Medical Policies - Surgery


Cardiac Restoration and Remodeling Procedures

Number:SUR707.026

Effective Date:10-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

For the purposes of this policy, cardiac restoration and remodeling procedures include surgical ventricular restoration (SVR) and partial left ventriculectomy (PLV).

Surgical Ventricular Restoration (SVR)

Surgical ventricular restoration is considered experimental, investigational and/or unproven for patients with akinetic segments of the heart caused by the following indications, including but not limited to:

Ischemic dilated cardiomyopathy,

Post-infarction left ventricular aneurysm,

Congestive heart failure (CHF),

Coronary artery disease (CAD),

Coronary valve insufficiency or stenosis, or

Any other coronary etiology.

Partial Left Ventriculectomy (PLV)

Partial left ventriculectomy is considered experimental, investigational and/or unproven for all indications.

EXCEPTION: Ventricular aneurysmectomy (ventricular aneurysm repair) may be done with or without SVR or PLV in patients undergoing a coronary artery bypass graft (CABG) for severe unresponsive CHF and ejection fraction (EF) equal to or less than 30%.

Description:

For the purposes of this policy, cardiac restoration and remodeling procedures include surgical ventricular restoration (SVR) and partial left ventriculectomy (PLV).

Background

Surgical Ventricular Restoration (SVR)

SVR is a procedure designed to restore or remodel the left ventricle to its normal, spherical shape and size in patients with akinetic (lack of muscle movement) segments of the heart, secondary to ischemic dilated cardiomyopathy.

The SVR procedure is also known as surgical anterior ventricular endocardial restoration (SAVER), left ventricular reconstructive surgery, endoventricular circular plasty (EVCPP), or the Dor procedure (named after Vincent Dor, MD). Dr. Dor pioneered the expansion of techniques for ventricular reconstruction (VR) and is credited with treating heart failure patients with SVR and coronary artery bypass grafting (CABG).

The SVR procedure is usually performed after CABG and may precede or be followed by mitral valve repair or replacement and other procedures, such as endocardectomy and cryoablation for treatment of ventricular tachycardia (VT). A key difference between SVR and ventriculectomy (i.e., for aneurysm removal) is that, in SVR, circular “purse string” suturing is used around the border of the aneurysmal scar tissue. Tightening of this suture is believed to isolate the akinetic or dyskinetic scar, bring the healthy portion of the ventricular walls together, and restore a more normal ventricular contour. If the defect is large (i.e., an opening >3 cm), the ventricle may also be reconstructed using patches of autologous or artificial material to maintain the desired ventricular volume and contour during closure of the ventriculotomy. In addition, SVR is distinct from partial left ventriculectomy (PLV) (discussed below), which does not attempt specifically to resect akinetic segments and restore ventricular contour.

Regulatory Status

In 2004, the CorRestore™ Patch System (Somanetics; acquired by Medtronic) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for use “as an intracardiac patch for cardiac reconstruction and repair.” The device consists of an oval tissue patch made from glutaraldehyde-fixed bovine pericardium. It is identical to other marketed bovine pericardial patches, except that it incorporates an integral suture bolster in the shape of a ring that is used along with ventricular sizing devices to restore the normal ventricular contour. FDA product code: DXZ.

Partial Left Ventriculectomy (PLV)

PLV is a surgical procedure aimed at improving the hemodynamic status of patients with end-stage congestive heart failure by directly reducing left ventricular size, and thereby improving the pump function of the left ventricle.

This surgical approach to the treatment of congestive heart failure (also known as the Batista procedure, cardio-reduction, or left ventricular remodeling surgery) is primarily directed at patients with an underlying non-ischemic dilated cardiomyopathy. Initially, the procedure was intended for patients awaiting cardiac transplantation, either as a “bridge” to transplantation or as an alternative to transplantation. The theoretical rationale for this procedure is that by reducing left ventricular wall volume, left ventricle wall tension is reduced and left ventricle pumping function will be improved.

Treatment of heart failure is generally through lifestyle modifications and medications. Medications are effective for controlling the symptoms of heart failure, but progression of disease can still occur. For end-stage heart failure, consideration of cardiac transplantation is the main alternative. Ventricular assist devices have been tested for this purpose, and total artificial hearts are also in development.

The original PLV procedure, as developed by Batista, involves a wide excision of the postero-lateral wall and apex of the heart and removal of a wedge-shaped portion of the left ventricle. PLV may be accompanied by repair of the mitral valve, either through valvuloplasty or annuloplasty. A variety of complications of PLV have been reported, including sudden death, progressive heart failure, arrhythmias, bleeding, renal failure, respiratory failure, and infection. More recently, modifications have been suggested that remove the septal-anterior wall preferentially, also called anterior PLV. The decision on the optimal approach may be determined by the degree of fibrosis seen in the apex and lateral walls.

Regulatory Status

PLV is a surgical procedure and, as such, is not subject to regulation by the FDA.

Rationale:

The policy for partial left ventriculectomy was created in 1999 and was included in the surgical ventricular restoration policy in 2010. The surgical ventricular restoration policy was created in 2006. The policy has been regularly updated with peer-reviewed scientific literature searches of the MedLine database through July 18, 2018 and has been based on the review compiled in the 1998 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment. The following is a summary of the key literature of both surgical procedures separately.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Surgical Ventricular Restoration (SVR)

Randomized Controlled Trial

In 2002, the international Surgical Treatment of Ischemic Heart Failure (STICH) trial was initiated to compare medical therapy with coronary artery bypass grafting (CABG) and/or SVR for patients with heart failure (HF) and coronary heart disease (CHD; NCT00023595). This trial was sponsored by the National Heart, Lung, and Blood Institute (NHLBI). Results of the STICH trial were published in 2009 (see Tables 1 and 2). (1) This unblinded trial was performed at 127 clinical sites in 26 countries. The STICH trial tested two hypotheses, examining the effect of:

1) Medical therapy versus medical therapy plus CABG; and

2) Medical therapy plus CABG versus medical therapy plus CABG and SVR.

Focusing on testing of the second hypothesis, a total of 1000 patients with coronary artery disease (CAD) and an ejection fraction of 35% or less were randomized to CABG alone (n=499) or CABG plus SVR (n=501) (see Table 2). The primary outcome was a composite of death from any cause and hospitalization for cardiac reasons.

Table 1. Summary of Key RCT Characteristics

Interventions

Author; Study

Countries

Sites

Dates

Participantsa

Active

Comparator

Jones et al. (2009) (1); STICH

U.S., Canada, South America, Europe, Asia

127

2002-2007

Patients with CAD treatable with CABG, and LVEF ≤35%

Exclusion for recent MI, need for AV replacement, planned PCI, or life expectancy <3 y

Medical therapy + CABG + SVR

Medical therapy + CABG

Table Key:

AV: aortic valve;

CAD: coronary artery disease;

CABG: coronary artery bypass grafting;

LVEF: left ventricular ejection fraction;

MI: myocardial infarction;

PCI: percutaneous coronary intervention;

RCT: randomized controlled trial;

SVR: surgical ventricular restoration;

a: Key eligibility criteria.

Table 2. Summary of Key RCT Results

Primary Outcomes

Secondary Outcomes

Study

Death From Any Cause

HOSP

Cardiac Causes

HOSP for Any Cause

Death From Any Cause at 30 days (ITT)

Acute MI

Stroke

Jones et al. (2009) (1)

CABG (n=499)

141 (28)

211 (42)

272 (55)

25 (5)

22 (4)

31 (6)

CABG + SVR (n=501)

138 (28)

204 (41)

268 (53)

26 (5)

20 (4)

23 (5)

HR

(95% CI)

1.00

(0.79 to 1.26)

0.97

(0.83 to 1.18)

0.98

(0.83 to 1.16)

NR

1.01

(0.54 to 1.87)

0.77

(0.45 to 1.32)

p

0.98

0.73

0.82

0.88

0.96

0.35

Table Key:

Values are n (%) unless otherwise indicated;

CABG: coronary artery bypass grafting;

CI: confidence interval;

HOSP: hospitalization;

HR: hazard ratio;

ITT: intention-to-treat;

MI: myocardial infarction;

NR: not reported;

RCT: randomized controlled trial;

SVR: surgical ventricular restoration.

While SVR reduced the end-systolic volume index by 19% compared with 6% with CABG alone, there was no difference between groups in the primary outcome. Cardiac symptoms and exercise tolerance also improved to similar degrees between groups. Other secondary outcomes, such as stroke, myocardial infarction (MI), and subsequent procedures, did not differ between groups. Subgroup analyses did not reveal any patient groups that benefited from SVR significantly more than the entire group.

STICH investigators subsequently conducted additional analyses to identify patient groups that might have improved outcomes with CABG plus SVR over CABG alone. A 2014 analysis evaluated whether, in the STICH trial, myocardial viability was associated with patient outcomes. (2) A total of 267 patients underwent single-photon emission computed tomography (SPECT) viability studies, and 191 were found to have myocardial viability. The investigators found no significant interaction between myocardial viability status and treatment group for the outcomes mortality (p=0.36) or mortality plus cardiac hospitalization (p=0.55).

Subgroup analyses published in 2013 did not find significantly improved outcomes in patients with better preoperative left ventricular function, using measures such as left ventricular ejection fraction (LVEF), end-systolic volume index, and/or end-diastolic volume index. (3, 4) A 2015 subgroup analysis found that patients with moderate-to-severe preoperative right ventricular dysfunction had worse outcomes when they underwent SVR plus CABG than CABG alone. (5) In an analysis adjusting for other prognostic factors, the interaction between right ventricular function and treatment group was statistically significant for all-cause mortality (p=0.022). A 2017 subgroup analysis found that left ventricular end-systemic volume index was the most important predictor of mortality following CABG or CABG plus SVR; the study also established that mortality following SVR was not predicted by left ventricular regional dysfunction. (6) Because subgroup analyses were performed post hoc, they are considered hypothesis generating, and findings would need to be confirmed in prospective trials.

A separate 2009 publication from the STICH trial reported on quality of life (QOL) outcomes. (7) The main QOL outcome measurement tool used was the Kansas City Cardiomyopathy Questionnaire (KCCQ), which is a 23-item scale that assesses the effect of HF symptoms on QOL. Secondary QOL measures included the Seattle Angina Questionnaire, the 12-Item Short-Form Health Survey, the Center for Epidemiologic Studies Depression Scale, the Cardiac Self-Efficacy Questionnaire, and the EuroQoL 5-D. The questionnaires were administered at baseline and 4, 12, 24, and 36 months post-randomization. Available numbers of patients at each time point were 991, 897, 828, 751, and 669, respectively. Scores on the KCCQ QOL measures improved for both groups to a similar degree; there was no incremental benefit for the SVR group compared with the CABG alone group. Similarly, there were no group differences noted on any of the secondary QOL measures.

A second RCT was published by Marchenko et al. (2011). (8) Performed in Russia, this study randomized 236 patients with ischemic heart failure to CABG alone or CABG plus SVR. The authors noted that “most” of the patients in the trial were also included in the STICH trial. Mean follow-up was 31 months. Outcome measures reported were perioperative mortality and survival at 1-, 2-, and 3-year follow-ups. Perioperative mortality was 5.8% in the CABG alone group compared with 3.5% in the CABG plus SVR group (p=NS). Survival at 1 and 3 years was 95% and 78%, respectively, in the CABG plus SVR group, compared with 83% and 78%, respectively, in the CABG alone group (statistical comparisons not reported). There were reductions in New York Heart Association (NYHA) functional and angina classes for both groups after surgery, but between-group statistical testing was not reported. For example, mean NYHA functional class decreased in the CABG plus SVR group from 3.1 at baseline to 2.2 at 3 years, compared with a decrease in the CABG alone group from 2.9 to 2.4.

Section Summary: RCT

Two RCTs have examined SVR for the treatment of ischemic dilated cardiomyopathy--the large multicenter NHLBI--sponsored STICH trial and a smaller single center Russian study that included patients enrolled in STICH. The STICH trial failed to demonstrate benefit from SVR. Overlap in the patients reported in the second trial limits any implications of its results.

Uncontrolled Studies

The Reconstructive Endoventricular Surgery, returning Torsion Original Radius Elliptical Shape to the LV (RESTORE) Group is an international group of cardiologists and surgeons from 13 centers that investigated SVR in more than 1000 patients with ischemic cardiomyopathy following anterior infarction. Athanasuleas et al. (2001), from the RESTORE Group, reported on early and 3-year outcomes in 662 patients who underwent SVR following anterior MI between 1998 and 2000. (9) In addition to SVR, patients concomitantly underwent CABG (92%), mitral repair (22%), and mitral replacement (3%). The authors reported that overall mortality during hospitalization was 7.7%; postoperative ejection fractions increased from 29.7% to 40.0% (p<0.05). The survival rate and freedom from hospitalization for HF at 3 years was 89.4% and 88.7%, respectively. In a separate 2001 publication on 439 patients from the RESTORE Group, Athanasuleas et al. reported that outcomes improved in younger patients, those with higher ejection fractions, and those not needing mitral valve replacement. (10)

Mickleborough et al. (2004) reported on 285 patients who underwent SVR by a single surgeon for class III or IV HF, angina, or ventricular tachyarrhythmia during the period of 1983 to 2002. (11) In addition to SVR, patients concomitantly underwent CABG (93%), patch septoplasty (22%), arrhythmia ablation (41%), mitral repair (3%), and mitral replacement (3%). SVR was performed on the beating heart in 7% of patients. The authors reported hospital mortality of 2.8%; postoperative ejection fractions increased 10% from 24% (p<0.000), and symptom class in 140 patients improved 1.3 functional classes per patient. Patients were followed for up to 19 years (mean, 63 months), and overall actuarial survival was reported as 92%, 82%, and 62% at 1, 5, and 10 years, respectively. The authors suggested wall-thinning should be used as a criterion for patient selection.

Bolooki et al. (2003) reported on 157 patients who underwent SVR by a single surgeon for class III or IV HF, angina, ventricular tachyarrhythmia, or MI using 3 surgical methods from 1979 to 2000. (12) SVR procedures consisted of radical aneurysm resection and linear closure (n=65), septal dyskinesia reinforced with patch septoplasty (n=70), or ventriculotomy closure with an intracavitary oval patch (n=22). The authors reported hospital mortality of 16%. Mean preoperative ejection fraction was 28%. Patients were followed for up to 22 years, and overall actuarial survival was reported as 53%, 30%, and 18% at 5, 10, and 15 years, respectively. The authors found factors improving long-term survival included SVR with intraventricular patch repair and ejection fraction of 26% or greater preoperatively.

Sartipy et al. (2005) reported on 101 patients who underwent SVR using the Dor procedure at a single center for class III or IV HF, angina, and ventricular tachyarrhythmia from 1994 to 2004. (13) In addition to SVR, patients concomitantly underwent CABG (98%), arrhythmia ablation (52%), and mitral valve procedure (29%). The authors reported early mortality (within 30 days of surgery) was 7.9%; LVEF increased from 27% to 33% postoperatively. Patients were followed for 4.4 years, and overall actuarial survival was reported as 88%, 79%, and 65% at 1, 3, and 5 years, respectively.

Hernandez et al. (2006) reported on the contemporary performance of SVR based on data from the Society of Thoracic Surgeons’ database. (14) From 2002 to 2004, 731 patients underwent procedures at 141 hospitals. The operative mortality was 9.3%; combined death or major complications occurred in 33.5%. Tulner et al. (2006) reported on 6-month follow-up for 21 patients with ischemic dilated cardiomyopathy who underwent SVR and bypass grafting; some also had valve annuloplasty. (15) Improvement in a number of clinical variables was noted, including decreased left ventricular dyssynchrony, reduced tricuspid regurgitation, and improved ejection fraction (27%-36%).

In a number of reports, SVR has been performed in conjunction with additional cardiac procedures. For example, Tulner et al. (2007) reported on 6-month outcomes for 33 patients with class III or IV HF who underwent SVR and/or restrictive mitral annuloplasty. (16) Operative mortality was 3%, and additional in-hospital mortality was 9%. QOL scores improved, as did 6-minute walking distance (248-422 meters). Williams et al. (2007) retrospectively reviewed outcomes following SVR in a series of 34 patients with NYHA class IV HF and 44 patients with class II or III HF who had surgery between 2002 and 2005. (17) There were 3 operative deaths in each group. While symptoms improved in both groups, there was a trend toward reduced survival at 32 months in those with class IV (68%) versus class II or III disease (88%). A 2009 nonrandomized comparative study from Europe involving patients with CAD who underwent CABG or CABG plus SVR reported an ejection fraction of 30% to 40%. (18) In this nonrandomized study, the authors concluded that patients in whom SVR was possible experienced more perioperative complications but had improved early and midterm outcomes. Ohira et al. (2017) reported on 44 consecutive patients who underwent a modified SVR procedure, many done in conjunction with CABG (93%) or mitral valve repair or replacement (58%). (19) Operative mortality was 11%. Patients demonstrated improvements in ejection fraction as well as end-systolic LV volume index after the procedure.

Section Summary: Uncontrolled Studies

While these and similar uncontrolled studies have shown some clinical improvements following surgery plus SVR, the nonrandomized nature of these studies limits the ability to draw conclusions. Controlled trials are needed to compare SVR outcomes with other alternatives.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in July 2018 did not identify any ongoing or unpublished trials that would likely influence this review.

Practice Guidelines and Position Statements

European Society of Cardiology et al.

In 2010, the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery developed joint guidelines on myocardial revascularization. (20) These guidelines considered SVR combined with CABG to be a surgical option for patients with ischemic heart failure and a LVEF of 35% or less (based on opinion and evidence not well-established). The guidelines also recommended SVR with CABG only be performed in centers with high levels of surgical expertise.

The 2014 joint guidelines on myocardial revascularization by these same 2 associations did not discuss SVR. (21)

Summary of Evidence: Surgical Ventricular Restoration (SVR)

For individuals who have ischemic dilated cardiomyopathy who receive surgical ventricular restoration (SVR) as an adjunct to coronary artery bypass grafting (CABG), the evidence includes a large randomized controlled trial (RCT; another RCT reported results, but most trial enrollees overlapped with those in the larger trial) and uncontrolled studies. Relevant outcomes are overall survival, symptoms, quality of life, hospitalizations, resource utilization, and treatment-related morbidity. The RCT, the Surgical Treatment of Ischemic Heart Failure (STICH) trial, did not report significant improvements in quality of life outcomes for patients undergoing SVR as an adjunct to standard CABG surgery. Several uncontrolled studies have suggested that SVR can improve hemodynamic functioning in selected patients with ischemic cardiomyopathy; however, these studies are considered lower quality evidence. The evidence is insufficient to determine the effects of the technology on health outcomes.

Partial Left Ventriculectomy (PLV)

This coverage for PLV was originally based on a 1998 BCBSA TEC Assessment, (22) which concluded that the available data were inadequate to permit conclusions regarding health benefits associated with PLV. Specifically, the BCBSA TEC Assessment concluded that the lack of any controlled comparison of PLV to medical therapies or other types of “bridge to transplantation” (i.e., ventricular assist devices) made scientific assessment of the efficacy of PLV impossible, either in its role as a potential bridge to transplant or as an adjunct to medical therapy.

In 2003, the results of the Third International Registry Report were published, (23) including data through 2002. This report noted that the incidence of left ventriculectomy reached a peak by 1998 and was largely abandoned by 2000, except in Asia, where experienced institutions continue to perform the procedure in patients in better condition with preserved myocardial contractility.

Results from an International Registry of patients undergoing left ventricular volume reduction surgery were published in 2005. (24) This publication reported on 568 patients from 12 countries in North America, Europe, and Asia, including patients with non-ischemic cardiomyopathy undergoing PLV, as well as patients with ischemic cardiomyopathy undergoing SVR. The number of procedures peaked in the years 1997-2000 and has subsequently declined since that time. The largest decline has been in North America and Europe, where few of these procedures have been performed since 2001, while use has persisted in Asia. Of the 568 patients enrolled in the registry, 271 (47.7%) died or were lost to follow-up. The main causes of death were progressive heart failure (48.4%), sudden death (10.3%), and arrhythmias (6.6%).

Case Series

Suma et al. treated 95 patients with idiopathic dilated cardiomyopathy between 1999 and 2006. (25) A total of 57 of 95 (60%) underwent PLV with excision of the lateral wall, and 38 of 95 (40%) underwent a septal anterior ventricular exclusion (SAVE or pacopexy procedure with excision of the anteroseptal wall). Hospital mortality was 11.6% (11/95), and 1-, 3-, and 5-year survival was 72.8%, 61.4%, and 50.5%, respectively. LV ejection fraction improved from 22.3% presurgery to 27.2% postsurgery (p<0.001), and cardiac index improved from 2.3±0.5 to 2.8+0.5 m2/min. There was an improvement in mean NYHA class from 3.5 to 1.7. The lack of a control group in this trial makes it difficult to determine the impact of PLV on clinical outcomes.

Franco-Cereceda et al. reported on the 1- and 3-year outcomes of 62 patients with dilated cardiomyopathy who underwent PLV. (26) At the time of surgery, all patients were either in NYHA functional class III or IV. Survival was 80% and 60% at 1 and 3 years after surgery, and freedom from heart failure was 49% and 26%, all respectively. Although 80% of the patients were alive at 1 year, this survival was achieved with the aggressive use of VADs and transplantation as a salvage therapy. The authors concluded that partial left ventriculectomy is not a predictable reliable alternative to transplantation.

Starling et al. treated 59 patients with dilated cardiomyopathy and advanced heart failure with PLV and mitral valve repair. (27) Hospital mortality was 3.5%, and actuarial survival at 1 year was 82%. Freedom from treatment failure (defined as death or relisting for transplantation) was 58% at 1 year. In patients with event-free survival at 12 months, there were improvements in NYHA class (3.6 to 2.1, p<0.001), left ventricular ejection fraction (13 to 24%, p<0.001), and peak oxygen consumption (10.8-16.0 mL/kg/min). However, worsening of heart failure was common among survivors over time, and the 3-year estimate of freedom from death, left ventricle assist device, transplantation, or worsening heart failure, was only 26%.

Sugiyama et al. reported on 11 children under the age of 3 years diagnosed with severe dilated cardiomyopathy. (28) Eight procedures were done on 6 of the children: 5 PLV and 3 mitral valve replacement. Two of them underwent mitral valve replacement after PLV. Follow up after PLV ranged from 2 months to 8 years. During follow up period, 4 patients remain alive, of whom 1 eventually underwent a heart transplant.

In 2009 Nishina et al. reported a study that aimed to investigate the effectiveness of an apex-sparing PLV compared to conventional PLV, to restore the ellipsoidal shape of the left ventricle, in 13 patients with dilated cardiomyopathy. (29) The authors reported left ventricular function improvement as the ejection fraction increased from 28% to 39% and the NYHA class improved from III to I. Survival rates were not reported in this small study.

In 2015, a systematic review of PLV over the last 12 years was conducted by Domingues et al. (30) The authors reported the following, “There has been a considerable number of reported successful cases and highly significant findings in regard to determining the most suitable region for the section [of the ventricular wall], proper selection of the patients indicated to the procedure, including the influence of the coronary artery anatomy in the nomination procedure and the need for preservation of ventricular geometry to ensure better quality of ventricular contractions after the sectioning. This surgical procedure has been successfully performed, mainly in Japan, improvements in its efficiency were found and the need for a mathematical modeling of the slice to be severed is a prominent factor in many studies.”

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in July 2018 did not identify any ongoing or unpublished trials that would likely influence this review.

Practice Guidelines and Position Statements

American College of Cardiology/American Heart Association (ACC/AHA)

In 2005, the ACC/AHA Guideline addressed PLV. The ACC guidelines considered PLV as a treatment for heart failure, and included the following as a Class III recommendation, “Partial left ventriculectomy is not recommended in patients with nonischemic cardiomyopathy and refractory end-stage heart failure.” (31) As of July 17, 2018, there is no longer an ACC/AHA guideline addressing PLV.

Society of Thoracic Surgeons (STS)

In 1997, the STS issued a policy statement recommending that PLV be considered an investigational procedure and that it should not be used as a primary strategy for the management of end-stage congestive heart failure. (32) As of July 17, 2018, there is no longer a STS guideline addressing PLV.

Summary of Evidence: Partial Left Ventriculectomy (PLV)

For individuals who have end-stage congestive heart failure who receive partial left ventriculectomy (PLV), the evidence includes several case series. Relevant outcomes are overall survival, symptoms, quality of life, hospitalizations, resource utilization, and treatment-related morbidity. Over the years, some clinical series have reported improvement in ejection fraction and symptoms following PLV; however, there is a lack of randomized controlled trials (RCT) comparing this procedure to alternative treatments. Perioperative mortality and complications are high, and the improvements reported in symptoms may not be a result of the surgical procedure. The high rates of perioperative morbidity and mortality, the lack of demonstrated long-term outcome benefits, and the high relapse rates, have led to diminished enthusiasm for this procedure. Additionally, there are no professional guidelines or position statements that exist to support the PLV procedure. The evidence is insufficient to determine the effects of the technology on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

Surgical ventricular restoration (SVR) involves increased physician work compared to standard ventriculectomy (also known as ventricular remodeling, SVR, SAVER, DOR procedure) and should be billed using CPT code 33548, not the same as PLV.

Partial left ventriculectomy (PLV; also known as the Batista procedure) should be billed using CPT code 33999. CPT codes 33542 and 33548 are not the same as PLV and should not be used to bill for PLV.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage versus. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

33542, 33548, 33999

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Jones RH, Velazquez EJ, Michler RE, et al. Coronary bypass surgery with or without surgical ventricular reconstruction. N Engl J Med. Apr 23 2009; 360(17):1705-17. PMID 19329820

2. Holly TA, Bonow RO, Arnold JM, et al. Myocardial viability and impact of surgical ventricular reconstruction on outcomes of patients with severe left ventricular dysfunction undergoing coronary artery bypass surgery: results of the Surgical Treatment for Ischemic Heart Failure trial. J Thorac Cardiovasc Surg. Dec 2014; 148(6):2677-84 e2671. PMID 25152476

3. Oh JK, Velazquez EJ, Menicanti L, et al. Influence of baseline left ventricular function on the clinical outcome of surgical ventricular reconstruction in patients with ischaemic cardiomyopathy. Eur Heart J. Jan 2013; 34(1):39-47. PMID 22584648

4. Michler RE, Rouleau JL, Al-Khalidi HR, et al. Insights from the STICH trial: change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction. J Thorac Cardiovasc Surg. Nov 2013; 146(5):1139-45 e1136. PMID 23111018

5. Kukulski T, She L, Racine N, et al. Implication of right ventricular dysfunction on long-term outcome in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting with or without surgical ventricular reconstruction. J Thorac Cardiovasc Surg. May 2015; 149(5):1312-21. PMID 25451487

6. Prior DL, Stevens SR, Holly TA, et al. Regional left ventricular function does not predict survival in ischaemic cardiomyopathy after cardiac surgery. Heart. Sep 2017; 103(17):1359-67. PMID 28446548

7. Mark DB, Knight JD, Velazquez EJ, et al. Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial. Am Heart J. May 2009; 157(5):837-44, 44 e1-3. PMID 19376309

8. Marchenko A, Chernyaversusky A, Efendiev V, et al. Results of coronary artery bypass grafting alone and combined with surgical ventricular reconstruction for ischemic heart failure. Interact Cardiovasc Thorac Surg. Jun 2011; 13(1):46-51. PMID 21402600

9. Athanasuleas CL, Stanley AW, Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) for dilated ischemic cardiomyopathy. Semin Thorac Cardiovascul Surg. Oct 2001; 13(4):448-58. PMID 11807740

10. Athanasuleas CL, Stanley AW, Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) in their dilated remodeled ventricle after anterior myocardial infarction RESTORE group. J Amer Coll Cardiol. Apr 2001; 37(5):1199-209. PMID 11300423

11. Mickleborough LL, Merchant N, Ivanov J, et al. Left ventricular reconstruction: Early and late results. J Thorac Cardiovascul Surg. Jul 2004; 128(1):27-37. PMID 15224018

12. Bolooki H, DeMarchena E, Mallon SM, et al. Factors affecting late survival after surgical remodeling of left ventricular aneurysms. J Thorac Cardiovascul Surg. Aug 2003; 126(2):374-83. PMID 12928633

13. Sartipy U, Albage A, Lindblom D, et al. The Dor procedure for left ventricular reconstruction. Ten-year clinical experience. Eur J Cardio-Thorac Surg. Jun 2005; 27(6): 1005-10. PMID 15896609

14. Hernandez AF, Velazquez EJ, Dullum MK, et al. Contemporary performance of surgical ventricular restoration procedures: data from the Society of Thoracic Surgeons’ National Cardiac Database. Amer Heart J. Sep 2006; 152(3):494-9. PMID 16923420

15. Tulner SA, Bax JJ, Bleeker GB, et al. Beneficial hemodynamic a clinical effects of surgical ventricular restoration in patients with ischemic dilated cardiomyopathy. Ann Thorac Surg. Nov 2006; 82(5):1721-7. PMID 17062236

16. Tulner SA, Steendijk P, Klautz RJ, et al. Clinical efficacy of surgical heart failure therapy by ventricular restoration and restrictive mitral annuloplasty. J Card Failure. Apr 2007; 13(3):178-83. PMID 17448414

17. Williams JA, Weiss ES, Patel ND, et al. Outcomes following surgical ventricular restoration for patients with clinically advanced congestive heart failure (New York Heart Association Class IV). J Card Failure. Aug 2007; 13(6):431-6. PMID 17675056

18. Dzemali O, Risteski P, Bakhtiary F, et al. Surgical left ventricular remodeling leads to better long-term survival and exercise tolerance than coronary artery bypass grafting alone in patients with moderate ischemic cardiomyopathy. J Thorac Cardiovascul Surg. Sep 2009; 138(3):663-8. PMID 19698853

19. Ohira S, Yamazaki S, Numata S, et al. Ten-year experience of endocardial linear infarct exclusion technique for ischaemic cardiomyopathy. Eur J Cardiothorac Surg. Sep 25 2017. PMID 29029034

20. Task Force on Myocardial Revascularization of the European Society of Cardiology, the European Association for Cardio-Thoracic S, European Association for Percutaneous Cardiovascular Interventions, Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization. Eur Heart J. Oct 2010; 31(20):2501-55. PMID 20802248

21. Windecker S, Kolh P, Alfonzo F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. Oct 1 2014; 35(37):2541-2619. PMID 25173339

22. Partial Left Ventriculectomy. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (1998) Tab 4.

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24. Kawaguchi AT, Suma H, Konertz W, et al. Left ventricular volume reduction surgery: the 4th International Registry Report 2004. J Card Surg. Nov-Dec 2005; 20(6):S5-11. PMID 16305637

25. Suma H, Horii T, Isomura T, et al. A new concept of ventricular restoration for nonischemic dilated cardiomyopathy. Eur J Cardio-Thorac Surg. Apr 2006; 29 Supplement 1:S207-12. PMID 16567106

26. Franco-Cereceda A, McCarthy PM, Blackstone EH, et al. Partial left ventriculectomy for dilated cardiomyopathy: is this an alternative to transplantation? J Thorac Cardiovascul Surg. May 2001; 121(5):879-93. PMID 11326231

27. Starling RC, McCarthy PM, Buda T, et al. Results of partial left ventriculectomy for dilated cardiomyopathy: hemodynamic, clinical and echocardiographic observations. J Am Coll Cardiol. Dec 2000; 36(7):2098-103. PMID 11127447

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29. Nishina T, Shimamoto T, Mauri A, et al. Impact of apex-sparing partial left ventriculectomy on left ventricular geometry, function, and long-term survival of patients with end-stage dilated cardiomyopathy. J Card Surg. Sep-Oct 2009; 24(5):499-502. PMID 19740283

30. Domingues JS, Vale Mde P, Barbosa MP. Partial left ventriculectomy: have well-succeeded cases and innovations in the procedure been observed in the last 12 years? Braz J Cardiovasc Surg. Oct 2015; 30(5):579-85. PMID 26735606

31. Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. Sep 20 2005; 112(12):e154-235. PMID 1616

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33. Surgical Ventricular Restoration. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 February) Surgery 7.01.103.

34. Partial Left Ventriculectomy (Archived ). Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 August) Surgery 7.01.66.

Policy History:

DateReason
10/1/2018 Document updated with literature review. Coverage unchanged. Reference 6 and 19 added.
7/15/2017 Reviewed. No changes.
7/15/2016 Document updated with literature review. Coverage unchanged.
11/1/2015 Reviewed. No changes.
4/15/2014 Document updated with literature review. Coverage unchanged.
3/1/2013 Document updated with literature review. Coverage remains unchanged. This medical document is no longer scheduled for routine literature review and update.
11/15/2010 Document updated with literature review. The following changes were made: 1) Partial Left Ventriculectomy (PLV) was combined into this document; PLV was previously addressed on SUR707.019, Partial Left Ventriculectomy. Coverage of PLV is unchanged. 2) Coverage of Surgical Ventricular Restoration is unchanged. 3) The following exception was added to Coverage section: Ventricular aneurysmectomy (ventricular aneurysm repair) may be done with or without SVR or PLV in patients undergoing coronary artery bypass grafting for severe unresponsive congestive heart failure and ejection fraction of equal to or greater than 30%. 4) Document title changed from Surgical Ventricular Restoration. Document title change to “Cardiac Restoration and Remodeling Procedures”. Surgical Ventricular Restoration :
10/1/2008 Revised/updated entire document
5/1/2006 Revised/updated entire document
1/1/2006 New medical document Partial Left Ventriculectomy :
6/1/2008 Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.
5/1/2007 Revised/updated entire document
1/1/1999 New medical document

Archived Document(s):

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