Cryoablation Balloon Procedure for Atrial Fibrillation
Cryoablation Balloon Procedure for Atrial Fibrillation
Background. Radiofrequency (RF) catheter ablation has provided an effective method for treating drug-refractory symptomatic atrial fibrillation. Recently, a cryoablation balloon approach has also received approval. The purpose of this study was to compare RF catheter ablation to cryoablation for the treatment of atrial fibrillation with respect to safety, immediate efficacy, and effects on procedural and fluoroscopy times. In addition, actual procedural costs were compared.
Methods. This study was approved by the Winthrop University Hospital Institutional Review Board to retrospectively examine cryoablation with the Arctic Front Cardiac CryoAblation balloon catheter (Medtronic, Inc) and compare it to RF catheter ablation for the treatment of drug-refractory symptomatic atrial fibrillation. Patient and procedural characteristics as well as immediate success were compared. Immediate failure was defined as incomplete pulmonary vein isolation of all veins.
Results. A total of 124 procedures (62 RFs and 62 cryoablations) were performed from December 2010 through July 2012. The cryoablation procedure took longer to perform than RF (171 ± 61 minutes vs 126 ± 49 minutes, respectively; P<.0001). There was no difference in fluoroscopy times between the two groups (29 ± 20 minutes for RF vs 32 ± 18 minutes for cryoablation; P=.39). The infusion of protamine following procedures was much more common in the cryoablation group (30 patients vs 2 patients in the RF group; P<.0001). The immediate success rate was 93.5% with RF ablation vs 96.7% with cryoablation (P=NS). There was not a significant difference in complications between the two approaches. The cost for each procedure was $24,391.88 ± 4826.77 for RF and $31,874.02 ± 8349.70 for cryoablation (P<.0001).
Conclusion. Cryoablation provides an additional and alternative approach to RF ablation for the treatment of symptomatic drug-refractory atrial fibrillation with comparable immediate success and complications. It is synergistic with RF and permits the ability to tackle the entire gamut of atrial fibrillation (ie, paroxysmal and persistent). This study showed no decrease in procedural or fluoroscopy times with our early experience. One significant limitation with cryoablation is the cost. Cryoablation resulted in over $7000 extra cost to the hospital per procedure. The clinical benefits achieved by this additional cost warrant further investigation.
For many years, symptomatic atrial fibrillation has been successfully treated via radiofrequency (RF) catheter ablation in which pulmonary vein isolation (PVI) formed the cornerstone of treatment. The most common PVI procedure was performed using RF energy. More recently, cryoablation with the Arctic Front Cardiac CryoAblation balloon catheter (Medtronic, Inc) received approval by the United States Food and Drug Administration (FDA) as another method besides RF ablation to treat symptomatic drug-refractory paroxysmal atrial fibrillation. This novel technology is used specifically to perform pulmonary vein isolation. A single probe, which includes an inflatable balloon, is placed across the atrial septum into the left atrium. This system pumps refrigerant (N2O) into the balloon, while contacting the pulmonary vein orifice. Contrast is injected into the pulmonary vein in order to demonstrate a good seal and physical contact with the balloon. A 4-minute freeze is typically applied to each pulmonary vein followed by a thaw and then another freeze.
There have been few trials that have compared a "real-world" clinical experience with the cryoablation balloon technique to RF catheter ablation since the system received FDA approval. The purpose of this study was to compare RF catheter ablation to cryoablation for the treatment of atrial fibrillation with respect to safety, immediate efficacy, and effects on procedural and fluoroscopy times. In addition, actual procedural costs were compared.
Abstract and Introduction
Abstract
Background. Radiofrequency (RF) catheter ablation has provided an effective method for treating drug-refractory symptomatic atrial fibrillation. Recently, a cryoablation balloon approach has also received approval. The purpose of this study was to compare RF catheter ablation to cryoablation for the treatment of atrial fibrillation with respect to safety, immediate efficacy, and effects on procedural and fluoroscopy times. In addition, actual procedural costs were compared.
Methods. This study was approved by the Winthrop University Hospital Institutional Review Board to retrospectively examine cryoablation with the Arctic Front Cardiac CryoAblation balloon catheter (Medtronic, Inc) and compare it to RF catheter ablation for the treatment of drug-refractory symptomatic atrial fibrillation. Patient and procedural characteristics as well as immediate success were compared. Immediate failure was defined as incomplete pulmonary vein isolation of all veins.
Results. A total of 124 procedures (62 RFs and 62 cryoablations) were performed from December 2010 through July 2012. The cryoablation procedure took longer to perform than RF (171 ± 61 minutes vs 126 ± 49 minutes, respectively; P<.0001). There was no difference in fluoroscopy times between the two groups (29 ± 20 minutes for RF vs 32 ± 18 minutes for cryoablation; P=.39). The infusion of protamine following procedures was much more common in the cryoablation group (30 patients vs 2 patients in the RF group; P<.0001). The immediate success rate was 93.5% with RF ablation vs 96.7% with cryoablation (P=NS). There was not a significant difference in complications between the two approaches. The cost for each procedure was $24,391.88 ± 4826.77 for RF and $31,874.02 ± 8349.70 for cryoablation (P<.0001).
Conclusion. Cryoablation provides an additional and alternative approach to RF ablation for the treatment of symptomatic drug-refractory atrial fibrillation with comparable immediate success and complications. It is synergistic with RF and permits the ability to tackle the entire gamut of atrial fibrillation (ie, paroxysmal and persistent). This study showed no decrease in procedural or fluoroscopy times with our early experience. One significant limitation with cryoablation is the cost. Cryoablation resulted in over $7000 extra cost to the hospital per procedure. The clinical benefits achieved by this additional cost warrant further investigation.
Introduction
For many years, symptomatic atrial fibrillation has been successfully treated via radiofrequency (RF) catheter ablation in which pulmonary vein isolation (PVI) formed the cornerstone of treatment. The most common PVI procedure was performed using RF energy. More recently, cryoablation with the Arctic Front Cardiac CryoAblation balloon catheter (Medtronic, Inc) received approval by the United States Food and Drug Administration (FDA) as another method besides RF ablation to treat symptomatic drug-refractory paroxysmal atrial fibrillation. This novel technology is used specifically to perform pulmonary vein isolation. A single probe, which includes an inflatable balloon, is placed across the atrial septum into the left atrium. This system pumps refrigerant (N2O) into the balloon, while contacting the pulmonary vein orifice. Contrast is injected into the pulmonary vein in order to demonstrate a good seal and physical contact with the balloon. A 4-minute freeze is typically applied to each pulmonary vein followed by a thaw and then another freeze.
There have been few trials that have compared a "real-world" clinical experience with the cryoablation balloon technique to RF catheter ablation since the system received FDA approval. The purpose of this study was to compare RF catheter ablation to cryoablation for the treatment of atrial fibrillation with respect to safety, immediate efficacy, and effects on procedural and fluoroscopy times. In addition, actual procedural costs were compared.
