Download Transcatheter Closure of Patent Foramen Ovale for Stroke Prevention

Transcatheter Closure of Patent Foramen Ovale for Stroke
Prevention
Policy Number:
MM.06.021
Line of Business:
HMO; PPO; QUEST Integration
Section:
Surgery
Place(s) of Service:
Outpatient; Inpatient
Original Effective Date
08/01/2013
Current Effective Date:
03/25/2016
I. Description
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
uninflated 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 a course of months after birth, an increase in left atrial
pressure and a decrease in right atrial pressure result in the permanent closure of the
foramen ovale in most individuals. However, patent foramen ovale (PFO) is a common
finding in normal adults, detected in up to 25% of adults. In some epidemiologic studies,
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 neurological
sources.
The role of PFO in patients with cryptogenic stroke remains controversial, although an
association seems likely in younger patients with atrial septal aneurysms and PFO. The
mechanism of cryptogenic stroke in these patients is presumed to be paradoxical embolism
via right-to-left shunt across the PFO. Treatment options include medical therapy with
antiplatelet or anticoagulant therapy based in part on the theory that clotting disorders may
be present in individuals with embolic stroke. Alternative treatments include open surgery
or transcatheter approaches using a PFO closure device in individuals with recurrent
cryptogenic stroke due to presumed paradoxical embolism who have failed conventional
drug therapy with anticoagulants.
Transcatheter closure of secundum atrial septal defects may be considered medically
necessary when using a device that has been FDA approved for that purpose and used
according to the labeled indications.
At present, 2 devices are FDA-approved for ASD closure: the Amplatzer™ Septal Occluder
(St. Jude Medical, Minneapolis, MN), and the GORE HELEX™ Septal Occluder (W.L. Gore &
Transcatheter Closure of Patent Foramen Ovale for Stroke Prevention
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Associates Inc., Newark, DE). The Amplatzer Septal Occluder was approved through FDA’s
premarket approval process in June 2002. The Amplatzer device is intended for the
occlusion of ASDs in the secundum position or in patients who have undergone 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.
The Gore Helix Septal Occluder was approved through the premarket approval process in
August 2006. It is indicated for the percutaneous, transcatheter closure of ostium secundum
ASDs.
On October 17, 2013 the FDA issued a warning alerting health care providers and patients
that in very rare instances, tissue surrounding the Amplatzer Atrial Septal Occluder (ASO)
can break down (erode) and result in life-threatening emergencies that require immediate
surgery. According to published estimates, these events occur in approximately 1 to 3 of
every 1,000 patients implanted with the Amplatzer ASO. As of March 31, 2013, there have
been 234,103 Amplatzer ASO devices sold worldwide. Physicians and patients should follow
the FDA recommendations listed on the warning.
II. Criteria/Guidelines
Transcatheter closure of PFO is covered (subject to Limitations and Administrative
Guidelines) for the prevention of subsequent stroke in patients with a documented history
of cryptogenic stroke and one of the following:
A. The patient has failed conventional drug therapy (e.g., warfarin, anti-platelet therapy);
B. The patient is not a candidate for conventional drug therapy (e.g., intolerance, allergy,
extremely young age); or
C. The patient is 60 years old or younger and has a complicating high risk factor such as
co-existing thrombophilia, deep venous thrombosis or pulmonary embolism
documented at the time of stroke, stroke occurring during Valsalva maneuver, or atrial
septal aneurysm with large shunt.
III. Limitations
A. Transcatheter closure of PFO has not been shown to improve health outcomes for any
other condition not listed above.
B. Procedures performed with non-FDA-approved devices are not covered.
IV. Administrative Guidelines
A. Precertification is required. To precertify, complete HMSA’s Precertification Request and
mail or fax the form as indicated. Include the following documentation:
1. Patient’s history and physical examination;
2. Clinical notes documenting previous stroke; and
3. Previous treatments that were tried and failed, or documentation describing the
patient’s intolerance to conventional therapy.
Transcatheter Closure of Patent Foramen Ovale for Stroke Prevention
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B. Applicable Codes:
CPT
93580
Description
Percutaneous transcatheter closure of congenital interatrial
communication (ie, fontan fenstration, atrial septal defect) with
implant [when specified as for patent foramen ovale]
ICD-10 Procedure
02U53JZ
Description
Supplement atrial septum with synthetic substitute,
percutaneous approach
Supplement atrial septum with synthetic substitute,
percutaneous endoscopic approach
02U54JZ
V. Important Reminder
The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is
not intended to dictate to providers how to practice medicine. Nothing in this Medical
Policy is intended to discourage or prohibit providing other medical advice or treatment
deemed appropriate by the treating physician.
Benefit determinations are subject to applicable member contract language. To the extent
there are any conflicts between these guidelines and the contract language, the contract
language will control.
This Medical Policy has been developed through consideration of the medical necessity
criteria under Hawaii’s Patients’ Bill of Rights and Responsibilities Act (Hawaii Revised
Statutes §432E-1.4), generally accepted standards of medical practice and review of medical
literature and government approval status. HMSA has determined that services not covered
under this Medical Policy will not be medically necessary under Hawaii law in most cases. If
a treating physician disagrees with HMSA’s determination as to medical necessity in a given
case, the physician may request that HMSA reconsider the application of the medical
necessity criteria to the case at issue in light of any supporting documentation.
VI. References
1. Wohrle J, Bertrand B, Sondergaard L, et al. PFO closuRE and CryptogenIc StrokE
(PRECISE) registry: a multi-center, international registry. Clin Res Cardiol 2012 101:787–
793.
2. Furlan AJ, Resiman M, Massaro J, et al. Closure or Medical Therapy for Cryptogenic
Stroke with Patent Foramen Ovale. N Engl J Med 2012; 366:991-9.
3. Braun MU, Fassbender D, Schoen SP, et al. Transcatheter closure of patent foramen
ovale in patients with cerebral ischemia. J Am Coll Cardiol. 2002 Jun 19; 39(12): 2019–
25.
4. U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health
(CDRH). CardioSEAL® Septal Occlusion System Transcatheter Cardiac Occlusion Device.
Summary of Safety and Probable Benefit. Humanitarian Device Exemption (HDE) No.
Transcatheter Closure of Patent Foramen Ovale for Stroke Prevention
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6.
7.
8.
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H990011. Rockville, MD: FDA; February 1, 2000. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf/H990005b.pdf . Accessed January 12,
2016.
Rengifo-Moreno P, Palacios IF, Junpaparp P, et al. Patent foramen ovale transcatheter
closure vs. medical therapy on recurrent vascular events: a systematic review and metaanalysis of randomized controlled trials. European Heart Journal. 2013 Nov; 34(43):
3342–3352.
Spies C, Hijazi ZM. Patent foramen ovale and cryptogenic stroke: is there still a role for
percutaneous closure? Clin Pract. 2013, 10(1): 103-112.
U.S. Food and Drug Administration (FDA). St Jude Amplatzer atrial septal occluder (ASO):
safety communication: reports of tissue erosion. Issued October 17, 2013. Available at:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm371145.htm.
Accessed January 12, 2016.
Windecker S, Wahl A, Chatterjee T, et al. Percutaneous closure of patent foramen ovale
in patients with paradoxical embolism long-term risk of recurrent thromboembolic
events. Circulation. 2000 Feb 29; 101(8):893-898.