Combination of Flow Reversal and Distal Filter for Cerebral Protection during Carotid Artery Stenting Kei Harada,1 Kousuke Kakumoto,1 Jun Morioka,2 Tarou Saito,3 and Kouzou Fukuyama,1 Fukuoka, Japan
Background: Carotid artery stenting (CAS) with distal filter protection allows continuous cerebral perfusion, although it is associated with a greater risk of cerebral ischemic complications than other protection systems. To reduce cerebral ischemic complications, CAS was performed under combined cerebral protection using both flow reversal (FR) and a distal filter. Methods: Fifty-six stenoses of 52 patients were treated with CAS using the combined protection of FR and a distal filter, with intermittent occlusion of both the common carotid artery (CCA) and the external carotid artery. The blood flow was reversed into the guiding catheter to the central venous system via an external filter, which collected the debris. Clinical outcomes, the rates of capturing visible debris, and new ischemic signals on diffusion-weighted magnetic resonance imaging (DWI-MRI) were evaluated. Results: The overall technical success rate was 92.9% (52/56). Successful stent deployment was achieved in 100% (56/56) of the cases. No procedural-related emboli causing a neurologic deficit were observed. In 38.5% (20/52) of the cases, visible debris were captured by only the external filter, and in 17.3% (9/52), visible debris were captured by both external and distal filters. In no case was visible debris noted in only the distal filter. New ischemic signals on DWI-MRI were detected in 9.6% (5/52). The 30-day myocardial infarction, stroke, and death rates were 0%. Conclusions: The additional use of a distal filter captures emboli in 17.3% of cases, and because the occlusion is only intermittent, the procedure is potentially applicable even in those who cannot tolerate prolonged balloon occlusion of the CCA.
INTRODUCTION Cerebral protection seems to have reduced cerebral ischemic complications during carotid artery stenting (CAS).1 The use of distal filters allows for continuous cerebral perfusion and visualization of the lesion during the procedure. However, distal filters 1 Department of Neurosurgery, Fukuoka Wajiro Hospital Heart & Neuro-Vascular Center, Fukuoka, Japan. 2 Department of Neurosurgery, Fukuoka Shinmizumaki Hospital, Fukuoka, Japan. 3 Department of Cardiology, Fukuoka Wajiro Hospital Heart & Neuro-Vascular Center, Fukuoka, Japan.
Correspondence to: Kei Harada, Fukuoka Wajiro Hospital Heart & Neuro-Vascular Center, 2-2-75, Wajirogaoka, Higashi-Ku, Fukuokacity, Fukuoka 811-0213, Japan; E-mail: [email protected] Ann Vasc Surg 2014; 28: 651–658 http://dx.doi.org/10.1016/j.avsg.2013.04.032 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: December 3, 2012; manuscript accepted: April 11, 2013; published online: December 28, 2013.
have some disadvantages in terms of unprotected lesion crossing and the migration into the cerebral artery of small particulate debris that is smaller than the filter pores.2,3 Flow reversal (FR) is an alternative method that uses balloons to occlude both the common carotid artery (CCA) and the external carotid artery (ECA), thus preventing the migration of debris into the cerebral artery through maintaining continuous blood FR in the internal carotid artery (ICA). However, its main disadvantages are patient intolerance of cerebral flow occlusion and the need for a large 9F arterial sheath. In Japan, the Angioguard XP distal filter protection device (Cordis, Miami Lakes, FL, USA) was first approved by the Ministry of Health, Labour and Welfare in October 2007. Another distal filter protection device, FilterWire EZ (Boston Scientific, Natick, MA, USA), was approved in April 2010. The MO.MA proximal cerebral protection 651
652 Harada et al.
device (INVATEC, Roncadelle, Italy) and the GORE Flow Reversal System (WL Gore and Associates, Flagstaff, AZ, USA) had not been approved by the Ministry of Health, Labour and Welfare in Japan at the time of this study. The authors have mainly used the Angioguard XP for filterprotected CAS. In their initial experience with a simple distal filter protection system, however, the results were unsatisfactory: that is, ischemic neurologic deficits occurred in 6.0% of cases, and diffusion-weighted magnetic resonance imaging (DWI-MRI) results showed a 44% incidence of new ischemic lesions.4 Therefore, the authors conducted a trial application using a guiding catheter to produce temporary balloon occlusion and temporary aspiration from the CCA to the central venous circulation via the guiding catheter. This approach was successful in reducing ischemic complications, with a 3.1% incidence of transient ischemic neurologic deficits and a 12.9% incidence of new ischemic lesions on DWI-MRI. These results were thus clearly superior to those obtained using simple distal filter protection. This method had, however, certain limitations concerning steady reverse flow in the ICA; continuous retrograde ICA flow was observed in only 47.9% of cases, whereas in 16.7% of cases, retrograde ICA flow was not achieved at all.4 To reduce the risk of cerebral ischemic complications, the authors performed CAS under the combined protection of FR and a distal filter. The combined protection enabled continuous reverse flow in the ICA during each procedural step, whereas the distal filter prevented embolus migration to the cerebral artery when ICA flow was restored. The goal of this study was to evaluate the safety and effectiveness of the combined protection of FR and a distal filter in patients undergoing CAS. This study was a retrospective investigation that evaluated the clinical results, the debris capture by FR and a distal filter, and the postprocedural ischemic DWI-MRI findings.
MATERIALS AND METHODS Characteristics of Patients and Lesions Sixty-seven patients with 72 carotid artery stenoses were treated with CAS between August 2011 and August 2012. An 8F sheath and 8F Optimo (Tokai Medical Products, Aichi, Japan), a guiding catheter for temporary balloon occlusion, were used in 55 patients with 59 stenoses in whom safe femoral artery and aortic access could be achieved. During the same period, 12 patients with 13 stenoses
Annals of Vascular Surgery
were treated with a normal 6F guiding sheath because of peripheral arterial disease of the lower limbs, or type III aortic arch: 1 was catheterized via the right radial artery, 2 via the right brachial artery, 3 via the femoral artery, and 7 via the CCA with surgical exposure. These 9 lesions were excluded from the present study. In 3 lesions, the distal ICA was narrow (diameter
Background: Carotid artery stenting (CAS) with distal filter protection allows continuous cerebral perfusion, although it is associated with a greater risk of cerebral ischemic complications than other protection systems. To reduce cerebral ischemic complications, CAS was performed under combined cerebral protection using both flow reversal (FR) and a distal filter. Methods: Fifty-six stenoses of 52 patients were treated with CAS using the combined protection of FR and a distal filter, with intermittent occlusion of both the common carotid artery (CCA) and the external carotid artery. The blood flow was reversed into the guiding catheter to the central venous system via an external filter, which collected the debris. Clinical outcomes, the rates of capturing visible debris, and new ischemic signals on diffusion-weighted magnetic resonance imaging (DWI-MRI) were evaluated. Results: The overall technical success rate was 92.9% (52/56). Successful stent deployment was achieved in 100% (56/56) of the cases. No procedural-related emboli causing a neurologic deficit were observed. In 38.5% (20/52) of the cases, visible debris were captured by only the external filter, and in 17.3% (9/52), visible debris were captured by both external and distal filters. In no case was visible debris noted in only the distal filter. New ischemic signals on DWI-MRI were detected in 9.6% (5/52). The 30-day myocardial infarction, stroke, and death rates were 0%. Conclusions: The additional use of a distal filter captures emboli in 17.3% of cases, and because the occlusion is only intermittent, the procedure is potentially applicable even in those who cannot tolerate prolonged balloon occlusion of the CCA.
INTRODUCTION Cerebral protection seems to have reduced cerebral ischemic complications during carotid artery stenting (CAS).1 The use of distal filters allows for continuous cerebral perfusion and visualization of the lesion during the procedure. However, distal filters 1 Department of Neurosurgery, Fukuoka Wajiro Hospital Heart & Neuro-Vascular Center, Fukuoka, Japan. 2 Department of Neurosurgery, Fukuoka Shinmizumaki Hospital, Fukuoka, Japan. 3 Department of Cardiology, Fukuoka Wajiro Hospital Heart & Neuro-Vascular Center, Fukuoka, Japan.
Correspondence to: Kei Harada, Fukuoka Wajiro Hospital Heart & Neuro-Vascular Center, 2-2-75, Wajirogaoka, Higashi-Ku, Fukuokacity, Fukuoka 811-0213, Japan; E-mail: [email protected] Ann Vasc Surg 2014; 28: 651–658 http://dx.doi.org/10.1016/j.avsg.2013.04.032 Ó 2014 Elsevier Inc. All rights reserved. Manuscript received: December 3, 2012; manuscript accepted: April 11, 2013; published online: December 28, 2013.
have some disadvantages in terms of unprotected lesion crossing and the migration into the cerebral artery of small particulate debris that is smaller than the filter pores.2,3 Flow reversal (FR) is an alternative method that uses balloons to occlude both the common carotid artery (CCA) and the external carotid artery (ECA), thus preventing the migration of debris into the cerebral artery through maintaining continuous blood FR in the internal carotid artery (ICA). However, its main disadvantages are patient intolerance of cerebral flow occlusion and the need for a large 9F arterial sheath. In Japan, the Angioguard XP distal filter protection device (Cordis, Miami Lakes, FL, USA) was first approved by the Ministry of Health, Labour and Welfare in October 2007. Another distal filter protection device, FilterWire EZ (Boston Scientific, Natick, MA, USA), was approved in April 2010. The MO.MA proximal cerebral protection 651
652 Harada et al.
device (INVATEC, Roncadelle, Italy) and the GORE Flow Reversal System (WL Gore and Associates, Flagstaff, AZ, USA) had not been approved by the Ministry of Health, Labour and Welfare in Japan at the time of this study. The authors have mainly used the Angioguard XP for filterprotected CAS. In their initial experience with a simple distal filter protection system, however, the results were unsatisfactory: that is, ischemic neurologic deficits occurred in 6.0% of cases, and diffusion-weighted magnetic resonance imaging (DWI-MRI) results showed a 44% incidence of new ischemic lesions.4 Therefore, the authors conducted a trial application using a guiding catheter to produce temporary balloon occlusion and temporary aspiration from the CCA to the central venous circulation via the guiding catheter. This approach was successful in reducing ischemic complications, with a 3.1% incidence of transient ischemic neurologic deficits and a 12.9% incidence of new ischemic lesions on DWI-MRI. These results were thus clearly superior to those obtained using simple distal filter protection. This method had, however, certain limitations concerning steady reverse flow in the ICA; continuous retrograde ICA flow was observed in only 47.9% of cases, whereas in 16.7% of cases, retrograde ICA flow was not achieved at all.4 To reduce the risk of cerebral ischemic complications, the authors performed CAS under the combined protection of FR and a distal filter. The combined protection enabled continuous reverse flow in the ICA during each procedural step, whereas the distal filter prevented embolus migration to the cerebral artery when ICA flow was restored. The goal of this study was to evaluate the safety and effectiveness of the combined protection of FR and a distal filter in patients undergoing CAS. This study was a retrospective investigation that evaluated the clinical results, the debris capture by FR and a distal filter, and the postprocedural ischemic DWI-MRI findings.
MATERIALS AND METHODS Characteristics of Patients and Lesions Sixty-seven patients with 72 carotid artery stenoses were treated with CAS between August 2011 and August 2012. An 8F sheath and 8F Optimo (Tokai Medical Products, Aichi, Japan), a guiding catheter for temporary balloon occlusion, were used in 55 patients with 59 stenoses in whom safe femoral artery and aortic access could be achieved. During the same period, 12 patients with 13 stenoses
Annals of Vascular Surgery
were treated with a normal 6F guiding sheath because of peripheral arterial disease of the lower limbs, or type III aortic arch: 1 was catheterized via the right radial artery, 2 via the right brachial artery, 3 via the femoral artery, and 7 via the CCA with surgical exposure. These 9 lesions were excluded from the present study. In 3 lesions, the distal ICA was narrow (diameter
