Off-Label Use of Drugs and Devices in the Neuroendovascular Suite

Abdihalim, Mohamed; Hassan, Ameer E.; Qureshi, Adnan I.

doi:10.3174/ajnr.a3447

Cited by 10 publications

(8 citation statements)

References 107 publications

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“…We used DEB for angioplasty as “off‐label use of FDA approved device” similar to cutting and scoring balloons for carotid ISR in previous studies 10 . Off‐label use is relatively common as companies do not seek U.S Food and Drug Administration (FDA) approval for neurovascular application for rare indications such as carotid artery ISR due to small market 26 . The Institutional Review Board approved the protocol for extracting and reporting data.…”

Section: Methodsmentioning

confidence: 99%

Drug‐Eluting Balloon Angioplasty for In‐Stent Restenosis Following Carotid Artery Stent Placement

Bhatia

Akhtar

Akinci

et al. 2020

Journal of Neuroimaging

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A total of seven studies demonstrating the use of the DEBs for treatment of carotid ISR were identified. They encompassed 31 patients, 11 (35.5%) of whom presented with symptomatic ISR, with the remaining 20 patients (64.5%) asymptomatic. DEB angioplasty followed by stent placement was performed in 3 patients, whereas DEB alone was utilized in 28 patients. Periprocedural complications included asymptomatic dissection from DEB inflation in 1 patient and transient neurological deficits in another patient. Follow-up period was variable and ranged from 1 month to 5 years. Three patients were noted to develop recurrent asymptomatic stenosis, whereas 1 patient developed an episode of symptomatic restenosis post procedural on follow-up. In our two cases, both patients were noted to have protracted period of hypotension postprocedure without any new or recurrent neurological symptoms. CONCLUSION: The use of DEBs is a promising development and a viable alternative for management of severe and recurrent carotid ISR.

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Section: Methodsmentioning

confidence: 99%

Drug‐Eluting Balloon Angioplasty for In‐Stent Restenosis Following Carotid Artery Stent Placement

Bhatia

Akhtar

Akinci

et al. 2020

Journal of Neuroimaging

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“…They are also used in intraprocedural thrombosis and ischemic events during neuroendovascular procedures. 35 Although the limited evidence that exists for the use of eptifibatide in acute ischemic strokes cannot be transferred wholesale to a venous disease, prospective, randomized, open-label phase II trials of tirofiban and eptifibatide have suggested it is safe to use in treating patients with an acute ischemic stroke. 36 Arterial and venous thrombosis are traditionally considered two very different conditions.…”

Section: Discussionmentioning

confidence: 99%

Management of a decompensated acute-on-chronic intracranial venous sinus thrombosis

Candel¹,

Hellstern²,

Beitlich

et al. 2019

Ther Adv Neurol Disord

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A 34-year-old female patient presented during the 10th week of her second gravidity with headache, nausea and vomiting 2 weeks before admission. Her medical history was remarkable for a heterozygous factor V Leiden mutation, elevated lipoprotein A, and a cerebral venous thrombosis (CVT) after oral contraceptive intake 15 years before. Magnetic resonance imaging (MRI) suggested acute and massive intracranial sinus thrombosis. Despite full-dose anticoagulation, the patient deteriorated clinically and eventually became comatose. Now, MRI/magnetic resonance angiography revealed vasogenic edema of both thalami, of the left frontal lobe, and of the head of the caudate nucleus, with venous stasis and frontal petechial hemorrhage. She was referred for endovascular treatment. Diagnostic angiography confirmed a complete superficial and deep venous sinus occlusion. Endovascular access to the straight and superior sagittal sinus was possible, but neither rheolysis nor balloon angioplasty resulted in recanalization of the venous sinuses. Monitored heparinization was continued and antiaggregation was initiated. The patient remained comatose for another 5 days and MRI showed progress of the cytotoxic edema. On day 6, infusion of eptifibatide at body-weight-adapted dosage was started. The following day, the patient improved and slowly regained consciousness. MRI confirmed regression of the edema. The eptifibatide infusion was continued for a total of 14 days. Thereafter two doses of 180 mg ticagrelor per os (PO) daily were started. The patient remained on acetylsalicylic acid (ASA), ticagrelor, and enoxaparin on an unchanged dosage regimen. She was discharged home 26 days after the endovascular treatment without serious neurological deficit, with the pregnancy intact. At the 30th week of pregnancy the dosage of ASA was reduced to 300 mg once PO daily. Cesarian delivery was carried out at the 38th week of pregnancy. The newborn was completely healthy. Ultima ratio therapeutic options for severe intracranial venous sinus thrombosis refractory to anticoagulation are discussed, with an emphasis on platelet-function inhibition.

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“…Tracking outcomes is also important since some medications and devices involved in EVTs are being used off-label. 20…”

Section: Discussionmentioning

confidence: 99%

“…Tracking outcomes is also important since some medications and devices involved in EVTs are being used off-label. 20 There are some potential limitations of our study. We had data only from responding facilities, but our overall response rate was 34%, which is typical if not slightly high for these types of studies.…”

mentioning

confidence: 90%

Availability of endovascular therapies for cerebrovascular disease at primary stroke centers

Alberts

Range

Spencer³

et al. 2016

Interv Neuroradiol

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Background Endovascular therapies (EVTs) are useful for treating cerebrovascular disease. There are few data about the availability of such services at primary stroke centers (PSCs). Our hypothesis was that some of these services may be available at some PSCs. Methods We conducted an internet-based survey of hospitals certified as PSCs by the Joint Commission. The survey inquired about EVTs such as intra-arterial (IA) lytics, IA mechanical clot removal, coiling of aneurysms, and cervical arterial stenting, physician training, coverage models, hospital type, and outcomes. Chi-square analyses were used to detect differences between academic and community PSCs. Results Data were available from 352 PSCs, of which 75% were community hospitals, 23% academic medical centers, and 80% were non-profit; almost half (48%) see 300 or more patients annually with ischemic stroke. A majority (60%) provided some or all EVTs on site, while 29% had none on site and no plans to add them. Among the respondents offering EVTs, 95% offered stenting of neck vessels, 86% IA lytics, 80% IA mechanical, and 74% aneurysm coiling. The majority (>55%) that did offer such services provided them 24/7/365. Most endovascular coverage was provided by interventional neuroradiologists (60%), fellowship trained endovascular neurosurgeons (42%), and interventional radiologists (41%). The majority of hospitals (81%) did not participate in an audited national registry. Conclusions A variety of EVT services are offered at many PSCs by interventionalists with diverse types of training. The availability of such services is clinically relevant now with the proven efficacy of mechanical thrombectomy for ischemic stroke.

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Off-Label Use of Drugs and Devices in the Neuroendovascular Suite

Cited by 10 publications

References 107 publications

Drug‐Eluting Balloon Angioplasty for In‐Stent Restenosis Following Carotid Artery Stent Placement

Drug‐Eluting Balloon Angioplasty for In‐Stent Restenosis Following Carotid Artery Stent Placement

Management of a decompensated acute-on-chronic intracranial venous sinus thrombosis

Availability of endovascular therapies for cerebrovascular disease at primary stroke centers

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