Percutaneous Closure of Patent Foramen Ovale and Atrial Septal Defect

Percutaneous Closure of Patent Foramen Ovale and Atrial Septal Defect

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Percutaneous closure is a surgical procedure used to treat patients with patent foramen ovale (PFO) and atrial septal defect (ASD). Advancements in device technology and image guidance now permit the safe and effective catheter-based closure of numerous intracardiac defects, including PFO and ASD. [1, 2] With these catheter-based closure procedures becoming more prevalent in adults, it is imperative that clinicians possess a sound understanding of intracardiac shunt lesions and indications for repair or closure.

The anatomy of PFO and ASD are shown in the images below.

Studies on annual recurrences after a cerebral vascular accident or a transient ischemic attack reported an incidence ranging from 3% to 16%. [3, 4] In a large study, the recurrent stroke rate or mortality from an embolic event was 6% to 8% per year. [5] A pooled analysis suggests that the presence of a PFO alone increased the risk for recurrent events 5-fold, with an even higher risk in the presence of an atrial septal aneurysm. [6]

Other studies have found no significant influence of an isolated PFO but show a strong influence by a PFO associated with an atrial septal aneurysm. In a trial randomizing patients to acetylsalicylic acid or coumadin, the individual presence of a PFO or an atrial septal aneurysm had no influence on the incidence of recurrent stroke. [7] There are differing results on the question of whether a PFO with or without hypermobility of the septum leads to recurrent stroke are presumably related to factors (besides patient selection) such as diagnostic accuracy of the tests and definitions used to identify both the PFO and the atrial septal aneurysm.

Homma et al [8] identified other risk factors for recurrent stroke, including the presence of a Eustachian valve directed toward the PFO, the gaping diameter of the PFO, and the number of microbubbles present in the left atrium during the first seconds after release of a Valsalva maneuver during a bubble test.

The effectiveness of percutaneous closure compared with surgical closure or medical management in preventing recurrent embolic events is currently unknown. Uncontrolled studies evaluating percutaneous device closure of a PFO or, much less often, an ASD in patients with at least one paradoxical embolic event (ie, transient ischemic attack, stroke, or a peripheral embolism) have reported results similar to those reported for surgical closure. [9] A clinical trial is currently ongoing to determine whether percutaneous closure is more effective than medical management in preventing recurrent embolic events.

Nagpal et al studied 414 patients who underwent percutaneous closure between 2002-2009. They concluded that the long-term rate of recurrent stroke is low and serious long-term complications are rare, particularly in patients with a single neurological event. [10]

Some studies have suggested that PFO closure may reduce the frequency and severity of migraine headaches in patients with significant right-to-left shunts. This data comes from single-center observational studies. [11] In a meta-analysis of 11 studies, Butera et al evaluated a total of 1,306 patients who underwent PFO closure, of whom 40% suffered from migraine. Quantitative synthesis showed complete cure of migraine in 46%, with resolution or significant improvement of migraine in 83% of cases. They concluded that a significant group of subjects with migraine headaches, particularly if treated after a neurological event, may benefit from percutaneous closure of their patent foramen ovale. However, no randomized, controlled studies are currently available to support this.

Heparin should be administered to achieve a recommended activated clotting time of greater than 200 seconds throughout the procedure.

Following percutaneous puncture of the femoral vein, a standard right heart catheterization is performed. An angiogram is sometimes performed demonstrate atrial communication.

Catheterization of the left atrium is done using a 45-degree left anterior oblique position and cranial angulation of 35-45 degrees, and then contrast medium is injected into the right upper pulmonary vein.

A 0.035-inch exchange J-tip guidewire is then introduced into the left atrium. Afterwards, a complaint balloon catheter is advanced over the exchange guidewire into the left atrium and used to determine the diameter of the defect.

For ASD closure, transesophageal echocardiography may be preferred. For PFO, intracardiac echocardiography may be preferred. Because the defect in PFO is small, this usually provides adequate images during device implantation.

If balloon sizing is performed in addition to echocardiographic measurements, a stop-flow technique should be used. The stop-flow technique is performed as follows.

Using a balloon specifically designed for sizing atrial communications (an Amplatzer sizing balloon), the catheter is passed over the exchange guidewire directly through the skin. To facilitate this percutaneous entry, an assistant should apply forceful negative pressure with an attached syringe.

Under fluoroscopic and echocardiographic guidance, the balloon catheter is placed across the defect and inflated with diluted contrast medium until the left-to-right shunt ceases as observed by echocardiography.

The balloon is deflated until flow is seen, and then reinflated until the shunting ceases. Measurements can then be made using echocardiographic imaging, fluoroscopy, or by using the sizing plate.

Once the diameter of the defect has been determined, an occlusion device is selected, which should be equal to or, if the identical is not available, 1 size larger than the defect. Then, the balloon catheter is removed, leaving the 0.035-inch exchange guidewire in place.

The delivery cable is passed though the loader and the device is screwed to the tip of the delivery cable. Once securely attached, the device and loader is immersed in cold (less than 5° C) sterile saline solution and the device is pulled into the loader with a jerking motion. Flush the device via the side arm.

The dilator is inserted into the delivery sheath and secured to the sheath with the locking mechanism. The dilator/delivery sheath assembly is then introduced through the groin.

Once the delivery sheath has reached the inferior vena cava, the dilator is removed to allow back bleeding to purge all air from the system. Then, the hemostasis valve is connected and flushed with a syringe before the atrium is entered. The sheath is advanced over the guidewire through the communication into the left upper pulmonary vein.

The correct position of the delivery sheath is verified by a test hand injection of contrast medium or by echocardiography. The guidewire is then removed and the sheath flushed with sterile saline.

The loading device is attached to the delivery sheath. Then, the device is advanced into the sheath by pushing the delivery cable. Under fluoroscopy and echocardiographic guidance, the left atrial disc is deployed and the device is pulled gently against the atrial septum.

With tension on the delivery cable, the sheath is pulled back and deployed into the right atrial disc. The sheath is pulled back by approximately 5-10 cm. A gentle “to-and-fro” motion with the delivery cable assures a secure position across the atrial septal defect, which can also be observed by echocardiography.

Correct placement should then be confirmed. See the image below.

If the device is unsatisfactory or if the device does not reconfigure to its original shape, the sheath can be advanced while retracting the delivery cable to recapture the device into the sheath and redeploy or replace with a new device.

The videos below demonstrate percutaneous closure.

In late 2001, the U.S. Food and Drug Administration (FDA) approved two PFO occluder devices—the Amplatzer Septal Occluder and the CardioSEAL Septal Occlusion System—for percutaneous atrial septal defect closure under a humanitarian device exemption for the treatment of patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a PFO who had failed conventional drug therapy. [12, 13]

However, the FDA withdrew approval for these devices effective October 31, 2006, after finding that the eligible population in the United States described by the approved indication was significantly greater than the 4000 patients per year limit permitted by an humanitarian device exemption. [14]

Another device, the CardioSEAL Septal Occlusion System has been used off-label for ASD and PFO closure but is FDA approved for use only for closure of certain complex ventricular septal defects. The humanitarian device exemptions for two patent foramen occluder devices, the CardioSEAL STARFlex Septal Occlusion system and the Amplatzer PFO occluder, were withdrawn in October 2006. These devices are now available in the United States for investigational use only.

Favorable outcomes have been reported in the great majority of patients treated with the Amplatzer device (see the image below).

In a series of 100 patients, for example, the Amplatzer device was successfully implanted in 93 with a procedure time ranging from 30 to 180 minutes. [15] The total ASD occlusion rate at 3 months was 99%.

The safety and efficacy of the HELEX device were evaluated in a nonrandomized, noninferiority study involving 247 patients (median age of 5.5 years) who were treated with either the device or open surgical repair. [16] In addition to usual criteria for closure of a secundum ASD, patients in the device arm were required to have a defect diameter less than or equal to 22 mm and adequate septal rims to secure the device, both of which were determined by transesophageal or intracardiac echocardiography. [17, 18]

At 12 months, there was no statistically significant difference between the two groups for the combined primary endpoint of device safety, the need for repeat procedures to the target ASD, and documentation of complete occlusion or clinically insignificant leak. The noninferiority of the device compared with surgery persisted even after controlling for baseline differences. The most common adverse outcome in the device group was device embolization requiring catheter retrieval (1.7%).

All patients should be kept overnight for observation. A limited transthoracic echocardiography should be performed prior to discharge. Patients with any observed small pericardial effusion following device implantation should be closely monitored with serial echocardiograms performed until resolution of the pericardial effusion. Higher risk patients should be followed more closely, including clinical follow-up with echocardiogram 1 week after device implantation.

All patients should be on low-dose aspirin for life. Clopidogrel should be continued for a total of 3 months. Transthoracic echocardiography should be repeated at 1 month and 3 months after the procedure. A final transesophageal echocardiogram is recommended at 6 months after the procedure.

Device implantation (and anticoagulation) can be associated with complications. In addition to the 6% procedural complication rate reported by Windecker et al, [19] including 4 cases of device embolization, there is the issue of device-related thrombus formation. In one report, device-related thrombi were reported in 2.5% of 593 implants for PFO. [20]

Technical failures have become extremely rare (eg, inability to cannulate the PFO is less than 1%). Complications may include cardiac tamponade, symptomatic air embolism, loss of device, or puncture site problems; however, these are rare. Complete closure at follow-up can be expected in 90-95% cases with the two devices currently in use. Some trivial residual shunt may be acceptable, albeit undesirable, as the device will act as a filter for particulate matter.

Events have recurred in cases where the PFO was not responsible for the index event, in cases where small emboli formed on the left side of the device, or in cases where closure is incomplete. [21] Recurrent events may come close to the natural course for the first year (about 3%), after which they are extremely rare. In contrast, the natural course under platelet inhibitors or warfarin tends to have a steady or even increasing rate of events over the years. [22] Hence, the follow-up curves do seem to diverge in favor of device closure in nonrandomized comparisons.

Van de Bruaene A, Stroobants D, Benit E. Percutaneous closure of inter-atrial communications (atrial septal defect and patent foramen ovale): single-centre experience and mid-term follow-up. Acta Cardiol. 2015 Apr. 70(2):133-40. [Medline].

Ates AH, Sunman H, Aytemir K, et al. Prevention of recurrent cryptogenic stroke with percutaneous closure of patent foramen ovale; one year follow-up study with magnetic resonance imaging and Holter monitoring. Turk Kardiyol Dern Ars. 2015 Jan. 43(1):38-46. [Medline].

Mas JL, Zuber M. Recurrent cerebrovascular events in patients with patent foramen ovale, atrial septal aneurysm, or both and cryptogenic stroke or transient ischemic attack. French Study Group on Patent Foramen Ovale and Atrial Septal Aneurysm. Am Heart J. 1995 Nov. 130(5):1083-8. [Medline].

Comess KA, DeRook FA, Beach KW, Lytle NJ, Golby AJ, Albers GW. Transesophageal echocardiography and carotid ultrasound in patients with cerebral ischemia: prevalence of findings and recurrent stroke risk. J Am Coll Cardiol. 1994 Jun. 23(7):1598-603. [Medline].

Mohr JP, Thompson JL, Lazar RM, et al. A comparison of warfarin and aspirin for the prevention of recurrent ischemic stroke. N Engl J Med. 2001 Nov 15. 345(20):1444-51. [Medline].

Overell JR, Bone I, Lees KR. Interatrial septal abnormalities and stroke: a meta-analysis of case-control studies. Neurology. 2000 Oct 24. 55(8):1172-9. [Medline].

Homma S, Sacco RL, Di Tullio MR, Sciacca RR, Mohr JP. Effect of medical treatment in stroke patients with patent foramen ovale: patent foramen ovale in Cryptogenic Stroke Study. Circulation. 2002 Jun 4. 105(22):2625-31. [Medline].

Homma S, Di Tullio MR, Sacco RL, Mihalatos D, Li Mandri G, Mohr JP. Characteristics of patent foramen ovale associated with cryptogenic stroke. A biplane transesophageal echocardiographic study. Stroke. 1994 Mar. 25(3):582-6. [Medline].

Braun M, Gliech V, Boscheri A, et al. Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism. Periprocedural safety and mid-term follow-up results of three different device occluder systems. Eur Heart J. 2004 Mar. 25(5):424-30. [Medline].

Nagpal SV, Lerakis S, Flueckiger PB, et al. Long-term outcomes after percutaneous patent foramen ovale closure. Am J Med Sci. 2013 Sep. 346(3):181-6. [Medline].

Trabattoni D, Fabbiocchi F, Montorsi P, et al. Sustained long-term benefit of patent foramen ovale closure on migraine. Catheter Cardiovasc Interv. 2011 Mar 1. 77(4):570-4. [Medline].

Inglessis I, Landzberg MJ. Interventional catheterization in adult congenital heart disease. Circulation. 2007 Mar 27. 115(12):1622-33. [Medline].

Meier B, Kalesan B, Mattle HP, et al. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med. 2013 Mar 21. 368(12):1083-91. [Medline].

U.S. FDA Center for Devices and Radiological Health. Information for physicians and patients on the withdrawal of two humanitarian device exemptions (HDEs) for patent foramen ovale (PFO) occluders. U.S. Food and Drug Administration. May 20, 2015. Available at http://1.usa.gov/oPzrHg.

Chan KC, Godman MJ, Walsh K, Wilson N, Redington A, Gibbs JL. Transcatheter closure of atrial septal defect and interatrial communications with a new self expanding nitinol double disc device (Amplatzer septal occluder): multicentre UK experience. Heart. 1999 Sep. 82(3):300-6. [Medline].

Pedra CA, Pihkala J, Lee KJ, et al. Transcatheter closure of atrial septal defects using the Cardio-Seal implant. Heart. 2000 Sep. 84(3):320-6. [Medline].

Heinisch C, Bertog S, Wunderlich N, et al. Percutaneous closure of the patent foramen ovale using the HELEX® Septal Occluder: acute and long-term results in 405 patients. EuroIntervention. 2012 Oct. 8(6):717-23. [Medline].

Musto C, Cifarelli A, Fiorilli R, et al. Gore Helex septal occluder for percutaneous closure of patent foramen ovale associated with atrial septal aneurysm: short- and mid-term clinical and echocardiographic outcomes. J Invasive Cardiol. 2012 Oct. 24(10):510-4. [Medline].

Windecker S, Wahl A, Nedeltchev K, et al. Comparison of medical treatment with percutaneous closure of patent foramen ovale in patients with cryptogenic stroke. J Am Coll Cardiol. 2004 Aug 18. 44(4):750-8. [Medline].

Krumsdorf U, Ostermayer S, Billinger K, et al. Incidence and clinical course of thrombus formation on atrial septal defect and patient foramen ovale closure devices in 1,000 consecutive patients. J Am Coll Cardiol. 2004 Jan 21. 43(2):302-9. [Medline].

Wahl A, Meier B, Haxel B, et al. Prognosis after percutaneous closure of patent foramen ovale for paradoxical embolism. Neurology. 2001 Oct 9. 57(7):1330-2. [Medline].

De Castro S, Cartoni D, Fiorelli M, et al. Morphological and functional characteristics of patent foramen ovale and their embolic implications. Stroke. 2000 Oct. 31(10):2407-13. [Medline].

Ehab Kasasbeh, MD Instructor in Cardiology, Fellow in Coronary, Peripheral and Structural Interventional Cardiology, Vanderbilt University Medical Center

Ehab Kasasbeh, MD is a member of the following medical societies: American College of Cardiology, American College of Physicians, American Heart Association, American Medical Association, American Medical Writers Association, Tennessee Medical Association

Disclosure: Nothing to disclose.

Karlheinz Peter, MD, PhD Professor of Medicine, Monash University; Head of Centre of Thrombosis and Myocardial Infarction, Head of Division of Atherothrombosis and Vascular Biology, Associate Director, Baker Heart Research Institute; Interventional Cardiologist, The Alfred Hospital, Australia

Karlheinz Peter, MD, PhD is a member of the following medical societies: American Heart Association, German Cardiac Society, Cardiac Society of Australia and New Zealand

Disclosure: Nothing to disclose.

John A McPherson, MD, FACC, FAHA, FSCAI Associate Professor of Medicine, Division of Cardiovascular Medicine, Director of Cardiovascular Intensive Care Unit, Vanderbilt Heart and Vascular Institute

John A McPherson, MD, FACC, FAHA, FSCAI is a member of the following medical societies: Alpha Omega Alpha, American College of Cardiology, American Heart Association, Society for Cardiac Angiography and Interventions, Society of Critical Care Medicine, and Tennessee Medical Association

Disclosure: CardioDx Consulting fee Consulting; Gilead Consulting fee Consulting; Abbott Vascular Corp. Consulting fee Consulting

Percutaneous Closure of Patent Foramen Ovale and Atrial Septal Defect

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