Medical Policy



Subject: Transcatheter Closure of Patent Foramen Ovale and Left Atrial Appendage for Stroke Prevention
Document #: SURG.00032 Current Effective Date:    09/27/2017
Status: Reviewed Last Review Date:    08/03/2017

Description/Scope

This document addresses the transcatheter approach for closure of patent foramen ovale and left atrial appendage (LAA) when performed to prevent stroke using cardiac occlusion devices, which are deployed under transesophageal echocardiographic or fluoroscopic guidance as a nonsurgical alternative to open heart surgery.

Note: Please see the following related document for additional information:

Position Statement

Medically Necessary:

Transcatheter closure of a patent foramen ovale (PFO) using a U.S. Food and Drug Administration (FDA) approved device approved for that indication (that is, AMPLATZER PFO Occluder [St. Jude Medical, Plymouth, MN]) is considered medically necessary for the prevention of subsequent stroke in individuals with a history of cryptogenic stroke who have failed conventional drug therapy, (for example, warfarin), or who are not candidates for conventional drug therapy.

Investigational and Not Medically Necessary:

Transcatheter closure of a patent foramen ovale for the prevention of stroke is considered investigational and not medically necessary when the criteria above are not met.

Transcatheter closure of a left atrial appendage is considered investigational and not medically necessary for all indications.

Rationale

A transcatheter PFO occluder is a permanently implanted device that provides a non-surgical method for PFO closure, blocking clots from passing from the right atrium to the left atrium. There was limited early evidence to support the net benefit of transcatheter closure of a PFO, in individuals with a history of cryptogenic stroke who have failed, or who are not candidates for medical anticoagulation therapy, mostly in the form of case series. These studies reported that the risk of an embolic event after transcatheter closure was comparable to open surgical closure, with minimal complications. An advisory article by O'Gara and colleagues (2009) reviewed studies of participants that underwent transcatheter closure for the treatment of PFO for stroke prevention. There is no clear objective evidence to demonstrate that either medical therapy (antiplatelet agents or vitamin K antagonists), transcatheter closure, or open surgical closure are superior treatment options for the prevention of transient ischemic attack (TIA) or recurrent stroke in individuals with cryptogenic stroke. Randomized controlled trials are needed to establish the safety and efficacy, as well as to determine the benefits, of one treatment option over another. Therefore, the Advisory identified a need for clinicians to refer individuals with cryptogenic stroke and PFO to one of the ongoing clinical trials (O'Gara, 2009). Ongoing studies include the randomized evaluation of recurrent stroke comparing PFO to established current standard of care treatment (RESPECT) and phase III/IV clinical trials that are comparing device closure to medical therapy in individuals who have cryptogenic stroke with high risk PFO.

On October 28, 2016 the FDA granted premarket approval for the AMPLATZER PFO Occluder. The device is indicated for percutaneous transcatheter closure of a PFO to reduce the risk of recurrent ischemic stroke in individuals (predominantly between ages 18 to 60 years of age) 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.

The AMPLATZER PFO Occluder approval was based on unpublished results from the RESPECT trial, a prospective, multi-center, randomized, unblinded study that enrolled 980 participants (aged 18 to 60 years old) with a PFO who had a cryptogenic stroke (stroke from unknown cause) within the last 270 days. Participants were randomized (1:1) to either the device group with PFO closure using the AMPLATZER PFO Occluder (n=499) or the medical management group (n=481) with four medical regimens allowed (aspirin alone, Coumadin alone, clopidogrel alone, or aspirin combined with dipyridamole). While the rate of new strokes in both treatment groups was very low, there was a clinically meaningful 50% relative risk reduction in the rate of new strokes in participants using the AMPLATZER PFO Occluder plus blood-thinning medications compared to participants taking only blood-thinning medications. The safety evaluation performed during the study found an acceptable rate of adverse events. Procedure-related risks include atrial fibrillation, access site bleeding, cardiac perforation, and deep vein thrombosis. In participants undergoing an AMPLATZER PFO Occluder implantation the risk of device or implantation procedure-related serious adverse events was 4.2% with no device related deaths. The RESPECT trial results showed that the AMPLATZER PFO Occluder is superior to current standard of care medical treatment in prevention of recurrent embolic stroke; the FDA concluded that probable benefits of the device outweigh the probable risks (AMPLATZER PFO Occluder Product Information, 2016).

Transcatheter closure of an LAA is a new treatment strategy that prevents travel of an LAA thrombus out of the LAA in individuals with non-valvular atrial fibrillation (AF). The LAA closure system is introduced in the right atrium and then passed into the left atrium through a PFO or through a puncture hole. The Holmes and colleagues (2009) randomized, non-inferiority trial compared LAA closure using the WATCHMAN LAA Closure Device (Boston Scientific, Marlborough, MA) versus warfarin therapy for prevention of stroke in individuals with AF. The study evaluated efficacy between the interventional group and the warfarin group based upon the primary endpoint of reported cardiovascular death (n=5 vs. n=10), all types of stroke (n=16 vs. n=12), and systemic embolism (n=2 vs. n=0). Researchers reported a higher occurrence of primary safety events in the interventional group compared to the warfarin therapy group; serious adverse events included major bleeding, pericardial effusion and device embolization. The authors concluded:

Thus, our strategy for closing the LAA was non-inferior to warfarin therapy in terms of primary efficacy endpoint of all stroke, cardiovascular death, and systemic embolism. Although there is a higher initial safety event rate for device implantation, adverse events were without long term sequelae for most patients. Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with non-valvular atrial fibrillation.

A study by Reddy and colleagues (2011) reported on preliminary outcomes from the Watchman LAA System for Embolic Protection in Patients with AF (PROTECT AF) trial and Continued Access PROTECT AF Registry (CAP Registry). Although with improved procedural experience there was a decline in safety events reported, there remains a higher risk of complications. The FDA granted PMA approval March 2015 for the WATCHMAN LAA Closure Device in individuals with non-valvular AF in facilities equipped for heart surgery as an alternative option to long-term warfarin therapy. According to the manufacturer, Boston Scientific Corporation:

WATCHMAN is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2 DS2 -VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

Reddy and colleagues (2014) reported long-term outcomes of the PROTECT AF trial. The randomized, multicenter study enrolled 707 participants with nonvalvular AF and at least one additional stroke risk factor (CHADS2 score greater than or equal to 1) who were randomized 2:1 to undergo left atrial appendage closure with the WATCHMAN LAA Closure Device (n=463, treatment group) or warfarin therapy (n=244, control group). The trial demonstrated a noninferior rate of cardiovascular death, stroke or systemic embolism, compared with warfarin alone. The authors concluded:

After 3.8 years of follow-up among patients with nonvalvular AF at elevated risk for stroke, percutaneous LAA closure met criteria for both noninferiority and superiority, compared with warfarin, for preventing the combined outcome of stroke, systemic embolism, and cardiovascular death, as well as superiority for cardiovascular and all-cause mortality.

A multicenter, randomized, clinical trial PREVAIL assessed safety and efficacy of the WATCHMAN LAA Closure device versus long-term warfarin in individuals with nonvalvular AF who had a CHADS2 score of 2 or more (CHADS2 score of 1 and another risk factor were eligible) (Holmes, 2014). Exclusion criteria included contraindication to warfarin or aspirin, stroke/transient ischemic attack within the last 90 days, symptomatic carotid disease, PFO or atrial septal defect (ASD), thromboembolism or bleeding. PREVAIL enrolled 407 participants, assigned randomly (2:1 ratio) to the device group (n=269) or control group (n=138). Unlike the PROTECT AF trial the PREVAIL did not demonstrate noninferiority in overall efficacy. The authors report that:

At 18 months, the rate of the first co primary efficacy endpoint (composite of stroke, systemic embolism [SE], and cardiovascular/unexplained death was 0.064 in the device group versus 0.063 in the control group (rate ratio 1.07 [95% credible interval (Crl): 0.57 to 1.89]) and did not achieve the pre-specified criteria noninferiority (upper boundary of 95% Crl ≥1.75). The rate for the second co-primary efficacy endpoint (stroke or SE > 7 days' post randomization) was 0.0253 versus 0.0200 (risk difference 0.0053 [95% Crl: -0.0190 to 0.0273], achieving noninferiority. Early safety events occurring in 2.2% of the Watchman arm, significantly lower than in PROTECT AF, satisfying the pre-specified safety performance goal. Using a broader, more inclusive definition of adverse events, these still were lower in PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial than in PROTECT AF (4.2% vs. 8.7%; p=0.004). Pericardial effusions requiring surgical repair decreasing from 1.6% to 0.4% (p=0.36), although the number of events was small.

LAA occlusion was noninferior to warfarin for ischemic stroke prevention or SE >7 days post-procedure. Although noninferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety has significantly improved. This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy.

Two randomized controlled trials have compared use of the WATCHMAN device for LAA closure in individuals with AF eligible for anticoagulation therapy. The peer reviewed published literature suggest that the WATCHMAN is associated with an increased periprocedural ischemic stroke risk. There is limited evidence supporting the net benefit of transcatheter closure of a LAA with the WATCHMAN LAA Closure device, in individuals with non-valvular AF who are deemed eligible for systemic anticoagulation. Further studies are needed to determine if the long-term risk of systemic anticoagulation exceeds the periprocedural risk of device implantation.

Ongoing trials include the PREVAIL continued access trial (NCT01760291) evaluating the long-term safety and efficacy of the WATCHMAN LAA Closure Device up to 5 years, another evaluating the safety and effectiveness of the WATCHMAN LAA Closure Device compared to single antiplatelet therapy or no therapy at the discretion of the study physician and one comparing the WATCHMAN LAA Closure Device to the LARIAT Suture Delivery Device (SentreHEART® , Redwood City, CA) used as LAA device occlusion for the treatment of AF. Presently, no other LAA closure system has been granted final approval by the FDA for this indication.

Background/Overview

Patent Foramen Ovale (PFO)
PFO describes the persistence of a component of the fetal circulation between the right and left atrium. Although PFOs are found in 10-15% of adults, they are typically clinically insignificant. However, they may be associated with paradoxical embolus, in which an embolus arising in the venous circulation gains access to the arterial circulation through the PFO. It is estimated that individuals with a history of PFO and paradoxical embolism have a 3.4% and 3.8% yearly risk of recurrent stroke or transient ischemic attack. Therefore, there has been interest in either open surgery or transcatheter approaches to close the PFO, in individuals with a history of embolic stroke of unknown cause. Treatment alternatives include chronic warfarin therapy, based, in part, on the theory that clotting disorders may be present in individuals with embolic stroke. To date, the AMPLATZER PFO Occluder is the only device which has received FDA approval for transcatheter closure of a PFO to reduce risk of stroke in individuals who had cryptogenic stroke due to presumed paradoxical embolism, after a comprehensive clinical evaluation (by neurologist and cardiologist) has been conducted to rule out other causes of stroke. Contraindications for the AMPLATZER PFO Occluder include: individuals with active endocarditis, untreated infection, other heart defects, or a tumor or blood clot in the vessels along the path of the heart. The GORE® HELEX® Septal Occluder/ GORE® Septal Occluder (W.L. Gore & Associates, Inc., Flagstaff, AZ) provide another potential treatment option for PFO closure in individuals who had a cryptogenic stroke, the devices are currently being studied as alternatives to anticoagulation therapy.

Left Atrial Appendage
In the U.S., AF is the most prevalent sustained cardiac arrhythmia, resulting in significantly greater risk of stroke due to migration of clots that may form in the LAA. As confirmed by echocardiography and autopsy, LAA is identified as a leading source of thrombi in individuals with non-valvular AF. By closing off the LAA, the occlusion device is designed to reduce risk of stroke and other cardiovascular complications. The WATCHMAN LAA Closure Device is the first of its kind treatment giving individuals with non-valvular AF an alternative option to long-term warfarin therapy. The AMPLATZER™ Cardiac Plug (ACP) (St. Jude Medical, St. Paul, MN) and LARIAT® Suture Delivery Device and Accessories provide other potential alternatives to closure, currently being studied as alternatives to standard anticoagulation therapy.

The CHADS (cardiac failure, hypertension, age, diabetes, stroke) score is a risk assessment tool that is based on a point system, in which 2 points are assigned for a history of stroke or TIA, and 1 point each is assigned for age over 75 and a history of hypertension, diabetes or recent HF. The adjusted stroke rate can be assessed based on the CHADS score. For example, a CHADS score of 2 is associated with an adjusted stroke rate of 4% per year (Fuster, 2006).

Definitions

Atrial fibrillation: A condition where there is disorganized electrical conduction in the atria, resulting in ineffective pumping of blood into the ventricle.

Cryptogenic stroke: A stroke or transient ischemic attack of obscure or unknown origin.

Left atrial appendage (LAA): A muscular pouch attached to the upper portion of the left atrium.

Patent foramen ovale (PFO): A component of the fetal circulation that consists of a communication between the left and right atria that generally closes after birth; if an opening remains after birth, the possibility of an embolus (blood clot that breaks free in the blood) getting to the brain exists, resulting in a stroke or transient ischemic attack.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT  
93580 Percutaneous transcatheter closure of congenital interatrial communication (ie, Fontan fenestration, atrial septal defect) with implant [when specified as closure of patent foramen ovale]
   
ICD-10 Procedure  
02U53JZ Supplement atrial septum with synthetic substitute, percutaneous approach [when specified as closure of patent foramen ovale]
   
ICD-10 Diagnosis  
G45.9 Transient cerebral ischemic attack, unspecified
I63.8 Other cerebral infarction
I63.9 Cerebral infarction, unspecified
Q21.1 Atrial septal defect [when specified as patent foramen ovale] 
Z86.73 Personal history of transient ischemic attack (TIA), and cerebral infarction without residual deficits

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT  
33340 Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation
   
ICD-10 Procedure  
02L73CK Occlusion of left atrial appendage with extraluminal device, percutaneous approach
02L73DK Occlusion of left atrial appendage with intraluminal device, percutaneous approach
   
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. Bartus K, Han FT, Bednarek J, et al. Percutaneous left atrial appendage suture ligation using the LARIAT device in patients with atrial fibrillation: initial clinical experience. J Am Col Cardiol. 2013; 62(2):108-118.
  2. Holmes DR, Doshi SK, Kar S, et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation. A patient-level meta-analysis. J Am Coll Cardiol. 2015; 65(24):2614-2623.
  3. Holmes DR, Kar S, Price MJ, et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014; 64(1):1-12.
  4. Holmes DR, Reddy VY, Turi ZG, et al.; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomized non-inferiority trial. Lancet. 2009; 374(9689):534-542.
  5. Kapadia SR. Patent foramen ovale closure: historical perspective. Cardiol Clin. 2005; 23(1):73-83.
  6. Kay JD, O'Laughlin MP, Ito K, et al. Five-year clinical and echocardiographic evaluation of the Das Angel Wings atrial septal occluder. Am Heart J. 2004; 147(2):361-368.
  7. O'Gara PT, Messa SR, Tuzcu EM, et al. Percutaneous device closure of patent foramen ovale for secondary stroke prevention: a call for completion of randomized clinical trials. A science advisory from the American Heart Association/American Stroke Association and the American College of Cardiology Foundation. J Am Coll Cardiol. 2009; 53(21):2014-2018.
  8. Onorato E, Melzi G, Casilli F, et al. Patent foramen ovale with paradoxical embolism: mid-term results of transcatheter closure in 256 patients. J Interv Cardiol. 2003; 16(1):43-50.
  9. Patel HT, Hijazi ZM. Pediatric catheter interventions: a year in review 2004-2005. Curr Opin Pediatr. 2005; 17(5):568-573.
  10. Pisters R, Lane DA, Nieuwlaat R, et al. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation. The Euro heart survey. Chest. 2010; 138(5):1093-1100.
  11. Price MJ, Reddy VY, Valderrabano M, et al. Bleeding outcomes after left atrial appendage closure compared with long-term warfarin. JACC. 2015; 8(15):1925-1932.
  12. Reddy VY, Doshi SK, Sievert H, et al. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-year follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for embolitic protection in patients with atrial fibrillation) Trial. Stroke. 2013; 127(6):720-729.
  13. Reddy VY, Holmes D, Doshi SK, et al. Safety of percutaneous left atrial appendage closure: results from the Watchman left atrial appendage system for embolic protection in patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011; 123(4):417-424.
  14. Reddy VY, Mobius-Winkler S, Miller MA, et al. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study with Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013; 61(25):2551-2556.
  15. Reddy VY, Sievert H, Halperin J, et al. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014; 312(19):1988-1998.
  16. Ries M, Kampmann C, Rupprecht HJ, et al. Nickel release after implantation of the Amplatzer occluder. Am Heart J. 2003; 145(4):737-741.
  17. Rome JJ, Kreutzer J. Pediatric interventional catheterization: reasonable expectations and outcomes. Pediatr Clin North Am. 2004; 51(6):1589-1610, viii.
  18. 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; 101(8):893-898.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. AGA Medical Corporation. Respect PFO Clinical Trial. NCT00465270. Last updated July 20, 2016. Available at: http://www.clinicaltrials.gov/ct2/show/study/NCT00465270?term=respect+and+pfo&rank=1. Accessed on June 28, 2017.
  2. Boston Scientific Corporation. Continued access to PREVAIL (CAP2). NLM Identifier: NCT01760291. Last updated on June 13, 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT01760291?term=PREVAIL+WATCHMAN&rank=2 . Accessed on June 28, 2017.
  3. Boston Scientific Corporation. Evaluation of the WATCHMAN LAA Closure Device in patients with atrial fibrillation versus long term warfarin therapy (PREVAIL). NLM Identifier: NCT01182441. Last updated on January 26, 2015. Available at: https://clinicaltrials.gov/ct2/show/NCT01182441?term=PREVAIL+WATCHMAN&rank=1 . Accessed on June 28, 2017.
  4. Boston Scientific Corporation. WATCHMAN Left Atrial Appendage System for embolic PROTECTion in patients with atrial fibrillation. NLM Identifier: NCT00129545. Last updated on April 29, 2015. Available at: https://clinicaltrials.gov/ct2/show/NCT00129545?term=PROTECT+AF&rank=1 . Accessed on June 28, 2017.
  5. Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute. Safety and Efficacy of Left Atrial Appendage Occlusion Devices. NCT01695564. Last updated January 04, 2017. Available at: http://clinicaltrials.gov/ct2/show/NCT01695564?term=LARIAT&rank=1. Accessed on June 28, 2017.
  6. Fuster V, Rydén LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Association and the Heart Rhythm Society. Circulation. 2006; 114(7):e257-e354. Available at: http://circ.ahajournals.org/content/114/7/e257.long. Accessed on June 28, 2017.
  7. January CT, Wann S, Alpert JS, et al. 2014 AHA/ACC/HRS practice guideline. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation. A report of the American College of Cardiology/American Heart Association Task force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2014; 130:e199-e267.
  8. Lip GY, Andreotti F, Fauchier L, et al. Bleeding risk assessment and management in atrial fibrillation patients: a position document from the European Heart Rhythm Association, endorsed by the European Society of Cardiology Working Group on Thrombosis. Europace. 2011; 13(5):723-746.
  9. Masoudi FA, Caukins H, Kavinsky CJ, et al. 2015 ACC/HRS/SCAI left atrial appendage occlusion device societal overview: a professional societal overview from the American College of Cardiology, Heart Rhythm Society, and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2015; 86(5):791-807.
  10. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics- 2015 update: a report from the American Heart Association. Circulation. 2015; 131:e29-e322.
  11. St. Jude Medical. AMPLATZER Cardiac Plug (ACP) registry-long term follow-up protocol (ACPR). NLM Identifier: NCT01786486. Last updated on September 19, 2016. Available at: https://clinicaltrials.gov/ct2/show/NCT01786486?term=AMPLATZER+AND+left+atrial+appendage&rank=1 . Accessed on June 28, 2017.
  12. St. Jude Medial. RESPECT PFO clinical trial. NLM Identifier: NCT00465270. Last updated on July 20, 2016. Available at: https://www.clinicaltrials.gov/ct2/show/NCT00465270?term=NCT00465270&rank=1 . Accessed on June 28, 2017.
  13. U.S. Food and Drug Administration (FDA). Premarket Approval (PMA). AMPLATZER PFO Occluder. No. P120021. Rockville, MD: FDA. October 28, 2016. Accessible at: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm526921.htm. Accessed on June 28, 2017.
  14. U.S. Food and Drug Administration (FDA). Premarket Approval (PMA). Watchman™ Left Atrial Appendage Closure Device. No. P130013. Rockville, MD: FDA. March 13, 2015. Available at: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm440621.htm . Accessed on June 28, 2017.
Websites for Additional Information
  1. American Heart Association. Patent foramen ovale (PFO). Revised March 29, 2017. Available at: http://www.heart.org/HEARTORG/Conditions/More/CardiovascularConditionsofChildhood/Patent-Foramen-Ovale-PFO_UCM_469590_Article.jsp. Accessed on June 28, 2017.
  2. American Heart Association website. Available at: http://www.heart.org. Accessed on June 28, 2017.
  3. Centers for Disease Control and Prevention. Atrial fibrillation fact sheet. Last updated August 13, 2015. Available at: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm . Accessed on July 3, 2017.
Index

AMPLATZER Cardiac Plug
AMPLATZER PFO Occluder
Atrial Fibrillation
CardioSeal Device
GORE HELEX Septal Occluder
LAA
LARIAT Suture Delivery Device
Left Atrial Appendage
Patent Foramen Ovale
PFO
Starflex
WATCHMAN LAA Closure Device

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History
Status Date Action
Reviewed 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale, References and Websites sections.
Revised 02/02/2017 MPTAC review. Clarified MN criteria for transcatheter closure of a PFO. Updated Rationale, Background, Index, References and Websites sections.
  01/01/2017 Updated Coding section with 01/01/2017 CPT changes; removed 0281T deleted 12/31/2016.
Reviewed 02/04/2016 MPTAC review. Updated References and Websites sections.
Reviewed 11/05/2015 MPTAC review. Updated Background, Index and Reference sections. Removed ICD-9 codes from Coding section.
Reviewed 08/06/2015 MPTAC review. Description, Rationale, Background, Index, References and Websites sections updated.
Reviewed 02/05/2015 MPTAC review. Updated Rationale, Reference, Websites and Index sections.
Reviewed 02/13/2014 MPTAC review. Updated Websites.
Reviewed 02/14/2013 MPTAC review. Description, Rationale, Background, Index, References and Websites Updated.
Reviewed 02/16/2012 MPTAC review. Updated References and Websites.
  01/01/2012 Updated Coding section with 01/01/2012 CPT changes.
Revised 02/17/2011 MPTAC review. Title change. Position statements for PFO clarified, Added investigational and not medically necessary statement for LAA. Removed position statements for patent ductus arteriosus, fenestrated Fontan procedure, atrial and ventricular defects. Transferred content addressing Transmyocardial/Perventricular transcatheter device closure of ventricular septal defects to a new medical policy, SURG.00123. Updated Description, Rationale, Definitions, Coding, Index, References and Websites.
Revised 08/19/2010 MPTAC review. Clarified medically necessary statement addressing transcatheter closure of ventricular septal defect (VSD) and secundum atrial septal defect (ASD). Updated Websites and References.
Revised 05/13/2010 MPTAC review. Changed title to "Transcatheter Closure of Cardiac Defects". Removed "complex" from ventricular septal defect (VSD) medically necessary criteria. Transcatheter closure investigational and not medically necessary position statement clarified. Definition, Websites and References updated.
Reviewed 02/25/2010 MPTAC review. Rationale, Background, Coding and References updated.
Reviewed 02/26/2009 MPTAC review. References updated.
Reviewed 02/21/2008 MPTAC review. Updated references. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Revised 03/08/2007 MPTAC review. A position statement was added to state that transmyocardial/perventricular device closure of VSDs is considered investigational/not medically necessary. Rationale section was also updated to include the FDA withdrawal of HDE marketing approval for the CardioSEAL STARFlex and AMPLATZER PFO occluders. Coding was also updated to add the new CPT Category III codes (0166T, 0167T) effective 01/01/2007.
Reviewed 06/08/2006 MPTAC review. References were updated, including information regarding current FDA-approved devices.
Revised 7/14/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

01/28/2004

SURG.00032 Transcatheter Closure of Patent Ductus Arteriosus, Foramen Ovale, Closure of a Fenestrated Fontan Procedure, and Atrial and Ventricular Septal Defects
WellPoint Health Networks, Inc.

09/23/2004

3.04.04 Catheter Closure for Atrial Septal Defect and Patent Foramen Ovale
 

06/24/2004

3.04.25 Transcatheter Closure for Patent Ductus Arteriosus