- Prepare equipment - Assist in valve implantation - Manage access site Cardiac Anesthesiologist Cardiac surgeon Cardiac imaging expert General anesthesia TRANSAPICAL/TRANSAORTIC TAVI POST-PROCEDURAL PHASE - ICU monitoring for at least 24 hours - Echocardiographic control within 24 hours - Clinical evaluation before discharge - Prescription of antithrombotic therapy - Outpatient follow-up at 1, 6 and 12 months: clinical evaluation, echocardiography, laboratory tests - In case of complications: rehospitalization,

1. THE GISE TAVI POSITION PAPER
Giuseppe Tarantini, MD, PhD, FESC
Chief – Interventional Cardiology Unit
Department of Cardiac, Thoracic and Vascular Sciences
Assistant professor - University of Padua
GISE president

2. Background # 1

3. III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
B
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
B
2014
2017
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
B
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
A
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
A
**
* upgraded
III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII
A SURTAVI - PARTNER 3
NOTION 2 – EVOLUT PRO
20XX
Nishimura et al JACC 2017
(2 days before SURTAVI)

4. INTEGRATED APPROACH FOR RISK STRATIFICATION
*Use of the STS PROM to predict risk in a given institution with reasonable reliability is appropriate only if institutional outcomes are within 1 standard deviation of STS average
observed/expected ratio for the procedure in question.
ŤSeven frailty indices: Katz Activities of Daily Living (independence in feeding, bathing, dressing, transferring, toileting, and urinary continence) and independence in ambulation (no walking aid or
assist required or 5-meter walk in <6 s). Other scoring systems can be applied to calculate no, mild-, or moderate-to-severe frailty.
ŦExamples of major organ system compromise: Cardiac-severe LV systolic or diastolic dysfunction or RV dysfunction, fixed pulmonary hypertension; CKD stage 3 or worse; pulmonary dysfunction
with FEV1<50% or DLCO2<50% of predicted; CNS dysfunction (dementia, Alzheimer’s disease, Parkinson’s disease, CVA with persistent physical limitation); GI dysfunction-Crohn’ s disease,
ulcerative colitis, nutritional impairment, or serum albumin<3.0; cancer-active malignancy; and liver - any history of cirrhosis, variceal bleeding, or elevated INR in the absence of VKA therapy.
Examples: tracheostomy present, heavily calcified ascending aorta, chest malformation, arterial coronary graft adherent to posterior chest wall, or radiation damage

6. PARTNER 1B PARTNER 1A
5,2
8,4
5
11,8
10,3
11,2
STS >8 (2007-2010) STS >8 (2002-2006) STS 4-8 (2007-2010)STS 4-8 (2002-2006) STS <4 (2007-2010) STS <4 (2002-2006)
1,71,7
6,4
5,4
11,9
14,4
1,61,7
5,55,5
13,613,9
SAVR
TAVR
LOW (<4%)INTERMEDIATE (4-8%)
PARTNER 2 S3IR SURTAVI
2,2
1,1
3,9 4,4
5,25,8
NOTION
2,1
2,9
30-daymortality
STACCATO
2,83,1
EXTREME-HIGH (>8%)
30-daymortality
83 83 84 82 82 80 AGE
(years)
77 77
65
AGE
(years)

7. SOURCE 3 Registry – Risk analysis
Tarantini G et al. PCR 2017 Tarantini G et al. Circulation Intervention 2018 in press
Age – 82Age – 78

8. PURE VALVE Registry 2007-2017 – 1150 TAVI pts
78
83,5
89
94,5
100
2007-2008 2009 2010 2011 2012 2013 2014 2015 2016
STSscore%
MeanAge

9. Heart Team
CLASS I LoE C

10. Clinical characteristics favoring TAVI:
➢ STS/EuroSCORE II ≥4% (logistic EuroSCORE I ≥10%)
➢ Presence of severe co-morbidity (not adequately reflected by scores)
➢ Age ≥75 years
➢ Previous cardiac surgery
➢ Frailty
➢ Restricted mobility and conditions that may affect the rehabilitation process after the
procedure
Anatomical and technical aspects favoring TAVI:
➢ Favourable access for TF TAVI
➢ Sequelae of chest radiation
➢ Porcelain aorta
➢ Presence of intact CABG at risk when sternotomy is performed
➢ Expected patient-prosthesis mismatch

11. Background # 2

12. PROCEDURAL EXPERIENCE AND RELATION TO OUTCOMES
Carroll et al, J Am Coll Cardiol. 2017 Jul 4;70(1):29-41
Data from 42,988 commercial procedures conducted at 395 hospitals submitting to the
Transcatheter Valve Therapy Registry from 2011 through 2015
IN-HOSPITAL MORTALITY 4% VASCULAR COMPLICATIONS 7.1% BLEEDING COMPLICATIONS 8.6%

13. SOURCE: GISE Think Heart 2018
20.4%TAVI from 2016 to 2017
91.2 procedures per mil inhabitants
TEMPORAL TRENDS IN
TAVI VOLUMES IN ITALY

14. Total centers Centers performing >30 TAVI/year
Out of 97 centers performing TAVI in Italy,
64 (65.9%) have a mean volume of >30 procedures/year
SOURCE: GISE Think Heart 2018
PROPORTION OF CENTERS
PERFORMING TAVI BY REGION

15. % without CCH on site
% with CCH on site
TOTAL
% without hybrid room
% with Hybrd room
TOTAL
On-site surgery Hybrid room
2016 2017 2016 2017
SOURCE: GISE Think Heart 2018
ON-SITE SURGERY AND HYBRID ROOMS
DISTRIBUTION

16. Background # 3

17. [17
NATIONAL SOCIETIES POSITION PAPERS

18. THE SICI-GISE POSITION PAPER
2011 POSITION PAPER
OBJECTIVES
• Define structural and organizational
requirements of TAVI center
• Establish training programs for proctors
and operators
NEW POSITION PAPER
OBJECTIVES
• Re-define structural and organizational
requirements of TAVI center
• Re- Establish training programs for
proctors and operators - revised
• Periprocedural set-up

19. Institutional
requirements

20. 1. CENTRES WITH BOTH DEPARTMENTS OF CARDIOLOGY AND CARDIAC
SURGERY ON SITE
EMERGENT CARDIAC SURGERY AND TAVI COMPLICATIONS AND MORTALITY
Eggebrecht H et al, Eur Heart J. 2018 Feb 21;39(8):676-684
European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI)
including 27,760 TF-TAVI procedures between 2013 and 2016
In patients >85 years where emergent surgery was not
associated with a significant benefit.
INSTITUTIONAL REQUIREMENTS- ESSENTIALS

21. 2. Multidisciplinary Heart Team
Cardiologist
Interventional
cardiologist
Cardiac surgeon
Cardiac imaging expert
Cardiac
anesthesiologist
Geriatrician/Vascular
surgeon/Radiologist
PATIENT WITH
SEVERE AORTIC
STENOSIS
INSTITUTIONAL REQUIREMENTS- ESSENTIALS

22. 1. Minimum activity level of 3 (preferably 5)/monthTAVI/month
2. On site cardiac surgery performing SAVR
o Annual mortality rate <6%
3. At least 2 Cath-lab laboratories (or one cath lab and one hybrid room)
o 1000 coronary angiographies/year
o 400 PCI/year
4. Post-procedure intensive care facility
5. Electrophysiology laboratory
6. Anesthesia unit with cardiac anesthesiologists
7. Vascular surgery
8. Cardiology unit with telemetry
9. Radiologic imaging: cardiac CT capabilities
10.Staffing specialities: neurology, nephrology, geriatry and/or internal
medicine
INSTITUTIONAL REQUIREMENTS- FACILITIES

23. 1. Fixed radiographic imaging system with high-resolution
fluoroscopy (mobile C-arm is not suitbale and its use could affect
the safety of the procedure)
2. Systems for fusion imaging (echocardiography, CT or CMR)
3. Automated systems for selection of fluoroscopy views that allow
proper device positioning
4. Electric generators that can supply eventual loss of normal power
during the procedure
5. Polygraph for hemodynamic monitoring (blood pressure,
electrocardiogram and peripheral oxygen saturation)
6. Contrast injector
INSTITUTIONAL REQUIREMENTS- EQUIPMENT

24. 7. Defibrillator with radio-transparent pads
8. Ventilator
9. Blood gas analyzer
10.A crash cart carrying medicine and equipment for use in
emergency resuscitations
11.Scialytic lamp
12.Extracorporeal circulation
13.Cardiac ultrasound machine with transesophageal probe
14.Multi-slice angio-CT
15.IABP
INSTITUTIONAL REQUIREMENTS- EQUIPMENT

25. 1. Surgical instruments
2. Wires, catheters, and balloons for valvuloplasty and prosthesis
implantation
3. Temporary pacemaker with pacing ability
4. Instruments for emergency pericardiocentesis
5. Material for endovascular procedures: aortic occlusion balloon
catheters, wires and balloon for peripheral arteries, covered
stents, long sheats of at least 20 F
6. Retrieval instruments (snare) of different sizes
7. Wires, catheters and balloons for percutaneous coronary
CATHETERIZATION LAB OR HYBRID ROOM

26. FIRST operator = TEAM LEADER
Skills: Perform valve implantation
Manage complications with a
transcatheter approach
Skills: Perform valve implantation
Manage complications
requiring surgical intervention
TRANSFEMORAL AND
TRANSSUBCLAVIAN TAVI
TRANSAPICAL AND
TRANSAORTIC TAVI
INSTITUTIONAL REQUIREMENTS - TEAM LEADER

27. Operator/ Proctor
requirements

28. 1. To be TF/TS first operator, since at least 5 years, for
coronary angiography, PCI, cardiac catheterization,
temporary pacemaker implantation
2. To perform more than 75 procedures/year (in a center with
a total number of more than 400 PCI/year)
3. To perform diagnostic and interventional procedures
through radial and femoral access and to use retrieval
systems
4. To have performed as first operator:
Aortic valvuloplasty
Pericardiocentesis (elective or urgent)
Angiography and percutaneous interventions on
peripheral vessels
OPERATORS REQUIREMENTS

29. RESIDENT
OPERATOR
TAVI
CENTER
Attend at least 2
procedures and
learn technical and
organizational
aspect
Perform at least 10
procedures with the
proctor on site
(preferably 2-3/
month)
Perform 2 more
procedure under the
supervision of the
proctor that has to
evaluate the
eventual need for
further training
AT LEAST 2 TAVI
OPERATORS ARE NEEDED IN
A TAVI CENTER
OPERATORS TRAINING PROGRAM

30. TAVI
CENTER
OPERATOR FROM
NO-TAVI CENTER
Participate into the
screening phase
(multidisciplinary
evaluation, imaging)
and get trained to
select the prosthesis
size and the access
Perform the
procedure with the
proctor, on the basis
of agreement
between Hopital and
institution
OPPORTUNITY TO LEARN
AND PERFORM TAVI AT
HUB CENTERS
OPERATORS TRAINING PROGRAM

31. 1. At least 100 TAVI performed as first operator
2. 100 implants of Prostar/Proglide for percutaneous
vascular access
3. 20 pericardiocentesis
4. Experience in peripheral interventions
5. Knowledge of the software for processing of
multislice CT
6. Regular meetings with other proctors to discuss
technical advances and uniform teaching
PROCTORS REQUIREMENTS

32. Periprocedural
SET-UP

33. Referring Physician
Detection of AS
Referring Cardiologist: ECHO
Confirmation of AS, severity, clinical/psychocosial status, comorbidities
Which possible therapeutic option?
Discussion with patient and relatives
Multidisciplinary cardiac and non cardiac evaluation
CARDIAC SURGEON (refusal)
HEART TEAM
TAVR MED TX
PRE-PROCEDURAL PHASE
“OLD-FASHION” WORK-UP SAS

34. Referring Physician
Detection of AS
Referring Cardiologist: ECHO
Confirmation of AS, severity, clinical/psychocosial status, comorbidities
Which possible therapeutic option?
Discussion with patient and relatives
Multidisciplinary cardiac and non cardiac evaluation
Likely SAVR/TAVR
CARDIAC SURGEON
SAVR HEART TEAM
TAVR
Favourable
to SAVR
Unfourable to SAVR
SAVR better
TAVR better
Medical Tx betterMED TX
“UPDATED” WORK-UP SAS
PRE-PROCEDURAL PHASE
Objectivate and standardize
Final decision pro/cons TAVI

35. Favours
TAVI
Favours
SAVR
STS/EuroSCORE II<4% +
STS/EuroSCORE II≥4% +
Severe comorbidity +
Age < 75 years +
Age ≥ 75 years +
Previous cardiac
surgery
+
Frailty +
Restricted mobility and
conditions that may
affect the rehabilitation
process
+
Suspicion of
endocarditis
+
CLINICAL CHARACTERISTICS
Favours
TAVI
Favours
SAVR
Favourable for TF access +
Sequelae of chest
radiation
+
Porcelain aorta +
Intact bypass at risk in
case of sternotomy
+
Expected patient-
prosthesis mismatch
+
Severe chest deformation +
Short distance between
coronary ostia and aortic
annulus
+
Annulus out of range for
TAVI
+
Aortic root unfavourable
for TAVI
+
Thrombi in aorta or LV +
Valve morphology
(bicuspid, calcification) +
ANATOMIC CHARACTERISTICS
Favours
TAVI
Favours
SAVR
Severe CAD requiring
CABG +
Severe primary mitral
disease which could be
treated surgically
+
Severe tricuspid valve
disease
+
Aneurysm of the
ascending aorta
+
Septal hypertrophy
requiring myectomy
+
OTHER CARDIAC CONDITIONS
Favouring TAVI Favouring SAVR
Clinical factors 2 1
Anatomic factors 2 0
Other cardiac
conditions
1 1
Total Score 5 2
CHECK LIST FOR THE CHOICE OF TAVI OR SAVR

36. IMPLANTATION EQUIPE BACKUP
PERI-PROCEDURAL PHASE
TRANSFEMORAL/TRANSSUBLCAVIAN TAVI
Perform valve
implantation.
Manage complications
with a transcatheter
TEAM
LEADER
Second
Operator
Cardiac
Anesthesiologist
Vascular
surgeon
Cardiac
imaging
expert
Local anesthesia
Conscious sedation

37. IMPLANTATION EQUIPE BACKUP
Perform valve
implantation.
Manage complications
requiring surgery
TEAM
LEADER
Second
Operator
Cardiac
Anesthesiologist
Vascular
surgeon
Cardiac
imaging
expert
General anesthesia
(TEE)
PERI-PROCEDURAL PHASE
TRANSAPICAL/TRANAORTIC TAVI

38. (Sub-)Intensive
care unit
• Laboratory exams
• 12-lead ECG
• Echocardiography
• Temporary pacing
Cardiology Unit
• Telemetry
• Diagnosis and
management of
eventual access site
complications
• Mobilization and early
discharge in absence of
complications
Follow-up at 30-
day
• Clinic control
• 12-lead ECG
• Echocardiography
• 24-h Holter ECG
ORGANIZATIONAL REQUIREMENTS
POST-PROCEDURAL PHASE
TRANSFEMORAL/TRANSSUBLCAVIAN TAVI

39. Spain
46,5M
Portugal
10,3M
Italy
60,7M
Total 117.527.944
*Source Eurostat
Looking forward to….. Another
Southern Europe Perspective