B P8 C74 Transcatheter Aortic Valve Replacement Flashcards
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
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
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.
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
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.
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
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.
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.
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.
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.
Class 1 indications for TAVR (ACC/AHA 2020)
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)
_____ imaging has become a fundamental diagnostic and procedure planning tool for all TAVR procedures.
Computed tomography (CT) contrast imaging
CT is routinely used to _____.
(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.
In the management of TAVR patients, echocardiography is used:
(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
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.
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.
In post-TAVR patients, routine transthoracic echocardiograms are usually incorporated into follow-up clinical assessments, at _____ year intervals, or in response to symptom changes.
1- or 2 year intervals
TAVR-associated complications
- Intraprocedural complications
- Coronary obstruction
- Vascular complications
- Postprocedural complications (Neurologic events, Conduction disturbances, Paravalvular regurgitation, PPM)
- Other complications (Bleeding 4-5%, AKI ~ 1%, endocarditis <1%)
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 <____%.
<0.5%
Acute coronary obstruction during TAVR is rare due to careful preoperative CT-imaging for risk assessment.
Important CT-measurements are the _____.
(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
The most frequent intraprocedural complication is related to transfemoral access with ______________ reported in 1.5%
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.
The _____% incidence of periprocedural stroke after TAVR has remained constant over the past 5 years.
2%