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Clinical Policy Title: Transcatheter aortic and mitral valve replacement and

repair

Clinical Policy Number: CCP.1192

Effective Date: January 1, 2016

Initial Review Date: September 16, 2015

Most Recent Review Date: October 2, 2018

Next Review Date: October 2019

Related policies:

None.

ABOUT THIS POLICY: AmeriHealth Caritas has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas’ clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by AmeriHealth Caritas when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas’ clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas will update its clinical policies as necessary. AmeriHealth Caritas clinical policies are not guarantees of payment

Coverage policy AmeriHealth Caritas considers the use of transcatheter aortic valve replacement to be clinically proven

and, therefore, medically necessary for the following diagnoses* (Nichimura, 2017; Nishimura, 2014):

1. Symptomatic patients with severe aortic stenosis with high risk for surgical arterial valve

replacement, or intermediate surgical risk, depending on patient-specific procedural risks,

values, and preferences.

2. Symptomatic patients with severe aortic stenosis who have a predicted post-transcatheter

aortic survival of >12 months.

3. An integrated multidisciplinary cardiology team has been consulted.

AmeriHealth Caritas considers the use of transcatheter mitral valve replacement to be medically

necessary for severely symptomatic patients (New York Hospital Association class III to IV) with chronic

severe secondary mitral regurgitation (stage D) who have persistent symptoms despite optimal

guideline-directed medical therapy for heart failure (Nishimura, 2017; Nishimura, 2014).

Policy contains:

CoreValve

MitraClip

SAPIAN Valve

Transcatheter valve

replacement

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AmeriHealth Caritas considers the use of transcatheter mitral valve repair to be medically necessary ( for

severely symptomatic patients (New York Hospital Association class III to IV) with chronic severe primary

mitral regurgitation (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 guideline-directed medical therapy for heart failure (Nishimura,

2017; Nishimura, 2014).

Limitations: All other uses of transcatheter aortic and mitral valve replacement, along with transcatheter

mitral valve repair, are considered to be investigational/experimental, and therefore not

medically necessary.

Alternative covered services:

Open surgical aortic valve replacement.

Open surgical mitral valve replacement.

Open surgical mitral valve repair.

Background

Aortic stenosis is the most common valvular heart disease in the western hemisphere. The

condition is defined as the abnormal narrowing of the aortic valve, which reduces blood flow to

the rest of the body. Aortic stenosis is much more common among the elderly; 12.4 percent of

persons over age 75 in Europe and North America have aortic stenosis, while 3.4 have a severe

version of the disease. Three-fourths of the severe cases are symptomatic (Osnabrugge, 2013).

Aortic stenosis is traditionally treated with surgical aortic valve replacement, which is considered

the gold standard of care; but, many patients have an increased operative risk and are unsuitable

candidates for open surgical valve replacement. Into this arena have stepped a number of less

invasive techniques for valvular replacement and repair, namely methods and devices capable of

implanting artificial aortic valves through a catheter, or transcatheter aortic valve replacement.

This procedure may be carried out transfemorally or transapically (antegrade) through the apex

of the left ventricle. Two major transcatheter aortic valve replacement devices are the Edwards

SAPIEN heart valve and the Medtronic CoreValve heart valve. Since the first Food and Drug

Administration approval of devices for the procedure in 2011, 50,000 Americans have undergone

the procedure, as of early 2017 (Otto, 2017).

The Edwards SAPIEN heart valve was studied in the Placement of Aortic Transcatheter Valve

(PARTNER) clinical trial. One-year mortality rates showed that transcatheter aortic valve replacement

was superior to standard open valve therapies in high-risk patients (Glower, 2012). Through the

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second year following valve replacement, there were no significant differences in all-cause mortality

between the surgical and transcatheter groups (Conradi 2012; Kodali, 2012).

Valve performance in transcatheter aortic valve replacement and surgery groups was also similar

(Makkar, 2012); however, aortic regurgitation after transcatheter aortic valve replacement was

associated with increased long-term mortality. Recent advances have further diminished 30-day

mortality rates following transcatheter aortic valve replacement with one-year and two-year morality

rates similar to those of open surgical patients but with an increased risk of death from early and late

stroke (Khatri, 2013). The Medtronic CoreValve heart valve is a self-expanding prosthesis for

transcatheter aortic valve replacement. All-cause mortality rates after transcatheter aortic valve

replacement with Core Valve at one year show the CoreValve significantly reduces mortality

compared to surgical valve replacement from 19.1 percent to 14.2 percent (Adams, 2014). A

significant reduction in the rate of major adverse cardiovascular and cerebrovascular events at one-

year and a lower risk of stroke at both 30-days and one-year time periods have also been

demonstrated.

Mitral stenosis and mitral regurgitation may remain asymptomatic for more than 10 years, and both

conditions may lead to chronic elevation of left atrial pressure and cardiomyopathy. Surgical mitral

valve replacement and repair is the typical treatment for mitral stenosis and mitral regurgitation;

however, many patients are older and present with comorbidities and left ventricular dysfunction. In

these patients, transcatheter mitral valve replacement has emerged as an alternative treatment

(DeBacker, 2014, Chiam, 2011).

Transcatheter mitral valve replacement and transcatheter mitral valve repair are appropriate for

patients with symptomatic, degenerative mitral valve regurgitation (grade 3+ or 4+) if the patient is

inoperable or at a high risk for surgery (Foster, 2013).

The key to successful transcatheter procedures lie in structural factors. Each member of the heart team

must know and execute their role. The team includes the primary cardiologist, imaging specialist, heart

valve/heart failure specialist, interventional cardiologist, and cardiac surgeon. In addition, procedures

should take place in heart centers, with cardiac catheterization labs and specialized intensive care units

after the procedure (O’Gara, 2013).

Searches: AmeriHealth Caritas searched PubMed and the databases of:

UK National Health Services Centre for Reviews and Dissemination.

Agency for Healthcare Research and Quality Guideline Clearinghouse and evidence-based

practice centers.

The Centers for Medicare & Medicaid Services.

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Searches were conducted on August 23, 2018, using the terms “transcatheter,” “aortic,” “mitral,”

“replacement,” “repair,” and “percutaneous.”

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes

and greater precision of effect estimation than in smaller primary studies. Systematic reviews

use predetermined transparent methods to minimize bias, effectively treating the review as a

scientific endeavor, and are thus rated highest in evidence grading hierarchies.

Guidelines based on systematic reviews.

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost

studies), reporting both costs and outcomes — sometimes referred to as efficiency studies —

which also rank near the top of evidence hierarchies.

Findings The 2014 guidelines from the American Heart Association/American College of Cardiology were upheld

in the 2017 version, based on the most recent peer-reviewed studies. Recommended criteria for

transcatheter aortic and valve replacement are given in the coverage section above (Nishimura, 2017;

Nishimura, 2014).

In an early clinical trial called PARTNER, 699 high-risk patients with severe aortic stenosis underwent

either transcatheter aortic valve replacement or surgery. At 30 days after the procedure, the death rate

in the transcatheter group was almost significantly lower than that in the surgical group (3.4 versus 6.5

percent, P =.07), but similar after one year (24.2 versus 26.8 percent, P =.44). Rates of major stroke

were higher for transcatheter patients at 30 days (3.8 versus 2.1 percent, P =.20) and one year (5.1

versus 2.4 percent, P =.07). After 30 days, the transcatheter group had a higher rate of major vascular

complication (11.0 versus 3.2 percent, P <.001), and lower rates for major bleeding (9.3 versus 19.5

percent, P <0.001), and new-onset atrial fibrillation (8.6 versus 16.0 percent, P =.006) (Smith, 2012).

All-cause mortality rates after transcatheter aortic valve replacement with Core Valve at one year

show the Core Valve significantly reduces mortality compared to surgical valve replacement from

19.1 percent to 14.2 percent (Adams, 2014).

A meta-analysis of six studies (n=3484) of low-surgical risk patients compared transcatheter aortic

valve replacement with surgery, after being followed up for two years (median). While the

transcatheter and surgical groups had no significant differences in short-term mortality (2.2 versus

2.6 percent, P =.62), transcatheter had a significantly higher intermediate-term mortality (17.2 versus

12.7 percent, P =.006). The transcatheter group also had lower rates of bleeding and renal failure,

but higher rates of vascular complications and pacemaker implantation (Witberg, 2018).

A meta-analysis of four randomized controlled trials (n=3758) comparing transcatheter aortic valve

implantation with surgery found women had significantly reduced mortality one and two years after

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the procedure (Risk ratio 0.68 and 0.74). However, no significant differences were observed among

males (1.09 and 1.05) (Panoulas, 2018). These findings were similar to those in another meta-

analysis (Saad, 2017).

A significant reduction in the rate of major adverse cardiovascular and cerebrovascular events at one

year and a lower risk of stroke at 30-days and one-year after transcatheter aortic valve replacement

have also been demonstrated (Adams, 2014). A more recent systematic review/meta-analysis of five

randomized controlled trials (n=5414) found insignificantly lower 30-day and one-year rates in

persons undergoing transcatheter aortic valve replacement compared to surgery of major stroke

(Risk Ratios 0.89, 0.92), all strokes (0.85, 0.92), and all cerebrovascular events (0.94, 1.03)

(Mohananey, 2018).

Among patients with low- to intermediate aortic stenosis, a meta-analysis of 12 randomized

controlled studies and prospective matched studies (n=9851) was conducted. All-cause mortality for

transcatheter aortic valve replacement compared to surgery was similar in the short term (Odds

Ratio 1.19, P  = 0.30), mid-term (Odds Ratio 0.97, P  = 0.84), and long term, (Odds Ratio 0.97, P

 = 0.76). The transcatheter group showed a lower risk of acute kidney injury and new-onset atrial

fibrillation (P  < 0.05), but a greater risk of permanent pacemaker implantation and paravalvular leaks

(Khan, 2017). A meta-analysis of 11 studies (n=5647) documented that mortality in intermediate-risk

patients at 30 days, one year, and two years were similar between the two groups (Lazkani, 2018).

A systematic review/meta-analysis of 16 studies (n=12,330) analyzed the relationship between

mortality and body weight after transcatheter aortic valve implantation. Each increase of 1 kg/m2

was associated with lower mortality after 30 days and superior long-term survival (P <.001 for both).

The 30-day mortality rate for obese patients compared with normal-weight patients was 31 percent

lower (P =.0024), leading authors to suggest the existence of an “obesity paradox” (Lv, 2017).

An analysis of 12 studies (n=1223) of patients undergoing transcatheter aortic valve implantation

documented a mortality rate of 13.0 percent (n=249, with 119 dying less than a month after the

procedure). During the first month, the most frequent causes of death were cardiac failure/multi-

organ failure (24 percent), sudden death/cardiac arrest (17), vascular and bleeding complications

(17), stroke (11), sepsis (11), and cardiac tamponade (10) (Moreno, 2011).

A meta-analysis of 28 studies (n=23,587) assessed whether transcatheter aortic valve implant had an

effect on stroke risk, compared to surgery. Compared to the surgical group, the transcatheter group

had (insignificantly) lower rates of stroke (2.7 versus 3.1 percent, P =.08) and disabling stroke (2.5

versus 2.9, P =.89) after 30 days. After one year, similar rates for stroke (5.0 versus 4.6 percent, P

=.96) and disabling stroke (4.1 versus 4.5 percent, P =.71) were found (Shah, 2018).

A systematic review/meta-analysis of 32 studies compared 30-day readmission rates for

transcatheter aortic valve replacement and surgery. The two rates were similar but both relatively

high, at 17 and 16 percent (Danielsen, 2018).

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A meta-analysis of 49 studies (n=16 063) of patients who underwent transcatheter aortic valve

implantation found that heart block requiring a permanent pacemaker was five times more common

with the CoreValve than the Sapien valve (25.2 versus 5.0 percent). The vascular complication rate was

highest with the Sapien valve (22.3 percent versus under 10.4 percent) (Khatri, 2013). Similar results for

pacemaker need was found in a meta-analysis of 8536 patients (Jilaihawi, 2012).

A systematic review of 21 studies (n=6463) of patients with severe mitral regurgitation at high surgical

risk compared outcomes for MitraClip with mitral valve surgery. No significant difference was observed

in technical success for MitraClip versus surgery (96 versus 98 percent). Pooled mortality at 30 days and

one year were 3.2 and 13.0 percent, leading authors to conclude that treatment of high-risk patients in

need of mitral valve procedures with MitraClip is equally effective as surgery (Philip, 2014). These

results support a systematic review of 12 studies reporting that procedural success, 30 day mortality,

functional status improvement, and survival for MitraClip was a viable option in treating high-risk

patients with severe mitral regurgitation (Munkholm-Larsen, 2014).

A systematic review/meta-analysis of persons in their 80s compared outcomes from transcatheter

mitral valve replacement and repair. The 30 day mortality was higher for replacement (10 studies,

n=3105, 13 percent) than repair (six studies, n=2642, seven percent), but not statistically significant, nor

was the difference in postoperative stroke (four versus three percent). Survival rates were higher for

repair at one year (69 versus 67 percent), and for replacement at five years (29 versus 23 percent).

Selecting which patients in their 80s should undergo the procedure is important (Andalib, 2014).

A systematic review of 37 observational studies showed patients functional status after transcatheter

mitral valve replacement (MitraClip) showed improvements in average New York Heart Association

class (20/29 studies), physical and mental Short-Form-12/36 scores (7/7), six minute walk distance

(9/15), and Minnesota Living with Heart failure questionnaire (8/8) (Iliadis, 2017). However, after four

years of follow up, patients with the MitraClip require mitral valve surgery more frequently (Mauri,

2013).

Some patients with moderate to severe aortic and mitral stenosis undergo combined transfer aortic and

mitral valve interventions. A systematic review of 37 studies (n=60) followed for a year showed a

mortality rate of 25 percent, and rare cases of paravalvular regurgitation after the procedure. Authors

classified outcomes as “reasonable” (Ando, 2018).

A review of 24 articles in the medical literature assessed the cost effectiveness of both transcatheter

aortic (and transcatheter mitral) valve replacement for high-risk patients. Both were considered cost

effective compared to medical management (Gialama, 2018).

Policy updates:

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A total of three guidelines/other and 18 peer-reviewed references were added to, and 14 peer-reviewed

references removed from this policy in August 2018.

Summary of clinical evidence:

Citation Content, Methods, Recommendations

Panoulas (2018)

Female versus male

mortality rates,

transcatheter aortic

replacement versus

surgery

Key points:

Meta-analysis of four randomized controlled trials (n=3758), patients with severe aortic

stenosis.

Group included 1706 females and 2052 males.

Comparison of mortality between transcatheter aortic valve replacement and traditional

surgery.

Female transcatheter mortality was significantly lower at one and two years (Odds Ratio

(OR) = 0.68, 0.74).

Male transcatheter mortality was not significantly different at one and two years (OR =

1.09, 1.05).

Khan (2017)

Transcatheter aortic

valve replacement for

low- and intermediate-

risk aortic stenosis

Key points:

Review of 12 randomized controlled studies and prospective matched studies (n=9851),

patients with low- and intermediate-risk aortic stenosis.

Transcatheter aortic valve replacement compared to surgery.

Mortality for transcatheter group similar to surgical group in the short term (Odds Ratio

(OR) 1.19, P = 0.30), mid-term (OR 0.97, P = 0.84), and long term, (OR 0.97, P = 0.76).

The transcatheter group showed a lower risk of acute kidney injury and new-onset atrial

fibrillation (P < 0.05).

The transcatheter group showed a greater risk of permanent pacemaker implantation and

paravalvular leaks (Khan, 2017).

Nishimura (2014)

American Heart

Association/American

College of Cardiology

guideline for the

management of patients

with valvular heart

disease

Key points:

American Heart Association/American College of Cardiology guidelines established

stages of severity for consideration of left heart valvular replacement and repair.

o Stages A and B include patients at risk and asymptomatic patients with less than

severe valve regurgitation.

o Stage C encompasses patients who meet criteria for severe mitral regurgitation

but remain asymptomatic.

The new definition of severe mitral regurgitation is based on integration of multiple

parameters, including valve anatomy, regurgitant severity, ventricular size and systolic

function and other consequences of chronic volume overload, such as pulmonary

hypertension and atrial fibrillation.

An effective orifice area of 0.4 cm2 or greater was defined as severe mitral regurgitation

because natural history studies have demonstrated poor clinical outcomes in patients

with this degree of valve regurgitation.

Adams (2014)

Transcatheter aortic-

Key points:

All-cause mortality was significantly lower in the transcatheter aortic valve replacement

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Citation Content, Methods, Recommendations

valve replacement with a

self-expanding prosthesis

group (14.2%) than the surgical aortic valve replacement group (19.1%) using Medtronic’s

CoreValve self-expanding prosthesis.

Exploratory analysis suggested a reduction in the rate of adverse cardiovascular and

cerebrovascular events and no increase in the risk of stroke.

The rate of major adverse cardiovascular and cerebrovascular events at one year was

significantly lower in the transcatheter aortic valve replacement group than the surgical

aortic valve replacement group (20.4% and 27.3%,respectively).

Khatri (2013)

Adverse Effects

Associated with

Transcatheter Aortic

Valve

Implantation.

Key points:

Survival:

o Overall — 30-day survival rate was 91.9%.

o Sapien valves — Transarterial replacement survival rates were significantly

higher than transapical replacement at 30 days (93.7% vs. 90.0%), and higher

at one year (80.2% vs. 74.7%).

Stroke:

o Overall — Early stroke rate was 2.9%.

o Sapien valves — Transarterial and transapical stroke rates were 3.5% and

2.8%, respectively.

o CoreValve — Stroke rate was 3.6%.

o Not significantly different.

Vascular complications:

o Overall — Complication rate was 10.4%.

o Method — Vascular complications occurred significantly more with

transarterial procedures than with transapical procedures (14.2% vs. 3.4%).

o Of the patients with transarterially inserted valves, those with the Sapien valve

experienced a significantly higher incidence of vascular complications than those

with CoreValves (22.3% vs. 10.8%).

Permanent pacemaker implantation:

o Overall — Permanent pacemaker implantation rate was 13.1%, making it the most

frequent complication among all the adverse effects.

o Device — The pacemaker implantation rate was five times higher for patients

receiving the CoreValve (25.2%) than for those receiving the Sapien valve (5.0%)

via the transarterial route.

Renal replacement therapy:

o Overall — Renal replacement therapy for acute renal failure rate was 4.9%.

o Sapien valves — The need for renal replacement therapy was significantly

higher with transapical procedures than transarterial procedures (8.2% vs.

2.8%).

Aortic regurgitation:

o Overall — Moderate to severe aortic regurgitation rate post-procedure was 4.5%.

o Sapien valves: Rates of aortic regurgitation were lower with the transapical

approach (1.4%) than the transarterial approach (4.6%), but this difference is

not statistically significant.

Valve embolism, myocardial infarction and coronary obstruction:

o Overall — Rates of valve embolization (1.3%), myocardial infarction (1.1%) and

coronary obstruction (0.8%) were relatively low.

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Citation Content, Methods, Recommendations

o Sapien valves — Myocardial infarction was more common transapically than

transarterially (1.9% vs. 0.8%). No differences between valve types or routes of

access were evident among cases involving valve embolization or coronary

obstruction.

Valve-in-valve implantation and conversion to open-heart surgery:

o Overall — Rates of valve-in-valve implantation and conversion to open-heart valve

replacement surgery were 2.2% and 1.2%.

o Devices — CoreValve had a larger rate of valve-in-valve implantation than the

Sapien valve implanted via the transarterial route (3.3% vs. 1.1%).

o Sapien valves — Transapical delivery resulted in a higher valve-in-valve

Mauri (2013)

4-Year results of a

randomized controlled

trial of percutaneous

repair versus surgery for

mitral regurgitation

Key points:

At four-year follow ups after MitraClip repair, the rate of the composite endpoint of

freedom from death, surgery, or 3+ or 4+ mitral regurgitation in the intention-to-treat

population was 39.8% vs. 53.4% in the percutaneous repair group and surgical

groups, respectively (P = 0.070).

Rates of death were 17.4% vs. 17.8% (P = 0.914), and 3+ or 4+ mitral regurgitation was

present in 21.7% vs. 24.7% (P = 0.745) at four-year follow ups, respectively.

Surgery for mitral valve dysfunction, however, occurred in 20.4% vs. 2.2% (P < 0.001) at 1

year and 24.8% vs. 5.5% (P < 0.001) at four years.

Kodali (2012)

Two-Year Outcomes

after Transcatheter or

Surgical Aortic-Valve

Replacement

Key points:

Mortality after transcatheter aortic valve replacement remained similar to that after

surgical replacement.

Stroke frequency was similar in the surgery and transcatheter groups after 30 days.

Periprocedural complications (strokes, major bleeding and major vascular events)

Affected mortality after transcatheter or surgical replacement.

Aortic regurgitation (even mild) after transcatheter was associated with increased

long-term mortality.

Valve performance in the transcatheter group was maintained during follow up and was

similar to that in the surgery group.

Makkar (2012)

Transcatheter Aortic-

Valve Replacement for

Inoperable Severe

Aortic Stenosis

Key points:

Two-year death rates were 43.3% in transcatheter patients and 68.0% in standard

therapy patients (including balloon aortic valvuloplasty).

Cardiac death rates for transcatheter and standard therapy were 31.0% and

62.4%, respectively.

Rate of stroke for transcatheter and standard therapy were 13.8% and 5.5%,

respectively, due to more ischemic events (6.7% and 1.7%).

Two-year rehospitalization rates for transcatheter and standard therapy were 35.0% and

72.5%, respectively.

Patients with severe aortic stenosis undergoing transcatheter had reduced rates of

death and hospitalization, with a decrease in symptoms and an improvement in valve

hemodynamics that were sustained at two- ears of follow up.

Smith (2012)

Key points:

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Citation Content, Methods, Recommendations

Clinical trial of

transcatheter aortic valve

replacement versus

surgery

Trial of 699 high-risk patients with severe aortic stenosis (PARTNER trial).

At 30 days, transcatheter group had lower mortality (3.4 percent (%) versus 6.5%, P =.07).

At one year, transcatheter group had similar mortality (24.2% versus 26.8% (P =.44).

At 30 days, transcatheter group had higher major stroke (3.8% versus 2.1%, P =.20).

At one year, transcatheter group had higher major stroke (5.1% versus 2.4%, P =.07).

At 30 days, transcatheter group had higher major vascular complications (11.0 versus 3.2

(P <.001).

At 30 days, transcatheter group had lower major bleeding (9.3% versus 19.5% (P <.001).

At 30 days, transcatheter group had lower new onset atrial fibrillation (8.6% versus 16.0%

(P =.006).

References

Professional society guidelines/other:

Mant J, Al-Mohammad A, Bolton P, et al. Acute heart failure: diagnosing and managing acute heart

failure in adults. London: National Institute for Health and Care Excellence, 2014.

https://www.nice.org.uk/guidance/cg187. Accessed August 27, 2018.

Nishimura RA, Otto CM, Bonow RO, et al. American College of Cardiology/American Heart Association

Task Force on Practice Guidelines. 2014 AHA/ACC 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. 2014;63(22):e57-185. Doi: 10.1016/j.jacc.2014.02.536.

Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC

guideline for the management of patients with valvular heart disease: A report of the American College

of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation.

2017;135:e1159–e1195. DOI: 10.1161/CIR.0000000000000503.

O’Gara PT, Calhoon JH, Moon MR, Tommaso CL. Transcatheter Therapies for Mitral Regurgitation. A

Professional Society Overview from the American College of Cardiology, American Association for

Thoracic Surgery, Society for Cardiovascular Angiography and Interventions Foundation, and the Society

of Thoracic Surgeons, 2013. https://www.nice.org.uk/guidance/cg187/chapter/1-

Recommendations#initial-nonpharmacological-treatment. Accessed August 23, 2018.

O'Gara PT, Calhoon JH, Moon MR, Tommaso CL. Transcatheter Therapies for Mitral Regurgitation: A

Professional Society Overview From the American College of Cardiology, the American Association for

Thoracic Surgery, Society for Cardiovascular Angiography and Interventions Foundation, and The Society

of Thoracic Surgeons. Journal of the American College of Cardiology. 2014; 63(8):840-852. Doi:

10.1016/j.jacc.2013.11.014.

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Otto CM, Kumbhani DJ, Alexander KP, et al. 2017 ACC expert consensus decision pathway for

transcatheter aortic valve replacement in the management of adults with aortic stenosis: A report of the

American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol.

2017;69(10). Doi: 10.1016/j.jacc.2016.12.006.

Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease

(version 2012). The Joint Task Force on the Management of Valvular Heart Disease of the European

Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). European

Heart Journal. 2012;42(4):S1-44. Doi:10.1093/ejcts/ezs455.

Peer-reviewed references:

Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding

prosthesis. N Engl J Med. 2014; 370(19):1790-1798. Doi: 10.1056/NEJMoa1400590.

Andalib A, Mamane S, Schiller I, et al. A systematic review and meta-analysis of surgical outcomes

following mitral valve surgery in octogenarians: implications for transcatheter mitral valve interventions.

EuroIntervention. 2014;9(10):1225-1234. Doi: 10.4244/EIJV9I10A205.

Ando T, Takagi H, Briasoulis A, et al. A systematic review of reported cases of combined transcatheter

aortic and mitral valve interventions. Catheter Cardiovasc Interv. 2018;91(1):124-134. Doi:

10.1002/ccd.27256.

Conradi L, Seiffert M, Treede H, et al. Transcatheter aortic valve implantation versus surgical aortic

valve replacement: A propensity score analysis in patients at high surgical risk. The Journal of Thorac

Cardiovasc Surg. 2012;143(1):64-71. Doi: 10.1016/j.jtcvs.2011.08.047.

Danielsen SO, Moons P, Sandven I, et al. Thirty-day readmissions in surgical and transcatheter aortic

valve replacement: A systematic review and meta-analysis. Int J Cardiol. 2018;268:85-91. Doi:

10.1016/j.ijcard.2018.05.026.

Foster E, Kwan D, Feldman T, et al. Percutaneous mitral valve repair in the initial EVEREST cohort.

Circ Cardiovasc Imaging. 2013;6(4):522-530. Doi: 10.1161/CIRCIMAGING.112.000098.

Gialama F, Prezerakos P, Apostolopoulos V, Maniadakis N. Systematic review of the cost-effectiveness

of transcatheter interventions for valvular heart disease. Eur Heart J Qual Care Clin Outcomes.

2018;4(2):81-90. Doi: 10.1093/ehjqcco/qcx049.

Glower D, Ailawadi G, Argenziano M, et al. EVEREST II randomized clinical trial: Predictors of mitral

valve replacement in de novo surgery or after the MitraClip procedure. The Journal of Thoracic and

Cardiovascular Surgery. 2012;143(4Suppl):S60-S63. Doi: 10.1016/j.jtcvs.2012.01.047.

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Iliadis C, Lee S, Kuhr K, et al. Functional status and quality of life after transcatheter mitral valve repair:

a prospective cohort study and systematic review. Clin Res Cardiol. 2017;106(12):1005-1017. Doi:

10.1007/s00392-017-1150-x.

Jilaihawi H, Chakravarty T, Weiss RE. Meta-analysis of complications in aortic valve replacement:

comparison of Medtronic-Corevalve, Edwards-Sapien and surgical aortic valve replacement in 8,536

patients. Catheter Cardiovasc Interv. 2012;80(1):128-38. Doi: 10.1002/ccd.23368.

Khatri PJ, Webb JG, Rodés-Cabau J, et al. Adverse effects associated with transcatheter aortic valve

implantation. Ann Int Med. 2013;158(1):35-46. Doi: 10.7326/0003-4819-158-1-201301010-00007.

Khan SU, Lone AN, Saleem MA, Kaluski E. Transcatheter vs surgical aortic-valve replacement in low- to

intermediate-surgical-risk candidates: A meta-analysis and systematic review. Clin Cardiol.

2017;40(11):974-981. Doi: 10.1002/clc.22807.

Kodali SK, Williams MR, Smth CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve

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Kumar R, Latib A, Colombo A. Self-expanding prostheses for transcatheter aortic valve replacement.

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implantation: a pooled analysis of 12 studies and 1223 patients. J Invasive Cardiol. 2011;23(5):180-184.

Munkholm-Larsen S, Wan B, Tian DH, et al. A systematic review on the safety and efficacy of

percutaneous edge-to-edge mitral valve repair with the MitraClip system for high surgical risk

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Osnabrugge RL, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number

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Saad M, Nairooz R, Pothineni NVK, et al. Long-term outcomes with transcatheter aortic valve

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Centers for Medicare & Medicaid Services National Coverage Determinations:

National Coverage Determination for Transcatheter Aortic Valve Replacement. Effective date May 1,

2012.Accessed August 27, 2018.

Local Coverage Determinations:

No Local Coverage Determinations identified as of the writing of this policy.

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This

is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals

14

and bill accordingly with those manuals.

CPT Code Description Comments

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.

33366 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure.

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.

0345T Transcatheter mitral valve repair percutaneous approach via the coronary sinus.

ICD-10 Code Description Comments

I05.0 Rheumatic mitral stenosis

I05.2 Rheumatic mitral stenosis with insufficiency

I06.0 Rheumatic aortic stenosis

I06.2 Rheumatic aortic stenosis with insufficiency

I08.0 Rheumatic disorders of both mitral and aortic valves

I34.2 Non-rheumatic mitral valve stenosis

I35.0 Non-rheumatic aortic valve stenosis

I35.2 Non-rheumatic aortic valve stenosis with insufficiency

I05.0 Rheumatic mitral stenosis

HCPCS Level II Code

Description Comments

N/A