TAVR Procedure guide

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

Transcatheter Aortic Valve Replacement (TAVR) Procedure Guide Microchapters
Overview
Definition
Risk Assessment
Diagnosis
Treatment General Approach Choice of Intervention Type of Valve and Discharge Anticoagulation Therapy
Do's
Don'ts

Overview

During the past 50 years, surgical aortic valve replacement (SAVR) was the standard of care for patients with severe AS. Global aging has raised concerns about safety and possibility of surgical procedure in old patients with associated co-morbidities. Transcatheter aortic valve replacement (TAVR) created a new era of safety for this population and enabled physicians to replace the stenotic valve with more certainty.
Preoperation evaluation, selecting the appropriate imaging modality, issues in TAVR procedure and patient follow up are the areas of more focused importance.
We will describe these factors based on the recent expert consensus for TAVR procedure.

Definition

The most important step is to define the severity of AS and appropriate patient that need TAVR. Severe sypmtomatic (Stage D) AS is considered as TAVR candidate.

Abbreviations: ΔP: mean gradient, Vmax: maximum aortic velocity, AVA: aortic valve area. AS: aortic stenosis, AR: aortic regurgitation.

Severe symptomatic AS (stage D)
STAGE	DEFINITION	SYMPTOMS	VALVE ANATOMY	VALVE HEMODYNAMICS	HEMODYNAMIC CONSEQUENCES
D1	Symptomatic severe high-gradient AS	Exertional dyspnea or decreased exercise tolerance Exertional angina Exertional syncope or presyncope	Severe calcification or congenital stenosis with severely reduced opening	Vmax ≥ 4 m/s or mean ΔP ≥ 40 mmHg AVA ≤ 1.0 cm² but may be larger with mixed AS and AR	LV diastolic dysfunction Left ventricular hypertrophy May present with pulmonary hypertension
D2	Symptomatic severe low-flow/low gradient AS with reduced LVEF	Heart failure Angina Syncope or presyncope	Severe calcification or congenital stenosis with severely reduced leaflet motion	AVA ≤ 1.0 cm² with resting aortic Vmax < 4 m/s or mean ΔP ≥ 40 mmHg Dobutamine stress echo shows AVA ≤ 1.0 cm² with Vmax ≥ 4 m/s at any flow rate	LV diastolic dysfunction Left ventricular hypertrophy LVEF <50%
D3	Symptomatic severe low gradient with normal LVEF	Heart failure Angina Syncope or presyncope	Severe calcification with severely reduced leaflet motion	AVA ≤ 1.0 cm² with Vmax < 4 m/s or mean ΔP ≤ 40 mmHg AVA ≤ 0.6 cm² Stroke volume index < 35 mL/m²	Increased LV relative wall thickness Small LV chamber with low stroke volume Restrictive diastolic filling LVEF ≥ 50%

TAVR Pathway outline

Abbreviations: CV: Cardiovascular, AVR: aortic valve replacement, AS: aortic stenosis, MR: Mitral regurgitation, AR: Aortic regurgitation, PAP: Pulmonary artery pressure, RV: right ventricle, CTA: CT angiography, PA: Pulmonary artery, TEE: Trans Esophageal Echocardiography, TTE: Trans Thoracic Echocardiography

Care Providing Team

Primary Care Provider                     Clinical Cardiologist                     Heart Valve Team: Cardiology Valve Expert CV Imaging Expert(s) Interventional Cardiologist CT Surgeon CV Anesthesiologist Valve Clinic Care Coordinators                     Hands off back to the Primary Care Provider and Clinical Cardiologist

Clinical Evaluation

AS Symptoms or Signs                   Severe AS with Indication for AVR                   Potential TAVR Candidate                   Patient Selection & Evaluation Shared Decision Making ❑ Goals of Care Clinical Information • Major CV comorbidites • Major non-CV comorbidities • Risk score assessment ❑ Functional Assessment • Frailty • Physical and cognitive function ❑ Risk Categories • Low risk • Intermediate risk • High or extreme risk                   TAVR Procedure ❑ Preplanning • Valve choice and access options • Anesthesia and procedure location • Anticipated complication management ❑ Procedural Details • Vascular access and closure • Valve delivery and deployment • Postdoploymont evaluation • Management of complications                   Post TAVR Management ❑ Early Post TAVR • Postprocedure monitoring and pain management • Early mobilization and discharge planning • Monitor for conduction abnormalities ❑ Long term Management • Antithrombotic therapy and endocarditis prophylaxis • Management of concurrent cardiac disease • Post-TAVR complications

Cardio-vascular Imaging

Pre TAVR ❑ Echo • Aortic valve anatomy • Confirm AS severity • LV function • MR. AR. PAP. RV function ❑ TAVR protocol CTA • Vascular access • Annular sizing • Aortic root anatomy • Interventional planning                   Echo ❑ (TEE or TTE) • Annular sizing • Valve placement • Paravalvular leak • Procedural complications                   Post TAVR Imaging ❑ Echo and ECG post-procedure, at 30 days and then annually • Valve function • LV size and function • PA systolic pressure • Cardiac rhythm

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

Heart Valve Team

Patients with severe AS should be evaluated by a multidisciplinary Heart Valve Team when intervention is considered.
Team members include:

• Cardiology Valve Expert
• Cardiovascular Imaging Expert(s)
• Interventional Cardiologist
• Cardio-Thoracic Surgeon
• Cardiovascular Anesthesiologist
• Valve Clinic Care Coordinators

Their specific tasks are:

1. Review the patient's medical condition and the severity of the valve abnormality
2. Determine which interventions are indicated, technically feasible, and reasonable
3. Discuss benefits and risks of these interventions with the patient and family, keeping in mind their values and preferences.

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).
• 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.

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.

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.

Imaging for TAVR

General Principles and Technical Considerations

• Transthoracic Echocardiography (TTE) is the best initial imaging modality for evaluating AS severity. Although, multimodality imaging is needed for preprocedural planning and intraoperative decision making given the complex 3D anatomy of the aortic valve, sinuses, and annulus.
• Multi-Detector CT (MDCT) is a core element of the standard imaging pathway for the preprocedural planning of TAVR.
• In patients being evaluated for TAVR, MDCT systems with at least 64 detectors and a spatial resolution of 0.5 to 0.6 mm are recommended.
• Evaluation of kidney function to avoid contrast induced nephropathy must be taken in to consideration.

Abbreviations: CV: Cardiovascular, AVR: Aortic valve replacement, AS: Aortic Stenosis, MR: Mitral Regurgitation, AR: Aortic Regurgitation, PAP: Pulmonary Artery Pressure, RV: Right Ventricle, CTA: CT angiography, PA: Pulmonary Artery, TEE: Trans Esophageal Echocardiography, TTE: Trans Thoracic Echocardiography AVA: Aortic Valve Area; CMR: Cardiovascular Magnetic Resonance Imaging; CT: Computed Tomography; ECG: Electrocardiogram; EF: Ejection Fraction; DSE: Dobutamine Stress Echocardiography; ESRD: End-Stage Renal Disease; GFR: Glomerular Filtration Rate; LFLG: Low-Flow Low-Gradient; LV: Left Ventricular; LVEF: Left Ventricular Ejection Fraction; MAC: Mitral Annular Calcification; MDCT: Multi Detector Computed Tomography; MRA: Magnetic Resonance Angiogram; MRI: Magnetic Resonance Imaging; MS: Mitral Stenosis; PET: Positron Emission Tomography; TAVR: Trans-catheter Aortic Valve Replacement

TAVR Imaging Checklist
Region of Interest	Recommended Approach and Key Measures	Additional Comments
Preprocedure
Aortic valve morphology	TTE: Trileaflet, bicuspid or unicuspid Valve calcification Leaflet motion Annular size and shape	TEE if can be safely performed, particularly useful for subaortic membranes Cardiac MRI if echocardiography nondiagnostic ECG-gated thoracic CTA if MRI contraindicated
Aortic valve function	TTE: Maximum aortic velocity Mean aortic valve gradient Aortic valve area Stroke volume index Presence and severity of AR	Additional parameters Dimensionless index AVA by planimetry (echo, CT, MRI) Dobutamine stress echocardiography for LFLG AS-Reduced EF Aortic valve calcium score if LFLG AS diagnosis in question
LV Geometry and other cardiac findings	TTE: LVEF, regional wall motion Hypertrophy, diastolic dysfunction Pulmonary pressure estimate Mitral valve (MR, MS, MAC) Aortic sinus anatomy and size	Myocardial ischemia and scar: CMR, PET, DSE, thallium CMR imaging for myocardial fibrosis and scar, identification of cardiomyopathies
Annular sizing	TAVR CTA- gated contrast enhanced CT thorax with multiphasic acquisition Typically reconstructed in systole 30-40% of the R-R window	Major/minor annulus dimension Major/minor average Annular area Circumference/perimeter
Aortic root measurements	Gated contrast-enhanced CT thorax with multiphasic acquisition. Typically reconstructed in diastole 60%–80%.	Coronary ostia heights Midsinus of Valsalva (sinus to commissure, sinus to sinus) Sinotubular junction Ascending aorta (40 cm above valve plane, widest dimension, at level of PA) Aortic root and ascending aorta calcification
Coronary disease and thoracic anatomy	Coronary angiography Nongated thoracic CTA	Coronary artery disease severity Bypass grafts: number/location RV to chest wall distance Aorta to chest wall relationship
Noncardiac imaging	Carotid ultrasound Cerebrovascular MRI	May be considered depending on clinical history

Vascular Access
Kidney Function Status	Recommended Approach	Key Parameters
Normal renal function (GFR >60) or ESRD not expected to recover	TAVR CTA	Aorta, great vessel, and abdominal aorta Dissection; atheroma; stenosis; calcification Iliac/subclavian/femoral luminal dimensions, calcification, and tortuosity
Borderline renal function	Contrast MRA Direct femoral angiography (low contrast)	Institutional dependent protocols Luminal dimensions and tortuosity of peripheral vasculature
Acute kidney injury or ESRD with expected recovery	Noncontrast CT of chest, abdomen, and pelvis Noncontrast MRA Can consider TEE if balancing risk/benefits	Degree of calcification and tortuosity of peripheral vasculature

TAVR Imaging Checklist
Imaging goals	Recommended Approach	Additional Details
Periprocedure
Interventional planning	TAVR CTA	Predict optimal fluoroscopy angles for valve deployment
Confirmation of annular sizing	Preprocedure MDCT	Consider contrast aortic root injection if needed 3C TEE to confirm annular size
Valve placement	Fluoroscopy under general anesthesia	TEE (if using general anesthesia)
Paravalvular leak	Direct aortic root angiography	TEE (if using general anesthesia)
Procedural complications	TTE TEE (if using general anesthesia) Intracardiac echocardiography (alternative)
Long-term Postprocedure
Evaluate valve function	TTE	Key elements of echocardiography: Maximum aortic velocity Mean aortic valve gradient Aortic valve area Paravalvular and valvular AR
LV geometry and other cardiac findings	TTE: LVEF, regional wall motion Hypertrophy, diastolic fucntion Pulmonary pressure estimate Mitral valve (MR, MS, MAC)

Specific CT measurements for TAVR

TAVR CT Measurement Summary
Valve Size and Type
Region of Interest	Specific Measurements	Measurement Technique	Additional Comments
Aortic valve morphology and function	Aortic valve	If cine images obtained, qualitative evaluation of valve opening Planimetry of aortic valve area in rare cases Calcium score with Agatston technique or a volumetric technique to quantify calcification of aortic valve	Most useful in cases of LFLG AS where diagnosis is otherwise unclear. May be helpful in defining number of valve cusps.
LV geometry and other cardiac findings	LV outflow tract	Measured with a double oblique plane at narrowest portion of the LV outflow tract Perimeter Area Qualitative assessment of calcification	Quantification of calcification not standardized. Large eccentric calcium may predispose for paravalvular regurgitation and annular rupture during valve deployment.
Annular sizing	Aortic annulus	Defined as double oblique plane at insertion point of all 3 coronary cusps Major/minor diameter Perimeter Area	Periprocedural TEE and/or balloon sizing can confirm dimensions during case.
Aortic root measurements	Sinus of Valsalva	Height from annulus to superior aspect of each coronary cusp Diameter of each coronary cusp to the opposite commissure Circumference around largest dimension Area of the largest dimension
Coronary and thoracic anatomy	Coronary arteries	Height from annulus to inferior margin of left main coronary artery and the inferior margin of the right coronary artery	Short coronary artery height increases risk of procedure. Evaluation of coronary artery and bypass graft stenosis on select studies. Estimate risk of coronary occlusion during valve deployment.
	Aortic root angulation	Angle of root to left ventricle Three-cusp angulation to predict best fluoroscopy angle	Reduce procedure time and contrast load by reducing number of periprocedural root injections
Vascular Access Planning
Vascular access	Aorta	Major/minor diameters of the following: Aorta at sinotubular junction Ascending aorta in widest dimension Ascending aorta prior to brachiocephalic artery Midaortic arch Descending aorta at isthmus Descending aorta at level of pulmonary artery Descending aorta at level of diaphragm Abdominal aorta at level of renal arteries Abdominal aorta at the iliac bifurcation	Measurements must be perpendicular to aorta in 2 orthogonal planes. Identify aortopathies. Evaluate burden of atherosclerosis. Identify dissection or aneurysms.
	Primary peripheral vasculature	Major/minor dimensions, tortuosity, calcification of the following: Carotid arteries Subclavian arteries Bracheocephalic artery Vertebral arteries Bilateral subclavian arteries Great vessels Iliac arteries Femoral arteries	No well-defined cutoff or definition of tortuosity or calcification has been established.
	Ancillary vasculature	Stenosis of the following: Celiac artery Superior mesenteric artery Both renal arteries
	Relationship of femoral bifurcation and femoral head	Distance from inferior margin of femoral head to femoral biforcation

TAVR Imaging Evaluation

TAVR CT

ECHO

Non-gated Angiogram of Chest, Abdomen and Pelvic Arteries for Vascular Access Selection

ECG-gated CT of Annulus and Aortic root for Valve Sizing Selection

Left Ventricle and other findings

Confirm Severe Aortic Stenosis

Transfemoral Approach

Annular Sizing

Aortic Root Sizing

Additional Procedural Planning

Subclavian Approach

Major/Minor Dimension

Coronary Ostia Height

Fluoroscopy Angulation

LVEF and LV Dimension

High Gradient AS

Apical Approach

Area

Aortic Sinus to Commissure Dimension

Bypass Grafts

Estimated Pulmonary Pressure

Low Gradient AS

Other Approaches

Circumferences

Sinotubular Junction

RV to Chest Wall Position

Other Valvular Abnormalities

Reduced EF

Carotid

Ascending Aorta Dimension

Preserved EF

Direct Aortic

Aortic Calcification

Transvenous

Preprocedural Evaluation

Aortic Valve Morphology

• Transthoracic Echocardiography (TTE) is performed for initial visualization of aortic valve to identify the number of leaflets; size, location, extent of calcification, leaflet motion, and a preliminary view of annular size and shape.
• If additional imaging is needed, valve anatomy and function can be evaluated by cardiac magnetic resonance imaging (CMR) or ECG-gated MDCT.

Aortic Valve Function

Doppler echocardiography is superior to other imaging modalities to evaluate Aortic valve function. AS severity should be evaluated according to the ESE/ASE Recommendations for Evaluation of Valvular Stenosis and staged according to the AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease.

LV Geometry and Other Cardiac Findings

TTE also is recommended for evaluation of LV hypertrophy, chamber size, LV diastolic function, regional wall motion, and ejection fraction as well as newer measures of LV function such as global longitudinal strain. In addition, TTE is useful for assessment of aortic dilation, presence of subvalvular outflow tract obstruction, estimation of pulmonary pressures, and identification of other significant valve abnormalities.

Annular Sizing

The 3D dataset provided by MDCT are more accurate than TTE findings regarding annular size. Measurement of LV outflow tract diameter on TTE has been well validated for calculation of aortic valve area and continues to be the standard for determination of AS severity. CMR can also provide comprehensive assessment of the aortic valve, annulus, and aortic root with good correlation with MDCT. CMR can be a valuable tool in patients who cannot undergo MDCT.

Aortic Root Measurements

MDCT allows for the careful measurement of the size of the sinuses of Valsalva, the coronary ostia distance from the annulus, the size of the aorta at the sinotubular junction and 40mm above the annulus, and the extent and position of aortic calcifications.

Presurgical Planning

MDCT also may be of use in identification of coronary artery and coronary bypass graft location and stenosis, evaluation of the RV to chest wall position, and identification of the aorta and LV apex to chest wall position in direct aortic approaches.

Noncardiac Imaging

Because of high prevalence of dementia and atherosclerosis in this elderly patient population, a preprocedural work-up including carotid ultrasound and cerebrovascular MRI might be considered prior to considering or such patients for TAVR.

Vascular Access

Because of the relatively large diameter of the delivery sheaths, appropriate vascular access imaging is critical for TAVR. It is important to evaluate the entire thoracoabdominal aorta, major thoracic arterial vasculature, carotids, and iliofemoral vasculature. MDCT is able to provide valuable dataset regarding vascular anatomy.

Periprocedural Evaluation

Interventional Planning

MDCT can assist with predicting the optimal delivery angle on fluoroscopy prior to valve deployment.

Confirmation of annular sizing

Preprocedural MDCT is the best modality to evaluate annular size. At the time of the procedure, Fluoroscopy is the main imaging modality. If questions remain about the correct annular sizing, balloon inflation with contrast root injection can be performed. Also, 3D TEE is able to evaluate the annular size, at the time of the procedure.

Valve Placement

Optimal deployment angles are obtained using fluoroscopy and root injections. Deployment is done under fluoroscopy at many institutions, although TEE is an alternative approach.

Paravalvular Leak

TEE and TTE are required to assess the valve in different aspects. Also, TEE can be used to assess the immediate gradient changes after valve seating. Aortic root angiography also may be used to assess for regurgitation after valve implantation. As the volume of cases performed without general anesthesia increases, there may be an expanding role for periprocedural TTE.

Procedural Complications

Immediate complications such as annular rupture resulting in pericardial effusion and tamponade can be detected by TEE, TTE, angiography, and direct hemodynamic measurements.

Long-Term Postprocedural Evaluation

Evaluate Valve Function

• Echocardiography is recommended to evaluate the valve postprocedurally to search for valvular and paravalvular leak, valve migration, complications such as annular or sinus rupture, valve thrombosis, endocarditis, paravalvular abscess, LV size, function and remodeling, and pulmonary pressures.
• MDCT can be used to evaluate valve anatomy A and to evaluate for valve thrombosis.
• CMR can also be used to quantify AR and can be complementary to TTE for the quantification of paravalvular leak.

LV Geometry and Other Cardiac Findings

TTE is used to evaluate changes in LV function after TAVR.

TAVR Procedure

The following table describes the TAVR procedure checklist. Abbreviations: AR: aortic regurgitation; AVR: aortic valve replacement; BAV: balloon aortic valvuloplasty; PA: pulmonary artery; TEE: transesophageal echocardiography

Checklist for TAVR Procedure
Key Steps	Essential Elements	Additional Details
Preplanning by Heart Team
Valve choice	Balloon-expandable Self-expanding Other	Annulus, native valve and root anatomy/Ca++ Sheath size Avoid rapid pacing when possible
Access choice	Transfemoral Alternative access	Suitability of access – careful reconstructions
Location of procedure	Catheterization laboratory Operating room Hybrid room	Imaging needed for procedure Possible cardiopulmonary bypass Interventional and surgical equipment Anesthesia requirements
Anesthesia considerations	Conscious sedation General anesthesia Allergies	Need for intraoperative TEE impacts anesthesia type
Anticipated complication management	Individual team member roles Difficult airway management Patient-specific concerns (language or communication barriers) Valve-related bailout strategies—valve-in-valve, surgical AVR Need for leave-in PA catheter, temporary pacer postimplant Prophylactic wiring of coronaries for low coronary heights and narrow sinuses/bulky leaflets Vascular bailout strategies	Feasibility of fem-fem bypass Bypass circuit primed or in-room only Need for crossover balloon technique Duration of temporary pacer per institutional protocol or patient condition Conversion to permanent pacing may be needed in certain patients.
Procedure Details
Anesthesia administration	Moderation sedation or general anesthesia Temporary pacer lead for rapid pacing Defibrillator and pre-placed patches Arterial pressure monitoring	Avoid hypothermia Volume status monitoring and optimization Antibiotic prophylaxis
Vascular access and closure	Transfemoral Transapical Transaortic Trans-subclavian Other: transcarotid, transcaval, antegrade aortic	Percutaneous Surgical cutdown
Pre-valve implant	Optimal fluoroscopic and intraprocedural views for device deployment Anticoagulation Balloon predilation (and sizing if necessary) Valve prepared with delivery system for rapid deployment if needed (if balloon sizing not required)	Assess AR immediately post-BAV as well as need for hemodynamic support
Valve delivery and deployment	Optimal positioning across the annulus Need for rapid pacing	Essential for balloon-expandable valve; optional for self-expanding valves
Post-deployment valve assessments	Satisfactory device position/location Valve embolization Assess aortic regurgitation Central Paravalvular Assess mitral valve	Immediate assessment with echo,hemodynamics, aortogram postimplant
Other complication assessment and management	Shock or hemodynamic collapse Coronary occlusion Annular rupture Ventricular perforation Complete heart block Stroke Bleeding/hemorrhage Access site-related complications

Preprocedural Planning

• The Heart Valve Team must decide and plan for valve selection, access choice and location of procedure.

Valve Choice

Valve selection is dependent on 2 major factors,

1. Which type of valve should be considered (balloon expandable or self expanding) based on anatomical reasons
2. Available valve sizes.

There currently are 2 TAVR valves commercially available in the United States:

1. The balloon-expandable Sapien family of transcatheter heart valves (Edwards Lifesciences) made of bovine pericardium mounted in a cylindrical, relatively short cobaltchromium stent.
2. The self-expanding CoreValve (Medtronic) family of transcatheter heart valves, which are made of porcine pericardium mounted in a taller, nitinol stent with an adaptive shape and supra-annular design.

Randomized clinical trials showed similar 1-year mortality, strokes, and readmissions due to heart failure with either valve.
Important factors that must be considered in valve selection:

• Annulus dimensions and geometry
• Native valve and aortic root/LV outflow tract anatomy
• Coronary height
• Amount and distribution of calcification

Self expanding valves are preferred over balloon expandable in the following circumstances:

1. Patients with heavy calcification of the aortic annulus/LV outflow tract with an attendant risk of rupture
2. Extremely oval-shaped annulus or for transfemoral access when femoral artery diameter is between 5.0 and 5.5 mm.

Balloon expanding valves are preferred over self expandable in this situations:

1. Dilated ascending (>43 mm) aorta
2. Severely angulated aorta (aortoventricular angle >70 degrees, particularly for transfemoral access).
3. A balloon-expandable valve is the only option in patients needing a transapical approach (e.g., those with a significant aortic calcification and peripheral vascular disease).

Several other valve designs and platforms are currently under investigation, and valve teams of the future will need to have a sound understanding of their relative merits and disadvantages for treating specific subsets of patients with AS.

Access Choice

The patient’s atherosclerotic load and location, arterial size and tortuosity, and presence of mural thrombus are important factors in access selection.
When possible, transfemoral access is the preferred TAVR delivery route.

Location of the Procedure

Optimal equipment requirements include a state-of-the-art, large-field-of-view fluoroscopic imaging system with a fixed overhead or floor-mounted system that has positioning capability rather than a portable C-arm system. other equipment that are required in the TAVR center include: 3D echocardiography, MDCT, CMR, full catheterization laboratory hemodynamic capability, cardiopulmonary bypass machines and related ancillary supplies, with an inventory of interventional cardiology equipment for balloon aortic valvuloplasty, coronary balloons, stents, and 0.014-inch wires if coronary occlusion occurs as a complication of device deployment.
The procedure location should also be fully capable of providing anesthesia services, including advanced airway management, general anesthesia, full hemodynamic monitoring, and administration of vasoactive agents into the central circulation.
In addition to the interventional cardiologist, cardiothoracic surgeon, and cardiovascular anesthesiologist, other personnel required during the TAVR procedure include a cardiovascular imaging specialist, cardiac perfusionists, and other personnel trained in hemodynamic monitoring and able to rapidly deal with procedural complications.

Anesthetic Considerations

Procedural complications, including hemodynamic collapse are common among patients undergoing TAVR. Preventing prolonged hypotension is a key goal during this procedure. Predictive factors for higher risk patients for intraprocedural instability include: Depressed EF, elevated pulmonary pressures, significant mitral or tricuspid regurgitation, incomplete revascularization, collateral-dependent coronary and cerebral circulation, chronic lung disease, heart failure, and acute/chronic kidney disease.
TAVR is evolving from a procedure done routinely under general anesthesia with invasive central monitoring, a pulmonary artery catheter and transesophageal echocardiography to one that can safely be performed with conscious sedation and minimal instrumentation. Recent surveys showed better outcomes with conscious sedation than general anesthesia. Now, it is recommended that TAVR procedures under conscious dsedation should be performed in highly experienced centers, and not as an initial starting strategy for a TAVR program, and only using the transfemoral approach.
Conscious sedation is best avoided in patients requiring TEE guidance during valve deployment and in those with borderline vascular access, cognitive or language barriers, an inability to stay still or lie flat, chronic pain, morbid obesity, or other issues.

Anticipated complication management

The following table summarizes the common complication for TAVR procedure and their treatment options.
Abbreviations: AVR: aortic valve replacement; CABG: coronary artery bypass grafting; CPB: cardiopulmonary bypass; CVA: cerebrovascular accident; PCI: percutaneous coronary intervention; PPM: permanent pacemaker; SAVR: surgical aortic valve replacement; TAVR: transcatheter aortic valve replacement

TAVR Procedural Complications and Management
Complication	Treatment Options
Valve embolization Aortic Left ventricle	Recapture or deploy in descending aorta if still attached to delivery system (self-expanding) Valve-in-valve Endovascular (snare) SAVR and extraction
Central valvular aortic regurgitation	Usually self-limited, but may require gentle probing of leaflets with a soft wire or catheter Delivery of a second TAVR device
Paravalvular aortic regurgitation	Post-deployment balloon dilation Delivery of a second TAVR device Repositioning of valve if low (recapture, snare) Percutaneous vascular closure devices (e.g., Amplatzer Vascular Plug) SAVR
Shock or hemodynamic collapse	Assess and treat underlying cause if feasible Inotropic support Mechanical circulatory support CPB
Coronary occlusion	PCI (easier if coronaries already wired before valve implantation) CABG
Annular rupture	Reverse anticoagulation Surgical repair Pericardial drainage
Ventricular perforation	Reverse anticoagulation Surgical repair Pericardial drainage
Complete heart block	Transvenous pacing with conversion to PPM if needed
Stroke Ischemic Hemorrhagic	Catheter-based, mechanical embolic retrieval for large ischemic CVA Conservative
Bleeding/hemorrhage	Treat source if feasible Transfusion Reversal of anticoagulation
Access site-related complications	Urgent endovascular or surgical repair

Procedural Details

Anesthesia Administration

Typically, a temporary transvenous lead is passed through the femoral or internal jugular veins or, in the case of transapical procedures, can also be sewn directly on the epicardial surface. Arterial pressure monitoring may be done via the radial artery. At least 1 large-volume line is obtained peripherally or centrally. Immediate access to a defibrillator device is necessary because ventricular fibrillation can occur with manipulation of catheters within the heart or with rapid ventricular pacing. Volume status needs to be supplemented carefully to prevent volume overload and hypovolemia. Inhaled nitric oxide or inhaled epoprostenol should be readily available for the treatment of severe pulmonary hypertension and right ventricular failure.
Routine surgical antibiotic prophylaxis administered prior to surgical incision or vascular access is warranted to decrease the risk of wound infection and endocarditis.

Vascular Access

Vascular ultrasound may be needed to assess vessel wall calcification prior to puncture.

• For transfemoral access, both percutaneous and cutdown access approaches are used. Percutaneous approaches are preferred when access sites are relatively large and free of significant atherosclerotic disease and calcification, and in patients with wound healing concerns.
• For transapical cases, access is obtained via a left anterior thoracotomy, which is made after localization of the apex by fluoroscopy, TTE, and/or TEE.
• For transaortic cases, access is either through an upper partial sternotomy or a minthoracotomy at the second or third right intercostal space.

Prevalve Implant

One of the key steps in preimplant is identifying the optimal fluoroscopic and intraprocedural views for device deployment. A pigtail catheter is typically placed in the noncoronary cusp (for self-expanding valves) and right coronary cusp (for balloon-expandable valves) and aortography is performed in a fluoroscopic view perpendicular to the native valve in order to identify the coplanar or coaxial view.
Anticoagulation therapy is usually initiated after insertion of the large sheath into the vasculature, and repeated to maintain an activated clotting time (ACT) of >250–300 seconds.
Following this, the aortic valve is crossed using standard interventional techniques and a stiff wire exchange is performed, with redundancy in the LV cavity to prevent loss of position. Prior to passage of the valve, predilation of the annulus may be required. Standard techniques of percutaneous balloon aortic valvuloplasty are employed, with rapid pacing during inflation. Radiographic contrast opacification of the root during maximal inflation may provide useful information when the location of the coronary ostia in relation to the annulus and the leaflet calcification or any other aortic root pathology requires further delineation.
This is also helpful in situations where valve sizing falls between valve sizes. For example, use a 22-mm or 23-mm Edwards balloon when deciding between a 23-mm and a 26-mm transcatheter valve. If the 22-mm or 23-mm balloon reaches the hinge points and there is no significant leak around the balloon on angiography, then generally the 23-mm transcatheter valve would be selected. If the 22-mm balloon does not reach the hinge points and/or there is clear leak into the ventricle around the balloon, then the 26-mm valve would generally be implanted.

Valve Delivery and Deployment

The transcatheter valve is positioned across the annulus in the predetermined coaxial annular plane. The optimal landing zone should be identified and will vary depending on the type of valve.

Post-deployment Valve Assessments

Immediately following implantation, valve position and location should be checked with echocardiography (TTE or TEE), hemodynamics, and/or aortography. A quick assessment for changes in MV or LV function and new pericardial effusion should also be routinely performed.
Post-TAVR AR must be characterized in terms of its location, severity, and cause and should integrate both central and paravalvular origins to allow for an estimate of overall volumetric impact.
Central regurgitation is generally a result of improper valve deployment or sizing. Paravalvular regurgitation is generally caused by underdeployment of the prosthesis, very low implants (e.g., below the valve skirt of the self-expanding valve), or calcific deposits, which prevent the valve unit from properly seating and sealing within the annulus. Acute leaks may respond to repeat ballooning of the valve to obtain a better seal and greater expansion of the valve.
Following TAVR deployment, the delivery system and sheath are removed. Anticoagulation is typically reversed and access site closure is performed.

Post-TAVR Clinical Management

The long-term management of patients after TAVR is similar to that of patients after SAVR. The major differences are that patients undergoing TAVR tend to be older and have more comorbid conditions; an access site replaces the surgical incision; and the long-term durability of transcatheter valves is not yet known.
Basic principles for management of patients after valve replacement include:

• Periodic monitoring of prosthetic valve function
• Management of comorbid conditions
• Monitoring for cardiac conduction defects and heart block
• Promotion of a healthy lifestyle with cardiac risk factor reduction
• Antithrombotic therapy as appropriate
• Optimal dental hygiene and endocarditis prophylaxis
• Patient education and coordination of care
• Cardiac rehabilitation and promotion of physical activity as appropriate.
  

The following table describes Checklist for Post-TAVR Clinical Management.

Abbreviations: ACC:American College of Cardiology; ADLs: activities of daily living; AF: atrial fibrillation; AHA: American Heart Association; AR: aortic regurgitation; ASA: aspirin; ECG: electrocardiogram; GI: gastrointestinal; LV: left ventricular; MD: medical doctor; NOAC: new oral anticoagulant; OT: occupational therapy; PA: pulmonary artery; PT: physical therapy; TAVR: transcatheter aortic valve replacement; VTE: venous thromboembolism.

Checklist for Post-TAVR Clinical Management
Key Steps	Essential Elements	Additional Details
Immediate Postprocedure Management
Waking from sedation	Early extubation (general anesthesia) Monitor mental status
Post-procedure monitoring	Telemetry and vital signs per hospital protocol for general or moderate sedation Monitor intake and output Labs (CBC, M6) Monitor access (groin or thorax) site for bleeding, hematoma, pseudoaneurysm	Ultrasound of groin site if concern for pseudoaneurysm Frequent neurological assessment
Pain management	Provide appropriate pain management Monitor mental status
Early mobilization	Mobilize as soon as access site allows Manage comorbidities PT and OT assessment	Encourage physical activity
Discharge planning	Resume preoperative medications Plan discharge location Predischarge echocardiogram and ECG Schedule postdischarge clinic visits	Family and social support Ability to perform ADLs Transportation Discharge medications Patient instructions and education
Long-Term Follow-up
Timing	TAVR Team at 30 days Primary cardiologist at 6 months and then annually Primary care MD or geriatrician at 3 months and then prn	Hand-off from TAVR team to primary cardiologist at 30 days More frequent follow up if needed for changes in symptoms, or transient conduction abnormalities. Coordination of care between TAVR team, primary cardiologist and primary care MD
Antithrombotic therapy	ASA 75–100 mg daily lifelong Clopidogrel 75 mg daily for 3–6 months Consider warfarin (INR 2–2.5) if at risk of AF or VTE	Management when warfarin or NOAC needed for other indications
Concurrent cardiac disease	Coronary disease Hypertension Heart failure Arrhythmias (especially AF) Manage cardiac risk factors (including diet and physical activity)	Monitor labs for blood counts, metabolic panel, renal function Assess pulmonary, renal, GI, and neurologic function by primary care MD annually or as needed
Monitor for post-TAVR complications	Echocardiography at 30 days then annually (if needed) ECG at 30 days and annually Consider 24 h ECG if bradycardia	Paravalvular AR New heart block LV function PA systolic pressure
Dental hygiene and antibiotic prophylaxis	Encourage optimal dental care Antibiotic prophylaxis per AHA/ACC guidelines

Immediate Postprocedure Management

After TAVR procedure, patients should be monitored for recovery from sedation and anesthesia.

Waking from sedation

When general anesthesia is used, early extubation is encouraged, as for any general anesthesia procedure.

Postprocedure Monitoring

Monitoring for mental status, telemetry, vital signs, volume status, postprocedure blood testing and access site for adequate hemostasis is required for either conscious sedation or general anesthesia.

Pain Management

Appropriate pain management, continued mental status monitoring, and early mobilization are especially important post-TAVR as patients often are elderly with a high burden of comorbidities.

Early Mobilization

Discharge plan should be prepared before the procedure and should include physical and occupational therapy.

Discharge Planning

Early discharge (within 72 hours) does not increase the risk of 30-day mortality, bleeding, pacer implantation or rehospitalization in selected patients undergoing transfemoral TAVR.

Long Term Follow up

Timing

Integration and coordination of medical care is essential post-TAVR to ensure optimal patient outcomes. Outcomes after TAVR depend strongly on overall patient health and clinical conditions other than the aortic valve disease.
Readmission rates are over 40% in the first year after the procedure, most often due to noncardiac causes (60% of readmissions); common readmission diagnoses include respiratory problems, infections and bleeding events. Cardiac readmissions are most often for arrhythmias or heart failure.
Mortality rates after TAVR remain very high, with about 30% of patients dying within 3 years of the procedure. Noncardiac causes of death predominate after the first 6 months. These data emphasize the need for integrated noncardiac and cardiac care in these patients, including end-of-life planning.
The Heart Valve Team is responsible for care for the first 30 days because procedural complications are most likely in this time interval. After 30 days, there should be a formal transfer of care from the Heart Valve Team back to the referring primary cardiologist. In stable patients with no complications and few comorbidities, the primary cardiologist should see the patient at 6 months and then annually, and more frequently as needed for complications or concurrent medical conditions. The primary care provider and cardiologist should communicate frequently to ensure coordination of care, with clear patient instructions on when and how to contact the care team.

Antithrombotic Therapy

The current standard antithrombotic therapy after TAVR is clopidogrel 75 mg orally daily for 3–6 months with oral aspirin 75–100 mg daily lifelong. Patients with chronic AF or other indications for long-term anticoagulation should receive anticoagulation as per guidelines for AF in patients with prosthetic heart valves. Vitamin-K antagonist therapy may be considered in the first 3 months after TAVR in patients at risk of AF or valve thrombosis, depending on the specific risk-benefit ratio in that patient. When vitamin-K antagonist therapy is used, continuation of aspirin is reasonable, but it may be prudent to avoid other antiplatelet therapy in some patients given the increased risk of bleeding with multiple simultaneous antithrombotic agents.

Concurrent Cardiac Disease

Long-term management focuses on treatment of comorbid cardiac and noncardiac conditions.

Cardiac comorbidities	Noncardiac comorbidities
Hypertension	Pulmonary disease
Coronary artery disease	Renal disease
AF
LV systolic dysfunction	Frailty
LV diastolic dysfunction	Arthritis
MV disease	Cognitive impairment
Pulmonary hypertension

noncardiac conditions are best managed by the primary care provider or geriatrician, with the cardiologist providing consultation regarding any changes in cardiac signs or symptoms. Referral back to the Heart Valve Team is appropriate when prosthetic valve dysfunction is a concern or if a second interventional procedure might be needed for another valve or for coronary artery disease. In addition to echocardiography, periodic ECG monitoring is recommended for detection of asymptomatic AF and because heart block or other conduction defects can occur late after TAVR.

Monitor for Post-TAVR Complications

Echocardiography before discharge provides a new baseline study of transcatheter valve function and should include:
the antegrade TAVR velocity, mean transaortic gradient, valve area, assessment of paravalvular AR, LV size, regional wall motion and ejection fraction, evaluation of MV anatomy and function, estimation of pulmonary pressures and evaluation of the right ventricle.
Repeat echocardiography is recommended at 30 days and then at least annually.
Routine ECG assessment is also recommended owing to a potential need for pacemaker implantation beyond the initial 30-day period, particularly following implantation of the self expanding TAVR.
The TAVR procedure is associated with a high risk of dislodgement of microdebris from arch atheroma or from the valve itself with subsequent embolic stroke. Clinical cerebrovascular event rates are around 3%–5% at 30 days.

Dental Hygiene and Antibiotic Prophylaxis

A TAVR is a risk factor for endocarditis, with reported rates of early prosthetic valve endocarditis ranging from 0.3% to 3.4 % per patient-year.
Standard antibiotic prophylaxis after TAVR is the same as for all prosthetic valves per ACC Guidelines. In addition, patients should be encouraged to use optimal dental hygiene and see a dentist regularly for routine cleaning and dental care, with antibiotic prophylaxis at each visit.

References