Populations	Interventions	Comparators	Outcomes
Individuals: · With ischemic dilated cardiomyopathy	Interventions of interest are: · Surgical ventricular restoration as an adjunct to standard coronary artery bypass grafting	Comparators of interest are: · Coronary artery bypass grafting	Relevant outcomes include: · Overall survival · Symptoms · Quality of life · Hospitalizations · Resource utilization · Treatment-related morbidity

Background

Surgical ventricular restoration (SVR) is also known as surgical anterior ventricular endocardial restoration, left ventricular reconstructive surgery, endoventricular circular plasty, or the Dor procedure. Named after the surgeon who pioneered the expansion of techniques for ventricular reconstruction and is credited with treating heart failure patients with SVR and coronary artery bypass grafting.

SVR is usually performed after coronary artery bypass grafting 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. A key difference between SVR and ventriculectomy (ie, 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 (ie, 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 (ie, the Batista procedure; see 'Partial Left Ventriculectomy' - Policy #007 in the Surgery Section), which does not attempt specifically to resect akinetic segments and restore ventricular contour.

Regulatory Status

The U.S. Food and Drug Administration regulates the marketing of devices used as intracardiac patches through the 510(k) clearance process. These devices are Class II and are identified as polypropylene, polyethylene terephthalate, or polytetrafluoroethylene patch or pledget placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures. Biological tissue may also be a component of the patches. In 2004, the CorRestore™ Patch System (Somanetics; acquired by Medtronic) was cleared for marketing by the U.S. Food and Drug Administration 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. Food and Drug Administration product code: DXZ..

Related Policies

• None

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and 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

Clinical Context and Therapy Purpose

The purpose of SVR as an adjunct to standard coronary artery bypass grafting (CABG) is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as coronary artery bypass grafting, in patients with ischemic dilated cardiomyopathy.

The question addressed in this policy is: does SVR as an adjunct to standard CABG improve the net health outcome for individuals with ischemic dilated cardiomyopathy?

The following PICOTS were used to select literature to inform this review.

Patients

The relevant population of interest are individuals with ischemic dilated cardiomyopathy.

Interventions

The therapy being considered is SVR as an adjunct to standard CABG.

Comparators

The main comparator of interest is CABG alone.

Outcomes

The general outcomes of interest are overall survival, symptoms, QOL, hospitalizations, resource utilization, and treatment-related morbidity. Symptoms of ischemic dilated cardiomyopathy may include heart palpitations, angina, edema, shortness of breath, dizziness or syncope, and fatigue.

Timing

The existing literature, particularly the Surgical Treatment of Ischemic Heart Failure (STICH) trial and its subsequent subgroup analyses, that evaluate SVR as an adjunct to standard CABG as a treatment for ischemic dilated cardiomyopathy has varying lengths of follow-up, 4 months to 19 years. While studies described below all reported at least one outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, long-term follow-up is considered necessary to demonstrate efficacy.

Setting

Patients with ischemic dilated cardiomyopathy are preoperatively managed by cardiologists and primary care providers in both outpatient and inpatient settings. SVR is performed by cardiovascular surgeons.

Study Selection Criteria

Methodologically credible studies were selected using the following principles: 

a.     To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

b.     In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

c.     To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

d.     Studies with duplicative or overlapping populations were excluded.

Randomized Controlled Trials

In 2002, the international STICH trial was initiated to compare medical therapy with CABG and/or SVR for patients with heart failure and coronary heart disease (NCT00023595). This trial was sponsored by the National Heart, Lung, and Blood Institute. 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 vs medical therapy plus CABG and (2) medical therapy plus CABG vs medical therapy plus CABG and SVR. Focusing on testing of the second hypothesis, a total of 1000 patients with coronary artery disease 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

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	Hospitalization for Cardiac Causes	Hospitalization 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)		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

Values are n (%) unless otherwise indicated.
CABG: coronary artery bypass grafting; CI: confidence interval; HR: hazard ratio; MI: myocardial infarction; RCT: randomized controlled trial; SVR: surgical ventricular restoration.

The purpose of the gaps tables (see Tables 3 and 4) is to display notable gaps identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of the evidence supporting the position statement.  

Table 3. Relevance Gaps

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Follow-Upe
Jones et al (2009)1,; STICH			2. Volume studies were not conducted for 66% of trial participants	6. The STICH trial’s 300 surgically treated patients in 12 centers had 6% mortality (range 3%–12%); much higher than the 1% mortality reported in 1978 of 1000 patients from the Cleveland Clinic

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.

^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.

^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.

^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3.  Delivery not similar intensity as intervention; 4. Not delivered effectively.

^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.

^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.

^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.

^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3.  Evidence of selective publication.

^d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).

^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.

^f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

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 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, 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. In 2018, a subgroup analysis investigated the association of sex (gender) and the long-term benefit of CABG plus medical therapy vs medical therapy on all-cause mortality, cardiovascular mortality, the composite of death or hospitalization, or surgical deaths in the STICH cohort to compare for gender-related interactions. The analyses found no association between sex and outcomes, recommending that gender should not influence CABG treatment decisions.²²

A separate 2009 publication from the STICH trial reported on QOL outcomes.^7, The main QOL outcome measurement tool used was the Kansas City Cardiomyopathy Questionnaire, which is a 23-item scale that assesses the effect of heart failure 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 Kansas City Cardiomyopathy Questionnaire 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 functional and angina classes for both groups after surgery, but between-group statistical testing was not reported. For example, mean New York Heart Association 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: Randomized Controlled Trials

Two RCTs have examined SVR for the treatment of ischemic dilated cardiomyopathy¾the large multicenter National Heart, Lung, and Blood Institute-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.

Nonrandomized Trials

Tables 5 and 6, below, summarize the characteristics and results of key nonrandomized trials and observational studies (n=6), including five cohort studies and one comparative review comparing SVR to other surgical interventions in multiple populations. The studies range in size (n=731) and duration of follow-up (n>22 years). The studies, as a whole, show some clinical improvements when SVR is utilized in the target patient population as a surgical intervention.

 Table 5. Summary of Key Nonrandomized Trial Characteristics

Study	Study Type	Country	Dates	Participants	Treatment1	Treatment2	Treatment3	Treatment4	Follow-Up
Athanasuleas (2001)9	Cohort	US, Monaco, Italy	1998-2000	who underwent SVR after anterior myocardial infarction with or without concomitant procedures (n=662)	SVR+CABG (n=609)	SVR+Mitral Repair (n=146)	SVR+Mitral Replacement (n=20)		3-years
Athanasuleas (2001)10	Cohort	US, Monaco, Italy	1998-1999	who underwent SVR after anterior myocardial infarction with or without concomitant procedures (n=439)	SVR+CABG (n=391)	SVR+Mitral Repair (n=97)	SVR+Mitral Replacement (n=18)		18-months
Mickleborough (2004)11	Cohort	CA	1983-2002	who underwent SVR for Class III or IV heart failure, angina, or ventricular tachyarrhythmia with or without concomitant procedures (n=285)	SVR+CABG (n=63)	SVR+arrythmia ablation (n=117)	SVR+mitral repair (n=9)	SVR+mitral replacement (n=9)	≤19 years; mean 63-months
Bolooki (2003)12	Cohort	US	1997-2000	who underwent SVR for Class III or IV heart failure, angina, ventricular tachyarrhythmia, or myocardial infarction (n=157)	Radical aneurysm resection+linear closure (n=65)	Septal dyskinesia reinforced with patch septoplasty (n=70)	Ventriculotomny closure+intracavitary oval patch (n=22)		≤22 years
Sartipy (2005)13	Cohort	Sweeden	1994-2004	who underwent SVR using Dor procedure for Class III or IV heart failure, angina, or ventricular tachyarrhythmia with or without concomitant procedures (n=101)	SVR+CABG (n=99)	SVR+arrythmia ablation (n=53)	SVR+mitral valve procedure (n=29)		5-years
Hernandez (2006)14	Comparative Study	US	2002-2004	Patient data from the Society of Thoracic Surgeons’ database	SVR procedure (n=731)

Table 6. Summary of Key Nonrandomized Trials Study Results

Study	In-hospital mortality	Increase in post-operative ejection fraction	Decrease in left ventricular end systolic volume index	Survival rate (post-op year)	Freedom from hospitalization
Athanasuleas (2001)9	7.7%	10.3% (p<0.05)		89.4% (3)	88.7% (3)
Athanasuleas (2001)10	6.6%	29 ± 10.4 to 39 ± 12.4%,	109 ± 71 to 69 ± 42 ml/m2(p < 0.005)	89.2% (18-months)	N
	In-hospital mortality	Increase in post-operative ejection fraction	Symptom-class improvement	Survival rate (post-op year 5)	Survival rate (post-op year 10)
Mickleborough (2004)11
Total (n=285)	2.8%	10% (p<.000)	1.3 classes/ patient for 140 patients	82%	62%
Sartipy (2005)13
SVR via Dor procedure for Class III or IV HF (n=101)	7.9% (early-mortality) measured, within 30 days_	6%	-	65%	-
Bolooki (2003)
SVR for Class III or IV HF	16%	9%	-	53%	30%
	Hospitals included	Years included	In-hospital mortality	Combined death or major complications
SVR (n=731)	141	2002-2004	9.3%	33.5%

NYHA: New York Heart Association; SVR: surgical ventricular restoration; RMA: restrictive mitral annuloplasty; ELIET: endocardial linear infarct exclusion technique; CI: confidence interval; Diff: difference; HR: hazard ratio; NNT: number needed to treat; OR: odds ratio; RCT: randomized controlled trial; RR: relative risk.

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 myocardial infarction 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 heart failure 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 (2001) 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 heart failure, 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<0.0001), 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 actutimes 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 heart failure, angina, ventricular tachyarrhythmia, or myocardial infarction 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 actutimes 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 an 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 heart failure, 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%; left ventricular ejection fraction increased from 27% to 33% postoperatively. Patients were followed for a median of 4.4 years, and overall actutimes 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 heart failure 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 New York Heart Association class IV heart failure and 44 patients with class II or III heart failure who had surgery between 2002 and 2005.^17, There were three 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%) vsclass II or III disease (88%). A 2009 nonrandomized comparative study from Europe involving patients with coronary artery disease 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 left ventricular volume index after the procedure.

Section Summary: Nonrandomized trials

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.

Summary of Evidence

For individuals who have ischemic dilated cardiomyopathy who receive SVR as an adjunct to CABG, the evidence includes a large RCT (another RCT reported results, but most trial enrollees overlapped with those in the larger trial) and uncontrolled studies. The relevant outcomes are overall survival, symptoms, QOL, hospitalizations, resource utilization, and treatment-related morbidity. The RCT and the STICH trial did not report significant improvements in QOL 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.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statement

European Society of Cardiology and European Association for Cardio-Thoracic Surgery

The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (2018) developed joint guidelines on myocardial revascularization.^20, The guidelines indicate that surgical ventricular restoration during coronary artery bypass grafting may be considered in selected patients treated in centers with the requisite expertise.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

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

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Surgical Ventricular Restoration
Cor Restore Patch System
Dor Procedure
Mannequin Endoventricular Shaping Device
SAVER (Surgical Anterior Ventricular endocardial Restoration)
Surgical Anterior Ventricular endocardial Restoration (SAVER)
Ventricular Remodeling
TRISVR System

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):1705-1717. 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):2677-2684 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):1139-1145 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):1312-1321. 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):1359-1367. 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):837-844, 844 e831-833. PMID 19376309

8. Marchenko A, Chernyavsky 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 Cardiovasc Surg. Oct 2001;13(4):448-458. PMID 11807740

10. Athanasuleas CL, Stanley AW, Jr., Buckberg GD, et al. Surgical anterior ventricular endocardial restoration (SAVER) in the dilated remodeled ventricle after anterior myocardial infarction. RESTORE group. Reconstructive Endoventricular Surgery, returning Torsion Original Radius Elliptical Shape to the LV. J Am Coll Cardiol. Apr 2001;37(5):1199-1209. PMID 11300423

11. Mickleborough LL, Merchant N, Ivanov J, et al. Left ventricular reconstruction: Early and late results. J Thorac Cardiovasc 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 Cardiovasc Surg. Aug 2003;126(2):374-383; discussion 383-375. PMID 12928633

13. Sartipy U, Albage A, Lindblom D. The Dor procedure for left ventricular reconstruction. Ten-year clinical experience. Eur J Cardiothorac Surg. Jun 2005;27(6):1005-1010. 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. Am Heart J. Sep 2006;152(3):494-499. PMID 16923420

15. Tulner SA, Bax JJ, Bleeker GB, et al. Beneficial hemodynamic and clinical effects of surgical ventricular restoration in patients with ischemic dilated cardiomyopathy. Ann Thorac Surg. Nov 2006;82(5):1721-1727. 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 Fail. Apr 2007;13(3):178-183. 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 Fail. Aug 2007;13(6):431-436. PMID 17675056

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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

33548