Latest Review Date: May 2024

Category: Medical

POLICY:

Transcatheter closure of a patent foramen ovale (PFO) using an FDA-approved closure device may be considered medically necessary to reduce the risk of recurrent ischemic stroke when all of the following are met:

• Diagnosis of PFO with a right to left shunt confirmed by echocardiography
• Diagnosis of cryptogenic stroke due to a presumed paradoxical embolism

 

Transcatheter closure of atrial septal defects (ASD) in adult or pediatric patients may be considered medically necessary for any of the following indications:

• For the occlusion of ASDs in secundum position OR patients who have undergone a fenestrated Fontan procedure who now require closure of the fenestration;
• Have echocardiographic evidence of ostium secundum ASD AND clinical evidence of right ventricular volume overload (e.g. 1.5:1 degree of left to right shunt or RV enlargement).
• Have echocardiographic evidence of ostium secundum ASD AND clinical evidence of paradoxical embolism
• Documented platypnea- orthodeoxia
• Presence of net left-to-right shunting, pulmonary artery pressure less than two thirds systemic levels, PVR less than two thirds systemic vascular resistance, or when responsive to either pulmonary vasodilator therapy or test occlusion of the defect

 

Transcatheter closure of atrial septal defects (ASD,) in all other situations, including but not limited to coronary sinus ASD, ostium primum ASD and sinus venosus ASD, is considered investigational.

 

Transcatheter closure of ventricular septal defects (VSD) may be considered medically necessary for any of the following indications:

• Complex VSD of significant size to warrant closure (e.g. large volume left to right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) AND are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.**
• Iatrogenic artifacts after surgical replacement of the aortic valve

 

**High-risk anatomical factors for transatrial or transarterial surgical closure include patients:

• Requiring left ventriculotomy or an extensive right ventriculotomy
• With a failed previous VSD closure
• With multiple apical and/or anterior muscular VSDs (Swiss Cheese Septum)
• With posterior apical VSDs covered by trabeculae

 

Transcatheter closure of ventricular septal defects (VSD) is considered investigational, including but not limited to, when the above criteria are not met and in patients with severe irreversible PAH.

 

Transcatheter closure of patent ductus arteriosus (PDA) may be considered medically necessary when using an FDA-approved device for this indication.

Despite the success of standard open-heart surgery to repair cardiac defects, the risks and morbidity of open-heart surgery remain.  Interventional cardiac catheterization techniques have advanced to a point where percutaneous transcatheter devices can be offered as an alternative for carefully selected patients.  Transcatheter closure devices are permanent implants designed to close defects between chambers of the heart, including atrial septal defect (ASD), ventricular septal defect (VSD), and patent foramen ovale (PFO). Devices are also used for persistent patent ductus arteriosus (PDA), which is an opening between the descending thoracic aorta and the pulmonary artery which fails close after birth.  These devices are self-expandable, self-centering umbrella-like devices.  They are implanted in the defect through catheters inserted into either a vein or an artery using a transcatheter or percutaneous approach.

The standard for managing clinically significant cardiac defects mentioned above has been surgical closure, which except for complex ventricular septal defects, is associated with a very low mortality. Conventional surgical closure is done through a midline sternotomy. The transcatheter approach offers repair of the defect without major thoracic surgery, less post-operative pain, and decreased hospital stay without compromising outcomes in a select group of patients.

Patent Foramen Ovale (PFO)

The foramen ovale, a component of fetal cardiovascular circulation, consists of a communication between the right and left atrium that functions as a vascular bypass of the un-inflated lungs. The ductus arteriosus is another feature of the fetal cardiovascular circulation, consisting of a connection between the pulmonary artery and the distal aorta. Prior to birth, the foramen ovale is held open by the large flow of blood into the left atrium from the inferior vena cava. Over the course of months after birth, an increase in left arterial pressure and a decrease in right atrial pressure result in the permanent closure of the foramen ovale in most individuals. However, a patent foramen ovale may be detected in up to 25% of asymptomatic adults. In some epidemiologic studies, patent foramen ovale (PFO) has been associated with cryptogenic stroke, a type of stroke defined as an ischemic stroke occurring in the absence of potential cardiac, pulmonary, vascular, or neurologic sources. Studies also show an association of PFO and migraine headache.

Atrial Septal Defect (ASD)

Unlike PFOs, which represents the postnatal persistence of normal fetal cardiovascular physiology, ASDs represent an abnormality in the development of the heart that results in free communication between the atria. ASDs are categorized according to their anatomy. Ostium secundum describes defects that are located mid-septally and are typically near the fossa ovalis. Ostium primum defects lie immediately adjacent to the atrioventricular valves and are within the spectrum of atrioventricular septal defects. Primum defects occur commonly in patients with Down syndrome. Sinus venous defects occur high in the atrial septum and are frequently associated with anomalies of the pulmonary veins.

Ostium secundum ASDs are the third most common form of congenital heart disorder and one of the most common congenital cardiac malformations in adults, accounting for 30% to 40% of these patients older than age 40 years. The ASD often goes unnoticed for decades because the physical signs are subtle and the clinical sequelae are mild. However, virtually all patients who survive into their sixth decade are symptomatic; fewer than 50% of patients survive beyond age 40 to 50 years due to heart failure or pulmonary hypertension related to the left-to-right shunt. Symptoms related to ASD depend on the size of the defect and the relative diastolic filling properties of the left and right ventricles. Reduced left ventricular compliance and mitral stenosis will increase left-to-right shunting across the defect. Conditions that reduce right ventricular compliance and tricuspid stenosis will reduce left-to-right shunting or cause a right-to-left shunt. Symptoms of an ASD include exercise intolerance and dyspnea, atrial fibrillation, and, less commonly, signs of right heart failure. Patients with ASDs are also at risk for paradoxical emboli.

Treatment

Repair of ASDs is recommended for those with a pulmonary to systemic flow ratio (Qp:Qs) exceeding 1.5:1.0. Despite the success of operative repair, there has been interest in developing a catheter-based approach to ASD repair to avoid the risks and morbidity of open heart surgery. A variety of devices have been researched. Technical challenges include minimizing the size of device so that smaller catheters can be used, developing techniques to properly center the device across the ASD, and ensuring that the device can be easily retrieved or repositioned, if necessary.

Individuals with ASDs and a history of cryptogenic stroke are typically treated with antiplatelet agents, given an absence of evidence that systemic anticoagulation is associated with outcome improvements.

Transcatheter Closure Devices

Transcatheter PFO and ASD occluders consist of a single or paired wire mesh discs that are covered or filled with polyester or polymer fabric that are placed over the septal defect. Over time, the occlusion system is epithelialized.  ASD occluder devices consist of flexible mesh disks that are delivered via catheter to cover the ASD.

Ventricular Septal Defect (VSD)

VSD is one of the most common congenital heart defects at birth and presents in approximately 42 out of every 10,000 births per year. Ventricular septal defects (VSDs) are usually present at birth but may also occur following myocardial infarction. Small VSDs may never be detected. A large VSD can allow blood to flow from the left to the right ventricle which increases load on the heart and lungs. this can cause symptoms such as shortness of breath, poor weight gain, and tiredness while feeding.

Treatment

Small VSDs may cause no problems and close on its own.  If the VSD is large, open heart surgery or transcatheter closure may be required which is usually performed in infancy or childhood.

Patent Ductal Arteriosus (PDA)

PDA is another fairly common type of congenital heart defect (CHD). Although it can affect full term babies, it is more common in premature babies. With this CHD, there is abnormal blood flow between the aorta and pulmonary artery. These two arteries are connected by the ductus arteriosus which is a normal and essential part of fetal blood circulation. Soon after birth, the vessel should close.  When the vessel does not close, it allows oxygen rich blood from the aorta to mix with oxygen poor blood from the pulmonary artery which may strain the heart and increase blood pressure in lung arteries.

Treatment

A PDA may be treated with medications, catheter based procedures or open surgery. Transcatheter closure of a PDA is an established treatment and is often the treatment of choice. 

KEY POINTS:

The most recent update with literature review is through May 13, 2024.

Summary of Evidence

PFO

For individuals who have PFO and cryptogenic stroke who receive PFO closure with a transcatheter device, the evidence includes multiple randomized controlled trials (RCTs) comparing device-based PFO closure with medical therapy, systematic reviews, meta-analyses, and observational studies. Relevant outcomes include overall survival, morbid events, and treatment-related morbidity and mortality. The RCTs comparing PFO closure with medical management have suggested that PFO closure is more effective than medical therapy in reducing event rates. Although these results were not statistically significant by intention-to-treat analyses in earlier trials (i.e. Amplatzer PFO Occluder with Medical Treatment in Patients with Cryptogenic Embolism [PC-Trial]), they were statistically significant in later trials (i.e., RESPECT [extended follow-up], Reduction in the use of Corticosteroids in Exacerbated COD [REDUCE], and Patent Foramen Ovale Closure or Anticoagulants versus Antiplatelet Therapy to Prevent Stroke Recurrence [CLOSE]). Use of appropriate patient selection criteria to eliminate other causes of cryptogenic stroke in RESPECT, REDUCE, and CLOSE trials contributed to findings of the superiority of PFO closure compared with medical management. Of note, higher rates of atrial fibrillation were reported in a few of the individual trials and in the meta-analysis that incorporated evidence from RESPECT, REDUCE, and CLOSE trials. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have PFO and migraines who receive PFO closure with a transcatheter device, the evidence includes 3 randomized controlled trials of PFO closure, multiple observational studies reporting on the association between PFO and migraine, and systematic reviews of these studies. Relevant outcomes are symptoms, quality of life, medication use, and treatment-related morbidity and mortality. Two sham-controlled RCT did not demonstrate significant improvements in migraine symptoms after PFO closure. A third RCT with blinded endpoint evaluation did not demonstrate improvements in migraine days after PFO closure, but was likely underpowered. Nonrandomized studies have shown highly variable rates of migraine improvement after PFO closure.  The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have PFO and conditions associated with PFO other than cryptogenic stroke or migraine (e.g., myocardial infarction with normal coronary arteries, decompression illness, high-altitude pulmonary edema, obstructive sleep apnea) who receive PFO closure with a transcatheter device, the evidence includes small case series and case reports. Relevant outcomes are symptoms, change in disease status, morbid events, and treatment-related morbidity and mortality. Comparative studies are needed to evaluate outcomes in similar patient groups treated with and without PFO closure. The evidence is insufficient to determine the effects of the technology on health outcomes.

ASD

For individuals who have ASD and evidence of left-to-right shunt or right-ventricular overload who receive ASD closure with a transcatheter device, the evidence includes systematic reviews, nonrandomized comparative studies and single-arm studies. Relevant outcomes are symptoms, change in disease status, and treatment-related morbidity and mortality. The available nonrandomized comparative studies and single-arm case series show high success rates of closure using closure devices approaching the high success rates of surgery, which are supported by meta-analyses of these studies. The percutaneous approach has a low complication rate and avoids the morbidity and complications of open surgery. In systematic reviews, the risk of overall mortality was similar with transcatheter device versus surgical closure, whereas in-hospital mortality was significantly reduced with transcatheter device closure. If the percutaneous approach is unsuccessful, ASD closure can be achieved using surgery. Because of the benefits of percutaneous closure over open surgery, it can be determined that transcatheter ASD closure improves outcomes in patients with an indication for ASD closure. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

VSD

For individuals who have a complex VSD of significant size and considered to be at high risk for surgical closure or have iatrogenic artifacts after surgical replacement of the aortic valve, the evidence includes prospective and retrospective studies.  The relevant outcomes include symptoms, change in disease status, and treatment-related morbidity and mortality.  The studies have shown for transcatheter closure of VSD high closure rates, low procedural mortality and positive short term results. Low complication rates and shorter hospital stays have made this procedure more favorable over the surgical treatment for appropriately selected individuals. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

PDA

For individuals who have a PDA and receive transcatheter closure with an FDA approved PDA device, the evidence includes observational studies, single arm multi-center study, and retrospective reviews.  The relevant outcomes include symptoms, change in disease status, and treatment-related morbidity and mortality. Studies have shown that this is a well established treatment, and is an efficient and safe procedure. Studies have shown excellent results for short and long term studies. Low complication rates and shorter hospital stays have made this procedure more favorable over the surgical treatment when appropriate. The evidence is sufficient to determine qualitatively that the technology results in a meaningful improvement in the net health outcome.

Practice Guidelines and Position Statements

PFO

American College of Chest Physicians

In 2012, the American College of Chest Physicians updated its guidelines on antithrombotic therapy and the prevention of thrombosis, which made the following recommendations related to patent foramen ovale (PFO) and cryptogenic stroke:

“We suggest that patients with stroke and PFO are treated with antiplatelet therapy following the recommendations for patients with noncardioembolic stroke…. In patients with a history of noncardioembolic ischemic stroke or TIA, we recommend long-term treatment with aspirin (75-100 mg once daily), clopidogrel (75 mg once daily), aspirin/extended release dipyridamole (25 mg/200 mg bid), or cilostazol (100 mg bid) over no antiplatelet therapy (Grade 1A), oral anticoagulants (Grade 1B), the combination of clopidogrel plus aspirin (Grade 1B), or triflusal (Grade 2B).”

American Academy of Neurology

In 2020, the American Academy of Neurology (AAN) issued updated evidence-based guidelines about the management of patients with stroke and PFO to address whether percutaneous closure of PFO is superior to medical therapy alone. This update to the practice advisory published in 2016 was completed due to the approval of the Amplatzer PFO Occluder and the GORE CARDIOFORM Septal Occluder.  Following a systematic review of the literature and structured formulation of recommendations, the AAN developed conclusions addressing percutaneous PFO closure as compared to medical therapy alone, for patients with cryptogenic stroke and PFO, percutaneous PFO closure:

• “probably reduces the risk of stroke recurrence with an HR [hazard ratio] of 0.41 (95% CI [confidence interval], 0.25–0.67, I2=12%) and an absolute risk reduction of 3.4% (95% CI, 2.0%–4.5%) at 5 years,"
• “probably is associated with a periprocedural complication rate of 3.9% (95% CI, 2.3%–5.7%),” and
• “probably is associated with the development of serious non-periprocedural atrial fibrillation, with a relative risk of 2.72 (95% CI,1.30–5.68, I2= 0%)."

The guidelines recommended:

"In patients being considered for PFO closure, clinicians should ensure that an appropriately thorough evaluation has been performed to rule out alternative mechanisms of stroke, as was performed in all positive PFO closure trials (level B). In patients with a PFO detected after stroke and no other etiology identified after a thorough evaluation, clinicians should counsel that having a PFO is common; that it occurs in about 1 in 4 adults in the general population; that it is difficult to determine with certainty whether their PFO caused their stroke; and that PFO closure probably reduces recurrent stroke risk in select patients (level B)."

"In patients younger than 60 years with a PFO and an embolic-appearing infarct and no other mechanism of stroke identified, clinicians may recommend closure following a discussion of potential benefits (reduction of stroke recurrence) and risks (procedural complication and atrial fibrillation) (level C). PFO closure may be offered in other populations, such as for a patient who is aged 60–65years with a very limited degree of traditional vascular risk factors (i.e., hypertension, diabetes, hyperlipidemia, or smoking) and no other mechanism of stroke detected following a thorough evaluation, including prolonged monitoring for atrial fibrillation (level C). PFO closure may be offered to younger patients (e.g., <30 years) with a single, small, deep stroke (<1.5 cm), a large shunt, and absence of any vascular risk factors that would lead to intrinsic small-vessel disease such as hypertension, diabetes, or hyperlipidemia (level C)."

American Heart Association and American Stroke Association

In 2021, the American Heart Association (AHA) and American Stroke Association published updated guidelines on the prevention of stroke in patients with ischemic stroke or TIA. The guidelines list the following recommendations for device-based closure for patent foramen ovale (PFO):

• "In patients 18 to 60 years of age with a nonlacunar ischemic stroke of undetermined cause despite a thorough evaluation and a PFO with high-risk anatomic features* it is reasonable to choose closure with a transcatheter device and long-term antiplatelet therapy over anti-platelet therapy alone for preventing recurrent stroke (Class IIa; Level of Evidence B-Randomized)"
• "In patients 18 to 60 years of age with a nonlacunar ischemic stroke of undetermined cause despite a thorough evaluation and a PFO without high-risk anatomic features,* the benefit of closure with a transcatheter device and long-term antiplatelet therapy over antiplatelet therapy alone for preventing recurrent stroke is not well established(Class IIb; Level of Evidence C-Limited Data)"
• "In patients 18 to 60 years of age with a nonlacunar ischemic stroke of undetermined cause despite a thorough evaluation and a PFO, the comparative benefit of closure with a transcatheter device versus warfarin is unknown(Class IIb; Level of Evidence C-Limited Data)"

*The guideline notes that high-risk anatomic features are not uniformly described throughout the literature.

The guideline also defined the following relevant terms:

• "Cryptogenic stroke: An imaging-confirmed stroke with unknown source despite thorough diagnostic assessment (including, at a minimum, arterial imaging, echocardiography, extended rhythm monitoring, and key laboratory studies such as a lipid profile and hemoglobin A1c [HbA1c])."
• "Embolic stroke of undetermined source (ESUS): A stroke that appears nonlacunar on neuroimaging without an obvious source after a minimum standard evaluation (including arterial imaging, echocardiography, extended rhythm monitoring, and key laboratory studies such as a lipid profile and HbA1c) to rule out known stroke etiologies such as cardioembolic sources and atherosclerosis proximal to the stroke. A diagnosis of ESUS implies that the stroke is embolic in origin, given the nonlacunar location; however, the source of the embolus is unknown, despite a minimal standard evaluation. Although cryptogenic stroke similarly implies that the cause of the origin is unknown, the stroke is not necessarily embolic. Individuals with ESUS have cryptogenic stroke, but the converse is not always the case."

ASD

American College of Cardiology and American Heart Association

In 2018, the AHA and ACC published guidelines for the management of adults with congenital heart disease.  Recommendations for surgical closure versus transcatheter closure are dependent on the underlying condition. The treatment recommendations are below:

American College of Cardiology and American Heart Association Recommendations for Treating Atrial Septal Defect

Condition	Recommendation	CORa/LOEb
Symptomatic isolated secundum ASD, right atrial and/or RV enlargement, and net left-to-right shunt sufficiency large enough to cause physiological sequelae, without cyanosis at rest or during exercise	Transcatheter or surgical closure	I1/B-NR2
Symptomatic primum ASD, sinus venosus defect, or coronary sinus defect, right atrial and/or RV enlargement, and net left-to-right shunt sufficiency large enough to cause physiological sequelae, without cyanosis at rest or during exercise	Surgical closure unless precluded by comorbidities	I1/B-NR2
Asymptomatic isolated secundum ASD, right atrial and RV enlargement, and net left-to-right shunt sufficiency large enough to cause physiological sequelae, without cyanosis at rest or during exercise	Transcatheter or surgical closure	IIa1/C-LD2
Secundum ASD when a concomitant surgical procedure is being performed and there is a net left-to-right shunt sufficiently large enough to cause physiological sequelae, and right atrial and RV enlargement without cyanosis at rest or during exercise	Surgical closure	IIa1/C-LD2
ASD when net left-to-right shunt is ≥1.5:1, PA systolic pressure and/or pulmonary vascular resistance is greater than of one-third of systemic resistance	Percutaneous or surgical closure	IIb1/B-NR2
ASD with PA systolic pressure greater than two-thirds systemic, pulmonary vascular resistance greater than two-thirds systemic, and/or a net left-to-right shunt	ASD closure should not be performed	III-Harm1/C- LD2

Adapted from Stout et al (2019)

ASD: atrial septal defect; COR: class (strength) of recommendation; LOE: level (quality) of evidence; PA: pulmonary artery; RCT: randomized controlled trial; RV: right ventricular.

^a COR key: I=strong; IIa=moderate; IIb=weak; III: No Benefit=weak; III: Harm=strong. ^b LOE key: A=high quality from >1 RCT, meta-analyses of high-quality RCTs, ≥1 RCT corroborated by high-quality registry studies; B-R=randomized, moderate-quality evidence from ≥1 RCT or meta-analysis of moderate-quality RCTs; B-NR=nonrandomized, moderate-quality evidence from ≥1 well-designed, well-executed nonrandomized study, observational study, or registry study, or meta-analyses of such studies; C-LD: limited data, randomized or nonrandomized observational or registry studies with limitations of design or execution, meta-analyses of such studies, or physiological or mechanistic studies in human subjects; C-EO: expert opinion

VSD

National Institute for Health and Care Excellence

In 2010, NICE issued a guideline that stated, “Current evidence on the safety and efficacy of transcatheter endovascular closure of perimembranous ventricular septal defect (VSD) is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.”

American College of Cardiology and American Heart Association

In 2018, the AHA and ACC published guidelines for the management of adults with congenital heart disease.  They did not have a specific recommendation for transcatheter VSD closure, but stated that “Transcatheter device occlusion of muscular and perimembranous VSD is feasible, and trials have demonstrated a good safety and efficacy profile. The following are their recommendations for VSD:

Recommendations for Ventricular Septal Defect

Recommendation	COR	LOE
Adults with a VSD and evidence of left ventricular volume overload and hemodynamically significant shunts (Qp:Qs ≥1.5:1) should undergo VSD closure, if PA systolic pressure is less than 50% systemic and pulmonary vascular resistance is less than one third systemic.	I	B-NR
Surgical closure of perimembranous or supracristal VSD is reasonable in adults when there is worsening aortic regurgitation (AR) caused by VSD.	IIa	C-LD
Surgical closure of a VSD may be reasonable in adults with a history of IE caused by VSD if not otherwise contraindicated.	IIb	C-LD
Closure of a VSD may be considered in the presence of a net left-to-right shunt (Qp:Qs ≥1.5:1) when PA systolic pressure is 50% or more than systemic and/or pulmonary vascular resistance is greater than one third systemic.	IIb	C-LD
VSD closure should not be performed in adults with severe PAH with PA systolic pressure greater than two thirds systemic, pulmonary vascular resistance greater than two thirds systemic and/or a net right-to-left shunt.	III	C-LD

PDA

In 2018, the AHA and ACC published guidelines for the management of adults with congenital heart disease.  They did not have a specific recommendation for transcatheter PDA closure, but stated that:

“When signs of volume overload are indicative of significant left-to-right shunt, closing the PDA is likely to prevent further left atrial or LV enlargement, progression or development of PAH, and pulmonary hypertension secondary to left HF and will possibly provide symptom relief if symptoms are present.  Closure is typically performed percutaneously with good success and minimal complications.”

U.S. Preventive Services Task Force Recommendations

Use of closure devices are not a preventive service.

KEY WORDS:

Atrial Septal Defect, ASD, Ventricular Septal Defect, VSD, Patent Foramen Ovale, PFO, Patent Ductus Arteriosus, PDA, AMPLATZER Septal Occluder, Gore HELEX Septal Occluder, CardioSEAL Septal Occlusion System with Qwik Load, AMPLATZER Muscular VSO Occluder, CardioSEAL STAR Flex Septal Occlusion System, AMPLATZER PFO Occluder, Monodisc Occluder, Occlutech, OcclutechASD Occluder

APPROVED BY GOVERNING BODIES:

Patent Foramen Ovale

The U.S. Food and Drug Administration (FDA) has approved two devices for PFO closure through the premarket approval process or a premarket approval supplement: the Amplatzer PFO Occluder and the GORE CARDIOFORM Septal Occluder.

In 2002, 2 transcatheter devices were cleared for marketing by the FDA through a humanitarian device exemption as a treatment for patients with cryptogenic stroke and PFO: the CardioSEAL® Septal Occlusion System (NMT Medical; device no longer commercially available) and the Amplatzer PFO Occluder. Following the limited FDA approval, use of PFO closure devices increased by more than 50-fold, well in excess of the 4000 per year threshold intended under the humanitarian device exemption, prompting the FDA to withdraw the humanitarian device exemption approval for these devices in 2007. The Amplatzer PFO Occluder was approved through the premarket approval process in 2016.

In March 2018, the FDA granted an expanded indication to the Gore® Cardioform Septal Occluder to include closure of PFO to reduce the risk of recurrent stroke. The new indication was based on the results of the REDUCE pivotal clinical trial.

Patent Foramen Ovale Closure Devices Approved by the U.S. Food and Drug Administration

Device	Manufacturer	PMA Approval Date	Indications
Amplatzer Talisman PFO Occluder	Abbott	Nov 2016	For percutaneous transcatheter closure of a PFO to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.
GORE CARDIOFORMSeptal Occluder	W.L. Gore & Associates	Mar 2018 (supplement)	PFO closure to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

 

Atrial Septal Defect

Five devices have been approved by the FDA through the premarket approval process or a premarket approval supplement for transcatheter ASD closure.

ASD Closure Devices Approved by the Food and Drug Administration

Device	Manufacturer	PMA Approval Date	Indications
Amplatzer Septal Occluder	St. Jude Medical (Abbott Medical)	Dec 2001	Occlusion of ASDs in the secundum position Use in patients who have had a fenestrated Fontan procedure who require closure of the fenestration Patients indicated for ASD closure have echocardiographic evidence of ostium secundum ASD and clinical evidence of right ventricular volume overload.
GORE HELEX Septal Occluder	W.L. Gore & Associates	Aug 2006 (discontinued)	Percutaneous, transcatheter closure of ostium secundum ASDs
GORE CARDIOFORM ASD Occluder	W.L. Gore & Associates	May 2019	Percutaneous, transcatheter closure of ostium secundum ASDs
GORE CARDIOFORM Septal Occluder	W.L. Gore & Associates	Apr 2015 (supplement)	Percutaneous, transcatheter closure of ostrium secundum ASDs
OcclutechASD Occluder	Occlutech	Dec 2023	Percutaneous, transcatheter closure of ostium secundum ASDs

ASD: atrial septal defect; PMA: premarket approval.

Ventricular Septal Defect

AMPLATZER® Muscular VSD Occluder received FDA approval via premarket application (PMA) on September 7, 2007 for closure of complex VSD of significant size to warrant closure on patients who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.

Patent Ductus Arteriosus

In October 2005, Abbott’s Amplatzer Duct Occluder received FDA approval via PMA for non-surgical closure of PDA.

In August 2013, the Nit-Occlud® PDA (PFM medical) received FDA approval via PMA for percutaneous, transcatheter closure of PDA.

In August 2013, the Amplatzer™ Duct Occluder II (2nd generation) received FDA approval via PMA for non-surgical closure of PDAs.

In January 2019, the Amplatzer Piccolo™ Occluder received FDA approval via PMA for the non-surgical closure of PDAs.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:   

93799	Unlisted cardiovascular service or procedure
93580	Percutaneous transcatheter closure of congenital interatrial communication (i.e., Fontan fenestration, atrial septal defect) with implant
93581	Percutaneous transcatheter closure of a congenital ventricular septal defect with implant
93582	Percutaneous transcatheter closure of patent ductus arteriosus
93315	Transesophageal echocardiography for congenital cardiac anomalies; including probe placement, image acquisition, interpretation and report
93462	Left heart catheterization by transseptal puncture through intact septum or by transapical puncture (List separately in addition to code for primary procedure).
93563	Injection procedure during cardiac catheterization including imaging supervision, interpretation, and report; for selective coronary angiography during congenital heart catheterization (list separately in addition to code for primary procedure).
93568	Injection procedure during cardiac catheterization including imaging supervision, interpretation, and report; for pulmonary angiography (list separately in addition to code for primary procedure)

REFERENCES:

1. Abaci A, Unlu S, Alsancak Y, et al. Short and long term complications of device closure of atrial septal defect and patent foramen ovale: meta-analysis of 28,142 patients from 203 studies. Catheter Cardiovasc Interv. Dec 1 2013; 82(7):1123-1138.
2. Abbott. Amplatzer Duct Occluders.  Available at: https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-pda.html
3. Abbott. Amplatzer™ Muscular VSD Occluder. https://www.sjm.com/en/professionals/featured-products/structural-heart/structural-heart-occluders/vsd-closure-devices/amplatzer-muscular-vsd-occluder.
4. Abbott. Amplatzer Septal Occluders. Available at:  https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-septal.html.
5. Abdul MK, Ullah Z, Ilyas S, et al. The outcome of transcatheter closure of patent ductus arteriosus: A single center experience. Cureus. 2022 Jan 24;14(1):e21577.
6. Alushi B, Biasco L, Orzan F, et al. Patent foramen ovale treatment strategy: an Italian large prospective study. J Cardiovasc Med (Hagerstown). Jun 27 2014.
7. Alushi, BB, Lauten, AA, Cassese, SS, et al. Patent foramen ovale closure versus medical therapy for prevention of recurrent cryptogenic embolism: updated meta-analysis of randomized clinical trials. Clin Res Cardiol, 2018 Apr 13;107(9).
8. American College of Chest Physicians. Comparing outcomes of medical management and percutaneous closure in patients with patent foramen ovale and cryptogenic stroke. Chest 2008; journal.publications.chestnet.org/article.aspx?articleid=1094512&resultClick=3. Accessed July 2015.
9. American Heart Association. Ventricular Septal Defect. http://www.heart.org/HEARTORG/Conditions/CongenitalHeartDefects/AboutCongenitalHeartDefects/Ventricular-Septal-Defect-VSD_UCM_307041_Article.jsp#.WyPUilVKhtQ..
10. Andersen A, Matzen KL, Andersen G, et al. Atrial fibrillation after closure of patent    foramen ovale in the REDUCEclinical study. Catheter Cardiovasc Interv. Nov 13 2021.
11. Baruteau AE, Petit J, Lambert V, et al. Transcatheter closure of large atrial septal defects: feasibility and safety in a large adult and pediatric population. Circ Cardiovasc Interv. Dec 2014; 7(6):837-843.
12. Behjati-Ardakani M, Rafiei M, et al. Long-term results of transcatheter closure of patent ductus arteriosus in adolescents and adults with amplatzer duct occluder. N Am J Med Sci. 2015 May; 7(5): 208-11.
13. Biasco L, Infantino V, Orzan F, et al. Impact of transcatheter closure of patent foramen ovale in the evolution of migraine and role of residual shunt. J Cardiol. Apr 5 2014.
14. Brochu MC, Baril JF, et al.  Improvement in exercise capacity in asymptomatic and mildly symptomatic adults after atrial septal defect percutaneous closure.  Circulation 2002; 106(14):1821-6.
15. Butera G, Biondi-Zoccai G, Sangiorgi G, et al. Percutaneous versus surgical closure of secundum atrial septal defects: a systematic review and meta-analysis of currently available clinical evidence. EuroIntervention. Jul 2011; 7(3):377-385.
16. Butera G, Saracino A, Danna P, et al. Transcatheter PFO closure with GORE ((R)) septal occluder: early and mid-term clinical results. Catheter Cardiovasc Interv. Nov 15 2013; 82(6):944-949.
17. Capodanno D, Milazzo G, Vitale L, et al. Updating the evidence on patent foramen ovale closure versus medical therapy in patients with cryptogenic stroke: a systematic review and comprehensive meta-analysis of 2,303 patients from three randomised trials and 2,231 patients from 11 observational studies. EuroIntervention. Mar 20 2014; 9(11):1342-1349.
18. Carroll JD, Saver JL, Thaler DE et al.  Closure of patent foramen ovale versus medical therapy after cryptogenic stroke.  N Engl J Med 2013; 368(12):1092-100.
19. Centers for Disease Control and Prevention. Congenital heart defects (CHDs). Available at //www.cdc.gov/ncbddd/heartdefects/ventricularseptaldefect.html. 
20. Chambault AL, Olsen K, Brown LJ, et al. Transcatheter versus surgical closure of atrial septal defects: asystematic review and meta-analysis of clinical outcomes. Cardiol Young. Jan 2022; 32(1): 1-9.
21. Chen TH, Hsiao YC, Cheng CC, et al. In-Hospital and 4-Year Clinical Outcomes Following Transcatheter Versus Surgical Closure for Secundum Atrial Septal Defect in Adults: A National Cohort Propensity Score Analysis. Medicine (Baltimore). Sep 2015;94(38):e1524.
22. Chen L, Luo S, Yan L, et al. A systematic review of closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and cryptogenic stroke or transient ischemic attack. J Neurol Sci. Feb 15 2014; 337(1-2):3-7.
23. De Rosa S, Sievert H, Sabatino J, et al. Percutaneous closure versus medical treatment in stroke patients with patent foramen ovale: a systematic review and meta-analysis. Ann Intern Med. Mar 6 2018;168(5):343-350.
24. Dowson A, Mullen MJ, Peatfield R, et al. Migraine Intervention With STARFlex Technology (MIST) trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation. Mar 18 2008; 117(11):1397-1404.
25. Du ZD, Hijazi ZM, et al.  Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial.  J Am Coll Cardiol 2002; 39(11):1836-44.
26. Du ZD, Koenig P, et al.  Comparison of transcatheter closure of secundum atrial septal defect using the Amplatzer septal occluder associated with deficient versus sufficient rims.  Am J Cardiol 2002; 90(8):865-9.
27. Eeckhout E, Martin S, Delabays A, et al. Very long-term follow-up after percutaneous closure of patent foramen ovale. EuroIntervention. Jan 17 2014.
28. Fischer G, Stieh J, et al. Experience with transcatheter closure of secundum atrial septal defects using the Amplatzer septal occluder: a single centre study in 236 consecutive patients. Heart 2003; 89(2):199-204.
29. Food and Drug Administration. Amplatzer PFO Occluder. Available at: //www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm526921.htm.
30. Food and Drug Administration. Amplatzer Piccolo Occluder.  Available at:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020024S052.
31. Food and Drug Administration. FDA Executive Summary: P120021 AMPLATZER Patent Foramen Ovale (PFO) Occluder. 2016; https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/Medical DevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM502193.pdf.
32. Food and Drug Administration. PMA P120021: FDA summary of safety and effectiveness data: Patent foramen ovale (PFO) Occluder. 2016; https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120021B.pdf. 
33. Food and Drug Administration. CardioSEAL® Septal Occlusion System with QuikLoad™. Summary of safety and effectiveness data. https://www.accessdata.fda.gov/cdrh_docs/pdf/P000049b.pdf. 
34. Food and Drug Administration. Gore® Cardioform Septal Occluder approval letter. https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050006s060a.pdf.
35. Food and Drug Administration. Summary of safety and effectiveness data. Gore Cardioform Septal Occluder.  https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050006s060b.pdf. 
36. Furlan AJ, Reisman M, Massaro J, et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med. Mar 15 2012; 366(11):991-999.
37. Ghaderian M, Merajie M, Mortezaeian H et al. A mid-term follow-up of the transcatheter closure of perimembranous ventricular septal defects in children using the amplatzer. J The Univ Heart Ctr 2015; 10(4): 182-187.
38. Gillespie MJ, Javois AJ, Moore P, et al. Use of the GORE(R) CARDIOFORM Septal Occluder for percutaneous closure ofsecundum atrial septal defects: Results of the multicenter U.S. IDE trial. Catheter Cardiovasc Interv. Jun 01 2020; 95(7): 1296-1304.
39. Grohmann J, Hohn R, Fleck T, et al. Transcatheter closure of atrial septal defects in children and adolescents: Single-center experience with the GORE septal occluder. Catheter Cardiovasc Interv. Mar 24 2014.
40. Gruenstein DH, Ebeid M, Radtke W, et al. Transcatheter closure of patent ductus arteriousus using the Amplatzer™ duct occluder II (ADO II). Catheter Cardiovasc Interv. 2017 MAY; 89(6):1118-1128.
41. Hakeem A, Marmagkiolis K, Hacioglu Y, et al. Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials. Cardiovasc Revasc Med. Nov-Dec 2013; 14(6):349-355.
42. Inglessis I, Elmariah S, Rengifo-Moreno PA, et al. Long-term experience and outcomes with transcatheter closure of patent foramen ovale. JACC Cardiovasc Interv. Nov 2013; 6(11):1176-1183.
43. Instruction for Use: Amplatzer® Septal Occluder System. In: AGA Medical Corporation; Golden Valley M, ed.
44. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
45. Jalal ZZ, Hascoët SS, Gronier CC, et al. Long-Term Outcomes After Percutaneous Closure of Ostium Secundum Atrial Septal Defect in the Young: A Nationwide Cohort Study. JACC Cardiovasc Interv, 2018 Apr 21;11(8). 
46. Javois AJ, Rome JJ, Jones TK, et al. Results of the U.S. Food and Drug Administration continued access clinical trial of the GORE HELEX septal occluder for secundum atrial septal defect. JACC Cardiovasc Interv. Aug 2014; 7(8):905-912.
47. Kent DM, Dahabreh IJ, Ruthazer R, et al. Device closure of patent foramen ovale after stroke: pooled analysis of completed randomized trials. J Am Coll Cardiol. Mar 01 2016;67(8):907-917.
48. Kernan WN, Ovbiagele B, Black HR, et al. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. Jul 2014; 45(7):2160-2236.
49. Khan AM, Ullah Z, Ilyas S, et al. the outcome of trans-catheter closure of patent ductus arteriosus: A single Center Experience. Cureus. 2022 Jan 24;14(1):e21577.
50. Khan AR, Bin Abdulhak AA, Sheikh MA, et al. Device closure of patent foramen ovale versus medical therapy in cryptogenic stroke: a systematic review and meta-analysis. JACC Cardiovasc Interv. Dec 2013; 6(12):1316-1323.
51. Khoshhal SQ, Al-Mutairi MB, Alnajjar AA, etc. Transcatheter device closure of ventricular septal defects in children: a retrospective study at a single cardiac center. Ann Saudi Med. Sep-Oct 2020;40(5):396-402.
52. Kitsios GD, Dahabreh IJ, Abu Dabrh AM, et al. Patent foramen ovale closure and medical treatments for secondary stroke prevention: a systematic review of observational and randomized evidence. Stroke. Feb 2012; 43(2):422-431.
53. Kitsios GD, Thaler DE, Kent DM.  Potentially large yet uncertain benefits:  a meta-analysis of patent foramen ovale closure trials.  Stroke 2013; 44(9):2640-3. 
54. Kleindorfer DO, Towfighi A, Chaturvedi S, et al. 2021 Guideline for the Prevention of Stroke in Patients With Strokeand Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association.Stroke. Jul 2021; 52(7): e364-e467.
55. Kotowycz MA, Therrien J, Ionescu-Ittu R, et al. Long-term outcomes after surgical versus transcatheter closure of atrial septal defects in adults. JACC Cardiovasc Interv. May 2013; 6(5):497-503.
56. Kwong JS, Lam YY, Yu CM. Percutaneous closure of patent foramen ovale for cryptogenic stroke: a meta-analysis of randomized controlled trials. Int J Cardiol. Oct 9 2013; 168(4):4132-4138.
57. Lansberg MG, O'Donnell MJ, Khatri P, et al. Antithrombotic and thrombolytic therapy for ischemic stroke: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. Feb 2012;141(2 Suppl):e601S-636S.
58. Lee PH, Song JK, Kim JS, et al. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. May 22 2018; 71(20): 2335-2342.
59. Li J, Liu J, Liu M, et al. Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack. Cochrane Database Syst Rev. Sep 08 2015(9):CD009938.
60. Lip PZ, Lip GY. Patent foramen ovale and migraine attacks: a systematic review. Am J Med. May 2014; 127(5):411-420.
61. Mandal KD, Su D, Pang Y. Long-term outcome of transcatheter device closure of perimembranous ventricular septal defects. Front Pediatr. 2018 May 3;6:128.
62. Mas JL, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. Sep 14 2017;377(11):1011-1021.
63. Mas JL, Guillon B, Charles-Nelson A, et al. Patent foramen ovale closure in stroke patients with migraine in the CLOSEtrial. The CLOSE-MIG study. Eur J Neurol. Aug 2021; 28(8): 2700-2707.
64. Mattle HP, Evers S, Hildick-Smith D, et al. Percutaneous closure of patent foramen ovale in migraine with aura, a randomized controlled trial. Eur Heart J. Jul 07 2016;37(26):2029-2036.
65. McDaniel N.L.  Ventricular and atrial septal defects, Pediatrics in Review 2001; 22(8).
66. Meier B, Kalesan B, Mattle HP, et al. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl JMed. Mar 21 2013; 368(12): 1083-91.
67. Messe SR, Gronseth G, Kent DM, et al. Practice advisory: Recurrent stroke with patent foramen ovale (update of practice parameter): Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. Aug 23 2016;87(8):815-821.
68. Messe SR, Gronseth GS, Kent DM, et al. Practice advisory update summary: Patent foramen ovale and secondarystroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology. Neurology. May19 2020; 94(20): 876-885.
69. Messe SR, Kasner SE. Is closure recommended for patent foramen ovale and cryptogenic stroke? Patent foramen ovale in cryptogenic stroke: not to close. Circulation. Nov 4 2008; 118(19):1999-2004.
70. Messe Sr, Silverman IE, Kizer JR, et al.  Practice parameter: recurrent stroke with patent foramen ovale and atrial septal aneurysm: report of the Quality Standards Subcommittee of the American Academy of Neurology.  Neurology.  2004 Apr 13; 62(7):1042-50.
71. Mojadidi MK, Gevorgyan R, Noureddin N, et al. The effect of patent foramen ovale closure in patients with platypnea-orthodeoxia syndrome. Catheter Cardiovasc Interv. Oct 2015; 86(4):701-707.
72. Nagaraja V, Raval J, Eslick GD, et al. Is transcatheter closure better than medical therapy for cryptogenic stroke with patent foramen ovale? A meta-analysis of randomized trials. Heart Lung Circ. Nov 2013; 22(11):903-909.
73. Nagpal SV, Lerakis S, Flueckiger PB, et al. Long-term outcomes after percutaneous patent foramen ovale closure. Am J Med Sci. Sep 2013; 346(3):181-186.
74. National heart, lung, and blood institute. What is patent ductus arteriosus? Available at: www.nhlbi.nih.gov/health/health-topics/topics/pda/. Accessed April 27, 2016.
75. National Institute for Clinical Excellence. Transcatheter endovascular closure of perimembranous ventricular septal defect. March 2010. Available at: www.nice.org.uk/guidance/ipg336/chapter/1-guidance
76. Ntaios G, Papavasileiou V, Makaritsis K, et al. PFO closure vs. medical therapy in cryptogenic stroke or transient ischemic attack: a systematic review and meta-analysis. Int J Cardiol. Oct 30 2013; 169(2):101-105.
77. Nyboe C, Hjortdal VE, Nielsen-Kudsk JE. First experiences with the GORE((R)) Septal Occluder in children and adults with atrial septal defects. Catheter Cardiovasc Interv. Nov 15 2013; 82(6):929-934.
78. Oho S, Ishizawa A, et al.  Transcatheter closure of atrial septal defects with the Amplatzer septal occluder – a Japanese clinical trial.  Circ J 2002; 66(9):791-4.
79. Paciaroni M, Agnelli G, Bertolini A, et al. Risk of recurrent cerebrovascular events in patients with cryptogenic stroke or transient ischemic attack and patent foramen ovale: the FORI (Foramen Ovale Registro Italiano) study. Cerebrovasc Dis. 2011; 31(2):109-116.
80. Pandit A, Aryal MR, Pandit AA, et al. Amplatzer PFO occluder device may prevent recurrent stroke in patients with patent foramen ovale and cryptogenic stroke: a meta-analysis of randomised trials. Heart Lung Circ. Apr 2014; 23(4):303-308.
81. Patti G, Pelliccia F, Gaudio C, et al. Meta-analysis of net long-term benefit of different therapeutic strategies in patients with cryptogenic stroke and patent foramen ovale. Am J Cardiol. Mar 15 2015; 115(6):837-843.
82. Pezzini A, Grassi M, Lodigiani C, et al. Propensity Score-Based Analysis of Percutaneous Closure Versus Medical Therapy in Patients With Cryptogenic Stroke and Patent Foramen Ovale: The IPSYS Registry (Italian Project on Stroke in Young Adults). Circ Cardiovasc Interv. Sep 2016;9(9).
83. PFM Medical. Available at: https://www.pfmmedicalusa.com/nit-occlud-pda/.
84. Pickett CA, Villines TC, Ferguson MA, et al. Percutaneous closure versus medical therapy alone for cryptogenic stroke patients with a patent foramen ovale: meta-analysis of randomized controlled trials. Tex Heart Inst J. Aug 2014; 41(4):357-367.
85. Pineda AM, Nascimento FO, Yang SC, et al. A meta-analysis of transcatheter closure of patent foramen ovale versus medical therapy for prevention of recurrent thromboembolic events in patients with cryptogenic cerebrovascular events. Catheter Cardiovasc Interv. Nov 15 2013; 82(6):968-975.
86. Pristipino C, Germonpre P, Toni D, et al. European position paper on the management of patients with patentforamen ovale. Part II - Decompression sickness, migraine, arterial deoxygenation syndromes and select high-riskclinical conditions. EuroIntervention. Aug 06 2021; 17(5): e367-e375.
87. Rhodes JF, Jr., Goble J. Combined prospective United States clinical study data for the GORE((R)) HELEX((R)) septal occluder device. Catheter Cardiovasc Interv. May 1 2014; 83(6):944-952.
88. Rigatelli G, Pedon L, Zecchel R, et al. Long-Term Outcomes and Complications of Intracardiac Echocardiography-Assisted Patent Foramen Ovale Closure in 1,000 Consecutive Patients. J Interv Cardiol. Oct 2016;29(5):530-538.
89. Rigatelli G, Zuin M, Roncon L, et al. Secundum atrial septal defects transcatheter closure versus surgery inadulthood: a 2000-2020 systematic review and meta-analysis of intrahospital outcomes. Cardiol Young. Apr 2021;31(4): 541-546.
90. Rogers T, Slack M, Waksman R. Overview of the 2016 US Food and Drug Administration Circulatory System Devices Panel Meeting on the Amplatzer Patent Foramen Ovale Occluder. Am J Cardiol. Jan 01 2017;119(1):153-155.
91. Sarmento JA, Coreia-Costa A, Goncalves E, et al. Percutaneous patent ductus arteriosus closure: twelve years experience.  Rev Port Cardiol (Engl Ed). 2021 Aug;40(8):561-568.
92. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. Sep 14 2017;377(11):1022-1032.
93. Shah R, Nayyar M, Jovin IS, et al. Device closure versus medical therapy alone for patent foramen ovale in patients with cryptogenic stroke: a systematic review and meta-analysis. Ann Intern Med. Mar 6 2018;168(5):335-342.
94. Slottow TL, Steinberg DH, Waksman R. Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel meeting on patent foramen ovale closure devices. Circulation. Aug 7 2007; 116(6):677-682.
95. Sondergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. Sep 14 2017;377(11):1033-1042. 
96. Snijder RJ, Luermans JG, de Heij AH, et al. Patent Foramen Ovale With Atrial Septal Aneurysm Is Strongly Associated With Migraine With Aura: A Large Observational Study. J Am Heart Assoc. Dec 01 2016;5(12).
97. Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. Sep 14 2017;377(11):1033-1042.
98. Stortecky S, da Costa BR, Mattle HP, et al. Percutaneous closure of patent foramen ovale in patients with cryptogenic embolism: a network meta-analysis. Eur Heart J. Jan 7 2015; 36(2):120-128.
99. Stout KK, Daniels CJ, Aboulhosn JA, et al. 2018 AHA/ACC guideline for the management of adults with congenital heart disease. Circulation. Apr 2 2019; 139: e698 –e800.
100. Thomson JD, Hildick-Smith D, Clift P, et al. Patent foramen ovale closure with the gore septal occluder: initial UK experience. Catheter Cardiovasc Interv. Feb 15 2014; 83(3):467-473.
101. Tobis JM, Charles A, Silberstein SD, et al. Percutaneous closure of patent foramen ovale in patients with migraine: the PREMIUM Trial. J Am Coll Cardiol. Dec 5 2017;70(22):2766-2774.
102. Tobis J, Shenoda M. Percutaneous Treatment of Patent Foramen Ovale and Atrial Septal Defects. J Am Coll Cardiol. 2012; 60(18):1722-1732.
103. Udell JA, Opotowsky AR, Khairy P, et al. Patent foramen ovale closure vs medical therapy for stroke prevention: meta-analysis of randomized trials and review of heterogeneity in meta-analyses. Can J Cardiol. Oct 2014; 30(10):1216-1224.
104. Wang YL, Wang FZ, Zhang Y, et al. Association of migraine with patent foramen ovale closure: A systematic review andmeta -analysis. Int J Cardiol Heart Vasc. Apr 2022; 39: 100992.
105. Wintzer-Wehekind J, Alperi A, Houde C, et al. Long-Term Follow-Up After Closure of Patent Foramen Ovale in Patients With Cryptogenic Embolism. J Am Coll Cardiol. Jan 29 2019; 73(3): 278-287.
106. Wolfrum M, Froehlich GM, Knapp G, et al. Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis. Heart. Mar 2014; 100(5):389-395.
107. Xu XD, Liu SX, Zhao XX, et al. Comparison of Medium-term Results of Transcatheter Correction Versus Surgical Treatment for Secundum Type Atrial Septal Defect Combined With Pulmonary Valve Stenosis. Int Heart J. Jul 10 2014; 55(4):326-330.
108. Yang J, Lifang Y, Shiqiang Y et al. Transcatheter versus surgical closure of perimembranous ventricular septal defects in children. Journal of the American College of Cardiology. 2014 Nov; 63(12):1159-1168.
109. Yang J, Yang L, Wan Y et al. Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes. Eur Heart J. 2010 Sep; 31(18): 2238-45.
110. Yilmazer MM, Guven B, Vupa-Cilengiroglu O, et al. Improvement in cardiac structure and functions early after transcatheter closure of secundum atrial septal defect in children and adolescents. Turk J Pediatr. Jul-Aug 2013; 55(4):401-410.

POLICY HISTORY:

Medical Policy Group, September 2011 (2): Effective April 12, 2011 Policy #039 Transcatheter Atrial Septal Occlusion Devices and Policy #068 Transcatheter Closure Devices for PFO Devices were merged with this policy.

Medical Policy Group, November 2011 (2): Effective November 7, 2011 Policy #107 Transcatheter Closure of Patent Ductus Arteriosus was merged with this policy. Policies #039, #068, and #107 were all archived.

Medical Policy Administration Committee, April 2011

Available for comment September 22 through November 7, 2011

Medical Policy Group, December 2011 (1): 2012 Code Updates; verbiage change on codes 99354, 99355, 99356, and 99357

Medical Policy Panel, September 2013

Medical Policy Group, October 2013 (2):  No change to policy statement.  Key Points and References updated to reflect information from latest literature search. 

Medical Policy Group, December 2013 (3):  2014 Coding Update – added new code 93582 to current coding (effective 01/01/14); added key words Patent Ductus Arteriosus and PDA

Medical Policy Panel, September 2014

Medical Policy Group, October 2014 (3):  2014 Updates to Description, Key Points & References; no change in policy statement

Medical Policy Group, July 2015 (4):  Added Monodisc occluder to Key Words

Medical Policy Group, November 2015: 2016 Annual Coding Update. Revised CPT codes 99354 and 99355.

Medical Policy Panel, April 2016

Medical Policy Group, June 2016 (4): Updates to Description, Key Points, Approved Governing Bodies, References. Multiple policy section updates; Added new PFO statement, added new ASD and VSD investigational statements; updated policy statements for ASD and VSD; removed CPT codes 93533, 93452, 93453, and 99354-99357. The listed codes should not have been on policy.

Medical Policy Administration Committee, July 2016

Available for comment June 29 through August 13, 2016

Medical Policy Group, January 2017 (4): Updates to Policy statement, Approved by Governing Bodies, and References due to FDA approval of Amplatzer PFO Occluder device.

Medical Policy Group, April 2017 (4): Update to Policy statement to clarify indications for PFO occlusion.

Medical Policy Panel, May 2017

Medical Policy Group, May 2017 (4): Updates to Description, Key Points, Approved by Governing Bodies, and References.  Update to investigational statement for VSDs.  Added “including but not limited to”….”and in patients with severe irreversible PAH”.  Policy intent unchanged.

Medical Policy Panel, May 2018

Medical Policy Group, June 2018 (4): Updates to Description, Key Points, Approved by Governing Bodies and References.  Clarified policy statement.

Medical Policy Panel, May 2019

Medical Policy Group, June 2019 (4): Updates to Description, Policy, Key Points, and References.  Removed the age limitation from PFO closure and added that the diagnosis of cryptogenic stroke must be from a presumed paradoxical embolism.  Added criteria point of paradoxical embolism for coverage for ASD closure.

Medical Policy Administrative Committee, June 2019

Available for Comment: June 18-August 2, 2019.

Medical Policy Panel, May 2020

Medical Policy Group, June 2020 (4):  Updates to Key Points, Approved by Governing Bodies, and References.  No change to policy statements.  Removed statements that were effective for dates of service on or after April 12, 2011 and prior to August 14, 2016.

Medical Policy Panel, May 2021

Medical Policy Group, June 2021: Updates to Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Removed the following References: Berger F., Ewert P., et al.  Percutaneous closure of large atrial septal defects with the Amplatzer septal occluder; Butera G., Bini M.R., et al.  Transcatheter closure of patent foramen ovale in patients with cryptogenic stroke; Cotran R.S., Kumar V., and Collins T.  Robbins pathologic basis of disease; Demkow M., Ruzyllo W., et al.  Transvenous closure of moderate and large secundum atrial septal defects in adults using the Amplatzer septal occluder; Formigari R., DiDonato R.M., et al.  Minimally invasive or interventional repair of atrial septal defects in children; Handke M, Harloff A, et al.  Patent foramen ovale and cryptogenic stroke in older patients; Harrer JU, Wessels T, et al.  Stroke recurrence and its prevention in patients with patent foramen ovale; Homma S., Sacco R.L., et al.  Effect of medical treatment in stroke patients with patent foramen ovale; Hung J., Ladzbert M.J., Jenkins K.J., et al.  Closure of patent foramen ovale or paradoxical emboli; Iverekk H.R., Bone I., Lees K.R.  Interatrial septal abnormalities and stroke: a meta-analysis.

Medical Policy Panel, May 2022

Medical Policy Group, June 2022 (4): Updates to Description, Key Points, and References.  No change to policy statements.

Medical Policy Panel, May 2023

Medical Policy Group, June 2023 (4):

Medical Policy Group, June 2023(4): Updates to Policy, Description, Key Points, Approved by Governing Bodies, Benefit Application, and References. No change to policy intent.  Removed policy statements effective for dates of service on and after August 14, 2016 through August 1, 2019.

Medical Policy Panel, May 2024

Medical Policy Group, May 2024 (4): Updates to Key Points, Key Words, Approved by Governing Bodies, and References.  No change to policy statements.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.