MINIMALLY INVASIVE AORTIC VALVE …webcast.aats.org/2013/files/Saturday/20130504_balla_0800...MINIMALLY INVASIVE AVR “ any procedure not performed with full sternotomy and CPB support”……

MINIMALLY INVASIVE AORTIC

VALVE REPLACEMENT

Mattia Glauber, MD

Fondazione Toscana G. Monasterio, Massa, Italy

DISCLOSURE:

Sorin: preceptorships and educational activities

Medtronic: consulting

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?

1. Right Anterior Minithoracotomy

2. Ministernotomy

MIAVR Surgical Access

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)

α

Angle α ≥45°

CT evaluation: Rule 3

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

Median Follow-up 30 months (IQR 17-54)

Survival : 96 %±2% RT vs 88%±4% FS (p=0.3)

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






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.

Echocardiographic Follow-up Data

Reproducible procedure

Short and Fast Learning Curve

# procedures

confidence

3 1 5

low

medium

high

7

Easy and fast procedure

Short learning curve







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%

Similar Mortality

2 fold increased risk of Stroke

€ 20,000 per patient

COST-EFFECTIVENESS

• 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

p=0.006

92% vs 46%

Median Follow-up : 20 months ( 6-36)

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







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

CONCLUSIONS

1996 2000 2004 2008 2012

4

3

2

1

0

MO

RT

AL

ITY

% STS

MIAVR

SUTURELESS

THANK YOU

Q1. The combination of RT and sutureless

bioprostheses may:

MINIMALLY INVASIVE AORTIC VALVE …webcast.aats.org/2013/files/Saturday/20130504_balla_0800...MINIMALLY INVASIVE AVR “ any procedure not performed with full sternotomy and CPB support”……

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