COMPARISON OF AMPLATZER® PFO VERSUS CARDIOSEAL/STARFLEX® VERSUS GORE HELEX DEVICES IN CLOSURE OF...
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i2 SUMMIT A212.E2005 JACC March 9, 2010 Volume 55, issue 10A COMPARISON OF AMPLATZER® PFO VERSUS CARDIOSEAL/STARFLEX® VERSUS GORE HELEX DEVICES IN CLOSURE OF PATENT FORAMEN OVALE: A SINGLE-CENTER EXPERIENCE i2 Poster Contributions Georgia World Congress Center, Hall B5 Monday, March 16, 2009, 9:30 a.m.-10:30 a.m. Session Title: Endovascular and New Technologies Abstract Category: PCI - Congenital Presentation Number: 2505-432 Authors: Babak Haddadian, Alix J. Tercius, Naoyo Mori, Louie Kostopoulos, Satish Velagapudi, Kambiz Shetabi, Krishna Nagendran, Hani Hashim, Abdelazim Hashim, Andleeb Bangash, Anjan Gupta, Suhail Allaqaband, Tanvir Bajwa, Aurora Cardiovasc Svcs, Aurora Sinai/St. Luke’s Med Ctrs, Univ Wisconsin Sch Med & Public Health-MCC, Milwaukee, WI, Center for Urban Population Health, University of Wisconsin-Milwaukee, Milwaukee, WI Background: Only a few studies have compared these devices for safety, complications, mortality, and recurrence of stroke, transient ischemic attack (TIA) and arrhythmia. We compared current devices for patent foramen ovale (PFO) closure with respect to procedural complications, residual shunt, and clinical outcome. Methods: We studied 114 consecutive patients who had PFO closure for various reasons (85% cryptogenic stroke). Amplatzer® PFO device (AGA Medical Corp., Plymouth, MN) versus CardioSEAL/STARflex® device (NMT Medical Inc., Boston, MA) versus Gore Helex device (W.L. Gore & Associates Inc., Flagstaff, AZ) were compared (Table). Results: Closure was equally successful for all devices. Clinical follow-up was completed in 95% of patients. There was no significant difference in rate of periprocedural complications, recurrence of TIA/stroke, or arrhythmia. One death related to closure occurred in each Amplatzer PFO (Hemothorax) and STARflex (retrocardiac hematoma) group. Immediate periprocedural shunts (mostly small) were more common in the Amplatzer PFO and Gore Helex devices. Conclusions: Most closure devices in the market have comparable safety and efficacy rates. Immediate post procedural residual small shunts were more commonly observed in Amplatzer PFO and Gore Helex devices. Results showed a higher out-of-hospital mortality rate associated with Amplatzer PFO device. Outcome by Device in Patients With PFO TYPE OF DEVICE CHARACTERISTIC Amplatzer PFO; n=30 No. (%) CardioSEAL/STARflex; n=71 No. (%) Gore Helex; n=13 No. (%) p-Value Demographics Age - mean ± SD years 57.6±16.56 52.1±14.35 54.1±11.59 NS Female 12 (40.0%) 29 (40.9%) 7 (53.9%) NS TIA 18 (60.0%) 38 (53.5%) 4 (30.8%) NS Stroke 17 (56.7%) 37 (52.1%) 8 (61.5%) NS Arrhythmia 3 (10.0%) 5 (7.0%) 1 (7.7%) NS Median follow-up - months (IQR) 15 (3-23) 19 (7-36) 5 (3-24) NS Device size - mean ± SD mm 25.8±5.39 25.5±4.04 26.5±4.47 NS Procedural Success 30 (100%) 70 (98.6%) 13 (100%) NS Post Procedural Shunt Small 6 (20.0%) 3 (4.2%) 3 (23.1%) <0.05 Moderate/Large 0 (0.0%) 2 (2.8%) 1 (7.7%) Complication 1 (3.3%) 1 (1.4%) 0 (0.0%) NS Death 5 (16.7%) 1 (1.4%) 0 (0.0%) <0.05 In-hospital 1 (3.3%) 1 (1.4%) 0 (0.0%) <0.05 Out-of-hospital 4(13.3%) 0(0.0%) 0(0.0%) Recurrent Event (follow-up) TIA 3 (10.0%) 4 (5.6%) 1 (7.7%) NS Stroke 0 (0.0%) 2 (2.8%) 0 (0.0%) NS Arrythmia 4 (13.3%) 4 (5.6%) 2 (15.4%) NS Abbreviations: IQR=interquartile range; PFO= patent foramen ovale; TIA=transient ischemic attack.
Transcript of COMPARISON OF AMPLATZER® PFO VERSUS CARDIOSEAL/STARFLEX® VERSUS GORE HELEX DEVICES IN CLOSURE OF...
i2 SUMMIT
A212.E2005
JACC March 9, 2010
Volume 55, issue 10A
COMPARISON OF AMPLATZER® PFO VERSUS CARDIOSEAL/STARFLEX® VERSUS GORE HELEX DEVICES
IN CLOSURE OF PATENT FORAMEN OVALE: A SINGLE-CENTER EXPERIENCE
i2 Poster ContributionsGeorgia World Congress Center, Hall B5
Monday, March 16, 2009, 9:30 a.m.-10:30 a.m.
Session Title: Endovascular and New TechnologiesAbstract Category: PCI - Congenital
Presentation Number: 2505-432
Authors: Babak Haddadian, Alix J. Tercius, Naoyo Mori, Louie Kostopoulos, Satish Velagapudi, Kambiz Shetabi, Krishna Nagendran, Hani Hashim,
Abdelazim Hashim, Andleeb Bangash, Anjan Gupta, Suhail Allaqaband, Tanvir Bajwa, Aurora Cardiovasc Svcs, Aurora Sinai/St. Luke’s Med Ctrs, Univ
Wisconsin Sch Med & Public Health-MCC, Milwaukee, WI, Center for Urban Population Health, University of Wisconsin-Milwaukee, Milwaukee, WI
Background: Only a few studies have compared these devices for safety, complications, mortality, and recurrence of stroke, transient ischemic
attack (TIA) and arrhythmia. We compared current devices for patent foramen ovale (PFO) closure with respect to procedural complications, residual
shunt, and clinical outcome.
Methods: We studied 114 consecutive patients who had PFO closure for various reasons (85% cryptogenic stroke). Amplatzer® PFO device (AGA
Medical Corp., Plymouth, MN) versus CardioSEAL/STARflex® device (NMT Medical Inc., Boston, MA) versus Gore Helex device (W.L. Gore & Associates
Inc., Flagstaff, AZ) were compared (Table).
Results: Closure was equally successful for all devices. Clinical follow-up was completed in 95% of patients. There was no significant difference
in rate of periprocedural complications, recurrence of TIA/stroke, or arrhythmia. One death related to closure occurred in each Amplatzer PFO
(Hemothorax) and STARflex (retrocardiac hematoma) group. Immediate periprocedural shunts (mostly small) were more common in the Amplatzer
PFO and Gore Helex devices.
Conclusions: Most closure devices in the market have comparable safety and efficacy rates. Immediate post procedural residual small shunts
were more commonly observed in Amplatzer PFO and Gore Helex devices. Results showed a higher out-of-hospital mortality rate associated with
Amplatzer PFO device.
Outcome by Device in Patients With PFOTYPE OF DEVICE
CHARACTERISTICAmplatzer PFO; n=30
No. (%)
CardioSEAL/STARflex; n=71
No. (%)
Gore Helex; n=13
No. (%)p-Value
DemographicsAge - mean ± SD years 57.6±16.56 52.1±14.35 54.1±11.59 NSFemale 12 (40.0%) 29 (40.9%) 7 (53.9%) NSTIA 18 (60.0%) 38 (53.5%) 4 (30.8%) NSStroke 17 (56.7%) 37 (52.1%) 8 (61.5%) NSArrhythmia 3 (10.0%) 5 (7.0%) 1 (7.7%) NSMedian follow-up - months (IQR) 15 (3-23) 19 (7-36) 5 (3-24) NSDevice size - mean ± SD mm 25.8±5.39 25.5±4.04 26.5±4.47 NSProcedural Success 30 (100%) 70 (98.6%) 13 (100%) NSPost Procedural ShuntSmall 6 (20.0%) 3 (4.2%) 3 (23.1%)
<0.05Moderate/Large 0 (0.0%) 2 (2.8%) 1 (7.7%)Complication 1 (3.3%) 1 (1.4%) 0 (0.0%) NSDeath 5 (16.7%) 1 (1.4%) 0 (0.0%) <0.05In-hospital 1 (3.3%) 1 (1.4%) 0 (0.0%)
<0.05Out-of-hospital 4(13.3%) 0(0.0%) 0(0.0%)Recurrent Event (follow-up)TIA 3 (10.0%) 4 (5.6%) 1 (7.7%) NSStroke 0 (0.0%) 2 (2.8%) 0 (0.0%) NSArrythmia 4 (13.3%) 4 (5.6%) 2 (15.4%) NSAbbreviations: IQR=interquartile range; PFO= patent foramen ovale; TIA=transient ischemic attack.
