CLINICAL SKILLS » THROMBECTOMY

The Need to More Efficiently Treat Large Vein Thrombus

Conceptualizing the new 8-F AngioJet™ ZelanteDVT™ Catheter.

MARK HILSE, MS


Over the years, physicians using the AngioJet™ Thrombectomy System for deep vein thrombosis (DVT) treatment expressed their need to more efficiently address the large thrombus burden that is often found in the iliofemoral veins. Specifically, physicians treat­ing DVTs in the iliofemoral veins found that a significant number of cases still required an overnight thrombolytic drip to achieve a more complete resolution of thrombus. This resulted in the need for a new AngioJet catheter: the ZelanteDVT™ (Boston Scientific Corporation), with power that could remove the thrombus burden in large venous vessels, aiding in decreased treatment times.

DESIGN CONSIDERATIONS FOR THE NEW ANGIOJET CATHETER

One of the barriers to removing large, organized throm­bus is the inflow window size of the current 6-F AngioJet catheters (Solent Omni and Solent Proxi). The unique mechanism of action within the AngioJet catheters is based on the high-speed jets that create a near-perfect vacuum to pull in and break up the thrombus. Because the inflow window size on the 6-F catheters only allows relatively small-sized thrombus to enter, Boston Scientific aimed to specially design a catheter to address large, organized thrombus burden, which meant having a larger inflow window. The resulting design demonstrated that having one large inflow window instead of three or four small windows, as on predicate catheters, enables this catheter to most optimally remove the thrombus burden found in larger iliofemoral and upper extremity peripheral veins. Because the inflow window pulls in thrombus from one side of the catheter, the outflow jet, which liberates the thrombus from the vessel wall, was shifted to the inflow window side of the catheter. Therefore, the design includes only one outflow window located on the same side as the large inflow window. The outflow jet is also more powerful than the 6-F AngioJet models, which aids this catheter in more efficient removal of tough thrombus from the vessel walls.

In addition, the unidirectional design of the windows drove the need for a rotating hub, so the single window could be swept around the vessel in order to clear throm­bus on all sides. To facilitate improved visualization of the window orientation, a marker band was added opposite the window and is visible under fluoroscopy. When using the rotating hub, the inflow window directional design allows the user to direct the thrombus removal power where it is needed most. The Power Pulse™ feature remains on the ZelanteDVT catheter but is also directionally controllable, which may aid in more uniform distribution of the physi­cian-specified fluid.

Lastly, from a design standpoint, a dedicated guidewire lumen was created to ensure that the 0.035-inch guidewire could not potentially exit through the now much-larger inflow window. Developing a catheter with a dedicated guidewire lumen also provides the user with easy guidewire exchanges and eliminates the need for a hemostasis valve. As a result, a larger 8-F lumen was required to accommo­date these requirements.

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

DESIGN CONSIDERATIONS FOR THE NEW ANGIOJET CATHETER

One of the barriers to removing large, organized throm­bus is the inflow window size of the current 6-F AngioJet catheters (Solent Omni and Solent Proxi). The unique mechanism of action within the AngioJet catheters is based on the high-speed jets that create a near-perfect vacuum to pull in and break up the thrombus. Because the inflow window size on the 6-F catheters only allows relatively small-sized thrombus to enter, Boston Scientific aimed to specially design a catheter to address large, organized thrombus burden, which meant having a larger inflow window. The resulting design demonstrated that having one large inflow window instead of three or four small windows, as on predicate catheters, enables this catheter to most optimally remove the thrombus burden found in larger iliofemoral and upper extremity peripheral veins. Because the inflow window pulls in thrombus from one side of the catheter, the outflow jet, which liberates the thrombus from the vessel wall, was shifted to the inflow window side of the catheter. Therefore, the design includes only one outflow window located on the same side as the large inflow window. The outflow jet is also more powerful than the 6-F AngioJet models, which aids this catheter in more efficient removal of tough thrombus from the vessel walls.

In addition, the unidirectional design of the windows drove the need for a rotating hub, so the single window could be swept around the vessel in order to clear throm­bus on all sides. To facilitate improved visualization of the window orientation, a marker band was added opposite the window and is visible under fluoroscopy. When using the rotating hub, the inflow window directional design allows the user to direct the thrombus removal power where it is needed most. The Power Pulse™ feature remains on the ZelanteDVT catheter but is also directionally controllable, which may aid in more uniform distribution of the physi­cian-specified fluid.

Lastly, from a design standpoint, a dedicated guidewire lumen was created to ensure that the 0.035-inch guidewire could not potentially exit through the now much-larger inflow window. Developing a catheter with a dedicated guidewire lumen also provides the user with easy guidewire exchanges and eliminates the need for a hemostasis valve. As a result, a larger 8-F lumen was required to accommo­date these requirements.

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

ATHERECTOMY AS A FIRST-LINE TREATMENT

In this article we describe our current approach in treat-ing de novo FP arterial disease and the rationale of using atherectomy as a first-line treatment followed by DCB. The use of stenting in our laboratory has been mostly for bailout purposes and is generally used in < 10% to 15% of our cases. It is clear at this time that devices that carry and effectively deliver antiproliferative drugs to the FP arterial wall will like-ly become the standard to treat FP disease. In the Zilver PTX randomized trial, the Zilver PTX stent (Cook Medical) had a superior 12-month event-free survival rate (90.4% vs 82.6%; P = .004) and primary patency rate (83.1% vs 32.8%;  

P < .001) when compared with POBA.13 In addition, data presented this spring from the MAJESTIC trial demon-strated 9-month primary patency results of 94.4% with the ELUVIA™ Drug-Eluting Vascular Stent System (Boston Scientific Corporation).14

DCBs have been consistent in showing that patency is markedly improved compared to POBA in treating FP arte-rial disease and most of these trials reduced TLR significant-ly.15-19 The data, however, have mostly been limited to short and intermediate lesion lengths. Another recent analysis showed no real significant differences in the current Zilver PTX stent and available DCBs in reducing TLR.20,21 Why do we really need atherectomy if one can get an effective treat-ment with a DCS or a DCB? In fact, why do we even need a DCS if the DCBs suffice, particularly with all the potential problems that may occur with stenting as described above? We’ll spend the next portion of the article answering those very questions.

“…the real challenge in treating the FP artery is in addressing complex disease such as long lesions, total occlusions, and calcified vessels. In lesions such as these, we employ a strategy of vessel prep with ather-ectomy first, prior to utilizing DCB.”

Figure 4. Jetstream SC catheters with Single Cutters (top two; tibial sizes) and Jetstream XC catheters with eXpandable Cutters (bottom two; SFA and popliteal sizes).
Figure 4. Jetstream SC catheters with Single Cutters (top two; tibial sizes) and Jetstream XC catheters with eXpandable Cutters (bottom two; SFA and popliteal sizes).
Figure 4. Jetstream SC catheters with Single Cutters (top two; tibial sizes) and Jetstream XC catheters with eXpandable Cutters (bottom two; SFA and popliteal sizes).
Figure 4. Jetstream SC catheters with Single Cutters (top two; tibial sizes) and Jetstream XC catheters with eXpandable Cutters (bottom two; SFA and popliteal sizes).

CONCLUSION

We conclude that a strategy of improving vessel compli-ance with debulking and less bailout stenting coupled with adjunctive DCB is likely to emerge as an effective alternative strategy in treating FP arterial disease, a concept that requires future validation with well-powered and randomized trials.

Nicolas W. Shammas, MD, MS, FACC, FSCAI, is President and Research Director, Midwest Cardiovascular Research Foundation in Davenport, Iowa. He has disclosed that he received related research and educational grants to the Midwest Cardiovascular Research Foundation from Boston Scientific Corporation, Medtronic, and CSI; and is a trainer for JETSTREAM™ Atherectomy System, is on the speaker bureau for Boston Scientific Corporation, and is a member of the JET steering committee. Dr. Shammas may be reached at shammas@mchsi.com.

*Results from case studies are not necessarily indicative of results in other cases. Results in other cases may vary.


1.  Shammas NW. Epidemiology, classification and modifiable risk factors of peripheral arterial disease. Vasc Health Risk Manag. 2007;3:229-234.

2.  Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879-1888.

3.  Schillinger M, Sabeti S, Dick P, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115:2745-2749.

4. Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial.

5.  Laird JR, Katzen BT, Scheinert D, et al; RESILIENT Investigators. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial. J Endovasc Ther. 2012;19:1-9.

6.  Krankenberg H, Schlüter M, Steinkamp HJ, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007;116:285-292.

7.  Schlager O, Dick P, Sabeti S, et al. Long-segment SFA stenting—the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther 2005;12:676-684.

8.  Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312-315.

9.  Garcia L, Jaff MR, Metzger C, et al. Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries: twelve-month results of the SUPERB trial. Circ Cardiovasc Interv. 2015 May;8(5). pii: e000937. doi: 10.1161/CIRCINTER-VENTIONS.113.000937.

10.  Dippel EJ, Makam P, Kovach R, et al. Randomized controlled study of excimer laser atherectomy for treatment of femoro-popliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015;8(1 Pt A):92-101.

11.  Shammas NW, Shammas G, Park H et al. Safety and In-hospital outcomes of Jetstream atherectomy in treating in-stent restenosis of femoropopliteal arteries. J Am Coll Cardiol. 2015;65(10_S):doi:10.1016/S0735-1097(15)61812-5.

12.  Banerjee S, Pershwitz G, Sarode K, et al. Stent and non-stent based outcomes of infrainguinal peripheral artery interventions from the multicenter XLPAD registry. J Invasive Cardiol. 2015;27:14-18.

13.  Dake MD, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4:495-504.

14.  Müller-Hülsbeck S. Femoropopliteal artery stenting with the Eluvia drug-eluting stent: primary endpoint results of the MAJESTIC trial. Presented at Charing Cross Symposium; April 28–May 1, 2015; London, England.

15.  Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014;7:10-19.

16.  Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358:689-699.

17.  Werk M, Albrecht T, Meyer DR, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 2012;5:831-840.

18.  Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008;13:1358-1365.

19.  Liistro F, Grotti S, Porto I, et al. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013;6:1295-1302.  

20.  Zeller T, Rastan A, Macharzina R, et al. Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions. J Endovasc Ther. 2014;21:359-368.

21.  Sarode K, Spelber DA, Bhatt DL, et al. Drug delivering technology for endovascular management of infrainguinal peripheral artery disease. JACC Cardiovasc Interv. 2014;7:827-839.

22.  Shammas NW, Coiner D, Shammas G, et al. Predictors of provisional stenting in patients undergoing lower extremity arterial interventions. Int J Angiol. 2011 ;20:95-100.

23.  Shammas NW, Coiner D, Shammas GA, et al. Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial. J Vasc Interv Radiol.

2011;22:1223-1228.

24.  Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study compar-ing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. 2014;26:355-360.

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BRIEF SUMMARY STATEMENT: Jetstream Catheters combined with Console. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. Catheter INDICATIONS: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature. Console INDICATIONS: The PV Console is designed for use only with the Jetstream Catheter and Control Pod. See the current revision of the applicable Catheter and Control Pod Instructions for Use for further information. CONTRAINDICATIONS: No known contraindications. Catheter WARNINGS/PRECAUTIONS: The Jetstream Catheter and Control Pod may only be used with the PV Console.  Take care to avoid being pinched when closing the aspiration and infusion pump doors.  Use room temperature infusate only. Use of heated infusate may lead to wrinkling, ballooning and/or bursting of the outer catheter sheath.  Do not bend or kink the Catheter during setup or during the procedure. This may damage the device and lead to device failure.  Operating the Catheter over a kinked guidewire may cause vessel damage or guidewire fracture.  During treatment, do not allow the Catheter tip within 10.0 cm of spring tip portion of the guidewire. Interaction between the Catheter Tip and this portion of the guidewire may cause damage to or detachment of the guidewire tip or complicate guidewire management.  The guidewire must be in place prior to operating the Catheter in the patient. Absence of the guidewire may lead to inability to steer the Catheter and cause potential vessel damage.  Do not inject contrast while the device is activated.  If the guidewire is accidentally retracted into the device during placement or treatment, stop use, and remove the Catheter and the guidewire from the patient. Verify that the guidewire is not damaged before re-inserting the guidewire. If damage is noticed, replace the guidewire.  Check the infusate bag frequently and replace when needed. Do not run the JETSTREAM System without infusate as this may cause device failure.  Hold the guidewire firmly during Catheter retraction process. Failure to do so may result in guidewire rotation within the vessel.  Do not manipulate the Catheter against resistance unless the cause for that resistance has been determined.  Use only listed compatible guidewires and introducers with the Jetstream System. The use of any supplies not listed as compatible may damage or compromise the performance of the Jetstream System.  Prior to use of the Jetstream System, confirm the minimum vessel diameter proximal to the lesion per the following: Jetstream SC Atherectomy Catheter 1.6 Minimum Vessel Diameter Proximal to Lesion 2.5 mm  Jetstream SC Atherectomy Catheter 1.85 Minimum Vessel Diameter Proximal to Lesion 2.75 mm  Jetstream XC Atherectomy Catheter 2.1-3.0 Minimum Vessel Diameter, Blades Down 3.0 mm; Minimum Vessel Diameter, Blades Up 4.0 mm  Jetstream XC Atherectomy Catheter 2.4-3.4 Minimum Vessel Diameter, Blades Down 3.5 mm; Minimum Vessel Diameter, Blades Up 4.5 mm  Console WARNINGS/PRECAUTIONS: WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.  Do not open either pump door during operation of the System. Doing so could result in loss of aspiration and/or infusion and will halt device activation.  Ensure the PV Console display is visible during the entire procedure.  Observe normal safety practices associated with electrical/electronic medical equipment.  Avoid excessive coiling or bending of the power cables during storage.  Store the PV Console using appropriate care to prevent accidental damage.  Do not place objects on the PV Console.  Do not immerse the PV Console in liquids.  ADVERSE EVENTS: Potential adverse events associated with use of this device and other interventional catheters include, but are not limited to the following (alphabetical order): Abrupt or sub-acute closure  Amputation  Bleeding complications, access site  Bleeding complications, non-access site  Death  Dissection  Distal emboli  Hypotension  Infection or fever  Perforation  Restenosis of the treated segment  Vascular complications which may require surgical repair  Thrombus  Vasospasm


  

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