Embed Size (px)
Citation preview
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
Crimped stent valve on delivery balloon catheter
Stent valve with bovine pericardial leaflets
Delivery flexible and steerable catheter with valvuloplasty balloon
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
Cardiac anaesthesia
Teaching screen
Evidence supporting TAVI
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
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%
P = .41
Mor
talit
y, %
THV (n = 179) Standard Therapy (n = 179)
Mortality at 30 days and 1 year
P = .001
P = 0.17
P < 0.0001
TAVI (n=179) Standard Rx (n=179)
%
Repeat hospitalization
“Balloon-expandable TAVI should be the new standard of care for patients with aortic stenosis who are not suitable candidates for surgery”
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
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
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?
