retroperitoneum, or elsewhere, as well as direct interference with clot lysis.
This unintentional intraarterial overdosing has arisen because no dose-ranging studies have been done specifically for intraarterial TPA stroke therapy, Dr. Connors said.
Doses for TPA that are typically used for intraarterial stroke therapy were arbitrarily chosen to be “one-third” of the total dose that was proved effective for intravenous stroke therapy by the National Institute of Neurological Disorders and Stroke IV TPA stroke trials. This decision resulted in the very high intraarterial dose used in the later intraarterial trials.
The data proving this paradox in dosing were obtained from direct pharmacokinetic testing as well as in vivo testing, Dr. Connors noted. Both alteplase and reteplase demonstrate well-defined bell-shaped curves of fibrinolytic activity. At twofold higher or lower concentration, activity is reduced by 25%. At eightfold higher or lower concentration, activity is reduced by 50%, compared with the optimal dose. At 100 times the optimal dose, activity might be cut by as much as 90%.
Dr. Connors suggested the lytic capability for intraarterial thrombolysis with reteplase and alteplase are about equal and the optimal infusion concentrations should be about 1 U reteplase/100 cc normal saline infused at 0.1–1 U/hr and 1 mg/100 cc for alteplase infused at 0.1–1 mg/hr.
The optimal dosing for urokinase might be 250,000–500,000 U/hr for urokinase (mixed in 100 cc of normal saline). These concentrations are typically infused into stagnant blood, thus preserving the high concentrations of even these extremely low doses.
As explanation of these recommendations, first it is important to remember that TPA itself does not dissolve clot—plasmin does, Dr. Connors said. TPAs are catalysts for the reaction that turns plasminogen into plasmin. Fibrinolysis occurs when plasmin binds to a receptor on fibrin and then causes lysis of fibrin. High doses of TPA flood these receptors and block plasmin's ability to bind with these receptors on fibrin, thus interfering with fibrinolysis.
“Don't oversaturate the receptors on fibrin with TPA. You want to optimally catalyze plasminogen into plasmin and allow the plasmin to then reach these receptors on fibrin in order to cause lysis,” Dr. Connors said.
Besides dose conservation, he said that intraarterial thrombolytic outcomes improve if therapy is started before the 3-hour mark but rarely beyond 7 hours (except in basilar artery thrombosis—a distinct entity of its own).
OAHU, HAWAII — Inadvertent overdosing of ischemic stroke patients with tissue plasminogen activator can significantly undermine the drug's effectiveness, Buddy Connors, M.D., said at a meeting sponsored by the American Society of Interventional and Therapeutic Neuroradiology.
When tissue plasminogen activator (TPA) is administered for treatment of an acute ischemic stroke, the dose used for catheter-directed intraarterial fibrinolysis might be inadvertently 100–1,000 times the optimal dose.
Few interventionalists or stroke neurologists realize that when these relatively “massive” doses are given intraarterially by catheter-directed therapy, thrombolytic activity may actually be decreased by up to 90%, according to Dr. Connors, medical director of interventional neuroradiology at Baptist Cardiac and Vascular Institute in Miami.
Although intravenous alteplase initiated within 3 hours after the onset of stroke symptoms is the only TPA treatment approved by the Food and Drug Administration for acute ischemic stroke, recombinant TPA, such as alteplase and reteplase, are being used off label for intraarterial lysis in ischemic stroke.
To gain more accurate clinical information about dosing of intraarterial thrombolytic agents and stroke outcomes, Dr. Connors urged the audience members to contribute data to the Interventional Stroke Therapy Outcomes Registry (INSTOR) at www.strokeregistry.org
In addition to TPA's direct neurotoxic effects, serious adverse events may result from overshooting the optimal dose. These can include increasing the risk of bleeding in the brain as well as remote areas such as the gums, gastrointestinal tract, retroperitoneum, or elsewhere, as well as direct interference with clot lysis.
This unintentional intraarterial overdosing has arisen because no dose-ranging studies have been done specifically for intraarterial TPA stroke therapy, Dr. Connors said.
Doses for TPA that are typically used for intraarterial stroke therapy were arbitrarily chosen to be “one-third” of the total dose that was proved effective for intravenous stroke therapy by the National Institute of Neurological Disorders and Stroke IV TPA stroke trials. This decision resulted in the very high intraarterial dose used in the later intraarterial trials.
The data proving this paradox in dosing were obtained from direct pharmacokinetic testing as well as in vivo testing, Dr. Connors noted. Both alteplase and reteplase demonstrate well-defined bell-shaped curves of fibrinolytic activity. At twofold higher or lower concentration, activity is reduced by 25%. At eightfold higher or lower concentration, activity is reduced by 50%, compared with the optimal dose. At 100 times the optimal dose, activity might be cut by as much as 90%.
Dr. Connors suggested the lytic capability for intraarterial thrombolysis with reteplase and alteplase are about equal and the optimal infusion concentrations should be about 1 U reteplase/100 cc normal saline infused at 0.1–1 U/hr and 1 mg/100 cc for alteplase infused at 0.1–1 mg/hr.
The optimal dosing for urokinase might be 250,000–500,000 U/hr for urokinase (mixed in 100 cc of normal saline). These concentrations are typically infused into stagnant blood, thus preserving the high concentrations of even these extremely low doses.
As explanation of these recommendations, first it is important to remember that TPA itself does not dissolve clot—plasmin does, Dr. Connors said. TPAs are catalysts for the reaction that turns plasminogen into plasmin. Fibrinolysis occurs when plasmin binds to a receptor on fibrin and then causes lysis of fibrin. High doses of TPA flood these receptors and block plasmin's ability to bind with these receptors on fibrin, thus interfering with fibrinolysis.
“Don't oversaturate the receptors on fibrin with TPA. You want to optimally catalyze plasminogen into plasmin and allow the plasmin to then reach these receptors on fibrin in order to cause lysis,” Dr. Connors said.
Besides dose conservation, he said that intraarterial thrombolytic outcomes improve if therapy is started before the 3-hour mark but rarely beyond 7 hours (except in basilar artery thrombosis—a distinct entity of its own).
Merci Enables Recanalization of Carotid Terminus
OAHU, HAWAII — Mechanical embolectomy with the Merci retrieval system successfully restored vascular patency in 70% of patients with acute ischemic stroke caused by heretofore difficult-to-reach occlusions in the carotid terminus, Ronald F. Budzik Jr., M.D., said at a meeting sponsored by the American Society of Interventional and Therapeutic Neuroradiology.
Recanalized patients had significantly better neurologic outcomes than nonrecanalized patients, said Dr. Budzik, a neuroradiologist and codirector of interventional neuroradiology at Riverside Methodist Hospital, Columbus, Ohio.
Attempts to treat occlusions of the terminal internal carotid artery bifurcation with intravenous or intraarterial thrombolytics, such as alteplase or urokinase, have been ineffective, as evidenced by low mean recanalization rates, poor neurologic outcomes, and significant mortality after treatment failure. “These poor results have prompted clinicians to try alternative strategies,” said Dr. Budzik, who is a consultant to Concentric Medical Inc., which makes the Merci retrieval system.
Dr. Budzik retrospectively analyzed the data from 20 patients with carotid terminus lesions in the MERCI (Mechanical Embolus Removal in Cerebral Ischemia) trial. The trial investigated the safety and efficacy of the Merci retriever for opening occluded intracranial large vessels within 8 hours of the onset of stroke symptoms in a prospective, nonrandomized, multicenter trial. Safety and efficacy results of the trial have recently been published. (See box.)
Twelve patients with carotid terminus lesions (60%) were successfully recanalized following clot retrieval alone, and 14 patients (70%) achieved vascular patency when adjunctive therapies were added. Successful recanalization was defined as final Thrombolysis in Myocardial Infarction (TIMI) grade 2 or 3 flow in all treatable vessels (internal carotid artery, terminus of the internal carotid artery, and middle cerebral arteries 1 and 2).
Revascularization was clearly associated with good neurologic outcome, said Dr. Budzik. When patients were stratified according to whether recanalization was successful, 64% of those who achieved vascular patency had modified Rankin scale scores of 0–3 at 90 days, compared with 0% of those who did not (P = .03). When good neurologic outcome was defined as modified Rankin scale scores of 0–2, a similar trend was seen between recanalized and nonrecanalized patients (43% vs. 0%, respectively, P = .16).
Alternatively, failure to recanalize had serious consequences. While the overall mortality rate for the group at 90 days was 50%, mortality rates were higher among patients who could not be recanalized, compared with those who could (83% vs. 36%, respectively, P = .15). For example, a 65-year-old man presented with severe clinical symptoms (National Institutes of Health Stroke Scale [NIHSS] score of 20) 61/2 hours after symptom onset. Angiography showed the lesion was localized to the internal carotid terminus. After two passes with the X5 model of the Merci retriever, a 3-cm clot was removed and patency was restored.
Dr. Budzik, who is a member of a dedicated stroke center, said that triage is critical for rapidly determining which patients are eligible for embolectomy, antithrombolytic therapy, stenting, or other procedures. Candidates for clot retrieval should have a CT scan that is negative for hemorrhage or infarction, an NIHSS score of at least 8, and symptom duration of less than 8 hours. Those with symptoms for more than 8 hours may be eligible if they have severe stroke symptoms but no established evidence of stroke. Embolectomy patients often present after the 3-hour tissue plasminogen activator time window or are otherwise ineligible for intravenous tissue plasminogen activator. “Mechanical embolectomy is the treatment of choice for stroke caused by internal carotid terminus lesions,” said Dr. Budzik. “These are very bad strokes with high mortality rates of 40%–65% without treatment.”
MERCI Trial
The MERCI trial included 141 patients with intracranial occlusions who underwent mechanical embolectomy between 2001 and 2003 using the X5 and X6 first-generation Merci Retriever devices (Stroke 2005;36:1432–8). These devices received Food and Drug Administration approval in August 2004 for removing clots from the cerebral artery in patients with stroke. Results of the more recent Multi-MERCI trial, which utilized the LX/L5 and LX/L6 second-generation Merci devices, have not yet been published. The LX/L5, a single-use device, has been approved by the FDA as a foreign-body retriever, and the LX/L6 has been submitted for approval.
OAHU, HAWAII — Mechanical embolectomy with the Merci retrieval system successfully restored vascular patency in 70% of patients with acute ischemic stroke caused by heretofore difficult-to-reach occlusions in the carotid terminus, Ronald F. Budzik Jr., M.D., said at a meeting sponsored by the American Society of Interventional and Therapeutic Neuroradiology.
Recanalized patients had significantly better neurologic outcomes than nonrecanalized patients, said Dr. Budzik, a neuroradiologist and codirector of interventional neuroradiology at Riverside Methodist Hospital, Columbus, Ohio.
Attempts to treat occlusions of the terminal internal carotid artery bifurcation with intravenous or intraarterial thrombolytics, such as alteplase or urokinase, have been ineffective, as evidenced by low mean recanalization rates, poor neurologic outcomes, and significant mortality after treatment failure. “These poor results have prompted clinicians to try alternative strategies,” said Dr. Budzik, who is a consultant to Concentric Medical Inc., which makes the Merci retrieval system.
Dr. Budzik retrospectively analyzed the data from 20 patients with carotid terminus lesions in the MERCI (Mechanical Embolus Removal in Cerebral Ischemia) trial. The trial investigated the safety and efficacy of the Merci retriever for opening occluded intracranial large vessels within 8 hours of the onset of stroke symptoms in a prospective, nonrandomized, multicenter trial. Safety and efficacy results of the trial have recently been published. (See box.)
Twelve patients with carotid terminus lesions (60%) were successfully recanalized following clot retrieval alone, and 14 patients (70%) achieved vascular patency when adjunctive therapies were added. Successful recanalization was defined as final Thrombolysis in Myocardial Infarction (TIMI) grade 2 or 3 flow in all treatable vessels (internal carotid artery, terminus of the internal carotid artery, and middle cerebral arteries 1 and 2).
Revascularization was clearly associated with good neurologic outcome, said Dr. Budzik. When patients were stratified according to whether recanalization was successful, 64% of those who achieved vascular patency had modified Rankin scale scores of 0–3 at 90 days, compared with 0% of those who did not (P = .03). When good neurologic outcome was defined as modified Rankin scale scores of 0–2, a similar trend was seen between recanalized and nonrecanalized patients (43% vs. 0%, respectively, P = .16).
Alternatively, failure to recanalize had serious consequences. While the overall mortality rate for the group at 90 days was 50%, mortality rates were higher among patients who could not be recanalized, compared with those who could (83% vs. 36%, respectively, P = .15). For example, a 65-year-old man presented with severe clinical symptoms (National Institutes of Health Stroke Scale [NIHSS] score of 20) 61/2 hours after symptom onset. Angiography showed the lesion was localized to the internal carotid terminus. After two passes with the X5 model of the Merci retriever, a 3-cm clot was removed and patency was restored.
Dr. Budzik, who is a member of a dedicated stroke center, said that triage is critical for rapidly determining which patients are eligible for embolectomy, antithrombolytic therapy, stenting, or other procedures. Candidates for clot retrieval should have a CT scan that is negative for hemorrhage or infarction, an NIHSS score of at least 8, and symptom duration of less than 8 hours. Those with symptoms for more than 8 hours may be eligible if they have severe stroke symptoms but no established evidence of stroke. Embolectomy patients often present after the 3-hour tissue plasminogen activator time window or are otherwise ineligible for intravenous tissue plasminogen activator. “Mechanical embolectomy is the treatment of choice for stroke caused by internal carotid terminus lesions,” said Dr. Budzik. “These are very bad strokes with high mortality rates of 40%–65% without treatment.”
MERCI Trial
The MERCI trial included 141 patients with intracranial occlusions who underwent mechanical embolectomy between 2001 and 2003 using the X5 and X6 first-generation Merci Retriever devices (Stroke 2005;36:1432–8). These devices received Food and Drug Administration approval in August 2004 for removing clots from the cerebral artery in patients with stroke. Results of the more recent Multi-MERCI trial, which utilized the LX/L5 and LX/L6 second-generation Merci devices, have not yet been published. The LX/L5, a single-use device, has been approved by the FDA as a foreign-body retriever, and the LX/L6 has been submitted for approval.
OAHU, HAWAII — Mechanical embolectomy with the Merci retrieval system successfully restored vascular patency in 70% of patients with acute ischemic stroke caused by heretofore difficult-to-reach occlusions in the carotid terminus, Ronald F. Budzik Jr., M.D., said at a meeting sponsored by the American Society of Interventional and Therapeutic Neuroradiology.
Recanalized patients had significantly better neurologic outcomes than nonrecanalized patients, said Dr. Budzik, a neuroradiologist and codirector of interventional neuroradiology at Riverside Methodist Hospital, Columbus, Ohio.
Attempts to treat occlusions of the terminal internal carotid artery bifurcation with intravenous or intraarterial thrombolytics, such as alteplase or urokinase, have been ineffective, as evidenced by low mean recanalization rates, poor neurologic outcomes, and significant mortality after treatment failure. “These poor results have prompted clinicians to try alternative strategies,” said Dr. Budzik, who is a consultant to Concentric Medical Inc., which makes the Merci retrieval system.
Dr. Budzik retrospectively analyzed the data from 20 patients with carotid terminus lesions in the MERCI (Mechanical Embolus Removal in Cerebral Ischemia) trial. The trial investigated the safety and efficacy of the Merci retriever for opening occluded intracranial large vessels within 8 hours of the onset of stroke symptoms in a prospective, nonrandomized, multicenter trial. Safety and efficacy results of the trial have recently been published. (See box.)
Twelve patients with carotid terminus lesions (60%) were successfully recanalized following clot retrieval alone, and 14 patients (70%) achieved vascular patency when adjunctive therapies were added. Successful recanalization was defined as final Thrombolysis in Myocardial Infarction (TIMI) grade 2 or 3 flow in all treatable vessels (internal carotid artery, terminus of the internal carotid artery, and middle cerebral arteries 1 and 2).
Revascularization was clearly associated with good neurologic outcome, said Dr. Budzik. When patients were stratified according to whether recanalization was successful, 64% of those who achieved vascular patency had modified Rankin scale scores of 0–3 at 90 days, compared with 0% of those who did not (P = .03). When good neurologic outcome was defined as modified Rankin scale scores of 0–2, a similar trend was seen between recanalized and nonrecanalized patients (43% vs. 0%, respectively, P = .16).
Alternatively, failure to recanalize had serious consequences. While the overall mortality rate for the group at 90 days was 50%, mortality rates were higher among patients who could not be recanalized, compared with those who could (83% vs. 36%, respectively, P = .15). For example, a 65-year-old man presented with severe clinical symptoms (National Institutes of Health Stroke Scale [NIHSS] score of 20) 61/2 hours after symptom onset. Angiography showed the lesion was localized to the internal carotid terminus. After two passes with the X5 model of the Merci retriever, a 3-cm clot was removed and patency was restored.
Dr. Budzik, who is a member of a dedicated stroke center, said that triage is critical for rapidly determining which patients are eligible for embolectomy, antithrombolytic therapy, stenting, or other procedures. Candidates for clot retrieval should have a CT scan that is negative for hemorrhage or infarction, an NIHSS score of at least 8, and symptom duration of less than 8 hours. Those with symptoms for more than 8 hours may be eligible if they have severe stroke symptoms but no established evidence of stroke. Embolectomy patients often present after the 3-hour tissue plasminogen activator time window or are otherwise ineligible for intravenous tissue plasminogen activator. “Mechanical embolectomy is the treatment of choice for stroke caused by internal carotid terminus lesions,” said Dr. Budzik. “These are very bad strokes with high mortality rates of 40%–65% without treatment.”
MERCI Trial
The MERCI trial included 141 patients with intracranial occlusions who underwent mechanical embolectomy between 2001 and 2003 using the X5 and X6 first-generation Merci Retriever devices (Stroke 2005;36:1432–8). These devices received Food and Drug Administration approval in August 2004 for removing clots from the cerebral artery in patients with stroke. Results of the more recent Multi-MERCI trial, which utilized the LX/L5 and LX/L6 second-generation Merci devices, have not yet been published. The LX/L5, a single-use device, has been approved by the FDA as a foreign-body retriever, and the LX/L6 has been submitted for approval.