Use of a Novel Septal Occluder Device for Left Atrial Appendage Closure in Patients With Postsurgical and Postlariat Leaks or Anatomies Unsuitable for Conventional Percutaneous Occlusion

Domenico G Della Rocca; Rodney P Horton; Nicola Tarantino; Christoffel Johannes Van Niekerk; Chintan Trivedi; Qiong Chen; Sanghamitra Mohanty; Alisara Anannab; Ghulam Murtaza; Krishna Akella; Carola Gianni; Mohamed Bassiouny; Ashkan Ahmadian-Tehrani; Amin Al-Ahmad; J David Burkhardt; Veronica N Natale; Matthew Price; G Joseph Gallinghouse; Douglas N Gibson; Dhanunjaya Lakkireddy; Luigi Di Biase; Andrea Natale

doi:10.1161/CIRCINTERVENTIONS.120.009227

Use of a Novel Septal Occluder Device for Left Atrial Appendage Closure in Patients With Postsurgical and Postlariat Leaks or Anatomies Unsuitable for Conventional Percutaneous Occlusion

Circ Cardiovasc Interv. 2020 Oct;13(10):e009227. doi: 10.1161/CIRCINTERVENTIONS.120.009227. Epub 2020 Sep 18.

Authors

Domenico G Della Rocca¹, Rodney P Horton^{1

2}, Nicola Tarantino³, Christoffel Johannes Van Niekerk⁴, Chintan Trivedi¹, Qiong Chen^{1

5}, Sanghamitra Mohanty¹, Alisara Anannab^{1

6}, Ghulam Murtaza⁷, Krishna Akella⁷, Carola Gianni¹, Mohamed Bassiouny¹, Ashkan Ahmadian-Tehrani^{1

8}, Amin Al-Ahmad¹, J David Burkhardt¹, Veronica N Natale⁹, Matthew Price⁴, G Joseph Gallinghouse¹, Douglas N Gibson⁴, Dhanunjaya Lakkireddy⁷, Luigi Di Biase^{1

10

3

11}, Andrea Natale^{1

4

11

12

13}

Affiliations

¹ Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin (D.G.D.R., R.P.H., C.T., Q.C., S.M., A.A., C.G., M.B., A.A.-A., J.D.B., G.J.G., L.D.B., A.N.).
² Department of Biomedical Engineering, Cockrell School of Engineering (R.P.H.), University of Texas, Austin.
³ Arrhythmia Services, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (N.T., L.D.B.).
⁴ Interventional Electrophysiology, Scripps Clinic, La Jolla, CA (C.J.V.N., M.P., D.N.G., A.N.).
⁵ Department of Cardiopulmonary Function Test, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, China (Q.C.).
⁶ Department of Cardiovascular Intervention, Central Chest Institute of Thailand, Nonthaburi (A.A.).
⁷ Kansas City Heart Rhythm Institute at HCA Midwest Health (G.M., K.A., D.L.).
⁸ Division of Internal Medicine, Department of Medicine, University of Texas Health Science Center, San Antonio (A.A.-T.).
⁹ Department of Pediatrics, Charlotte R. Bloomberg Children's Center, Johns Hopkins University, Baltimore, MD (V.N.N.).
¹⁰ Department of Internal Medicine, Dell Medical School (L.D.B.), University of Texas, Austin.
¹¹ Department of Clinical and Experimental Medicine, University of Foggia, Italy (L.D.B., A.N.).
¹² Department of Cardiology, MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH (A.N.).
¹³ Division of Cardiology, Stanford University, CA (A.N.).

PMID: 32942913
DOI: 10.1161/CIRCINTERVENTIONS.120.009227

Abstract

Background: Interventional therapies aiming at excluding the left atrial appendage (LAA) from systemic circulation have been established as a valid alternative to oral anticoagulation in patients at high thromboembolic risk. However, their efficacy on stroke prophylaxis may be compromised owing to incomplete LAA closure. Additionally, the need for an alternative thromboembolic prevention may remain unmet in patients with contraindications to oral anticoagulation whose appendage anatomy is unsuitable for some conventional devices commercially available. We aimed at evaluating the feasibility of LAA closure with the novel Gore Cardioform Septal Occluder in patients with incomplete appendage ligation or anatomic features which do not meet the manufacturer's requirements for Watchman deployment.

Methods: Twenty-one consecutive patients (mean age: 72±6 years; 85.7% males; CHA₂DS₂-VASc: 4.5±1.4; HAS-BLED: 3.6±1.0) were included. Transesophageal echocardiography was performed within 2 months to assess for residual LAA patency.

Results: Fourteen patients had incomplete LAA closure following surgical (n=6) or Lariat ligation (n=8). In 7 patients with an appendage anatomy unsuitable for Watchman deployment, the mean maximal landing zone size and LAA depth were 14.4±1.3 and 18.6±2.8 mm. Successful Cardioform Septal Occluder deployment was achieved in all patients. No peri-procedural complications were documented. Procedure and fluoroscopy times were 46±13 and 14±5 minutes. Follow-up transesophageal echocardiography after 58±9 days revealed complete LAA closure in all patients.

Conclusions: Transcatheter LAA closure via a Cardioform Septal Occluder device might be a valid alternative in patients with residual leaks following failed appendage ligation or whose LAA anatomy does not meet the minimal anatomic criteria to accommodate a Watchman device. Graphic Abstract: A graphic abstract is available for this article.

Keywords: atrial appendage; atrial fibrillation; mitral valve; patent foramen ovale; transoesophageal echocardiography.

Publication types

Multicenter Study

MeSH terms

Aged
Aged, 80 and over
Atrial Appendage / diagnostic imaging
Atrial Appendage / physiopathology*
Atrial Fibrillation / complications
Atrial Fibrillation / diagnosis
Atrial Fibrillation / physiopathology
Atrial Fibrillation / therapy*
Atrial Function, Left*
Cardiac Catheterization / adverse effects
Cardiac Catheterization / instrumentation*
Clinical Decision-Making
Echocardiography, Doppler, Color
Echocardiography, Transesophageal
Feasibility Studies
Female
Heart Rate
Humans
Male
Middle Aged
Prospective Studies
Prosthesis Design
Risk Factors
Septal Occluder Device*
Thromboembolism / prevention & control*
Time Factors
Treatment Outcome