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Transradial aortic valve valvuloplasty
Ruzsa Z., Bárczi Gy., Édes I. F., Molnár L., Becker D., Merkely B.
AimRadial 2017
Financial disclosures
I have no conflict of interest to declare
Vascular complications increase the mortality
after TAVI
Predictors of mortality
N=419 pts TF TAVI after TAVI in PARTNER
1A és 1B után (22/24 F)
64 pts has major vascular complications after TAVI by VARC definitions
Généreux et al. JACC 2012;60:1043-52
How to decrease the complications during TAVI-
IMAGING (US, Fluoro and CT)
Background
• BAV indications
• Bridge to TAVI
• Bridge to death
Patients with symptomatic AS and any of the following:
- Bridge to surgical AVR in hemodynamically unstable patients
- Increased perioperative risk, STS risk score >15%
- Anticipated survival of <3 y
- Age in the late 80s or 90s and prefer BAV over open thoracotomy
Severe comorbidities such as porcelain aorta, severe lung disease, and others for
which the CV surgeon prefers not to operate
Severe and/or disabling neuromuscular or arthritic conditions that would limit the
ability to undergo postoperative rehabilitation
Is it a forgotten therapy (BAV in UK and Hu) ???
BAV complications (NHLBI Balloon Valvuloplasty Registry.)
Circulation. 1991;84:2383-2397
Haematoma 7%
Vascular Surgery Required 5%
Embolism 2%
Transfusion 20%
Limitations of BAV
• Balloon “slip”
• Use of rapid pacing
• Obstruction of LV output
• Balloon rupture
• Annular injury
• Acute result
• Long term durability
• Long term mortality
Transradial access for balloon aortic valvuloplasty
Levente Molnár, Zoltán Ruzsa, Roland Papp, Béla Merkely
Heart and Vascular Center of Semmelweis University, Budapest, Hungary
Introduction:
Balloon aortic valvuloplasty
(BAV) may be considered as to
bridge to surgical or TAVI
procedure (IIb/C). Bridge to
TAVI is common indication in
Hungary.
Aims and methods:
Some of our patients had the need
for non-transfemoral BAV. Our goal
was to prove feasibility and safety
with this access. 9 patient recieved
transradial BAV between June
2016 and april 2017. Cut off limit
was radial artery diamater > 2.0
mm confirmed by echo (2,0-3,2
mm). Radial echo controll was
performed on day 5. 30 day follow-
up controll included cardiac echo
parameters.
Results:
• Age: 81 ± 5 years
• Log. EuroSCORE: 24,5% ± 8%
• Male/female: 6/3
• Bridge to TAVI:7
• Palliative therapy: 2
• Radial and ulnar artery echo
• Balloon sizeing compared to
annulus parameters on CT or
Echo.
• 7-9 Fr radialis/Destination sheath
• 4 cases with Tyshak 18-20x40
mm (NuMEd-8 Fr ; RBP: 2 atm)
• 5 cases XXL Vascular 16-18x40
mm (BSC-7 Fr; RBP: 5 atm)
Conclusion:
Transradial BAV is feasible and
safe in selected cases. Patient
selection with echo for radial
access is necessary. Further
investigation is needed.
procedural 30 day
Aortic Peak Gradient 92±22,5 Hgmm 71± 18Hgmm
Aortic Mean Gradient 50±19 Hgmm 39±16 Hgmm
AVA 0,72±0,21 cm2 0,98±0,23 cm2
NYHA st. III-IV I-III
Aortic regurge 0-I 0-II
Methods
• Prospective pilot study inclusing 17 patients
• Inclusion criteria
• Pts with BAV indication
• Exclusion criteria
• Contraindications of the RA access
• Less than ½ year life expectancy
• End points
• Primary
• Procedural success
• MAEs
• Secondary
• Procedural complications including vascular complications, MACCE
• Procedural reletaed factors
Preparing the patient in the hybrid lab
Ultrasound guided puncture
RIGHT RADIAL 6F-8F and LEFT RADIAL 5-6F
BAV procedure
• 1. Vascular US of both radial and ulnar arteries
• 2. Puncture of the bigger and non-calcified artery
• 5F Left radial
• 6F Right radial
• 3. Temporary pacemaker from jugular vein (US puncture)
• 4. Coronary angiography if necessary
• 5. Pig tail from the left radial access and aortography
• 6. AL1 or AL2 from right radial approach and passing the Terumo GW in the LW
• 7. Changing for Starter GW and Ventriculography and measuring the Peak to peak
gradient
• 7. Changing for Amplatz Super Stiff
• 8. Upsizing the sheath for 7-8F Terumo (femoral) sheath
• 7. BAV
• 8. Controll aortography and Pressure measurements
• 9. Sheath and PM removal
• 10. Early mobilisation
Results
Demographic and clinical data n (%)
Demographic data Age (years)
Male
Hypertension
Current smokers
Diabetes mellitus
- IDDM
- NIDDM
Weight (kg)
Height (cm)
Chronic obstuctive pulmonary disease
Renal insuffitiency
70,13± 9
9 (50)
11 (61)
6 (35.2)
10 (55)
1 (5)
9 (50)
80,9 ± 22
167,4 ± 12
2 (11)
6 (33)
Cardiac and vascular history CAD
PAD
Previous PCI or coronary bypass
Previous valve surgery
Symptoms
- Angina
- Dyspnoea
- Collapse
(6) 33
(2) 11
(6) 33
(1) 5
(13) 72
(18) 100
(3) 16
Indications
Preferences
- Physician preference
- Patient /Family preference
- Surgical preference
- „Bridge” procedure
6
1
0
11
Results
Pre-interventional Postinterventional
Vascular ultrasound
- Radial artery (mm)
- Ulnar artery (mm)
2,03±0,48
1,92±0,57
2,05±0,5
1,94±0,5
Cardiac ultrasound
- LVEF
- 50-70%
- 30-50%
- 30%
- Aortic gradient (peak)
- Aortic gradient (Mean)
- AVA (mm2)
- Aortic regurgitation
- No or mild
- Moderate to severe
- Mitral regurgitation
- No or mild
- Moderate to severe
8
9
1
85±32
52±21
0,59±0,14
18
0
14
4
9
8
2
70±18
43±11
0,62±0,19
18
0
14
4
Haemodinamic data
- Peak to peak gradient 85±30 58±12
The first patient.....
Presented atTCT 2016
Final angiography and coronary angiography
What has been changed during the study
• Long sheath 6-7F 60-70 cm
• Dual injection and 2 short sheath (5F and 7F)
• Routine
• Left radial - Snuff Box
• Radial radial – BAV with 7 or 8F
• Side depends on US result
• (7F only when the RAO is bigger than 1.5 mm and it is not severely
calcifiedí)
Limitations (dedicated vs non-dedicated balloons)
Non dedicated LARGE
balloons
Dedicated BAV balloons
XXL balloon from Boston Sci
XL Balloon from Cordis
Intervalve (12 F)
Tyshak Nucleus
Z med II
Cristal
Conclusion
• Transradial BAV is safe end effective for treating high risk patients
with aortic stenosis as a bridge therapy
Thank you very much

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19 Ruzsa aimradial20170922 Valvuloplasty BAV

  • 1. Transradial aortic valve valvuloplasty Ruzsa Z., Bárczi Gy., Édes I. F., Molnár L., Becker D., Merkely B. AimRadial 2017
  • 2. Financial disclosures I have no conflict of interest to declare
  • 3. Vascular complications increase the mortality after TAVI Predictors of mortality N=419 pts TF TAVI after TAVI in PARTNER 1A és 1B után (22/24 F) 64 pts has major vascular complications after TAVI by VARC definitions Généreux et al. JACC 2012;60:1043-52
  • 4. How to decrease the complications during TAVI- IMAGING (US, Fluoro and CT)
  • 5. Background • BAV indications • Bridge to TAVI • Bridge to death Patients with symptomatic AS and any of the following: - Bridge to surgical AVR in hemodynamically unstable patients - Increased perioperative risk, STS risk score >15% - Anticipated survival of <3 y - Age in the late 80s or 90s and prefer BAV over open thoracotomy Severe comorbidities such as porcelain aorta, severe lung disease, and others for which the CV surgeon prefers not to operate Severe and/or disabling neuromuscular or arthritic conditions that would limit the ability to undergo postoperative rehabilitation
  • 6. Is it a forgotten therapy (BAV in UK and Hu) ???
  • 7. BAV complications (NHLBI Balloon Valvuloplasty Registry.) Circulation. 1991;84:2383-2397 Haematoma 7% Vascular Surgery Required 5% Embolism 2% Transfusion 20%
  • 8. Limitations of BAV • Balloon “slip” • Use of rapid pacing • Obstruction of LV output • Balloon rupture • Annular injury • Acute result • Long term durability • Long term mortality
  • 9. Transradial access for balloon aortic valvuloplasty Levente Molnár, Zoltán Ruzsa, Roland Papp, Béla Merkely Heart and Vascular Center of Semmelweis University, Budapest, Hungary Introduction: Balloon aortic valvuloplasty (BAV) may be considered as to bridge to surgical or TAVI procedure (IIb/C). Bridge to TAVI is common indication in Hungary. Aims and methods: Some of our patients had the need for non-transfemoral BAV. Our goal was to prove feasibility and safety with this access. 9 patient recieved transradial BAV between June 2016 and april 2017. Cut off limit was radial artery diamater > 2.0 mm confirmed by echo (2,0-3,2 mm). Radial echo controll was performed on day 5. 30 day follow- up controll included cardiac echo parameters. Results: • Age: 81 ± 5 years • Log. EuroSCORE: 24,5% ± 8% • Male/female: 6/3 • Bridge to TAVI:7 • Palliative therapy: 2 • Radial and ulnar artery echo • Balloon sizeing compared to annulus parameters on CT or Echo. • 7-9 Fr radialis/Destination sheath • 4 cases with Tyshak 18-20x40 mm (NuMEd-8 Fr ; RBP: 2 atm) • 5 cases XXL Vascular 16-18x40 mm (BSC-7 Fr; RBP: 5 atm) Conclusion: Transradial BAV is feasible and safe in selected cases. Patient selection with echo for radial access is necessary. Further investigation is needed. procedural 30 day Aortic Peak Gradient 92±22,5 Hgmm 71± 18Hgmm Aortic Mean Gradient 50±19 Hgmm 39±16 Hgmm AVA 0,72±0,21 cm2 0,98±0,23 cm2 NYHA st. III-IV I-III Aortic regurge 0-I 0-II
  • 10. Methods • Prospective pilot study inclusing 17 patients • Inclusion criteria • Pts with BAV indication • Exclusion criteria • Contraindications of the RA access • Less than ½ year life expectancy • End points • Primary • Procedural success • MAEs • Secondary • Procedural complications including vascular complications, MACCE • Procedural reletaed factors
  • 11. Preparing the patient in the hybrid lab
  • 13. RIGHT RADIAL 6F-8F and LEFT RADIAL 5-6F
  • 14.
  • 15. BAV procedure • 1. Vascular US of both radial and ulnar arteries • 2. Puncture of the bigger and non-calcified artery • 5F Left radial • 6F Right radial • 3. Temporary pacemaker from jugular vein (US puncture) • 4. Coronary angiography if necessary • 5. Pig tail from the left radial access and aortography • 6. AL1 or AL2 from right radial approach and passing the Terumo GW in the LW • 7. Changing for Starter GW and Ventriculography and measuring the Peak to peak gradient • 7. Changing for Amplatz Super Stiff • 8. Upsizing the sheath for 7-8F Terumo (femoral) sheath • 7. BAV • 8. Controll aortography and Pressure measurements • 9. Sheath and PM removal • 10. Early mobilisation
  • 16.
  • 17.
  • 18.
  • 19.
  • 20. Results Demographic and clinical data n (%) Demographic data Age (years) Male Hypertension Current smokers Diabetes mellitus - IDDM - NIDDM Weight (kg) Height (cm) Chronic obstuctive pulmonary disease Renal insuffitiency 70,13± 9 9 (50) 11 (61) 6 (35.2) 10 (55) 1 (5) 9 (50) 80,9 ± 22 167,4 ± 12 2 (11) 6 (33) Cardiac and vascular history CAD PAD Previous PCI or coronary bypass Previous valve surgery Symptoms - Angina - Dyspnoea - Collapse (6) 33 (2) 11 (6) 33 (1) 5 (13) 72 (18) 100 (3) 16
  • 21. Indications Preferences - Physician preference - Patient /Family preference - Surgical preference - „Bridge” procedure 6 1 0 11
  • 22. Results Pre-interventional Postinterventional Vascular ultrasound - Radial artery (mm) - Ulnar artery (mm) 2,03±0,48 1,92±0,57 2,05±0,5 1,94±0,5 Cardiac ultrasound - LVEF - 50-70% - 30-50% - 30% - Aortic gradient (peak) - Aortic gradient (Mean) - AVA (mm2) - Aortic regurgitation - No or mild - Moderate to severe - Mitral regurgitation - No or mild - Moderate to severe 8 9 1 85±32 52±21 0,59±0,14 18 0 14 4 9 8 2 70±18 43±11 0,62±0,19 18 0 14 4 Haemodinamic data - Peak to peak gradient 85±30 58±12
  • 24.
  • 25. Final angiography and coronary angiography
  • 26. What has been changed during the study • Long sheath 6-7F 60-70 cm • Dual injection and 2 short sheath (5F and 7F) • Routine • Left radial - Snuff Box • Radial radial – BAV with 7 or 8F • Side depends on US result • (7F only when the RAO is bigger than 1.5 mm and it is not severely calcifiedí)
  • 27. Limitations (dedicated vs non-dedicated balloons) Non dedicated LARGE balloons Dedicated BAV balloons XXL balloon from Boston Sci XL Balloon from Cordis Intervalve (12 F) Tyshak Nucleus Z med II Cristal
  • 28. Conclusion • Transradial BAV is safe end effective for treating high risk patients with aortic stenosis as a bridge therapy