Aetna Catheter-Directed Cardiac Procedures Coverage

inv-01: Medically Necessary Indications

Aetna considers transcatheter closure using FDA‑approved devices medically necessary when the following indication‑specific criteria are met:

ASD indications: Transcatheter closure of atrial septal defects (ASDs) using FDA‑approved closure devices is medically necessary for either: (1) closure of a fenestration in individuals who have undergone a fenestrated Fontan procedure; OR (2) occlusion of ASDs in secundum position.

VSD indications: Transcatheter closure of ventricular septal defects (VSDs) using FDA‑approved closure devices is medically necessary for complex VSDs in pediatric or adult members who are considered to be at high‑risk for standard transatrial or transarterial surgical closure.

High‑risk surgical candidacy determined by anatomy/medical comorbidity (see background).

PFO indications: Transcatheter occlusion of patent foramen ovale (PFO) by an FDA‑approved device is medically necessary for adults 18 to 60 years of age who have had a cryptogenic ischemic stroke.age 18-60 years; cryptogenic ischemic stroke

PDA indications: Transcatheter occlusion of patent ductus arteriosus (PDA) is medically necessary when performed with the Amplatzer duct occluder or other closure devices approved by the FDA for this indication.

inv-02: Experimental and Investigational

The following procedures and device uses are considered experimental and investigational (not medically necessary) because effectiveness has not been established:

Experimental/Investigational procedures and devices: Closure devices not approved by the FDA for transcatheter occlusion of PDA; left atrial to coronary sinus shunting (APTURE Transcatheter Shunt System) for heart failure; Neovasc Reducer (coronary sinus reducer) for relief of angina symptoms; Nit‑Occlud Lê VSD coil for peri‑membranous VSD closure; percutaneous transcatheter implantation of inter‑atrial septal shunt device for heart failure; transcatheter closure of ASDs or PFOs for migraine prophylaxis or for other indications not listed as medically necessary; transcatheter occlusion of PFO for transient ischemic attack (TIA) or arterial emboli due to presumed paradoxical embolism through a PFO; transcatheter removal/debulking of intra‑cardiac mass (e.g., AngioVac) for left‑sided or arterial masses; transmyocardial transcatheter/perventricular closure of VSDs with implants.

List not necessarily exhaustive.

inv-03: Coverage-relevant patient selection and comparative context

Coverage‑relevant patient selection expectations and comparative context inferred from FDA approval and pivotal trials:

FDA‑indicated patient selection: Patient predominantly age 18–60 years with a cryptogenic ischemic stroke attributed to presumed paradoxical embolism AND evaluated by a neurologist and a cardiologist to exclude other known causes of ischemic stroke (per Amplatzer PFO Occluder PMA).

Source: FDA PMA and RESPECT trial documentation.

Comparative management context: Medical therapy (antiplatelet or anticoagulation) is the primary comparator used in randomized trials; device closure was compared with medical management and results vary by analysis (intention‑to‑treat vs extended follow‑up).

Trials and systematic reviews provide the comparative context.

inv-04: PFO closure — evidence-based selection

Covered when ALL of the following evidence‑derived considerations are met (selection aligned with published randomized trials and guidance):

Patient selection for PFO closure: Patient age within trial ranges (typically 16–60 or 18–60 years) AND recent cryptogenic ischemic stroke attributed to PFO with an embolic‑appearing infarct AND no identified alternative high‑risk mechanism of stroke (comprehensive neurologic and cardiologic evaluation documented).age per trials; absence of alternative mechanism

Trials showing benefit predominantly enrolled patients with large inter‑atrial shunt or atrial septal aneurysm; document PFO anatomy and shunt size.

inv-05: VSD closure — selection and comparative considerations

Covered when ALL of the following are met (VSD device closure — evidence‑derived considerations and comparative context):

VSD device closure selection: Defect anatomy suitable for a transcatheter or perventricular device approach (e.g., muscular VSDs or select peri‑membranous defects deemed amenable) AND consideration of patient age/size and hemodynamic significance (e.g., Qp/Qs > 1.5 or evidence of clinical/echocardiographic volume overload when applicable) AND counseling regarding risks including residual shunt, arrhythmia, valvular dysfunction, and complete atrio‑ventricular block.

Transcatheter closure is generally reserved for patients at high surgical risk or defects not amenable to standard surgical repair; center expertise and surgical backup recommended.

Comparative approach: Choice among conventional surgical repair, transcatheter device closure, and perventricular device closure should be individualized based on comparative effectiveness and complication profiles; perventricular closure may reduce some complications versus surgical repair in selected patients.

inv-06: Neovasc Coronary Sinus Reducer — implied coverage criteria

Evidence summary and implied coverage considerations for the Neovasc Coronary Sinus Reducer (CS Reducer):

Eligibility for CS Reducer: Patient with refractory angina (persistent >= 3 months) despite optimal medical and interventional therapies AND objective evidence of myocardial ischemia AND judged unsuitable for further coronary revascularization.

Supportive evidence consists mainly of observational studies and one randomized trial; HTA graded evidence as moderate with limitations in internal/external validity; prior authorization and rigorous documentation are reasonable.

inv-07: AngioVac transcatheter thrombectomy/debulking — implied coverage considerations

Implied coverage considerations for transcatheter thrombectomy/debulking with the AngioVac System based on available literature:

Indications reported in literature: Percutaneous removal of right‑sided vegetations, right atrial/caval thrombi, and select pulmonary emboli in patients at high surgical risk or as a bridge to surgery; evidence largely from case series, single‑center studies, and meta‑analyses.

Outcomes and success rates vary by indication; data for left‑sided or arterial use are limited and often off‑label.

inv-08: AngioVac — evidence summary

Evidence‑focused summary statements regarding AngioVac from systematic reviews, observational cohorts, and meta‑analyses:

AngioVac evidence: Available data are predominantly case reports, retrospective series, and meta‑analyses indicating high procedural success (e.g., pooled procedural success ~89.2 %) and clinical success (~79.1 %) for right‑sided infective endocarditis and removal of right‑sided masses, but prospective randomized comparisons to surgery or medical management are lacking; safety and efficacy for left‑sided or arterial applications are limited and off‑label.

Authors call for larger, prospective randomized trials to define indications, comparative effectiveness, and safety.

inv-09: APTURE Transcatheter Shunt — evidence summary

Early feasibility evidence for the APTURE left atrial to coronary sinus shunt (APTURE Transcatheter Shunt System):

APTURE evidence: Single‑arm early feasibility study (n=87) demonstrated device success in ~90% of attempted implants, low 30‑day safety events (2.3%), and improvements in NYHA class and KCCQ at 6 months; however, lack of a sham control, small sample size, and short follow‑up limit interpretation of effectiveness and durability.

Investigators recommend a definitive randomized, sham‑controlled trial to establish clinical benefit.

Transcatheter closure procedures for atrial and ventricular septal defects and related catheter-directed cardiac interventions are covered only when performed for indications supported by evidence or by FDA approval. The policy excludes a range of uses that lack supportive data or are specifically listed as experimental, including transcatheter closure of ASDs and PFOs for migraine prophylaxis, closure for unlisted ASD subtypes (for example, coronary sinus ASD, ostium primum ASD, and sinus venosus ASD), and other indications not described in the medically necessary criteria. The CPT/HCPCS and ICD-10 codes in the policy are linked to these coverage determinations and should be applied only when the specific selection criteria are met.

Randomized, sham-controlled trials have not demonstrated consistent benefit of PFO closure for migraine prophylaxis. Large randomized trials (for example, the STARFlex sham-controlled study and the MIST trial series) failed to meet primary endpoints for migraine resolution, and reviewers and guideline authors have concluded that evidence of benefit for migraine is unconvincing. Therefore, PFO closure for the indication of migraine prophylaxis is not supported by randomized trial evidence and is not recommended as routine clinical practice.

Before considering PFO closure, clinicians should perform a thorough evaluation to exclude alternative mechanisms of stroke. When a higher-risk alternative mechanism of stroke is identified, PFO closure should not be routinely recommended. Documentation that other causes have been excluded is expected when closure is considered.

Transcatheter closure of ventricular septal defects is generally not the first-line approach. For most patients requiring VSD closure, primary patch surgical repair is preferred because of its excellent outcomes; transcatheter or perventricular device approaches are reserved for defects not amenable to surgery and should be performed only in experienced centers with surgical backup.

Evidence for the Neovasc Coronary Sinus Reducer (CS Reducer) is limited to small observational studies, systematic reviews, and a single randomized trial identified in health-technology assessments. Uncertainties include the mechanism of action, limited long-term safety data, and inconsistent objective ischemia assessments. These evidence limitations justify caution; routine use outside the specific refractory-angina context studied and outside prospective trials should be avoided.

The AngioVac vacuum-assisted aspiration system has been reported primarily in case series, single-center cohorts, and meta-analyses for right-sided intravascular and cardiac masses and vegetations. Use of AngioVac for left heart or arterial masses is not FDA-approved and is considered off-label; device dimensions and access constraints limit its applicability for left-sided or arterial aspiration. Reported data are limited and do not support routine approval for left-heart or arterial uses.

Clinical Policy Bulletins provide a general description of plan or program benefits and are intended to assist in administering coverage determinations. They are not contracts and do not replace individualized plan documents or provider‑member contracts. Coverage for a specific member depends on the terms of the member’s benefit plan, medical necessity review, and applicable medical policy criteria.

Excluded and investigational indications are reiterated here for clarity: transcatheter closure of ASD/PFO for migraine prophylaxis, PFO closure for stroke prevention outside the age and selection criteria described in the policy, transcatheter occlusion of PFO for transient ischemic attacks or presumed paradoxical arterial emboli outside specified criteria, left atrial to coronary sinus shunts, Neovasc Reducer implantation outside refractory-angina criteria, the Nit‑Occlud Lê VSD coil for unapproved indications, AngioVac use for left heart or arterial masses, and other procedures or devices noted as experimental in the policy.

Multiple systematic reviews, randomized trials, and editorials have cautioned against performing PFO closure for migraine outside of randomized clinical trials. The STARFlex sham-controlled study and other randomized investigations did not meet primary migraine endpoints, and contemporary reviews recommend against routine PFO closure for migraine until higher-quality evidence demonstrates benefit.

Routine PFO closure is not recommended for indications that lack high‑quality supporting evidence. Randomized trial meta-analyses and systematic reviews show that benefits are limited to selected patients with cryptogenic stroke meeting specific trial-based criteria; for other indications (for example, migraine with aura or unselected cryptogenic stroke without defining high‑risk PFO features) routine closure is not supported.

Given the limited size of the clinical evidence base for the CS Reducer, the device’s routine adoption is not supported outside the population studied. Use may be considered only for patients with refractory angina (persistent symptoms ≥3 months despite optimal medical and interventional therapy) with documented objective ischemia and who are not candidates for further revascularization; otherwise, routine CS Reducer implantation may be considered not medically necessary.

This document segment does not contain explicit standalone 'not medically necessary' statements for every device, but the overall evidence summaries indicate insufficient data to define precise inclusion or exclusion criteria for several interventions. Where randomized controlled data are lacking, small sample sizes, single‑center designs, or off‑label use raise questions about appropriateness and coverage decisions may require case‑by‑case review and prior authorization.

Provider Requirements, Prior Authorization, and Documentation

Billing Rule

Code-level coverage tied to selection criteria

Code-level coverage is conditional on meeting the policy selection criteria; CPT and HCPCS codes listed as covered (e.g., 93580, 93581, 93582, C1817) are payable only when the member meets the clinical inclusion criteria and documented indications in this policy. Codes listed as not covered (e.g., 0613T, C9783, Nit-Occlud Lê VSD coil, Neovasc Reducer, AngioVac System for excluded indications) remain noncovered when used for investigational or excluded indications.

Covered CPT/HCPCS codes payable only if selection criteria and documentation met (see policy covered indications).
Do NOT submit covered procedure codes when indications are for excluded/experimental uses (e.g., PFO for migraine prophylaxis).

Prior Authorization

Prior authorization should cite device, indication, and evidence

Prior authorization is expected for device-based procedures in many jurisdictions and should explicitly cite: the device name, the indication (including supporting clinical details), and the evidence or trial/device-specific rationale for use (e.g., Amplatzer PFO Occluder with RESPECT trial data). When requesting authorization, include documentation that demonstrates how the member meets the policy's selection criteria.

Include device brand/model (e.g., AMPLATZER PFO Occluder) in request.
State the precise indication (e.g., cryptogenic stroke with age and imaging criteria) and reference relevant trial evidence if applicable.

Prior Authorization

Prior authorization recommended for CS Reducer (Neovasc Reducer)

Prior authorization is recommended for the Neovasc Coronary Sinus Reducer (CS Reducer) because available evidence is limited and its use is generally considered investigational or of uncertain net clinical benefit. Requests should document that the patient has refractory angina despite optimal medical therapy and is not a candidate for further revascularization.

Document: duration of refractory angina (≥ 3 months), objective evidence of ischemia, and that revascularization is not feasible.
Attach prior failed/insufficient trials of guideline-directed medical therapy and procedural notes showing non-amenability to revascularization.

Prior Authorization

Prior authorization not specified in these chunks — verify payer rules

Some policy segments do not specify a formal prior authorization requirement; in those cases, clinical documentation standards and code-level coverage rules still apply and payers may require prior authorization through separate administrative processes. Confirm payer-specific PA rules where absent from this document segment.

If prior authorization is not specified in policy text, verify benefit plan rules or prior authorization portals before scheduling.
Lack of PA language in this section does not imply automatic coverage—use documented selection criteria to determine medical necessity.

Denial Risk

Use of non–FDA-approved devices — investigational/not covered

Procedures using devices that are not FDA-approved for the intended indication are considered experimental/investigational and are not covered under this policy. Requests involving off-label or non–FDA-approved devices should include justification and supporting evidence but are generally expected to be denied.

Do not bill covered-device codes for procedures performed with non–FDA-approved devices for excluded indications (e.g., PFO closure for migraine).
If proposing use of a non‑approved device, provide high-quality evidence and an explanation why no approved alternative is suitable (review will typically classify as investigational).

Documentation Required

Specialist evaluation required prior to PFO occluder use

For PFO closure with FDA-approved devices (e.g., Amplatzer PFO Occluder), documentation must include specialist evaluations by both a neurologist and a cardiologist to exclude other causes of ischemic stroke, consistent with FDA labeling and trial protocols.

Submit neurology and cardiology consult notes stating thorough etiologic evaluation and rationale that PFO is the most likely cause of stroke.
Include neurovascular imaging reports and documentation excluding high-risk alternative stroke mechanisms.

Note

Evidence limitations may affect coverage

Evidence limitations (small studies, single-center cohorts, heterogeneous outcomes, or moderate-to-low GRADE assessments) may affect coverage determinations. Where evidence is limited or safety data are incomplete, payers may restrict coverage, require prior authorization with additional documentation, or deem the procedure investigational.

For devices with limited/low-quality evidence (e.g., CS Reducer, AngioVac left-sided use), include RCT data if available or otherwise robust observational evidence.
Be prepared for request denials or requests for more information when device safety/efficacy data are inconclusive.

Note

Not provided in this document segment — confirm administrative procedures separately

This document segment does not provide exhaustive administrative instructions (e.g., specific payer prior authorization forms or submission portals). Providers must follow their contracted payer's operational procedures in addition to meeting the clinical documentation described here.

Confirm payer-specific submission workflows, required forms, and timelines externally to this policy.
Maintain copies of all submitted supporting clinical documentation for appeals if needed.

Documentation Required

Required procedural and pre-procedure documentation

Pre-procedural and procedural documentation is required to support medical necessity and appropriate device selection. Key items include echocardiographic ASD/PFO morphology, balloon sizing/stretched diameter assessments, and intra-procedural imaging (TEE/ICE) reports.

Include TEE/ICE reports describing septal anatomy, rim adequacy, defect size, and shunt quantification.
Provide balloon-stretched diameter measurements and rationale for chosen device size/model.

Documentation Required

Required pre-procedure evaluation and follow-up (per trial/approval)

Follow-up and pre-procedure evaluations should mirror trial and device-approval protocols: document baseline and scheduled follow-up visits (discharge, 1 month, 6 months, 12 months, 18 months, yearly) and post-procedure imaging per device trials (e.g., RESPECT schedule for Amplatzer).

Attach follow-up visit schedule and TEE bubble study results (e.g., 6-month closure assessment) when applicable.
Document anti-platelet/anticoagulation plans and duration as per device labeling or trial protocols.

Documentation Required

Pre-procedure evaluation documentation — rule out alternative mechanisms

Pre-procedure evaluation documentation must demonstrate exclusion of other stroke mechanisms, characterization of PFO anatomy, and reasoning that closure is indicated. This includes neurovascular imaging, cardiac rhythm monitoring results, and specialist opinions.

Submit CT/MR neuroimaging that supports embolic-appearing infarct.
Provide Holter/telemetry data ruling out atrial fibrillation as an alternative cause if available.

Documentation Required

PFO closure patient selection documentation

Patient selection documentation for PFO closure should reflect the trial and guideline-based elements: patient age, cryptogenic stroke with embolic-appearing infarct, absence of alternative mechanism after specialist work-up, and echocardiographic features (e.g., large shunt, atrial septal aneurysm) when applicable.

Include patient age (typically 16–60 years where recommended), timing of index stroke (often ≤ 6 months), and description of embolic-appearing infarct.
Document that medical therapy options were considered and discuss risks/benefits with the patient; if medical therapy chosen, document regimen.

Documentation Required

Pre-procedural planning notes

Pre-procedural planning notes should address technical considerations described in the literature, such as optimal transeptal puncture height, cerebral protection strategies, and extracorporeal support planning when left-sided or high-risk procedures are contemplated.

Document plans for cerebral protection (e.g., Sentinel) when extracting left‑sided masses or performing high embolic-risk maneuvers.
Note contingency plans (surgical backup, extracorporeal support) and operator/center experience level.

Note

Medical therapy as comparator/precedent for PFO closure

Medical therapy is an established comparator and, in some cases, a reasonable alternative to device-based interventions. Randomized trials compared PFO closure with medical therapy; documentation should show whether medical therapy was offered and the regimen used when closure is being considered.

When PFO closure is requested, include history of medical therapy offered (antiplatelet or anticoagulation), duration, and patient preference.
If medical therapy is pursued instead of closure, document the chosen regimen and rationale.

Step Therapy

Medical therapy as an alternative prior step

Medical therapy can be an alternative prior step to device closure; trials have compared closure to antiplatelet or anticoagulation strategies. Providers should document that medical management was considered and, if applicable, attempted.

Document prior anti-platelet or anticoagulant use and reasons for failure or contraindication if closure is being requested subsequently.
If anticoagulation is chosen due to contraindication to closure, include bleeding-risk assessment.

Documentation Required

Surgical-first / specialty limitation for VSDs

For certain defects (e.g., most VSDs), a surgical-first approach remains preferred; transcatheter closure is reserved for select cases (high surgical risk or lesions not amenable to surgical repair) and should be performed at experienced centers with surgical backup.

Document why surgical repair is unsuitable or high-risk when proposing transcatheter VSD closure.
Confirm center experience and availability of cardiothoracic surgical backup in procedural planning notes.

Step Therapy

Step therapy: confirm failure of standard therapies before device use

When step therapy applies (noted for some device types), prior authorization should confirm failure of standard therapies before device implantation (e.g., refractory angina despite optimal medical therapy and non-amenability to revascularization before CS Reducer).

Provide documentation of optimal medical therapy trials and objective ischemia evidence prior to CS Reducer authorization.
Document heart-team decision that patient is not a candidate for further revascularization.

Step Therapy

No step therapy sequencing requirements provided in this segment

This policy segment does not establish a comprehensive step-therapy sequencing requirement across all devices; where step therapy is not specified, follow device-specific guidance and payer benefit rules.

Absence of stated step-therapy sequencing in this section does not preclude the payer from applying plan-level step edits.
If in doubt, obtain prior authorization and clarify required pre-steps with the payer.

Note

No step therapy requirements are described

No additional step therapy requirements are described in these chunks for other device categories; providers should rely on the explicit selection criteria and consult payer administratively for any plan-level utilization management controls.

Follow documented selection criteria in policy for clinical necessity.
Confirm with payer for any additional utilization management rules not documented here.

Definitions and Device Descriptions

Amplatzer septal occluder — definition and indication

Device descriptionA self-centering nitinol disk device composed of two round Nitinol wire mesh disks linked by a connecting waist

FDA-approved indicationsIndicated for closure of ostium secundum ASD with echocardiographic evidence of RV volume overload and for closure of fenestrated Fontan fenestrations

Approval yearReceived FDA approval in 2001

CardioSEAL Septal Occlusion System — definition

Device identityCardioSEAL Septal Occlusion System (second-generation Clamshell occluder)

FDA indicationApproved under HDE for closure of complex ventricular septal defects (VSDs) in patients considered high-risk for standard surgical closure

High-risk anatomical examplesIndications include left ventriculotomy required, multiple apical/ anterior muscular VSDs, posterior apical VSDs covered by trabeculae, or prior failed VSD closure

AMPLATZER PFO Occluder — indication and approval summary

Indication summaryAMPLATZER PFO Occluder approved for percutaneous transcatheter closure of PFO to reduce recurrent ischemic stroke in patients predominantly aged 18–60 after neurologist and cardiologist evaluation to exclude other causes

Supporting trialApproval supported by the RESPECT randomized multicenter trial included in the PMA submission

Regulatory findingFDA concluded reasonable assurance of safety and effectiveness when used per indicated labeling (PMA Oct 2016)

Cryptogenic stroke — definition and relevance to PFO closure

DefinitionCryptogenic stroke: an ischemic stroke for which no clear alternative mechanism (e.g., atrial fibrillation, carotid stenosis) is identified

Relevance to PFO closurePFO closure is considered in patients with cryptogenic ischemic stroke when PFO is judged the most likely cause after neurologic and cardiologic evaluation

Age/contextTrials and guidance typically address patients aged up to 60 years with embolic-appearing infarct and no alternative mechanism

Peri-membranous VSD (pmVSD) — definition

DefinitionPeri‑membranous VSD (pmVSD): a ventricular septal defect located in the peri‑membranous region of the interventricular septum

Clinical concernpmVSD device closure is associated with concerns about adverse events, especially conduction disturbances such as complete AV block

Evidence summaryMeta-analysis of pmVSD device closure included 6,762 patients with a pooled device implantation success of 97.8%

cAVB — definition and relevance

DefinitionComplete atrio‑ventricular block (cAVB): a complete block of conduction between atria and ventricles; a serious conduction complication

Relevance to device closurecAVB was reported as a complication after pmVSD device closure with pooled incidence ~1.1% in meta-analysis

Clinical implicationRisk of cAVB informs device selection and need for specialized center experience and counseling about conduction risk

IASD — inter-atrial septal device definition

DefinitionInter‑atrial septal device (IASD): a transcatheter implant intended to create a permanent atrial shunt to lower left atrial pressure for symptomatic heart failure

Intended useEvaluated for symptomatic heart failure with preserved or mildly reduced ejection fraction to reduce left atrial pressure

Procedure detailsImplantation performed percutaneously as an inter-atrial shunt device (investigational in several contexts)

CS Reducer — Neovasc Coronary Sinus Reducer definition

Device identityNeovasc Coronary Sinus Reducer (CS Reducer): a transvenous implant placed in the coronary sinus to modify myocardial blood flow distribution

Procedure descriptionImplanted via a minimally invasive transvenous procedure similar to coronary stent insertion, usually completed in ~20 minutes

Intended indicationDesigned for relief of refractory angina by increasing perfusion to ischemic myocardium when revascularization is not feasible

Coronary Sinus Reducer (CS Reducer) — summary

Device descriptionCoronary Sinus Reducer: a transcatheter coronary sinus reduction device implanted via a minimally invasive transvenous approach to alter coronary venous flow

Clinical goalIntended to increase perfusion of ischemic myocardium and relieve angina symptoms in refractory angina patients

Patient selectionTargeted to patients with refractory angina (≥3 months despite optimal therapy) who are not candidates for further revascularization

AngioVac System — definition and intended use

Device identityAngioVac System: a vacuum‑assisted percutaneous device for filtering and aspirating intravascular thrombi and right‑sided cardiac vegetations using veno‑venous bypass

Intended useUsed for percutaneous removal of right‑sided vegetations, right atrial/caval thrombi, and select pulmonary emboli in patients at high surgical risk or as bridge to surgery

Evidence characteristicsPublished literature comprises case series, systematic reviews and meta-analyses with variable success and mortality rates; randomized comparative data are lacking

Refractory angina — definition (>=3 months despite therapy)

DefinitionRefractory angina: persistent angina for ≥3 months despite optimal medical and interventional therapies and not amenable to further revascularization

Clinical significanceDefines eligibility for interventions such as the CS Reducer when conventional options are exhausted

Source referenceDefinition cited in systematic reviews and reviews of Neovasc Reducer literature

Procedural success (AngioVac meta-analysis) — definition

Procedural success (definition)Ability of AngioVac to produce residual vegetation size (RVS) < 50% without serious procedural complications

Context of useUsed as primary outcome in meta-analyses of AngioVac-assisted vegetation debulking

Metric implicationProcedural success quantifies immediate device efficacy separate from in‑hospital or long‑term clinical outcomes

Clinical success (AngioVac meta-analysis) — definition

Clinical success (definition)Composite defined as RVS < 50%, in‑hospital survival, absence of recurrent bacteremia, and valve function not requiring further intervention

PurposeUsed as a composite endpoint in reviews/meta-analyses to capture broader clinical benefit beyond technical removal

Reported ratesMeta-analysis reported clinical success in 79.1% of patients (95% CI: 67.9% to 87.2%)

FDA device summaries — cited PMA/HDE documents

FDA summaries referencedMultiple FDA device summaries and PMA/HDE documents cited, including Amplatzer PFO Occluder PMA (P120021, Oct 28, 2016) and Amplatzer Septal Occluder SSED (Sept 9, 2002)

CardioSEAL HDECardioSEAL Septal Occlusion System HDE No. H990011 and subsequent FDA documents are cited in references

Reference list detailThe policy references FDA CDRH summaries and PMA/HDE documents supporting device indications and approvals

C9783	Blinded procedure for transcatheter implantation of coronary sinus reduction device or placebo control (investigational)
C9792	Blinded or nonblinded procedure for transcatheter implantation of left atrial to coronary sinus shunt (investigational)

C1760	Closure device, vascular (implantable/insertable)
C2628	Catheter, occlusion

I23.1	Atrial or ventricular septal defect as current complication following acute myocardial infarction
I51.0	Cardiac septal defect acquired
I63.9	Cerebral infarction, unspecified [cryptogenic stroke]
Q21.0	Ventricular septal defect
Q21.10	Atrial septal defect
Q25.0	Patent ductus arteriosus

G43.00	Migraine
G45.0	Transient cerebral ischemic attacks and related syndromes
I50.1	Left ventricular failure

OpenPayer

Catheter-Directed Cardiac Procedures

Coverage Criteria and Policy Determinations

Coding and Billing (CPT / HCPCS / ICD-10)

Provider Requirements, Prior Authorization, and Documentation

Background and Clinical Context

Definitions and Device Descriptions

Revision History and Document Dates

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