Global Transcatheter Aortic Valve Replacement (TAVR) Market Report: 2013 Edition - Koncept Analytics
The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative •...
Transcript of The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative •...
![Page 1: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/1.jpg)
Robert O. Bonow, MD, MS
No Relationships to Disclose
Northwestern University Feinberg School of MedicineBluhm Cardiovascular Institute
Northwestern Memorial HospitalEditor-in-Chief, JAMA Cardiology
The New Aortic ValveGuidelines Update
![Page 2: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/2.jpg)
• Evaluation by a Heart Team • TAVR for patients with prohibitive surgical risk and life expectancy >12 months
• TAVR or SAVR for patients at high surgical risk
• TAVR or SAVR for patients at intermediate surgical risk
• Surgical AVR for patients at low surgical risk
In decisions regarding type of aortic valve intervention (SAVR vs TAVR) in symptomatic patients with AS, which of the following is NOT a Class I recommendation in the 2017 ACC/AHA Guidelines Update?
![Page 3: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/3.jpg)
www.acc.orgwww.americanheart.org
![Page 4: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/4.jpg)
www.esc.org
www.acc.orgwww.americanheart.org
![Page 5: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/5.jpg)
Indications for AVR
• Symptomatic patients with severe AS
Aortic Stenosis
class I
…if it is likely that the symptomsare cardiac in origin
![Page 6: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/6.jpg)
• Asymptomatic severe AS
• Low-flow, low gradient severe AS
• Indications for TAVR
Management challenges:
Aortic Stenosis
![Page 7: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/7.jpg)
Management challenges:
Aortic Stenosis
• Asymptomatic severe AS
• Low-flow, low gradient severe AS
• Indications for TAVR
![Page 8: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/8.jpg)
Indications for valve replacement
Exercise test results:• Symptoms• Hypotension
class I
class IIa
How are symptoms determined? • Everyone has symptoms on stress test• Are the symptoms cardiac in origin?• What level of exercise?
How is hypotension defined?• Less than 20 mmHg increase (?)
Aortic Stenosis
![Page 9: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/9.jpg)
Indications for valve replacement
Exercise test results:• Symptoms• Hypotension
class I
class IIa
Should asymptomatic patientswith severe AS undergo AVR?
…when they are really asymptomatic?
Aortic Stenosis
![Page 10: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/10.jpg)
Indications for valve replacement:
class IIa
Asymptomatic Aortic Stenosis
• Very severe AS:Vmax ≥5 m/s
![Page 11: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/11.jpg)
class IIb
Indications for valve replacement:
class IIa
Asymptomatic Aortic Stenosis
• Very severe AS:Vmax ≥5 m/s
• Rapid progression and low surgical risk
![Page 12: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/12.jpg)
class IIb
Indications for valve replacement:
class IIa
class IIa
Asymptomatic Aortic Stenosis
• Very severe AS: Vmax >5.5 m/s
• Very severe AS:Vmax ≥5 m/s
• Rapid progression and low surgical risk
![Page 13: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/13.jpg)
class IIb
Indications for valve replacement:
class IIa
class IIa
Asymptomatic Aortic Stenosis
• Very severe AS:Vmax ≥5 m/s
• Rapid progression and low surgical risk
• Very severe AS: Vmax >5.5 m/s
• Severe valve calcificationand rapid progression
![Page 14: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/14.jpg)
class IIb
Indications for valve replacement:
class IIa
class IIa
Asymptomatic Aortic Stenosis
• Very severe AS:Vmax ≥5 m/s
• Rapid progression and low surgical risk
• Very severe AS: Vmax >5.5 m/s
• Severe valve calcificationand rapid progression
• Markedly elevated BNP>3x age/sex normal limit
![Page 15: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/15.jpg)
class IIb
Indications for valve replacement:
class IIa
class IIa
Asymptomatic Aortic Stenosis
• Very severe AS:Vmax ≥5 m/s
• Rapid progression and low surgical risk
• Very severe AS: Vmax >5.5 m/s
• Severe valve calcificationand rapid progression
• Markedly elevated BNP>3x age/sex normal limit
• Pulmonary hypertension>60 mmHg at rest
![Page 16: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/16.jpg)
Indications for valve replacement:
Asymptomatic Aortic Stenosis
The ACC/AHA and ESC/EACTS guidelines have lowered the threshold for surgery in asymptomatic patients with AS
• Severity of AS• Severity of calcification• Left ventricular function• Exercise response
![Page 17: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/17.jpg)
Indications for valve replacement:
Asymptomatic Aortic Stenosis
The ACC/AHA and ESC/EACTS guidelines have lowered the threshold for surgery in asymptomatic patients with AS
• Severity of AS• Severity of calcification• Left ventricular function• Exercise response• BNP?
![Page 18: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/18.jpg)
Management challenges:
Aortic Stenosis
• Asymptomatic severe AS
• Low-flow, low gradient severe AS
• Indications for TAVR
![Page 19: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/19.jpg)
class IIa
class I
Low Flow, Low Gradient Aortic StenosisIndications for valve replacement:
Reduced EF:• With contractile reserve
Reduced EF:• Dobutamine study showing:
Vmax >4 m/s orMean Δ >40 mmHg orAVA ≤1 sq cm
![Page 20: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/20.jpg)
class IIa
class IIa
class I
Low Flow, Low Gradient Aortic StenosisIndications for valve replacement:
Reduced EF:• Dobutamine study showing:
Vmax >4 m/s orMean Δ >40 mmHg orAVA ≤1 sq cm
Normal EF: • Only if clinical, anatomicand hemodynamic data support severe AS
Reduced EF:• With contractile reserve
![Page 21: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/21.jpg)
class IIa
class IIa
class I
class IIa
Low Flow, Low Gradient Aortic StenosisIndications for valve replacement:
Reduced EF:• Dobutamine study showing:
Vmax >4 m/s orMean Δ >40 mmHg orAVA ≤1 sq cm
Normal EF: • Only if clinical, anatomicand hemodynamic data support severe AS
Reduced EF:• With contractile reserveNormal EF: • Only after carefulconfirmation of severe AS
![Page 22: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/22.jpg)
Management challenges:
Aortic Stenosis
• Asymptomatic severe AS
• Low-flow, low gradient severe AS
• Indications for TAVR
![Page 23: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/23.jpg)
Indications for TAVR vs surgical AVR:
class I
Intervention for Severe AS
• Evaluation by a Heart Team
![Page 24: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/24.jpg)
Indications for TAVR vs surgical AVR:
class I
Intervention for Severe AS
class I
• Evaluation by a Heart Team
• Surgical AVR for patients at low surgical risk
![Page 25: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/25.jpg)
Indications for TAVR vs surgical AVR:
class I
Intervention for Severe AS
class I
class I
• Evaluation by a Heart Team
• Surgical AVR for patients at low surgical risk
• TAVR for patients with prohibitive surgical risk and life expectancy >12 months
![Page 26: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/26.jpg)
Indications for TAVR vs surgical AVR:
class I
Intervention for Severe AS
class I
class I
• Evaluation by a Heart Team
• Surgical AVR for patients at low surgical risk
• TAVR for patients with prohibitive surgical risk and life expectancy >12 months
• TAVR or SAVR for patientsat high surgical risk class INew 2017
![Page 27: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/27.jpg)
Indications for TAVR vs surgical AVR:
class I
Intervention for Severe AS
class I
class I
class I
• Evaluation by a Heart Team
• Surgical AVR for patients at low surgical risk
• TAVR for patients with prohibitive surgical risk and life expectancy >12 months
• TAVR or SAVR for patientsat high surgical risk
• TAVR or SAVR for patientsat intermediate surgicalrisk
class IIa
class I
ACC/AHA
ESC/EACTS
New 2017
New 2017
![Page 28: The New Aortic Valve Guidelines Update...TAVR 2017 • TAVR has been truly transformative • Surgical AVR remains the standard with proven durability and safety for most patients](https://reader033.fdocuments.in/reader033/viewer/2022041902/5e615a17bcebd56fba73433f/html5/thumbnails/28.jpg)
TAVR 2017
• TAVR has been truly transformative
• Surgical AVR remains the standard with proven durability and safety for most patients
• TAVR provides treatment options for patients who previously had no options other than a predictably very poor short term outcome
• TAVR is an alternative to SAVR in patients at high and intermediate surgical risk
• The threshold for TAVR is declining in clinical trials, registries and clinical practice
• Multidisciplinary heart team is
• All patients want this
• Determining when to withhold TAVR is difficult
essential