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Clinical Policy Title: Heart valve transplant

Clinical Policy Number: CCP.1210

Effective Date: January 1, 2016

Initial Review Date: November 18, 2015

Most Recent Review Date: November 6, 2018

Next Review Date: November 2019

Related policies:

CCP.1034 Heart transplants

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 heart valve transplants to be clinically proven and, therefore,

medically necessary when the following indications are present (Nishimura, 2014):

Aortic valvular incompetence.

Pulmonary valvular incompetence.

Aortic valvular stenosis.

Pulmonary valvular stenosis.

Complex left ventricular outflow tract obstruction.

Complex right ventricular outflow tract obstruction.

Congenital lesions associated with valvular derangement.

Policy contains:

Bioprosthetic heart valve.

Aortic allograft valve.

Ross procedure.

Valvular heart disease.

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AmeriHealth Caritas considers the use of heart valve tissue engineering based on decellularized

xenogenic or allogeneic starter matrices to be investigationalexperimental and, therefore, not medically

necessary (Weber, 2013).

Limitations:

All other uses of heart valve transplants are not medically necessary.

Absolute contraindications for heart valve transplant recipients include, but are not limited to, the

following:

Metastatic cancer.

Ongoing or recurring infections not effectively treated.

Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant

surgery.

Serious conditions unlikely to be improved by transplantation as life expectancy can be

finitely measured.

Active, systemic lupus erythematosus or sarcoid with multisystem involvement.

Any systemic condition with a high probability of recurrence in the transplanted heart.

Demonstrated patient noncompliance, which places the organ at risk by not adhering to

medical recommendations.

Potential complications from immunosuppressive medications that are unacceptable to the

patient.

Acquired immune deficiency syndrome (diagnosis based on Centers for Disease Control and

Prevention definition of CD4 count, 200 cells/mm3) unless the following are noted:

o CD4 count greater than 200 cells/mm3 for greater than six months.

o Human immunodeficiency virus-1 ribonucleic acid undetectable.

o Stable antiretroviral therapy longer than three months.

o No other complications from acquired immune deficiency syndrome (e.g.,

opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis,

resistant fungal infections, Kaposi's sarcoma, or other neoplasm).

Alternative covered services:

Prosthetic cardiac valve implantation.

Background

The aortic valve, one of four valves in the heart that maintain proper blood flow, delivers blood from the

heart to the body. The valve may not function properly, either as a congenital defect or one that

develops later in life. Various types of aortic valve disease are known. The valve may not close properly;

among the most common heart valve disorders are regurgitation (blood leaking backward to the left

ventricle) and stenosis (narrowed valve). Rates are increasing because of the growing elderly population,

which have higher prevalence of heart valve disease (Vahanian, 2011).

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Symptoms of aortic valve disease include heart murmur, shortness of breath, dizziness, fainting, chest

pain or tightness, irregular heartbeat, fatigue or reduced activity, and swelling of the feet and ankles.

Children may not eat enough and not gain enough weight. Aortic valve disease raises the risk of stroke,

blood clots, and heart rhythm abnormalities (Mayo Clinic, 2018).

Valvular heart disease is frequently undiagnosed. A large-scale screening program increased the

prevalence of valvular heart disease among the elderly by 51 percent, with a predicted 122 percent

increase by the year 2014 (d’Arcy, 2016).

An estimated 182,000 heart valve transplants are conducted in the United States each year

(iDataResearch, 2018). The most common treatment for end-stage valvular heart diseases is surgical

replacement by either mechanical or bioprosthetic heart valves. Bioprosthetic heart valve replacements

are either of animal origin (xenografts) or taken from human donors (homografts). Cryopreserved donor

valves are the heart valve replacements closest to the natural valve, being non-thrombogenic and

having a low risk of infection.

An emerging trend in treatment of aortic stenosis by transcatheter approaches (transfemoral,

transapical) has created a body of evidence regarding the efficacy and safety of minimally invasive

implantation of a mechanical prosthetic versus open-surgical transplantation of tissue. In general,

patients who are younger (i.e., < 60 years of age) and who can tolerate lifetime anticoagulation

medication may benefit more from a minimally invasive mechanical device implantation than a

bioprosthetic.

Over time, several types of new, less invasive procedures have become available to surgically transplant

heart valves. Two of these are transcatheter aortic valve replacement and sutureless aortic valve

replacement, which are now used more frequently than the traditional surgical methods (Shinn, 2018).

The Ross procedure was first devised in 1967 and sought to provide a permanent aortic valve

substitution which would not degenerate like a homograft valve and would not require chronic anti-

coagulation therapy like a prosthetic valve. Ross sought to attain a balance between a more complicated

surgical procedure (essentially a double valve replacement) and a potentially more durable and

physiologic aortic valve replacement. It is thought that the autografted pulmonary valve will grow with

the young patient, thus obviating the need for re-operation. Ross is now being used more frequently

than other mechanical and homograft aortic valve replacement (Etnel, 2016).

Searches

AmeriHealth Caritas searched PubMed and the databases of:

• UK National Health Services Center for Reviews and Dissemination.

• Agency for Healthcare Research and Quality’s National Guideline Clearinghouse and other

evidence-based practice centers.

• The Centers for Medicare & Medicaid Services.

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We conducted searches on September 24, 2018. Search terms were: "heart valve transplant ," "valve

allograft," and "prosthetic heart valve."

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

An American College of Cardiology/American Heart Association Task Force published guidelines for the

management of patients with valvular heart disease — including criteria for heart valve transplantation

— that are summarized in Appendix A (Nishimura, 2014).

The European Society of Cardiology also has guidelines for when heart valve transplant should be

considered, including:

1. In symptomatic patients with left ventricular ejection fraction and low-flow, low-gradient aortic

stenosis (valve area less than 1 cm2, fraction less than 40 percent, mean pressure gradient less

than 40 mm Hg), low-dose dobutamine stress echocardiography should be considered to

identify those with severe aortic stenosis suitable for valve replacement.

2. Patients with severe aortic stenosis who are not suitable for surgery as assessed by a “heart

team” and have predicted post-transcatheter aortic valve implantation survival greater than one

year.

3. Patients fit for surgery with severe aortic regurgitation (all symptomatic and asymptomatic

patients with resting left ventricular ejection fraction up to 50 percent (Ponikowski, 2016).

A meta-analysis of four studies (n = 4,125) assessed quality of life for transcatheter aortic valvular

replacement versus surgical aortic valve replacement. Transfemoral transcatheter patients had higher

quality of life scores at 30 days, but no differences were noted between groups at one year (Ando,

2018).

A systematic review/meta-analysis of 34 studies and 42 cohorts (n = 3,105 children) followed aortic

valve replacement patients for an average of 6.6 years. Compared with other mechanical aortic valve

replacement and homograft aortic valve replacement, patients with the Ross procedure had significantly

lower early mortality rates (4.20 versus 7.34 and 12.82 percent) and lower late mortality rates (0.64

versus 1.23 and 1.59 percent) (Etnel, 2016).

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A large systematic review of 93 studies (n = 53,884) consisted of mostly males with aortic stenosis and

aortic valve replacement with a prosthetic valve who were followed for at least two years. Median

survival was 16 years (patients less than age 65), 12 years (65 to 75), seven years (75 to 85), and six

years (over 85). The incidence of stroke was 0.25 per 100 patient years, and 2.90 for atrial fibrillation.

Freedom from structural valve deterioration was 94.0 percent, 81.7 percent, and 52.0 percent at 10, 15,

and 20 years. These data represent only slightly better survival than valve replacement patients without

aortic stenosis (Foroutan, 2016).

A systematic review/meta-analysis of five studies (n = 342) compared surgical aortic valve replacement

with valve-in-valve transcatheter aortic valve implantation for patients with failed degenerated aortic

bioprostheses. No difference was observed between the two groups in total mortality during the

procedure (P = .67), at 30 days (P = .64), and cardiovascular mortality at an average follow-up of 18

months (P = .86). Valve-in-valve procedures versus surgical re-do had greater cumulative survival (P =

.039), permanent pacemaker implantations (P = .002), and shorter intensive care unit stays (P < .001)

and hospital stays (P = .02). Surgical re-do was associated with lower incidence of patient-prosthesis

mismatch (P  = .008), fewer paravalvular leaks (P  = .023), and lower mean postoperative aortic valve

gradients in the pre-specified analysis (P  = .017) (Godzek, 2018).

Transcatheter aortic valve implantation studies have generally assessed high-risk patients. One

systematic review/meta-analysis of 12 studies (n = 9,851) included low- and intermediate-risk patients.

All-cause mortality between transcatheter and surgical patients was similar in the short term (odds ratio

1.19, P = .30), mid term (odds ratio 0.97, P = 0.84), and long term (odds ratio 0.97, P = 0.76). No

significant differences were noted for stroke, and reduced risk of acute kidney injury and new-onset

atrial fibrillation in the transcatheter group (P < .05) was observed. Increased incidence of permanent

pacemaker implantation and paravalvular leaks were observed in the transcatheter group (Khan, 2017).

A systematic review/meta-analysis of seven studies (n = 1,148) of patients with prior cardiac surgery

(97.6 percent bypass) compared surgical and transcatheter aortic valve replacement from 2011 to 2015.

The transcatheter group had significantly lower incidence of stroke (3.8 percent versus 7.9 percent, P =

.04) and major bleeding (8.3 percent versus 15.3 percent, P = .04). The transcatheter group had a

significantly higher incidence of mild/severe paravalvular leakage (14.4 percent /10.9 percent versus 0.0

percent, P < .0001) and pacemaker implantation (11.3 percent versus 3.9 percent, P = .01). No significant

differences between groups were observed in the incidence of acute kidney injury (9.7 percent versus

8.7 percent, P = .99), major adverse cardiovascular events (8.7 percent versus 12.3 percent, P = 0.21),

30-day mortality (5.1 percent versus 5.5 percent, P = .70), or one-year mortality (11.6 percent versus

11.8 percent, P = .97) (Sheheda, 2018).

A systematic review and meta-analysis of eight studies (n = 1,775) found early and standard discharges

had similar 30-day mortality rates (odds ratio 0.65) and similar discharge to 30-day new permanent

pacemaker implementation (odds ratio 1.61). Early discharge patients were less likely to be readmitted

when compared with standard discharge patients (P = .04) (Kotronias, 2018).

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A systematic review and meta-analysis of 15 studies (n = 5,346) showed persons undergoing the Ross

procedure had decreased late mortality, compared with prosthetic and homographic aortic valve

replacement patients. No difference was observed in mortality less than 30 days after surgery (McClure,

2018).

A systematic review of nine studies (n = 769) consisted of elderly patients with prior cardiac surgery who

underwent transcatheter aortic valve implementation, 96 percent of which were coronary artery bypass

graft. The 30-day mortality was 5.6 percent, not significantly higher compared to patients with no

history of prior cardiac surgery. Incidence of stroke, myocardial infarction, acute kidney injury, and

permanent pacemaker implantation were 3.6 percent, 1.7 percent, 13.8 percent, and 14.2 percent;

authors conclude the transcatheter method is an attractive alternative in heart valve transplant

(Shehada, 2017).

A systematic review of 50 studies (n = 7,063) followed patients for a median of two to three years.

Infective endocarditis rates were higher for patients with bovine jugular vein valves versus other valves,

the difference of 5.4 percent versus 1.2 percent was statistically significant at P < .0001. For patients

with bovine valves, incidence of infective endocarditis was not significantly different (P = .83) between

surgical and catheter-based valve implantation (Sharma, 2017).

A systematic review/meta-analysis of 15 studies (two randomized controlled) included 1,412 patients

who underwent aortic valve replacement. Patients with Ross procedure had a lower (superior) mean

aortic gradient at discharge and latest follow-up, significant for both at P < .0001. No significant

difference was observed in the incidence of severe aortic regurgitation at latest follow-up between

patients undergoing the Ross procedure and those having other procedures (Um, 2018).

A systematic review/meta-analysis of three studies (n = 1,852) assessed outcomes of elderly patients

who received transcatheter aortic valve replacement because surgery was contraindicated. One trial (n

= 358) showed superior all-cause mortality for transcatheter patients versus those with medical therapy

(hazard ratios at one and five years were 0.58 and 0.50). The other two trials showed no significant

differences between transcatheter and surgical approaches in mortality at one and five years (hazard

ratios 1.03 and 0.83), and thus the study concluded that the transcatheter approach was effective when

surgery was contraindicated (Liu, 2018).

A meta-analysis of four randomized controlled trials (n = 3,758), recognizing that mortality was lower for

transcatheter aortic valve implantation than it was for surgery, analyzed patterns for both genders. For

females, death rates for those in the transcatheter group were significantly lower (odds ratios 0.68 and

0.74 at one and two years). For males, there was no mortality difference for the same time periods (1.09

and 1.05). No explanation was offered for this pattern (Panoulas, 2018).

A systematic review/meta-analysis of seven studies (n = 1,238) compared sutureless aortic valve

replacement with transcatheter aortic valve implantation, two recently-developed methods. Early

mortality was significantly lower in the sutureless group (2.5 versus 5 percent, P = .02), as was post-

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procedural significant paravalvular leak (P < .0001). Post-procedural stroke and need for pacemaker

were not significantly different (Shinn, 2018).

A systematic review/meta-analysis of 33 articles compared 30-day hospital readmissions for surgical and

transcatheter aortic valve replacement. No significant difference existed between the surgical and

transcatheter groups (17 percent versus 16 percent); both were judged to be high by authors

(Danielsen, 2018).

Heart valve tissue engineering based on decellularized xenogenic or allogeneic starter matrices is

feasible today; however, availability of healthy homologous donor valves is limited, and xenogenic

materials are associated with infectious and immunologic risks (Weber, 2013). To address such

limitations, biodegradable synthetic materials have been pursued as a means for the creation of living

autologous tissue-engineered heart valves in vitro. The host repopulation capacity of such technology in

a non-human primate model with up to eight weeks’ follow-up revealed mobile and thin leaflets after

eight weeks, with mild-to-moderate valvular insufficiency and relative leaflet shortening. These results

suggest that human cell-derived bioengineered decellularized materials are a promising start for heart

valve tissue engineering.

A systematic review/meta-analysis of four trials (n = 3,179) showed that, compared with surgery,

transcatheter aortic valve implantation reduced mortality, stroke, life-threatening bleeding, atrial

fibrillation, and acute kidney injury. However, the treatment was linked to higher short-term aortic valve

re-intervention, permanent pacemaker insertion, and moderate or severe symptoms of heart failure

(Siemieniuk, 2016). Policy updates:

A total of four guidelines/other and 13 peer-reviewed references were added to, and three peer-

reviewed references removed from, this policy in September 2018.

Summary of clinical evidence:

Citation Content

Panoulas (2018) Differences in transcatheter and surgical aortic valve replacement by gender

Key points:

Meta-analysis of four randomized controlled trials (n = 3,758). Prior studies show lower mortality for transcatheter aortic valve implantation than surgery. For females, one- to two-year death rates in the transcatheter group were significantly lower

(odds ratios 0.68 and 0.74). For males, no difference in one- to two-year death rates were observed between

transcatheter and surgical groups for the same periods (1.09 and 1.05). No explanation was offered for this pattern.

Shehada (2018) Outcomes for heart valve implantation patients with prior cardiac surgery

Key points:

Systematic review/meta-analysis of seven studies (n = 1,148), 2011 – 2015. All patients had prior cardiac surgery (97.6 percent coronary artery bypass graft). Outcomes compared for patients with surgical or transcatheter aortic valve replacement. The transcatheter group had significantly lower incidence of stroke (3.8% versus 7.9%, P =

.04) and major bleeding (8.3% versus 15.3%, P = .04).

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The transcatheter group had a significantly higher incidence of mild/severe paravalvular leakage (14.4%/10.9% versus 0.0%, P < .0001) and pacemaker implantation (11.3% versus 3.9%, P = .01).

No significant differences between groups were observed in the incidence of acute kidney injury (9.7% versus 8.7%, P = .99), major adverse cardiovascular events (8.7% versus 12.3%, P = 0.21), 30-day mortality (5.1% versus 5.5%, P = .70), or one-year mortality (11.6% versus 11.8%, P = .97)

Shinn (2018) Sutureless aortic valve replacement compared to transcatheter impantation

Key points:

Systematic review/meta-analysis of seven studies (n = 1,238). Comparison of outcomes of patients who underwent sutureless aortic valve replacement or

transcatheter aortic valve implantation, two recently-developed methods. Early mortality rates were significantly lower in the sutureless group (2.5% versus 5%, P =

.02). Post-procedural significant paravalvular leak risk significantly lower in the sutureless group

(P < .0001). No significant differences observed between the two groups for post-procedural stroke and

need for pacemaker.

Khan (2017) Transcatheter versus surgical outcomes for low/intermediate-risk patients with aortic valve transplant

Key points:

Systematic review/meta-analysis of 12 studies (n = 9,851) of low/intermediate-risk patients. Those patients who underwent transcatheter or surgical aortic replacement compared. All-cause mortality similar in the short term (odds ratio =1.19, P = .30), mid term (odds ratio

= 0.97, P = 0.84), and long term (odds ratio = 0.97, P = 0.76). No significant differences between groups noted for stroke rate. Reduced risk of acute kidney injury and new-onset atrial fibrillation in the transcatheter group

(P < .05) was observed. Increased incidence of permanent pacemaker implantation and paravalvular leaks were

observed in the transcatheter group.

Etnel (2016) Outcomes for types of aortic valve replacement in children

Key points:

Systematic review/meta-analysis of 34 studies and 42 cohorts (n = 3,105 children). Subjects followed for an average of 6.6 years after aortic valve replacement. Compared with other mechanical aortic valve replacement and homograft aortic valve

replacement, patients with the Ross procedure had significantly lower early mortality rates (4.20% versus 7.34% and 12.82%) and lower late mortality rates 0.64% versus 1.23% and 1.59%).

References

Professional society guidelines/other:

D’Arcy JL, Coffey S, Loudon MA, et al. Large-scale community echocardiographic screening reveals a

major burden of undiagnosed valvular heart disease in older people: the OxVALVE Population Cohort

Study. Eur Heart J. 2016;37(47):3515-3522. Doi: 10.1093/eurheartj/ehw229.

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iDataResearch. Over 182,000 heart valve replacements per year in the United States. Burnaby, British

Columbia: idataresearch, 2018. https://idataresearch.com/over-182000-heart-valve-replacements-per-

year-in-the-united-states/. Accessed September 25, 2018.

Mayo Clinic. Aortic Valve Disease. Rochester MN: Mayo Clinic, March 8, 2018.

https://www.mayoclinic.org/diseases-conditions/aortic-valve-disease/symptoms-causes/syc-20355117.

Accessed September 25, 2018.

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

Association (AHA) Task Force. Guidelines for the management of patients with valvular heart disease:

executive summary: a report of the American College of Cardiology/American Heart Association Task

Force on Practice Guidelines. Circulation. 2014 10;129(23):2440-2492.

Doi:10.1161/CIR.0000000000000029.

Ponikowski P, Voors AA, Ander SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute

and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart

failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart

Failure Association (HFA) of the ESC. Eur Heart J. 2016; 37(27):2129-2200. Doi:

10.1093/eurheartj/ehw128.

Peer-reviewed references:

Ando T, Takagi H, Briasoulis A, Grines CL, Afonso L. Comparison of health related quality of life in

transcatheter versus surgical aortic valve replacement: A meta-analysis. Heart Lung Circ. 2018 Aug 17.

pii: S1443-9506(18)31841-9. Doi: 10.1016/j.hlc.2018.07.013.

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.

Etnel JR, Elmont LC, Ertekin E, et al. Outcome after aortic valve replacement in children: A systematic

review and meta-analysis. J Thorac Cardiovasc Surg. 2016;151(1):143-152.e1-3. Doi:

10.1016/j.jtcvs.2015.09.083.

Foroutan F, Guyatt GH, O'Brien K, et al. Prognosis after surgical replacement with a bioprosthetic aortic

valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies.

BMJ. 2016 28;354:i5065. Doi: 10.1136/bmj.i5065.

Godzek M, Raffa GM, Suwalski P, et al. Comparative performance of transcatheter aortic valve-in-valve

implantation versus conventional surgical redo aortic valve replacement in patients with degenerated

aortic valve bioprostheses: systematic review and meta-analysis. Eur J Cardiothorac Surg.

2018;53(3):495-504. Doi: 10.1093/ejcts/ezx347.

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Huygens SA, Mokhles MM, Hanif M, Bekkers JA, Bogers AJ, Rutten-van Mölken MP, Takkenberg JJ.

Contemporary outcomes after surgical aortic valve replacement with bioprostheses and allografts: a

systematic review and meta-analysis. Eur J Cardiothorac Surg. 2016;50(4):605-616. Epub 2016 Mar 29.

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.

Kotronias RA, Teitelbaum M, Webb JG, et al. Early versus standard discharge after transcatheter aortic

valve replacement: A systematic review and meta-analysis. JACC Cardiovasc Interv. 2018;11(17):1759-

1771. Doi: 10.1016/j.jcin.2018.04.042.

Liu Z, Kidney E, Bem D, et al. Transcatheter aortic valve implantation for aortic stenosis in high surgical

risk patients: A systematic review and meta-analysis. PLoS One. 2018;13(5):e0196877. Doi:

10.1371/journal.pone.0196877.

McClure GR, Belley-Cote EP, Um K, et al. The Ross procedure versus prosthetic and homograft aortic

valve replacement: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2018. Doi:

10.1093/ejcts/ezy247.

Panoulas VF, Francis DP, Ruparelia N, et al. Female-specific survival advantage from transcatheter aortic

valve implantation over surgical aortic valve replacement: Meta-analysis of the gender subgroups of

randomised controlled trials including 3758 patients. Int J Cardiol. 2018;250:66-72. Doi:

10.1016/j.ijcard.2017.05.047.

Sharma A, Cote AT, Hosking MCK, Harris KC. A systematic review of infective endocarditis in patients

with bovine jugular vein valves compared with other valve types. JACC Cardiovasc Interv.

2017;10(14):1449-1458. Doi: 10.1016/j.jcin.2017.04.025.

Shehada SE, Elhmidi Y, Puluca N, et al. Impact of previous cardiac surgery in patients undergoing

transcatheter aortic valve implantation: a systematic review. J Cardiovasc Surg (Torino). 2017;58(5):787-

793. Doi: 10.23736/S0021-9509.17.09636-7.

Shehada SE, Elhmidi Y, Ozturk O, et al. Transcatheter versus surgical aortic valve replacement after

previous cardiac surgery: A systematic review and meta-analysis. Cardiol Res Pract. 2018;2018:4615043.

Doi: 10.1155/2018/4615043.

Siemieniuk R, Agoritsas T, Manja V, et al. Transcatheter versus surgical aortic valve replacement in

patients with severe aortic stenosis at low and intermediate risk: systematic review and meta-analysis

BMJ 2016;354:i5130. Doi: 10.1136/bmj.i5130.

Um KJ, Mcclure GR, Belley-Cote EP, et al. Hemodynamic outcomes of the Ross procedure versus other

aortic valve replacement: a systematic review and meta-analysis. J Cardiovasc Surg (Torino).

2018;59(3):462-470. Doi: 10.23736/S0021-9509.18.10255-2.

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Vahanian A, Iung B, Himbert D, Nataf P. Changing demographics of valvular heart disease and impact on

surgical and transcatheter valve therapies. Int J Cardiovasc. 2011;27(8):1115-1122. Doi: 10.1007/s10554-

011-9804-7.

Weber B, Dijkman PE, Scherman J, et al. Off-the-shelf human decellularized tissue-engineered heart

valves in a non-human primate model. Biomaterials. 2013;34(30):7269-7280. Doi:

10.1016.jbiomaterials.2013.04.059.

Centers for Medicare & Medicaid Systems National Coverage Determination:

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

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 and

bill accordingly.

ICD-10 Code Description Comment

I06.0 – I06.9 Rheumatic aortic valve diseases I08.0 Rheumatic disorders of both mitral and aortic valves

I35.0 – I35.9 Nonrheumatic aortic valve disorders

CPT Code Description Comment

33406 Replacement, aortic valve, with cardiopulmonary bypass; with allograft valve (freehand)

33410 Replacement, aortic valve, with cardiopulmonary bypass; with stentless tissue valve 33411 Replacement, aortic valve; with aortic annulus enlargement, noncoronary sinus

33412 Replacement, aortic valve; with transventricular aortic annulus enlargement (Konno procedure)

33413 Replacement, aortic valve; by translocation of autologous pulmonary valve with allograft replacement of pulmonary valve (Ross procedure)

33475 Replacement, pulmonary valve

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I37.0 – I37.9 Nonrheumatic pulmonary valve disorders I44.0 – I44.5 Atrioventricular block

Q22.0 Pulmonary valve atresia Q22.1 Congenital pulmonary valve stenosis Q22.3 Other congenital malformations of pulmonary valve Q23.0 Congenital stenosis of aortic valve Q23.1 Congenital insufficiency of aortic valve Q23.8 Other congenital malformations of aortic and mitral valves Q23.9 Congenital malformation of aortic and mitral valves, unspecified

HCPCS Code Level II

Description Comment

N/A

Appendix A

ACC/AHA (2014) guidelines for the management of patients with valvular heart disease:

Evaluation and Selection of Prosthetic Valves

10.1.1. Diagnosis and Follow-Up

Class I

1. An initial TTE study is recommended in patients after prosthetic valve implantation for

evaluation of valve hemodynamics. (Level of Evidence: B)

2. Repeat TTE is recommended in patients with prosthetic heart valves if there is a change in

clinical symptoms or signs suggesting valve dysfunction. (Level of Evidence: C)

3. TEE is recommended when clinical symptoms or signs suggest prosthetic valve dysfunction.

(Level of Evidence: C)

Class IIa

1. Annual TTE is reasonable in patients with a bioprosthetic valve after the first 10 years, even in

the absence of a change in clinical status. (Level of Evidence: C)

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10.1.2. Intervention

Class I

1. The choice of valve intervention, that is, repair or replacement, as well as type of prosthetic

heart valve, should be a shared decision-making process that accounts for the patient's values

and preferences, with full disclosure of the indications for and risks of anticoagulant therapy and

the potential need for and risk of reoperation. (Level of Evidence: C)

2. A bioprosthesis is recommended in patients of any age for whom anticoagulant therapy is

contraindicated, cannot be managed appropriately, or is not desired. (Level of Evidence: C)

Class IIa

1. A mechanical prosthesis is reasonable for AVR or MVR in patients less than 60 years of age who

do not have a contraindication to anticoagulation. (Level of Evidence: B)

2. A bioprosthesis is reasonable in patients more than 70 years of age. (Level of Evidence: B)

3. Either a bioprosthetic or mechanical valve is reasonable in patients between 60 and 70 years of

age. (Level of Evidence: B)

Class IIb

1. Replacement of the aortic valve by a pulmonary autograft (the Ross procedure), when

performed by an experienced surgeon, may be considered in young patients when VKA

anticoagulation is contraindicated or undesirable. (Level of Evidence: C)

10.2. Antithrombotic Therapy for Prosthetic Valves

Class I

1. Anticoagulation with a VKA and international normalized ratio (INR) monitoring is

recommended in patients with a mechanical prosthetic valve. (Level of Evidence: A)

2. Anticoagulation with a VKA to achieve an INR of 2.5 is recommended in patients with a

mechanical AVR (bileaflet or current-generation single tilting disc) and no risk factors for

thromboembolism. (Level of Evidence: B)

3. Anticoagulation with a VKA is indicated to achieve an INR of 3.0 in patients with a mechanical

AVR and additional risk factors for thromboembolic events (AF, previous thromboembolism, LV

dysfunction, or hypercoagulable conditions) or an older-generation mechanical AVR (such as

ball-in-cage). (Level of Evidence: B)

4. Anticoagulation with a VKA is indicated to achieve an INR of 3.0 in patients with a mechanical

MVR. (Level of Evidence: B)

5. Aspirin 75 mg to 100 mg daily is recommended in addition to anticoagulation with a VKA in

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patients with a mechanical valve prosthesis. (Level of Evidence: A)

Class IIa

1. Aspirin 75 mg to 100 mg per day is reasonable in all patients with a bioprosthetic aortic or mitral

valve. (Level of Evidence: B)

2. Anticoagulation with a VKA is reasonable for the first 3 months after bioprosthetic MVR or

repair to achieve an INR of 2.5. (Level of Evidence: C)

Class IIb

1. Anticoagulation, with a VKA, to achieve an INR of 2.5 may be reasonable for the first 3 months

after bioprosthetic AVR. (Level of Evidence: B)

2. Clopidogrel 75 mg daily may be reasonable for the first 6 months after TAVR in addition to life-

long aspirin 75 mg to 100 mg daily. (Level of Evidence: C)

Class III: Harm

1. Anticoagulant therapy with oral direct thrombin inhibitors or anti-Xa agents should not be used

in patients with mechanical valve prostheses. (Level of Evidence: B)

10.3. Bridging Therapy for Prosthetic Valves

Class I

1. Continuation of VKA anticoagulation with a therapeutic INR is recommended in patients with

mechanical heart valves undergoing minor procedures (such as dental extractions or cataract

removal) where bleeding is easily controlled. (Level of Evidence: C)

2. Temporary interruption of VKA anticoagulation, without bridging agents while the INR is

subtherapeutic, is recommended in patients with a bileaflet mechanical AVR and no other risk

factors for thrombosis who are undergoing invasive or surgical procedures. (Level of Evidence:

C)

3. Bridging anticoagulation with either intravenous unfractionated heparin (UFH) or subcutaneous

low-molecular-weight heparin (LMWH) is recommended during the time interval when the INR

is subtherapeutic preoperatively in patients who are undergoing invasive or surgical procedures

with a 1) mechanical AVR and any thromboembolic risk factor, 2) older-generation mechanical

AVR, or 3) mechanical MVR. (Level of Evidence: C)

Class IIa

1. Administration of fresh frozen plasma or prothrombin complex concentrate is reasonable in

patients with mechanical valves receiving VKA therapy who require emergency noncardiac

surgery or invasive procedures. (Level of Evidence: C)

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10.4. Excessive Anticoagulation and Serious Bleeding With Prosthetic Valves

Anticoagulation for Prosthetic Valves. Risk factors include AF, previous thromboembolism, LV

dysfunction, hypercoagulable condition, and older-generation mechanical AVR. AF indicates

atrial fibrillation; ASA, aspirin; AVR, aortic valve replacement; INR, international normalized

ratio; LMWH, low-molecular-weight heparin; MVR, mitral valve replacement; PO, by mouth; QD,

every day; SC, subcutaneous; TAVR, transcatheter aortic valve replacement; UFH, unfractionated

heparin; and VKA, vitamin K antagonist.

Class IIa

1. Administration of fresh frozen plasma or prothrombin complex concentrate is reasonable in

patients with mechanical valves and uncontrollable bleeding who require reversal of

anticoagulation. (Level of Evidence: B)

10.5. Prosthetic Valve Thrombosis

Evaluation and Management of Suspected Prosthetic Valve Thrombosis.

10.5.1. Diagnosis and Follow-Up

Class I

1. TTE is indicated in patients with suspected prosthetic valve thrombosis to assess hemodynamic

severity and follow resolution of valve dysfunction. (Level of Evidence: B)

2. TEE is indicated in patients with suspected prosthetic valve thrombosis to assess thrombus size

and valve motion. (Level of Evidence: B)

Class IIa

1. Fluoroscopy or CT is reasonable in patients with suspected valve thrombosis to assess valve

motion. (Level of Evidence: C)

10.5.2. Medical Therapy

Class IIa

1. Fibrinolytic therapy is reasonable for patients with a thrombosed left-sided prosthetic heart

valve, recent onset (<14 days) of NYHA class I to II symptoms, and a small thrombus (<0.8 cm2).

(Level of Evidence: B)

2. Fibrinolytic therapy is reasonable for thrombosed right-sided prosthetic heart valves. (Level of

Evidence: B)

10.5.3. Intervention

Class I

1. Emergency surgery is recommended for patients with a thrombosed left-sided prosthetic heart

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valve with NYHA class III to IV symptoms. (Level of Evidence: B)

Class IIa

1. Emergency surgery is reasonable for patients with a thrombosed left-sided prosthetic heart

valve with a mobile or large thrombus (>0.8 cm2). (Level of Evidence: C)

10.6. Prosthetic Valve Stenosis

Class I

1. Repeat valve replacement is indicated for severe symptomatic prosthetic valve stenosis. (Level

of Evidence: C)

10.7. Prosthetic Valve Regurgitation

Class I

1. Surgery is recommended for operable patients with mechanical heart valves with intractable

hemolysis or HF due to severe prosthetic or paraprosthetic regurgitation. (Level of Evidence: B)

Class IIa

1. Surgery is reasonable for operable patients with severe symptomatic or asymptomatic

bioprosthetic regurgitation. (Level of Evidence C)

2. Percutaneous repair of paravalvular regurgitation is reasonable in patients with prosthetic heart

valves and intractable hemolysis or NYHA class III/IV HF who are at high risk for surgery and have

anatomic features suitable for catheter-based therapy when performed in centers with

expertise in the procedure. (Level of Evidence B)