SCAI CHAP 42 TAVR Flashcards
Fill-in-the-Blank Quiz:
Age-related calcific aortic stenosis (AS) is the most common form of AS. Approximately ___% of patients over the age of 75 years have severe AS.
The development of the cardinal symptoms of angina, syncope, or heart failure portends a dismal prognosis, so treatment is recommended at the earliest onset of __________ or decline in functional status.
Surgical aortic valve replacement (SAVR) remained the standard of care for many years after the advent of transcatheter aortic valve replacement (TAVR), first performed by Dr. Alain Cribier in _________.
ACC/AHA guidelines currently give a class 1A recommendation for either SAVR or TAVR for patients ___ to ___ years of age and recommend TAVR for those over 80 years.
TAVR volume now far surpasses SAVR volume for the treatment of isolated aortic valve stenosis, accounting for ___% of all such procedures in 2021.
The most rapid increase in application of TAVR has been in patients younger than ___ years.
The explosive growth of TAVR has occurred concomitantly with significant growth in the aging population with severe symptomatic AS, such that the relative proportion of patients not receiving indicated treatment remains __________.
There are also gender, racial, and geographic __________ in access to this intervention.
Answers:
3%
dyspnea
2002
65 to 80
88%
65
significant
disparities
Fill-in-the-Blank Quiz:
There are two dominant transcatheter valve platforms on the US market: SAPIEN by Edwards Lifesciences and __________ by Medtronic ( CoreValve platform )
The current generation SAPIEN 3 Ultra Resilia valve consists of a __________-expandable cobalt chromium frame with bovine pericardial leaflets. It has a polyethylene terephthalate outer sealing skirt to reduce __________.
The current generation Evolut Pro+ valve has a __________-expanding nitinol frame with porcine pericardial leaflets.
Both the SAPIEN 3 UR and Evolut Pro+ valves have an external sealing skirt intended to reduce __________.
The BE ( ballon expandable ) SAPIEN valve is deployed in an __________-annular position, whereas the SE ( self expandable ) Evolut valve has a __________-annular design.
The Evolut Pro+ is also __________ and repositionable.
The SE second-generation Navitor valve recently received FDA approval for patients at high or extreme __________ risk.
The Trilogy valve has completed enrollment in its pivotal trial for high-risk patients with aortic __________.
The ACURATE neo2 valve has an ongoing pivotal trial including patients across all __________ risk levels.
Boston Scientific’s Lotus valve obtained approval for high risk patients and was discontinued after a voluntary recall due to issues with the __________ system.
Answers:
Evolut
balloon, paravalvular leak (PVL)
self
paravalvular leak (PVL)
intra, supra
recapturable
surgical
regurgitation (AR)
surgical
delivery
Show a picture of Evolut and Sapien valve deployment
Show a picture of commercially available TAVR VALVES
Fill-in-the-Blank Quiz:
In the United States, the landmark __________ trial led to FDA approval for TAVR in inoperable!! patients with severe AS.
There were two cohorts in this study: A and B. Cohort B consisted of __________ patients with severe symptomatic AS deemed inoperable by two cardiac surgeons.
In the standard medical therapy arm, __________% of patients underwent balloon aortic valvuloplasty.
The primary endpoint was superiority of TAVR in all-cause __________.
At 1 year, there was __________% all-cause mortality in those undergoing standard therapy as compared to __________% in patients treated with TAVR (P < .001).
TAVR was associated with a higher rate of major strokes at 30 days (__________% vs 1.1%, P = .06).
The FDA approved the use of the __________ valve for inoperable patients with severe symptomatic AS in November 2011.
Answers:
PARTNER
358
83.8%
mortality
50.7%, 30.7%
5.0%
SAPIEN
Fill-in-the-Blank Quiz:
PARTNER cohort A examined the role of TAVR in patients with severe symptomatic AS deemed to have high but not prohibitive risk for surgery, with the Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) of at least ___%. A total of ___ patients were randomized to TAVR or SAVR.
Of the 348 patients randomized to TAVR, ___ underwent TF-TAVR. The TA-TAVR ( transapical approach ) patients had higher rates of peripheral vascular disease and prior __________.
Unlike PARTNER B, the primary endpoint of PARTNER A was noninferiority in all-cause mortality. At ___ year, there were no significant differences in all-cause mortality between TAVR and SAVR, a finding maintained at ___ years.
An increased risk of major stroke after TAVR persisted, with a rate of ___% in the TAVR group versus ___% in the surgical group at 1 year (P = .07).
In October 2012, the FDA extended its approval of the __________ valve to encompass high-risk patients with severe symptomatic AS.
Answers:
10%, 699
244, coronary bypass surgery
1, 3
5.1%, 2.4%
SAPIEN
Fill-in-the-Blank Quiz:
The PARTNER 2A study randomized 2032 _________ patients ( STS PROM ___%, ___% ) to TAVR with the second-generation SAPIEN XT valve or SAVR.
At 2 years, there were no significant differences in the primary endpoint of all-cause mortality or __________ stroke between the groups. Notably, there was no difference in rates of disabling stroke, which was ___% in the TAVR group and 6.4% in the SAVR group (P = .83).
PARTNER 2 S3i was a prospective registry of intermediate-risk patients undergoing TAVR with the third-generation __________ valve. This cohort of 1032 patients was then compared to the surgical cohort in PARTNER 2A.
A propensity-matched analysis showed that SAPIEN 3 TAVR was _____ to SAVR for the conmposite primary endpoint of all-cause mortality, stroke, and ____________.
Surgery resulted in superior outcomes compared to those of patients left with moderate or greater AR after TAVR, highlighting the importance of minimizing PVL ( paraventricaulr leak)
In August 2016, on the basis of the results from PARTNER 2A and PARTNER 2 S3i, the FDA approved the use of the SAPIEN XT and SAPIEN 3 valves for __________-risk patients with severe symptomatic AS.
Answers:
intermediate risk, 4%-8%
disabling, 6.2%
SAPIEN 3
superior, moderate or severe AI ( i think they mean AI as a complication )
intermediate
True or False: The PARTNER 3 trial included 1000 patients at high operative risk, defined as an STS PROM less than 4%, randomized to TAVR or SAVR.
True or False: All patients in the PARTNER 3 trial were required to have adequate vascular access for TF placement of the SAPIEN 3 valve.
True or False: The composite outcome of all-cause death, stroke, or rehospitalization at 1 year was higher in the TAVR group than in the SAVR group.
True or False: Based on the results of the PARTNER 3 trial, the FDA extended its approval for the SAPIEN valve to include only patients at high surgical risk.
Answer: False. The FDA extended its approval for the SAPIEN valve to encompass patients across the full spectrum of surgical risk, not just high-risk patients
Answer: False. The PARTNER 3 trial included patients at low operative risk, not high, with an STS PROM less than 4%.
Answer: True. Adequate vascular access was a requirement to accomodate a TF placement of the SAPIEN 3 valve in the trial.
Answer: False. The composite outcome occurred less frequently in the TAVR group (8.5%) compared to the SAVR group (15.1%).
Answer: False. The FDA extended its approval for the SAPIEN valve to encompass patients across the full spectrum of surgical risk, not just high-risk patients.
True or False: The CoreValve US Pivotal Extreme Risk Trial randomized patients to medical therapy or TAVR.
True or False: The CoreValve device was approved by the FDA 3 years after the SAPIEN valve for extreme-risk patients with severe symptomatic AS.
True or False: In the CoreValve US Pivotal High Risk Trial, TAVR was associated with a higher mortality at 1 year compared to SAVR.
True or False: The SURTAVI trial defined intermediate risk as an STS PROM between 3% and 15%.
True or False: In the SURTAVI trial, the rate of new pacemaker implantation was higher in the SAVR group compared to the TAVR group.
True or False: The Evolut Low Risk trial ( below 3%) showed that TAVR met the prespecified criteria for noninferiority compared to SAVR.
True or False: In the Evolut Low Risk trial, rates of major bleeding and new-onset atrial fibrillation were higher in the TAVR group compared to the SAVR group.
True or False: The FDA approved the use of the Evolut R and Evolut Pro valves in low-risk patients in 2019.
Answer: False. The trial did not randomize patients to medical therapy; instead, it enrolled 489 patients who all underwent attempted TAVR with the CoreValve.
Answer: True. The CoreValve entered the market 3 years later than the SAPIEN valve and after meeting specific endpoints, was approved by the FDA in January 2014 for extreme-risk patients.
Answer: False. CoreValve TAVR was associated with a lower mortality at 1 year compared to SAVR (14.2% vs 19.1%), also numerically lower stroke rates. Need for a permanent pacemaker and significant paravalvular regurgitation occurred more frequently with TAVR. In June 2014, the FDA extended its approval of CoreValve for the treatment of high-risk patients with severe symptomatic AS.
Answer: True. Intermediate risk in the SURTAVI trial was defined as an STS PROM between 3% and 15%. The primary endpoint was death or disabling stroke at 24 months. TAVR was noninferior to SAVR with regard to the primary endpoint
Answer: False. The rate of new pacemaker implantation was higher in the TAVR group (25.9%) compared to the SAVR group (6.6%).
Answer: True. The Evolut Low Risk trial showed that TAVR met the prespecified criteria for noninferiority with respect to the primary endpoint. The primary endpoint of all-cause mortality or disabling stroke occurring in 5.3% of patients undergoing TAVR and 6.7% of patients undergoing SAVR at 2 years
Answer: False. Rates of major bleeding and new-onset atrial fibrillation were higher in the SAVR group, not the TAVR group. Whereas patients receiving TAVR had higher rates of new pacemaker implantation (17.4% vs 6.1%, P < .05) and moderate to severe PVL (3.5% vs 0.5%, P < .05) !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Answer: True. The FDA approved the use of the Evolut R and Evolut Pro valves for low-risk patients in 2019.
Consider a schematic of different bicuspid aortic valve morphologies based on number of rafe.
Fill-in-the-Blank Quiz:
Patients with bicuspid AS were excluded from all pivotal randomized trials, but observational data with early generation TAVR devices demonstrated higher rates of implantation failure, moderate or greater PVL, and __________ implantation compared to cases of TAVR in __________ AS.
Subsequent experiences with later generation devices have been more successful, but several __________ remain. Adding further complexity to their management, these patients tend to present at a __________ age and often have concomitant aortopathy that cannot be addresses transcatheter fashion.
Bicuspid valves display wide variability in __________. The Sievers and Schmidtke classification, based on surgical pathology specimens, relies primarily on the number of __________ present, also the spatial position of the ______raphe.
Since the native valve is not excised during TAVR, a more relevant classification scheme in the modern era would anticipate how TAVR devices may interact with various bicuspid __________.
Using computed tomography (CT) analysis of 1034 patients with bicuspid AS, Yoon et al demonstrated that significant raphe and leaflet ________were associated with increased risk of adverse outcomes, including 30-day mortality, moderate or greater PVL, and __________ injury.
In contrast, patients with bicuspid AS without calcified raphe and excess leaflet calcification had __________ outcomes.
Answers:
pacemaker, tricuspid
challenges, younger
anatomy, raphe, fused
morphologies
calcification, annular
favorable
The annulus tends to be ______ in bicuspid valves, sometimes exceeding the treatment range of currently available TAVR prostheses. It is also more often __________ and __________, which can prove challenging for prosthesis sizing and may contribute to more than mild _________.
Oversizing may account for the slightly increased risk of __________ implantation seen in bicuspid AS patients (9.1% vs 7.5%; P = .03) compared to their propensity-matched tricuspid counterparts in the __________ registry.
The PARTNER 3 bicuspid registry included ______ patients ineligible for enrollment in the randomized trial based on the presence of bicuspid morphology. There were no differences in key clinical outcomes after TAVR in these highly selected bicuspid patients compared to their propensity-matched counterparts with __________ AS.
Notably, almost half the screened patients in PARTNER 3 were excluded, predominantly due to significant __________ calcification. These findings suggest that with widespread use of multidetector CT imaging for preprocedural planning, carefully selected patients with bicuspid morphology can be considered for __________.
Based on the available data, patients with heavily calcified raphe or leaflets warrant careful consideration of the risk of annular injury, moderate or greater PVL, and __________ implant when weighing TAVR against SAVR.
Answers:
larger, elliptical, asymmetric, PVL
pacemaker, STS/ACC TVT
low risk, tricuspid
raphe, TAVR
pacemaker
Define/develop the following concepts within the context of TAVR.
1- LGAS or low gradient severe AS
2- Classical LGAS
3- Paradoxical LGAS
4- Low Flow State and TAVR mortality
5- Procedural Outcomes
6- Mortality Benefit
7- Stroke Volume
LGAS - Variant of severe AS with low transvalvular gradient due to decreased stroke volume [ SV <35ml/m2, calculated AVA < 1 cm2, mean gradient < 40mmHG and Vmax < 4m/s]
Classical LGAS - Occurs with depressed LV systolic function; ACC/AHA stage D2.
Paradoxical LGAS - Occurs with preserved ejection fraction; ACC/AHA stage D3.
Low Flow State - Strong predictor of increased mortality; about a third of patients died within 3 years after TAVR, in one registry. The predictor is independant of LVF or mean gradient ( yet mortality benefit TAVR or AVR is the same !! don’t be confused ).
Procedural Outcomes - Similar to those in patients with normal stroke volume after TAVR.
Mortality Benefit - Consistent between patients with LGAS and classic high gradient AS ( 11,000 patients randomized to AVR or no AVR, LGAS benefit of valve replacement ).
Stroke Volume - Less than 35 mL/m² in patients with LGAS.
TAVR in LGAS and AI
1- True or False: Contractile reserve assessment with dobutamine stress echocardiography is highly correlated with outcomes after TAVR.
2- True or False: Older surgical data support the use of contractile reserve assessment for predicting perioperative mortality.
3- True or False: A CT-derived calcium score greater than 1300 HU in women is predictive of mortality in AS patients.
4- True or False: A dimensionless index (DI) value ≤0.25 is consistent with severe LGAS. [ LVOT velocity/ AV velocity].
5- True or False: Patients with LGAS have a better overall prognosis compared to those with normal stroke volume.
6- True or False: Patients with LGAS are expected to experience a comparable magnitude of benefit from AVR as those with normal stroke volume.
7- True or False: The Trilogy Heart Valve System for AI relies on annular calcium for valve anchoring.
8- True or False: Aortic regurgitation (AR) is discussed in detail within the scope of this chapter.
9- True or False: Large annular sizes in AR often exceed the recommended treatment ranges of commercially approved prostheses.
10- True or False: The Trilogy Heart Valve System completed enrollment in a pivotal trial for patients at high surgical risk with severe symptomatic AR.
1- False: Contractile reserve assessment with dobutamine stress echocardiography has shown poor correlation with outcomes after TAVR.
2- True: Older surgical data support the use of contractile reserve assessment for predicting perioperative mortality. This does not seem to apply in TAVR ( see 1.)
3- True: A CT-derived calcium score greater than 1300 HU in women is predictive of TAVR mortality in AS patients ( 2000 HU in men ).
4- True: A dimensionless index (DI) value ≤0.25 is consistent with severe LGAS.
5- False: Patients with LGAS have a poorer overall prognosis compared to those with normal stroke volume.
6- True: Patients with LGAS are expected to experience a comparable magnitude of benefit from AVR as those with normal stroke volume.
7- False: The Trilogy Heart Valve System does not rely on annular calcium for valve anchoring, because AI usually has no calcium. It has another novel anchoring mechanism.
8- False: Aortic regurgitation (AR) is not discussed in detail within the scope of this chapter.
9- True: Large annular sizes in AR often exceed the recommended treatment ranges of commercially approved prostheses.
10- True: The Trilogy Heart Valve System completed enrollment in a pivotal trial for patients at high surgical risk with severe symptomatic AR.
Fill-in-the-Blank Quiz:
The considerable data amassed over the past 2 decades have led to a paradigm shift in the approach to the patient with AS, particularly those who are __________ and at lower surgical risk.
Patients are increasingly presenting with a preference for __________ over SAVR at the time of their initial evaluation.
While the clinical decision making for an elderly patient is often more straightforward, there are many factors to consider in younger and healthier patients whose life expectancy is likely to extend beyond the lifespan of a single __________ valve.
SAVR is associated with higher risks of postoperative _________ and __________ injury.
TAVR is associated with higher risks of significant __________ and pacemaker implantation.
The key factors framing the discussion in a younger patient include (1) valve durability; (2) feasibility of future __________ procedures; (3) risk of future surgery.
Answers:
younger
TAVR
bioprosthetic
atrial fibrillation, kidney
PVL (paravalvular leak)
valve-in-valve (ViV)
Fill-in-the-Blank Quiz for valve durability:
When TAVR was still a relatively new technology, there was concern that rates of structural valve degeneration (SVD) leading to __________ valve failure (BVF) may be __________ than with surgical __________ valves.
The earliest trials enrolled highly comorbid and sick patients with high __________ rates, limiting the ability to accrue __________-term data.
The intermediate risk trials (PARTNER 2 and SURTAVI) have reported follow-up at 5 years demonstrating similar __________ rates between __________ and __________.
Rehospitalization and repeat valve intervention were more common in patients receiving a __________ valve than in those undergoing __________ in PARTNER 2. Outcomes of SURTAVI were similar at 5 years, with higher __________ rates in the __________ cohort .
Answers:
bioprosthetic, higher, bioprosthetic
mortality, long
mortality, SAVR, TAVR
BE (balloon-expandable), SAVR
reintervention, TAVR
Fill-in-the-Blank Quiz for valve durability:
The NOTION trial was the first randomized trial of low-risk patients comparing outcomes of __________ and __________ with a first-generation CoreValve prosthesis.
At 8 years of follow-up, there was no significant difference in the composite outcome of __________, __________, or myocardial infarction.
By the time the NOTION trial was conducted, the Valve Academic Research Consortium (VARC) had established standardized definitions of the causes of BVF including __________, __________, endocarditis, PVL, or patient-prosthesis mismatch (PPM).
SVD ( degeneration ) was defined by the presence of one of the following criteria: increase of mean gradient ≥10 mm Hg resulting in a mean gradient ≥20 mm Hg, decrease in aortic valve area (AVA) by ≥0.3 cm² or 20%, decrease in DI ( dimensionless index) by ≥0.1 or 20%, or ≥moderate __________.
BVF ( failure ) was defined as either severe SVD [ increase of mean gradient ≥20 mm Hg resulting in a mean gradient ≥30 mm Hg, decrease in AVA by ≥0.6 cm² or 50%, decrease in DI ( dimensionless index ) by ≥0.2 or 40%, or severe AR] , or SVD resulting in clinical __________, valve __________, or valve-related __________.
Answers:
SAVR, TAVR, death, stroke
SVD ( structural valve degeneration ) , thrombosis
AR (aortic regurgitation)
heart failure, reintervention, death
In the NOTION trial, investigators found that the TAVR group had _____ effective orifice area (EOA) and _______ mean gradients at each yearly echocardiogram compared to their counterparts who underwent SAVR. While this correlated with lower rates of __________ , rates of __________ were similar between groups.
In contrast, AVALON was a multicenter all-comers registry comparing low-risk patients undergoing elective and isolated SAVR and TAVR. In a propensity score-matched analysis, there was no difference in mortality at 2 years, but SAVR was associated with a 30% reduction in mortality beyond __________ years !! One explanation for these findings is _________ , with healthier, more robust patients being selected for __________. Additionally, different surgical bioprostheses have widely disparate rates of __________.
Mitroflow (Sorin Group Italia S.r.l., Saluggia, VC, IT) and Trifecta (Abbott Laboratories, Abbott Park, IL, USA) valves were used more frequently in __________ than in AVALON and have both been associated with earlier SVD.
Long-term follow-up from the randomized studies of low-risk patients will be necessary to address the critical question of whether the method of __________, and consequent implications for valve construction, are key factors impacting their __________.
Answers:
higher, lower, SVD, BVF
SAVR, TAVR, 5, selection bias, SAVR, SVD
NOTION
implantation, durability
please solve the following problem:
You have a patient whose valve mean gradient was measured at 50 mm Hg before implantation and increased to 80 mm Hg after implantation, few years after. The valve area was 1 cm² before and increased slightly to 1.1 cm² after. Additionally, the patient has mild aortic regurgitation (AR). Does the patient have SVD?
According to the Valve Academic Research Consortium (VARC) criteria, structural valve degeneration (SVD) is indicated by an increase in mean gradient of at least 10 mm Hg resulting in a mean gradient of at least 20 mm Hg, a decrease in aortic valve area (AVA) by at least 0.3 cm² or 20%, or moderate or greater AR.
Solution:
Initial mean gradient: 50 mm Hg
Post-implantation mean gradient: 80 mm Hg
Increase in mean gradient: (80 - 50 = 30) mm Hg
Initial valve area: 1 cm²
Post-implantation valve area: 1.1 cm²
Change in valve area: Increase by 0.1 cm²
Aortic regurgitation: Mild
According to the criteria, the increase in mean gradient is greater than 10 mm Hg, and the resulting mean gradient is greater than 20 mm Hg. The valve area has increased, not decreased, and the AR is mild, not moderate or greater.
Answer: Yes, the valve has become degenerative due to the increase in mean gradient.
does the same patient above has BVF ?
Criteria for BVF: severe SVD ( see below criteria ) or SVD resulting in clinical heart failure, valve reintervention, or valve-related death.
Severe SVD:
Increase in mean gradient ≥20 mm Hg resulting in a mean gradient ≥30 mm Hg.
Decrease in aortic valve area (AVA) by ≥0.6 cm² or 50%.
Moderate or greater aortic regurgitation (AR).
Patient Data:
Mean Gradient: Increased from 50 mm Hg to 80 mm Hg (increase of 30 mm Hg).
Valve Area: Increased from 1 cm² to 1.1 cm² (no decrease).
Aortic Regurgitation: Mild.
Analysis:
Mean Gradient: The increase of 30 mm Hg meets the criteria for severe SVD.
Valve Area: The valve area increased, which does not meet the criteria for a decrease.
Aortic Regurgitation: Mild AR does not meet the criteria for moderate or greater AR.
Conclusion: The patient does not meet all the criteria for BVF, as the valve area did not decrease and the AR is mild. However, the significant increase in mean gradient suggests severe SVD, which is a component of BVF. Therefore, based on the increase in mean gradient alone, the patient could be considered to have BVF due to severe SVD.
Answer: Yes, the patient has BVF due to the severe increase in mean gradient, indicating severe SVD.
A patient undergoes valve replacement, and the following data is recorded:
Mean gradient before implantation: 50 mm Hg
Mean gradient 4 years after implantation: 40 mm Hg
Valve area before implantation: 0.6 cm²
Valve area 4 years after implantation: 0.5 cm²
Based on the Valve Academic Research Consortium (VARC) criteria, determine whether the patient has structural valve degeneration (SVD) or bioprosthetic valve failure (BVF).
Options:
A. The patient has SVD but not BVF.
B. The patient has BVF but not SVD.
C. The patient has both SVD and BVF.
D. The patient has neither SVD nor BVF.
Criteria for SVD:
- Increase in Mean Gradient: The mean gradient should increase by at least 10 mm Hg.
- Decrease in Aortic Valve Area (AVA): The AVA should decrease by at least 0.3 cm² or 20%.
- Moderate or Greater Aortic Regurgitation (AR): Not applicable here as no AR data is provided.
Criteria for BVF:
- Severe SVD:
Increase in mean gradient ≥20 mm Hg resulting in a mean gradient ≥30 mm Hg.
Decrease in AVA by ≥0.6 cm² or 50%.
Moderate or greater AR. - SVD Resulting in Clinical Heart Failure, Valve Reintervention, or Valve-Related Death: Not applicable here as no such data is provided.
Analysis:
The mean gradient decreased, which does not indicate SVD.
The valve area decreased by 0.1 cm², which does not meet the criteria for a decrease of 0.3 cm² or 20% (0.12 cm² decrease or a 20% decrease from 0.6 cm², so it needs to be 0.48 cm2 or below).
No information on AR or clinical outcomes is provided.
Conclusion:
SVD: The patient does not meet the criteria for SVD as the mean gradient decreased and the valve area did not decrease sufficiently.
BVF: The patient does not meet the criteria for BVF as there is no severe SVD or other criteria met.
Answer is D ( No, the patient does not have SVD or BVF based on the provided data ).
True or False quiz :
1- True or False: An ascending aortic aneurysm is a common coexisting condition in patients undergoing evaluation for aortic valve replacement.
2- True or False: For younger, lower-risk patients with bicuspid AS and an ascending aortic aneurysm, transcatheter aortic valve replacement (TAVR) is the best approach.
3- True or False: In the Evolut Low Risk Trial, moderate comorbid CAD with a SYNTAX score greater than 22 was an exclusion criterion.
4- True or False: Severe CAD with a SYNTAX score greater than 33 was an exclusion criterion in the PARTNER 3 trial.
5- True or False: The optimal method of revascularization should be determined independently of the preferred method of treating aortic stenosis (AS).
6- True or False: A younger patient with disease in the left main or proximal left anterior descending artery is best treated with TAVR.
7- True or False: The durability of a left internal mammary artery graft is a consideration for younger patients with concomitant coronary artery disease.
8- True or False: The presence of an ascending aortic aneurysm does not influence the choice between surgical and transcatheter approaches in younger patients.
9- True or False: The Evolut Low Risk Trial and PARTNER 3 trial both had exclusion criteria based on the severity of coronary artery disease.
1- True: An ascending aortic aneurysm is a common coexisting condition in patients undergoing evaluation for aortic valve replacement.
2- False: For younger, lower-risk patients with bicuspid AS and an ascending aortic aneurysm, surgery is the best approach.
3- True: In the Evolut Low Risk Trial, moderate comorbid CAD with a SYNTAX score greater than 22 was an exclusion criterion.
4- True: Severe CAD with a SYNTAX score greater than 33 was an exclusion criterion in the PARTNER 3 trial.
5- True: The optimal method of revascularization should be determined independently of the preferred method of treating aortic stenosis (AS).
6- False: A younger patient with disease in the left main or proximal left anterior descending artery is best treated with surgery ( bypass and SAVR ).
7- True: The durability of a left internal mammary artery graft is a consideration for younger patients with concomitant coronary artery disease.
8- False: The presence of an ascending aortic aneurysm does influence the choice between surgical and transcatheter approaches in younger patients.
9- True: The Evolut Low Risk Trial and PARTNER 3 trial both had exclusion criteria based on the severity of coronary artery disease.
Rapid fire questions:
1- What are the two management options for failing bioprosthetic valves?
2- What conditions can lead to early valve failure requiring urgent or emergent procedures?
3- What factors must be considered in the management strategies for failing bioprosthetic valves?
4- What are some factors contributing to structural valve degeneration (SVD)?
5- What are the key considerations for late bioprosthetic valve failure (BVF)?
1- Answer: Surgical explantation or transcatheter valve-in-valve (ViV) interventions.
2- Answer: Early valve failure can occur in the setting of endocarditis or moderate or worse paravalvular leak (PVL).
3- Answer: Management strategies must consider the risk profile of the patient and the mechanism of valve failure.
4- Answer: Factors contributing to SVD include smaller prosthesis size and patient-prosthesis mismatch (PPM).
5- Answer: Key considerations include risk factors for PPM, strategies to mitigate PPM and coronary obstruction, and the relevant risk of reoperative surgical aortic valve replacement (SAVR) compared to ViV transcatheter aortic valve replacement (TAVR).
Rapid fire questions :
1- What does PPM stand for, and how is it broadly defined?
2- What are the primary risk factors for PPM ?
3- According to the VARC-3 Writing Committee in 2021, how is severe PPM defined?
4- Why should the hemodynamics of the valve shortly after implant be considered when evaluating PPM?
5- What factors are there disagreements over incorporating when evaluating PPM?
6- What does the preponderance of data suggest about the impact of PPM after SAVR or TAVR?
7- How does PPM impact procedural outcomes and future interventions?
8- Why is attention to minimizing PPM particularly important in younger patients?
1- Answer: PPM stands for patient-prosthesis mismatch, and it is broadly defined as an effective orifice area (EOA) that is too small in relation to the patient’s body size.
2- Answer: The primary risk factors for PPM include obesity, female gender, small annulus size, and valve-in-valve (ViV) status.
3- Answer: Severe PPM is defined as an indexed effective orifice area (EOAi) ≤0.65 cm²/m².
4- Answer: It should be considered to limit the impact of structural valve degeneration (SVD) on the calculated valve area.
5- Answer: There is disagreement over incorporating factors such as obesity, underlying flow state, and the measured or predicted orifice area of specific prostheses.
6- Answer: The preponderance of data suggests that PPM after SAVR or TAVR increases the likelihood of SVD, heart failure, and mortality.
7- Answer: PPM impacts short- and midterm procedural outcomes and has significant implications for future interventions, particularly in younger patients who may need multiple valve interventions.
8- Answer: It is important because younger patients may need a second or even third valve intervention during their lifespan, and minimizing PPM can improve their long-term outcomes.
The indexed effective orifice area (EOAi) is a measure used in cardiology to assess the effective orifice area (EOA) of a heart valve relative to a patient’s body size.
How do you calculate it ?
It is calculated by dividing the EOA of the valve by the patient’s body surface area (BSA). To calculate the indexed effective orifice area (EOAi), you need the following measurements:
Effective Orifice Area (EOA): This is the cross-sectional area through which blood flows through the valve. It is typically measured in square centimeters (cm²) and can be obtained via echocardiography using Doppler ultrasound to assess the flow velocity across the valve.
Body Surface Area (BSA): This is a measure of the total surface area of the human body, typically expressed in square meters (m²). BSA can be calculated using various formulas, such as the Mosteller formula: BSA = √[(height in cm * weight in kg) / 3600].
If the EOA of a valve is 1.0 cm² and the patient’s BSA is 1.8 m², the EOAi would be:
1/1.8 = 0.5 cm2/m2
The EOAi provides a more personalized assessment of valve function, accounting for the patient’s body size, which is crucial for identifying patient-prosthesis mismatch (PPM).
determine if there is PPM for each of the following patients:
patient 1: eoa 1.5 cm2 and bsa 2 m2,
patient 2: eoa 0.9 cm2 and bsa 0.8 m2,
patient 3: eoa 0.7 cm2 and bsa 1.9 m2
Patient 1:
EOA: 1.5 cm²
BSA: 2 m²
EOI = 1.5/2 = 0.75 cm2/m2
Interpretation: Since 0.75 cm²/m² is greater than 0.65 cm²/m², this patient does not have severe PPM.
Patient 2:
EOA: 0.9 cm²
BSA: 0.8 m²
EOI= 0.9/0.8=1.125 cm2/m2
Interpretation: Since 1.125 cm²/m² is greater than 0.65 cm²/m², this patient does not have severe PPM.
Patient 3:
EOA: 0.7 cm²
BSA: 1.9 m²
EOI=0.7/1.9=0.368
Interpretation: Since 0.368 cm²/m² is less than 0.65 cm²/m², this patient does have severe PPM.
Summary:
Patient 1: No severe PPM.
Patient 2: No severe PPM.
Patient 3: Severe PPM.
1- What surgical strategies are mentioned for addressing patient-prosthesis mismatch (PPM)?
2- How does aortic root enlargement (ARE) affect the indexed effective orifice area (EOAi) and rates of PPM according to the meta-analysis?
3- What was the impact of ARE on perioperative mortality in the unadjusted analysis?
4- What change in utilization was observed in ARE procedures following FDA approval of the CoreValve for ViV procedures in 2015?
5- What was the increase in the proportion of implanted valves that were 23 mm or larger after the FDA approval of the CoreValve for ViV ?
6- Why is it challenging to compare rates of PPM after SAVR and TAVR?
7- What were the rates of PPM after TAVR and SAVR in the PARTNER 3 trial, and which group was associated with worse clinical outcomes?
8- In the subanalysis of the CoreValve US Pivotal High Risk Trial, how did rates of PPM in small- and medium-sized annuli compare between CoreValve and SAVR?
9- How did annular size correlate with rates of PPM and 2-year mortality in patients undergoing SAVR compared to those undergoing TAVR?
10- What is the purpose of the ongoing SMART trial, and what is it comparing?
1- Aortic root enlargement (ARE), supra-annular implant, use of stentless or sutureless valves, and the Ross procedure.
2- ARE increases the EOAi and significantly reduces rates of PPM.
3- ARE was associated with a slight increase in perioperative mortality in the unadjusted analysis.
4- There was an increase in the utilization of ARE procedures from 3.9% to 6.3%. ( ?? as if they are saying that ARE rates went high after approval of CoreValve for viv. Viv is a risk factor for PPM. So the moment they approved a valve for ViV, they started doing more ARE )
5- The proportion increased from 61% to 67% (P = .001). ( ViV is a risk factor for PPM )
6- Due to significant heterogeneity between the multiple transcatheter platforms and surgical bioprostheses in use.
7- Rates of PPM were 4.6% after TAVR and 6.3% after SAVR (P = .3), with worse clinical outcomes associated with women.
8- Rates of PPM were lower with CoreValve than with SAVR in small- and medium-sized annuli (less than 26 mm).
9- Rates of PPM and 2-year mortality correlated with annular size in patients undergoing SAVR but not in those undergoing TAVR.
10- The SMART trial is randomizing patients with small annuli to TAVR with either a current generation Evolut or SAPIEN prosthesis to demonstrate whether there are meaningful differences in SVD and clinical outcomes.
Fill in the blank for ViV:
1- As increasingly younger patients are being offered TAVR, there may be increasing numbers of patients who ultimately need two or even three _______ over the course of their lives.
2- Each implant introduces constraints on the maximum achievable _____ , impacting the risk of _______ and potentially limiting valve _______.
3- Another important consideration when assessing the feasibility of ViV TAVR is the risk of _______ obstruction due to sinus sequestration or displacement of the leaflets of the initial bioprosthesis toward the _______ .
4- The only way to circumvent all the limitations of ViV TAVR is to perform _______ with removal of either the initial surgical bioprosthesis or transcatheter valve.
5- Reoperative SAVR is associated with a roughly ____ fold increase in risk compared to native SAVR.
6- When compared to ViV TAVR, a recent meta-analysis showed that re-do SAVR was associated with higher 30-day _______ but ViV TAVR had higher rates of _______.
7- The simplest way to decrease the risk of PPM is to implant the ________ initial prosthesis that can be safely accommodated by the patient’s _______.
8- In patients with pre-existing PPM conferred by their initial implant, there is an increase in both 30-day and 1-year _______. Strategies like balloon valve ______ , high deployment of a BE valve, and use of a supra-annular SE valve have been used to mitigate the risk of _______.
9 - For patients who undergo initial management of their AS with TAVR and then end up having elevated risk for PPM or coronary obstruction with ViV TAVR, there are limited data on outcomes after ___________ of transcatheter valves. Mortality within 30 days of SAVR after TAVR in a small cohort was 17% ( all had high STS PROM score above 8 ). The EXPLANT-TAVR registry described another cohort of patients undergoing surgery after TAVR and again showed elevated mortality rates compared to that expected based on STS PROM score. Notably, the mortality rate of TAVR explant was not associated with _________ at the time of index TAVR, suggesting that surgical explantation of a transcatheter valve is an inherently higher risk endeavor due to significant ___________often resulting in the need for aortic root repair.
10- Both the CoreValve US Expanded Use Study and PARTNER 2 ViV registry have shown favorable results of ViV TAVR with regard to BVF at 5 years. The PARTNER registry excluded patients with labeled valve size below _____ mm , while the CoreValve registry included valves with a minimal inner diameter of _____mm and larger ( i think they mean small size valves do not necessarily show good ViV outcome ) .
Answers:
1- Valves
2- EOAi, patient-prosthesis mismatch (PPM), durability
3- coronary, coronary ostium
4-SAVR
5- two
6- mortality, PPM
7- largest, anatomy
8- mortality, fracture, PPM
9 - surgical explantation, STS PROM score , neoepithelialization
10- 21, 17
Rapid fire questions about coronary obstruction:
1- What is a potential treatment for coronary obstruction in the setting of native TAVR and TAVR-in-SAVR?
2- What procedure do you know as a pre-emptive strategy to mitigate the risk of coronary obstruction, and what is its limitation in TAVR-in-TAVR?
3- What unique risk is associated with TAVR-in-TAVR, and what tool is proposed for risk stratification?
4- Why might it be beneficial to refer patients to high-volume centers when adjunct procedures like BASILICA are necessary?
Answers:
1- A potential treatment for coronary obstruction in the setting of native TAVR and TAVR-in-SAVR is snorkel (or chimney) stenting.
2- The BASILICA ( Biopsothesis or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during AVR), procedure is a pre-emptive strategy to mitigate the risk of coronary obstruction. Its limitation in TAVR-in-TAVR is the lower rate of commissural alignment during TAVR compared to SAVR.
3- Sinus sequestration is the unique risk associated with TAVR-in-TAVR, and a risk stratification scheme based on parameters measured on CT has been proposed.
4- Referring patients to high-volume centers when adjunct procedures like BASILICA are necessary might be beneficial because these centers have greater experience, which can improve patient outcomes.
T or F questions about Imaging in TAVR
1- True or False: Multidetector computed tomography (MDCT) is not recommended for assessing TAVR candidates.
2- True or False: MDCT provides information about the iliofemoral anatomy to determine the feasibility of transfemoral (TF) access.
3- True or False: The presence of ascending aortic calcification, also known as a porcelain aorta, can be assessed using MDCT.
4- True or False: The size of the prosthesis does not impact the risk of device embolization or paravalvular leak (PVL).
5- True or False: An oversized prosthesis increases the risk of annular rupture, aortic dissection, and coronary obstruction.
6- True or False: The aortic annulus is the widest part of the aortic root.
7- True or False: The aortic annulus is defined as a virtual plane connecting three anchor points at the nadir of each coronary cusp.
8- True or False: Three-dimensional multiplanar reconstruction of MDCT images is used to measure the height from the annulus to the ostia of the coronary arteries.
9- True or False: MDCT cannot measure the dimensions of the sinuses of Valsalva and the sinotubular junction (STJ).
10- True or False: Accurate measurement of the aortic annulus is essential for proper prosthesis sizing in TAVR procedures.
Answers
1- False: MDCT is indeed recommended and is the preferred imaging modality for the anatomic assessment of TAVR candidates because it provides detailed and accurate measurements necessary for planning the procedure.
2- True: MDCT is used to assess the iliofemoral anatomy, which is crucial for determining whether transfemoral (TF) access is feasible for the TAVR procedure.
3- True: MDCT can evaluate the presence of calcification in the ascending aorta, often referred to as a “porcelain aorta,” which is important for procedural planning and risk assessment.
4- False: The size of the prosthesis is critical; if it is too small, there is a higher risk of device embolization and significant paravalvular leak (PVL).
5- True: An oversized prosthesis can lead to serious complications, including annular rupture, aortic dissection, and coronary obstruction, due to excessive pressure on the surrounding structures.
6- False: The aortic annulus is actually the narrowest part of the aortic root, which is why its accurate measurement is crucial for selecting the correct prosthesis size.
7- True: The aortic annulus is defined as a virtual plane that connects three anchor points at the nadir of each coronary cusp, which helps in accurately determining its size and shape.
8- True: Three-dimensional multiplanar reconstruction of MDCT images allows for precise measurement of the height from the annulus to the ostia of the coronary arteries, which is essential for avoiding coronary obstruction.
9- False: MDCT can indeed measure the dimensions of the sinuses of Valsalva and the sinotubular junction (STJ), which are important for understanding the anatomy and planning the procedure.
10- True: Accurate measurement of the aortic annulus is essential for selecting the appropriate prosthesis size, ensuring a good fit, and minimizing the risk of complications during TAVR.
TAVR and Preprocedural planning :
1- True or False: Preprocedural evaluation of the vasculature is important to determine the suitability for transfemoral (TF) or alternative access.
2- True or False: The Edwards SAPIEN 3 valve is available in three sizes.
3- True or False: The 29 mm Edwards SAPIEN 3 valve can be delivered through a 14F sheath.
4- True or False: The Evolut Pro valve is available in four sizes, including a 34 mm valve.
5- True or False: All but the largest Evolut Pro valve can be delivered through a 14F in-line sheath.
6- True or False: The iterative reductions in the diameter of delivery sheaths have decreased the rate of TF-TAVR.
7- True or False: Transapical access is the most common alternative approach for TAVR.
8- True or False: Transcarotid, transcaval, and direct aortic are alternative access sites for TAVR.
9- True or False: Transapical access was previously used in about a third of cases before 2013.
10- True or False: The recommended minimum luminal diameter for the 34 mm Evolut Pro valve is 5.0 mm.
1- Answer: True
Explanation: Evaluating vessel size, calcification, and tortuosity is crucial for determining if TF access is feasible or if an alternative route is needed.
2- Answer: False
Explanation: The Edwards SAPIEN 3 is available in four sizes: 20, 23, 26, and 29 mm.
3- Answer: False
Explanation: The 29 mm valve requires a 16F sheath for delivery, with a recommended minimum luminal diameter (MLD) of 6.0 mm.
4- Answer: True
Explanation: The Evolut Pro is available in four sizes: 23, 26, 29, and 34 mm.
5- Answer: True
Explanation: All except the largest (34 mm) Evolut Pro valve can be delivered through a 14F in-line sheath with a recommended MLD of 5.0 mm.
6- Answer: False
Explanation: The reductions in sheath diameter have reduced vascular complication rates and increased the rate of TF-TAVR, now exceeding 95%.
7- Answer: False
Explanation: Transaxillary or subclavian access is the most common alternative approach, while transapical access has decreased dramatically.
8- Answer: True
Explanation: These are mentioned as alternative access sites when adequate iliofemoral anatomy is not present.
9- Answer: True
Explanation: Transapical access was indeed used in about a third of cases prior to 2013 but has since decreased significantly.
10- Answer: False
Explanation: The 34 mm Evolut Pro valve requires a recommended MLD of 6.0 mm for delivery through an 18F in-line sheath.
Draw the main imaging components of TAVR planning
Diagnosis of concomittant CAD in TAVR.
1- What is the primary method for diagnosing CAD in the presence of severe symptomatic AS?
A) Stress tests
B) Invasive angiography
2- What can be used as a screening tool for significant CAD at the time of MDCT?
A) Stress echocardiography
B) Computed tomographic angiography (CTA)
3- What does a recent meta-analysis suggest about performing PCI prior to TAVR?
A) It shows no clinical benefit and increased risk of bleeding.
B) It significantly improves patient outcomes.
4- In which scenario is selective performance of invasive angiography at the time of TAVR considered reasonable?
A) When the patient has no symptoms of angina.
B) When the patient has angina as the predominant symptom.
5- What is recommended against TAVR if the patient’s life expectancy is less than:
A) 2 years
B) 1 year
1- Answer: B) Invasive angiography
Explanation: Stress tests may be contraindicated in severe symptomatic aortic stenosis (AS), making invasive angiography the primary method for diagnosing coronary artery disease (CAD).
2- Answer: B) Computed tomographic angiography (CTA)
Explanation: CTA can be safely used as a screening tool for significant CAD during MDCT, with no significant difference in major adverse events compared to invasive angiography.
3- Answer: A) It shows no clinical benefit and increased risk of bleeding.
Explanation: The meta-analysis demonstrated no clinical benefit from PCI before TAVR and highlighted increased risks, such as bleeding.
4- Answer: B) When the patient has angina as the predominant symptom.
Explanation: Selective angiography is reasonable when angina is the main symptom, indicating potential CAD that may need addressing. Also with impaired LV function or proximal lesions, selective PCI is reasonable.
5- Answer: B) 1 year
Explanation: Current guidelines recommend against TAVR if the patient’s life expectancy is less than one year, considering the procedure’s benefits versus risks.
1- What is an example of a validated measure of frailty ?
A) The Katz Activities of Daily Living Score
B) The New York Heart Association Classification
2- What is the impact of severe symptomatic AS on stress test sensitivity for ischemia?
A) Increases sensitivity
B) Decreases sensitivity
3- What is the approach to managing stable CAD discovered during evaluation prior to TAVR?
A) Routine revascularization
B) Medically managing most patients
4- What alternative access site has become the most common for TAVR when iliofemoral anatomy is inadequate?
A) Transapical access
B) Transaxillary or subclavian access
5- What is the trend in using transapical access for TAVR cases since 2013?
A) Increased dramatically
B) Decreased dramatically
1- Answer: A) The Katz Activities of Daily Living Score
Explanation: The text mentions the Ka Activities of Daily Living Score as a validated measure of frailty that can be used in clinical evaluations.
2- Answer: B) Decreases sensitivity
Explanation: Severe symptomatic AS can decrease the sensitivity of stress tests for detecting ischemia due to increased left ventricular wall tension.
3- Answer: B) Medically managing most patients
Explanation: There has been a shift toward medically managing stable CAD, moving away from routine revascularization.
4-Answer: B) Transaxillary or subclavian access
Explanation: Transaxillary or subclavian access has emerged as the most common alternative when iliofemoral access is not suitable.
5- Answer: B) Decreased dramatically
Explanation: Transapical access, previously used frequently, has decreased significantly and now accounts for less than 1% of cases.
1- The standard TF approach to TAVR is preferred and feasible in over _______ of cases.
2- In the absence of randomized comparisons ( TF vs nonTF patients ), it is not possible to distinguish between the role of patient factors such as increased severity of _______ and _________factors,
3- Observational studies have consistently reported increased rates of _______ with alternative access.
4- Since most TAVR programs perform small numbers of non TF cases (alternative access ) , consideration should be given to transferring the care of patients requiring alternative access to _______ centers.
5- A hybrid operating room/catheterization laboratory is necessary for TAVR procedures and should allow for both fluoroscopy-guided catheter manipulation and emergent conversion to _______ .
6- The team for a TAVR procedure should include cardiac anesthesiologists, echocardiographers, perfusionists, cardiac surgeons, and _______ cardiologists.
7- Most teams have transitioned to a “minimalist” approach to TAVR, with avoidance of general anesthesia, pulmonary artery catheterization, and _______ catheterization.
8- Adoption of a “minimalist” approach has been associated with decreased length of stay and _______ costs
1- 90%
2- peripheral vascular disease, procedural
3- stroke
4- high-volume
5- open surgery
6- interventional
7- bladder
8- hospital
1- Meticulous attention to access technique is required to minimize the risk of _______ complications.
2- Ultrasound-guided access of the femoral vessels using small-bore micropuncture needles is recommended to ensure access in a location without anterior wall _______, and in a ________ over the femoral head.
3- The most common method of TF access site management involves the “preclosure” technique using a _______ Proglide device. Either one or two devices are deployed but not _____ .
4- In a femoral artery of sufficient caliber, use of a Perclose suture can be combined with an ___________ plug such as an Angioseal device.
5- The collagen-based _______ device can be used for hemostasis after use of 10 to 20F access sheaths. It is deployed _______ removal of the valve delivery system.
6- Anticoagulation with heparin to attain an activated clotting time of _______ seconds should be initiated at the time of, or immediately following placement of the _______ sheath.
7- _______ should be avoided as it cannot be reversed in the event of a major bleeding complication.
8- Venous access is obtained in the __________ groin for placement of a temporary transvenous _______.
1- vascular
2- calcification, compressible location
3- Perclose, locked
4- extravascular
5- MANTA, after
6- 250-300, large bore
7- Bivalirudin
8- contralateral, pacemaker
1- Once percutaneous access is obtained in the common femoral artery, the vessel undergoes serial _______.
2- The large bore sheath is carefully inserted under fluoroscopic guidance over a ____ supportive wire.
3- Anticoagulation with heparin to attain an activated clotting time of _______ to _______ seconds should be initiated at the time of or immediately following placement of the large bore sheath.
4- _______ should be avoided as it cannot be reversed in the event of a major bleeding complication.
5- A second site of arterial access is obtained to facilitate introduction of a _______ catheter.
6- The large bore sheath is inserted under _______ guidance.
7- Anticoagulation with _______ is used to achieve the desired activated clotting time.
1- dilation
2- stiff
3- 250, 300
4- Bivalirudin
5- pigtail
7- fluoroscopic
8- heparin
Question 1: What are the two primary fluoroscopic views used for valve positioning and deployment?
Question 2: In the coplanar view, which coronary cusp is in the middle?
Question 3: What rule is used to adjust the image detector angulation during aortography?
Question 4: Which platform recommends using the coplanar view during deployment?
Question 5: What does the cusp overlap view superimpose?
Question 6: In the cusp overlap view, which cusp is isolated?
Question 7: What anatomical feature is elongated in the cusp overlap view
( RAO CAU ) ?
Question 8: What does the cusp overlap view facilitate in terms of valve positioning?
Question 9: What is the benefit of higher valve positioning when using SE valve platforms?
Question 10: What is a potential consequence of conduction disturbances with TAVR ?
Answer 1: Coplanar view ( LAO CRA. It is perpendicular to the AV annulus ) and cusp overlap view ( RAO CAU )
Answer 2: Right coronary cusp.
Answer 3: “Follow the right cusp” rule.
Answer 4: SAPIEN platform.
Answer 5: The right and left coronary cusps.
Answer 6: Noncoronary cusp.
Answer 7: LV outflow tract ( thus enabling more accurate assessment of implant depth relative to the membranous septum )
Answer 8: Higher positioning of the transcatheter valve.
Answer 9: Lower rates of conduction disturbances.
Answer 10: Need for a pacemaker
Draw a coplanar ( LAO CRA ) and cusp overlap view ( RAO CAU ) .
Question 1: Under what guidance is the advancement of the valve delivery system to the native aortic valve performed?
Question 2: What is performed using a pigtail catheter to assess the depth and coaxiality of the transcatheter valve?
Question 3: In which views can the aortogram be performed?
Question 4: What is necessary for the inflation of a balloon-expandable (BE) valve to minimize ventricular ejection and valve embolization?
Question 5: What pacing rates facilitate stability during the deployment of self-expanding (SE) valves?
Question 6: What is mandatory during postdilation to prevent valve embolization during balloon inflation, regardless of valve type?
Question 7: What is the purpose of rapid ventricular pacing during valve implantation?
Question 8: What is assessed with the aortogram before valve deployment?
Answer 1: Fluoroscopic guidance.
Answer 2: An aortogram.
Answer 3: Coplanar or cusp overlap view.
Answer 4: Rapid ventricular pacing at 160 to 200 beats per minute (bpm).
Answer 5: 120 to 160 bpm.
Answer 6: Rapid pacing.
Answer 7: To minimize ventricular ejection and prevent valve embolization.
Answer 8: The depth and coaxiality of the transcatheter valve
Draw a picture, illustrating the relationship between membraneous septum and bundle of His
Question 1: What may be required immediately following valve deployment if hypotension occurs?
Question 2: What should be assessed if blood pressure recovery does not occur quickly after valve deployment?
Question 3: What tools are used for a quick assessment if hypotension persists post-deployment?
Question 4: What types of regurgitation should be checked for after valve deployment?
Question 5: What cardiac function should be assessed immediately after valve deployment?
Question 6: What might be necessary if valve function assessment indicates issues post-deployment?
Question 7: What should be checked for alongside valve function and regurgitation after deployment?
Question 8: What determines the need for further intervention after valve deployment?
Answer 1: Administration of inotropes and vasopressors.
Answer 2: Valve position, function, presence of regurgitation, pericardial effusion, and ventricular systolic function.
Answer 3: Fluoroscopy, angiography, and echo.
Answer 4: Central or paravalvular regurgitation.
Answer 5: Ventricular systolic function.
Answer 6: Further intervention such as postdilation or placement of a second valve.
Answer 7: Presence of a pericardial effusion.
Answer 8: Assessment of valve function immediately after deployment.
Question 1: In which view is the Edwars SAPIEN valve positioned?
Question 2: Where is the central marker dot typically located when positioning the SAPIEN valve?
Question 3: What does the final angiography show for the SAPIEN valve placement in the picture ?
Question 4: In which view is the Evolut valve positioned?
Question 5: What feature does the Medtronic Evolut valve have up to the point of anchoring in the annulus?
Question 6: Where is the Evolut valve placed relative to the noncoronary cusp?
Question 7: What does the final angiography show for the Evolut valve placement?
Answer 1: Coplanar view.
Answer 2: In the middle of the pigtail catheter positioned in the right coronary cusp.
Answer 3: Appropriate placement approximately 10% to 20% ventricular position and no leak.
Answer 4: Cusp overlap view.
Answer 5: It is retrievable and repositionable.
Answer 6: 3 to 4 mm below the noncoronary cusp.
Answer 7: Appropriate placement with no leak.
Question 1: How does the stroke rate after TAVR compare to that after SAVR in low-risk patients?
A) More common after TAVR
B) Less common after TAVR
Question 2: What is the typical range of stroke rates in most contemporary TAVR trials?
A) 1% to 5%
B) 1% to 2%
Question 3: What imaging technique has shown that multiple embolic lesions occur in more than 75% of TAVR patients?
A) CT scan
B) Diffusion-weighted magnetic resonance imaging
Question 4: Which of the following is a risk factor for stroke associated with TAVR?
A) Low valve calcium score
B) High valve calcium score
Question 5: What is the name of the only FDA-approved device for use during TAVR to reduce the risk of procedural stroke?
A) Guardian cerebral protection system
B) Sentinel cerebral protection system
Question 6: Did the PROTECTED TAVR trial show a statistically significant reduction in stroke within 72 hours or discharge from the hospital when using the Sentinel device?
A) Yes
B) No
Question 7: What was the numerical difference in disabling strokes between patients with and without the Sentinel device in the PROTECTED TAVR trial?
A) 0.5% vs 1.3%
B) 1.5% vs 2.3%
Question 8: Has the Sentinel device seen widespread adoption for use during TAVR?
A) Yes
B) No
Answer 1: B) Less common after TAVR. Source either atheroma or valave thrombus.
Answer 2: A) 1% to 5% but largely decreasing with new material also because younger patients are getting TAVR.
Answer 3: B) Diffusion-weighted magnetic resonance imaging. Majority are silent events.
Answer 4: B) High valve calcium score ( also ViV status, Bicuspid AV and balloon valvuloplasty )
Answer 5: B) Sentinel cerebral protection system
Answer 6: B) No ( the device did not meet its primary efficacy endpoint. Also the rate of stroke in the entrire population was low ).
Answer 7: A) 0.5% vs 1.3%
Answer 8: B) No
Question 1: What antithrombotic strategy was found to increase bleeding risk compared to low-dose aspirin monotherapy after TAVR?
Question 2: What was the outcome of using rivaroxaban 10 mg daily after TAVR compared to an antiplatelet strategy?
Question 3: What is currently recommended after TAVR in patients without a separate indication for anticoagulation?
Question 4: What should patients with atrial fibrillation take after TAVR?
Question 5: Does the addition of aspirin reduce stroke or major adverse cardiovascular events in patients with atrial fibrillation after TAVR?
Question 6: What are some examples of vascular complications mentioned in the text?
Question 7: What are the rates of major or life-threatening access site bleeding according to the STS/ACC TVT registry?
Question 8: What skills are requisite for TAVR operators in managing vascular complications?
Question 9: Why is prior knowledge of access vessel diameter and tortuosity important for TAVR operators?
Question 10: What measures can be taken when conservative efforts to manage vascular complications fail?
Answer 1: Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel confers increased bleeding risk without any reducation in ischemic events.
Answer 2: It resulted in increased mortality, thromboembolic events, and bleeding compared to 3 months DAPT followed by ASA mono.
Answer 3: Low-dose aspirin monotherapy.
Answer 4: Anticoagulation without concomitant antiplatelet therapy. Addition of aspirin does not appear to reduce stroke or major adverse cardiovascular events while increasing the risk of bleeding.
Answer 5: No, it does not reduce stroke or major adverse cardiovascular events and increases the risk of bleeding.
Answer 6: Access site events, catastrophic aortic dissection, and annular rupture.
Answer 7: Around 3% for major bleeding and 2% for life-threatening bleeding.
Answer 8: The ability to manage vascular complications from the contralateral groin or from the radial artery.
Answer 9: To quickly tamponade any bleeding with an appropriately sized balloon and deploy a covered stent when conservative measures fail.
Answer 10: Deploying a covered stent after tamponading bleeding with an appropriately sized balloon
Question 1: The bundle of His is located in the _______ septum of the _______ ventricular outflow tract inferior to the _______ cusp.
Question 2: This location is susceptible to direct ________ , _________ , and _______ during and after valve deployment.
Question 3: Following TAVR, varying degrees of _______ block and _______ bundle branch block can occur.
Question 4: The risk of new pacemaker implantation has steadily ______ with improvements in both device technology and implant techniques, but the risk remains _______ after TAVR than SAVR.
Question 5: Overall rates remain about _______ in the STS/ACC TVT registry, with _______ rates using ______ valves than _______ valves.
Question 6: While pre-existing _______ bundle branch block is consistently the strongest predictor of need for a pacemaker, procedural factors such as prosthesis _________ ________ are modifiable risk factors.
Question 7: Procedural factors such as prosthesis implantation _________ and degree
of _________ are modifiable risk factors impacting the risk of a pacemaker after TAVR.
Answer 1: membranous, left, noncoronary
Answer 2: trauma, compression, ischemia
Answer 3: heart, left
Answer 4: declined, higher
Answer 5: 10%, higher, SE, BE
Answer 6: right, implantation depth
Answer 7: depth, oversizing
Question 1: Extensive annular and root _________ , _________ and ________ of the prosthesis , as well as improper positioning resulting in the _________ being either too high or too low relative to the native annulus are all risk factors for the development of PVL.
Question 2: Widespread adoption of _______ evaluation for procedural planning, iterative advances in valve technology ( external skirt modification ), and refinement of _______ technique have contributed to significant reductions in the incidence and severity of _______ .
Question 3: Whereas it was previously seen in _______ to _______ of TAVR cases, PVL is now estimated to occur in less than _______ of cases with current generation devices.
Question 4: What has not changed is that when it does occur, moderate or greater _______ portends a worse prognosis, including increased _______ , heart failure hospitalizations, and need for _______ .
Answer 1: calcification, undersizing, underexpansoin, skirt
Answer 2: MDCT, implant, PVL
Answer 3: 10%, 25%, 5%
Answer 4: PVL, mortality, reintervention
Question 1: While there is some _______ in how best to assess and grade PVL, there is some evidence that even mild PVL may have an effect on _________ .
Question 2: In the PARTNER A cohort, the presence of mild PVL after TAVR was associated with decreased _______ at _______ years.
Question 3: Similarly, survival at _______ years was lower in propensity-matched patients with mild PVL relative to those without PVL (HR, 1.41; 95% CI, 1.04-1.91).
Question 4: Importantly, these studies used a grading scheme comprised of three classes (mild, moderate, and severe), as opposed to another study showing higher _______ only in patients with !!! at least !!! mild-to-moderate (grade 2) PVL on a _______ -point grading scheme.
Question 5: VARC-3 guidelines recommend shifting to a more granular _______ -point classification scheme to characterize _______ of PVL.
Answer 1: inconsistency, clinical outcomes.
Answer 2: survival, 2
Answer 3: 5
Answer 4: mortality, five
Answer 5: five, severity
Question 1: The intraprocedural management of PVL includes _______ dilatation of the valve, either with additional _______ in the delivery balloon or with a larger _______ balloon.
Question 2: In severe cases, and depending on the mechanism of PVL, use of a vascular _______ or deployment of a second _______ may be required.
Answer 1: balloon, volume, diameter
Answer 2: occluder, valve
Question 1: What is an important aspect of preprocedural planning for TAVR?
A) Determining the risk of coronary ostial obstruction
B) Selecting the type of anesthesia
Question 2: During which type of procedure is the risk of coronary obstruction higher?
A) SAVR procedures
B) ViV procedures
Question 3: What can cause coronary obstruction during ViV procedures?
A) Leaflet prolapse or sequestration of the sinuses
B) Valve misalignment
Question 4: Which factors impact the risk of coronary obstruction?
A) Patient’s age and weight
B) Height of the coronary ostia, dimensions of the sinuses of Valsalva, and height and diameter of the STJ.
Question 5: What is the mortality rate associated with unexpected coronary artery obstruction?
A) 25%
B) 50%
Question 6: What are the two approaches considered if an increased risk of obstruction is identified during preprocedural planning?
A) Prophylactic coronary wiring and BASILICA procedure
B) Medication adjustment and lifestyle changes
Question 7: In prophylactic wiring, what is placed into the coronary artery at risk before valve deployment?
A) A stent
B) A coronary guide and wire
Question 8: What does the BASILICA procedure involve?
A) Electrophysiological mapping
B) Electrified coronary guidewire to perforate and split the potentially obstructing leaflet
Question 9: What did the BASILICA trial demonstrate?
A) Successful leaflet laceration in 95% of attempts with no cases of coronary obstruction
B) Increased risk of coronary obstruction
Question 10: What are concerns associated with snorkel stenting ( If coronary obstruction occurs, urgent percutaneous coronary revascularization with a stent intentionally protruding into the aorta and “snorkelled” upward toward the top of the valve frame can be performed ) ?
A) Coronary access and risk of in-stent restenosis
B) High cost and limited availability
Question 11: In younger patients with increased risk of coronary obstruction, what should be given preferential consideration?
A) SAVR and use of BASILICA
B) Immediate discharge
Question 12: What does BASILICA stand for?
A) Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR
B) Basic Aortic Surgical Intervention for Coronary Artery
Answer 1: A) Determining the risk of coronary ostial obstruction
Answer 2: B) ViV procedures
Answer 3: A) Leaflet prolapse into the coronary ostium or sequestration of the sinuses
Answer 4: B) Height of the coronary ostia relative to the annulus, dimensions of the sinuses of Valsalva, and height and diameter of the STJ.
Answer 5: B) 50%
Answer 6: A) Prophylactic coronary wiring and BASILICA procedure
Answer 7: B) A coronary guide and wire
Answer 8: B) Electrified coronary guidewire to perforate and split the potentially obstructing leaflet
Answer 9: A) Successful leaflet laceration in 95% of attempts with no cases of coronary obstruction
Answer 10: A) Coronary access and risk of in-stent restenosis
Answer 11: A) SAVR and use of BASILICA
Answer 12: A) Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR
Question 1: If an increased risk of obstruction is identified during preprocedural planning, two approaches can be considered: prophylactic _______ of the coronary or the _______ procedure.
Question 2: In the former, a coronary _______ and wire are placed into the coronary artery at risk prior to _________ __________ .
Question 3: If coronary obstruction occurs, urgent percutaneous coronary revascularization with a _______ intentionally protruding into the aorta and “snorkelled” upward toward the top of the valve frame can be performed.
Question 4: Alternatively, BASILICA uses an _______ coronary guidewire to _______ and split the potentially obstructing leaflet.
Question 5: The BASILICA trial demonstrated successful leaflet laceration in _______ of attempts with ____ cases of coronary obstruction.
Question 6: While snorkel stenting is more __________ across a broad spectrum of operators, coronary access and risk of in-stent _________ remain concerns.
Question 7: Particularly in a younger patient, when increased risk of coronary obstruction is identified on _______ evaluation, _______ and use of_______ in the patient at increased surgical risk should be given preferential consideration.
Answer 7: MDCT
Answer 1: wiring, BASILICA
Answer 2: guide, valve deployment
Answer 3: stent
Answer 4: electrified, perforate
Answer 5: 95%, no
Answer 6: feasible, restenosis
Answer 7: MDCT, SAVR, BASILICA
Guess the following:
1 - Uses an electrified coronary guidewire to perforate and split the potentially obstructing leaflet.
2- A technique where a stent is intentionally protruding into the aorta and “snorkelled” upward toward the top of the valve frame.
3- Used to identify increased risk of coronary obstruction during preprocedural planning.
4- Considered alongside BASILICA for patients at increased surgical risk, especially when coronary obstruction risk is high, particularly in young patients.
1- BASILICA procedure
2- Snorkel stenting
3- MDCT evaluation
4- SAVR
A case of TAVR-in-SAVR using BASILICA of the left coronary cusp and implantation of 26 mm Evolut Pro valve. Left coronary cusp angiogram demonstrates risk of obstruction from surgical valve leaflet (A).
An electrified Astato wire is used to puncture through the left cusp and is snared in the LVOT (B).
A coronary balloon is inflated to confirm the wire has traversed the leaflet and facilitate leaflet splaying (C).
The externalized Astato is intentionally kinked to create a “V,” which is then electrified again and used to lacerate the leaflet (D).
The Evolut Pro valve is then positioned (E) and deployed (F).
Mechanisms of transcatheter aortic valve replacement (TAVR)-induced coronary obstruction and mitigation by BASILICA.
A: In a deficient sinus of Valsalva ( no out pouch) , the outwardly displaced leaflets directly obstruct the coronary artery ostium.
B: In a low sinus of Valsalva and narrow sinotubular junction, the outwardly displaced leaflets indirectly obstruct the coronary artery ostium by sequestering the sinus.
C: A bulky leaflet mass can directly obstruct the coronary ostium.
D: In a low coronary ostium, the fabric-covered frame or skirt can directly obstruct the coronary artery ostium.
E: An electrified BASILICA guidewire lacerates the prior aortic valve leaflets.
F: A TAVR implant splays the lacerated leaflets and ensures inflow to the threatened coronary ostium after BASILICA.
