Author + information
- Francesco Santini, MD∗ (, )
- Francesco Onorati, MD,
- Filippo Rapetto, MD,
- Giancarlo Passerone, MD,
- Giuseppe Faggian, MD and
- Alessandro Mazzucco, MD
- ↵∗Division of Cardiac Surgery, IRCCS Azienda Ospedaliera Universitaria San Martino – IST, Largo Rosanna Benzi 10, 16132 Genova, Italy
We read with interest the safety review paper by Moore et al. (1) aimed at outlining the available information on the safety of atrial septal defect (ASD) closure devices (Amplatzer septal occluder [ASO], St. Jude Medical, St. Paul, Minnesota, and Helex septal occluder, W.L. Gore, Flagstaff, Arizona) with a focus on cardiac perforation.
In this endeavor, the authors of that paper quoted the analysis by DiBardino et al. (2), which presented 51 cardiac perforations reported to the Manufacturer and MAUDE (User Facility Device Experience) database, with a concerning overall mortality of 19.6% and evidence that ruptures may occur as late as 3 years after deployment.
Similarly, Moore et al. (1) reported a MAUDE database analysis by the U.S. Food and Drug Administration showing how erosion contributes to 15% of medical device reports, with an overall 16.2% mortality in 80 patients who required device removal. Again, the time to erosion reported in the 13 deaths ranged from 1 day to 2.2 years (3).
Cardiac perforation is a rare complication of ASD closure devices, not encountered in the pivotal or post-market approval studies, which is particularly troubling in view of the potential for late occurrence, the few convincing data on risk factors, and the impending catastrophic outcome.
Although not quoted by Moore et al. (1), we reported the longest time frame (5 years) ever recorded for an ASO-related cardiac perforation, which occurred during an intense isometric exertion in a 54-year-old patient (4).
Although anecdotal, our observation might have 2-fold importance. On the one hand, the potential for an even more delayed adverse event should not be underestimated. Indeed, this late occurrence might suggest a more cautious revision of the follow-up imaging schedule after device implantation (1).
On the other hand, the occurrence of the event during an intense isometric exertion raises the question whether dynamic changes in the anatomic relationship between the device and surrounding cardiac structures, particularly during Valsalva maneuvers or other pressurizing conditions, might play a role in the determinism of the complication. This issue could be of the utmost importance in people exposed to strenuous physical activity.
This hypothesis might suggest 2 precautionary initiatives: 1) the introduction of stress echocardiography in the routine assessment of patients after ASD closure device implantation to evaluate the appropriateness of the device positioning under dynamic conditions; and 2) greater restriction imposed during intense physical activity in ASD closure devices holders until this issue is finally elucidated.
- American College of Cardiology Foundation
- Moore J.,
- Hegde S.,
- El-Said H.,
- et al.
- DiBardino D.J.,
- McElhinney D.B.,
- Kaza A.K.,
- Mayer J.E.
- ↵U.S. FDA. FDA Executive Summary Memorandum—May 24, 2012: Circulatory System Advisory Panel Meeting—Transcatheter ASD Occluders: Clinical Update and Review of Events [pdf]. May 24, 2012. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystem DevicesPanel/ucm300073.htm. Accessed December 4, 2012