minimally invasive aortic valve...
TRANSCRIPT
MINIMALLY INVASIVE AORTIC
VALVE REPLACEMENT
Mattia Glauber, MD
Fondazione Toscana G. Monasterio, Massa, Italy
Brown J. M. et al.; J Thorac Cardiovasc Surg 2009;137:82-90
Risk-adjusted mortality for AVR during 10 years in
the Society of Thoracic Surgeons database
Several minimally invasive techniques have developed as
an alternative to FS to reduce the ‘‘invasiveness’’ of the
surgical procedure, while maintaining the same quality and
safety of the standard AVR approach.
Schitto JD et al JACC 2010;56:455-62
MINIMALLY INVASIVE AVR
“ any procedure not performed with full sternotomy and CPB
support”…… STS database (2003)
“ ….small chest incision that does not include full sternotomy”
….AHA statement (2008)
WHICH IS THE REAL AND OPTIMAL
MIAVR ALTERNATIVE TO SAVR?
WHY SURGICAL MIAVR ?
Reduction of surgical dissection low blood loss
Reduction of postoperative pain
Improvement of postoperative respiratory function
Early mobilization & shorter hospital stay
Faster recovery to functional activity
Less rehabilitation resources
Cosmetically superior incision
Facilitation for reoperation at a later date
Reduction of costs
HIGH RISK PATIENTS
•Metanalysis of retrospective studies: potential advantage
in mortality, blood transfusion, early estubation and hospital
discharge.
• Metanalysis of 4 RCTs: no difference in early mortality,
cross clamp time, ventilation time, ICU and hospital stay,
incidence of AF, postoperative pain and sternal
complications.
Brown ML et al. JTCV 2009;137:670-679: Ministernotomy vs conventional
sternotomy for aortic valve replacement: a systematic review and meta-analysis
Murutza B. et al.; Ann Thorac Surg 2008;85:1121-1131: Minimall invasive
AVR; is it worth it ?
MAJOR CRITICISMS
1. Prolonged CPB and ACC time
2. Cosmesis rather than clinical benefit
3. Morbidity related to cannulation through the groin
4. Costs related to the surgical instrumentation
5. TAVIs represent the real MIAVR alternative to SAVR
FTGM Experience started in 2005 with 2 main goals:
Repeat or improve previous promising studies results
Overwhelm evidenced weakness
1. Adoption of several “conventional” technical solutions
2. Continuous results analysis
HOW?
CT evaluation: Rules 1 &2
Patients are suitable for RT if at the level of PA bifurcation:
Rule 2. The distance from ascending aorta to sternum < 10 cm
Rule 1. Aorta is rightward (>50% aorta from right sternal)
RT AVR: Surgical steps
6 - 7 cm RT 2° I.S.
Percutaneous one-stage
venous cannulation in IVC –
SVC
Central aortic cannulation
and cross clamp.
CO2 line
Antegrade cardioplegia
Vent into right superior
pulmonary vein
January 2005
June 2010
192 consecutive patients
Prospectively collected data
Observational
Exclusion criteria for RT:
• previous cardiac surgery,
• Right-sided pleuritis,
• ascending aorta aneurysm
Baseline characteristics
Age (yrs ± SD) 67.3 ± 12.4
Female gender (n. patients, %) 59 (31)
COPD (n. patients, %) 25 (13.4)
Hypertension (n. patients, %) 130 (68)
Diabetes mellitus (n. patients, %) 37 (19)
NYHA III-IV functional class (n. patients, %) 49 (26)
Ejection Fraction (n. patients, %) 56 ± 7
Cerebrovascular disease (n. patients, %) 21 (10)
Aortic valve disease (n. patients, %)
Aortic stenosis
Aortic regurgitation
Mixed
90 (47)
40 (21)
62 (32)
Log EuroSCORE I (median, range) 5.2 (2.5-8.6)
Intraoperative Data
Aortic -femoral venous cannulation (n. pts, %) 173 (90)
Arterial femoral-venous cannulation (n. pts, %) 19 (10)
Prosthetic sutured valves (n. pts, %)
• Biological
• Mechanical
160 (83)
32 (17)
Mean CPB time (min ± SD) 123 ±45
Mean Cross clamp (min ± SD) 89 ±32
Conversion to sternotomy (n. patients, %) 3 (1.6)
Intraoperative Patient Characteristics (192 RT)
Overall mortality (n. patients, %) 3 (1.6)
Stroke (n. patients, %) 1 (0.5%)
Re-exploration for bleeding (n. patients, %) 12 (6%)
Postoperative renal dysfunction (n. patients, %) 4 ( 2%)
Operative MI 2 (1%)
Blood Transfutions (ICU) (n. patients, %) 31 (16%)
Atrial Fibrillation (n.patients, %) 35 (18%)
Ventilation time, hours (median, range) 6 (5-9)
Length of stay, days (median, range) 5 (4-6)
Early postoperative outcomes
Median follow up of 24 months (interquartile range 12-41)
Non cardiac death 0.5%
Freedom from reoperation 99% *
Wound infection & neurological events 0
NYHA functional class I 95%
Cosmetic satisfaction 96%
Back to work or normal life within 4 weeks 93%
FOLLOW UP
* Reoperation at 9 months for sterile endocarditis
RT (N=138) FS (N=138) p
CPB (min ± SD) 121.6±45 107.1 ±32.3 0.003
X-clamp (min ± SD) 86.9±31.8 72.8 ±27 <0.0001
Conversion
(n.patients, %)
2 (1.5%) - -
INTRAOPERATIVE DATA
COST ANALYSIS
FTGM Experience : 2005-2010
631 consecutive AVR patients
MIAVR SAVR p value
No of patients 286 345
Blood transfusions 28.23% 65.23% p=0.02
ICU stay 1.39 days 1.66 days p=0.001
QALY
@ 3 months
@6 months
@ 12 months
0.855
0.89
0.965
0.715
0.791
0.820
p=0.001
p=0.004
p=0.0001
Presented at ISMICS 2012, Los Angeles
631 consecutive patients
Incremental cost of MIAVR vs SAVR of only + 567 €
but at 12 months SAVR is more expensive vs MIAVR for
QALY (+ 3906.2€ )
MIAVR SAVR p value
No of patients 286 345
Mean costs of
procedure per pt
8047.03€ 7480.63€ p=0.42
COST ANALYSIS
Presented at ISMICS 2012, Los Angeles
ANSWERS TO MAJOR CRITICISMS
1. Prolonged CPB and ACC time
2. Cosmesis rather than clinical benefit
3. Morbidity related to cannulation through the groin
4. Costs related to the surgical instrumentation
5. TAVIs represent the real MIAVR alternative to SAVR
Sutureless AVR – Overall Experience in Massa
Collected data updated on January 18th,
2013
From May 2010 to January 2013
236 sutureless/rapid deployment valves
May 2010 March 2011 March 2012
n=32 3F Enable ATS
n=186 Perceval S
N=18
Edwards Intuity
January 2013
Unique radially collapsed profile
Superior visibility
Less traumautic insertion
Reproducible technique
Short learning curve
Significant reduction in cross clamp
time and cardiopulmunary bypass
time
Patient faster recovery
Excellent clinical outcome
Procedural costs saving
Why Choose Perceval S in MIAVR?
Operation time in MIAVR approaches:
Perceval S vs sutured valves
-48 minutes (-53%)
-55 minutes (-43%)
-47 minutes (-56%)
-66 minutes (-54%) XCT
CBT
Right Thoracotomy Ministernotomy
Perceval S in RT Cohort (137 pts):
Age (yrs ± SD) 76.6±7.1
Male (n. patients, %) 47 (34%)
COPD (n. patients, %) 19 (14%)
Pulmonary hypertension (n. patients, %) 19 (14%)
Obesity (BMI> 30 kg/sq m) 35 (25.5%)
NYHA III-IV (n. patients, %) 74 (54%)
Ejection Fraction (n. patients, %) 58.5 ± 8.5
Previous stroke (n. patients, %) 4 (2.9%)
Aortic valve disease (n. patients, %)
Aortic stenosis
Mixed
83 (60%)
54 (40%)
Redo surgery 2 (1.5%)
Log EuroSCORE I (median, range) 10 (7-48)
Implant success 100 %
Conversion 0
Mortality (30 days) 0
Stroke 3 (2.2 %)
Myocardial infarction 1 (0.7 %)
Re-exploration for bleeding 7 (5.1 %)
AV block III grade 5 (3.6 %)
Paravalvular leakage (mild) 2 (1.5)
Early Postoperative Outcomes
Ventilation time, hours (median, IQR) 6 (5-8)
ICU length of stay, days (median, IQR) 1 (1-1)
Length of stay, days (median, IQR) 6 (6-7)
Median follow up of 6 months (interquartile range 3-12)
Non cardiac death 0.7 %
Freedom from reoperation 99.3 %*
Wound infection & neurological events 0
NYHA functional class I 92.0 %
Cosmetic satisfaction 96.4 %
Back to work or normal life within 4 weeks 92.0 %
FOLLOW-UP
* One case with fungine endocarditis 6 months after surgery.
Reproducible procedure
Short and Fast Learning Curve
# procedures
confidence
3 1 5
low
medium
high
7
Easy and fast procedure
Short learning curve
ANSWERS TO MAJOR CRITICISMS
1. Prolonged CPB and ACC time
2. Cosmesis rather than clinical benefit
3. Morbidity related to cannulation through the groin
4. Costs related to the surgical instrumentation
5. TAVIs represent the real MIAVR alternative to SAVR
TAVI: Early, 1 and 2 Year Outcomes
30 days 1 YEAR 2 Year
Surgery TAVI Surgery TAVI Surgery TAVI
Stroke or TIA 2.4% 5.5% 4.3% 8.7% 6.5% 11.2%
Vascular complication 3.8% 17% 3.8% 11.3% 3.8% 11.6%
PARAVALVULAR LEAKAGE
1 YEAR 2 Year
MODERATE-SEVERE AR (PV
leak )
Surgery TAVI Surgery TAVI
1.9% 7% 0.9% 6.9%
• No studies have compared RT vs TAVI
approach.
• Our experience justifies a single center
comparative study
• Aim of our study was to evaluate early
outcomes and midterm follow-up in
patients undergoing MIAVR via RT vs
TAVI.
Jan 2005
Oct 2012
RT AVR vs TAVI
1011 AVR procedures
Mini and full sternotomy,
endocarditis, porcelain aorta
Right anterior minithoracotomy (RT)
N=336
TAVI
N= 84 (TA= 44; TF=40)
Baseline Characteristics RT (N=336) TAVI (N=84) p
Age (yrs ± SD) 69.2 ± 12.4 79.8 ± 6.9 <0.0001
Female (n. patients, %) 128 (38.1) 43 (51.2) 0.039
COPD (n. patients, %) 44 (13) 28 (33.3) 0.01
Hypertension (n. patients, %) 228 (67.9) 71 (84.5) 0.004
Diabetes mellitus (n. patients, %) 61 (18.2) 21 (25) 0.2
NYHA III-IV functional class(n. patients, %) 93 (27.7) 60 (71.4) <0.0001
Ejection Fraction (n. patients, %) 55 ± 6.1 50.6 ± 7.8 <0.0001
Extracardiac vasculopaty (n, patients%) 34 (10.1) 32 (38.1) <0.001
Redo (n. patients, %) 4 (1.2) 27 (32.1) <0.001
Serum Creatinine (mg/dl ± SD) 1.05± 0.8 1.25± 0.9 0.08
Pulmonary Hypertension (n. patients, %) 33 (9.8) 20 (23.8) 0.01
Log. EuroSCORE (median, range)
6 (3-11)
19 (11-32)
<0.0001
RT vs TAVI (before matching...)
Baseline Characteristics RT (N=38) TAVI (N=38) p
Age (yrs ± SD) 78.9 ± 8.6 78.6 ± 5.6 0.85
Female (n. patients, %) 19 (50) 18 (47.4) 1
COPD (n. patients, %) 5 (13.1) 7 (18.4) 0.86
Hypertension (n. patients, %) 31 (81.6) 32 (84.2) 1
Diabetes mellitus (n. patients, %) 10 (26.3) 7 (18.4) 0.62
NYHA III-IV functional class(n. patients, %) 25 (65.8) 22 (57.9) 0.58
Ejection Fraction (n. patients, %) 55 ± 6.1 50.6 ± 7.8 0.73
Extracardiac vasculopaty (n, patients%) 12 (31.6) 11 (28.9) 1
Redo (n. patients, %) 4 (10.5) 4 (10.5) 1
Serum Creatinine (mg/dl ± SD) 1.3± 1.5 1.25± 0.9 0.79
Pulmonary Hypertension (n. patients, %) 5 (13.1) 8 (21.1) 0.3
EuroSCORE (median, range)
12 (8-16)
13 (11-23)
0.15
RT vs TAVI (after propensity score matching...)
RT (N=38) TAVI (N=38) p
Mortality (n. patients, %) 1(2.6) 2 (5.2) 0.7
Stroke (n. patients, %) 0 1 (2.7) 1
Conversion to sternotomy (n. patients, %) 2 (5.2) 2 (5.2) 1
Major bleeding (n. patients, %) 3 (8.1) 3 (8.1) 1
Pulmonary dysfunction (n. patients, %) 2 (5.4) 7 (18.9) 0.5
Renal failure (n. patients, %) 2 (5.4) 4 (10.8) 0.68
ICU stay (median day, range)* 1 (1-2) 1(1-1) 0.5
Ward stay (median day, range) 7 (6-8) 4.5 (3-6) <0.001
RT vs TAVI
* RT vs TA
PV leak : 1 RT (2.6%) vs 17 TAVI (44.7%)
p=0.23
83% vs 55% vs 40%
2.6 % vs 31.6 %
0% vs 13.2 %
Median Follow-up : 20 months ( 6-36)
• Retrospective study
• PS match: limited by available variables
• Small sample size
• Learning curve
• Sutureless and sutured implanted in RT
LIMITATIONS
ANSWERS TO MAJOR CRITICISMS
1. Prolonged CPB and ACC time
2. Cosmesis rather than clinical benefit
3. Morbidity related to cannulation through the groin
4. Costs related to the surgical instrumentation
5. TAVIs represent the real MIAVR alternative to SAVR
AVR: Current FTGM Strategy
Hig
h
Low
Surgical approach
TAVI
Op
era
ble
In
op
era
ble
MIAVR - AVR
Sev
erit
y o
f cl
inic
al p
ictu
re (
Ris
k)
Complex AVR Isolated AVR
LOW
M
ED
IUM
H
IGH
AVR SURGERY