Systems and methods for embolization procedures for treatment of defects in the vasculature

Abstract

Methods, systems, and kits for treating unruptured brain arteriovenous malformations in a human patient with reduced procedure time by embolizing by delivering a first embolic agent comprising N-butyl cyanoacrylate (“n-BCA”) within at least one blood vessel adjacent a vascular tangle in a first group of human patients and achieving a reduced embolization procedure time compared to a second group of human patients treated by delivering a second embolic agent. Methods, systems, and kits for reducing costs of embolization by at least approximately 18% are described.

1 . A method for treating unruptured brain arteriovenous malformations in a human patient with reduced procedure time, the method comprising:
 embolizing, by a first catheter, by delivering a first embolic agent comprising N-butyl cyanoacrylate (the “n-BCA”) within at least one blood vessel adjacent a vascular tangle in a first group of human patients; and   decreasing embolization procedure time by at least 0.5 hours, by delivering the n-BCA, compared to a second group of human patients treated by delivering a second embolic agent within at least one blood vessel adjacent a vascular tangle.   
     
     
         2 . The method according to  claim 1 ,
 wherein the second group of human patients is treated by embolizing, by a second catheter, by delivering the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) within the least one blood vessel adjacent the vascular tangle, and   wherein the embolization procedure time is at least 30% lower for the first group versus the second group.   
     
     
         3 . The method according to  claim 1 ,
 wherein the second group of human patients is treated by embolizing, by a third catheter, by delivering the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) within the least one blood vessel adjacent the vascular tangle, and   wherein the embolization procedure time is at least 57% lower for the first group versus the second group.   
     
     
         4 . The method  1  according to  claim 1 ,
 wherein the second group of human patients is treated by embolizing, by a fourth catheter, by delivering the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) within the least one blood vessel adjacent the vascular tangle, and 
 wherein the embolization procedure time is at least 53% lower for the first group versus the second group. 
 
     
     
         5 . The method according to  claim 1 , further comprising:
 achieving, by the n-BCA and the first catheter, approximately 67% lower embolization procedure time for treating at least four blood vessels adjacent a vascular tangle versus the second group treated by the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) and a second catheter.   
     
     
         6 . The method according to  claim 1 , further comprising:
 achieving, by the n-BCA and the first catheter, approximately 81% lower embolization procedure time for treating at least four blood vessels adjacent a vascular tangle versus the second group treated by the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) and a third catheter.   
     
     
         7 . The method according to  claim 1 , further comprising:
 achieving, by the n-BCA and the first catheter, approximately 79% lower embolization procedure time for treating at least four blood vessels adjacent a vascular tangle versus the second group treated by the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) and a fourth catheter.   
     
     
         8 . The method according to  claim 1 , further comprising calculating a cost adjustment ratio for embolizing at least one blood vessel adjacent a vascular tangle in the first group of human patients compared to the second group of human patients, wherein the cost adjusted ratio comprises conditions comprising at least one of:
 embolization procedure time,   units of first or second embolic agent,   concentration of first or second embolic agent per unit,   type of catheter,   number of catheters, and   angiography suite time; and   identifying at least one condition in the cost adjusted ratio to achieve at least 18% reduced embolization cost of the first group compared to the second group, the cost adjustment ratio being determined by a Generalized estimating equations (GEE) model.   
     
     
         9 . A method for treating unruptured brain arteriovenous malformations in a human patient at a reduced cost, the method comprising:
 embolizing, by a first catheter, by delivering a first embolic agent comprising N-butyl cyanoacrylate (the “n-BCA”) within at least one blood vessel adjacent a vascular tangle in a first group of human patients; and   achieving at least 18% reduced total cost of the embolization procedure in the respective human patient of the first group compared to a second group of human patients treated by delivering a second embolic agent within at least one blood vessel adjacent a vascular tangle, wherein the reduced total cost comprises reducing at least one of:
 embolization procedure time for the first embolic agent compared to the second embolic agent, 
 units of the first embolic agent delivered compared to the second embolic agent, 
 concentration of the first embolic agent per unit compared to the second embolic agent per unit, 
 number of catheters for delivering the first embolic agent compared to the second embolic agent, and 
 angiography suite time embolic agent compared to the second embolic agent. 
   
     
     
         10 . The method according to  claim 9 ,
 wherein the second group of the plurality of human patients is treated by embolizing, by a second catheter, by delivering the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) within the least one blood vessel adjacent the vascular tangle, and   wherein the embolization procedure cost is at least 30% lower for the first group versus the second group.   
     
     
         11 . The method according to  claim 9 ,
 wherein the second group of the plurality of human patients is treated by embolizing, by a third catheter, by delivering the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) within the least one blood vessel adjacent the vascular tangle, and   wherein the embolization procedure cost is at least 57% lower for the first group versus the second group.   
     
     
         12 . The method according to  claim 9 ,
 wherein the second group of the plurality of human patients is treated by embolizing, by a fourth catheter, by delivering the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) within the least one blood vessel adjacent the vascular tangle, and   wherein the embolization procedure cost is at least 53% lower for the first group versus the second group.   
     
     
         13 . The method according to  claim 9 , further comprising:
 achieving, by the n-BCA and the first catheter, approximately 67% lower embolization procedure cost for treating at least four blood vessels adjacent a vascular tangle versus the second group treated by the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) and a second catheter.   
     
     
         14 . The method according to  claim 9 , further comprising:
 achieving, by the n-BCA and the first catheter, approximately 81% lower embolization procedure cost for treating at least four blood vessels adjacent a vascular tangle versus the second group treated by the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) and a third catheter.   
     
     
         15 . The method according to  claim 9 , further comprising:
 achieving, by the n-BCA and the first catheter, approximately 79% lower embolization procedure cost for treating at least four blood vessels adjacent a vascular tangle versus the second group treated by the second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”) and a fourth catheter.   
     
     
         16 . The method according to  claim 9 ,
 wherein the cost of the first embolic agent is at least 30% lower versus the cost of the second embolic agent.   
     
     
         17 . A kit for treating at least one unruptured brain arteriovenous malformation pedicle in
 a human patient at a reduced embolization procedure cost, the kit comprising:
 a first embolic agent comprising N-butyl cyanoacrylate (the “n-BCA”); 
 a first catheter configured to deliver at least one unit of n-BCA; and 
 the kit configured to achieve at least 18% reduced cost for embolization procedure in a respective human patient. 
   
     
     
         18 . The kit according to  claim 17 , the kit further configured to achieve at least 30% reduced cost for a respective human patient treated with the n-BCA versus a second group of human patients treated with a second kit comprising:
 a second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”); and   a balloon catheter configured to deliver at least two units of EVOH.   
     
     
         19 . The kit according to  claim 17 , the kit further configured to achieve at least 57% reduced cost for a respective human patient treated with the n-BCA versus a second group of human patients treated with a second kit comprising:
 a second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”); and   a detachable-tip catheter configured to deliver at least two units of EVOH in a first concentration and at least two units of EVOH in a second concentration.   
     
     
         20 . The kit according to  claim 17 , the kit further configured to achieve at least 53% reduced cost for a respective human patient treated with the n-BCA versus a second group of human patients treated with a second kit comprising:
 a second embolic agent comprising ethylene vinyl alcohol copolymer (“EVOH”); and   a plug and push catheter configured to deliver at least two units of EVOH in a first concentration and at least two units of EVOH in a second concentration.