TAVR Patient selection

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1],Associate Editor(s)-in-Chief: Seyedmahdi Pahlavani, M.D. [2]

Overview

Patient selection is critical prior to performance of transcatheter aortic valve implant (TAVI). TAVI candidates must have severe aortic stenosis with a contraindication(s) to surgery. The patients selected for this procedure should have a potential for functional improvement after valve replacement.[1] Selection criteria depend on thorough evaluation of the aortic valve, mitral valve, ejection fraction, vascular access and coronary angiography. A thorough echocardiographic evaluation of the aortic valve is necessary to determine the valve area, calcification, peak velocity, the transvalvular gradient and aortic annulus size. Aortic incompetence should be assessed as well since more than moderate aortic incompetence before the procedure is a contraindication for TAVI. Tortuosity, calcification and minimal luminal diameter of the aorta, iliac and femoral arteries would also influence patient selection and the technical approach used during the procedure.
TAVR potential candidates should be assessed for AS symptoms and severity, baseline clinical situation, cardiac comorbidities and non-cardiac comorbidities. In addition functional assessment is a key step for patient evaluation.

Patient selection

Initial assessment

Initial Asseeement
Key Steps Essential Elements Additional Details
AS symptoms and severity Symptoms

AS severity

Intensity, acuity

Echo and other imaging

Baseline clinical data Cardiac history

Physical exam and labs

Chest irradiation

Dental evaluation

Allergies

Social support

Prior cardiac interventions

Routine blood tests, PFTs

Access issues, other cardiac effects

Treat dental issues before TAVR

Contrast, latex, medications

Recovery, transportation, post discharge planning

Major CV comorbidity Coronary artery disease Coronary angiography
LV systolic dysfunction LV ejection fraction
Concurrent valve disease Severe MR or MS
Pulmonary hypertension Assess pulmonary pressures
Aortic disease Porcelain aorta (CT scan)
Peripheral vascular disease Prohibitive re-entry after previous open heart surgery (CT scan)

Hostile chest


Major non CV comorbidity Malignancy Remote or active, life expectancy
Gastrointestinal and liver disease IBD, cirrhosis, varices, GIB, ability to take antiplatelets/anticoagulation
Kidney disease eGFR <30cc/min or dialysis
Pulmonary disease Oxygen requirement, FEV1 <50% predicted or

DLCO<50% predicted

Neurological disorders Movement disorders, dementia

Functional Assessment

Abbreviations: BMI: body mass index; CV: cardiovascular; MMSE: mini mental state examination; MNA: mini nutritional assessment.

Functional Asseeement
Key Steps Essential Elements Additional Details
Frailty and Disability Frailty Assessment Gait Speed (<0.5m/sec or < 0.83 m/sec with

disability/cognitive impairment)

Frailty (Not Frail or Frail by Assessments)

Nutritional Risk/Status Nutritional Risk Status (BMI<21, albumin

<3.5mg/dl, >10-pound weight loss in past year,

or ≤11 on MNA)

Physical Function Physical function and endurance

Independent living

6-minute walk <50 m or unable to walk

Dependent in>=1 activities

Cognitive Function Cognitive Impairment

Depression and Prior Disabling Stroke

MMSE <24 or dementia

Depression history or positive screen

Futility Life expectancy

Lag-time to benefit

<1 year life expectancy

Survival with benefit of <25% at 2 years

Frailty

  • Evaluation for frailty, physical function and independence in the activities of daily living (ADL) such as, feeding, bathing, toileting and transferring).[2]
  • Evaluation should be start with screening for independence, cognition and slow walking speed (gait speed, 3 timed trials over a 5 meter distance).
  • Those with gait speed over 0.83 m/s, preserved cognition and independence are likely not frail.

Physical functioning

To assess the physical functioning, the 6 minute walk test should be done. It is possible to perform this test in outpatient setting.[3]

Cognitive Functioning

The Mini Mental Status Examination (MMSE) is utilized to assess the cognitive status and scores less than 24 are considered as abnormal. Also, evaluation for depression must be done by using a validated tool such as, the Center for Epidemiologic Studies Depression Scale.[4]

Futility

Those patients with <1 year life expectancy and who has a chance of survival with benefit of <25% at 2 years.
Survival with benefit means, survival with improvement by at least 1 New York Heart Association class in heart failure or by at least 1 Canadian Cardiovascular Society class angina symptoms, improvement in quality of life or improvement in life expectancy.[5]

Risk Assessment

Underlying risk for SAVR is basic component to consider patient for TAVR. This risk assessment is based on several components that include:

  • The Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score. To calculate this score please click here.
  • Frailty
  • Main organ system dysfunction
  • Procedure-specific impediments



SAVR risk assessment
Risk Index Low Risk
(Must meet ALL criteria in This column)
Intermediate Risk
(Any 1 criterion in this column)
High Risk
(Any 1 criterion in this column)
Prohibitive Risk
(Any 1 criterion in this column)
STS PROM <4% 4% to 8% >8% Predicted risk with surgery of death or major morbidity (all-cause) >50% at 1 y
Frailty† None 1 Index (mild) ≥ 2 Indices (moderate to severe) Predicted risk with surgery of death or major morbidity (all-cause) >50% at 1 y
Major organ system compromise
not to be improved postoperatively‡
None 1 Organ system No more than 2 organ systems ≥ 3 Organ systems
Procedure specific impediment ¶ None Possible procedure specific impediment Possible procedure specific impediment Severe procedure specific impediment

† Seven frailty indices include: Katz Activities of Daily Living (independence in feeding, bathing, dressing, transferring, toileting,and urinary continence) and independence in ambulation (no walking aid or assist required or 5-meter walk in <6 s).

‡ Examples of major organ system compromise:

  1. Cardiac: severe LV systolic or diastolic dysfunction or RV dysfunction, fixed pulmonary hypertension
  2. CKD stage 3 or worse
  3. Pulmonary dysfunction with FEV1 <50% or DLCO <50% of predicted
  4. CNS dysfunction (dementia, Alzheimer’s disease, Parkinson’s disease, CVA with persistent physical limitation)
  5. GI dysfunction: Crohn’s disease, ulcerative colitis, nutritional impairment, or serum albumin <3.0
  6. Cancer: active malignancy
  7. Liver: any history of cirrhosis, variceal bleeding, or elevated INR in the absence of VKA therapy.

¶ Examples: tracheostomy present, heavily calcified ascending aorta, chest malformation, arterial coronary graft adherent to posterior chest wall, or radiation damage.


Integrated Benefit-risk of TAVR and Shared Decision-making



 
 
 
 
 
 
 
 
 
 
 
 
 
AS Severity
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Less than stage D
 
 
 
 
 
 
 
Stage D
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
❑ Periodic monitoring of AS
severity and symptoms
❑ Re-evaluate when AS severe
or symptoms occur
 
 
 
Severe symptomatic AS but
Benefit < Risk (futility)
 
 
 
 
 
AVR indicated
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
❑Life expectancy <1 year
❑Chance of survival with benefit at 2 years <25%
 
 
SAVR preferred over TAVR
 
 
 
TAVR preferred
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
❑Discussion with patient and family
❑Palliative care inputs
❑Palliative balloon aortic valvuloplasty in selected patients
 
 
❑Lower risk for surgical AVR
❑Mechanical valve preferred
❑Other surgical considerations
 
 
 
Consider:
❑Symptom relief or improved survival
❑Possible complications and expected recovery
❑Review of goals and expectations
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
❑SAVR recommended in lower-risk patients
❑Valve durability considerations in younger patients
❑Concurrent surgical procedure needed (e.g.aortic root replacement)
 
 
 
❑Discussion with patient and family
❑Proceed with TAVR imaging evaluation and procedure

References

  1. Vavuranakis M, Voudris V, Vrachatis DA, Thomopoulou S, Toutouzas K, Karavolias G, Tolios I, Sbarouni E, Lazaros G, Chrysohoou C, Khoury M, Brili S, Balanika M, Moldovan C, Stefanadis C (2010). "Transcatheter aortic valve implantation, patient selection process and procedure: two centres' experience of the intervention without general anaesthesia" (PDF). Hellenic Journal of Cardiology : HJC = Hellēnikē Kardiologikē Epitheōrēsē. 51 (6): 492–500. PMID 21169181. Retrieved 2011-03-21.
  2. Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE (2014). "Frailty assessment in the cardiovascular care of older adults". J. Am. Coll. Cardiol. 63 (8): 747–62. doi:10.1016/j.jacc.2013.09.070. PMC 4571179. PMID 24291279.
  3. Kim CA, Rasania SP, Afilalo J, Popma JJ, Lipsitz LA, Kim DH (2014). "Functional status and quality of life after transcatheter aortic valve replacement: a systematic review". Ann. Intern. Med. 160 (4): 243–54. doi:10.7326/M13-1316. PMC 4039034. PMID 24727842.
  4. Milaneschi Y, Simonsick EM, Vogelzangs N, Strotmeyer ES, Yaffe K, Harris TB, Tolea MI, Ferrucci L, Penninx BW (2012). "Leptin, abdominal obesity, and onset of depression in older men and women". J Clin Psychiatry. 73 (9): 1205–11. doi:10.4088/JCP.11m07552. PMC 3486693. PMID 22687702.
  5. Lindman BR, Alexander KP, O'Gara PT, Afilalo J (2014). "Futility, benefit, and transcatheter aortic valve replacement". JACC Cardiovasc Interv. 7 (7): 707–16. doi:10.1016/j.jcin.2014.01.167. PMC 4322002. PMID 24954571.