Transcript Title of Session Case Study

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
What is available for what valve?
• Transcatheter aortic valve implantation
• Mitral valve repair
• Pulmonary valve implantation
• What are the implications for cardiac nurses?
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
Transcatheter aortic valve implantation
Stent valve with bovine pericardial
leaflets
Delivery flexible and steerable catheter
with valvuloplasty balloon
Crimped stent valve on
delivery balloon catheter
TAVI approaches
Transfemoral
Transapical
Transfemoral TAVI
• Femoral artery puncture
• Steerable catheter
• Retrograde approach
–
Common iliac arteries
–
Aorta
–
Aortic root
–
Into native annulus
• Primary operator: Interventional cardiologist
Transfemoral TAVI
Transapical TAVI
• Mini-thoracotomy
• Vascular access sheath inserted
into apex of LV
• Primary operator: Cardiac
surgeon
Transapical TAVI
Hybrid Cath Lab/OR
Fluoroscopy
Advanced hemodynamic monitoring
Hybrid Cath Lab/OR
Cardiac surgery bypass capacity
Teaching screen
Cardiac anaesthesia
Evidence supporting TAVI
PARTNER A: Inoperable patients
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Patients Screened
Total = 1,057 patients
N = 699
High Risk
Inoperable
2 Parallel Trials
N = 358
ASSESSMENT:
Transfemoral Access
Yes
No
1:1 Randomization
N = 179
TF TAVR
Not In Study
N = 179
VS
Standard
Therapy
Primary Endpoint: All-Cause Mortality
Superiority
PARTNER B: Most patients were over 80
Percent of Patients
60%
50%
50%
40%
30%
22%
20%
20%
10%
7%
2%
0%
< 60
60 - 69
70 - 79
Age (years)
80 - 89
>= 90
Mortality at 30 days and 1 year
P = .001
Mortality, %
P = .41
THV (n = 179)
Standard Therapy (n = 179)
Repeat hospitalization
P < 0.0001
%
P = 0.17
TAVI (n=179)
Standard Rx (n=179)
“Balloon-expandable TAVI should be the new standard of
care for patients with aortic stenosis who are not suitable
candidates for surgery”
PARTNER A
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
Total = 1,057 patients
N = 699
Yes
High Risk
ASSESSMENT:
Transfemoral Access
Transfemoral (TF)
1:1 Randomization
Transfemoral Access
Transapical (TA)
1:1 Randomization
N = 248
N = 104
N = 103
TF TAVR
AVR
TA TAVR
AVR
VS
N = 358
ASSESSMENT:
No
N = 244
VS
Inoperable
2 Parallel Trials:
Individually Powered
Primary Endpoint: All-Cause Mortality at 1 yr
Non-inferiority
Yes
No
1:1 Randomization
N = 179
TF TAVR
Not In Study
N = 179
VS
Standard
Therapy
Primary Endpoint: All-Cause Mortality
Superiority
All-cause mortality at 1 year
0.5
HR [95% CI] =
0.93 [0.71, 1.22]
P (log rank) = 0.62
TAVR
AVR
0.4
26.8
0.3
24.2
0.2
0.1
0
0
6
No. at Risk
12
18
24
Months
TAVR
348
298
260
147
67
AVR
351
252
236
139
65
Transfemoral AVR
• Is superior to medical management in
inoperable patients
• Is equivalent to surgery in selected, high risk
patients even if they are “operable”
Improved technology = Improved procedural success
Mitral valve repair
• Edge to edge repair
• Coronary sinus annuloplasty
• Mitral valve implantation
Edge to edge repair
Coronary sinus MV annuloplasty
Coronary sinus
Mitral valve ‘cinching’
Mitral valve implantation
Pulmonary valve implantation
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?
Thank you
[email protected]