Aortic Stenosis and TAVR TARUN NAGRANI, MD INTERVENTIONAL AND ENDOVASCULAR CARDIOLOGIST, SOMC

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Aortic Stenosis  AS is an insidious disease with a long latency period followed by rapid progression after the appearance of symptoms, resulting in a high rate of death (50% in the 1st 2 years).  SAVR reduces symptoms and improves survival in patients with AS, and in the absence of serious coexisting conditions, the procedure is associated with low operative mortality.  About 30% of patients with severe symptomatic AS do not undergo SAVR owing to advanced age, LVD, or the presence of multiple coexisting conditions.

Stages of Aortic stenosis

Work up - Class 1  TTE is indicated in patients with signs or symptoms of AS or a BAV for accurate diagnosis of the cause of AS, hemodynamic severity, LV size, and systolic function, and for determining prognosis and timing of valve intervention. (LOE: B)

Class 2  Low-dose DSE testing using echo or invasive hemodynamic measurements is reasonable in patients with stage D2 AS with all of the following (LOE: B) :  Calcified AV with reduced systolic opening;  LVEF < 50% and calculated AVA 1.0 cm2 or less; and aortic velocity < 4.0 m/s or mean PG < 40 mm Hg.  EST is reasonable to assess physiological changes with exercise and to confirm the absence of symptoms in asymptomatic patients with a calcified AV and a Vp >= 4.0 m per second or MPG >=40 mm Hg (Stage C1) (LOE: B)

Class III  Exercise testing should not be performed in symptomatic patients with AS when the aortic velocity is 4.0 m per second or greater or mean pressure gradient is 40 mm Hg or higher (stage D). (Level of Evidence: B)

Risk stratification

PARTNER TRIAL  The PARTNER Trial (Placement of AoRtic TraNscathetER Valves) was initiated to investigate the safety and effectiveness of a less invasive treatment in severe AS. It consists of two individually powered patient cohorts.  In Cohort A, the safety and effectiveness of the balloon- expandable Edwards SAPIEN THV was compared to SAVR in high- risk patients with severe symptomatic AS.  In Cohort B, the safety and effectiveness of the balloon-expandable Edwards SAPIEN THV was compared to standard therapy (best medical management) in inoperable patients with severe symptomatic AS.

Cohort A - 12 months

CORE VALVE

CORE valve study  795 patients with severe aortic stenosis with high estimated surgical risk were randomly assigned to self- expanding TAVR or SAVR.  Mortality rate at one year was lower in the TAVR group than in the surgical group (14.2 versus 19.1 percent).  Major vascular complications, cardiac perforation, and permanent pacemaker implantation were more frequent after TAVR.

CORE Valve study  Life-threatening or disabling bleeding, AKI, and new- onset or worsening AF were more frequent after surgery.  TAVR was non-inferior to surgical therapy with respect to echocardiographic indices of valve stenosis, functional status, and quality of life at one year.  Exploratory analyses suggested a reduced rate of major adverse cardiovascular at one year and no increase in risk of stroke at one year with TAVR.

CHOICE TRIAL  Comparison of THV in High Risk Patients with severe AS (CHOICE) trial randomly assigned 241 patients to either the BE Edwards SAPIEN XT valve or the SE MCV.  Primary end point was device success (a composite of successful vascular access, device deployment, retrieval of the delivery system, correct device position, intended valve performance without moderate or severe regurgitation, and only one valve implanted in the proper anatomic location).

CHOICE TRIAL  Device success was achieved more frequently with the BEV than with the SEV (95.9 versus 77.5 percent). This difference was caused by a lower frequency of greater than mild AI and less need for implanting more than one valve in the balloon-expandable group.  Cardiovascular mortality at 30 days was similar in the BEV and SEV groups (4.1 and 4.3 %). The combined safety end point occurred at similar rates in the two groups (18.2 and 23.1 %).  PPM was less frequent in the BEV group (17.3 vs 37.6 %).

TAVR - ACC GUIDELINES  Severe AS who have an unacceptably high estimated surgical risk, or due to technical issues with surgery, e.g. a porcelain aorta or prior significant mediastinal radiation, prior pericardiectomy with dense adhesions or a patent LIMA lying beneath the sternum. Exclusions  Bicuspid or unicuspid or noncalcified aortic valve or severe AI ( >3+)  Native aortic annulus size as measured by echo the largest annulus size for which a TAVR device is available (29 mm).  AMI within one month before the intended treatment.  Hemodynamic/respiratory instability requiring inotropic support, MV, or MHA within 30 days of screening evaluation.  Need for emergency surgery  Hypertrophic cardiomyopathy with or without obstruction

Exclusions  Left ventricular ejection fraction <20 % or severe PHT and RVD.  Renal insufficiency (eg, creatinine >3.0 mg/dL) and/or ESRD on HD.  Echo evidence of intracardiac mass, thrombus, or vegetation  MRI confirmed stroke or transient ischemic attack within six months (180 days).  Severe incapacitating dementia  Estimated life expectancy <12 months due to noncardiac comorbid conditions  Severe mitral regurgitation

COMPLICATIONS OF TAVR  Shock and low CO during and following deployment  Annular rupture  Vascular complications  Myocardial injury  Heart block: RBBB and self expanding valve  Paravalvular AI: frequency of moderate or severe paravalvular AI was lower one year after self-expanding TAVR than at discharge (4.2 versus 10.7 percent).  Stroke: 2 – 5%

Predictors of Mortality  Independent predictors of mortality at 30 days included certain procedural complications (conversion to open heart surgery, cardiac tamponade, major vascular or access site complications) as well as baseline characteristics (left ventricular ejection fraction <40 percent, prior balloon valvuloplasty, and diabetes mellitus).  Independent predictors of mortality between 30 days and one year included prior stroke, postprocedural paravalvular leak ≥2+, prior acute pulmonary edema, and chronic kidney disease.

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