Medical Policy

 

Subject: Transcatheter Heart Valve Procedures
Document #: SURG.00121 Publish Date:    12/27/2017
Status: Revised Last Review Date:    08/03/2017

Description/Scope

This document addresses the transcatheter (percutaneous or catheter-based) approach for aortic or pulmonary heart valve replacement (for example, Edwards SAPIEN® , SAPIEN XT™, or SAPIEN 3 Transcatheter Heart Valve [THV] [Edwards Lifesciences, Inc., Irvine, CA]; CoreValve™ System, CoreValve™ Evolut™ R System and CoreValve™ Evolut™ PRO System [Medtronic, Inc., Santa Ana, CA]; Medtronic Melody® transcatheter pulmonary valve [TPV] [Medtronic, Inc., Minneapolis, MN]); and transcatheter mitral valve repair using leaflet repair (for example, MitraClip® Clip Delivery System [Abbott Laboratories, Abbott Park, Illinois]) or percutaneous annuloplasty (for example, CARILLON® Mitral Contour System [Cardiac Dimentions, Inc., Kirkland, WA]).

Position Statement

Medically Necessary:

Transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN, SAPIEN XT, or SAPIEN 3 Transcatheter Heart Valve is considered medically necessary when all the following criteria have been met:

  1. The individual has a calcified aortic valve; and
  2. The individual has severe native valve aortic stenosis as demonstrated by at least one of the following:
    1. mean aortic valve gradient greater than 40 mm Hg; or
    2. jet velocity greater than 4.0 m/sec; or
    3. the aortic valve area (AVA) is less than 0.8 cm2 ; or
    4. the AVA index is less than 0.5 cm2 /m2 ; and
  3. The individual has documented New York Heart Association (NYHA) functional class II or greater; and
  4. The individual is at intermediate or greater risk for open surgical therapy (that is, predicted risk of surgical mortality greater than or equal to 3% at 30 days) as determined by at least two physicians; and
  5. None of the following comorbid conditions or contraindications that would preclude the expected benefit from aortic stenosis correction are present:
    1. abdominal aortic or thoracic aneurysm (defined as maximal luminal diameter 5 cm or greater); or
    2. intolerance to anticoagulation/antiplatelet regimen or bleeding dyscrasias (for example, leucopenia, acute anemia, thrombocytopenia); or
    3. hypertrophic cardiomyopathy with or without obstruction; or
    4. congenital heart valve anomalies including but not limited to congenital unicuspid or bicuspid valve; or
    5. active bacterial endocarditis, echocardiographic evidence of intracardiac mass, thrombus or vegetations, or other active infections; or
    6. severe ventricular dysfunction with left ventricular ejection fraction less than or equal to 20 percent; or
    7. life expectancy less than 12 months due to non-cardiac co-morbid conditions; or
    8. acute myocardial infarction within 1 month of planned TAVR procedure; or
    9. cerebral vascular accident (CVA) or transient ischemic attack (TIA) within last 6 months; or
    10. end stage renal disease requiring chronic dialysis; or
    11. severe (greater than 3+) mitral regurgitation; or
    12. severe (greater than 3+) aortic regurgitation; or
    13. pre-existing mechanical prosthetic or transcatheter bioprosthetic heart valve in the aortic position; or
    14. iliofemoral vessel would preclude safe placement of 22F or 24F introduction sheath such as severe obstruction calcification, severe tortuosity or vessels size less than 7 mm in diameter (applicable for transfemoral introduction); or
    15. individual was offered surgery but refused.

Transcatheter aortic valve replacement with the CoreValve System, CoreValve Evolut R System and CoreValve Evolut PRO System is considered medically necessary when all the following criteria have been met:

  1. The individual has severe degenerative, native valve aortic stenosis demonstrated by one of the following:
    1. the AVA is equal to or less than 0.8 cm2 ; or
    2. the AVA index is equal to or less than 0.5 cm2 /m2 ; and
  2. The individual has severe degenerative, native valve aortic stenosis demonstrated by one of the following:
    1. either a mean aortic valve gradient of more than 40 mm Hg; or
    2. a peak aortic-jet velocity of more than 4.0 m/sec; and
  3. The individual has a native aortic annulus diameter between 18 and 29 mm; and
  4. Heart failure symptoms of New York Heart Association (NYHA) class II or greater; and
  5. The individual is at intermediate or greater risk for open surgical therapy (that is, predicted risk of surgical mortality greater than or equal to 3% at 30 days) as determined by at least three physicians ; and
  6. None of the following comorbid conditions or contraindications that would preclude the expected benefit from aortic stenosis correction are present:
    1. intolerance to anticoagulation/antiplatelet regimen or bleeding dyscrasias (for example, leucopenia, acute anemia, thrombocytopenia; gastrointestinal bleeding within past 3 months); or
    2. hypertrophic obstructive cardiomyopathy; or
    3. congenital bicuspid or unicuspid aortic valve; or
    4. active bacterial endocarditis, echocardiographic evidence of intracardiac mass, thrombus or vegetations, or other active infections; or
    5. severe ventricular dysfunction with left ventricular ejection fraction less than or equal to 20 percent; or
    6. life expectancy less than 12 months due to non-cardiac co- morbid conditions; or
    7. acute myocardial infarction within 1 month of planned TAVR procedure; or
    8. cerebral vascular accident (CVA) or transient ischemic attack (TIA) within last 6 months; or
    9. end stage renal disease requiring chronic dialysis or creatinine clearance less than 20cc/min; or
    10. mixed aortic valve disease (aortic stenosis and aortic regurgitation with severity [3-4+]); or
    11. moderate to severe (3-4+) mitral regurgitation;or
    12. moderate to severe mitral stenosis; or
    13.  severe (4+) tricuspid regurgitation; or
    14. pre-existing mechanical prosthetic or transcatheter bioprosthetic heart valve in any position; or
    15. individual was offered surgery but refused.

Transcatheter aortic valve replacement with a U.S. Food and Drug Administration (FDA)-approved transcatheter heart valve system (SAPIEN XT or CoreValve System), performed via an approach consistent with the device's FDA-approved labeling, is considered medically necessary for the treatment of individuals with a failed (that is, stenosed, insufficient, or both) previous open surgical bioprosthetic aortic valve (valve-in-valve implantation), identified by the heart team to have high or greater risk for open surgical therapy (that is, Society of Thoracic Surgeons operative risk score greater than or equal to 8% or at a 15% or greater risk of operative mortality at 30 days).

Transcatheter pulmonary valve (TPV) implantation is considered medically necessary when the following criteria are met:

  1. Existence of a full (circumferential) right ventricular outflow tract (RVOT) conduit that was equal to or greater than 16 mm in diameter when originally implanted; and
  2. Dysfunctional RVOT conduits with one of the following clinical indications for intervention:
    1. moderate or greater pulmonic regurgitation; or
    2. pulmonic stenosis with a mean RVOT gradient greater or equal to 35 mm Hg.

Investigational and Not Medically Necessary:

Transcatheter aortic valve replacement is considered investigational and not medically necessary when all of the criteria specified above are not met, or for the treatment of all other conditions.

Transcatheter aortic valve replacement with any device other than those listed above as medically necessary is considered investigational and not medically necessary.

Transcatheter pulmonary valve implantation is considered investigational and not medically necessary when the above criteria are not met.

Transcatheter mitral valve repair using leaflet repair (for example, MitraClip Clip Delivery System) is considered investigational and not medically necessary for all indications.

Transcatheter mitral valve repair using percutaneous annuloplasty (for example, CARILLON Mitral Contour System) is considered investigational and not medically necessary for all indications.

Transcatheter valve implantation in other valve locations is considered investigational and not medically necessary for all indications.

Rationale

TAVR:

According to the 2008 update of the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the management of individuals with valvular heart disease, the society made a Class I recommendation for conventional surgical aortic valve replacement (AVR) in symptomatic individuals with severe aortic stenosis (Bonow, 2008). Aortic valve replacement is also recommended in certain circumstances for individuals with severe stenosis who are asymptomatic, and for individuals with mild to moderate stenosis undergoing coronary artery bypass graft (CABG) when there is evidence that progression may be rapid.

A multicenter case series evaluated the outcomes of 345 TAVR (also known as transcatheter aortic valve implantation) procedures (transfemoral [TF]: 168; transapical [TA]: 177) in 339 participants, who presented with severe symptomatic aortic stenosis at very high or prohibitive surgical risk (Rodés-Cabau, 2010). Outcome results were reported in 332 cases, 30-day procedural success rate (93.3%) and 10.4% mortality (TF: 9.5%, TA: 11.3%). A survival rate of 76% was reported at 1 year follow-up, with the majority of deaths resulting from non-cardiac conditions. The authors concluded the need for further evaluation; the PARTNER (Placement of AoRTic traNscatheterER valves) clinical trial will provide needed randomized comparison of TAVR with normal therapy.

Leon and colleagues (2010), reported on the ongoing PARTNER clinical trial. This multicenter study evaluated the safety and effectiveness of Edwards SAPIEN transcatheter heart valve (THV) via TF delivery, in a stratified population of inoperable subjects (called the Cohort B study). The inoperable candidates with severe symptomatic aortic stenosis in Cohort B were randomized to treatment with TF TAVR or control with standard therapy (including balloon aortic valvuloplasty) with 179 in each group; clinical outcomes were evaluated at 30 days and 1 year (median follow-up 1.6 years). Investigators determined each candidate's vascular access for TF delivery; individuals who failed to meet the criteria for TF delivery were not enrolled. In the TAVR group, 173 individuals underwent the procedure receiving heparin during the TAVR and dual antiplatelet therapy (aspirin and clopidogrel) regimen for 6 months post procedure. Other study enrollment eligibility included a functional NYHA class II or greater. Severe symptomatic aortic stenosis was defined by aortic-valve area of less than 0.8 cm2 , a mean aortic-valve gradient of 40 mm Hg or more, or a peak aortic-jet velocity of 4.0 m per second or more. Additionally, at least two cardiovascular surgeon investigators had to agree that the individual was not a suitable candidate for surgery due to coexisting conditions that would be associated with a predicted probability of 50% or more of either death by 30 days after surgery or a serious irreversible condition. Study exclusion criteria for Cohort B included: a bicuspid or noncalcified aortic valve, acute myocardial infarction, a left ventricular ejection fraction of less than 20%, a significant abdominal or thoracic aortic disease including aneurysm, a transient ischemic attack or stroke within the previous 6 months, hypertrophic cardiomyopathy with or without obstruction, blood dyscrasias, echocardiographic evidence of intra-cardiac mass, thrombus or vegetation, severe renal insufficiency and life expectancy of less than 12 months due to non-cardiac co-morbid conditions. Researchers categorized the overall population at high risk (Society of Thoracic Surgeons (STS) score, 11 ± 6%) including both study groups, although there were individuals with low STS scores who had pre-existing conditions that contributed to the surgeon's rationale for deeming a participant ineligible for surgery. In the TAVR group there were 11 (6.4%) reported deaths in the initial 30 days after the procedure. The author identified limitations in the study as evidenced by the protocol-mandated selection criteria with relevant individual subgroups: individuals in need of treatment for coronary stenosis and severe peripheral vascular disease. Additional concerns with the study relate to the equivalence and management of the control group. The control and treatment groups differed in several domains such as presence of atrial fibrillation and extensive aortic calcification, which might indicate the presence of confounders not equalized by the randomization. In addition, some, but not all, of the control group underwent balloon valvuloplasty (83.8%), although the natural history of the aortic stenosis was unchanged and some even had aortic valve surgery regardless of their initial inoperable classification. The mortality in this control arm exceeded that expected for an untreated population which raises the concern that this group may not have been an appropriate control or that the treatment they received was somehow harmful. In summary, the authors emphasized the need for other randomized trials instead comparing aortic-valve replacement with TAVR in high-risk individuals with aortic stenosis who are viable surgical candidates, as well as in the low-risk population.

A multicenter study by Smith and colleagues (2011) compared transcatheter versus surgical aortic valve replacement (SAVR) in high-risk individuals with aortic stenosis. A total of 699 individuals were randomized to receive the TAVR or surgical replacement with the primary end point of death from any cause at 1 year. The 30-day mortality rate was 3.4% for the TAVR group and 6.5% for the surgical group (p=0.07) and at 1 year 24.2% and 26.8% (p=0.44). The rate of periprocedural risks such as major bleeding and new onset atrial fibrillation were significantly higher in the surgical population. The incidence of  major stroke reported for the TAVR group was 3.8% and 2.1% in the surgical group at 30 days; at 1 year 5.1% and 2.4% (p=0.07). Also at 30 days, more major vascular complications were reported in the TAVR (11.0%) group than in the surgical group (3.2%) (p<0.001). The authors concluded "in high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with a similar rate of survival at 1 year, although there were important differences in periprocedural risk."

A health-related quality of life study (Reynolds, 2011) evaluated participants after transcatheter aortic valve replacement (TAVR) in inoperable individuals with severe aortic stenosis. The quality of life assessments were performed at baseline, 1, 6 and 12 months using the 12-item Short Form-12 General Health Survey (SF-12) and Kansas City Cardiomyopathy Questionnaire (KCCQ) (range, 0-100; higher = better). The PARTNER clinical trial evaluated the Edwards SAPIEN valve in individuals with calcific aortic stenosis who are considered high-risk for conventional open-heart valve surgery. The KCCQ summary score improved in both groups, although the TAVR group reported greater improvement than to the control group. Individuals in the TAVR group reported higher SF-12 physical and mental health scores at 12 months with mean differences compared with standard care. The author concluded "among inoperable patients with severe aortic stenosis, compared with standard care, TAVR resulted in significant improvements in health-related quality of life that were maintained for at least 1 year."

The Agency for Healthcare Research and Quality's (AHRQ) original percutaneous heart valve replacement technical brief (Williams, 2010) compares the types of prosthetic heart valves currently in use and under development for percutaneous heart valve (PHV) replacement. The report concluded:

Percutaneous valve replacement has been demonstrated to be feasible for aortic stenosis, and short-term outcomes are promising. Several companies are developing these valves, and the reported clinical experience is increasing rapidly. Percutaneous valves have the potential to expand access to valve replacement for a large group of older adults with severe valve disease and concurrent medical conditions that currently preclude surgery. Percutaneous valves also have the potential to substitute for some conventional valve replacements and expand the indications for valve replacements. However, existing data are inadequate to determine the most appropriate clinical role for these valves or the specific patient populations for whom these valves might eventually be indicated. Many unanswered questions remain pertaining to the effects—intended or unintended—of expanding the clinical indication for percutaneous heart valve replacement to groups of patients in whom this treatment modality has not yet been evaluated.

Decision modeling, coupled with high-quality systematic reviews, could inform clinical and policy decisions in the near future. Findings from the ongoing PARTNER clinical trial should yield important efficacy data when they become available. Over the longer term, device registries could be established for the purpose of evaluating comparative effectiveness since randomized trials may not be feasible for some clinically important questions.

The Edwards SAPIEN transcatheter heart valve implant is an aortic prosthetic valve approved November 2, 2011 by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process. Approval of the Edwards SAPIEN valve is based on study results evaluating the treatment of individuals with severe calcific aortic stenosis who were considered to be non-operable for conventional open-heart valve replacement surgery. In these rare situations, there is currently a lack of good quality, published, peer reviewed literature to guide clinical care. While there are significant potential complications to intervention with a TAVR, in particular the risks of stroke and catheter related vascular injury, based, in part, on clinical input received and the potential to enhance the quality of life (Reynolds, 2011), the use of the transcatheter heart valve implant may be considered as beneficial as any established alternatives in this circumstance and it is reasonable to consider this option in individuals with severe aortic stenosis who are considered inoperable.

In 2012, the FDA expanded label indications for TAVR (TF or TA approach) for operative candidates with operative risk of greater than or equal to 8% or a risk of mortality greater than or equal to 15% with surgical valve replacement. An American College of Cardiology Foundation Expert Consensus document on Transcatheter Aortic Valve Replacement (2012) reported from the SAPIEN Aortic Biosprosthesis European Outcome (SOURCE) registry a higher risk for major bleeding events in participants who underwent the TA approach versus TF TAVR approach (3.9% vs. 2.3%). Kodali and colleagues (2012) report findings from a 2-year analysis of the randomized PARTNER trial, death for any cause for TAVR vs. surgery groups were similar (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; p=0.41) and at 2 years (Kaplan–Meier analysis) were 33.9% in the TAVR group (TF n=74 [30.9%]; TA n=42 [41.1%]) and 35.0% in the surgery group (p=0.78). The authors conclude:

This 2-yr follow-up of patients in the PARTNER trial support the use of TAVR as an alternative to surgery in selected high-risk patients with aortic stenosis. The two treatments were similar with respect to mortality, reduction in cardiac symptoms, and improved valve hemodynamic. The early increase in the risk of stroke with TAVR was attenuated over time.

However, it should be noted that there is no survival benefit in the high-risk (Cohort A) population which is different from what was seen in the inoperable (Cohort B) population in the Partner trial. There is, however, an increased risk of stroke and vascular complications with associated medical and quality of life impacts. Thus, while there is efficacy data regarding use of TAVR in the high-risk group, the increased stroke and vascular complication rates are a significant negative health outcome which means that TAVR in the high-risk group is not as beneficial as the established alternative of surgical AVR.

The Edward SAPIEN XT Transcatheter Heart Valve is a second generation, balloon expandable system; the SAPIEN XT received approval June 16, 2014 by the FDA through the PMA process for relief of aortic stenosis in individuals with symptomatic heart disease (Nishimura, 2014) as a result of severe native calcific aortic stenosis. The FDA approval of the SAPIEN XT was based on clinical outcomes from registry data in Cohort B of the PARTNER II trial comparing the SAPIEN XT with the first generation SAPIEN THV in individuals who cannot undergo surgery (inoperable). Participants of Cohort B were randomized in a 1:1 ratio, the control arm received SAPIEN THV with RetroFlex 3 delivery system (TF approach) and participants in the treatment arm received an SAPIEN XT THV with the NovaFlex+ delivery system (TF). Primary safety and effectiveness end point was a non-hierarchical composite of death (all cause), disability major stroke and rehospitalization for aortic stenosis related to valve procedure at 1 year. Serious adverse events reported at 1 year for SAPIEN XT THV (trial arm) and SAPIEN THV (control arm); death from any cause 22.34% vs. 22.50%, major stroke 4.61% vs. 5.1%, repeat hospitalization 21.63% vs. 22.51%. Device success was reported in 45.3% of the SAPIEN group and 58.5% of the SAPIEN XT group. The relative risk ratio of SAPIEN XT vs. SAPIEN was 0.759 (95% CI 0.582, 0.990), p<0.0001. The FDA also reviewed data from the European SOURCE XT Registry (High Risk), an international, multi-center prospective, observation registry for individuals with symptomatic aortic stenosis requiring TAVR who have a high risk for operative mortality, or are inoperable. A total of 2688 participants were identified as meeting study criteria; participants received SAPIEN XT inserted using TA (33.3%), TF (62.7%), transaortic (TAo) (3.76%), or subclavian (0.3%) approach. At 30 days post THV implant with TF, TA/TAo 6.2% of participants died (3% due to cardiac death), 3.6% of population suffered a stroke and 6.6% had a major vascular complication. One year post implantation for TF, TA/TAo population, 19.5% of participants died (9.5% as a result of cardiac death), and 6.3% had suffered a stroke. Currently there is lack of randomized controlled trials demonstrating either the SAPIEN or SAPIEN XT THV superior to open surgical repair for high-risk cohort.

In August 2016, Edwards Lifesciences received FDA expanded approval for use of the SAPIEN XT and SAPIEN 3 Transcatheter Heart Valves, stating that use of TAVR is indicated for relief of aortic stenosis in individuals with symptomatic heart disease due to severe calcific aortic stenosis at intermediate or greater risk for open surgical therapy (that is, predicted risk of surgical mortality greater than or equal to 3% at 30 days) as determined by at least two physicians. The FDA approval is based on reported results from the PARTNER 2 cohort, two parallel prospective, multicenter, randomized trials that enrolled 2032 individuals with severe aortic stenosis, at intermediate-risk to undergo SAPIEN XT TAVR or SAVR (Leon, 2016). Participants that met enrollment criteria were stratified in cohorts according to access route (transfemoral or transthoracic) then randomized at a 1:1 ratio to undergo TAVR or SAVR. "Patients with concomitant noncomplex coronary artery disease requiring revascularization could be enrolled and treated according to the judgment of the heart team with percutaneous coronary intervention (PCI) or coronary-artery bypass graft (CABG) surgery." The primary composite end point results:

The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan-Meyer event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation.

Leon and colleagues concluded that:

in intermediate-risk patients with severe symptomatic aortic stenosis, surgical and transcatheter valve replacement were similar with respect to the primary endpoint of death or disabling stroke for up to 2 years and resulted in a similar degree of lessening of cardiac symptoms.

Thourani and colleagues (2016) reported results from two prospective multicenter studies. The SAPIEN 3 observational, multicenter, post-hoc study enrolled 1077 intermediate-risk participants to TAVR with SAPIEN 3. The authors then compared 1-year outcomes in intermediate-risk populations with SAVR in the PARTNER 2A trial. To account for differences between trial baseline characteristics, authors used a prespecified propensity score analysis. At 1 year follow-up, authors included 963 participants treated with SAPIEN 3 TAVR and 747 with SAVR using the propensity score analysis.

For the primary composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, TAVR was both non-inferior (pooled weighted proportion difference of -9.2%; 90% CI -12.4 to -6; p<0.0001) and superior (-9.2%, 95% CI -13.0 to -5.4; p<0.0001) to surgical valve replacement.

In summary, the authors concluded that the:

TAVR and SAPIEN 3 in intermediate-risk patients with severe aortic stenosis is associated with low mortality, strokes, and regurgitation at 1 year. The propensity score analysis indicates a significant superiority for our composite outcome with TAVR compared with surgery, suggesting that TAVR might be the preferred treatment alternative in intermediate-risk patients.

The CoreValve System (including the CoreValve Evolut 23 mm, and the CoreValve 26 mm, 29 mm and 31 mm valves) is a transcatheter aortic valve approved January 17, 2014 by the FDA through the PMA process. The device is indicated for relief of aortic stenosis in individuals with symptomatic heart disease due to severe native calcific aortic stenosis and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team (2 cardiac surgeons and 1 interventional cardiologist), to be at extreme risk or inoperable for open surgical therapy. The FDA approval of the CoreValve device was granted without an independent device advisory panel review after reviewing the clinical outcomes in CoreValve U.S. pivotal trial - Extreme Risk Study, presented at the Transcatheter Cardiovascular Therapeutics (TCT) Committee. In June 2014, the FDA has granted expanded approval for the CoreValve System, allowing its use in individuals with severe aortic stenosis who are at high mortality risk if they undergo traditional open-heart procedures, without going through an expert panel review.

Adams and colleagues (2014) reported outcomes from the CoreValve U.S. pivotal trial - High Risk Study. The multicenter study evaluated 795 eligible participants with severe aortic stenosis and heart failure symptoms of NYHA class II or higher who were at increased surgical risk as determined by the heart team (two cardiac surgeons and one interventional cardiologist) who estimated the risk of death within 30 days after surgery was 15% or more and the risk of death or irreversible complications within 30 days after surgery was less than 50%. Eligible participants were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (n=394 intention-to-treat population; n=390 as-treated population) or to open surgical aortic-valve replacement (n=401 intention-to-treat population; n=357 as-treated population). The primary end point was the rate of death from any cause at 1 year.

The authors reported that at 1 year, the rate of death from any cause was lower in the TAVR group than in the surgical group (14.2% vs. 19.1%; p<0.001 for noninferiority, p=0.04 for superiority). In addition, the rate of major adverse cardiovascular and cerebrovascular events at 1 year was significantly lower in the TAVR group than in the surgical group (20.4% vs. 27.3%, p=0.03). Stroke risk did not significantly differ between TAVR and open valve repair. The rates of any stroke were 4.9% in the TAVR group and 6.2% in the surgical group at 30 days (p=0.46) and 8.8% and 12.6%, respectively, at 1 year (p=0.10).

TAVR Valve-in-Valve:

Dvir and colleagues (2014) reported results using a multinational (55 centers) valve-in valve registry that included 459 participants (mean age 77.6 years) with degenerative aortic valve bioprosthesis, undergoing valve-in-valve implantation using balloon or self-expandable THV. At 30 days post procedure, 35 (7.6%) deaths were reported; higher mortality rate was reported for stenosis group (10.5% vs. 4.3% in the regurgitation group and 7.2% in the combined group; p=0.04). There was no difference between the self-expandable and balloon expandable device groups in terms of mortality or stroke rates. There were more major/life threatening bleeding and more acute kidney injury events reported in the balloon-expandable device in terms of mortality or stroke rates, the self-expanding population had more permanent pacemaker implantation. The authors concluded, "In this registry of patients who underwent transcatheter valve-in valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprosthetic valves and in those with predominant surgical valve stenosis."

In March 2015 the FDA expanded approval of the CoreValve System TAVR in the treatment of individuals with failure (stenosed, insufficient, or combined) of a previous open surgical bioprosthetic aortic valve (valve-in-valve implantation), identified by the heart team (two cardiac surgeons and one interventional cardiologist) to have high or greater risk for open surgical therapy (that is, Society of Thoracic Surgeons operative risk score greater than or equal to 8% or at a 15% or greater risk of operative mortality at 30 days). The FDA expanded indication is based on preliminary data collected from 143 participants in registry 6 of the "TAV-in-SAV" observational study (NCT01675440) (Dvir, 2014). In October 2015, Edwards Lifesciences received expanded approval for the SAPIEN XT THV for aortic with failure (stenosed, insufficient, or combined) of a  previous open surgical bioprosthetic aortic valve (valve-in-valve implantation), identified by the heart team (two cardiac surgeons and one interventional cardiologist) to have high or greater risk for open surgical therapy (that is, Society of Thoracic Surgeons operative risk score greater than or equal to 8% or at a 15% or greater risk of operative mortality at 30 days) based on nested registry of PARTNER II trial (NCT01314313) with 197 valve-in-valve participants treated. The registry data provides initial results for use of TAVR valve-in-valve approach. Based on registry data, TAVR after failed surgical bioprosthetic valve offers a treatment option for high or greater risk individuals that are not candidates for open surgical therapy.

Paravalvular leak (PVL) is a potential risk for individuals undergoing aortic valve replacement, the incidence of PVL after TAVR is greater than in SAVR. The incorrect sizing of the TAV may lead to an incomplete seal of the prosthetic valve resulting in a PVL; advancements in technology and newer models of TAVs should reduce the number of PVLs. Although early European Registry data is promising, a randomized, comparative trial is needed to establish the efficacy and safety of repeat TAVR (TAVR-in-TAV). To date, none of the TAVR systems have received FDA approval for use in the treatment of repeat TAVR of prior TAV.

TPV:

McElhinney and colleagues (2010) reported on 124 subjects with dysfunctional right ventricular outflow tract obstruction who underwent pulmonary valve placement. The study protocol received approval by the FDA as a clinical trial under the humanitarian device exemption (HDE). This feasibility study looked at the procedural success, safety and short-term effectiveness of the Medtronic Melody transcatheter pulmonary valve in subjects with dysfunctional RVOT conduits as defined by either moderate (3+) or severe (4+) pulmonary regurgitation or mean RVOT gradient greater than or equal to 35 mm Hg. The authors concluded that:

In this updated report from the first prospective multicenter TPV trial; we demonstrated an ongoing high rate of procedural success and encouraging short-term function of the Melody valve. The addition of two sites to the original trial protocol supports the conclusion that this technology can be adopted safely and effectively by properly trained, experienced interventional pediatric/congenital cardiologists. The fact that all reinterventions in the series were for RVOT obstruction highlights the importance of appropriate patient selection, adequate relief of obstruction at the time of Melody valve placement, and measures to prevent and manage stent fracture.

The Melody TPV and Ensemble Delivery System received Humanitarian Device Exemption (HDE) in January of 2010, providing a newer, less invasive treatment option without open heart surgery for individuals with RVOT conduit regurgitation or stenosis using a less invasive procedure. According to the FDA news release in January 2010, the approval was based on clinical studies of 99 subjects in the United States and 68 subjects in Europe, demonstrating device improved heart function and majority of subjects with noted improvement in clinical symptoms. The device showed similar, limited durability compared with existing alternative treatments; 21% of U.S. participants experienced a stent fracture, a rate consistent with stent fractures reported for the bare metal stents presently used to treat congenital heart defects of the pulmonary valve. According to the FDA new release:

Like other valves, the Melody does not cure the heart condition and over time, the Melody may wear and require replacement. However, it is implanted without open heart surgery, can prop open the poorly functioning conduit, and keeps blood flowing in the proper direction because of the tissue valve in the Melody. These characteristics will allow an individual's conduit to function longer than usual, which can delay the need for more invasive open-heart surgery.

Currently there are no randomized controlled trials to compare the transcatheter approach to open-heart surgical technique. There are ongoing post approval studies to assess long-term clinical performance of the Melody TPV over a period of five years after transcatheter implantation in participants with dysfunctional RVOT conduits.

Transcatheter Mitral Valve Repair:

An open surgical technique introduced in the early 1990s to treat mitral regurgitation (MR) involves approximating the middle scallops of the mitral leaflets to create a double orifice with improved leaflet coaptation. The MitraClip Delivery System was developed as a percutaneous method to accomplish a similar repair. Using a trans-septal approach, general anesthesia, fluoroscopy, and echo guidance, the clip device is centered over the mitral orifice, passed into the left ventricle, and then pulled back to grasp the mitral leaflets creating a double orifice. The MitraClip System consists of implant catheters and the MitraClip permanent implant device.

A prospective, multi-center, single-arm feasibility, safety, and efficacy trial of the MitraClip system was reported by Feldman and colleagues (2009). A total of 107 participants with 3 to 4+ MR meeting ACC/AHA guidelines for intervention were treated with the device. Ten (9%) had a major adverse event, including 1 non-procedural death. Overall, 79 (74%) participants achieved acute success, and 51 (64%) of those achieving acute success were discharged with MR of 1+ or less. Thirty-two (30%) individuals required open mitral valve surgery within 3 years. At 12 months, 50 of 76 (66%) individuals with acute procedural success remained free from death, mitral valve surgery, or MR >2+ (primary efficacy end point). Within this cohort, 23 participants with functional (not degenerative) MR had similar acute results and durability.

Feldman and colleagues (2011) reported on the EVEREST II trial in which 279 operable participants, with moderately severe (3+) or severe (4+) MR were enrolled at a 2:1 ratio to undergo either percutaneous mitral valve repair (n=184) or conventional surgery to repair or replace the mitral valve (n=95). The overall rates of achieving a composite efficacy end point were 55% in the percutaneous repair group and 73% in the conventional surgery group at 12 months. The rates of the components of the primary end points for the percutaneous repair versus conventional surgery were reported as follows: death rate of 6% for both groups; surgery for mitral-valve dysfunction, 20% versus 2%; and MR grade (3+) to (4+), 21% versus 20% at 12 months. The primary safety end point was a composite of major adverse events (MAEs) within 30 days. MAE occurred in 15% of participants in the percutaneous-repair group and 48% of participants in the surgery group at 30 days. At 12 months, both groups had improved left ventricular size, New York Heart Association functional class and quality-of-life measures, as compared with baseline. Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery at 12 months, the procedure was associated with a lower adverse event rate. The authors concluded "longer-term follow-up will provide additional data to better understand percutaneous treatment of mitral regurgitation."

Mauri and colleagues (2013) reported 4-year results from the EVEREST II trial. At 48 months, the composite end point of freedom from death, surgery for mitral valve dysfunction, and 3+ or 4+ MR was 39.8% in the transcatheter mitral valve repair arm versus 53.4% in the surgical arm (p=0.070). Participants treated with transcatheter mitral valve repair more commonly underwent surgery to treat residual MR compared to the conventional mitral valve surgery group with a rate of 20.4% versus 2.2% (p<0.0001) at 1 year and 24.8% versus 5.5% (p<0.001) at 4 years. The authors concluded:

At 4 years, surgery remains the standard of care for treatment of MR among eligible patients. Percutaneous repair is associated with similar mortality and symptomatic improvement but a higher rate of MR requiring repeat procedures, and less improvement in left ventricular dimensions than surgery. Although percutaneous repair of the mitral valve to treat MR was associated with a higher rate of residual MR at 1 year, there was no difference in later occurrence of MR or mitral valve intervention between 1-year and 4-year follow-up.

The MitraClip System obtained CE Mark approval in March 2008 in Europe. Maisano and colleagues (2013) reported results from the ACCESS-EU registry study. ACCESS-EU was a prospective, nonrandomized, post-approval study which enrolled at 14 sites a total of 567 subjects with significant MR (77.1% functional; 22.9% degenerative) treated with MitraClip therapy in Europe. A total of 85% of participants were in NYHA functional class III or IV, and 53% had an ejection fraction ≤ 40%. Subjects in this registry were older and at higher surgical risk than those studied in the EVEREST II comparison trial. A total of 19 participants who underwent a MitraClip implantation died within 30 days after the procedure. The Kaplan-Meier freedom from mortality at 1 year was 81.8%. Among participants undergoing the MitraClip implantation, a total of 98 (17.3%) deaths were reported within 12 months. There were no device embolizations. Thirty-six participants (6.3%) required MV surgery within 12 months of the procedure. The severity of MR improved at twelve months compared to baseline (p<0.001), with 78.9% of participants with MR 2+ or less. At 12 months, 71.4% of participants were in NYHA Class I or II.

Whitlow and colleagues (2012) reported acute and 12-month results from a study of a high mitral valve operative risk cohort (EVEREST II High Risk Study (HRS). All participants had congestive heart failure (89% NYHA Class III or IV), and the majority had a history of coronary artery disease with more than half having had prior cardiac surgery. Individuals were required to have symptomatic MR (3+ to 4+) and an estimated surgical mortality rate of greater than or equal to 12% (Society of Thoracic Surgeons [STS] calculator). The study enrolled 78 participants (46 functional MR; 32 degenerative MR) for percutaneous mitral valve repair with the MitraClip device. Mean age was 77 years. Outcomes of those treated with MitraClip repair (HRS cohort) were contrasted with a comparator group of 58 participants screened concurrently. Twenty-two of the screened comparator group subjects were not included due to lack of institutional review board approval, lack of informed consent, or inability to contact the participant. Of the remaining 36 subjects, 8 met HRS eligibility criteria but were not enrolled in the HRS because enrollment had closed or they elected to not enroll. Seven of the comparator group were judged eligible based on echo assessment of MR severity, but anatomic eligibility based on transthoracic echo was not confirmed. The remaining 21 subjects in the comparator group met all eligibility criteria for HRS except for 1 or more anatomic criteria related to MitraClip placement. The comparison group either received standard medical management (86%) or open mitral valve surgery (14%). STS predicted surgical mortality in the MitraClip group was 14.2% and 14.9% in the comparator group.

The major effectiveness end points at 12 months for the HRS cohort were survival, survival and MR ≤ 2+, NYHA functional class, LV measurements, SF-36 Health Survey quality of life, and rehospitalizations for CHF. The 30 day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p=NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p=0.047). At 12 months, 78% of the surviving HRS cohort had MR grade of ≤ 2+ and both LV end-diastolic and end-systolic volume improved along with NYHA functional class (74% NYHA class I/II versus 89% class III/IV at baseline; p<0.0001). SF-36 quality of life measures at 12 months were improved (32.1 vs 36.1; p=0.014) and annual rate of hospitalization for CHF in surviving HRS cohort participants decreased from baseline for those subjects with available matched data.

There are several limitations to the EVEREST II HRS study. The "comparator" group was recruited retrospectively and was small in size. A randomized comparison of treatment arms was not performed. Follow-up was limited to 12 months. A portion of the individuals in the comparator group did not meet anatomic criteria for MitraClip placement and, therefore, was not directly comparable. In addition, the functional and echocardiographic data at 12 months may overestimate the benefit of the procedure since measures prior to death of non-surviving subjects were not included. The early results at 1 year of the EVEREST II HRS study suggests the MitraClip device may reduce MR in a subset of individuals deemed at high-risk for mitral valve surgery and result in improvement in clinical symptoms and left ventricular function. However, at this time, there is insufficient published evidence in the medical literature to demonstrate a safety and durable efficacy benefit over standard therapies.

The FDA granted PMA approval October 2013 for the MitraClip device. Its labeled indication is for percutaneous reduction of symptomatic mitral regurgitation (MR greater than or equal to 3+) due to a primary abnormality of the mitral valve (degenerative MR) in individuals who have been determined to be at prohibitive risk for mitral valve surgery. The FDA Approval of the MitraClip Clip Delivery System was granted based on unpublished trial results from 127 individuals with symptomatic mitral regurgitation due to degenerative MR included in the EVEREST II HRR and REALISM HR registries. The outcomes of this combined cohort were compared with 65 individuals with degenerative MR in a Duke University Medical Center database (Duke High Risk Cohort) who were managed non-surgically. Kaplan-Meier curves showed mortality in the MitraClip cohort was 6.4% at 30 days and 24.8% at 12 months compared to 10.9% at 30 days and 30.6% at 12 months in the Duke High Risk DMR cohort. The analysis cohort was developed post-hoc which limits the interpretation of the data and the results were described as "only descriptive". Currently there are ongoing post-approval studies evaluating the long term effectiveness of transcatheter mitral valve leaflet repair in this population.

The 2017 AHA/American College of Cardiology (ACC) focused update of the 2014 guideline for the management of valvular heart disease in adults maintains a Class IIb recommendation for transcatheter mitral valve repair for treatment of heart failure including:

Severely symptomatic patients (NYHA class III to IV) with chronic severe primary MR (stage D) who have favorable anatomy for the repair procedure and a reasonable life expectancy but who have a prohibitive surgical risk because of severe comorbidities and remain severely symptomatic despite optimal GDMT for heart failure (HF).

The CARILLON Mitral Contour System, an implantable device with a percutaneous catheter delivery system, is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation (FMR). Rapidly delivered via the venous vasculature, CARILLON has the potential to treat most heart failure individuals in a minimally invasive fashion. There is an ongoing clinical trial evaluating the use of the CARILLON system to treat individuals with heart failure as a result of FMR. Presently, the CARILLON system has not been granted final approval by the FDA for this indication.

Background/Overview

Transcatheter heart valve replacement is a less invasive alternative to conventional open-heart surgery. This alternative approach to conventional valve replacement surgery does not require heart-lung bypass. A catheter inserted using a TF, TA, or transaortic approach allows the introduction of an expandable prosthetic heart valve which is then delivered to the diseased native valve. Two minimally invasive alternatives to surgical mitral valve repair include transcatheter leaflet repair and percutaneous annuloplasty. The purpose of transcatheter mitral valve leaflet repair is to keep the two valve leaflets more closely fitted together, thereby reducing regurgitation. Percutaneous annuloplasty attempts to reshape the mitral annulus using catheters guided through the vasculature to reach the heart to reduce regurgitation.

Transcatheter Heart Valve:

The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX, sizes 23 mm and 26 mm and accessories received PMA from the FDA November 2, 2011; the device is authorized by Federal law (USA) for TF delivery in severe symptomatic individuals who are not eligible for open-heart surgery for replacement of their aortic valve and have a calcified aortic annulus (calcium build-up in the fibrous ring of the aortic heart valve). In order to determine if the SAPIEN THV is an appropriate treatment option, the product label advises that a heart surgeon should be involved in determining if the individual is inoperable for open AVR and if there are any existing co-morbidities that would preclude the expected benefit from correction of the individual's aortic stenosis and if so the heart surgeon determines if the SAPIEN Transcatheter Heart Valve is an appropriate treatment for the individual. According to the FDA news release November 2011:

Edwards Lifesciences, the manufacturer of the SAPIEN THV, will continue to evaluate the outcomes with the SAPIEN THV through a national Transcatheter Valve Therapy (TVT) registry. The Society of Thoracic Surgeons and the American College of Cardiology have been working with the FDA and the Centers for Medicare and Medicaid Services to facilitate the creation of the national TVT registry that will serve as a platform for continued evaluation of post market experience with this and future transcatheter devices and procedures for the treatment of aortic stenosis.

The FDA labeled indications for the Edward SAPIEN Transcatheter Heart Valve were expanded in October 2012 for operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons predicted operative risk greater than or equal to 8% or are judged by the heart team to be at a greater than or equal to 15% risk of mortality for surgical aortic valve replacement. On September 2013 the labeled indications were expanded to include access for inoperable individuals who require an alternative access point.

In June 2014, Edwards SAPIEN XT™ Transcatheter Heart Valve, model 9300TFX, 23, 26, and 29 mm, and accessories (NovaFlex+ delivery system, models 9355FS23, 9355FS26, and 9355FS29, with crimp stopper and Qualcrimp crimping accessory) received FDA approval for relief of aortic stenosis in individuals with symptomatic heart disease due to severe native calcific aortic stenosis, in October 2015 the FDA expanded use for individuals with failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve, with native anatomy appropriate for the 23, 26, or 29 mm valve system, who are judged by a heart team including a cardiac surgeon, to be at high or greater risk for open surgical therapy (that is, Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥ 15% risk of mortality at 30 days).

In June 2015, the Edwards SAPIEN 3 Transcatheter Heart Valve, Model 9600TFX, 20, 23, 26 and 29 mm, and accessories were granted FDA approval. This is the third generation SAPIEN THV to receive approval for use in individuals with aortic valve stenosis who are inoperable or at high risk for death or complications associated with open-heart surgery. The major design change adds a skirt at the base of the valve to minimize leakage around the valve. According to the FDA, "clinical data showed that the SAPIEN 3 Transcatheter Heart Valve is superior to the first generation SAPIEN Transcatheter Heart Valve, with significantly less leakage through and around the valve." On June 5, 2017 the FDA approved expanded use of the SAPIEN 3 Transcatheter Heart Valve, Model 9600TFX for treatment of individuals with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator). The FDA approval was based on unpublished retrospective, observational data from TVTR registry reporting valve function before valve-in-valve repair, upon discharge and 30 days post procedure. Although the registry data is promising, a randomized, comparative trial is needed to establish the efficacy and safety of open surgical repair (aortic or mitral) of failed bioprosthesis compared to SAPIEN 3 Transcatheter Heart Valve replacement of failed surgically implanted bioprosthesis (aortic or mitral valve)

Edwards Lifesciences received expanded approval by the FDA for the SAPIEN XT and SAPIEN 3 in August, 2016, for use in the treatment of individuals with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the Society of Thoracic Surgeons [STS] risk score and other clinical co-morbidities unmeasured by the STS risk calculator) (SAPIEN XT, SAPIEN 3 Product Information, 2016).

In 2016 the SAPIEN XT THV and delivery system received expanded approval by the FDA for use in children and adults with a dysfunctional, non-compliant RVOT conduit with a clinical indication for intervention and moderate or greater pulmonary regurgitation and/or mean RVOT gradient greater than or equal to 35 mmHg. The procedure is contraindicated in individuals with an inability to tolerate anticoagulation/antiplatelet regimen and present with active bacterial endocarditis.

On March 20, 2017 the FDA granted approval for Medtronic's next-generation CoreValve Evolut R and CoreValve Evolut PRO systems indicated for use in individuals with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (that is, Society of Thoracic Surgeons predicted risk of operative mortality score ≥ 8% or at a ≥ 15% risk of mortality at 30 days). The device is a repositionable, self-expanding valve aimed to decrease paravalvular leaks. July 10, 2017 the FDA expanded FDA approval of the CoreValve System, CoreValve Evolut System and CoreValve Evolut PRO System TAVR for treatment of individuals with severe aortic stenosis who are at intermediate or greater risk for open-heart surgery and have a risk of mortality of ≥ 3 percent at 30 days following procedure. The risk assessment is determined by a heart team, including a cardiac surgeon and interventional cardiologist). The FDA approval is based on 2 year results from the landmark SURTAVI trial (NCT01586910), a randomized study comparing TAVR (CoreValve System) with surgical aortic valve replacement in individuals with severe, symptomatic aortic stenosis at intermediate surgical risk. In individuals with severe aortic stenosis at intermediate surgical risk, TAVR was found to be a noninferior alternative to SAVR (Reardon, 2017).

Melody Transcatheter Pulmonary Valve:

The Melody Transcatheter Pulmonary Valve (TPV) has an HDE approval from the FDA and is authorized by Federal law (USA) for use in pediatric and adult candidates with a regurgitant or stenotic RVOT conduit (greater than or equal to 16 mm in diameter when originally implanted). The effectiveness of this device for this use has not been demonstrated. FDA approval has been granted for devices for specific indications, through the HDE process. The HDE approval process is applicable to devices intended to benefit individuals in the treatment or diagnosis of conditions or diseases that affect fewer than 4000 individuals in the U.S. per year. An HDE application does not require submission of the results of scientifically valid clinical investigations demonstrating the effectiveness of the device for its intended use. However, the application must contain sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable health benefit outweighs the risks from its use.

MitraClip Clip Delivery System:

On October 24, 2013 Abbott Laboratories was granted premarket approval (PMA) by the FDA for use of the MitraClip Clip Delivery System. The labeled indication is:

For percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in individuals who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

Definitions

Aortic valve stenosis: Also known as aortic stenosis, this form of valvular heart disease is characterized by narrowing of the aortic valve opening.

Congenital heart disease (CHD): Heart problems present at birth.

Humanitarian Device Exemption (HDE): Similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose and does not pose an unreasonable or significant risk of illness or injury. The use of the device is limited to 4000 or less individuals per year.

Mitral regurgitation (also known as mitral insufficiency): A disorder in which the heart valve that separates the upper and lower chambers on the left side of the heart does not close properly, resulting in leakage of blood backward through the mitral valve each time the left ventricle contracts and increased pressure and congestion in the lungs.

Pre-Market Approval (PMA): The most stringent type of device marketing application required by the FDA. A PMA is an application submitted to the FDA to request clearance to market or to continue marketing of a Class III medical device. Class III medical devices are those devices that present significant risk to the individual and/or require significant scientific review of the safety and effectiveness of the medical device prior to commercial introduction.  Frequently the FDA requires follow-up studies for these devices.

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

 

33361

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach

33362

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach

33363

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach

33364

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach

33365

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy)

33366

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (eg, left thoracotomy)

33367

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (eg, femoral vessels)

33368

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels)

33369

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery)

33477

Transcatheter pulmonary valve implantation, percutaneous approach, including pre-stenting of the valve delivery site, when performed

 

 

ICD-10 Procedure

 

02RF3JH

Replacement of aortic valve with synthetic substitute, transapical, percutaneous approach

02RF3JZ

Replacement of aortic valve with synthetic substitute, percutaneous approach

02RF4JZ

Replacement of aortic valve with synthetic substitute, percutaneous endoscopic approach

02RH3JH

Replacement of pulmonary valve with synthetic substitute, transapical, percutaneous approach

02RH3JZ

Replacement of pulmonary valve with synthetic substitute, percutaneous approach

02RH4JZ

Replacement of pulmonary valve with synthetic substitute, percutaneous endoscopic approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When services are Investigational and Not Medically Necessary:
For the 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

 

33418

Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis

33419

Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis(es) during same session

33999

Unlisted procedure, cardiac surgery [when specified as transcatheter replacement of tricuspid heart valve]

0345T

Transcatheter mitral valve repair percutaneous approach via the coronary sinus

0483T

Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; percutaneous approach, including transseptal puncture, when performed

0484T

Transcatheter mitral valve implantation/replacement (TMVI) with prosthetic valve; transthoracic exposure (eg, thoracotomy, transapical)

 

 

ICD-10 Procedure

 

02RG3JH

Replacement of mitral valve with synthetic substitute, transapical, percutaneous approach

02RG3JZ

Replacement of mitral valve with synthetic substitute, percutaneous approach

02RG4JZ

Replacement of mitral valve with synthetic substitute, percutaneous endoscopic approach

02RJ4JZ

Replacement of tricuspid valve with synthetic substitute, percutaneous endoscopic approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Adams DH, Popma JJ, Reardon MJ, et al.; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014; 370(19):1790-1798.
  2. Bleiziffer S, Ruge H, Mazzitelli D, et al. Valve implantation on the beating heart: catheter-assisted surgery for aortic stenosis. Dtsch Arztebl Int. 2009; 106(14):235-241.
  3. Dvir D, Webb JG, Bleiziffer S, et al.; Valve-in-Valve International Data Registry Investigators. Transcatheter aortic valve implantation in failed bioprosthetic surgical valves. JAMA. 2014; 312(2):162-170.
  4. Feldman T, Foster E, Glower DD, et al.; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011; 364(15):1395-1406.
  5. Feldman T, Kar S, Rinaldi M, et al.; EVEREST Investigators. Percutaneous mitral repair with MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge Repair Study) cohort. J Am Coll Cardiol. 2009; 54(8):686-694.
  6. Feldman T, Saibal K, Elmariah S, et al. Randomized comparison of percutaneous repair of surgery for mitral regurgitation. 5-year results of EVERST II. JACC. 2015; 66(25):2844-2854.
  7. Feldman T, Wasserman HS, Herrmann HC, et al. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol. 2005; 46(11):2134-2140.
  8. Glower DD, Saibal K, Trento A, et al. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients. Results of the EVEREST II study. JACC. 2014; 64(2):172-181.
  9. Guerios EE, Gloekler S, Pilgrom T, et al. Second valve implantation for the treatment of a malpositioned transcatheter aortic valve. J Invasive Cardiol 2012;24:457–462.
  10. Kapadia SR, Leon MB, Makkar RR, et al. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomized controlled trial. Lancet. 2015; 385:2485-2491.
  11. Kodali SK, Williams MR, Smith CR, et al.; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012; 366(18):1686-1695.
  12. Leon MB, Smith CR, Mack M, et al.; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010; 363(17):1597-1607.
  13. Leon MB, Smith CR, Mack M, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016; 374:1609-1620.
  14. Machaalany J, Bilodeau L, Hoffmann R, et al. Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial. Am Heart J. 2013 May; 165(5):761-769.
  15. Mack MJ, Leon MB, Smith CR, et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high risk patients with aortic stenosis (PARTNER 1): a randomized controlled trial. Lancet. 2015; 385:2477-2484.
  16. Maisano F, Franzen O, Baldus S, et al. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013; 62(12):1052-1061.
  17. Mauri L, Foster E, Glower DD, et al.; EVEREST II Investigators. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol. 2013; 62(4):317-328.
  18. Mauri L, Garq P, Massaro JM, et al. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010; 160(1):23-29.
  19. McElhinney DB, Cheatham JP, Jones TK, et al. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. 2011; 4(6):602-614.
  20. McElhinney DB, Hellenbrand WE, Zahn EM, et al. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010; 122(5):507-516.
  21. Millan X, Skaf S, Joseph L, et al. Transcatheter reduction of paravalvular leaks: a systematic review and meta-analysis. Canadian J of Cardiol. 2015; 260-269.
  22. Piazza N, van Gameren M, Jüni P, et al. A comparison of patient characteristics and 30-day mortality outcomes after transcatheter aortic valve implantation and surgical aortic valve replacement for the treatment of aortic stenosis: a two-centre study. EuroIntervention. 2009; 5(5):580-588.
  23. Popma JJ, Adams DH, Reardon MJ, et al.; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014; 63(19):1972-1981.
  24. Popma JJ, Reardon MJ, Khabbaz K, et al. Early clinical outcomes after transcatheter aortic valve replacement using a novel self-expanding bioprosthesis in patients with severe aortic stenosis who are suboptimal for surgery: results of the Evolut R U.S. study. JACC Cardiovasc Interv. 2017; 10(3):268-275.
  25. Reardon MJ, Van Mieghem JJ, Popma NS, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017; 376:1321-1331.
  26. Reynolds MR, Magnuson EA, Lei Y, et al.; Placement of Aortic Transcatheter Valves (PARTNER) Investigators.  Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation. 2011; 124(18):1964-1972.
  27. Rodés-Cabau J, Webb JG, Cheung A, et al. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010; 55(11):1080-1090.
  28. Smith CR, Leon MB, Mack MJ, et al.; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011; 364(23):2187-2198.
  29. Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016; 387:2218-2225.
  30. Thomas M, Schymik G, Walther T, et al. Thirty-day results of the SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010; 122(1):62-69.
  31. Vahanian A, Alfieri O, Al-Attar N, et al. Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European association of cardio-thoracic surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). EuroIntervention. 2008; 4(2):193-199.
  32. Whitlow PL, Feldman T, Pedersen WR, et al.; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012; 59(2):130-139.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Agency for Healthcare Research and Quality. Technical brief: percutaneous heart valve replacement. August 2010. Project ID EHC056-EF. Available at: http://www.effectivehealthcare.ahrq.gov/reports/final.cfm. Accessed on June 30, 2017.
  2. Baumgartner H, Bonhoeffer P, De Groot NM, et al. European Society of Cardiology (ESC). ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). The task force on the management of grown-up congenital heart disease of the European Society of Cardiology (ESC). Available at: http://eurheartj.oxfordjournals.org/content/ehj/31/23/2915.full.pdf. Accessed on June 30, 2017.
  3. Bonow RO, Carabello BA, Kanu C, et al. 2008 Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (writing committee to revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): developed in collaboration with the Society of Cardiovascular Anesthesiologists: endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. Available at: http://circ.ahajournals.org/content/118/15/e523.full.pdf. Accessed on June 30, 2017.
  4. Centers for Medicare and Medicaid Services. National Coverage Determinations (NCD) for transcatheter mitral valve (TMVR) (20.33). Effective April 6, 2015. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=363&ncdver=1&bc=AgAAQAAAAAAAAA%3d%3d& . Accessed on June 30, 2017.
  5. Edwards Lifesciences. PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial. NLM Identifier: NCT00530894. Last updated on April 3, 2017. Available at: https://www.clinicaltrials.gov/ct2/show/NCT00530894?term=NCT00530894&rank=1 . Accessed on June 30, 2019.
  6. Holmes DR, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement, Journal of the American College of Cardiology (2012). Available at: http://content.onlinejacc.org/article.aspx?articleid=1206372. Accessed on June 30, 2017.
  7. Medtronic Cardiovascular. Safety and efficacy study of the Medtronic CoreValve System in the treatment of severe, symptomatic aortic stenosis in intermediate risk subjects who need aortic valve replacement (SURTAVI). (SURTAVI). NLM Identifier: NCT01586910. Last updated on April 18, 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT01586910 . Accessed on August 9, 2017.
  8. Medtronic Cardiovascular. Safety and efficacy study of the Medtronic CoreValve System in the treatment of symptomatic severe aortic stenosis in high risk and very high risk subjects who need aortic valve replacement. NLM Identifier: NCT0001240902. Last updated on April 27, 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT01240902 . Accessed on June 30, 2017.
  9. Medtronic Heart Valves. Melody transcatheter pulmonary valve feasibility study: post approval study of the original IDE cohort (Melody IDE). NLM Identifier: NCT00740870. Last updated on October 31, 2016. Available at: https://clinicaltrials.gov/ct2/results?term=NCT00740870&Search=Search . Accessed on June 30, 2017.
  10. Nishimura R, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 Guideline for the management of patients with valvular heart disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2017; pii:S0735-1097(17)36019-9. [Epub ahead of print]. Accessed on June 30, 2017.
  11. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling. Medtronic CoreValve Evolute Pro System. Premarket approval application No. P130021/S029. Available at: https://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/ucm551042.pdf . Accessed on June 30, 2017.
  12. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Medtronic CoreValve System. Premarket approval application No. P130021/S033. Rockville, MD: July 10, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_template.cfm?id=p130021s033 . Accessed on June 30, 2017.
  13. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling. MitraClip Clip Delivery System. Premarket approval application No. P100009. Rockville, MD: October 24, 2013. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p100009 . Accessed on June 30, 2017.
  14. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN 3 Transcatheter Heart Valve. Premarket approval No. P140031/S028. Rockville, MD. June 5, 2017. Available at: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm561731.htm . Accessed on June 30, 2017.
  15. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPIEN Transcatheter Heart Valve (THV) Model 9000TFX and Accessories. Premarket approval application No. P110021. Rockville, MD: October 19, 2012. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p110021 . Accessed on June 30, 2017.
  16. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPEIN XT Transcatheter Heart Valve (THV) with the NovaFlex+ Delivery System. Premarket approval application No. P130009/S037. Rockville, MD: February 29, 2016. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130009S037. Accessed on June 30, 2017.
  17. U.S. Food and Drug Administration (FDA). Center for Devices and Radiologic Health (CDRH). Summary of Safety and Effectiveness and labeling: Edwards SAPEIN XT Transcatheter Heart Valve (THV) Model 9300TFX, 23, 26, and 29mm and accessories. Premarket approval application No. P130009/S057. Rockville, MD: August 18, 2016. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S057d.pdf. Accessed on June 30, 2017.
  18. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and labeling: Medtronic CoreValve System. Premarket approval application No. P130021/S002. June 12, 2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130021S002a.pdf. Accessed on June 30, 2017.
  19. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Summary of Safety and Effectiveness and Probable Benefit: Melody TPV Transcatheter Pulmonary Valve Replacement using the Ensemble Delivery System. Humanitarian Device Exemption No. H080002. Rockville, MD: January 25, 2010. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=h080002 . Accessed on June 30, 2017.
Websites for Additional Information
  1. American Heart Association. Available at: http://www.americanheart.org. Accessed on June 30, 2017.
  2. Cardiac Dimensions. Carillon Mitral Contour System. Available at: http://cardiacdimensions.com/. Accessed on June 30, 2017.
  3. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Humanitarian Use Devices. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm. Accessed on June 30, 2017.
Index

Aortic valve replacement (AVR)
Carillon Mitral Contour System
Edwards SAPIEN transcatheter heart valve
Edwards SAPIEN XT transcatheter heart valve
Edward SAPIEN 3 transcatheter heart valve
Medtronic CoreValve Evolut PRO System
Medtronic CoreValve Evolut R System
Medtronic CoreValve System
Melody transcatheter pulmonary valve (TPV)
MitraClip Clip Delivery System
Percutaneous annuloplasty
Percutaneous heart valves (PHV)
Prosthetic heart valve
Right ventricular outflow tract (RVOT)
Transcatheter aortic valve implantation (TAVI)
Transcatheter aortic valve replacement (TAVR)
Transcatheter heart valve
Transcatheter mitral valve repair (TMVR)
Valvular heart disease

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

  12/27/2017

The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Coding section with 01/01/2018 CPT changes; added codes 0483T and 0484T.

Revised 08/03/2017 Medical Policy & Technology Assessment Committee (MPTAC) Revised MN statement for TAVR with the CoreValve System, CoreValve Evolut R System and CoreValve Evolut PRO System to include coverage for individuals at intermediate or greater risk when criteria met. Updated Background, References and Websites sections.
Revised 05/04/2017 MPTAC review. Revised MN statement for TAVR with CoreValve System to include the CoreValve Evolut R System and CoreValve Evolut PRO System. Updated Description, Rationale, Background, Index, References and Websites sections.
Reviewed 02/02/2017 MPTAC review. Updated Rationale, Background, References and Websites sections.
Revised 11/03/2016 MPTAC review. Updated formatting in Position Statement section. Revised MN statement for TAVR with the Edwards SAPIEN, SAPIEN XT or SAPIEN 3 Transcatheter Heart Valve to include coverage for individuals at intermediate or greater risk when criteria met. Updated Rationale, Background, References, Websites, and Index sections.
Revised 08/04/2016 MPTAC review. Added MN statement for TAVR with an FDA-approved transcatheter heart valve system (SAPIEN XT or CoreValve System) for the treatment of individuals with a previous open surgical bioprosthetic aortic valve (valve-in-valve) when criteria met. Clarified contraindications for TAVR performed with the Edwards SAPIEN, SAPIEN XT, SAPIEN 3 or CoreValve system. Reformatted MN criteria. Updated Rationale, References and Websites sections.
  01/01/2016 Updated Coding section with 01/01/2016 CPT changes; removed 0262T deleted 12/31/2015.
Revised 11/05/2015 MPTAC review. Defined abbreviation in TAVR medically necessary criteria. Added SAPIEN 3 to TAVR medically necessary statement. Updated Description, Rationale, Background, References and Websites. Removed ICD-9 codes from Coding section.
Revised 11/13/2014 MPTAC review. Added the Edwards SAPIEN XT THV as medically necessary when criteria met. Clarified TAVR medically necessary criteria for CoreValve System. Updated Description, Rationale, Background and Index sections.  Updated Coding section with 01/01/2015 CPT changes; removed 0343T, 0344T deleted 12/31/2014.
Reviewed 08/14/2014 MPTAC review. Updated Description, Rationale, Background, References, Websites.
Revised 05/15/2014 MPTAC review. Changed title to: Transcatheter Heart Valve Procedures. Added medically necessary statement for transcatheter aortic valve replacement with the CoreValve system. Revised investigational and not medically necessary statement transcatheter aortic valve replacement with any device other than those listed above as medically necessary. Added investigational and not medically necessary statements addressing transcatheter mitral valve repair using leaflet repair (e.g. MitraClip Clip Delivery System) and transcatheter mitral valve repair using percutaneous annuloplasty (e.g. Carillon Mitral Contour System). Updated Description, Rationale, Background, Index, Definitions, References and Websites.
Revised 02/13/2014 Medical Policy & Technology Assessment Committee (MPTAC) review. Medically necessary criteria updated, removed requirement that the delivery of the TAVR be through a transfemoral approach. Added TAVR with any device other than the Edwards SAPIEN transcatheter heart valve as investigational and not medically necessary. Removed alternate approaches from investigational and not medically necessary statement. Updated Rationale, Background, Coding, Index, References and Websites.
  01/01/2014 Updated Coding section with 01/01/2014 CPT changes; removed 0318T deleted 12/31/2013.
Revised 02/14/2013 MPTAC review. Added medically necessary criteria for transcatheter pulmonary valve and revised investigational and not medically necessary statement for transcatheter pulmonary valve. Updated Rationale, Coding, References and Websites.
  01/01/2013 Updated Coding section with 01/01/2013 CPT changes; removed 0256T, 0257T, 0258T, 0259T deleted 12/31/2012.
Revised 02/16/2012 MPTAC review. Added medically necessary criteria and investigational and not medically necessary statement for transcatheter aortic heart valve. Added additional investigational and not medically necessary statement to address other valves and other methods of implantation. Revised investigational and not medically necessary statement addressing transcatheter pulmonary valve Updated Rationale, Background, Coding, Index, Websites and References.
Reviewed 11/17/2011 MPTAC review. Updated Rationale, Background, Websites and References.
  10/01/2011 Updated Coding section with 10/01/2011 ICD-9 changes.
  07/01/2011 Updated Coding section with 07/01/2011 CPT changes.
New 11/18/2010 MPTAC review. Initial document development.