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A shifting paradigm of care: Advances in transcatheter heart valve procedures
Sandra Lauck MSN, RN, CCN(C)
Clinical Nurse Specialist, Arrhythmia Management and Interventional Cardiology
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What is available for what valve?
• Transcatheter aortic valve implantation
• Mitral valve repair
• Pulmonary valve implantation
• What are the implications for cardiac nurses?
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Transcatheter approaches• Minimally invasive• No cardiac bypass• Vascular access:
– Transfemoral– Transvenous– Transapical
• Use of catheters to deliver device or perform repair• No valve replacement – Native annulus remains in place• Imaging requirements:
– Fluoroscopy– Echocardiography
• Operators: Interventional cardiologists and cardiac surgeons
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Transcatheter aortic valve implantation
Crimped stent valve on delivery balloon catheter
Stent valve with bovine pericardial leaflets
Delivery flexible and steerable catheter with valvuloplasty balloon
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TAVI approaches
Transfemoral Transapical
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Transfemoral TAVI
• Femoral artery puncture
• Steerable catheter
• Retrograde approach– Common iliac arteries
– Aorta
– Aortic root
– Into native annulus
• Primary operator: Interventional cardiologist
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Transfemoral TAVI
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Transapical TAVI
• Mini-thoracotomy
• Vascular access sheath inserted into apex of LV
• Primary operator: Cardiac surgeon
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Transapical TAVI
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Hybrid Cath Lab/OR
Fluoroscopy
Advanced hemodynamic monitoring
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Hybrid Cath Lab/OR
Cardiac surgery bypass capacity
Cardiac anaesthesia
Teaching screen
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Evidence supporting TAVI
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N = 699 N = 358High RiskHigh Risk InoperableInoperable
PARTNER A: Inoperable patients Symptomatic Severe Aortic StenosisSymptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate3,105 Patients Screened
ASSESSMENT: High-Risk AVR Candidate3,105 Patients Screened
Total = 1,057 patients
2 Parallel Trials
StandardTherapyStandardTherapy
ASSESSMENT: Transfemoral
Access
ASSESSMENT: Transfemoral
Access
Not In StudyNot In Study
TF TAVRTF TAVR
Primary Endpoint: All-Cause Mortality
Superiority
Primary Endpoint: All-Cause Mortality
Superiority
1:1 Randomization1:1 Randomization
VS
YesYes NoNo
N = 179 N = 179
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0%
10%
20%
30%
40%
50%
60%
< 60 60 - 69 70 - 79 80 - 89 >= 90
PARTNER B: Most patients were over 80P
erce
nt o
f P
atie
nts
Age (years)
2%7%
20%
50%
22%
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P = .41
Mor
talit
y, %
THV (n = 179) Standard Therapy (n = 179)
Mortality at 30 days and 1 year
P = .001
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P = 0.17
P < 0.0001
TAVI (n=179) Standard Rx (n=179)
%
Repeat hospitalization
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“Balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery”
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N = 179
N = 358InoperableInoperable
StandardTherapyStandardTherapy
ASSESSMENT: Transfemoral
Access
ASSESSMENT: Transfemoral
Access
Not In StudyNot In Study
TF TAVRTF TAVR
Primary Endpoint: All-Cause Mortality Superiority
Primary Endpoint: All-Cause Mortality Superiority
1:1 Randomization1:1 Randomization
VS
YesYes NoNo
N = 179
TF TAVRTF TAVR AVRAVR
Primary Endpoint: All-Cause Mortality at 1 yrNon-inferiority
Primary Endpoint: All-Cause Mortality at 1 yrNon-inferiority
TA TAVRTA TAVR AVRAVR VS VS
N = 248 N = 104 N = 103N = 244
PARTNER ASymptomatic Severe Aortic StenosisSymptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate3,105 Total Patients Screened
ASSESSMENT: High-Risk AVR Candidate3,105 Total Patients Screened
Total = 1,057 patients
2 Parallel Trials: Individually Powered
N = 699 High RiskHigh Risk
ASSESSMENT: Transfemoral
Access
ASSESSMENT: Transfemoral
Access
Transapical (TA)Transapical (TA)Transfemoral (TF)Transfemoral (TF)
1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization
YesYes NoNo
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0
0.1
0.2
0.3
0.4
0.5
0 6 12 18 24
TAVR
AVR
Months
348 298 260 147 67
351 252 236 139 65
No. at Risk
TAVR
AVR
26.8
24.2
All-cause mortality at 1 yearHR [95% CI] =
0.93 [0.71, 1.22]P (log rank) = 0.62
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Transfemoral AVR
• Is superior to medical management in inoperable patients
• Is equivalent to surgery in selected, high risk patients even if they are “operable”
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Improved technology = Improved procedural success
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Mitral valve repair
• Edge to edge repair
• Coronary sinus annuloplasty
• Mitral valve implantation
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Edge to edge repair
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Coronary sinus MV annuloplasty
Coronary sinus
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Mitral valve ‘cinching’
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Mitral valve implantation
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Pulmonary valve implantation
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Implications for cardiac nurses
• ‘Hybrid’ procedures– Cath lab nursing
– OR nursing
– Cardiology and cardiac surgery recovery areas
• ‘New’ patient population– Low volume and higher risk
– Decision-making support and unique processes of care
– Evidence-based inter-disciplinary program development
– Same-day discharge?
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