Author + information
- Thomas K. Jones, MD⁎ (, )
- Larry A. Latson, MD,
- Evan Zahn, MD,
- Craig Fleishman, MD,
- Joth Jacobson, MS,
- Robert Vincent, MD and
- Kirk Kanter, MD
- ↵⁎Cardiac Catheterization Laboratories, Seattle Children’s Hospital, 4800 Sand Point Way, NE, Seattle, Washington 98015
We appreciate the interest by Drs. Bhindi and Ormerod who comment favorably on our paper, “Results of the Multicenter Pivotal Study of the Helex Septal Occluder for Percutaneous Closure of Secundum Atrial Septal Defects,” recently published in the Journal(1). They report their own successful experience with the use of the Helex Septal Occluder in 38 patients with atrial septal defect (ASD) at the John Radcliffe Hospital in Oxford, United Kingdom. They go on to draw a distinction between the procedural and fluoroscopic time in their own experience versus what was reported in our paper. Furthermore, they speculate that some of this difference could be due to their routine use of intracardiac echocardiography (ICE) instead of transesophageal echocardiography.
There are several factors that likely contributed to the differences in procedural and fluoroscopic time reported in their experience and our multicenter trial. Our pivotal trial represented some of the earliest human experience with this technique when best clinical practices were being first defined. All of our subjects were being treated for ASD, and most of them were children. Some of those ASDs proved to be relatively large for this device design (18 to 20 mm). Occasionally, the investigators made several attempts with multiple devices to close these larger defects. This additional effort accounted for the wide range of fluoroscopy time reported in our series, 6 min to 148 min. This is why we chose to report the median fluoroscopy time of 22 min rather than the mean time of 28 min, believing it more accurately represented the experience of the majority our subjects. Furthermore, a complete hemodynamic study was a protocol requirement that took time to perform. Drs. Bhindi and Ormerod do not comment on their use of defect balloon sizing in selecting proper size device, a time-consuming but not universally practiced technique. Balloon sizing in our study was another protocol-specified step that could further account for the time differences. Finally, the Helex delivery system available in Europe for several years, version 1.5, is much simpler and faster to use. The older 1.0 version used in our trial is still the only approved delivery system available in the U.S.
We do agree with Drs. Bhindi and Ormerod that the routine use of ICE, at the time unavailable for the vast majority of our subjects, has the effect of significantly reducing anesthesia time and improving patient comfort by eliminating the requirement for general endotracheal anesthesia. The impact of the use of ICE on fluoroscopy time, however, is less certain and more likely related to the other factors stated. We believe the biggest drawback to the wide acceptance of ICE in much of the world remains the cost of the imaging catheter. We look forward to improvements in design and manufacturing technology that bring down the cost of this useful modality so that it is affordable for all.
- American College of Cardiology Foundation