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. 2020 Jun 17;2(6):915–918. doi: 10.1016/j.jaccas.2020.05.008

Cardioform Septal Occluder in the Management of Cardiac Tamponade as a Complication of LAA Closure

Nabil Braiteh 1,, Mouhamed Amr Sabouni 1, Alon Yarkoni 1
PMCID: PMC8302018  PMID: 34317381

Abstract

Cardiac tamponade is a life-threatening complication during left atrial appendage (LAA) closure. We report a 77-year-old woman who underwent a transseptal puncture for LAA closure with the Watchman device that was complicated by tamponade. This was successfully treated with the deployment of a Cardioform 25-mm septal occluder device. (Level of Difficulty: Intermediate.)

Key Words: atrial fibrillation, pericardial effusion, tamponade

Abbreviations and Acronyms: AF, atrial fibrillation; LA, left atrial/atrium; LAA, left atrial appendage; PE, pericardial effusion; TEE, transesophageal echocardiogram

Graphical abstract

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Cardiac tamponade is a life-threatening complication during left atrial appendage (LAA) closure. We report a 77-year-old woman who underwent a transseptal…


A 77-year-old Caucasian woman was referred for left atrial (LA) appendage (LAA) closure. Warfarin was stopped 72 h before the procedure. Laboratory testing on the morning of the procedure revealed a platelet count of 156,000/mm3 and international normalized ratio of 1.68.

Learning Objectives

  • To report the novel use of the Cardioform septal occluder device in treating cardiac tamponade due to left atrial perforation during transseptal puncture.

  • To introduce a potentially new nonsurgical approach for the management of atrial wall perforation.

Under ultrasound guidance, the right femoral vein was accessed, and a 6-F sheath was inserted over a 0.035-inch guidewire. Transseptal puncture was attempted using SL0 sheath and C-1 NRG transseptal needle system (Baylis Medical USA, Burlington, Massachusetts) in the usual manner in the left anterior oblique projection using fluoroscopy and transesophageal echocardiography (TEE) guidance. The sheath was advanced over the needle; however, contrast injection confirmed the sheath position to be within the pericardial space, likely due to perforation through the posterior wall of the LA. TEE demonstrated a rapidly accumulating pericardial effusion (PE) (Figure 1) with subsequent hemodynamic instability. No anticoagulation was given.

Figure 1.

Figure 1

TEE Demonstrating a Rapidly Accumulating PE With Evidence of a Blood Clot

LV = left ventricle; PE = pericardial effusion; RV = right ventricle; TEE = transesophageal echocardiography.

Cardiothoracic surgery was promptly called, and a pericardial window was performed to evacuate around 400 ml of fresh blood and clots from the pericardial space. A pericardial drain was placed through the subxiphoid window. However, continued bleeding into the pericardium was noted by TEE (Video 1).

Online Video 1.

Download video file (909.7KB, mp4)

TEE Demonstrating a Rapidly Accumulating Pericardial Effusion With Evidence of a Blood Clot

An Amplatz Super Stiff guidewire (Boston Scientific, Marlborough, Massachusetts) was advanced to the pericardium through the SL0 sheath, then the SL0 sheath was withdrawn. To prevent further bleeding into the pericardial space, it was felt that sealing the LA perforation was necessary. A GORE Cardioform 25-mm septal occluder device (W. L. Gore & Associates, Newark, Delaware) was advanced over the Amplatz wire. The distal disc was exposed in the pericardial space and pulled up against the LA tissue. The proximal disc was then exposed within the LA, and the device was released with good approximation of the LA tissue (Figures 2 and 3, Video 2).

Figure 2.

Figure 2

Fluoroscopy Showing Deployment of the Septal Occluder Device

The septal occluder device is indicated by the white arrow.

Figure 3.

Figure 3

Bicaval View by TEE Showing the LA Disk of the Cardioform Septal Occluder Device

The Cardioform septal occluder device is indicated by the red arrow. LA = left atrium; RA = right atrium; TEE = transesophageal echocardiogram.

Online Video 2.

Download video file (730.5KB, mp4)

TEE Demonstrating the Deployment of the Cardioform Septal Occluder Device

No further pericardial fluid accumulation was noted. The patient regained hemodynamic stability and was then transferred to the cardiac intensive care unit.

Past Medical History

Nonvalvular atrial fibrillation (AF), CHA2DS2-VASc = 6, HAS-BLED = 5, multiple falls, sleep apnea, hypertension, and noncompliance with anticoagulation.

Differential Diagnosis

The differential diagnosis for her acute drop in blood pressure included retroperitoneal bleed, oversedation, or a large hemorrhagic PE leading to tamponade.

Investigations

Transesophageal echocardiography revealed a large PE with tamponade physiology.

Management

A pericardial window was performed to evacuate fresh blood and clots from the pericardial space. That was followed by deploying a 25-mm Cardioform septal occluder device to seal the LA perforation and prevent further bleeding into the pericardial space.

Discussion

AF is the most common cardiac rhythm disorder, with a prevalence of 1% in the general population, and it is estimated to affect 5.5 million individuals in the United States (1). Warfarin and novel anticoagulant agents are the treatment of choice for thromboembolic stroke prevention, which is one of the most devastating clinical consequences of AF (1,2).

Percutaneous LAA device closure with the Watchman (Boston Scientific) device is a Food and Drug Administration–approved nonpharmacological alternative approach for stroke prevention in patients with nonvalvular AF and a CHA2DS2-VASc ≥2 who are at an increased risk of bleeding or are unable to tolerate oral anticoagulation (1).

With improvement in operator technique and experience, the incidence of major procedural complications has been reduced significantly (<1% to 2%) (3). In the PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) and PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trials, the 7-day periprocedural complications, were defined as the composite of PE requiring surgical repair (0.4% to 1.6%), effusions requiring pericardiocentesis or a pericardial window (1.5% to 2.9%), cardiac perforation, ischemic stroke (0.7% to 1.1%), vascular complications, and device embolization (0.4% to 0.7%) occurring in the first week after implantation (4,5).

Pericardial tamponade is one of the most serious and life-threatening complications of LAA device closure, with an overall incidence of 1.3% in a pooled analysis of Watchman device registries and clinical trials (3), with the root cause being perforation due to initial transseptal puncture, guidewire or catheter manipulation while accessing the LAA, manipulation of the delivery system within the LAA, or overprotrusion of WATCHMAN anchors into the LAA. In almost 30% of the cases, no definitive cause is identified (1).

Techniques to avoid PEs are: 1) the use of TEE guidance and pressure monitoring play a key role in ensuring a safe transseptal puncture at the correct site; 2) the use of a 4- or 5-F pigtail catheter inside or a looped wire in the LAA to facilitate a safe approach into the LAA; 3) careful and slow catheter and device manipulation within the LA; and 4) tug (stability) testing after device implantation should be performed under TEE guidance (6).

The Cardioform device is Food and Drug Administration approved for patent foramen ovale and atrial septal defect closure (7). It is a transcatheter implant occluder that is constructed of platinum-filled nitinol wire frames covered by a proprietary thromboresistant expanded polytetrafluoroethylene material forming 2 self-expandable discs (8).

In our case, PE occurred after a posterior interatrial septal puncture was attempted, which is the preferred location for septal puncture during LAA closure procedure, leading to the stitching of the posterior LA wall. The patient was in a hybrid room, with a cardiothoracic surgery team as backup. We felt that an urgent pericardial window would be better than performing pericardiocentesis in this case since there was evidence of a large blood clot as seen in Video 1.

Even though a pericardial window was performed, there appeared to be ongoing bleeding, and knowing the size of the sheath was 8-F, it was therefore felt that sealing the LA perforation would be necessary by either a surgical or transcatheter approach. Surgical repair would require a more extensive procedure with a sternotomy.

Subsequently, we felt that closure device would be an appropriate approach to stop the ongoing leak and to avoid a recurrent effusion. The Cardioform occluder device comes in 2 sizes (25 mm and 30 mm). Both could have been used for an 8-F hole, but the smallest (25 mm) was chosen in our case to better approximate the LA walls and to prevent buckling within the pericardial space.

The use of the Cardioform septal occluder device provided adequate seal at the LA perforation site and prevented further blood accumulation into the pericardial space.

Follow-Up

A transthoracic echocardiogram was performed on the following day after the procedure and revealed the complete resolution of the PE (Figure 4). The pericardial drain was removed on post-operative day 2. The patient was discharged home 4 days following the procedure. Three-month follow-up with transthoracic echocardiogram revealed no recurrence of PE.

Figure 4.

Figure 4

TTE Revealed the Complete Resolution of the Pericardial Effusion

P = pericardium; TTE = transthoracic echocardiogram; other abbreviations as in Figures 1 and 3.

Conclusions

To the best of our knowledge, this is the first case to report the successful use of a Cardioform septal occluder device in a potentially life-threatening PE complicating LAA closure. This represents a novel use of this device that maybe helpful in similar critical scenarios.

Footnotes

The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Case Reportsauthor instructions page.

Appendix

For supplemental videos, please see the online version of this paper.

References

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