National Medical Policy Subject:
Transcatheter Aortic Valve Replacement (TAVR)
Effective Date*: May 2012 Updated:
May 2016 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document
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Source National Coverage Determination (NCD)
National Coverage Manual Citation Local Coverage Determination (LCD) Article (Local) Other
Reference/Website Link National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR): http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx
Decision Memo for Transcatheter Aortic Valve Replacement (TAVR):
http://www.cms.gov/medicare-coveragedatabase/details/nca-decisionmemo.aspx?NCAId=257 MLM Matters MM8168: http://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNMattersArticles/Downloads/MM8168.pdf MLM Matters MM8537: https://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNMattersArticles/Downloads/MM8537.pdf
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Current Policy Statement I.
Health Net, Inc. considers transcatheter aortic valve replacement (TAVR) performed via a transfemoral delivery approach using the Edwards SAPIEN Transcatheter Heart Valve, medically necessary in individuals with severe symptomatic native aortic valve stenosis and an ejection fraction >20% who have been determined by a cardiac surgeon to be inoperable (i.e., prohibitive surgical risk) for open aortic valve replacement and in whom existing comorbidities would not preclude the expected benefit from correction of the aortic stenosis. The hospital in which TAVR is performed must participate in a prospective, national, audited registry that follows the patient for at least 1 year but tracks outcomes for 5 years.
II. Health Net, Inc. considers transcatheter aortic valve replacement (TAVR) using the Edwards SAPIEN Transcatheter Heart Valve, medically necessary when performed via a transapical or transfemoral delivery in patients with severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency and with ejection fraction > 20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to be operative candidates for aortic valve replacement but who have a Society of Thoracic Surgeons operative risk score 8% or are judged by the heart team to be at a 15% risk of mortality for surgical aortic valve replacement. III. Health Net, Inc. considers transcatheter aortic valve replacement (TAVR) using Medtronic CoreValve medically necessary in individuals with severe symptomatic calcified native aortic valve stenosis (aortic valve area < 0.8 cm2, a mean aortic valve gradient of > 40 mmHg, or a peak aortic-jet velocity of > 4.0 m/s), with ejection fraction > 20%, and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity > 50% at 30 days.) Note: The ACC/AHA guidelines define severe AS as:
A mean gradient >40 mm Hg; or
An aortic jet velocity > 4.0 m/sec; and
A valve area of < 1.0 cm2 *
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*2014 AHA/ACC guideline on Management of Patients With Valvular Heart Disease state the primary criterion for the definition of severity of AS is based on aortic velocity or mean pressure gradient. Calculations of valve area may be supportive but are not necessary when a high velocity or gradient is present. In contrast, valve area calculations are essential for patients with AS and a low ejection fraction or stroke volume as defined for stages D2 and D3. The guideline also notes that symptomatic patients who have a calcified aortic valve with reduced opening and an aortic valve area between 0.8 cm2 and 1.0 cm2 should be closely evaluated to determine whether they would benefit from valve intervention. The Online Society of Thoracic Surgeons Risk Calculator is available at: http://riskcalc.sts.org/STSWebRiskCalc273/de.aspx
Definitions TAVR TAVI PAVR STS AVR AS LV CAD CABG COPD VARC TF TA AVA LVEF AMI VC
Transcatheter aortic valve replacement Transcatheter aortic valve implantation Percutaneous aortic valve replacement Society of Thoracic Surgeons Surgical aortic valve replacement Aortic stenosis Left ventricle Coronary artery disease Coronary artery bypass graft Chronic obstructive pulmonary disease Valve Academic Research Consortium Trans-femoral Trans-apical approaches Aortic valve area Left ventricular ejection fraction Acute myocardial infarction Vascular complications
Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets.
ICD-9 Codes 424.1 ICD-10 Codes I34.0-I34.9
Aortic Valve disorders
Nonrheumatic aortic valve disorders
CPT Codes 33361 33362
Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach; Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach
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33363 33364 33365 33366 0318T
Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy) Transcatheter aortic valve replacement (TAVR/TAVI) ) with prosthetic valve: transapical approach Implantation of catheter-delivered prosthetic aortic heart valve, open thoracic approach , (eg, transapical, other than transaortic) (code deleted 12/2014)
HPCS Codes N/A
Scientific Rationale – Update May 2016 Gleason et al (2016) sought to characterize the incidence of new clinically detectable neurologic events, or any comparative change in indices of higher cognitive function following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) within the framework of a prospective, randomized clinical trial for high-risk patients. High-risk patients (predicted SAVR mortality 15%) with severe aortic stenosis (n = 750) were randomized 1:1 to TAVR or SAVR and underwent evaluation using the National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale assessment at each follow-up and any suspected event. Neurologic outcomes were ascertained by a neurologist and further evaluated by Mini-Mental State Examination (MMSE), visual fields testing, gait assessment, hand function, writing evaluation, and drawing assessment. The 30-day, 1-year, and 2year stroke rates were 4.9%, 8.7%, and 10.9%, respectively, for TAVR and 6.2%, 12.5%, and 16.6%, respectively, for SAVR (P = .46, .11, and .05, respectively). Allcause mortality in patients with a major stroke was 83.3% for TAVR and 54.5% for SAVR at 2 years (P = .29). Late major stroke was disproportionately higher (23.8% at 2 years) among patients with poor iliofemoral access randomized to SAVR. Peripheral vascular disease and falls within 6 months predicted early stroke, and severe aortic calcification and high Charlson score (≥5) predicted 1-year stroke postTAVR. NIHSS and MMSE scores trended higher after SAVR than after TAVR. Lack of dual antiplatelet therapy use during and after TAVR was associated with early stroke. The authors concluded this study defines an equivalent postprocedural stroke risk, stroke extent, and degree of cognitive change after TAVR or SAVR in a high-risk population, and also defines several predictors of stroke after TAVR. Aalaei Andabili et al (2016) compared stroke occurrence and outcomes between TAVR and SAVR, both peri-procedural and at follow-up. 391 consecutive patients underwent TAVR (n=290) or isolated SAVR (n=101), concomitantly. Patients' data were prospectively collected. TAVR patients had more comorbidities. One (0.34%) TIA and 9 (3.11%) strokes occurred in-hospital following TAVR, but no cerebrovascular event occurred after SAVR (p=0.11). One stroke (0.99%) and one TIA (0.99%) were detected in SAVR group within 30- days. Among TAVR patients, one (0.75%) stroke at 6-months, 2 (1.9%) strokes and 2 (1.9%) TIAs at 12-month were diagnosed. Kaplan-Meier analysis revealed that 96% and 99% 12-month CVA free survival following TAVR and SAVR, respectively (p=0.67). Pre-operative mean trans- aortic valve systolic pressure gradient higher than 40 mmHg remained as risk factor for stroke in TAVR patients only, OR: 4.48 (CI: 1.2-16.54, p=0.02). One intraoperative death, and 5 (4 with CVA) in-hospital deaths occurred after TAVR; whereas only one patient died in SAVR group (p=0.49). Thirty-day mortality was Transcatheter Aortic Valve Replacement May 16
3.8% (11/290) for TAVR and 0.99% (1/101) for SAVR patients. SAVR patients' survival was 99% at 6 months, 97.9% at 12, and 96.4% at 24 months, whereas survival in TAVR was 97.5% at 6, 92% at 12, and 73.6% at 24 months (HR: 8.43 (CI: 2.47-28.73), p 40 mmHg, or a peak aortic-jet velocity of > 4.0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity > 50% at 30 days.) Continued approval of this PMA is contingent upon the submission of periodic reports, at intervals of one year (unless otherwise specified) from the date of approval of the original PMA. Implantation of the Medtronic CoreValve system should be performed only by physicians who have received Medtronic CoreValve training. Medtronic performed a clinical study to establish a reasonable assurance of safety and effectiveness of TAVT with the Medtronic CoreValve System for iliofemoral or non-iliofemoral (i.e., subclavian and direct aortic) delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by two cardiac surgeons to be at extreme risk for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. This CoreValve U.S. pivotal trial used to support this PMA was a prospective, non-randomized, unblinded, multi-center investigational study evaluating the safety and effectiveness of the Medtronic CoreValve System in a stratified population of patients unsuitable for cardiac surgery (referred to as the Extreme Risk study). Once the patient was determined as being at extreme risk for surgery, a determination of vascular access was made. All enrolled patients were assigned to transcatheter aortic valve replacement (TAVR) with the Medtronic CoreValve System (MCS). Patients received the CoreValve device through either an iliofemoral or a non-iliofemoral (subclavian or direct aortic) access route. Popma et al (2014) reported results of this study. The primary end point was a composite of all-cause mortality or major stroke at 12 months, which was compared with a prespecified objective performance goal (OPG). A total of 41 sites in the US recruited 506 patients. 471 patients over the age of 83 who underwent extensive demographic evaluation including assessment of co-morbidities, frailty and disability and were deemed to be at extreme risk for surgical aortic valve replacement by two cardiac surgeons and an external surgical review were included in the study. Individuals in the study had a high frequency of medical co-morbidities including coronary artery disease, peripheral vascular disease, previous myocardial infarction and severe STS Chronic Lung Disease. They were also extremely frail, had a low body mass index, poor grip strength and dependence on home oxygen. An OPG was used to estimate the risk of all-cause mortality or major stroke in patients treated with standard therapy The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound = 29.9%) vs. 43.0% with Transcatheter Aortic Valve Replacement May 16
the OPG (p20% (P< 0.05), respectively. Investigators concluded the ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis Abdel-Wahab et al (2014) reported on a randomized comparison trial of a balloonexpandable or self-expandable TAVR systems to determine whether the balloonexpandable device is associated with a better success rate than the self-expandable device. The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure. One hundred twenty-one patients were randomly assigned to receive a balloonexpandable valve (Edwards Sapien XT) and 120 were assigned to receive a selfexpandable valve (Medtronic CoreValve). Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany. The primary end point was device success, which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, intended performance of the heart valve without moderate or severe regurgitation, and only 1 valve implanted in the proper anatomical location. Secondary end points included cardiovascular mortality, bleeding and vascular complications, postprocedural pacemaker placement, and a combined safety end point at 30 days, including all-cause mortality, major stroke, and other serious complications. Device success occurred in 116 of 121 patients (95.9%) in the balloon-expandable valve group and 93 of 120 patients (77.5%) in the selfexpandable valve group (relative risk [RR], 1.24, 95% CI, 1.12-1.37, P20% who have been examined by a heart team including an experienced cardiac surgeon and a cardiologist and found to either be either inoperable and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. Clinical studies to support the expanded approval included a clinical study of 348 surgical patients who received the Sapien THV and 351 similar patients who received aortic valve replacement (AVR) through open-heart surgery. Both groups had similar death rates at one month, one year, and two years after the procedures. Those who received the THV showed an increased risk for major vascular complications, such as artery dissection or perforation, and for stroke during the first month following the procedure. Patients who received the AVR were more likely than the THV recipients to experience major vascular bleeding during the procedure. The manufacturer of the Sapien THV, Edwards Lifesciences Corp., will continue to evaluate the device through a national Transcatheter Valve Therapy registry, which facilitates the continued evaluation of transcatheter devices and procedures. Numerous clinical trials evaluating TAVR were identified on Clinicaltrial.gov. Another device, the Medtronic CoreValve is also being evaluating in clinical trials. At this time, the device has not received FDA approval in the U.S. Codner et al (2013) reported the long-term clinical experience in treating patients with severe symptomatic aortic stenosis using TAVI. They analyzed the outcomes of 153 TAVI-treated patients who were followed for ≤2 years. All patients were at very high risk of surgical valve replacement. The Medtronic-CoreValve device was used in 59.5% and the Edwards-SAPIEN device in 40.5% of the patients. The primary end point was death from any cause during follow-up. The mean ± SD patient age was 81.1 ± 6 years, and 62% of the patients were women. The procedural success rate was 97.4%. At 30 days of follow-up, the all-cause mortality was 3.9%. Two-year follow-up data were obtained for 108 patients, with 85.5% survival of treated patients. The 30-day stroke rate was 3.9%. No significant differences in mortality were found when angioplasty was performed before or during TAVI compared with TAVI alone. Multivariate analysis showed that increased baseline creatinine and increased logistic European System for Cardiac Operative Risk Evaluation score predicted all-cause mortality. Authors concluded the clinical outcome of TAVI is favorable. The use of both procedural devices and multiple techniques in the same institution is feasible and potentially desirable. Transcatheter Aortic Valve Replacement May 16
Khatri et al (2013) sought to quantify the adverse effects associated with TAVI, and to evaluate whether the type of transcatheter valve and the route of valve implantation are associated with differences in adverse outcomes studies that included at least 100 patients who had TAVI and reported at least 1 outcome of interest. Two reviewers abstracted the data independently. A random-effects model was used to combine data on adverse outcomes and conduct stratified analyses. A total of 49 studies enrolling 16 063 patients met the inclusion criteria. Overall 30-day and 1-year survival after TAVI were 91.9% and 79.2%, respectively. Heart block requiring permanent pacemaker implantation was the most common adverse outcome (13.1%) and was 5 times more common with the CoreValve (Medtronic), than the Sapien valve (Edwards Lifesciences) implanted using the transarterial route (25.2% vs. 5.0%, respectively). The overall rate of vascular complications was 10.4% and was highest with transarterial implantation of the Sapien valve (22.3%). Acute renal failure requiring renal replacement therapy was the third most common complication, occurring in 4.9% of patients. The reviewers noted limitations included overestimation of rates of major vascular complications owing to rapidly evolving TAVI technology. They concluded the most common adverse effects associated with TAVI are heart block, vascular complications, and renal failure. The type of transcatheter valve and the route of implantation are associated with observed variations in the risks for some adverse effects. Kala et al (2012) compared the quality of life after TAVI and surgical replacement (SAVR) at one year. The study included 45 consecutive high-risk patients (average age 82.0 years; logistic Euroscore 22.3%) with symptomatic severe aortic stenosis allocated to TAVI transfemoral, TAVI transapical using the Edwards-Sapien valve or SAVR with the Edwards Perimount bioprosthesis (n=15 in each). The pre-operative characteristics were similar except for more myocardial infarctions in TAVI. The quality of life was assessed using the standardized EQ-5D questionnaire at baseline and on days 30, 90 and 360. A total of 7 patients (15.5%) died during follow-up. At baseline no significant differences in any of the quality-of-life parameters were found except for usual activities described as "best" (46.7% in SAVR vs. 10.0% in TAVI). At 30 and 90 days surviving patients were similar and at 360 days only the anxiety/depression score was "best" in 83.3% SAVR vs. 59.1%. Functional status improved in all patients (NYHA class I-II in 13.3% at baseline vs. 78.9% at 360days) and the general health median significantly improved in TAVI patients (from 50 to 67) with a positive trend in SAVR patients. At one year, the general quality of life of high-risk patients had significantly improved after transcatheter aortic valve implantation with a positive trend in surgically treated patients. Zhao et al (2012) presented the procedural results and analyzed the death causes of 30-day mortality and clinical events in patients who underwent TAVI with Edwards prosthetic valves in one facility. The patients with severe aortic stenosis but at high surgical risk or inoperable were considered as candidates for TAVI. Forty-eight patients undergoing TAVI from July 2010 to September 2011 were enrolled in this registry. The Edwards prosthetic valves were solely used in this clinical trial. Overall 48 patients underwent TAVI, 28 of which accepted TAVI by trans-femoral (TF) approaches, 20 by trans-apical approaches (TA). The aortic valve area (AVA) was (0.70 ± 0.23) cm(2), left ventricular ejection fraction (LVEF) was (57.4 ± 17.6)%, Log EuroSCORE was (19.2 ± 15.8)%, mean gradient was (47.0 ± 16.6) mmHg. There were no significant differences between TF and TA groups in all these baseline parameters. Device success rate was 95.8%, and procedural success rate was 93.7% in total. Procedural mortality was 6.7% (3/48): two deaths in TA group (10%), and one death in TF group (3.6%). Forty-six Edwards valves were implanted: 10 Edwards Sapien and 36 Edwards XT. Procedure-related complications included cardiac tamponade in 2 cases (4.2%), acute myocardial infarction (AMI) in 1 case (2.1%), permanent pacemaker implantation in 1 case (2.1%), life-threatening and major Transcatheter Aortic Valve Replacement May 16
bleeding in 3 cases; access site related major complication in 1 case, AKI stage 3 in 3 cases (6.3%), minor stroke in 1 case (2.1%). Thirty-day survival rate was 89.6%. There were 5 deaths in total (10.4%): 4 in TA group (20%) and 1 in TF group (3.6%). Investigators concluded the procedural success rate and 30-day mortality were acceptable in these high risk patients with Edwards prosthetic valves in the first 48 TAVI. Dvir et al (2012) sought to assess the clinical profile, outcome, and predictors for mortality of "real-world" high-risk severe aortic stenosis patients according to the mode of treatment assigned. Patients were referred to a dedicated clinic for meticulous screening and multidisciplinary team assessment and 343 were finally assigned treatment: TAVR with the Edwards SAPIEN or CoreValve device, 100 (29.2%); surgical aortic valve replacement (SAVR), 61 (17.8%); balloon valvuloplasty (as definitive therapy), 27 (7.9%); medication only, 155 (45.2%). No patient was lost to follow-up. The balloon valvuloplasty group had a significantly higher 1-month mortality rate (18.5%) than the TAVR group (3%) and medical therapy group (3.9%), without significant difference from the SAVR group (11.5%). One-year cumulative survival was significantly higher in the TAVR group (92%) than in the other groups (SAVR 71%, balloon valvuloplasty 61.5%, medication 65%). Among survivors, 1-year rates of high functional class (NYHA I/II) were as follows: TAVR, 84.6%; SAVR, 63.3%; balloon valvuloplasty, 18.2%; medication, 21.4% (TAVR vs. SAVR; SAVR vs. balloon valvuloplasty or medical therapy). On multivariate regression analysis, renal failure not performing TAVR and pulmonary pressure were independent predictors of 1-year mortality. Investigators concluded TAVR, performed in carefully selected high-risk patients, is associated with an excellent survival rate and high functional class. Patients treated with another of the available modalities, including SAVR, had a worse outcome, regardless of which alternative treatment they receive. Généreux et al (2012) sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) TAVR. From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22- or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed. Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1year mortality. The only identifiable independent predictor of major VC was female gender. Major VC and renal disease at baseline were identified as independent predictors of 1-year mortality. Investigators concluded that major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1year mortality decreased with lower-risk populations.
Scientific Rationale – Initial The most common cause of valvular aortic stenosis (AS) in adults is calcification of a normal trileaflet or congenital bicuspid valve. Calcific AS is characterized by lipid accumulation, inflammation, fibrosis, and calcification and is common in the United States. It typically presents in older individuals (i.e., >75 years). In adults with valvular AS, the obstruction develops gradually, typically over many years during Transcatheter Aortic Valve Replacement May 16
which the left ventricle (LV) adapts to the systolic pressure overload with progressive concentric hypertrophy that results in diastolic dysfunction, reduced coronary reserve, myocardial ischemia, and eventually, depressed contractility resulting in LV systolic dysfunction. Ultimately, in some patients, heart failure or sudden death occurs. Typically, patients with AS are free from cardiovascular symptoms (i.e., angina, syncope, and heart failure) until late in the course of the disease. However, once symptoms manifest, the prognosis is poor, with the interval from the onset of symptoms to the time of death being approximately 2 years in patients with heart failure, 3 years in those with syncope, and 5 years in those with angina. Invasive cardiac catheterization has historically been the standard for quantification of AS, however, this function has been largely replaced by echocardiography. Echocardiographic diagnosis is made by the observation of a calcified valve with restricted leaflet opening by two-dimensional (2D) echocardiography with quantification of the peak and mean AV gradient made by applying the simplified Bernoulli equation to the maximal velocity recorded through the aortic valve by continuous-wave Doppler. According to guidelines from the American College of Cardiology/ American Heart Association (ACC/AHA) for the management of patients with valvular heart disease (Bonow et al), the severity of AS is based on graded AS severity on the basis of a variety of hemodynamic and natural history using definitions of aortic jet velocity, mean pressure gradient, and valve area as follows:
Mild (area 1.5 cm2, mean gradient less than 25 mm Hg, or jet velocity less than 3.0 m per second)
Moderate (area 1.0 to 1.5 cm2, mean gradient 25 to 40 mm Hg, or jet velocity 3.0 to 4.0 m per second)
Severe (area less than 1.0 cm2, mean gradient greater than 40 mm Hg, or jet velocity greater than 4.0 m per second).
Some patients with severe AS remain asymptomatic, whereas others with only moderate stenosis develop symptoms. Therapeutic decisions, particularly those related to corrective surgery, are based largely on the presence or absence of symptoms. Thus, the absolute valve area (or transvalvular pressure gradient) is not the primary determinant of the need for aortic valve replacement (AVR). Patients with severe AS and low cardiac output often present with a relatively low transvalvular pressure gradient (i.e., mean gradient less than 30 mm Hg). Such patients can be difficult to distinguish from those with low cardiac output and only mild to moderate AS. There are a number of potential treatment recommendations for patients with AS (i.e., surgical aortic valve replacement, transcatheter aortic valve replacement, balloon aortic valvuloplasty and medical therapy). Consideration of the risk/benefit of each option needs to be carefully evaluated and discussed with the patient and family. The involvement of the heart team in decision making is also essential. There are no proven medical treatments to prevent or delay the disease process in the aortic valve leaflets. However, evaluation and modification of cardiac risk factors is important in patients with aortic valve disease to prevent concurrent coronary artery disease (CAD). Longer-term palliative medical management of symptomatic AS may be appropriate for patients who are either not candidates for aortic valve surgery due to comorbidities or in patients who refuse AVR.
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In adults with severe, symptomatic, calcific AS, AVR is the only effective treatment that improves symptoms and prolongs survival. AVR is the only effective treatment considered a Class I recommendation by ACCF/AHA and ESC guidelines in adults with severe symptomatic AS. Younger patients with congenital or rheumatic AS may be candidates for valvotomy. In symptomatic patients with AS, AVR improves symptoms and improves survival. According to the ACC, in the absence of serious comorbid conditions, AVR is indicated in virtually all symptomatic patients with severe AS. Because of the risk of sudden death, AVR should be performed promptly after the onset of symptoms. Age is not a contraindication to surgery, with several series showing outcomes similar to age-matched normal subjects in the very elderly. They note further there is a difference of opinion among clinicians regarding the indications for AVR in asymptomatic patients with severe AS, because the probability of remaining free of cardiac symptoms without surgery is less than 50% at 5 years. There is general agreement that the risk of AVR exceeds any potential benefit in patients with severe AS who are truly asymptomatic with normal LV systolic function. ACC Class I Indications for Aortic Valve Replacement: CLASS I AVR is indicated for symptomatic patients with severe AS. (Level of Evidence: B) AVR is indicated for patients with severe AS undergoing coronary artery bypass graft surgery (CABG). (Level of Evidence: C) AVR is indicated for patients with severe AS undergoing surgery on the aorta or other heart valves. (Level of Evidence: C) AVR is recommended for patients with severe AS and LV systolic dysfunction (ejection fraction less than 0.50). (Level of Evidence: C) Cardiopulmonary bypass is used in aortic valve operations, and these procedures are usually performed through a median sternotomy incision. Complications of AVR include stroke, thromboembolism, sternal wound infection and other surgical complications of renal, hepatic, neurological, and pulmonary disease compromise. Current data from The Society of Thoracic Surgeons (STS) registry documents a mortality that is under 3% for all patients undergoing AVR. As with any procedure, operative mortality is strongly correlated with the severity of the disease and comorbidity of patients. The operative risks can be estimated with online risk calculators from the STS and the European System for Cardiac Operative Risk Evaluation. However, risk estimates are subject to inaccuracies (eg, the logistic EuroSCORE appears to overestimate mortality risk in patients undergoing high-risk aortic valve replacement) and the models do not account for some clinical characteristics (eg, porcelain aorta, systemic pulmonary hypertension, or RV dysfunction) that may impact surgical mortality. In patients undergoing aortic valve replacement, the STS model may provide more accurate risk stratification than the logistic. These scoring systems are only applicable to patients undergoing surgery and are not validated nor considered accurate in a TAVI/ TAVR/PAVR eligible cohort of patients. As older, more frail patients with extensive comorbidities undergo AVR, the risk of death and morbidity as well as length of hospitalization increases significantly. In addition to comorbidity, preoperative functional performance is also a maker of postoperative morbidity/mortality. Despite substantial contemporary experience with successful AVR in elderly patients, multiple series have documented that 30% to 40% of patients with severe AS do not undergo surgery owing to advanced age, LV dysfunction, multiple coexisting conditions, and patient preference or physician recommendation.
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The determination of inoperability in any given patient depends on the judgment of the medical team. Inoperability from the surgeon’s judgment may result from technical considerations that preclude safe performance of AVR, such as prior mediastinal irradiation, porcelain aorta or severe periannular calcification, severe aortic atheromatous disease, prior cardiac operations, among others including the internal mammary artery crossing the midline. In addition, it is generally agreed that patients with limited life expectancy due to concurrent conditions such as malignancy, dementia, primary liver disease, chronic obstructive pulmonary disease (COPD), among others, are not appropriate for AVR. Frailty and related conditions of debility and deconditioning are known to result in inability to recover from major heart surgery such as AVR, despite operative survival and hospital discharge. These conditions can potentially contribute to increased surgical mortality and morbidity in the elderly. Balloon aortic valvuloplasty was considered to be a less invasive and safe alternative to AVR, particularly in high surgical risk patients with multiple medical comorbidities. Although balloon aortic valvuloplasty results in immediate hemodynamic improvement with a significant decrease in transvalvular gradients resulting in larger valve area, it does not result in sustained clinical improvement because of high recurrence rates; restenosis or recoil of the aortic valve usually occurs within 6 months. Patients treated with balloon aortic valvuloplasty alone have shown poor prognosis, with survival rates of 50% at 1 year, 35% at 2 years, and 20% at 3 years. In addition, serious complications due to balloon aortic valvuloplasty occur in 15% to 25% of patients. Balloon aortic valvuloplasty, therefore, should not be used as a substitute for AVR in patients who are candidates for surgical AVR. Although balloon aortic valvuloplasty as a stand-alone treatment is not recommended, it may still be used in contemporary practice as a bridge to subsequent AVR (both Class IIb, Level of Evidence C recommendation) Given the increased mortality and morbidity of AVR surgery for high-risk patients and the poor long-term results of balloon aortic valvuloplasty, there has been interest in the development of a percutaneously delivered aortic heart valve. Transcatheter aortic valve replacement (TAVR), also known as Transcatheter aortic valve implantation (TAVI) offer new and potentially transformational technology for patients with severe aortic valvular stenosis who are either extremely high-risk candidates or inoperable for surgical AVR or who are inoperable by virtue of associated comorbidities. Two major catheter-based techniques for replacing the aortic valve have been investigated, however, at the present time only a balloon-expandable valve, the Edwards SAPIEN, (Edwards Life Sciences, Inc., Irvine, CA) with the Retroflex3 system, has received FDA approval. It is a trileaflet valve made from bovine pericardium in a stainless steel frame that is designed to be expanded by a balloon. The other valve under current investigation, but not yet approved by the FDA, is a self-expanding valve, the Medtronic CoreValve (Medtronic, Inc., Minneapolis, MN). It is a trileaflet valve made from porcine pericardium in a self-expanding nitinol frame. The primary benefit of TAVR is the ability to treat AS in patients who would otherwise be ineligible for surgical valve replacement. It may also be useful for patients at high surgical risk. Stroke is one of the major adverse events associated with TAVR. Other potential harms include the need for conversion to an open procedure, perioperative death, MI, bleeding, valve embolization, valve failure or clotting, endocarditis, aortic regurgitation, heart block that requires a permanent pacemaker, renal failure, pulmonary failure, and major vascular complications such as cardiac perforation or arterial dissection.
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According to the FDA approval, the Edwards SAPIEN Transcatheter Heart Valve is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. Per the FDA approval, labeling must specify the specific training or experience practitioners need in order to use the device. Expiration dating for this device has been established and approved at 2 years. Continued approval of this PMA is contingent upon the submission of periodic reports, required, at intervals of one year (unless otherwise specified) from the date of approval of the original PMA. In addition, two post-approval studies must be conducted to continue the follow-up of patients from the premarket study through five years post-implant and to follow newly enrolled patients in a registry through five years post-implant. The Edwards SAPIEN transcatheter heart valve and delivery system are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections. Per the National Institute for Health and Clinical Guidance (NICE) guidance on Transcatheter aortic valve implantation for aortic stenosis (Mar 2012):
“Evidence on the safety of transcatheter aortic valve implantation (TAVI) for aortic stenosis shows the potential for serious but well-recognized complications. For patients with aortic stenosis who are considered to be unsuitable for surgical aortic valve replacement (SAVR) the evidence on the efficacy of TAVI is adequate. For these patients, TAVI may be used with normal arrangements for clinical governance, consent and audit. For patients with aortic stenosis for whom SAVR is considered suitable but to pose a high risk, the evidence on the efficacy of TAVI is inadequate. For these patients TAVI should only be used with special arrangements for clinical governance, consent and data collection or research. For patients with aortic stenosis for whom SAVR is considered suitable and not to pose a high risk, the evidence on the efficacy of TAVI is inadequate. For these patients TAVI should only be used in the context of research”
A technology assessment from the California Technology Assessment Forum (CTAF), “Transcatheter Aortic Valve Replacement In Patients With Severe Aortic Stenosis Who Cannot Undergo Surgery” (Feb 2012) concluded, “Use of the SAPIEN transcatheter aortic valve meets CTAF TA Criterion 1 through 5 for safety, effectiveness and improvement in net health outcomes when used for the treatment of severe, symptomatic aortic stenosis in patients determined to be inoperable by a cardiac surgeon who can be treated using the transfemoral approach.” The TVT Registry is a new benchmarking tool to track patient safety and real-world outcomes related to transcatheter aortic valve replacement (TAVR). Created by the ACC and the STS, the TVT Registry is designed to monitor the safety and efficacy of this new procedure for the treatment of aortic stenosis. According to the STS, the TVT Registry serves as the main repository for clinical data related to TAVR and is positioned to incorporate future catheter-based procedures. There are only limited clinical data on the durability of TAVR valves, up to 2 years, in the PARTNER trial and up to 5 years in other registry experiences. According to the 2012 ACCF/AATS/SCAI/STS Expert Consensus Document on Transcatheter Aortic Valve Replacement, “The registries demonstrate in high-risk patients that TAVR may be deployed with a high degree of procedural success, predictable risk of stroke, device dependent high risk of pacemaker implantation (particularly with CoreValve), and a 30-day mortality rate that seems potentially acceptable in a debilitated and ill Transcatheter Aortic Valve Replacement May 16
patient population. Importantly, TAVR seems to alleviate AS to a similar degree as surgical AVR and patients tend to return to Class I or II symptoms with substantial improvements in quality of life. Future registries should be designed to include contemporary (i.e., VARC) definitions of procedural and quality-of-life outcomes and utilize an independent clinical events committee when possible to standardize event reporting. Longer-term follow-up studies are needed to demonstrate the continued durability of TAVR in the high-risk and inoperable patients.” The PARTNER trial, (The Placement of Aortic Transcatheter Valves Trial) was a prospective, unblinded, randomized, controlled, multicenter pivotal trial evaluating the safety and effectiveness of the Edwards Sapien THV transcatheter aortic valve; 2 distinct populations were enrolled; inoperable, or Cohort B, and high-risk operable, or Cohort A. Potential candidates were presented on a national conference call for approval for treatment. Randomization was stratified based on operability for AVR surgery and within cohorts by vascular access for transfemoral delivery. Patients who were considered high surgical risk and eligible for transfemoral access were stratified into Cohort A and randomized to treatment (transfemoral AVR) or control (surgical AVR). Cohort A patients who were not eligible for transfemoral access were evaluated as candidates for transapical delivery and, if appropriate, randomized to treatment (transapical AVR) or control (surgical AVR). Nonsurgical candidates were stratified into Cohort B and randomized to treatment (transfemoral AVR) or control (“standard” therapy). Inoperability was formally defined as >50% predicted probability of mortality or serious irreversible complication by 30 days by 1 cardiologist and 2 cardiothoracic surgeons”. Cohort B patients who did not meet the criteria for transfemoral delivery were not enrolled in the study because transapical delivery was deemed too risky in Cohort B. Of the 3,105 patients screened, a total of 1,057 subjects (34%) were enrolled at 25 sites in 2 arms—699 patients in Cohort A and 358 patients in Cohort B. There were 2 co-primary endpoints for the inoperable cohort: freedom from death over the duration of the trial with all patients followed for at least 1 year from randomization; and hierarchical composite of death and recurrent hospitalization. In the high-risk cohort, the primary endpoint was freedom from all-cause death at 1 year. Pre-specified secondary endpoints included rate of death from cardiovascular causes, NYHA functional class, the rate of repeat hospitalization due to valve-related or procedural-related clinical deterioration, the distance covered during a 6-minute walk test, valve performance (assessed by echocardiography),and the rates of myocardial infarction, stroke, acute kidney injury, vascular complications, and bleeding. All patients were followed during the index hospitalization; at 30 days, 6 months, and 1 year; and yearly thereafter. In the inoperable Cohort B patients with symptomatic severe AS, TAVR substantially reduced all-cause mortality by nearly 50% and the composite of all-cause mortality and repeat hospitalization by 55% compared with standard therapy at 1-year follow-up. In addition, all key secondary endpoints including patient function significantly improved at 30 days and 1 year. TAVR was associated with an increased risk for stroke and procedure-related adverse events such as bleeding and vascular complications. Sensitivity analyses of patients as they were treated all favored TAVR. Overall, the benefit from TAVR in inoperable patients with symptomatic severe AS greatly exceeds the risk. In the high-risk Cohort A patients, TAVR was noninferior to AVR for all-cause mortality at 1 year (24.2% vs. 26.8%). AVR mortality at 30 days (6.5%) was lower than expected operative mortality (11.8%). Whether this discrepancy can be attributed to chance alone (ideal outcomes with expert surgeons within the idealized environment of a randomized trial) or due to “calibration drift” as surgical outcomes improve over time is not clear. All neurological events (30-day major stroke, 3.8% vs. 2.1%) and vascular complications (30-day, 11.1% vs. 3.2%) were more frequent Transcatheter Aortic Valve Replacement May 16
with TAVR. By contrast, major bleeding and new onset atrial fibrillation were more frequent with AVR. Improvements in echocardiographic findings were similar in both groups, although paravalvular regurgitation was increased with TAVR. The 2012 ACCF/AATS/SCAI/STS Expert Consensus Document on Transcatheter Aortic Valve Replacement concluded, “The data from this cohort further support TAVR as an acceptable alternative to surgical AVR in selected high-risk operable patients. They note, the 30-day mortality (generally thought to be procedure-related) in Cohort A (3.4%) and Cohort B (5.0%) was lower than the published SOURCE registry mortality (8.5%), despite a relatively lower-risk patient population enrolled in the latter (1-year mortality of 30.7% in Cohort B, 22.2% in Cohort A, and 18.9% in SOURCE). This arguably raises questions about the generalizability of the randomized trial data to clinical practice.” The quality-of-life results from Cohort B arm, the inoperable cohort, TAVR patients had improvement in the 6-minute walk performance compared with baseline, whereas standard therapy patients did not. In addition, TAVR patients were less symptomatic (New York Heart Association class), had reduced hospitalization stay, and improved physical functioning compared with standard therapy. In the high-risk cohort, both New York Heart Association class and 6-minute walk test favored TAVR at 30 days, but the differences were not significant at 1 year. TAVR patients had shorter index hospitalization length of stay (8 vs. 12 days). Quality of life as assessed by disease-specific measures (Kansas City Cardiomyopathy Questionnaire [KCCQ]) and by general health-related quality of life (Short Form-12 Health Questionnaire) improved at 1, 6, and 12 months in the TAVR group and were significantly higher than in the control arm. This supports that general and disease specific quality of life are improved with TAVR to 1 year over standard care among inoperable patients. The 2012 ACCF/AATS/SCAI/STS Expert Consensus Document on Transcatheter Aortic Valve Replacement concluded “TAVR is a complex procedure that continues to evolve. A foundational requirement of TAVR is a team-based approach to patient care. Given the high-risk profile of patients, who often have multiple comorbidities, as well as the technical complexity of the procedure involved, this team-based care will need to include multiple contributors at different stages in the process but will be mainly centered around the primary cardiologist, the cardiovascular surgeon, and the interventional cardiologist. In adults with severe, symptomatic, calcific stenosis of a trileaflet aortic valve who have aortic and vascular anatomy suitable for TAVR and a predicted survival >12 months: ● TAVR is recommended in patients with prohibitive surgical risk. ● TAVR is a reasonable alternative to surgical AVR in patients at high surgical risk.” According to the consensus document, Prohibitive surgical risk is defined as an estimated 50% or greater risk of mortality or irreversible morbidity at 30 days (as assessed by one cardiologist and 2 cardiothoracic surgeons), or other factors such as frailty, prior radiation therapy, porcelain aorta, and severe hepatic or pulmonary disease. Kodali et al (2012) reported the PARTNER Trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with TAVR and surgical replacement. The investigators sought to determine the long-term follow-up to determine whether TAVR has prolonged benefits. At 25 centers, 699 high-risk patients with severe aortic stenosis were randomly assigned to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. The rates of death from any cause were similar in the TAVR and surgery groups and at 2 Transcatheter Aortic Valve Replacement May 16
years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group. The frequency of all strokes during follow-up did not differ significantly between the two groups. At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR, and even mild paravalvular regurgitation was associated with increased late mortality. Investigators concluded a 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. Miller et al (2012) analyzed all neurologic events in the PARTNER randomized trial comparing TAVR with surgical AVR. High-risk patients with aortic stenosis were stratified into transfemoral (TF, n = 461) or transapical (TA, n = 196) strata based on their arterial anatomy and randomized: 657 received treatment assigned ("as treated"), 313 underwent AVR, and 344 TAVR. Neurologic events were prospectively adjudicated by an independent Clinical Events Committee. Multivariable, multiphase hazard analysis elucidated factors associated with increased likelihood of neurologic events. Forty-nine neurologic events (15 transient ischemic attacks, 34 strokes) occurred in 47 patients (TAVR, n = 31; AVR, n = 16). An early peaking high hazard phase occurred within the first week, which declined to a constant late hazard phase out to 2 years. The risk in the early phase was higher after TAVR than AVR, and in the TAVR arm in patients with a smaller aortic valve area index. In the late risk phase, the likelihood of neurologic event was linked to patient-related factors in both arms ("non-TF candidate," history of recent stroke or transient ischemic attack, and advanced functional disability), but not by treatment (TAVR vs AVR) or any intraprocedural variables. The likelihood of sustaining a neurologic event was lowest in the AVR subgroup in the TF stratum during all available follow-up. Investigators concluded after either treatment, there were 2 distinct hazard phases for neurologic events that were driven by different risk factors. Neurologic complications occurred more frequently after TAVR than AVR early, but thereafter the risk was influenced by patient- and disease-related factors. Holzhey et al (2012) compared the short and long-term outcomes after AVR surgery carried out via standard sternotomy/partial sternotomy versus transapical transcatheter AV implantation (taTAVI). All 336 patients who underwent taTAVI between 2006 and 2010 were compared with 4533 patients who underwent conventional AVR between 2001 and 2010. Using propensity score matching, the investigators identified and consecutively compared 2 very similar groups of 167 patients each. The focus was on periprocedural complications and long-term survival. The 30-day mortality rate was 10.8% and 8.4% for the conventional AVR patients and the TAVI patients, respectively. The percentages of postoperative pacemaker implantations (15.0% versus 6.0%) and cases of renal failure requiring dialysis (25.7% versus 12.6%) were higher in the TAVI group. Kaplan-Meier curves diverged after half a year in favor of conventional surgery. The estimated 3-year survival rates were 53.5% ± 5.7% (TAVI) and 66.7% ± 0.2% (conventional AVR). The investigators concluded the study shows that even with all the latest successes in catheter-based AV implantation, the conventional surgical approach is still a very good treatment option with excellent long-term results, even for older, high-risk patients. In a single-center analysis, Motloch et al (2012) assessed clinical data, preoperative risk scores (Society for Thoracic Surgeons score, logistic European System for Transcatheter Aortic Valve Replacement May 16
Cardiac Operative Risk Evaluation), preprocedural electrocardiograms, and 72-hour postprocedural rhythm monitoring of 170 patients undergoing TAVI (n=84) or surgical AVR (n=86). In a subanalysis, transapical (n=43) and transfemoral TAVI (n=41) were compared. The TAVI patients were significantly older, presented with more severe symptoms, had higher Society for Thoracic Surgeons score, higher logistic European System for Cardiac Operative Risk Evaluation score, and revealed more frequently intermittent atrial fibrillation compared with SAVR patients. Despite this more compromised health state; prevalence of postprocedural atrial fibrillation was significantly lower in the TAVI group (6.0%, versus 33.7% after SAVR). More than two thirds of TAVI patients but no SAVR patient with atrial fibrillation in preprocedural electrocardiograms had stable sinus rhythm during 72-hour postprocedural monitoring. Notably, no atrial fibrillation was observed after transfemoral TAVI. Whereas atrial fibrillation onset in the SAVR group predominantly occurred on postoperative day 3, atrial fibrillation onset after transapical TAVI was obtained within the first 24 hours after the intervention. Investigators concluded results indicate that TAVI, compared with SAVR, reduces the risk of periprocedural atrial fibrillation. Furthermore, preprocedural atrial fibrillation may be converted into sinus rhythm particularly after transfemoral TAVI, suggesting an impact of decreased intracardiac pressures in the absence of adverse periprocedural factors that might promote atrial fibrillation. Conradi et al (2012) compared outcomes after TAVI to those after surgical AVR. From June 2009 through June 2010, 82 consecutive patients underwent TAVI via a transapical (n = 60) or transfemoral (n = 22) approach using the Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, Calif). Mean patient age was 81.9 ± 5.2 years, 64.6% were women. Logistic EuroSCORE was 23.6% ± 1.4% and Society of Thoracic Surgeons score was 8.7% ± 1.3%. A group of 82 patients after surgical AVR was retrieved from our database, yielding a control group that was matched to the cases with respect to baseline demographics and typical risk factors. Overall mortality did not differ significantly between TAVI and AVR groups at 30 days (7.3% vs 8.6%), 90 days (13.6% vs 11.1%), or 180 days (17.8% vs 16.9%; P = .889). Conversion to surgery was necessary in 2 (2.4%) TAVI cases. Perioperative stroke occurred in 2 (2.4%) cases per group. Pacemakers were implanted for new-onset heart block in 3.7% and 2.4% in the TAVI and AVR groups, respectively. TAVI resulted in shorter operative times, shorter ventilation times, and shorter length of stay in the intensive care unit. Duration of hospital stay, however, was not significantly different. Investigators concluded, mortality rates are similar after both types of procedure. Patients receiving TAVI benefit from faster postoperative recovery. Until more clinical data become available, the optimal procedure has to be determined for each patient according to individual risk factors. Pilgrim et al (2011) investigated clinical outcomes of high-risk patients with severe aortic stenosis undergoing medical treatment (n=71) or TAVI (n=256) stratified by left ventricular ejection fraction (LVEF) in a prospective single center registry. Twenty-five patients (35%) among the medical cohort were found to have an LVEF≤30% (mean 26.7±4.1%) and 37 patients (14%) among the TAVI patients (mean 25.2±4.4%). Estimated peri-interventional risk as assessed by logistic EuroSCORE was significantly higher in patients with severely impaired LVEF as compared to patients with LVEF>30% (medical/TAVI 38.5±13.8%/40.6±16.4% versus medical/TAVI 22.5±10.8%/22.1±12.8%). In patients undergoing TAVI, there was no significant difference in the combined endpoint of death, myocardial infarction, major stroke, life-threatening bleeding, major access-site complications, valvular re-intervention, or renal failure at 30 days between the two groups (21.0% versus 27.0%). After TAVI, patients with LVEF≤30% experienced a rapid improvement in LVEF (from 25±4% to 34±10% at discharge) associated with improved NYHA functional class at 30 days (decrease ≥1 NYHA class in 95%). During Transcatheter Aortic Valve Replacement May 16
long-term follow-up no difference in survival was observed in patients undergoing TAVI irrespective of baseline LVEF, whereas there was a significantly higher mortality in medically treated patients with severely reduced LVEF (log rank p=0.001). Investigators concluded TAVI in patients with severely reduced left ventricular function may be performed safely and is associated with rapid recovery of systolic left ventricular function and heart failure symptoms. Stöhr et al (2011) compared 30-day mortality of high-risk patients treated by TAVI versus surgical AVR. A total of 175 patients (60 men; mean age, 80±6 years; Euroscore 21±13%) having undergone TAVI were compared with 175 matched patients (76 men; mean age, 79±3 years; Euroscore 17±9%), which have undergone conventional AVR and were deemed to be high-risk patients by the cardiothoracic surgeons. Thirty-day mortality and major adverse events were recorded in both groups. Patients' characteristics were analyzed for predictors of mortality in the TAVI group. Twenty-one patients (12%) in the TAVI group and 13 patients (8%) in the surgical group died within 30 days of the procedure. Two patients (1%) in the TAVI group and one patient (0.5%) in the conventional surgery group had a major stroke. Seven patients (4%) in the TAVI group and 25 patients (14%) in the conventional surgery group required dialysis post procedure. The average length of stay in the intensive care unit was lower in the TAVI group compared with the conventional surgical group (3.3±3.1 vs. 6.6±10.5 days). Age was the only independent predictor of mortality in the TAVI group (odds ratio=1.009; 95% confidence interval: 1.001-1.018 per additional year; P=0.0186) and in the total study population (odds ratio=1.007; 95% confidence interval: 1.0011.013 per additional year; P=0.0186). Investigators concluded in high-surgical risk patients, TAVI can be performed at a mortality risk comparable with conventional surgery with a reduced length of post interventional intensive care unit stay and less need for dialysis. Thomas et al (2011) reported on the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P=0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality. Authors concluded the SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured. Smith et al (2011) compared in a randomized trial compared transcatheter versus surgical aortic-valve replacement involving high-risk patients who were candidates for surgical replacement. At 25 centers, we randomly assigned 699 high-risk Transcatheter Aortic Valve Replacement May 16
patients with severe aortic stenosis to undergo either transcatheter aortic-valve replacement with a balloon-expandable bovine pericardial valve (either a transfemoral or a transapical approach) or surgical replacement. The primary end point was death from any cause at 1 year. The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement. The rates of death from any cause were 3.4% in the transcatheter group and 6.5% in the surgical group at 30 days (P=0.07) and 24.2% and 26.8%, respectively, at 1 year (P=0.44), a reduction of 2.6 percentage points in the transcatheter group (upper limit of the 95% confidence interval, 3.0 percentage points; predefined margin, 7.5 percentage points; P=0.001 for noninferiority). The rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group at 30 days (P=0.20) and 5.1% and 2.4%, respectively, at 1 year (P=0.07). At 30 days, major vascular complications were significantly more frequent with transcatheter replacement (11.0% vs. 3.2%, P70 Years of Age with Severe Aortic Stenosis. Braz J Cardiovasc Surg. 2016 Feb;31(1):1-6. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 2. Tarantini G, Mojoli M, Windecker S, et al. Prevalence and Impact of Atrial Fibrillation in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement: An Analysis From the SOURCE XT Prospective Multicenter Registry. JACC Cardiovasc Interv. 2016 Apr 7. Thomopoulou S, Vavuranakis M, Karyofyllis P, et al. Four-year clinical results of transcatheter self-expanding Medtronic CoreValve implantation in high-risk patients with severe aortic stenosis. Age Ageing. 2016 Mar 24. Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016 Apr 1. Wöhrle J, Gonska B, Rodewald C, et al. Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic StenosisImpact of Valve Size in a Single Center Experience. PLoS One. 2016 Mar 22;11(3):e0151247. Zweng I, Shi WY, Palmer S, et al. Transcatheter versus Surgical Aortic Valve Replacement in High-risk Patients: A propensity-score matched analysis. Heart Lung Circ. 2016 Feb 11.
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Blackstone EH, Suri RM, Rajeswaran J, et al. Propensity-Matched Comparisons of Clinical Outcomes after Transapical or Transfemoral TAVR: A PARTNER-I Trial Substudy. Circulation. 2015 Apr 1. pii: CIRCULATIONAHA.114.012525. Bozkurt E, Keleş T, Durmaz T, et al. Early outcomes of transcatheter aortic valve replacement in patients with severe aortic stenosis: single center experience. Postepy Kardiol Interwencyjnej. 2014;10(2):84-90. Chang HH, Chen IM, Chen PL, et al. Comparison of balloon-expandable valves versus self-expandable valves in high-risk patients undergoing transcatheter
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aortic valve replacement for severe aortic stenosis. J Chin Med Assoc. 2015 Mar 28 Minha S, Waksman R. Evaluation of the Edwards Lifesciences SAPIEN transcatheter heart valve. Expert Rev Med Devices. 2014 Nov;11(6):553-62 Papadopoulos N, Schiller N, Fichtlscherer S, et al. Propensity matched analysis of longterm outcomes following transcatheter based aortic valve implantation versus classic aortic valve replacement in patients with previous cardiac surgery. J Cardiothorac Surg. 2014 Jun 10;9:99 Zhang Y, Pyxaras SA, Wolf A, et al. Propensity-matched comparison between Direct Flow Medical, Medtronic Corevalve, and Edwards Sapien XT prostheses: Device success, thirty-day safety, and mortality. Catheter Cardiovasc Interv. 2015 Jan 10
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Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison of Balloon-Expandable vs Self-expandable Valves in Patients Undergoing Transcatheter Aortic Valve Replacement: The CHOICE Randomized Clinical Trial. JAMA. 2014 Mar 30. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis. N Engl J Med. 2014 Mar 29. Athappan G, Gajulapalli RD, Sengodan P, et al. Influence of TAVR strategy and Valve design on Stroke after Transcatheter Aortic Valve Replacement - A MetaAnalysis and Systematic Review of Literature. J Am Coll Cardiol. 2014 Mar 3. Diemert P, Lange P, Greif M, et al. Edwards Sapien XT valve placement as treatment option for aortic regurgitation after transfemoral CoreValve implantation: a multicenter experience. Clin Res Cardiol. 2014 Mar;103(3):18390. D'Onofrio A, Rizzoli G, Messina A, et al. Conventional surgery, sutureless valves, and transapical aortic valve replacement: what is the best option for patients with aortic valve stenosis? A multicenter, propensity-matched analysis. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1065-70 Elmariah S, Palacios IF, McAndrew T, et al. Outcomes of transcatheter and surgical aortic valve replacement in high-risk patients with aortic stenosis and left ventricular dysfunction: results from the Placement of Aortic Transcatheter Valves (PARTNER) trial (cohort A). Circ Cardiovasc Interv. 2013 Dec;6(6):60414 Ferrante G, Pagnotta P, Petronio AS, et al. Sex differences in postprocedural aortic regurgitation and mid-term mortality after transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2014 Jan 9. Kapadia SR, Svensson LG, Roselli E, et al. Single center TAVR experience with a focus on the prevention and management of catastrophic complications. Catheter Cardiovasc Interv. 2014 Jan 9 Lindman BR, Pibarot P, Arnold SV, et al. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Diabetes and Severe Aortic Stenosis at High Risk for Surgery: An Analysis of the PARTNER Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Mar 25;63(11):1090-9. Linke A, Wenaweser P, Gerckens U, et al. Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study. Eur Heart J. 2014 Mar 28. Mack MJ, Brennan JM, Brindis R, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA. 2013 Nov 20;310(19):2069-77. Makkar RR, Jilaihawi H, Mack M, et al. Stratification of outcomes after transcatheter aortic valve replacement according to surgical inoperability for technical versus clinical reasons. J Am Coll Cardiol. 2014 Mar 11;63(9):901-11 Murray MI, Geis N, Pleger ST, et al. Procedural Results with the Self-Expanding 31mm CoreValve Aortic Bioprosthesis in Patients with Large Annuli. J Interv Cardiol. 2014 Apr;27(2):191-8.
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14. Nijhoff F, Agostoni P, Amrane H, et al. Transcatheter aortic valve implantation in patients with severe aortic valve stenosis and large aortic annulus, using the self-expanding 31-mm Medtronic CoreValve prosthesis: First clinical experience. J Thorac Cardiovasc Surg. 2013 Nov 19 15. Pendyala LK, Minha S, Barbash IM, et al. Commercial versus PARTNER study experience with the transfemoral Edwards SAPIEN valve for inoperable patients with severe aortic stenosis. Am J Cardiol. 2014 Jan 15;113(2):342-7 16. Popma JJ, Adams DH, Reardon MJ, et al. Transcatheter Aortic Valve Replacement Using A Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery. J Am Coll Cardiol. 2014 Mar 13. 17. Sabaté M, Cánovas S, García E, et al. In-hospital and Mid-term Predictors of Mortality After Transcatheter Aortic Valve Implantation: Data From the TAVI National Registry 2010-2011. Rev Esp Cardiol (Engl Ed). 2013 Dec;66(12):94958 18. Sawa Y, Saito S, Kobayashi J, et al. First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis. Circ J. 2014 Apr 25;78(5):1083-90 19. Sherif MA, Zahn R, Gerckens U, et al. .Effect of gender differences on 1-year mortality after transcatheter aortic valve implantation for severe aortic stenosis: results from a multicenter real-world registry. Clin Res Cardiol. 2014 Mar 6. 20. Silberman S, Abu Akr F, Bitran D, et al. Comparison between transcatheter and surgical aortic valve replacement: a single-center experience. J Heart Valve Dis. 2013 Jul;22(4):448-54. 21. Osnabrugge RL, Speir AM, Head SJ, et al. Performance of EuroSCORE II in a large US database: implications for transcatheter aortic valve implantation. Eur J Cardiothorac Surg. 2014 Mar 6. 22. Unbehaun A, Pasic M, Drews T, et al. Transapical aortic valve implantation: predictors of survival up to 5 years in 730 patients. An update. Eur J Cardiothorac Surg. 2014 Mar 5. 23. U.S. Food and Drug Administration. Medtronic CoreValve System - P130021. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num= P130021 24. Waksman R, Thomas M, Gloekler S, et al. The impact of live case transmission on patient outcomes during transcatheter aortic valve replacement: Results from the VERITAS study. Cardiovasc Revasc Med. 2014 Mar;15(2):63-8. 25. Wendt D, Thielmann M, Kahlert P, et al. Comparison between different risk scoring algorithms on isolated conventional or transcatheter aortic valve replacement. Ann Thorac Surg. 2014 Mar;97(3):796-802
References – Update May 2013 1.
Chieffo A, Buchanan GL, Van Mieghem NM, et al. Transcatheter Aortic Valve Implantation With the Edwards SAPIEN Versus the Medtronic CoreValve Revalving System Devices: A Multicenter Collaborative Study: The PRAGMATIC Plus Initiative (Pooled-RotterdAm-Milano-Toulouse In Collaboration). J Am Coll Cardiol. 2013 Feb 26;61(8):830-6. Codner P, Assali A, Dvir D, et al. Two-Year Outcomes for Patients With Severe Symptomatic Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation. Am J Cardiol. 2013 Feb 14. Dvir D, Sagie A, Porat E, et al. Clinical profile and outcome of patients with severe aortic stenosis at high surgical risk: Single-center prospective evaluation according to treatment assignment. Catheter Cardiovasc Interv. 2013 Apr;81(5):871-81. Fassa AA, Himbert D, Vahanian A. Transcatheter aortic valve replacement: current application and future directions. Curr Cardiol Rep. 2013 Apr;15(4):353.
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Fernández D, Cevallos J, Brugaletta S, et al. Percutaneous transcatheter aortic valve implantation: present and future perspective. Expert Rev Med Devices. 2013 Mar;10(2):185-99. Forrest JK. Transcatheter aortic valve replacement: design, clinical application, and future challenges. Yale J Biol Med. 2012 Jun;85(2):239-47. Freeman M, Webb JG. Edwards SAPIEN and Edwards SAPIEN XT transcatheter heart valves for the treatment of severe aortic stenosis. Expert Rev Med Devices. 2012 Nov;9(6):563-9. Généreux P, Webb JG, Svensson LG, et al. Vascular complications after transcatheter aortic valve replacement: insights from the PARTNER (Placement of AoRTic TraNscathetER Valve) trial. J Am Coll Cardiol. 2012 Sep 18;60(12):1043-52. Gilard M, Eltchaninoff H, Iung B, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. Kala P, Tretina M, Poloczek M, et al. Quality of life after transcatheter aortic valve implantation and surgical replacement in high-risk elderly patients. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2012 Sep 5. Khatri PJ, Webb JG, Rodés-Cabau J, et al. Adverse effects associated with transcatheter aortic valve implantation: a meta-analysis of contemporary studies. Ann Intern Med. 2013 Jan 1;158(1):35-46. Krane M, Deutsch MA, Piazza N, et al. One-year results of health-related quality of life among patients undergoing transcatheter aortic valve implantation. Am J Cardiol. 2012 Jun 15;109(12):1774-81. Medtronic CoreValve U.S. Pivotal trial. Available at: http://www.medtronic.com/aorticstenosistrial/index.html Nielsen HH, Klaaborg KE, Nissen H, et al. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial. EuroIntervention. 2012 Jul 20;8(3):383-9. Nombela-Franco L, Ruel M, Radhakrishnan S, et al. Comparison of Hemodynamic Performance of Self-Expandable CoreValve Versus BalloonExpandable Edwards SAPIEN Aortic Valves Inserted by Catheter for Aortic Stenosis. Am J Cardiol. 2013 Apr 1;111(7):1026-33. Staubach S, Franke J, Gerckens U, et al. Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: Results from the prospective multicenter German TAVI registry. Catheter Cardiovasc Interv. 2013 Feb;81(2):348-55. Taramasso M, Latib A, Cioni M, et al. Quality of life improvement is maintained up to two years after transcatheter aortic valve implantation in high-risk surgical candidates. EuroIntervention. 2012 Aug;8(4):429-36. U.S. Food and Drug Administration. Edwards SAPIEN Transcatheter Heart Valve (THV) - P110021. October 2012. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num= P110021 Wendler O, Walther T, Schroefel H, et al. Transapical aortic valve implantation: mid-term outcome from the SOURCE registry. Eur J Cardiothorac Surg. 2013 Mar;43(3):505-11. Wilbring M, Tugtekin SM, Alexiou K, et al. Transapical transcatheter aortic valve implantation vs conventional aortic valve replacement in high-risk patients with previous cardiac surgery: a propensity-score analysis. Eur J Cardiothorac Surg. 2013 Jan 22. Ye J, Webb JG, Cheung A, et al. Transapical transcatheter aortic valve-in-valve implantation: Clinical and hemodynamic outcomes beyond 2 years. J Thorac Zhao QM, Lognone T, Ivascau C, et al. Procedural results and 30-day clinical events analysis following Edwards transcatheter aortic valve implantation in 48
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consecutive patients: initial experience. Chin Med J (Engl). 2012 Aug;125(16):2807-10.
References Initial 1.
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Clavel MA, Webb JG, Rodés-Cabau J, et al. Comparison between transcatheter and surgical prosthetic valve implantation in patients with severe aortic stenosis and reduced left ventricular ejection fraction. Circulation. 2010 Nov 9;122(19):1928-36. Conradi L, Seiffert M, Treede H, et al. Transcatheter aortic valve implantation versus surgical aortic valve replacement: a propensity score analysis in patients at high surgical risk. J Thorac Cardiovasc Surg. 2012 Jan;143(1):64-71. Dewey TM, Brown D, Ryan WH, et al. Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement. J Thorac Cardiovasc Surg. 2008 Jan;135(1):180-7. Holzhey DM, Shi W, Rastan A, et al. Transapical versus conventional aortic valve replacement--a propensity-matched comparison. Heart Surg Forum. 2012 Feb;15(1):E4-8. Johansson M, Nozohoor S, Kimblad PO, et al. Transapical versus transfemoral aortic valve implantation: a comparison of survival and safety. Ann Thorac Surg. 2011 Jan;91(1):57-63. Kodali SK, Williams MR, Smith CR, et al. Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. 2012 Mar 26 Available at: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1200384 Leon MB, Smith CR, Mack M, Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. Available at: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1008232 Miller DC, Blackstone EH, Mack MJ, et al. Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: Occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg. 2012 Apr;143(4):832-843.e13. Motloch LJ, Reda S, Rottlaender D, et al. Postprocedural atrial fibrillation after transcatheter aortic valve implantation versus surgical aortic valve replacement.Ann Thorac Surg. 2012 Jan;93(1):124-31. Piazza N, van Gameren M, Jüni P, et al. A comparison of patient characteristics and 30-day mortality outcomes after transcatheter aortic valve implantation and surgical aortic valve replacement for the treatment of aortic stenosis: a twocentre study. EuroIntervention. 2009 Nov;5(5):580-8. Pilgrim T, Wenaweser P, Meuli F, et al. Clinical outcome of high-risk patients with severe aortic stenosis and reduced left ventricular ejection fraction undergoing medical treatment or TAVI. PLoS One. 2011;6(11):e27556. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. Available at: http://www.nejm.org/doi/pdf/10.1056/NEJMoa1103510 Stöhr R, Dohmen G, Herpertz R, et al. Thirty-day outcome after transcatheter aortic valve implantation compared with surgical valve replacement in patients with high-risk aortic stenosis: a matched comparison. Coron Artery Dis. 2011 Dec;22(8):595-600. Tamburino C, Barbanti M, Capodanno D et al. Comparison of Complications and Outcomes to One Year of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis. Am J Cardiol. 2012 Feb 20. Thomas M, Schymik G, Walther T, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2011 Jul 26;124(4):425-33.
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16. Thomas M, Schymik G, Walther T, et al. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010 Jul 6;122(1):62-9. 17. U.S. Food and Drug Administration. Edwards SAPIEN Transcatheter Heart Valve. Nov 2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100041a.pdf 18. Wenaweser P, Pilgrim T, Guerios E,et al. Impact of coronary artery disease and percutaneous coronary intervention on outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation. EuroIntervention. 2011 Sep;7(5):541-8. 19. Zajarias A, Cribier AG. Outcomes and safety of percutaneous aortic valve replacement. J Am Coll Cardiol. 2009 May 19;53(20):1829-36. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. states, prior notice or website posting is required before an amendment is deemed effective.
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depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member’s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member’s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member’s contract shall govern. The Policies do not replace or amend the Member’s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. “Reconstructive surgery” means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean “cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation.
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