Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience

https://doi.org/10.1016/j.ijcard.2020.11.029Get rights and content

Highlights

  • •

    Trans-catheter closure is nowadays the first-choice treatment of ASD with self-centering or non self-centering devices

  • •

    The GORE® Cardioform ASD Occluder device has high anatomic compliance, as the non self-centering devices, but the potential to close large defects.

  • •

    Thanks to its anatomic compliance this device could expand the eligible ASD population to include patientswith plain “surgical” indication

Abstract

Background

This perspective, observational study evaluated safety and efficacy of the GORE® Cardioform ASD Occluder (WL Gore & Associates, Flagstaff, AZ), compliant and potentially innovative prosthesis recently approved for closure of ostium secundum atrial septal defects (ASD).

Methods

Between January and June 2020, 43 unselected patients with -significant ASD were submitted to trans-catheter closure with GORE® Cardioform ASD Occluder at two high-volume Italian Pediatric Cardiology centers. Primary endpoints were procedural success and safety. Secondary endpoints were closure rate and clinical safety at 1-month follow-up.

Results

Patients' age and weight were 8.2 ± 3.9 years (range 3–21, median 9.9) and 29.6 ± 15.3 kg (range 16–57, median 33.3), respectively. ASD diameter was 16.6 ± 4.5 mm (median 10), resulting in QP/QS of 1.7 ± 0.7 (median 1.6). Seventeen pts. (39.5%) were considered “surgical” candidates due to challenging septum morphology, ASD rim deficiency or ASD diameter/patient weight ratio ≥ 1.2. Device placement was successfully achieved in all but one patient (97.7%), in whom it embolized early after deployment, resulting in rescue surgical repair. No cross-over with different devices was recorded. Median procedure and fluoroscopy times were 40 and 6.8 min, respectively. Major adverse events were recorded in 7.0% (3 pts). Complete closure rate was 78.5% at discharge, rising to 92.9% (39/42 pts) at 1 month evaluation, without cardiac or extra-cardiac adverse events. “Challenging” procedures were more time-consuming but as effective and safe as the “simple” ones.

Conclusions

The GORE® Cardioform ASD Occluder device was highly effective and versatile in closure of ASDs with different anatomy and size, even in challenging settings.

Introduction

Ostium secundum Atrial Septal Defect (ASD) is a common congenital heart defect, found in about 1.0/1.000 live births and causing right ventricular volume overload, atrial arrhythmias, pulmonary hypertension, systemic embolism and premature death over a long-term follow-up [[1], [2], [3], [4]]. Trans-catheter closure is nowadays considered as the first-line treatment of ASD [[3], [4], [5], [6], [7]]. To date, two different philosophies of closure are suggested on the basis of defect size and anatomy, i.e. use of self-centering (Amplatzer Septal Occluder or Amplatzer-like devices) or non self-centering device [GORE® Cardioform Septal Occluder (GSO), Amplatzer Cribriform device, Amplatzer Cribriform-like devices]. The former approach allows to treat larger ASDs due to the “stenting” mechanism of closure at the expense of a greater impact on local anatomy and physiology caused by intrinsic stiffness of the device [7,8]. Conversely, the latter approach grounds the occluding capacity of the device on ASD “coverage” and therefore can be used to close defects smaller than 18–20 mm [9], albeit at a lower risk of anatomic and functional interference and hence low rate of predicted long-term complications [10,11]. The new GORE® Cardioform ASD Occluder device (WL Gore & Associates, Flagstaff, AZ) has been recently claimed as a significant technical innovation in trans-catheter ASD treatment since it combines high softness and anatomic compliance with the potential to close defects as large as 35 mm. This device has just recently received the US Food and Drug Administration and European Community approval [12,13] and is still in early post-marketing evaluation [14,15].

This paper reports on the first European series of unselected ASD patients treated with the new GORE® Cardioform ASD Occluder.

Section snippets

Patient population

This perspective single-arm study was performed at the Pediatric Cardiology and GUCH Unit of the Heart Hospital “G. Pasquinucci” of Massa and the Pediatric Cardiology Unit of the University of Padua, by enrolling all pediatric and young adult patients with isolated, hemodynamically significant ASD scheduled for percutaneous closure between January and June 2020. Only common atrium type ASD and sinus venosus type ASD with anomalous pulmonary vein drainage were excluded, as were the patients with

Patient population

Between January and June 2020, 43 patients with hemodynamically significant ASD, whose demographic characteristics are summarized in the Table 1, were submitted to attempt of percutaneous closure with the GORE® Cardioform ASD Occluder device. Neither significant differences in demographic characteristics of the enrolled cohorts nor in technical skills of the interventional cardiologists of either centre was recorded. None of the patients had associated cardiac malformations but one patient, who

Discussion

Over time, trans-catheter option emerged as a cost-benefit alternative to surgical repair of ASD [5,6] and is nowadays widely considered as the first-line treatment of this malformation at any age [[2], [3], [4],[7], [8], [9], [10], [11],16]. Based on ASD size and morphology, trans-catheter closure may be achieved with self-centering or non self-centering devices. The former approach allows to close larger defects due to the “stenting” mechanism of occlusion, at the expense of a greater impact

Study limitations

The aim of this study of evaluating procedure safety and effectiveness as well as early outcome of percutaneous ASD closure with the Gore ASD Occluder might be hampered by some theoretical limitations. First, the patient population is quite small, thereby precluding any reliable multi-factorial analysis on the impact of patient's demographic and anatomic profiles on the procedural risk and early complications of this device. However, this is the first study after the post-marketing pilot report

Conclusion

In conclusion, the new GORE® Cardioform ASD Occluder could be considered an appealing, significant advance in ASD treatment, so confirming the favorable efficacy and safety profile already reported in the preliminary post-marketing studies. In our opinion, this device could significantly expand the current arsenal of devices for ASD closure and the feasibility range of ASDs potentially treatable by trans-catheter approach, so potentially allowing to close defects previously considered of plain

Funding

No private or public fund was provided in planning and performing this study.

Ethics committee approval

No ethics committee approval was deemed necessary since this observational study reported data from an approved and free-marketed device.

Patient and Public Involvement statement

There was no patient or public involvement in ideation and performance of this study.

Author Statement Form – International Journal of Cardiology

Giuseppe Santoro and Biagio Castaldi conceived the study, Magdalena Cuman, Angela Di Candia, Alessandra Pizzuto, Domenico Sirico, Massimiliano Cantinotti and Silvia Garibaldi collected the data and made the statistical analysis, and finally Vitali Pak and Giovanni Di Salvo drafted and critically revised the paper.

GS is proctor for Abbott, Italy, Occlutech, Italy and WL Gore, Italy. There is no relationship with industry for any other of the authors.

On behalf of all Co-Authors, the corresponding

Declaration of Competing Interest

GS is Proctor of Abbott, WL Gore and Occlutech, Italy. None of the other Authors disclose any conflict of interest.

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    The First 2 Authors equally contributed to the paper. The Authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.

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