Percutaneous Device Closure of Patent Foramen Ovale Using the Premere Occlusion Device: Initial Experience, Procedural, and Intermediate-Term Results

Abstract: Background. Percutaneous device closure is a therapeutic option in patients with presumed stroke complicating paradoxical emboli. Newer devices with lower profiles and potentially reduced thrombogenicity have emerged, such as the Premere PFO occlusion device (St Jude Medical, Inc.); there are limited data on the efficacy and procedural experience with this device. Methods. We evaluated our initial experience with the Premere device in a contemporary patient cohort, comparing the procedural and intermediate follow-up characteristics with the currently utilized Amplatzer PFO occluder. Results. Both devices were similarly effective in terms of immediate procedural success and defect closure. Procedures using the Premere device tended to be longer and required larger vascular access-sheath sizes; there were also significantly more adverse events in the Premere group (4/29) compared to the Amplatzer group (0/42; P=.02), including 1 retroperitoneal bleed, 2 hematomas, and 1 myocardial infarction. Conclusions. While the Amplatzer device may offer advantages in terms of safety and procedural simplicity, this in part reflects the early procedural experience with this new device. The Premere and Amplatzer PFO occlusion devices are similarly effective in achieving PFO closure when applied to appropriate anatomy and should be considered complementary when performing such procedures.

J INVASIVE CARDIOL 2012;24(4):164-168

Key words: PFO closure, PFO occlusion

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Percutaneous device closure of patent foramen ovale (PFO) has emerged as a safe, therapeutic option for patients with stroke and transient cerebral ischemia complicating presumed paradoxical embolism.¹ Additional potential indications for PFO closure include hypoxemia complicating right to left shunting^2-4 and refractory migraine.^5-7 A number of devices have been devised for interatrial defect closure, with the largest experience using the Amplatzer PFO occlusion device.^8-11 While safe, described complications of device closure include thrombosis, erosion, and arrhythmia;^12-14 furthermore, residual shunting may occur, with a long PFO tunnel a potential mechanism for the presence of a persistent defect.¹¹

The Premere PFO device is a low-profile occlusion device with an adjustable waist to allow for exact positioning of the left and right atrial discs across the interatrial septum, irrespective of the tunnel length; the low-profile left-sided disc potentially reduces the risk of thrombosis.^7,13 There are limited published data on the procedural aspects of the Premere device and associated intermediate and late outcomes.

We performed a multicenter, retrospective review to evaluate the initial experience using the Premere PFO occlusion device with respect to procedural outcomes as well as intermediate results (3-6 month follow-up). We compared the procedural experience and outcomes with the Premere device to those undergoing PFO closure using the established Amplatzer device during the same time period.

Methods

All patients undergoing PFO closure using either the Premere or Amplatzer device since the Premere device became available at the study institutions until November 2009 were included for assessment with 1 year follow-up available for all patients. Device implant selection was at the discretion of the operator, with atrial septal aneurysm considered a contraindication for Premere device use; the presence or absence of a long tunnel was not a component of device selection.

Demographic, clinical, and procedural data were collected retrospectively following review of the clinical record. The study was approved by the Gold Coast Health Service and Hunter New England Area Research Ethics committees.

Statistical analysis was performed using STATA version 10 (STATA). Comparison between patients undergoing closure with the Premere and Amplatzer devices was performed using the Student’s t test for continuous variables or Chi square test for dichotomous or categorical variables.

The procedure was performed under either local or general anesthesia with transesophageal echocardiography according to physician preference. All patients undergoing device closure received intravenous heparin and antibiotic prophylaxis at the time of procedure. Patients were typically commenced on aspirin and clopidogrel therapy for thrombus prevention post procedure; however, the nature and duration of adjunctive medical therapy after discharge, including the need for anticoagulation, was based on treating physician preference. Similarly, follow-up contrast echocardiography was performed according to local protocol.

The Premere is a low-profile device with the ability to adjust the distance between the left and right atrial discs according to PFO tunnel length (Figure 1). After positioning the 11 Fr delivery sheath in the left atrium, the left-sided disc only is released and retracted with the delivery sheath toward the septum. Once the left atrial disc is against the interatrial septum and the delivery sheath retracted into the right atrium, the right atrial disc is then actively advanced over a central flexible tether through the delivery sheath until positioned against the right atrial septal wall. Once position is confirmed using echocardiography, the discs are then locked into position using the specific locking mechanism. The locking mechanism is then removed over the central tether and a specifically designed cutting tool is advanced over the tether to the inferior aspect of right atrial disc, thus releasing the device. In previous small series with limited follow-up, the Premere device has been an effective percutaneous therapy for interatrial defect closure.¹⁵

A number of specific procedural issues relating to the use of the Premere device are noted. The Amplatzer device can be easily retrieved into the delivery sheath if device position is not optimal. The retrieval of the Premere device is more problematic and requires removal of the Premere locking system over the central tether and insertion of a dedicated retrieval basket (Figures 2A and 2B) through the delivery sheath. This is technically more challenging and time consuming compared to the straightforward retrieval mechanism of the Amplatzer device. Furthermore, in the event of device misplacement, the Premere device cannot be reused and requires implantation of another device. Secondly, the need for a degree of tension on the central tether is important in order to maintain the left atrial disc position while actively advancing the right atrial disc into position (in contrast to the fixed position of the discs in the Amplatzer device). When there is insufficient tension, the left and right discs may not be in optimal position with a larger than required distance between discs (Figures 3A and 3B); we noted that the use of a second operator to hold the central tether to fix the left atrial disc position while the primary operator advances the right atrial disc through the delivery sheath prevents separation of the discs across the septum. When this separation occurs, it can be overcome by pulling the left atrial disc taut against the septum, removing the delivery system and advancing the cutting tool to “push” the right atrial disc toward the interatrial septum over the central tether. This is an issue unique to the Premere device due to adjustable nature of the waist between the atrial discs.

Results

A total of 73 patients underwent percutaneous PFO device closure during the study period, with the Amplatzer device used in 42 patients and the Premere device used in 29; two procedures were abandoned due to inability to successfully cross the PFO. Baseline clinical characteristics, including indication as well as relevant echocardiographic data, are outlined in Table 1 with no significant baseline differences.

Procedural details, including adverse events, are outlined in Table 2. Immediate procedural success was similar in the two populations, with procedure successful in 100% of the Amplatzer group and 97% of the Premere group; in 1 patient, the Premere device was malpositioned and retrieved. In this case, the anatomy was felt to also be suitable for an Amplatzer device, with the patient undergoing subsequent uncomplicated closure using the Amplatzer PFO occluder due to greater operator comfort and experience with this device. In 1 case, a patient receiving a Premere PFO occlusion device also underwent concomitant atrial septal defect (ASD) closure using an Amplatzer ASD occlusion device. Fluoroscopy duration was longer (6:49 minutes in Amplatzer group vs 9:25 in the Premere group) and delivery sheath size larger in the Premere group.

There were no adverse events observed for the Amplatzer device, compared to 4 adverse events with the Premere device; this association was statistically significant (P=.02). A single patient experienced a retroperitoneal hemorrhage following use of the Premere device, with 2 further Premere patients noted to have significant postprocedural hematoma. Another Premere procedure was complicated by acute inferior myocardial infarction, likely due to air embolization. No patient developed device-related thrombosis or significant arrhythmia in either group.

Follow-up transthoracic echocardiography at 6 months was available in 51 of the 71 patients from baseline (34/42 [80%] of the Amplatzer group and 17/29 [60%] of the Premere group). The presence of residual shunt was determined at transthoracic echocardiography for right to left shunting by positive agitated saline contrast examination following Valsalva maneuver and release; complete closure was achieved in 28/34 (82%) of the Amplatzer group and 13/17 (78%) of the Premere group.

Clinical follow-up was complete for all patients undergoing device closure with both groups free of recurrent embolic events during a minimum of twelve months’ follow-up.

Discussion

We evaluated the procedural and intermediate results of the use of the Premere PFO occlusion device and compared them to a contemporary group undergoing closure with the Amplatzer device. The Premere PFO occlusion device did have significantly more adverse events and was similar to the Amplatzer device in terms of procedural success and achieving interatrial defect closure at 6 months in our cohort. These results are noted in the context of additional procedural complexity encountered when performing Premere device implantation, in part reflecting the expected learning curve when using a new device.

Appreciation of the different nature of interatrial septum anatomy and the available devices for PFO closure is potentially important to ensure appropriate device selection and optimal procedural results.¹⁶ This reinforces the need for adequate preprocedure imaging to identify the length of the PFO tunnel and the presence of an atrial septal aneurysm, as well as highlights the advantages of familiarity with multiple devices.

The variable length of the tunnel in the PFO can be problematic when using the Amplatzer device, as the device may tent the septum (Figure 4) and predispose to residual shunt.¹¹ While the Premere device overcomes this by adjusting the device waist according to tunnel anatomy, the Amplatzer device has demonstrated superior closure rates when compared to other available devices and is designed to achieve PFO closure regardless of PFO tunnel anatomy.¹⁷ Furthermore, the presence of an atrial septal aneurysm dictates the need for an Amplatzer device and thus the Premere device is therefore clearly not suitable for all patients. However, the Premere device was safe and effective in achieving defect closure and may offer advantages in terms of duration of antiplatelet therapy as the low-profile nature of the device is attractive in terms of reducing the potential risk of thrombus, erosion, and arrhythmia.

From a procedural perspective, the Premere device tended to take longer, related to the expected learning curve when using a new device, but also to the need for precise positioning of the atrial discs, in comparison to the Amplatzer device, in which the discs take up a predetermined position. The Premere device requires adjustment of the tunnel length to individualize the position of the left and right atrial components, which typically requires echocardiography to guide adjustment of the right atrial disc position and subsequent locking into place; this also contributes to the longer procedural duration. While the procedural duration in this cohort when using the Amplatzer device was similar to previously published contemporary experience,¹⁸ the procedural duration when utilizing the Premere device was indeed similar to the initial published experience when the Ampatzer PFO occcluder was first used.¹⁹ The difference in procedural duration in this cohort in part reflects both the expected learning curve when using a new device and physician experience with both the established Amplatzer PFO and the similar Amplatzer atrial septal defect occlusion devices. It is understandable that procedural duration would be superior when comparing these more familar devices to using a new device technology.

The use of the Amplatzer device in PFO closure has been further simplified by allowing the widespread performance of the procedure under local anesthesia using fluoroscopy alone without need for adjunctive echocardiography. In contrast, the Premere typically needs echocardiographic imaging to optimize disc positioning and device placement. Intracardiac echocardiography offers excellent imaging when performing interatrial interventions using either device;²⁰ however, it is not yet widely available and expensive. In cases where echocardiographic guidance is required, such as when using the Premere device, transesophageal echocardiography represents a more commonly available alternative.

As noted in our study, the Premere device requires the use of ≥ 11 Fr delivery sheath in contrast to the smaller sheath size when using the Amplatzer device; this likely predisposes to vascular injury, with the only significant hemorrhagic complications in our cohort occurring in patients treated with the Premere device. Use of suture-mediated vascular closure devices may limit venous injury caused by larger sheath sizes.²¹

While an additional advantage of the Premere device is the theoretical need for a shorter duration of dual antiplatelet therapy due to the low-profile nature of the device, thrombosis following Amplatzer device implant is uncommon.²² In our cohort, one pregnant patient was treated with aspirin monotherapy without thrombotic sequelae. While longer durations of dual antiplatelet therapy are typical, aspirin monotherapy may be suitable for both devices when clopidogrel use is problematic.²² Longer-term data are required to determine the risk of device thrombosis as well as other previously described complications, such as erosion and arrhythmia.

These devices may be considered complementary when considering PFO occlusion, given they both adequately achieve interatrial defect closure. As similar procedural results may be achieved with the Premere and Amplatzer devices, optimizing procedural results relies on appropriate device selection and deployment and the importance of adequate preprocedural imaging and defect assessment cannot be over-emphasized. It should be recognized that the Premere device predisposes to a greater degree of procedural complexity, noting an expected learning curve, which should be considered prior to device implantation.

This study is limited by the overall sample size, making outcome comparisons between the groups difficult; however, it allowed sufficient experience to identify differences in terms of device deployment characteristics. Follow-up transesophageal echocardiography may have allowed for additional information on device closure and thombosis rates.

Conclusion

The Premere device is effective in achieving percutaneous PFO closure in patients with appropriate anatomy as demonstrated by similar intermediate results when comparing the Premere device to the Amplatzer device. The Premere device offers the ability to tailor the tunnel length according to anatomy as well as the potential for less intense antiplatelet therapy. Use of the Premere device requires the need for adjunctive imaging, associated with general anesthesia when transesophageal echocardiography is utilized, and larger vascular access sheath size, which may increase the risk of vascular injury. The intricacies of Premere device deployment, and indeed retrieval, can be expected to contribute to a longer procedural duration, particularly early in the experience of utilizing this new device technology. Given similar intermediate results and acknowledging variations in individual atrial septal anatomy, these devices may be considered complementary in achieving PFO closure.

Acknowledgment. The authors would like to acknowledge the assistance of Mr Vivek Kulkarni for maintenance of the procedural database.

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From the ¹Cardiovascular Unit, John Hunter Hospital, New Lambton, Australia, ²the Cardiology Department, Gold Coast Health Services District, Southport, Australia, and ³the Department of Epidemiology and Biostatistics, University of Newcastle, Callaghan, Australia.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Manuscript submitted August 3, 2011, provisional acceptance given September 20, 2011, final version accepted January 9, 2012.
Address for correspondence: Nick Collins, Cardiovascular Unit, John Hunter Hospital, Lookout Rd, New Lambton, NSW 2305, Australia. Email: nandl_collins@yahoo.com.au