For selected patients with basal cell carcinoma, one-stop shopping – diagnosing, subtyping, and excising the lesion all in one visit – using reflectance confocal microscopy was found noninferior to the standard approach of obtaining a punch biopsy to diagnose and subtype the lesion in one visit and performing surgical excision in a separate visit.

Those were the findings of an open-label, randomized, noninferiority trial in the Netherlands comparing the two approaches in 95 adults with suspected basal cell carcinoma (BCC), investigators reported.

In addition to reducing the number of visits and the total time required for treatment, this new approach uses noninvasive reflectance confocal microscopy in the place of punch biopsy, which patients will likely prefer, said Daniel J. Kadouch, MD, of the department of dermatology, Academic Medical Center, Amsterdam, and his associates (British J Derm. 2017 Apr 9. doi: 10.1111/bjd.15559).

The study excluded patients who had lesions in a high-risk location of the face, lesions larger than 20 mm, recurrent lesions, and macroscopic ulcerating lesions, as well as patients who had basal cell nevus syndrome. Another 22 patients who were found to have non-BCC lesions (1 melanoma, 2 squamous cell carcinomas, 5 cases of Bowen’s disease, and 11 nonmalignant lesions) also were excluded, leaving 40 patients with BCC in the one-stop shopping group and 33 in the standard of care (control) group.

The primary outcome – the proportion of patients with tumor-free margins on the final pathology report after surgical excision – was 100% (40 of 40) in the one-stop shopping group and 94% (31 of 33) in the control group, which demonstrates the noninferiority of the new, less invasive approach, Dr. Kadouch and his associates said.

The mean total treatment time was 2 hours and 23 minutes for the one-stop shopping group. The total treatment time could not be determined for the control group because their surgical times weren’t recorded.

Adverse events included four postoperative wound infections in the one-stop shopping group, all of which were successfully treated with oral antibiotics, and one case of excessive postoperative bleeding in the control group, which required 3 days of hospitalization.

This study was limited in that it excluded patients with large lesions and those with BCC on high-risk areas of the face, which reduces the generalizability of the findings. In addition, a follow-up time of at least 1 year would be needed to detect signs of BCC recurrence in the study participants, the investigators said.

For selected patients with basal cell carcinoma, one-stop shopping – diagnosing, subtyping, and excising the lesion all in one visit – using reflectance confocal microscopy was found noninferior to the standard approach of obtaining a punch biopsy to diagnose and subtype the lesion in one visit and performing surgical excision in a separate visit.

Those were the findings of an open-label, randomized, noninferiority trial in the Netherlands comparing the two approaches in 95 adults with suspected basal cell carcinoma (BCC), investigators reported.

In addition to reducing the number of visits and the total time required for treatment, this new approach uses noninvasive reflectance confocal microscopy in the place of punch biopsy, which patients will likely prefer, said Daniel J. Kadouch, MD, of the department of dermatology, Academic Medical Center, Amsterdam, and his associates (British J Derm. 2017 Apr 9. doi: 10.1111/bjd.15559).

The study excluded patients who had lesions in a high-risk location of the face, lesions larger than 20 mm, recurrent lesions, and macroscopic ulcerating lesions, as well as patients who had basal cell nevus syndrome. Another 22 patients who were found to have non-BCC lesions (1 melanoma, 2 squamous cell carcinomas, 5 cases of Bowen’s disease, and 11 nonmalignant lesions) also were excluded, leaving 40 patients with BCC in the one-stop shopping group and 33 in the standard of care (control) group.

The primary outcome – the proportion of patients with tumor-free margins on the final pathology report after surgical excision – was 100% (40 of 40) in the one-stop shopping group and 94% (31 of 33) in the control group, which demonstrates the noninferiority of the new, less invasive approach, Dr. Kadouch and his associates said.

The mean total treatment time was 2 hours and 23 minutes for the one-stop shopping group. The total treatment time could not be determined for the control group because their surgical times weren’t recorded.

Adverse events included four postoperative wound infections in the one-stop shopping group, all of which were successfully treated with oral antibiotics, and one case of excessive postoperative bleeding in the control group, which required 3 days of hospitalization.

This study was limited in that it excluded patients with large lesions and those with BCC on high-risk areas of the face, which reduces the generalizability of the findings. In addition, a follow-up time of at least 1 year would be needed to detect signs of BCC recurrence in the study participants, the investigators said.

For selected patients with basal cell carcinoma, one-stop shopping – diagnosing, subtyping, and excising the lesion all in one visit – using reflectance confocal microscopy was found noninferior to the standard approach of obtaining a punch biopsy to diagnose and subtype the lesion in one visit and performing surgical excision in a separate visit.

Those were the findings of an open-label, randomized, noninferiority trial in the Netherlands comparing the two approaches in 95 adults with suspected basal cell carcinoma (BCC), investigators reported.

In addition to reducing the number of visits and the total time required for treatment, this new approach uses noninvasive reflectance confocal microscopy in the place of punch biopsy, which patients will likely prefer, said Daniel J. Kadouch, MD, of the department of dermatology, Academic Medical Center, Amsterdam, and his associates (British J Derm. 2017 Apr 9. doi: 10.1111/bjd.15559).

The study excluded patients who had lesions in a high-risk location of the face, lesions larger than 20 mm, recurrent lesions, and macroscopic ulcerating lesions, as well as patients who had basal cell nevus syndrome. Another 22 patients who were found to have non-BCC lesions (1 melanoma, 2 squamous cell carcinomas, 5 cases of Bowen’s disease, and 11 nonmalignant lesions) also were excluded, leaving 40 patients with BCC in the one-stop shopping group and 33 in the standard of care (control) group.

The primary outcome – the proportion of patients with tumor-free margins on the final pathology report after surgical excision – was 100% (40 of 40) in the one-stop shopping group and 94% (31 of 33) in the control group, which demonstrates the noninferiority of the new, less invasive approach, Dr. Kadouch and his associates said.

The mean total treatment time was 2 hours and 23 minutes for the one-stop shopping group. The total treatment time could not be determined for the control group because their surgical times weren’t recorded.

Adverse events included four postoperative wound infections in the one-stop shopping group, all of which were successfully treated with oral antibiotics, and one case of excessive postoperative bleeding in the control group, which required 3 days of hospitalization.

This study was limited in that it excluded patients with large lesions and those with BCC on high-risk areas of the face, which reduces the generalizability of the findings. In addition, a follow-up time of at least 1 year would be needed to detect signs of BCC recurrence in the study participants, the investigators said.

The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation, according to a report published online April 24 in JAMA Internal Medicine.

A recent observational Canadian study suggested that blood from young donors and female donors increased the recipients’ risk of death – a finding which, if confirmed, would have immediate implications for medical practice.

A separate group of Scandinavian researchers attempted to replicate these findings by performing a retrospective cohort study using similar but more nuanced statistical methods. Gustaf Edgren, MD, PhD, of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and his associates analyzed information collected on 968,264 patients over a 10-year period from a Swedish and Danish transfusion database.

In initial, unadjusted analyses, both extremes of age (young and old) and female sex in the donor were associated with reduced survival in the recipient. However, that association disappeared when the data were adjusted to account for the total number of transfusions a patient received, a marker of their severity of illness. The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99. This pattern also occurred in sensitivity analyses, the investigators noted (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0890).

“When studying associations between ... transfusions with a particular characteristic and the risk of death in the recipient, [the] underlying disease severity ... may still confound the association. However, with meticulous adjustment for total number of transfusions, it should be possible to block the confounding effect of patient disease severity entirely,” they noted.

“We believe that, rather than reflecting true biologic effects, the Canadian results can be explained by residual confounding (i.e., that the observations resulted from incomplete adjustment for the number of transfusions),” Dr. Edgren and his associates said.

“In addition, we believe these data reinforce the importance of extreme caution in assessing epidemiologic analyses in this field, given the tremendous clinical and logistical implications of false-positive findings,” they added.

The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation, according to a report published online April 24 in JAMA Internal Medicine.

A recent observational Canadian study suggested that blood from young donors and female donors increased the recipients’ risk of death – a finding which, if confirmed, would have immediate implications for medical practice.

A separate group of Scandinavian researchers attempted to replicate these findings by performing a retrospective cohort study using similar but more nuanced statistical methods. Gustaf Edgren, MD, PhD, of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and his associates analyzed information collected on 968,264 patients over a 10-year period from a Swedish and Danish transfusion database.

In initial, unadjusted analyses, both extremes of age (young and old) and female sex in the donor were associated with reduced survival in the recipient. However, that association disappeared when the data were adjusted to account for the total number of transfusions a patient received, a marker of their severity of illness. The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99. This pattern also occurred in sensitivity analyses, the investigators noted (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0890).

“When studying associations between ... transfusions with a particular characteristic and the risk of death in the recipient, [the] underlying disease severity ... may still confound the association. However, with meticulous adjustment for total number of transfusions, it should be possible to block the confounding effect of patient disease severity entirely,” they noted.

“We believe that, rather than reflecting true biologic effects, the Canadian results can be explained by residual confounding (i.e., that the observations resulted from incomplete adjustment for the number of transfusions),” Dr. Edgren and his associates said.

“In addition, we believe these data reinforce the importance of extreme caution in assessing epidemiologic analyses in this field, given the tremendous clinical and logistical implications of false-positive findings,” they added.

The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation, according to a report published online April 24 in JAMA Internal Medicine.

A recent observational Canadian study suggested that blood from young donors and female donors increased the recipients’ risk of death – a finding which, if confirmed, would have immediate implications for medical practice.

A separate group of Scandinavian researchers attempted to replicate these findings by performing a retrospective cohort study using similar but more nuanced statistical methods. Gustaf Edgren, MD, PhD, of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and his associates analyzed information collected on 968,264 patients over a 10-year period from a Swedish and Danish transfusion database.

In initial, unadjusted analyses, both extremes of age (young and old) and female sex in the donor were associated with reduced survival in the recipient. However, that association disappeared when the data were adjusted to account for the total number of transfusions a patient received, a marker of their severity of illness. The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99. This pattern also occurred in sensitivity analyses, the investigators noted (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0890).

“When studying associations between ... transfusions with a particular characteristic and the risk of death in the recipient, [the] underlying disease severity ... may still confound the association. However, with meticulous adjustment for total number of transfusions, it should be possible to block the confounding effect of patient disease severity entirely,” they noted.

“We believe that, rather than reflecting true biologic effects, the Canadian results can be explained by residual confounding (i.e., that the observations resulted from incomplete adjustment for the number of transfusions),” Dr. Edgren and his associates said.

“In addition, we believe these data reinforce the importance of extreme caution in assessing epidemiologic analyses in this field, given the tremendous clinical and logistical implications of false-positive findings,” they added.

Dermatitis herpetiformis

The primary lesions of DH are vesicles and papules in a grouped or “herpetic” formation. However, as these lesions are extremely pruritic, the primary lesions may be absent in many cases and instead replaced by secondary excoriations and erosions. DH has a very classic distribution pattern, particularly involving the bilateral extensor surfaces, buttocks, and scalp. Although some cases of oral DH have been reported, mucosal involvement is generally considered to be very rare.

Despite its strong association with underlying celiac disease, most patients with DH do not report any associated gastrointestinal symptoms. Those with DH may present with any variety of other autoimmune conditions, with hypothyroidism being the most common. Interestingly, patients with DH have been shown to be at an increased development of non-Hodgkin lymphoma. It is not certain whether adherence to a strict gluten-free diet reduces this risk in this population.

Diagnosis can be made with a proper clinical history and examination, tissue pathology, direct immunofluorescence microscopy (DIF), and/or serology, with DIF being the most definitive. Perilesional skin is preferred for DIF, as lesional biopsies have been found to have higher rates of false negative results. The characteristic DIF finding diagnostic of DH is granular IgA deposits within dermal papillae, which was seen in this patient’s DIF.

Adequate treatment of DH can usually be accomplished with a combination of dapsone and a gluten-free diet. Initially, dapsone may be used for more immediate relief of associated pruritus and other bothersome symptoms. A strict gluten-free diet should be implemented as soon as possible, and dapsone can be tapered approximately 2-3 months after initiation as to avoid potential adverse effects with longterm treatment at higher doses.

The case and photo were submitted by Natasha Cowan, BS, University of California, San Diego, School of Medicine, and Nick Celano, MD, of San Diego Family Dermatology.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].

Dermatitis herpetiformis

The primary lesions of DH are vesicles and papules in a grouped or “herpetic” formation. However, as these lesions are extremely pruritic, the primary lesions may be absent in many cases and instead replaced by secondary excoriations and erosions. DH has a very classic distribution pattern, particularly involving the bilateral extensor surfaces, buttocks, and scalp. Although some cases of oral DH have been reported, mucosal involvement is generally considered to be very rare.

Despite its strong association with underlying celiac disease, most patients with DH do not report any associated gastrointestinal symptoms. Those with DH may present with any variety of other autoimmune conditions, with hypothyroidism being the most common. Interestingly, patients with DH have been shown to be at an increased development of non-Hodgkin lymphoma. It is not certain whether adherence to a strict gluten-free diet reduces this risk in this population.

Diagnosis can be made with a proper clinical history and examination, tissue pathology, direct immunofluorescence microscopy (DIF), and/or serology, with DIF being the most definitive. Perilesional skin is preferred for DIF, as lesional biopsies have been found to have higher rates of false negative results. The characteristic DIF finding diagnostic of DH is granular IgA deposits within dermal papillae, which was seen in this patient’s DIF.

Adequate treatment of DH can usually be accomplished with a combination of dapsone and a gluten-free diet. Initially, dapsone may be used for more immediate relief of associated pruritus and other bothersome symptoms. A strict gluten-free diet should be implemented as soon as possible, and dapsone can be tapered approximately 2-3 months after initiation as to avoid potential adverse effects with longterm treatment at higher doses.

The case and photo were submitted by Natasha Cowan, BS, University of California, San Diego, School of Medicine, and Nick Celano, MD, of San Diego Family Dermatology.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].

Dermatitis herpetiformis

The primary lesions of DH are vesicles and papules in a grouped or “herpetic” formation. However, as these lesions are extremely pruritic, the primary lesions may be absent in many cases and instead replaced by secondary excoriations and erosions. DH has a very classic distribution pattern, particularly involving the bilateral extensor surfaces, buttocks, and scalp. Although some cases of oral DH have been reported, mucosal involvement is generally considered to be very rare.

Despite its strong association with underlying celiac disease, most patients with DH do not report any associated gastrointestinal symptoms. Those with DH may present with any variety of other autoimmune conditions, with hypothyroidism being the most common. Interestingly, patients with DH have been shown to be at an increased development of non-Hodgkin lymphoma. It is not certain whether adherence to a strict gluten-free diet reduces this risk in this population.

Diagnosis can be made with a proper clinical history and examination, tissue pathology, direct immunofluorescence microscopy (DIF), and/or serology, with DIF being the most definitive. Perilesional skin is preferred for DIF, as lesional biopsies have been found to have higher rates of false negative results. The characteristic DIF finding diagnostic of DH is granular IgA deposits within dermal papillae, which was seen in this patient’s DIF.

Adequate treatment of DH can usually be accomplished with a combination of dapsone and a gluten-free diet. Initially, dapsone may be used for more immediate relief of associated pruritus and other bothersome symptoms. A strict gluten-free diet should be implemented as soon as possible, and dapsone can be tapered approximately 2-3 months after initiation as to avoid potential adverse effects with longterm treatment at higher doses.

The case and photo were submitted by Natasha Cowan, BS, University of California, San Diego, School of Medicine, and Nick Celano, MD, of San Diego Family Dermatology.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected].

Hepatitis B and C appear to increase the risk of later Parkinson’s disease, according to a report published online ahead of print March 29 in Neurology.

The etiology of Parkinson’s disease is complex, and several factors, including environmental toxins and head trauma, may increase the likelihood of the disorder. Two recent epidemiologic studies in Taiwan found an association between hepatitis C and Parkinson’s disease risk, said Julia Pakpoor, BM BCh, with the Unit of Health-Care Epidemiology, Nuffield Department of Population Health, University of Oxford, United Kingdom, and her associates.

To further explore that association, the investigators performed a retrospective cohort study using data from National Health Service hospitals across England for 1999 to 2011. They assessed the risk of Parkinson’s disease among 21,633 people with hepatitis B, 48,428 with hepatitis C, 6,225 with autoimmune hepatitis, 4,234 with chronic active hepatitis, 19,870 with HIV, and 6,132,124 control subjects with other disorders.

The risk of developing Parkinson’s disease was elevated following hospitalization for hepatitis B (relative risk [RR], 1.76) and hepatitis C (RR, 1.51). “These findings may be explained by a specific aspect of viral hepatitis (rather than a general hepatic inflammatory process or general use of antivirals), but whether this reflects shared disease mechanisms, shared genetic or environmental susceptibility, sequelae of viral hepatitis per se, or a consequence of treatment remains to be determined,” Dr. Pakpoor and her associates said.

The reason for this association is not yet known. “Neurotropic features of hepatitis C have been described previously and include the potential for cognitive impairment, independent of hepatic encephalopathy. Further, all essential hepatitis C virus receptors have been shown to be expressed on the brain microvascular endothelium … suggesting one mechanism by which the virus may affect the CNS,” they noted.

In addition, parkinsonism has been described as an adverse effect of treatment with interferon and ribavirin, which are commonly used in hepatitis C infection. Parkinsonism also is known to develop in association with liver cirrhosis. Cirrhosis status was not available for the members of this study cohort.

More studies are needed to confirm this association and verify that it is causal. Such research will also provide insight into pathophysiologic pathways of Parkinson’s disease, “which may be important to understanding the development of Parkinson’s disease more broadly,” Dr. Pakpoor and her associates said.

—Mary Ann Moon

Suggested Reading

Pakpoor J, Noyce A, Goldacre R, et al. Viral hepatitis and Parkinson disease: A national record-linkage study. Neurology. 2017 Mar 29 [Epub ahead of print].

Hepatitis B and C appear to increase the risk of later Parkinson’s disease, according to a report published online ahead of print March 29 in Neurology.

The etiology of Parkinson’s disease is complex, and several factors, including environmental toxins and head trauma, may increase the likelihood of the disorder. Two recent epidemiologic studies in Taiwan found an association between hepatitis C and Parkinson’s disease risk, said Julia Pakpoor, BM BCh, with the Unit of Health-Care Epidemiology, Nuffield Department of Population Health, University of Oxford, United Kingdom, and her associates.

To further explore that association, the investigators performed a retrospective cohort study using data from National Health Service hospitals across England for 1999 to 2011. They assessed the risk of Parkinson’s disease among 21,633 people with hepatitis B, 48,428 with hepatitis C, 6,225 with autoimmune hepatitis, 4,234 with chronic active hepatitis, 19,870 with HIV, and 6,132,124 control subjects with other disorders.

The risk of developing Parkinson’s disease was elevated following hospitalization for hepatitis B (relative risk [RR], 1.76) and hepatitis C (RR, 1.51). “These findings may be explained by a specific aspect of viral hepatitis (rather than a general hepatic inflammatory process or general use of antivirals), but whether this reflects shared disease mechanisms, shared genetic or environmental susceptibility, sequelae of viral hepatitis per se, or a consequence of treatment remains to be determined,” Dr. Pakpoor and her associates said.

The reason for this association is not yet known. “Neurotropic features of hepatitis C have been described previously and include the potential for cognitive impairment, independent of hepatic encephalopathy. Further, all essential hepatitis C virus receptors have been shown to be expressed on the brain microvascular endothelium … suggesting one mechanism by which the virus may affect the CNS,” they noted.

In addition, parkinsonism has been described as an adverse effect of treatment with interferon and ribavirin, which are commonly used in hepatitis C infection. Parkinsonism also is known to develop in association with liver cirrhosis. Cirrhosis status was not available for the members of this study cohort.

More studies are needed to confirm this association and verify that it is causal. Such research will also provide insight into pathophysiologic pathways of Parkinson’s disease, “which may be important to understanding the development of Parkinson’s disease more broadly,” Dr. Pakpoor and her associates said.

—Mary Ann Moon

Suggested Reading

Pakpoor J, Noyce A, Goldacre R, et al. Viral hepatitis and Parkinson disease: A national record-linkage study. Neurology. 2017 Mar 29 [Epub ahead of print].

Hepatitis B and C appear to increase the risk of later Parkinson’s disease, according to a report published online ahead of print March 29 in Neurology.

The etiology of Parkinson’s disease is complex, and several factors, including environmental toxins and head trauma, may increase the likelihood of the disorder. Two recent epidemiologic studies in Taiwan found an association between hepatitis C and Parkinson’s disease risk, said Julia Pakpoor, BM BCh, with the Unit of Health-Care Epidemiology, Nuffield Department of Population Health, University of Oxford, United Kingdom, and her associates.

To further explore that association, the investigators performed a retrospective cohort study using data from National Health Service hospitals across England for 1999 to 2011. They assessed the risk of Parkinson’s disease among 21,633 people with hepatitis B, 48,428 with hepatitis C, 6,225 with autoimmune hepatitis, 4,234 with chronic active hepatitis, 19,870 with HIV, and 6,132,124 control subjects with other disorders.

The risk of developing Parkinson’s disease was elevated following hospitalization for hepatitis B (relative risk [RR], 1.76) and hepatitis C (RR, 1.51). “These findings may be explained by a specific aspect of viral hepatitis (rather than a general hepatic inflammatory process or general use of antivirals), but whether this reflects shared disease mechanisms, shared genetic or environmental susceptibility, sequelae of viral hepatitis per se, or a consequence of treatment remains to be determined,” Dr. Pakpoor and her associates said.

The reason for this association is not yet known. “Neurotropic features of hepatitis C have been described previously and include the potential for cognitive impairment, independent of hepatic encephalopathy. Further, all essential hepatitis C virus receptors have been shown to be expressed on the brain microvascular endothelium … suggesting one mechanism by which the virus may affect the CNS,” they noted.

In addition, parkinsonism has been described as an adverse effect of treatment with interferon and ribavirin, which are commonly used in hepatitis C infection. Parkinsonism also is known to develop in association with liver cirrhosis. Cirrhosis status was not available for the members of this study cohort.

More studies are needed to confirm this association and verify that it is causal. Such research will also provide insight into pathophysiologic pathways of Parkinson’s disease, “which may be important to understanding the development of Parkinson’s disease more broadly,” Dr. Pakpoor and her associates said.

—Mary Ann Moon

Suggested Reading

Pakpoor J, Noyce A, Goldacre R, et al. Viral hepatitis and Parkinson disease: A national record-linkage study. Neurology. 2017 Mar 29 [Epub ahead of print].

HOUSTON—Among patients who undergo thrombectomy under general anesthesia, a decrease in blood pressure during treatment is associated with worse functional outcome, according to research presented at the International Stroke Conference 2017. The data suggest the importance of stringent blood pressure targets for improving outcome in patients treated under general anesthesia, said Kilian M. Treurniet, MD, a physician-researcher at the Academic Medical Center in Amsterdam.

The MR CLEAN trial indicated that intra-arterial treatment, including mechanical thrombectomy, is an effective and safe treatment for acute ischemic stroke. The investigators noticed, however, a loss of treatment effect when the procedure was performed on patients under general anesthesia. The researchers hypothesized that decreases in blood pressure might explain this loss of effect, said Dr. Treurniet.

To test this hypothesis, he and his colleagues performed a post hoc analysis of the MR CLEAN data to examine whether decreases from baseline in blood pressure during intervention under general anesthesia were associated with functional outcome. Patients were included in the analysis if their baseline blood pressure had been recorded and if they had regular blood pressure measurements during induction and maintenance anesthesia. The investigators focused on mean arterial pressure on the presumption that it most closely approximates cerebral perfusion pressure. The primary outcome was modified Rankin Scale (mRS) score at 90 days. The investigators performed a primary analysis before adjusting the data for known prognostic factors such as NIH Stroke Scale score and occlusion location.

In all, 60 patients treated under general anesthesia were included in the analysis. Age, sex, and occlusion location were similarly distributed in this population, compared with the larger MR CLEAN population. The majority of patients received propofol as an induction anesthetic and sevoflurane as a maintenance anesthetic.

At baseline, patients’ median systolic blood pressure was 140 mm Hg, and median mean arterial pressure was 100 mm Hg. The average decline in mean arterial pressure during the intervention, compared with baseline blood pressure, was 17 mm Hg. Patients with greater decreases in blood pressure had higher mRS scores at 90 days. Few patients in the analysis had low mRS scores, however, which makes the estimation of the association less precise, said Dr. Treurniet.

In the primary analysis, average mean arterial pressure during the intervention and lowest mean arterial pressure during the intervention were significantly associated with functional outcome. After adjustment, the association between average mean arterial pressure and functional outcome remained significant.

One of the limitations of the analysis is that the data came from nine centers and thus were heterogeneous. Blood pressure was not measured with the same frequency at every center. In addition, the sample size was small, and patients were not randomized to general anesthesia or to local anesthesia. Baseline blood pressure was based on a single manual measurement that could incorporate variability. Finally, the centers used invasive and noninvasive measurements during the procedure, and this heterogeneity could have influenced the results, said Dr. Treurniet.

“A decrease in mean arterial pressure during intervention under general anesthesia is associated with worse outcome in our study,” he added. “It might be that blood pressure management in those patients is of the utmost importance. We are looking forward to possible post hoc analyses of the SIESTA trial on this topic, and the upcoming results of the GOLIATH trial for [more] information.”

—Erik Greb

Suggested Reading

Simonsen CZ, Sørensen LH, Juul N, et al. Anesthetic strategy during endovascular therapy: General anesthesia or conscious sedation? (GOLIATH - General or Local Anesthesia in Intra Arterial Therapy) A single-center randomized trial. Int J Stroke. 2016;11(9):1045-1052.

Sivasankar C, Stiefel M, Miano TA, et al. Anesthetic variation and potential impact of anesthetics used during endovascular management of acute ischemic stroke. J Neurointerv Surg. 2016;8(11):1101-1106.

Treurniet KM, Berkhemer OA, Immink RV, et al. A decrease in blood pressure is associated with unfavorable outcome in patients undergoing thrombectomy under general anesthesia. J Neurointerv Surg. 2017 Apr 12 [Epub ahead of print].

Whalin MK, Lopian S, Wyatt K, et al. Dexmedetomidine: a safe alternative to general anesthesia for endovascular stroke treatment. J Neurointerv Surg. 2014;6(4):270-275.

HOUSTON—Among patients who undergo thrombectomy under general anesthesia, a decrease in blood pressure during treatment is associated with worse functional outcome, according to research presented at the International Stroke Conference 2017. The data suggest the importance of stringent blood pressure targets for improving outcome in patients treated under general anesthesia, said Kilian M. Treurniet, MD, a physician-researcher at the Academic Medical Center in Amsterdam.

The MR CLEAN trial indicated that intra-arterial treatment, including mechanical thrombectomy, is an effective and safe treatment for acute ischemic stroke. The investigators noticed, however, a loss of treatment effect when the procedure was performed on patients under general anesthesia. The researchers hypothesized that decreases in blood pressure might explain this loss of effect, said Dr. Treurniet.

To test this hypothesis, he and his colleagues performed a post hoc analysis of the MR CLEAN data to examine whether decreases from baseline in blood pressure during intervention under general anesthesia were associated with functional outcome. Patients were included in the analysis if their baseline blood pressure had been recorded and if they had regular blood pressure measurements during induction and maintenance anesthesia. The investigators focused on mean arterial pressure on the presumption that it most closely approximates cerebral perfusion pressure. The primary outcome was modified Rankin Scale (mRS) score at 90 days. The investigators performed a primary analysis before adjusting the data for known prognostic factors such as NIH Stroke Scale score and occlusion location.

In all, 60 patients treated under general anesthesia were included in the analysis. Age, sex, and occlusion location were similarly distributed in this population, compared with the larger MR CLEAN population. The majority of patients received propofol as an induction anesthetic and sevoflurane as a maintenance anesthetic.

At baseline, patients’ median systolic blood pressure was 140 mm Hg, and median mean arterial pressure was 100 mm Hg. The average decline in mean arterial pressure during the intervention, compared with baseline blood pressure, was 17 mm Hg. Patients with greater decreases in blood pressure had higher mRS scores at 90 days. Few patients in the analysis had low mRS scores, however, which makes the estimation of the association less precise, said Dr. Treurniet.

In the primary analysis, average mean arterial pressure during the intervention and lowest mean arterial pressure during the intervention were significantly associated with functional outcome. After adjustment, the association between average mean arterial pressure and functional outcome remained significant.

One of the limitations of the analysis is that the data came from nine centers and thus were heterogeneous. Blood pressure was not measured with the same frequency at every center. In addition, the sample size was small, and patients were not randomized to general anesthesia or to local anesthesia. Baseline blood pressure was based on a single manual measurement that could incorporate variability. Finally, the centers used invasive and noninvasive measurements during the procedure, and this heterogeneity could have influenced the results, said Dr. Treurniet.

“A decrease in mean arterial pressure during intervention under general anesthesia is associated with worse outcome in our study,” he added. “It might be that blood pressure management in those patients is of the utmost importance. We are looking forward to possible post hoc analyses of the SIESTA trial on this topic, and the upcoming results of the GOLIATH trial for [more] information.”

—Erik Greb

Suggested Reading

Simonsen CZ, Sørensen LH, Juul N, et al. Anesthetic strategy during endovascular therapy: General anesthesia or conscious sedation? (GOLIATH - General or Local Anesthesia in Intra Arterial Therapy) A single-center randomized trial. Int J Stroke. 2016;11(9):1045-1052.

Sivasankar C, Stiefel M, Miano TA, et al. Anesthetic variation and potential impact of anesthetics used during endovascular management of acute ischemic stroke. J Neurointerv Surg. 2016;8(11):1101-1106.

Treurniet KM, Berkhemer OA, Immink RV, et al. A decrease in blood pressure is associated with unfavorable outcome in patients undergoing thrombectomy under general anesthesia. J Neurointerv Surg. 2017 Apr 12 [Epub ahead of print].

Whalin MK, Lopian S, Wyatt K, et al. Dexmedetomidine: a safe alternative to general anesthesia for endovascular stroke treatment. J Neurointerv Surg. 2014;6(4):270-275.

HOUSTON—Among patients who undergo thrombectomy under general anesthesia, a decrease in blood pressure during treatment is associated with worse functional outcome, according to research presented at the International Stroke Conference 2017. The data suggest the importance of stringent blood pressure targets for improving outcome in patients treated under general anesthesia, said Kilian M. Treurniet, MD, a physician-researcher at the Academic Medical Center in Amsterdam.

The MR CLEAN trial indicated that intra-arterial treatment, including mechanical thrombectomy, is an effective and safe treatment for acute ischemic stroke. The investigators noticed, however, a loss of treatment effect when the procedure was performed on patients under general anesthesia. The researchers hypothesized that decreases in blood pressure might explain this loss of effect, said Dr. Treurniet.

To test this hypothesis, he and his colleagues performed a post hoc analysis of the MR CLEAN data to examine whether decreases from baseline in blood pressure during intervention under general anesthesia were associated with functional outcome. Patients were included in the analysis if their baseline blood pressure had been recorded and if they had regular blood pressure measurements during induction and maintenance anesthesia. The investigators focused on mean arterial pressure on the presumption that it most closely approximates cerebral perfusion pressure. The primary outcome was modified Rankin Scale (mRS) score at 90 days. The investigators performed a primary analysis before adjusting the data for known prognostic factors such as NIH Stroke Scale score and occlusion location.

In all, 60 patients treated under general anesthesia were included in the analysis. Age, sex, and occlusion location were similarly distributed in this population, compared with the larger MR CLEAN population. The majority of patients received propofol as an induction anesthetic and sevoflurane as a maintenance anesthetic.

At baseline, patients’ median systolic blood pressure was 140 mm Hg, and median mean arterial pressure was 100 mm Hg. The average decline in mean arterial pressure during the intervention, compared with baseline blood pressure, was 17 mm Hg. Patients with greater decreases in blood pressure had higher mRS scores at 90 days. Few patients in the analysis had low mRS scores, however, which makes the estimation of the association less precise, said Dr. Treurniet.

In the primary analysis, average mean arterial pressure during the intervention and lowest mean arterial pressure during the intervention were significantly associated with functional outcome. After adjustment, the association between average mean arterial pressure and functional outcome remained significant.

One of the limitations of the analysis is that the data came from nine centers and thus were heterogeneous. Blood pressure was not measured with the same frequency at every center. In addition, the sample size was small, and patients were not randomized to general anesthesia or to local anesthesia. Baseline blood pressure was based on a single manual measurement that could incorporate variability. Finally, the centers used invasive and noninvasive measurements during the procedure, and this heterogeneity could have influenced the results, said Dr. Treurniet.

“A decrease in mean arterial pressure during intervention under general anesthesia is associated with worse outcome in our study,” he added. “It might be that blood pressure management in those patients is of the utmost importance. We are looking forward to possible post hoc analyses of the SIESTA trial on this topic, and the upcoming results of the GOLIATH trial for [more] information.”

—Erik Greb

Suggested Reading

Simonsen CZ, Sørensen LH, Juul N, et al. Anesthetic strategy during endovascular therapy: General anesthesia or conscious sedation? (GOLIATH - General or Local Anesthesia in Intra Arterial Therapy) A single-center randomized trial. Int J Stroke. 2016;11(9):1045-1052.

Sivasankar C, Stiefel M, Miano TA, et al. Anesthetic variation and potential impact of anesthetics used during endovascular management of acute ischemic stroke. J Neurointerv Surg. 2016;8(11):1101-1106.

Treurniet KM, Berkhemer OA, Immink RV, et al. A decrease in blood pressure is associated with unfavorable outcome in patients undergoing thrombectomy under general anesthesia. J Neurointerv Surg. 2017 Apr 12 [Epub ahead of print].

Whalin MK, Lopian S, Wyatt K, et al. Dexmedetomidine: a safe alternative to general anesthesia for endovascular stroke treatment. J Neurointerv Surg. 2014;6(4):270-275.

WASHINGTON – Red blood cell distribution width provides a novel tool for cardiovascular risk stratification in patients with systemic lupus erythematosus (SLE), Chang H. Kim, MD, reported at the annual meeting of the American College of Cardiology.

In a retrospective cohort study of nearly 70,000 patients with SLE, the 10-year rate of major adverse cardiovascular events (MACE) rose stepwise according to quintile of red cell distribution width (RDW) from 5.3% in patients with an RDW of 13.2% or less to 38.6% in those with an RDW of 15.8% or greater, according to Dr. Kim of Case Western Reserve University in Cleveland.

He utilized the Explorys database to determine the 10-year cumulative incidence of MACE – defined as acute MI, heart failure, or cerebrovascular accident – during 2007-2016 in 69,920 patients with SLE and 14,825,240 controls. Explorys is an 8-year-old Cleveland-based company that maintains a health care database incorporating 26 health care systems across the United States with nearly 50 million patients. It is part of IBM Watson Health.

[email protected]

WASHINGTON – Red blood cell distribution width provides a novel tool for cardiovascular risk stratification in patients with systemic lupus erythematosus (SLE), Chang H. Kim, MD, reported at the annual meeting of the American College of Cardiology.

In a retrospective cohort study of nearly 70,000 patients with SLE, the 10-year rate of major adverse cardiovascular events (MACE) rose stepwise according to quintile of red cell distribution width (RDW) from 5.3% in patients with an RDW of 13.2% or less to 38.6% in those with an RDW of 15.8% or greater, according to Dr. Kim of Case Western Reserve University in Cleveland.

He utilized the Explorys database to determine the 10-year cumulative incidence of MACE – defined as acute MI, heart failure, or cerebrovascular accident – during 2007-2016 in 69,920 patients with SLE and 14,825,240 controls. Explorys is an 8-year-old Cleveland-based company that maintains a health care database incorporating 26 health care systems across the United States with nearly 50 million patients. It is part of IBM Watson Health.

[email protected]

WASHINGTON – Red blood cell distribution width provides a novel tool for cardiovascular risk stratification in patients with systemic lupus erythematosus (SLE), Chang H. Kim, MD, reported at the annual meeting of the American College of Cardiology.

In a retrospective cohort study of nearly 70,000 patients with SLE, the 10-year rate of major adverse cardiovascular events (MACE) rose stepwise according to quintile of red cell distribution width (RDW) from 5.3% in patients with an RDW of 13.2% or less to 38.6% in those with an RDW of 15.8% or greater, according to Dr. Kim of Case Western Reserve University in Cleveland.

He utilized the Explorys database to determine the 10-year cumulative incidence of MACE – defined as acute MI, heart failure, or cerebrovascular accident – during 2007-2016 in 69,920 patients with SLE and 14,825,240 controls. Explorys is an 8-year-old Cleveland-based company that maintains a health care database incorporating 26 health care systems across the United States with nearly 50 million patients. It is part of IBM Watson Health.

[email protected]

Three-quarters of parents who have used telemedicine services for their children say the experience was better than an in-person office visit, according to a new study.

The analysis, released April 23, 2017, by Nemours Children’s Health System operating in five states, surveyed 500 child caregivers between February 15 and 20 about their awareness and usage of telemedicine services for their children aged 17 years and younger (mean age 10 years). Of caregivers surveyed, 15% had tried telemedicine services for their children, while another 61% reported they plan to use telemedicine in the next year for their children’s medical care, according to the study. Eight percent of caregivers did not plan to use telemedicine, and 31% of those surveyed were unsure.

Of child caregivers who have used telemedicine, 75% of reported their telemedicine experience was better than an in-person visit, according to the survey. Convenience, after-hours accessibility, and immediacy were the top three reasons caregivers sought an online visit for their child. Compared with a similar survey conducted by Nemours in 2014, parents’ use of telemedicine for their children has grown by 125% and awareness of the practice has increased by 88%, the study found.

The overall takeaway is that parents are using telemedicine because of its ease and accessibility and they’re having satisfactory experiences with the technology, said Shayan Vyas, MD, a pediatrician based in Nemours’ Orlando location and director of telemedicine for Nemours Children’s Hospital.

[email protected]

On Twitter @legal_med

Three-quarters of parents who have used telemedicine services for their children say the experience was better than an in-person office visit, according to a new study.

The analysis, released April 23, 2017, by Nemours Children’s Health System operating in five states, surveyed 500 child caregivers between February 15 and 20 about their awareness and usage of telemedicine services for their children aged 17 years and younger (mean age 10 years). Of caregivers surveyed, 15% had tried telemedicine services for their children, while another 61% reported they plan to use telemedicine in the next year for their children’s medical care, according to the study. Eight percent of caregivers did not plan to use telemedicine, and 31% of those surveyed were unsure.

Of child caregivers who have used telemedicine, 75% of reported their telemedicine experience was better than an in-person visit, according to the survey. Convenience, after-hours accessibility, and immediacy were the top three reasons caregivers sought an online visit for their child. Compared with a similar survey conducted by Nemours in 2014, parents’ use of telemedicine for their children has grown by 125% and awareness of the practice has increased by 88%, the study found.

The overall takeaway is that parents are using telemedicine because of its ease and accessibility and they’re having satisfactory experiences with the technology, said Shayan Vyas, MD, a pediatrician based in Nemours’ Orlando location and director of telemedicine for Nemours Children’s Hospital.

[email protected]

On Twitter @legal_med

Three-quarters of parents who have used telemedicine services for their children say the experience was better than an in-person office visit, according to a new study.

The analysis, released April 23, 2017, by Nemours Children’s Health System operating in five states, surveyed 500 child caregivers between February 15 and 20 about their awareness and usage of telemedicine services for their children aged 17 years and younger (mean age 10 years). Of caregivers surveyed, 15% had tried telemedicine services for their children, while another 61% reported they plan to use telemedicine in the next year for their children’s medical care, according to the study. Eight percent of caregivers did not plan to use telemedicine, and 31% of those surveyed were unsure.

Of child caregivers who have used telemedicine, 75% of reported their telemedicine experience was better than an in-person visit, according to the survey. Convenience, after-hours accessibility, and immediacy were the top three reasons caregivers sought an online visit for their child. Compared with a similar survey conducted by Nemours in 2014, parents’ use of telemedicine for their children has grown by 125% and awareness of the practice has increased by 88%, the study found.

The overall takeaway is that parents are using telemedicine because of its ease and accessibility and they’re having satisfactory experiences with the technology, said Shayan Vyas, MD, a pediatrician based in Nemours’ Orlando location and director of telemedicine for Nemours Children’s Hospital.

[email protected]

On Twitter @legal_med

BOSTON– Early results from an industry-funded registry of Parkinson’s disease patients who underwent deep brain stimulation (DBS) reveal that their quality-of-life scores grew by 22% at 6 months.

Patients, their caregivers, and their clinicians all overwhelmingly reported improvement.

The study, which examined two types of technology that are not approved in the United States, aims to fill a gap in DBS research: How do patients fare in normal conditions – “real life” – outside of clinical trials?

KUO CHUN HUNG/Thinkstock

[email protected]

BOSTON– Early results from an industry-funded registry of Parkinson’s disease patients who underwent deep brain stimulation (DBS) reveal that their quality-of-life scores grew by 22% at 6 months.

Patients, their caregivers, and their clinicians all overwhelmingly reported improvement.

The study, which examined two types of technology that are not approved in the United States, aims to fill a gap in DBS research: How do patients fare in normal conditions – “real life” – outside of clinical trials?

KUO CHUN HUNG/Thinkstock

[email protected]

BOSTON– Early results from an industry-funded registry of Parkinson’s disease patients who underwent deep brain stimulation (DBS) reveal that their quality-of-life scores grew by 22% at 6 months.

Patients, their caregivers, and their clinicians all overwhelmingly reported improvement.

The study, which examined two types of technology that are not approved in the United States, aims to fill a gap in DBS research: How do patients fare in normal conditions – “real life” – outside of clinical trials?

KUO CHUN HUNG/Thinkstock

[email protected]

HOUSTON—A flow-diverter device can treat small to medium-sized unruptured aneurysms safely and effectively, according to research presented at the International Stroke Conference 2017. The device has a high rate of aneurysm occlusion and is associated with no aneurysm rupture or recurrence at one year. The treatment also entails low rates of morbidity and mortality at one year.

One flow diverter is the Pipeline embolization device. The Pipeline device is inserted into the blood vessel and incorporates a mesh that covers the mouth of the aneurysm. The mesh allows the inner lining of the blood vessel to grow and patch the aneurysm from the inside. In April 2011, the Pipeline embolization device was approved in the United States for the treatment of aneurysms larger than 10 mm on the carotid artery. Many physicians have used the device to treat smaller aneurysms, but no investigators had examined its safety and efficacy in this indication.

Examining an Off-Label Use of the Device

Ricardo Hanel, MD, PhD, Director of Baptist Neurological Institute in Jacksonville, Florida, and colleagues conducted a prospective, multicenter study to evaluate the safety and efficacy of the Pipeline device in the treatment of small to medium-sized (ie, 12 mm or smaller), wide-necked, unruptured aneurysms on the internal carotid artery or vertebral artery. Eligible patients were between ages 22 and 80 and had an aneurysm neck that was 4 mm or larger. Patients with subarachnoid hemorrhage in the previous 30 days and those who had received an intracranial implant in the area of the target aneurysm within the previous 12 weeks were excluded.

The primary efficacy end point was complete aneurysm occlusion without significant parent artery stenosis at one year post procedure. The secondary efficacy end point was device deployment success rate. The primary safety end point was major stroke in the area supplied by the treated artery or neurologic death at one year post treatment. Secondary safety end points included major stroke or neurologic death at 30 days post treatment. Follow-up was conducted at 30 days, six months, one year, two years, and three years.

Dr. Hanel and colleagues enrolled 141 patients into the trial. The population’s mean age was approximately 55, and about 88% of the population was female. Participants had few, if any, symptoms. Approximately 48% of the population had hypertension, 38% had hyperlipidemia, and 44% were current smokers or had smoked within the previous 10 years.

Most Patients Had Complete Occlusion

Mean aneurysm size at baseline was 5 mm. About 84% of the aneurysms were smaller than 7 mm, and 16% were between 7 mm and 12 mm. Approximately 97% of aneurysms were saccular; 12% of saccular aneurysms involved a side branch, and 84% involved a sidewall, but no branch. About 4% of aneurysms were fusiform. About 95% of aneurysms were on the carotid artery. The two most common patient risk factors for treatment were patient preference (63%) and hypertension (48%).

The device was deployed to the target site successfully in about 99% of patients. Mean procedure time was approximately 80 minutes. The mean number of Pipeline devices required to treat each aneurysm was one. Ten patients received multiple Pipeline devices.

The investigators achieved complete occlusion without significant stenosis or retreatment at one year in approximately 84% of patients. This end point was documented by angiogram and adjudicated by an independent core laboratory. The reasons for treatment failure included residual aneurysm (8% of all patients), residual neck (6%), stenosis greater than 50% (1%), and aneurysm retreatment (2%).

At 30 days, three safety events had occurred in two patients. Both patients had a major stroke, and one of them died. The 30-day safety event rate thus was about 1%. One other safety event, a stroke, occurred at 169 days after treatment. The rate of major stroke and death at one year was approximately 2%. Two-year and three-year data are forthcoming.

The study was not designed to define which patients should be treated with a flow diverter, which is “a much broader and harder question,” said Dr. Hanel. Neurologists treat between 20% and 25% of patients with aneurysms smaller than 7 mm. The decision to treat is based on risk factors such as medical history and aneurysm location.

Aneurysms like those in the study “are difficult to treat with current armamentarium devices,” said Ralph L. Sacco, MD, Professor and Olemberg Chair of Neurology at the University of Miami. The current study indicates that the Pipeline device is safe and that these aneurysms can be treated, he added.

Dr. Hanel is a consultant for Medtronic, the manufacturer of the Pipeline device and the funder of the study.

—Erik Greb

Suggested Reading

Becske T, Potts MB, Shapiro M, et al. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2016 Oct 14:1-8. [Epub ahead of print].

Brinjikji W, Murad MH, Lanzino G, et al. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013;44(2):442-447.

HOUSTON—A flow-diverter device can treat small to medium-sized unruptured aneurysms safely and effectively, according to research presented at the International Stroke Conference 2017. The device has a high rate of aneurysm occlusion and is associated with no aneurysm rupture or recurrence at one year. The treatment also entails low rates of morbidity and mortality at one year.

One flow diverter is the Pipeline embolization device. The Pipeline device is inserted into the blood vessel and incorporates a mesh that covers the mouth of the aneurysm. The mesh allows the inner lining of the blood vessel to grow and patch the aneurysm from the inside. In April 2011, the Pipeline embolization device was approved in the United States for the treatment of aneurysms larger than 10 mm on the carotid artery. Many physicians have used the device to treat smaller aneurysms, but no investigators had examined its safety and efficacy in this indication.

Examining an Off-Label Use of the Device

Ricardo Hanel, MD, PhD, Director of Baptist Neurological Institute in Jacksonville, Florida, and colleagues conducted a prospective, multicenter study to evaluate the safety and efficacy of the Pipeline device in the treatment of small to medium-sized (ie, 12 mm or smaller), wide-necked, unruptured aneurysms on the internal carotid artery or vertebral artery. Eligible patients were between ages 22 and 80 and had an aneurysm neck that was 4 mm or larger. Patients with subarachnoid hemorrhage in the previous 30 days and those who had received an intracranial implant in the area of the target aneurysm within the previous 12 weeks were excluded.

The primary efficacy end point was complete aneurysm occlusion without significant parent artery stenosis at one year post procedure. The secondary efficacy end point was device deployment success rate. The primary safety end point was major stroke in the area supplied by the treated artery or neurologic death at one year post treatment. Secondary safety end points included major stroke or neurologic death at 30 days post treatment. Follow-up was conducted at 30 days, six months, one year, two years, and three years.

Dr. Hanel and colleagues enrolled 141 patients into the trial. The population’s mean age was approximately 55, and about 88% of the population was female. Participants had few, if any, symptoms. Approximately 48% of the population had hypertension, 38% had hyperlipidemia, and 44% were current smokers or had smoked within the previous 10 years.

Most Patients Had Complete Occlusion

Mean aneurysm size at baseline was 5 mm. About 84% of the aneurysms were smaller than 7 mm, and 16% were between 7 mm and 12 mm. Approximately 97% of aneurysms were saccular; 12% of saccular aneurysms involved a side branch, and 84% involved a sidewall, but no branch. About 4% of aneurysms were fusiform. About 95% of aneurysms were on the carotid artery. The two most common patient risk factors for treatment were patient preference (63%) and hypertension (48%).

The device was deployed to the target site successfully in about 99% of patients. Mean procedure time was approximately 80 minutes. The mean number of Pipeline devices required to treat each aneurysm was one. Ten patients received multiple Pipeline devices.

The investigators achieved complete occlusion without significant stenosis or retreatment at one year in approximately 84% of patients. This end point was documented by angiogram and adjudicated by an independent core laboratory. The reasons for treatment failure included residual aneurysm (8% of all patients), residual neck (6%), stenosis greater than 50% (1%), and aneurysm retreatment (2%).

At 30 days, three safety events had occurred in two patients. Both patients had a major stroke, and one of them died. The 30-day safety event rate thus was about 1%. One other safety event, a stroke, occurred at 169 days after treatment. The rate of major stroke and death at one year was approximately 2%. Two-year and three-year data are forthcoming.

The study was not designed to define which patients should be treated with a flow diverter, which is “a much broader and harder question,” said Dr. Hanel. Neurologists treat between 20% and 25% of patients with aneurysms smaller than 7 mm. The decision to treat is based on risk factors such as medical history and aneurysm location.

Aneurysms like those in the study “are difficult to treat with current armamentarium devices,” said Ralph L. Sacco, MD, Professor and Olemberg Chair of Neurology at the University of Miami. The current study indicates that the Pipeline device is safe and that these aneurysms can be treated, he added.

Dr. Hanel is a consultant for Medtronic, the manufacturer of the Pipeline device and the funder of the study.

—Erik Greb

Suggested Reading

Becske T, Potts MB, Shapiro M, et al. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2016 Oct 14:1-8. [Epub ahead of print].

Brinjikji W, Murad MH, Lanzino G, et al. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013;44(2):442-447.

HOUSTON—A flow-diverter device can treat small to medium-sized unruptured aneurysms safely and effectively, according to research presented at the International Stroke Conference 2017. The device has a high rate of aneurysm occlusion and is associated with no aneurysm rupture or recurrence at one year. The treatment also entails low rates of morbidity and mortality at one year.

One flow diverter is the Pipeline embolization device. The Pipeline device is inserted into the blood vessel and incorporates a mesh that covers the mouth of the aneurysm. The mesh allows the inner lining of the blood vessel to grow and patch the aneurysm from the inside. In April 2011, the Pipeline embolization device was approved in the United States for the treatment of aneurysms larger than 10 mm on the carotid artery. Many physicians have used the device to treat smaller aneurysms, but no investigators had examined its safety and efficacy in this indication.

Examining an Off-Label Use of the Device

Ricardo Hanel, MD, PhD, Director of Baptist Neurological Institute in Jacksonville, Florida, and colleagues conducted a prospective, multicenter study to evaluate the safety and efficacy of the Pipeline device in the treatment of small to medium-sized (ie, 12 mm or smaller), wide-necked, unruptured aneurysms on the internal carotid artery or vertebral artery. Eligible patients were between ages 22 and 80 and had an aneurysm neck that was 4 mm or larger. Patients with subarachnoid hemorrhage in the previous 30 days and those who had received an intracranial implant in the area of the target aneurysm within the previous 12 weeks were excluded.

The primary efficacy end point was complete aneurysm occlusion without significant parent artery stenosis at one year post procedure. The secondary efficacy end point was device deployment success rate. The primary safety end point was major stroke in the area supplied by the treated artery or neurologic death at one year post treatment. Secondary safety end points included major stroke or neurologic death at 30 days post treatment. Follow-up was conducted at 30 days, six months, one year, two years, and three years.

Dr. Hanel and colleagues enrolled 141 patients into the trial. The population’s mean age was approximately 55, and about 88% of the population was female. Participants had few, if any, symptoms. Approximately 48% of the population had hypertension, 38% had hyperlipidemia, and 44% were current smokers or had smoked within the previous 10 years.

Most Patients Had Complete Occlusion

Mean aneurysm size at baseline was 5 mm. About 84% of the aneurysms were smaller than 7 mm, and 16% were between 7 mm and 12 mm. Approximately 97% of aneurysms were saccular; 12% of saccular aneurysms involved a side branch, and 84% involved a sidewall, but no branch. About 4% of aneurysms were fusiform. About 95% of aneurysms were on the carotid artery. The two most common patient risk factors for treatment were patient preference (63%) and hypertension (48%).

The device was deployed to the target site successfully in about 99% of patients. Mean procedure time was approximately 80 minutes. The mean number of Pipeline devices required to treat each aneurysm was one. Ten patients received multiple Pipeline devices.

The investigators achieved complete occlusion without significant stenosis or retreatment at one year in approximately 84% of patients. This end point was documented by angiogram and adjudicated by an independent core laboratory. The reasons for treatment failure included residual aneurysm (8% of all patients), residual neck (6%), stenosis greater than 50% (1%), and aneurysm retreatment (2%).

At 30 days, three safety events had occurred in two patients. Both patients had a major stroke, and one of them died. The 30-day safety event rate thus was about 1%. One other safety event, a stroke, occurred at 169 days after treatment. The rate of major stroke and death at one year was approximately 2%. Two-year and three-year data are forthcoming.

The study was not designed to define which patients should be treated with a flow diverter, which is “a much broader and harder question,” said Dr. Hanel. Neurologists treat between 20% and 25% of patients with aneurysms smaller than 7 mm. The decision to treat is based on risk factors such as medical history and aneurysm location.

Aneurysms like those in the study “are difficult to treat with current armamentarium devices,” said Ralph L. Sacco, MD, Professor and Olemberg Chair of Neurology at the University of Miami. The current study indicates that the Pipeline device is safe and that these aneurysms can be treated, he added.

Dr. Hanel is a consultant for Medtronic, the manufacturer of the Pipeline device and the funder of the study.

—Erik Greb

Suggested Reading

Becske T, Potts MB, Shapiro M, et al. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2016 Oct 14:1-8. [Epub ahead of print].

Brinjikji W, Murad MH, Lanzino G, et al. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013;44(2):442-447.