TARGET® intracranial aneurysm coiling prospective multicenter registry

Final analysis of peri-procedural and long-term safety and efficacy results

Osama O. Zaidat, Alicia C. Castonguay, Ansaar T. Rai, Aamir Badruddin, William J. Mack, Amer K. Alshekhlee, Qaisar A. Shah, Syed I. Hussain, Mouhammed R. Kabbani, Ketan R. Bulsara, Asif M. Taqi, Vallabh Janardhan, Mary S. Patterson, Brittany L. Nordhaus, Lucas Elijovich, Ajit S. Puri

Research output: Contribution to journalArticle

Abstract

Background and Purpose: To describe the final results of the TARGET Registry, a multicenter, real-world study of patients with intracranial aneurysms treated with new generation TARGET Coils. Methods: The TARGET Registry is a prospective, single-arm study with independent medical event monitoring and core-lab adjudication. Patients with de novo intracranial aneurysms were embolized with either TARGET-360° or helical coils in 12 US centers. The primary outcome was aneurysm packing density (PD), which was assessed immediately post-procedure. The secondary outcomes were immediate and long-term aneurysm occlusion rate using the Raymond Scale, and independent functional outcome using the modified Rankin Scale (mRS). A secondary analysis investigated the influence of the use of 100% 360-complex coils on clinical and angiographic outcomes. Results: 148 patients with 157 aneurysms met the inclusion and exclusion criteria. 58 (39.2%) patients with ruptured and 90 (61.8%) with unruptured aneurysms were treated using TARGET 360°, helical Coils, or both. Median age was 58.3 (IQR 48.1-67.4), 73% female, and 71.6% were Caucasian. Median follow-up time was 5.9 (IQR 4.0-6.9) months. The majority were treated with TARGET 360-coils (63.7%), followed by mixed and helical coils only. Peri-procedural morbidity and mortality was seen in 2.7% of patients. A good outcome at discharge (mRS 0-2) was seen in 89.9% of the full cohort, and in 84.5 and 93.3% in the ruptured and unruptured patients, respectively. The median packing density was 28.8% (IQR 20.3-41.1). Long-term complete and near complete occlusion rate was seen in 90.4% of aneurysms and complete obliteration was seen in 66.2% of the aneurysms. No significant difference in clinical and angiographic outcomes were noted between the pure 360-complex coiling vs. mixed 360-complex/Helical coiling strategies. In a multivariate analysis, predictors for long-term aneurysm occlusion were aneurysm location, immediate occlusion grade, and aneurysm size. The long-term independent functional outcome was achieved in 128/135 (94.8%) patients and all-cause mortality was seen in 3/148 (2%) patients. Conclusion: In the multicenter TARGET Registry, two-thirds of aneurysms achieved long-term complete occlusion and 91.0% achieved complete or near complete occlusion with excellent independent functional outcome.

Original languageEnglish (US)
Article number737
JournalFrontiers in Neurology
Volume10
Issue numberJUL
DOIs
StatePublished - Jan 1 2019

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Intracranial Aneurysm
Aneurysm
Registries
Safety
Mortality
Multivariate Analysis
Morbidity

All Science Journal Classification (ASJC) codes

  • Neurology
  • Clinical Neurology

Cite this

TARGET® intracranial aneurysm coiling prospective multicenter registry : Final analysis of peri-procedural and long-term safety and efficacy results. / Zaidat, Osama O.; Castonguay, Alicia C.; Rai, Ansaar T.; Badruddin, Aamir; Mack, William J.; Alshekhlee, Amer K.; Shah, Qaisar A.; Hussain, Syed I.; Kabbani, Mouhammed R.; Bulsara, Ketan R.; Taqi, Asif M.; Janardhan, Vallabh; Patterson, Mary S.; Nordhaus, Brittany L.; Elijovich, Lucas; Puri, Ajit S.

In: Frontiers in Neurology, Vol. 10, No. JUL, 737, 01.01.2019.

Research output: Contribution to journalArticle

Zaidat, OO, Castonguay, AC, Rai, AT, Badruddin, A, Mack, WJ, Alshekhlee, AK, Shah, QA, Hussain, SI, Kabbani, MR, Bulsara, KR, Taqi, AM, Janardhan, V, Patterson, MS, Nordhaus, BL, Elijovich, L & Puri, AS 2019, 'TARGET® intracranial aneurysm coiling prospective multicenter registry: Final analysis of peri-procedural and long-term safety and efficacy results', Frontiers in Neurology, vol. 10, no. JUL, 737. https://doi.org/10.3389/fneur.2019.00737
Zaidat, Osama O. ; Castonguay, Alicia C. ; Rai, Ansaar T. ; Badruddin, Aamir ; Mack, William J. ; Alshekhlee, Amer K. ; Shah, Qaisar A. ; Hussain, Syed I. ; Kabbani, Mouhammed R. ; Bulsara, Ketan R. ; Taqi, Asif M. ; Janardhan, Vallabh ; Patterson, Mary S. ; Nordhaus, Brittany L. ; Elijovich, Lucas ; Puri, Ajit S. / TARGET® intracranial aneurysm coiling prospective multicenter registry : Final analysis of peri-procedural and long-term safety and efficacy results. In: Frontiers in Neurology. 2019 ; Vol. 10, No. JUL.
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abstract = "Background and Purpose: To describe the final results of the TARGET Registry, a multicenter, real-world study of patients with intracranial aneurysms treated with new generation TARGET Coils. Methods: The TARGET Registry is a prospective, single-arm study with independent medical event monitoring and core-lab adjudication. Patients with de novo intracranial aneurysms were embolized with either TARGET-360° or helical coils in 12 US centers. The primary outcome was aneurysm packing density (PD), which was assessed immediately post-procedure. The secondary outcomes were immediate and long-term aneurysm occlusion rate using the Raymond Scale, and independent functional outcome using the modified Rankin Scale (mRS). A secondary analysis investigated the influence of the use of 100{\%} 360-complex coils on clinical and angiographic outcomes. Results: 148 patients with 157 aneurysms met the inclusion and exclusion criteria. 58 (39.2{\%}) patients with ruptured and 90 (61.8{\%}) with unruptured aneurysms were treated using TARGET 360°, helical Coils, or both. Median age was 58.3 (IQR 48.1-67.4), 73{\%} female, and 71.6{\%} were Caucasian. Median follow-up time was 5.9 (IQR 4.0-6.9) months. The majority were treated with TARGET 360-coils (63.7{\%}), followed by mixed and helical coils only. Peri-procedural morbidity and mortality was seen in 2.7{\%} of patients. A good outcome at discharge (mRS 0-2) was seen in 89.9{\%} of the full cohort, and in 84.5 and 93.3{\%} in the ruptured and unruptured patients, respectively. The median packing density was 28.8{\%} (IQR 20.3-41.1). Long-term complete and near complete occlusion rate was seen in 90.4{\%} of aneurysms and complete obliteration was seen in 66.2{\%} of the aneurysms. No significant difference in clinical and angiographic outcomes were noted between the pure 360-complex coiling vs. mixed 360-complex/Helical coiling strategies. In a multivariate analysis, predictors for long-term aneurysm occlusion were aneurysm location, immediate occlusion grade, and aneurysm size. The long-term independent functional outcome was achieved in 128/135 (94.8{\%}) patients and all-cause mortality was seen in 3/148 (2{\%}) patients. Conclusion: In the multicenter TARGET Registry, two-thirds of aneurysms achieved long-term complete occlusion and 91.0{\%} achieved complete or near complete occlusion with excellent independent functional outcome.",
author = "Zaidat, {Osama O.} and Castonguay, {Alicia C.} and Rai, {Ansaar T.} and Aamir Badruddin and Mack, {William J.} and Alshekhlee, {Amer K.} and Shah, {Qaisar A.} and Hussain, {Syed I.} and Kabbani, {Mouhammed R.} and Bulsara, {Ketan R.} and Taqi, {Asif M.} and Vallabh Janardhan and Patterson, {Mary S.} and Nordhaus, {Brittany L.} and Lucas Elijovich and Puri, {Ajit S.}",
year = "2019",
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TY - JOUR

T1 - TARGET® intracranial aneurysm coiling prospective multicenter registry

T2 - Final analysis of peri-procedural and long-term safety and efficacy results

AU - Zaidat, Osama O.

AU - Castonguay, Alicia C.

AU - Rai, Ansaar T.

AU - Badruddin, Aamir

AU - Mack, William J.

AU - Alshekhlee, Amer K.

AU - Shah, Qaisar A.

AU - Hussain, Syed I.

AU - Kabbani, Mouhammed R.

AU - Bulsara, Ketan R.

AU - Taqi, Asif M.

AU - Janardhan, Vallabh

AU - Patterson, Mary S.

AU - Nordhaus, Brittany L.

AU - Elijovich, Lucas

AU - Puri, Ajit S.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background and Purpose: To describe the final results of the TARGET Registry, a multicenter, real-world study of patients with intracranial aneurysms treated with new generation TARGET Coils. Methods: The TARGET Registry is a prospective, single-arm study with independent medical event monitoring and core-lab adjudication. Patients with de novo intracranial aneurysms were embolized with either TARGET-360° or helical coils in 12 US centers. The primary outcome was aneurysm packing density (PD), which was assessed immediately post-procedure. The secondary outcomes were immediate and long-term aneurysm occlusion rate using the Raymond Scale, and independent functional outcome using the modified Rankin Scale (mRS). A secondary analysis investigated the influence of the use of 100% 360-complex coils on clinical and angiographic outcomes. Results: 148 patients with 157 aneurysms met the inclusion and exclusion criteria. 58 (39.2%) patients with ruptured and 90 (61.8%) with unruptured aneurysms were treated using TARGET 360°, helical Coils, or both. Median age was 58.3 (IQR 48.1-67.4), 73% female, and 71.6% were Caucasian. Median follow-up time was 5.9 (IQR 4.0-6.9) months. The majority were treated with TARGET 360-coils (63.7%), followed by mixed and helical coils only. Peri-procedural morbidity and mortality was seen in 2.7% of patients. A good outcome at discharge (mRS 0-2) was seen in 89.9% of the full cohort, and in 84.5 and 93.3% in the ruptured and unruptured patients, respectively. The median packing density was 28.8% (IQR 20.3-41.1). Long-term complete and near complete occlusion rate was seen in 90.4% of aneurysms and complete obliteration was seen in 66.2% of the aneurysms. No significant difference in clinical and angiographic outcomes were noted between the pure 360-complex coiling vs. mixed 360-complex/Helical coiling strategies. In a multivariate analysis, predictors for long-term aneurysm occlusion were aneurysm location, immediate occlusion grade, and aneurysm size. The long-term independent functional outcome was achieved in 128/135 (94.8%) patients and all-cause mortality was seen in 3/148 (2%) patients. Conclusion: In the multicenter TARGET Registry, two-thirds of aneurysms achieved long-term complete occlusion and 91.0% achieved complete or near complete occlusion with excellent independent functional outcome.

AB - Background and Purpose: To describe the final results of the TARGET Registry, a multicenter, real-world study of patients with intracranial aneurysms treated with new generation TARGET Coils. Methods: The TARGET Registry is a prospective, single-arm study with independent medical event monitoring and core-lab adjudication. Patients with de novo intracranial aneurysms were embolized with either TARGET-360° or helical coils in 12 US centers. The primary outcome was aneurysm packing density (PD), which was assessed immediately post-procedure. The secondary outcomes were immediate and long-term aneurysm occlusion rate using the Raymond Scale, and independent functional outcome using the modified Rankin Scale (mRS). A secondary analysis investigated the influence of the use of 100% 360-complex coils on clinical and angiographic outcomes. Results: 148 patients with 157 aneurysms met the inclusion and exclusion criteria. 58 (39.2%) patients with ruptured and 90 (61.8%) with unruptured aneurysms were treated using TARGET 360°, helical Coils, or both. Median age was 58.3 (IQR 48.1-67.4), 73% female, and 71.6% were Caucasian. Median follow-up time was 5.9 (IQR 4.0-6.9) months. The majority were treated with TARGET 360-coils (63.7%), followed by mixed and helical coils only. Peri-procedural morbidity and mortality was seen in 2.7% of patients. A good outcome at discharge (mRS 0-2) was seen in 89.9% of the full cohort, and in 84.5 and 93.3% in the ruptured and unruptured patients, respectively. The median packing density was 28.8% (IQR 20.3-41.1). Long-term complete and near complete occlusion rate was seen in 90.4% of aneurysms and complete obliteration was seen in 66.2% of the aneurysms. No significant difference in clinical and angiographic outcomes were noted between the pure 360-complex coiling vs. mixed 360-complex/Helical coiling strategies. In a multivariate analysis, predictors for long-term aneurysm occlusion were aneurysm location, immediate occlusion grade, and aneurysm size. The long-term independent functional outcome was achieved in 128/135 (94.8%) patients and all-cause mortality was seen in 3/148 (2%) patients. Conclusion: In the multicenter TARGET Registry, two-thirds of aneurysms achieved long-term complete occlusion and 91.0% achieved complete or near complete occlusion with excellent independent functional outcome.

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U2 - 10.3389/fneur.2019.00737

DO - 10.3389/fneur.2019.00737

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JO - Frontiers in Neurology

JF - Frontiers in Neurology

SN - 1664-2295

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