tavr for aortic insufficiency - solaci · • less risk of annular rupture during deployment •...

TAVR for Aortic Insufficiency

Dr. Antonio Dager GómezAngiografía de Occidente

Cali - Colombia

CoreValve First Cases 2004

1st Generation 25F

2004-2005

•Bovine Pericardium – Commercial Surgical Valve

•Intra-annular valve function

•1 piece for sealing

•Annulus range 20-23 mm

•Cut-down, GA, Fem-Fem Bypass Aortic StenosisAortic Regurgitation

12 Jul 2004AS + AR

21 Aug 2004Pure AR

Gold Standard: Surgery Possibility of repair Addresses aortic aneurysm Large annuli allow for large bioprosthesis

Lower risk for PPM Good landing zone for future valve in valve TAVI

Only treatment for endocarditis

Aortic Regurgitation: Up to 70% of patients with AR have dilated aortic

roots Common in patients with bicuspid AV

Cuspabnormality of perforation OR

Aortic rootdilatation withmalcoaptationor aortic cusps

Lack of commissuralsupport withmalcoaptationof aortic cusps

Contraindications toconventional AV repair / replacement

• Patients at high risk for surgery

• Reasons for inoperability:

• “Porcelain aorta”; prior irradiation of the thorax; thoracic deformity

• Severe cerebral sclerosis

• Severe lung, liver, or renal disease, malignant tumors, frailty

• Patients with failed repairs

• Majority of reasons for inoperability related to the need for extracorporeal circulation

• Need for off-pump procedures even in AR

Edwards Sapiens 3: - Balloon Expandable- External Adaptative Seal

Anna Franzone et al, Transcatheter Aortic Valve Replacement for the Treatment of Pure Native Aortic Valve Regurgitation A SystematicReview J A C C : CARDI O V AS C ULAR I NT E R V E N T IONS VOL . 9 , NO. 2 2 , 2 0 1 6

Etiology of Aortic Regurgitation

SEVERE AI SECONDARY TO LVADIMPLANTS INCREASING

EXPONENTIALLY.

Gender: MaleAge: 80 y.o

- Heart Failure simptoms III/IV NYHA- Angina- PMH

- Hypertension- CKF Stage III- FA- One vassel CAD (OM + D1)

Clinical Case N°1

Ventriculography and Aortography

Left Atrial Dilation

LVH

LVEF 45%

Severe AR

Moderate MR

Moderada TR

SPAP: (78 mmHg)

Echocardiogram

Perimeter: 92

Max Diameter: 34Min Diameter: 24

Vascular Plug Implant

Vascular Plug Implant

Valve Implant Final Result

COREVALVE N°31

© Springer International Publishing Switzerland 2015H. van Assen et al. (Eds.): FIMH 2015, LNCS 9126, pp. 364–372, 2015.DOI: 10.1007/978-3-319-20309-6_42

Fig. 1. CircAdapt model representation (left) with aorta and aortic valve parameters (right). RA: rightatrium, LA: left atrium, RV: right ventricle, LV: left ventricle, TV: tricuspid valve, PV: pulmonary valve,MV: mitral valve, pAo: aortic pressure, AAo: cross-sectional area of the aorta, Aw: cross-sectional areaof the aortic wall, ALV: cross-sectional area of the left ventricle, pLV: left ventricular pressure,AAoValve: cross-sectional area of the aortic valve, lAoValve: length of the aortic valve, Δp: pressuredrop across the aortic valve.

Fig. 2. Simulated protocol. Three AR degrees (0 cm2, 0.15 cm2 and 0.40cm2) with normal and low aortic compliance. The parameters k and ROAin CircAdapt are changed to simulate low/normal aortic compliance anddifferent AR degrees, respectively.

© Springer International Publishing Switzerland 2015H. van Assen et al. (Eds.): FIMH 2015, LNCS 9126, pp. 364–372, 2015.DOI: 10.1007/978-3-319-20309-6_42

Fig. 4. Effect of AR and aortic compliance on pressure. Aortic pressures (dashed line)and left ventricular pressures (solid line) for normal (A) and low (B) aortic compliancedisplayed for each AR degree: ROA of 0 cm2 (black), 0.15 cm2 (gray) and 0.40 cm2 (lightgray) (Color figure online).

© Springer International Publishing Switzerland 2015H. van Assen et al. (Eds.): FIMH 2015, LNCS 9126, pp. 364–372, 2015.DOI: 10.1007/978-3-319-20309-6_42

VENTRICULAR STRAIN

Fig. 6. Simulated and measured blood flow velocities. A: Simulated blood flowvelocities at ROA of 0.15 cm2 with normal (left) and low (right) aortic compliance; B:CW Doppler velocity in a 78-year-old patient with AR. Positive axis correspond tobackward blood flow velocity. © Springer International Publishing Switzerland 2015

H. van Assen et al. (Eds.): FIMH 2015, LNCS 9126, pp. 364–372, 2015.DOI: 10.1007/978-3-319-20309-6_42

0

0,5

1

1,5

2

2,5

0 0,5 1 1,5 2 2,5

AoVO

ARO

AO

C

OM

PLI

AN

CE

SUR

VIV

AL

Incidence 13.2% (all valve disease) Prognosis (medical treatment): high mortality, 25% per year!

Survival of severe AR with severe LV Disfunction

Dujardin et al.

1Roy, et al., J Am Coll Cardiol 2013; 61:1577-84; 2Testa, et al., EuroIntervention 2014;10:739-74

TAVI in Pure Aortic RegurgitationCoreValve Series1,2

• In early experience, CoreValve was preferred over balloon-expandable valves for several reasons:

• Self-expanding frame seemed better for anchoring in the absence of calcification

• Less risk of annular rupture during deployment

• Ability to treat larger anatomies

• Two early series represent the majority of published experience using CoreValve in pure AR patients

Study Baseline Characteristics

N Age (yrs) STS (%) % MaleAnnulus

Diameter (mm)Ascending Aortic Diameter (mm)

Roy1 43 75.3 ± 8.8 10.2 47 24.0 ± 2.3 35.9 ± 8.8

Testa2 26 73 ± 10 13.1 63 25 ± 2 38 ± 6

• Self-expanding Nitinol frame with flexible stent posts

• Porcine root valve

• Clip fixation of native leaflets

• Rapid pacing not required

• Annular range: 21 – 27 mm

• 3 valve sizes: 23, 25, 27 mm

• 32Fr introducer sheath

JenaValve TA: Design Features

2Ensminger, et al., presented at TVT 2013

1Schlingloff, et al., Interact Cardiovasc Thorac Surg 2014; 19:388-93; 2Seiffert, et. al. , J Am Coll Cardiol Intv 2014; 7: 1168-74

Study Baseline Characteristics

N Age (yrs) STS (%) % MaleAnnulus

Diameter (mm)Ascending Aortic Diameter (mm)

Schlingloff1 10 79 ± 9 6.7% 60% NR NR

Seiffert2 31 74 ± 9 5.4% 64.5% 24.7 ± 1.5 36.6 ± 7.0

JenaValve TA Series1,2

• JenaValve TA has a self-positioning geometry and specific fixation mechanism which might be more suited to this anatomy

• Two series represent the majority of published experience with JenaValve TA in pure AR

• This is the only TAVI device which is CE marked for treatment of pure AR

JenaValve TA Series1,2

• As with CoreValve, early mortality was high

• The JenaValve design effectively eliminated PVL and the need for a second valve, which led to high device success

Study Outcomes

Device Success

2nd ValveConversion

to SAVR30-Day

MortalityModerate / Severe PVL

Permanent Pacemaker

Schlingloff1 NR 0% 0% 30% 0% NR

Seiffert2 96.8% 3.2% 0% 12.9% 0% 6.4%

1Schlingloff, et al., Interact Cardiovasc Thorac Surg 2014; 19:388-93; 2Seiffert, et. al. , J Am Coll Cardiol Intv 2014; 7: 1168-74

• Self-expanding Nitinol frame

• Porcine aortic valve

• Clasper—independently operated 3D ring that corresponds to the native sinuses, orients the valve stent, and captures the native leaflets

• Annular range: 19 – 27 mm

• 4 valve sizes: 21, 23,25, and 27 mm

• 27Fr sheathless transapical delivery catheter

J-Valve Design Features

1Zhu, et. al. , J Am Coll Cardiol 2016; 67: 2803-5

Study Baseline Characteristics

N Age (yrs) Log EuroSCORE (%) % MaleAnnulus Diameter

(mm)Ascending Aortic Diameter (mm)

Zhu1 33 74.2 24.4% 79% 25.2 ± 1.1 39.5 ± 4.9

J-Valve Series1

• The J-Valve is another transapical system with active fixation and a flexible connection between the anchor and the valve stent

• Outcomes in a series of 33 patients with pure AR were recently described• Only one death occurred in this series of high risk patients. This patient had developed moderate PVL post procedure and died of

congestive heart failure on day 20.

• The results are very encouraging with high procedural success.

Study Outcomes

Device Success

2nd ValveConversion to

SAVR30-Day Mortality

Moderate / Severe PVL

Permanent Pacemaker

Zhu1 94% 0% 3% 3% 3% 6.1%

Clinical Case N°2• 78 y.o STS: 8,5• Heart Failure• Degenerative Cerebral Disease (Mild to moderate)• Hypertension • Chronic Alcoholism• Echocardiogram:

– Severe Aortic Insufficiency IV/IV– EF: 35%

• Creatinine: 2.0

Aortic Regurgitation

18 19 20 21 22 23 24 25 26 27 28 29 30

56.5 62.8 72.3 81.7 94.2

23 mm 26 mm 29 mm 34 mm

Diameter (mm)

Perimeter (mm) †

Evolut R System

Aortic Regurgitation

Angulo: 61°

No PPM PPM 130

PPM 150

Critical moment to release the device

Second Attempt

Third AttemptOscillatory Movements of the Device

Aumento de PPM a 170 lpm

Mantaining PPMEven after last 1/3 of reléase PPM

170

Final Result

Challenges in treatment of non-calcified AR

Insufficient anchoring

Dislocation / embolisation

Residual AR

Annular rupture

Concomitant aortic dilation

Large annuli

PHASES FOR DEVICE RELEASE

First Phase: Absence of Displacement, Peacemaker not needed (stable system).

No PPM PPM 130

First Phase: Should start peacemaker at 130 to 150 bpm.

BPM 150

Critical moment to release the

device

Second phase: Even with PPM 150 BPM the system hasn’t achieved annular contact with the annular

system, you can tell by the movement. Displacement should be avoided and Increase pacing at 170-180 BPM.

Third Phase: SPIN OFF Movement. At no-Recapture point the valve is still out of adequate

contact, and is still bound to migrate unless we increase the pulse rate. (BPM 160-180)

Fourth phase: No movement, achieved at rates between 180 - 200 BPM.

Ventricular Migration of Prosthesis This phase should always be done under pacing and fluoroscopy visualization, and slowly decrease rate without stopping abruptly to avoid this:

KEY POINTS:• Once at the No-Recapture point (pre-release) and

recovery of PA continue drive with pacemaker. (DO NOTSUSPEND ABRUPTLY THE DRIVE WITH PACEMAKERSIN THE FINAL PHASE OF LIBERATION).

• Gradual decrease of heart rate under fluoroscopyvisualization.

• Rapid reduction or suspension of the drive withpacemaker implies risk of dislocation of the device dueto increased preload.

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. Sung-Han Yoon. DEC 2017

Outcomes According to Devices

Mortality and Post-

Procedural Aortic Regurgitation

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. Sung-Han Yoon. DEC 2017

According to Individual Devices

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. Sung-Han Yoon. DEC 2017

All cause mortality predictors

STS Score

LVEF < 45%Mitral Regurgitation > Moderate at baseline

POST-PROCEDURAL AORTIC REGURGITATION > MODERATE

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. Sung-Han Yoon. DEC 2017

NON or MILD Calcification:The mayority have no valvecalcification but it didhihger mortality during theprocedure, conversión tosurgery and need for asecond valve implatation.

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. Sung-Han Yoon. DEC 2017

Predictors of ComplicationsEarly Vs Late Experience

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. Sung-Han Yoon. DEC 2017

Predictors of ComplicationsEarly Vs Late Experience

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. Sung-Han Yoon. DEC 2017

CASE 3.M, 75YO.

W: 75KG, H 172CMS, STS: 6,2% RISK.

5 months of functional class deterioration NYHA III.

ECHO:

– LVEF 53%, AV: SEVERE INSUFFICIENCY, CV:7mm. SPP:50mmHg.

– MV: Moderate Insufficiency.

CORONARY ARTERIOGRAPHY

– No coronary artery disease

– LVEF 50%

– AV: Severe Regurgitation IV/IV

CT:

– LVEF 49%, Diameter Min: 23,6mm Max. 28,7mm. Perimeter 86,5mm

ECHO

DIAGNOSTIC ANGIOGRAPHY

CORONARY

CT

Angle: 86°

AREA: 440mm

Perimeter: 835mmArea: 545mm

DIAMETER: 15,4 cms2,89 cms

PROCEDURE

WIRE IN HORIZONTAL PLANE, NOT BELLY UP.

PROCEDURE

PROCEDURE

PRELIMINARY RESULTS

• Symptoms:• Dyspnea 15 (68%)• Chest pain/angina in 10 (45%)• Presyncope in 3 (14%)• Palpitations in 2 (9%)• Syncope in 1 (4.6%)

• The mechanisms of aortic regurgitation were unclear in most patients (18, 82%), out of which 6 (27%) had mild to moderate calcific deposits in the valve cusps,

• 3 Patients (14%) had prolapse of one of more cusps

• 9 (41%) had significant valve thickening with associated cusp restriction.

• Two (9%) had bicuspid valves, one (4.6%

TABLE BASELINE CHARACTERISTICS

+ 34 (X2)

PRELIMINARY RESULTS

PRELIMINARY RESULTS

PRELIMINARY RESULTS

0

5

10

15

20

25

30

35

5 10 15 20 25 30

Mortalidad

PRELIMINARY RESULTS

Gender: Male

Age: 72 y.o.

Weight: 74 kg

Height: 1.68 mts

Medical History: Severe Aortic Regurgitation

LV disfunction

HT

COPD

DM2

PPM 2016

Clinical Case N°4

Coronary Angiography, Ventriculogram and Aortogram

Valve Deformation During Snare

CONCLUSIONS: In the general cohort, the TAVR for NAVR is associatedwith high rates of complications during the procedure.

However, new generation devices (NGD) wereassociated with better procedure results:

• Lower rate of second valve implant• Aortic insufficiency less to moderate post-

procedure

• Post-procedure aortic insufficiency greater thanmoderate was associated with increased mortalityfrom all causes, late mortality and re-hospitalizations.

• The accumulated experience and the technology of thedevice have allowed to increase the OFF LABEL use ofthe TAVR for the aortic valve disease.

CONCLUSIONS: