Objectives
Background
Methods and Results
Conclusions
Introduction
Risk Scores and Comorbidities
- Piazza N.
- Wenaweser P.
- van Gameren M.
- Pilgrim T.
- Tzikas A.
- Otten A.
- et al.

Comorbidities | Definition/criteria | Diagnostic modalities |
---|---|---|
Porcelain aorta or severely atherosclerotic aorta | Heavy circumferential calcification or severe atheromatous plaques of the entire ascending aorta extending to the arch such that aortic cross-clamping is not feasible | Noncontrast axial CT at levels:
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Frailty | Slowness, weakness, exhaustion, wasting and malnutrition, poor endurance and inactivity, loss of independence Criteria: |
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Severe liver disease/cirrhosis | Any of the following:
|
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Hostile chest | Any of the following or other reasons that make redo operation through sternotomy or right anterior thoracotomy prohibitively hazardous:
|
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IMA or other critical conduit(s) crossing midline and/or adherent to posterior table of sternum | A patent IMA graft that is adherent to the sternum such that injuring it during reoperation is likely. A patient may be considered at extreme risk if any of the following are present:
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- Rudski L.G.
- Lai W.W.
- Afilalo J.
- Hua L.
- Handschumacher M.D.
- Chandrasekaran K.
- et al.


Patient Stratification: The Heart Team Approach
- Mack Jr., D.R.
- Holmes M.J.
- Kaul S.
- Agnihotri A.
- Alexander K.P.
- Bailey S.R.
- et al.
Clinical Endpoints
Mortality
All-cause mortality |
Cardiovascular mortality
|
|
Myocardial Infarction
Periprocedural MI (≤72 h after the index procedure)
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Spontaneous MI (>72 h after the index procedure) Any 1 of the following criteria:
|
Stroke
Diagnostic criteria
|
Stroke classification
|
Stroke definitions
|
- Miller D.C.
- Blackstone E.H.
- Mack M.J.
- Svensson L.G.
- Kodali S.K.
- Kapadia S.
- et al.
Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: Occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial.
Bleeding Complications
Life-threatening or disabling bleeding
|
Major bleeding (BARC type 3a)
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Minor bleeding (BARC type 2 or 3a, depending on the severity)
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Acute Kidney Injury
Stage 1
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Stage 2
|
Stage 3
|
Vascular Complications
Major vascular complications
|
Minor vascular complications
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Percutaneous closure device failure
|
Conduction Disturbances and Arrhythmias
- Camm A.J.
- Kirchhof P.
- Lip G.Y.
- Schotten U.
- Savelieva I.
- Ernst S.
- et al.
Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC).
Up to 72 h, continuous rhythm monitoring is recommended in order to maximize the detection of arrhythmias |
Data elements to be collected should include
|
Other TAVI-Related Complications
Conversion to open surgery
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Unplanned use of cardiopulmonary bypass (CPB)
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Coronary obstruction
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Ventricular septal perforation
|
Mitral valve apparatus damage or dysfunction
|
Cardiac tamponade
|
Endocarditis
|
Valve thrombosis
|
Valve malpositioning
|
TAV-in-TAV deployment
|
Additional Considerations
Valvular Function
- Bonow R.O.
- Carabello B.A.
- Chatterjee K.
- Faxon Jr., A.C.
- de Leon D.P.
- Freed M.D.
- et al.
2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
Transcatheter Valve Stenosis
- Zoghbi W.A.
- Chambers J.B.
- Dumesnil J.G.
- Foster E.
- Gottdiener J.S.
- Grayburn P.A.
- et al.
Prosthetic aortic valve stenosis | |||
---|---|---|---|
Normal | Mild stenosis | Moderate/severe stenosis | |
Quantitative parameters (flow-dependent) | |||
Peak velocity (m/s) | <3 m/s | 3-4 m/s | >4 m/s |
Mean gradient (mm Hg) | <20 mm Hg | 20-40 mm Hg | >40 mm Hg |
Quantitative parameters (flow-independent) | |||
Doppler velocity index | >0.35 | 0.35-0.25 | <0.25 |
Effective orifice area | >1.1 cm2 | 1.1-0.8 cm2 | <0.8 cm2 |
Effective orifice area | >0.9 cm2 | 0.9-0.6 cm2 | <0.6 cm2 |
Prosthesis–patient mismatch (PPM) | |||
Insignificant | Moderate | Severe | |
Indexed effective orifice area (cm2/m2) | >0.85 cm2/m2 | 0.85-0.65 cm2/m2 | <0.65 cm2/m2 |
Indexed effective orifice area (cm2/m2) | >0.70 cm2/m2 | 0.90-0.60 cm2/m2 | <0.60 cm2/m2 |
Prosthetic aortic valve regurgitation | |||
Mild | Moderate | Severe | |
Semiquantitative parameters | |||
Diastolic flow reversal in the descending aorta—PW | Absent or brief early diastolic | Intermediate | Prominent, holodiastolic |
Circumferential extent of prosthetic valve paravalvular regurgitation (%) | <10% | 10%-29% | ≥30% |
Quantitative parameters | |||
Regurgitant volume (mL/beat) | <30 mL | 30-59 mL | ≥60 mL |
Regurgitant fraction (%) | <30% | 30-49% | ≥50% |
EROA (cm2) | 0.10 cm2 | 0.10-0.29 cm2 | ≥0.30 cm2 |
- Head S.J.
- Mokhles M.M.
- Osnabrugge R.L.
- Pibarot P.
- Mack M.J.
- Takkenberg J.J.
- et al.

Transcatheter Valve Regurgitation
- Bonow R.O.
- Carabello B.A.
- Chatterjee K.
- Faxon Jr., A.C.
- de Leon D.P.
- Freed M.D.
- et al.
2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to revise the 1998 guidelines for the management of patients with valvular heart disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.
- Vahanian A.
- Baumgartner H.
- Bax J.
- Butchart E.
- Dion R.
- Filippatos G.
- et al.
Committee for Practice Guidelines. Guidelines on the management of valvular heart disease: The Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology.
- Zoghbi W.A.
- Chambers J.B.
- Dumesnil J.G.
- Foster E.
- Gottdiener J.S.
- Grayburn P.A.
- et al.
Follow-up Assessments
Quality of Life
Quality of Life Evaluation in Aortic Stenosis
- Reynolds M.R.
- Magnuson E.A.
- Lei Y.
- Leon M.B.
- Smith C.R.
- Svensson L.G.
- et al.
Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis.
Recommended Endpoints and Timing of Assessment
Additional Considerations
- Reynolds M.R.
- Magnuson E.A.
- Lei Y.
- Leon M.B.
- Smith C.R.
- Svensson L.G.
- et al.
Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis.
Composite Endpoints
Rationale and Caveats
Specific Composite Endpoints
Device success
|
Early safety (at 30 days)
|
Clinical efficacy (after 30 days)
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Time-related valve safety
|
Discussion
Funding
Appendix 1
- Cardialysis (Rotterdam, The Netherlands)
- Cardiovascular Research Foundation (New York, NY)
- Duke Clinical Research Institute (Durham, NC)
- Harvard Clinical Research Institute (Boston, Mass)
- American College of Cardiology
- European Association for CardioThoracic Surgery
- European Society of Cardiology
- Society of Thoracic Surgeons
Appendix 2
- (i) Cardialysis/Erasmus MC, Rotterdam, The Netherlands
- Head, SJ
- Morel, MA
- Serruys, PW
- Van Es, GA
- Van Mieghem, NM
- Vranckx, P
- (ii) Cardiovascular Research Foundation, New York, NY
- Généreux, P
- Hahn, RT
- Kirtane, AJ
- Kodali, SK
- Leon, MB
- Maxwell, Y
- Mehran, R
- (iii) Duke Clinical Research Institute, Durham, NC
- Alexander, KP
- Douglas, DS
- Krucoff, MW
- Petersen, J
- (iv) Harvard Cardiovascular Research Institute, Boston, Mass
- Cutlip, DE
- Borer, JS: Howard Gilman Institute for Heart Valve Diseases, Brooklyn, NY
- Cohen, DJ: Saint Luke's Mid America Heart Institute, Kansas City, Mo
- Holmes, DR Jr: Mayo Clinic Rochester, Rochester, Minn
- Iung, B: CHU Bichat, Paris, France
- Makkar, RR: Cedars-Sinai Heart Institute, Los Angeles, Calif
- Piazza, N: German Heart Center, Munich, Germany; and McGill University Health Center, Montral, Canada
- Popma, JJ: Beth Israel—Deaconess Medical Center, Boston, Mass
- Rodès-Cabau, J: Quebec Heart and Lung Institute, Quebec, Canada
- Thomas, M: Guys and St Thomas Hospital, London, UK
- Tuzcu, EM: Cleveland Clinic Foundation, Cleveland, Ohio
- Vahanian, A: CHU Bichat, Paris, France
- Webb, JG: St Paul's Hospital, Vancouver, BC, Canada
- Windecker, S: University Hospital Bern, Bern, Switzerland
- Adams, DH: Mount Sinai Medical Center, New York, NY
- Cameron, DE: The Johns Hopkins Medical Institutions, Baltimore, Md
- Fontana, GP: Lenox Hill Heart and Vascular Institute, New York, NY
- Kappetein, AP: Erasmus MC, Rotterdam, The Netherlands
- Mack, MJ: Baylor Health Care Systems, Tex
- Maisano, F: San Raffaele Hospital, Milan, Italy
- Miller, DC: Stanford University, Calif
- Moat, NE: Royal Brompton and Harefield National Health Service (NHS) Foundation Trust, London, UK
- Walther, T: Kerckhoff Heartcenter Bad Nauheim, Bad Nauheim, Germany
- Geleijnse, ML: Erasmus University Medical Center, Rotterdam, The Netherlands
- Brott, TG: Mayo Clinic, Jacksonville, Fla
- Van der Worp, HB: University Medical Center Utrecht, Utrecht, The Netherlands
- Blackstone, EH: Cleveland Clinic Foundation, Cleveland, Ohio
- Aguel, F
- Dunn, B
- Getzoff, N
- Laschinger, J
- Patel, S
- Sansing, V
- Sastry, A
- Swain, J
- Zuckerman, B
- Akin, J: Edwards Lifesciences, Orange, Calif
- Allocco, D: Boston Scientific, Minneapolis, Minn
- Armitage, T: Medtronic CardioVascular, Minneapolis, Minn
- Bebeau, V: St Jude Medical, Minneapolis, Minn
- Concepcion, B: Boston Scientific, Minneapolis, Minn
- Fonseca, T: Medtronic CardioVascular, Minneapolis, Minn
- Robb, R: Medtronic CardioVascular, Minneapolis, Minn
- Schroeder R: Heart Leaflet Technologies, Minneapolis, Minn
- Sethuraman, B: Abbott Vascular, Santa Clara, Calif
- Sheahan, B: Direct Flow Medical, Santa Rosa, Calif
- Tatarek, N: St Jude Medical, Minneapolis, Minn
- Fitzgerald, S
- Carroll, JD
- Edwards, FH
- Lansky, AJ
- Prager, RL
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Article info
Publication history
Footnotes
Grants have been provided to the ARC Board including representatives of Cardialysis, the Cardiovascular Research Foundation, Duke Clinical Research Institute, and Harvard Clinical Research Institute to cover the costs of travel, meeting rooms, and lodging for academic attendees at the Washington and Rotterdam meetings by Abbott Vascular, Boston Scientific, Direct Flow Medical, Edwards Lifesciences, Heart Leaflet Technologies, Medtronic Corporation, and St. Jude Medical.
Disclosures: N. Piazza has received consultancy fees from Medtronic, his institution has received grants/grants pending from Medtronic. E.H. Blackstone has received study support from Edwards Lifesciences consultancy fees from Edwards Lifesciences. D.J. Cohen has received consultancy fees from Medtronic, his institution has received grants/grants pending from Medtronic and Edwards Lifesciences. G.A van Es is an employee of Cardialysis BV, The Netherlands. M.W. Krucoff has received study support from Edwards Lifesciences. S. Kodali is a Board member of St. Jude Medical and Thubrikar Aortic Valve and has received consultancy fees from Medtronic and Edwards Lifesciences. R. Mehran has received consultancy fees from Astra Zeneca, Janssen (Johnson & Johnson), Regado, Abbott Laboratories, Merck Sharpe & Dohme Corp., Maya Medical. Her institution has received grants/grants pending from BMS/Sanofi, The Medicines Company, Lilly/Daiichi Sanko. J. Rodés-Cabau has received consultancy fees from Edwards Lifesciences, St. Jude Medical. J.G. Webb has received consultancy fees from Edwards Lifesciences, his institution has received grants/grants pending from Edwards Lifesciences. S. Windecker has received speakers bureaus fees from Edwards Lifesciences and Medtronic, his institution has received a Swiss National Science Foundation Grant (32003B_135807) and has grants/ grants pending from Edwards Lifesciences and Medtronic. M.B. Leon is on the advi-sory Board for Edwards Lifesciences. The others authors have declared to have no conflict of interests for this paper. The VARC meetings involved members of the Interventional Cardiology Devices Branch, of the Office of Device Evaluation, Center for Devices and Radiological Health, USFDA. The opinions or assertions herein are the private views of the authors and are not to be construed as reflect-ing the views of the FDA.
The article has been copublished in the European Heart Journal, EuroIntervention, Journal of the American College of Cardiology, European Journal of Cardio-Thoracic Surgery, and the Journal of Thoracic and Cardiovascular Surgery.
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