Study Compares 3 Different Devices for PFO Closure

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While procedural complications and long-term neurological events are rare regardless of the device used for percutaneous closure of patent foramen ovale (PFO), recurrent events are reduced after closure using the Amplatzer device compared with the CardioSEAL/STARFlex or Helex devices, according to data appearing online July 9, 2013, in the European Heart Journal.

Researchers led by Horst Sievert, MD, PhD, of CardioVascular Center Frankfurt (Frankfurt, Germany), randomized 660 patients at their institution with cryptogenic stroke and PFO to 3 different closure devices between January 2001 and December 2004: Amplatzer (AGA/St. Jude, Plymouth, MN), CardioSEAL/STARFlex (NMT Medical, Boston, MA), and Helex (WL Gore, Newark, DE). NMT ceased business operations in 2011.

Baseline characteristics were similar among the 3 groups with the exception of atrial septal aneurysms, which were found in 43% of Helex patients, 37% of CardioSEAL patients, and 28% of Amplatzer patients (P = 0.0062).

Device implantation was technically successful in all patients. Mean procedural and fluoroscopy times were longest in the Helex group (33.5 min; 6.6 min), although the differences were small compared with the Amplatzer (28.6 min; 4.1 min) and CardioSEAL (31.4 min; 4.9 min) groups. Mean hospital stay was longest in the CardioSEAL group (19.8 hours) compared with the Amplatzer (18.1 hours) and Helex (18.8 hours) groups.

Slightly Fewer Primary Endpoint Events with Amplatzer

At 5-year follow-up, the overall stroke and death rate was 3.8%, with no differences among the 3 groups (P = 0.5827). The combined primary endpoint of TIA, stroke, cerebral death, or paradoxical embolism occurred more often in the CardioSEAL and Helex groups compared with the Amplatzer group (table 1). Events such as thrombus formation and A-fib, meanwhile, were also more common in the Helex or CardioSEAL groups.

Table 1. Five-Year Outcomes

^aP value for Amplatzer vs. both CardioSEAL and Helex; no significant difference for Amplatzer vs. Helex.
^bP value for CardioSEAL vs. both Amplatzer and Helex; no significance difference for Amplatzer vs. Helex.
^cP value for Helex vs. both Amplatzer and CardioSEAL; no significant difference for Amplatzer vs. CardioSEAL.

Survival analysis using the log-rank test demonstrated superiority of the Amplatzer device compared with CardioSEAL (P = 0.01) regarding the occurrence of primary endpoint events. Compared with Helex, there was a trend for fewer primary endpoint events with Amplatzer (P = 0.079).

Immediate periprocedural complications and ischemic events in the study were rare, the researchers note, adding that complete closure was achieved in the vast majority of patients at final follow-up. But “most importantly, in our study, the events the devices were intended to prevent (strokes and TIAs) were significantly less common after Amplatzer implantation compared with both other devices,” the authors conclude.

Type of Device May Impact PFO Closure

They observe that given the neutral findings of CLOSURE I as well as the slightly positive findings of the RESPECT and PC trials, the efficacy of closure vs. medical therapy may depend on the type of implanted device.

“Percutaneous PFO closure is safe,” Dr. Sievert and colleagues conclude. “The overall incidence of neurological events after closure is low. However, there appear to be significant differences in the neurological event rate between devices. Hence, the choice of device may determine the efficacy of PFO closure.”

In an e-mail communication with TCTMD, CLOSURE I principal investigator Anthony J. Furlan, MD, of Case Western Reserve University (Cleveland, OH), questioned many aspects of the study. “The clinical conclusions (stroke + TIA) are of no value in this study especially considering [patients with migraine were] randomized and there was no independent adjudication,” he said, adding that the lack of baseline data comparing demographics, vascular risk factors, PFO anatomy, and neuroimaging make “the comparability of the 3 groups unclear.”

Actual StarFLEX Use Questioned

Also, since STARFlex is no longer commercially available, Dr. Furlan questioned how the researchers even obtained the devices. “CardioSEAL was the commercially available NMT device. CardioSEAL and STARFlex are not the same (STARFlex had certain technical improvements). It should be clarified exactly which NMT product was used and how they got STARFlex if, in fact, they really used it,” he said.

Overall, Dr. Furlan noted, “the Amplatzer appears to be the best device available, but the key remaining question is patient selection and this study provides no useful information in that regard. Also there are no useful data on best medical therapy.”

In response, first author Marius Hornung, MD, of CardioVascular Center Frankfurt, replied by e-mail that none of the patients randomized in the trial were included because of migraine alone. “All patients suffered from at least 1 cerebral ischemic event,” he told TCTMD.

The paper’s methods section specifies that inclusion criteria were cryptogenic stroke, TIA, migraine, and/or decompression sickness.

Amplatzer, Appendectomy, and Car Accidents

Furthermore, baseline comparison data were described in a previous paper, Dr. Hornung explained (Taaffe M, et al. Am J Cardiol. 2008;101:1353-1358). Concerning device availability, the “CardioSEAL was replaced by the CardioSEAL STARFlex in 1999,” Dr. Hornung said, adding that the latter device has been available in Europe under the same name since that time.

Regarding patient selection and medical therapy, Dr. Hornung responded, “Our study was a comparison between different devices for PFO closure. Not providing information about patient selection or the type of best medical therapy was part of our study design. I think this point is not fair. It’s like saying that CLOSURE I gave no useful information about the Amplatzer, appendectomy, or car accidents.”

 

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Source:
Hornung M, Bertog SC, Franke J, et al. Long-term results of a randomized trial comparing three different devics for percutaneous closure of a patent foramen ovale. Eur Heart J. 2013;Epub ahead of print.

 

 

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