B P8 C74 Transcatheter Aortic Valve Replacement

Question 1

Identify the trial

This randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve.

The primary end point was the rate of death from any cause

Answer 1

PARTNER 1B trial (2010)
Prohibitive risk/not suitable for surgery
TAVR vs Medical Tx +/- Balloon Valvuloplasty

In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events.

TAVR superior vs MedTx

Question 2

Identify the trial

This randomly assigned 699 high-risk 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.

Answer 2

PARTNER 1A (2011)
High risk
TAVR vs SAVR

In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks

Question 3

Identify the trial

This randomly assigned 699 high-risk 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.

Answer 3

PARTNER 1A (2011)
High risk
TAVR vs SAVR

In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks

Question 4

Identify the trial

This randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years.

The primary hypothesis was that TAVR would not be inferior to surgical replacement.

Answer 4

PARTNER 2A (2016)
Intermediate risk patients
TAVR vs SAVR

In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke.

Question 5

Identify the trial

This randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery.

The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population.

Answer 5

PARTNER 3 (2019)
Low risk
TAVR vs SAVR

Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery.

Question 6

Class 1 indications for TAVR (ACC/AHA 2020)

Answer 6

For symptomatic patients of any age with severe AS and a high or prohibitive surgical risk, TAVR is recommended if predicted post-TAVR survival is >12 months with an acceptable quality of life (IA)

For symptomatic patients with severe AS who are >80 years of age or for younger patients with a life expectancy <10 years and no anatomic contraindication to transfemoral access, TAVR is recommended (IA)

For symptomatic patients with severe AS who are 65 to 80 years of age and no anatomic contraindication to transfemoral access, after shared decision making, TAVR is an alternative to SAVR (IA)

In asymptomatic patients with severe AS and an LVEF <50% who are ≤80 years of age and no anatomic contraindication to transfemoral access, TAVR is an alternative to SAVR (preference according to age) (IB)

Question 7

_____ imaging has become a fundamental diagnostic and procedure planning tool for all TAVR procedures.

Answer 7

Computed tomography (CT) contrast imaging

Question 8

CT is routinely used to _____.

Answer 8

(1) Optimally select the transcatheter valve size

(2) Assess anatomic features of the iliofemoral arteries to determine the suitability of transfemoral access for a given TAVR system

(1) aortic root assessment, including calcification, coronary artery height, sinus of Valsalva diameter, and sinotubular junction height and diameter
(2) aortic annulus measurements for valve sizing, including diameters, perimeter, area, and ellipticity
(3) landing zone calcification
(4) valve morphology—calcification patterns and bicuspid or tricuspid anatomy
(5) vascular anatomy, including iliofemoral dimensions and aorta size and tortuosity.

Question 9

In the management of TAVR patients, echocardiography is used:

Answer 9

(1) Pretreatment for diagnosis of stenosis severity and for procedure planning

(2) Intra-procedure to determine the etiology of complications and to assess PVR

(3) During follow-up as a clinical and research tool to assess long-term bioprosthetic valve function, especially in the setting of recurrent symptoms

Question 10

Complications post TAVR

True or False

The early TAVR randomized trials clearly indicated that PVR was more common after TAVR compared with surgery and was associated with increased late mortality.

Answer 10

True
The incidence of moderate-severe PVR post TAVR has diminished significantly to approximately 1.5%

Other complications:
Acute coronary obstruction during TAVR is rare due to careful preoperative CT-imaging for risk assessment.

The 2% incidence of periprocedural stroke after TAVR has remained constant over the past 5 years.

The incidence of new permanent pacemaker (PPM) implantation due to high-degree atrioventricular block ranges from 6% to 7% with balloon-expandable valves to 17% to 18% with self-expanding valves, with an overall national rate of 11% for TAVR

Severe and moderate prosthesis-patient mismatches were present following TAVR in 12% and 25%; worse outcomes after SAVR

The incidence of other important complications after TAVR is low,48 including major or life-threatening bleeding 4% to 5%, acute kidney injury ∼1%, and endocarditis <1%. The frequency of endocarditis after TAVR is approximately the same as after surgical AVR.

Question 11

In post-TAVR patients, routine transthoracic echocardiograms are usually incorporated into follow-up clinical assessments, at _____ year intervals, or in response to symptom changes.

Answer 11

1- or 2 year intervals

Question 12

TAVR-associated complications

Answer 12

• Intraprocedural complications
• Coronary obstruction
• Vascular complications
• Postprocedural complications (Neurologic events, Conduction disturbances, Paravalvular regurgitation, PPM)
• Other complications (Bleeding 4-5%, AKI ~ 1%, endocarditis <1%)

Question 13

Intraprocedural major complications during TAVR have declined over time and are currently uncommon. In the 2020 TVT registry report of >275,000 TAVR procedures overall and 73,000 in 2019, the incidence of acute structural complications (annulus rupture, chamber perforation, and valve embolization), need for cardiopulmonary bypass support, and conversion to open heart surgery were all <____%.

Answer 13

<0.5%

Question 14

Acute coronary obstruction during TAVR is rare due to careful preoperative CT-imaging for risk assessment.

Important CT-measurements are the _____.

Answer 14

(1) Coronary orifice height above the aortic annulus

(2) Size of the sinuses of Valsalva relative to the annulus and the ascending aorta relative to the type and size of the planned valve

Question 15

The most frequent intraprocedural complication is related to transfemoral access with ______________ reported in 1.5%

Answer 15

Major vascular complications

If vascular complications do occur, most can be success- fully managed by an experienced operator using an endovascular approach, with the seldom need for surgical cutdown and open repair.

Question 16

The _____% incidence of periprocedural stroke after TAVR has remained constant over the past 5 years.

Answer 16

2%

Question 17

New atrioventricular conduction disturbances after TAVR remain an ongoing concern without complete resolution.

The incidence of new permanent pacemaker (PPM) implantation due to high-degree atrioventricular block ranges from _____% with balloon-expandable valves to _____% with self-expanding valves, with an overall national rate of 11% for TAVR.

Answer 17

Balloon-expandable valves: 6% to 7%

Self-expanding valves: 17-18%

Question 18

There has been a focus on procedural techniques to ______, which have been shown to reduce the need for new PPM.

Answer 18

(1) Avoid oversizing the valve relative to the annulus

(2) Minimize the depth of valve implantation to reduce trauma to the membranous septum

Question 19

TAVR may be suitable for some BAVD patients with a _____________________ and those ______________________ of the valve leaflets and LV outflow tract.

Answer 19

Non- or minimally calcified raphe
Without bulky eccentric calcification

Question 20

The early TAVR randomized trials clearly indicated that PVR was more common after TAVR compared with surgery and was associated with increased late mortality.

The incidence of moderate-severe PVR post-TAVR has diminished significantly to approximately ____%, based on site reports in the most recent TVT registry.

Answer 20

1.5%

Question 21

There are a number of factors responsible for reduced PVR:

Answer 21

(1) Routine use of CT-imaging to accurately assess annular dimensions for selection of the optimal valve size

(2) New generation transcatheter valve designs, which incorporate external wraps (polymers or biologic materials) to fill gaps and promote flush contact with the annulus

(3) Intraprocedure recognition of PVR and the use of post-dilation strategies which commonly resolves or greatly diminishes the severity of PVR.

Question 22

Placement of a ______ can help to resolve the PVR if initial placement location was imprecise.

Answer 22

Second valve inside the initial valve (TAVR in TAVR)

Question 23

If moderate or severe PVR persists after the procedure, ______ can be performed and is usually successful.

Answer 23

Transcatheter device closure, most commonly using a vascular plug

Question 24

_____ is a condition where the effective orifice area (EOA) of a normally functioning prosthesis is too small in relation to the patient’s body size and has been associated with worse outcomes after surgical AVR

Answer 24

Prosthesis–patient mismatch

Although TAVR prostheses generally have larger valve orifices, a recent analysis of the TVT registry demonstrated that severe and moderate prosthesis-patient mismatches were present following TAVR in 12% and 25% of patients, respectively.

Predictors of severe prosthesis-patient mismatch included:
Small (≤23-mm diameter) valve prosthesis
Valve-in-valve procedures
Larger body surface area
Female sex
Younger age
Non-white/Hispanic race
Lower ejection fraction
Atrial fibrillation (AF)
Severe mitral or tricuspid regurgitation

Question 25

Recent studies have noted that Doppler echocardiography may _____ the severity of prosthesis-patient mismatch post-TAVR due to pressure recovery considerations and assumptions made in calculating transvalvular gradients in a nonstenotic prosthetic valve

Answer 25

Overestimate

Question 26

The sentinel imaging findings of subclinical leaflet thrombosis

Answer 26

Hypoattenuated leaflet thickening (HALT)
Reduced leaflet motion

Observed in approximately 20% of patients during the first year after TVR

Question 27

The ______ found that subclinical leaf- let thrombosis was more frequent in transcatheter compared with surgical valves at 30 days but not at 1 year, a significant minority of patients had either resolution of 1-month HALT by 1 year or newly appearing HALT at 1 year, and the impact of HALT on thromboembolic complications and SVD was indeterminate and required long-term follow-up.

Answer 27

PARTNER 3 CT-substudy

Question 28

At the current time, __________________ is the preferred post-TAVR pharmacotherapy strategy in patients without recent coronary stents and without other indications for antithrombotic agents.

Answer 28

Aspirin monotherapy (or another single antiplatelet agent)

Question 29

Predictors of severe prosthesis-patient mismatch included _____________

Answer 29

Small (≤23-mm diameter) valve prosthesis
Valve-in-valve procedures
Larger body surface area
Female sex
Younger age
Non-white/Hispanic race
Lower ejection fraction
Atrial fibrillation (AF)
Severe mitral or tricuspid regurgitation.

Question 30

The tissue from both surgical and transcatheter bioprostheses is prone to ______, which could lead to hemodynamic valve dysfunction.

Answer 30

Structural valve deterioration (SVD)

Question 31

In studies of surgical valves, SVD commonly begins _________ after implantation, with marked acceleration after 10 years.

Answer 31

8 years

Follow-up surgical series indicate that the overall freedom from reintervention or death in patients with surgical aortic valves is approximately 95% at 5 years, 70% to 90% at 10 years, and 50% to 80% at 15 years

Question 32

If a patient with AS and AF is a surgical candidate, then surgical valve replacement with a concomitant _____ is a meaningful option.

Answer 32

Maze procedure and left atrial appendage occlusion

Patients with AF who undergo TAVR should have preprocedure anticoagulation regimens maintained after TAVR, and the use of combined or staged transcatheter left atrial appendage closure is currently being studied in a randomized clinical trial.

Question 33

In general, patients <50 years are best treated with a _____ valve if anticoagulation is acceptable, and in patients >60 to 65 years, a _____ is preferable.

Answer 33

< 50 yrs: Mechanical valve
> 6- to 65 yrs: Bioprosthetic valve

Question 34

As a general rule, if a patient has clinical indications for procedural valve therapy and is a reasonable surgical candidate, multivalve disease is best treated with ______.

Answer 34

Surgery

Question 35

_________ due to mitral annular calcification usually does not improve after TAVR

Answer 35

Mitral stenosis and/or regurgitation

Question 36

Approximately two-thirds of patients with AS and _____ (mainly those with LV myocardial reserve) show reduced severity of MR and improved symptoms of pulmonary congestion, as LV afterload is reduced after TAVR.

Answer 36

Secondary MR

Question 37

Patients with significant _______ , usually due to secondary etiologies, do not experience meaningful reduction in cardiac symptoms after TAVR alone, especially when irreversible pulmonary artery hypertension and/or significant right ventricular dysfunction is present

Answer 37

Tricuspid regurgitation (TR)

Question 38

In patients who are preferred TAVR candidates with high-grade proximal coronary lesions, _____ has become the preferred therapy under most circumstances.

Answer 38

Percutaneous coronary intervention prior to TAVR

Question 39

Those with _______ are preferentially treated using a surgical approach and those with less-complex lesions are treated with staged percutaneous coronary intervention (PCI) followed by TAVR.

Answer 39

Left main, multivessel, or complex coronary disease and AS

Question 40

True or False

TAVR therapy usually improves symptoms and other clinical outcomes in these LFLG patients with reduced LV function

Answer 40

True