Dr. Nithin P G

Transcatheter Aortic Valve Intervention

3rd April 2012

Dr Nithin P G

Dr. Nithin P G

Overview

• Introduction

• Procedure– Indications & Pre-procedural work up – Procedure & Hardware – Post-op care, Complications & Management– Review of evidence

• Conclusions

Dr. Nithin P G

Introduction

AVR

High risk for surgery

Complications

30-40% do not undergo Sx•Advanced age•LV dysfunction•Multiple co-morbidities•Pt. preference•Physician assessment

“Symptomatic Severe Aortic Stenosis” Prohibitive risk

Inoperability

•~3% mortality (STS, EuroSCORE)•~2% Stroke•~11% prolonged ventilation•Organ failure•Thromboembolic Complications•Bleeding•Prosthetic valve Dysfunction

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Introduction

Alternatives

• Balloon Aortic Valvuloplasty– Palliation – Bridge to AVR

• Medical management

• TAVI

Dr. Nithin P G

Transcatheter Aortic Valve Intervention

Indications & Pre-procedural work up

Dr. Nithin P G

Indications

• A Symptomatic severe calcific Aortic Stenosis [trileaflet] who have aortic and vascular anatomy suitable for TAVR and a predicted survival >12 months, and who have a prohibitive surgical risk as defined by an estimated 50% or greater risk of mortality or irreversible morbidity at 30 days or other factors such as frailty, prior radiation therapy, porcelain aorta, and severe hepatic or pulmonary disease.

• TAVR is a reasonable alternative to surgical AVR in patients at high surgical risk (PARTNER Trial Criteria: STS >8)

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Indications

Patient selection in clinical trials

Logistic EuroSCORE >20% or STS Score > 10.

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Indications

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Requisites

• ‘Heart team’ approach– Specific team leader– Close communication– ‘Preplanning procedure’

• Large cathlabs/ ‘hybrid’ rooms– Fluoroscopic imaging– TEE capabilities– GA/ CPB– Vascular intervention – Urgent AVR, CABG, Vascular

complications

• Anesthesia– Conscious sedation/ GA– CPB facility– Hemodynamic monitoring

and management

Dr. Nithin P G

Work up

• Pre-anesthetic work up

• Cardiothoracic evaluation [access, AVR, risk assessment]

• Imaging– AS severity, morphology, calcification, annular size and shape– Aortic root, annulus to coronary ostia (>8mm), Atheroma burden,

calcification– Other valvular disease, sub aortic obstruction– LV function– Vascular anatomy from access site to annulus– Cerebro vascular imaging

Dr. Nithin P G

Work up

Role of imaging in pre-procedural and post procedural assessment

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Transcatheter Aortic Valve Intervention

Procedure & Hardware

Dr. Nithin P G

Procedure & Hardware

• LA + Conscious sedation/ GA, hemodynamic stability [ SBP~120 mm Hg / MAP >75 mm Hg]

• Vascular access– Sites

• Transfemoral• Transapical

– Left ant. thoracotomy– More direct, shorter catheter– Septal hypertrophy– Ascendra2, Sapien valve

• Transaortic – Upper partial sternotomy– Mini-sternotomy 2/3 RICS– Aorta 5 cm above valve– Less painful, familiar approach– Manipulation of ascending aorta

• Subclavian

Percutaneous or Cut-down technique

J. Am. Coll. Cardiol. 2012;59;1200-1254Modified from www.edwards.comwww.edwards.com

Dr. Nithin P G

Procedure & Hardware

• Pacing leads – Trans venous or epicardial• Anticoagulation

– Large sheaths – Heparin [ACT>300]

• Intra-procedural TEE– Guidewire placement– Valve placement

• Stable position• No coronary obstruction• No interference with mitral valve function• No conduction system impingement• No overhanging native aortic leaflets• Avoidance of aortic root complications (rupture & dissection)

– Post deployment assessment [MR, AR]

TEE- Mid esophageal long axis view

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Procedure & Hardware

Balloon Aortic Valvotomy• Prepping and draping Anesthesia Diagnostic arterial access: C/L FA

access with 6F sheath pigtail catheter for C/L iliofemoral angiography, location of puncture marked

• Femoral vein access: I/L to diagnostic access with 7F sheath, for RHC and pacing leads

• Therapeutic arterial access: Percutaneous puncture/surgical preparation standard diagnostic J 0.035 Guidewire +14F long (24 cm) sheath, heparin

• Valve crossing: AL1 into ascending aorta exchanged with straight tip 0.035 Guidewire to cross AV AL1 into LV & wire exchanged with Amplatz extrastiff 0.035, 260 cm length Guidewire

BAV Valve implantation

MMCTS.2007.003077

Dr. Nithin P G

Procedure & Hardware

• Balloon aortic valvuloplasty: 20x30 mm (for # 23) or 23x30 mm (for #

26)Appropriate angiographic projection in line with the plane of annulus

[LAO200/Cran200] midpoint of balloon at the annular level PACE

INFLATE CHECK DEFLATE stop pacing

• Balloon aortic valvuloplasty videoMMCTS.2007.003077

Dr. Nithin P G

Procedure & Hardware‘Sapien XT’ device ‘CoreValve’ device

Self expandable Nitinol frame

Porcine Pericardial Tissue

European Heart Journal (2011) 32, 140–147

Cardiol Clin 29 (2011) 211–222

•Superior hemodynamics•Lower risk for PPM

Dr. Nithin P G

Procedure & Hardware

CrimperDilator set Inflation device

www.edwards.com

Dr. Nithin P G

Procedure & Hardware

•‘Sapien’ Deployment video

•‘Sapien XT’ video

•‘CoreValve’ Deployment video

www.edwards.com

Dr. Nithin P G

Procedure & Hardware

Pressure tracings before and after TAVR

European Heart Journal (2011) 32, 140–147

Dr. Nithin P G

Procedure & Hardware

‘Sapien’ device • Balloon deployment• Transapical

deployment also• Leaflets in open

mode, more chance for AR

‘CoreValve’ device• Partially repositionable• Larger annular size• Higher chance for CHB

‘Sapien XT’ device • Lesser calcification

[reduction of 98% calcium binding sites]

• Shorter stent size• More radial strength grater

durability• More closed form, less

chance for AR

www.edwards.com www.medtronic.com

Dr. Nithin P G

Procedure & Hardware

European Heart Journal (2011) 32, 140–147

Dr. Nithin P G

Procedure & Hardware

Device success

– Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system

– Correct position of the device in the proper anatomical location

– Intended performance of the prosthetic heart valve (AVA >1.2 cm2 and mean AV gradient < 20 mm Hg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR)

– Only 1 valve implanted in the proper anatomical location

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Transcatheter Aortic Valve Intervention

Post-op care, Complications & Mx

Dr. Nithin P G

Post-Operative Care & Monitoring

• Immediate or early extubation, early mobilization

• Adequate analgesia, control postoperative hypertension, monitor for any bleed

• Monitor vital parameters including fluid balance, renal status, and AV conduction system.

• Pre-discharge TTE, DAPT

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Complications & Management

Dr. Nithin P G

Complications & Management

Left main stem compromise with semi-occlusive displacement of calcified nodule from aortic valve.Treated with CPB device explantation AVRAlso PCI/CABG

Cardiol Clin 29 (2011) 211–222J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Complications & Management

• Incidence of CHB requiring permanent pacemaker implantation has been higher with the CoreValve (19.2% to 42.5%) than with the Sapien valve (1.8% to 8.5%) [larger profile and extension low into the LVOT

• Occurrence of CHB/LBBB– BAV 46%– Balloon/prosthesis positioning &wire-crossing of the aortic valve 25%– Prosthesis expansion 29%.

• Pre-existing RBBB risk factor for CHB

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Complications & Management Aortic Regurgitation

•Typically paravalvular mild or mild-moderate severity•Most of AR disappears or reduces at 1 yr follow-up [13% absent, 80% mild AR]

J. Am. Coll. Cardiol. 2012;59;1200-1254Cardiol Clin 29 (2011) 211–222

Dr. Nithin P G

Complications & Management

Paravalvular AR

Central valvular AR

Post-deployment balloon dilation, rapid RV pacing for stabilization, ‘valve in valve’ implantation

Usually self-limited, Gentle probing of leaflets with a soft wire or catheterDelivery of a 2nd TAVR device, ‘valve in valve’

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Complications & Management Rapid Pacing for stabilization

‘Valve in Valve’ Implantation

Reduction of diastole

Cardiol Clin 29 (2011) 211–222

Dr. Nithin P G

Complications & Management

Causes of hypotension after TAVI

•Vascular complications—iliac rupture

•Ventricular rupture

•Acute valve dysfunction

•Coronary artery obstruction

•Multiple rapid pacing episodes in pts with poor LV function

•‘Suicidal’ LV in severe LVH [After removing AV obstruction LV decompresses to such an extent that the subvalvular hypertrophy obstructs outflow] treated with fluids & avoiding diuretics

Cardiol Clin 29 (2011) 211–222J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Complications & Management

Significant annular ruptureVentricular perforation

•Pericardial drainage, auto-transfusion •Conversion to open surgical closure

Device malposition

Device embolization

Overlapping ‘valve in valve’

Urgent endovascular/ surgical management

Major ischemic stroke

Minor ischemic stroke

Hemorrhagic stroke

Catheter-based, mechanical embolic retrieval

Aspirin, anticoagulants

Anticoagulation reversal, coagulopathy correction

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Complications & Management

Atrial fibrillationRate control/ rhythm control via pharmacological or electrical cardioversion

Shock, low cardiac outputMajor bleedingVascular complications

•Careful systemic pressure management, inotropic support, IABP, or CPB•Hemodynamic support, blood transfusion•Urgent endovascular repair/surgery

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Transcatheter Aortic Valve Intervention

Review of evidence

Dr. Nithin P G

Review of Evidence

Registry data

•Age> 80 years

•EuroSCORE [> 23 ‘Sapien’, >16 ‘CoreValve’]

•Route of implantation no difference in procedural success rate b/w TF & TA accesses

•Major bleeding more in TA vs. more vascular complications in TF

J. Am. Coll. Cardiol. 2012;59;1200-1254

Dr. Nithin P G

Review of EvidencePARTNER Trial Design

Cohort A84 yrsN=699

Cohort B83 yrsN=358

J. Am. Coll. Cardiol. 2012;59;1200-1254www.nejm.org

Dr. Nithin P G

Conclusion

• Evolving field, may be used in lower risk patients, bicuspid AoV

• ‘Criteria to screen eligible patients’ dynamic

• With refinement in procedures and newer improved hardware may become an attractive alternative to AVR, repeat procedure possible

• However for Severe symptomatic AS with low risk for surgery, AVR Sx remains the standard treatment

Dr. Nithin P G

Thank You

Dr. Nithin P G

MCQ’s

1. Which of the following is not a contraindication for TAVI?

a) Expected survival >12 months

b) Severe PAH

c) Severe aortic disease

d) LVEF<20%

Dr. Nithin P G

MCQ’s

2. Best investigation for planning the precise coaxial alignment of the stent-valve along the centerline of the aortic valve and aortic root

a) TEE

b) Angiography

c) CMR

d) MDCT

Dr. Nithin P G

MCQ’s

3. Preferred access route in case of septal hypertrophy?

a) Transfemoral

b) Transapical

c) Transaortic

d) Subclavian

Dr. Nithin P G

MCQ’s

4. TAVR using ‘CoreValve’ device is not done via

a) Transfemoral

b) Transapical

c) Transaortic

d) Subclavian

Dr. Nithin P G

MCQ’s

5. Advantages of Sapien XT include all except-

a) Lesser calcification

b) Longer stent size

c) More radial strength

d) Lesser risk for AR

Dr. Nithin P G

MCQ’s

6. ‘Device success’ is not achieved if

a) AVA =1.2 cm2

b) mean AV gradient= 30 mm Hg

c) peak velocity =2.75 m/s

d) mild prosthetic valve AR

Dr. Nithin P G

MCQ’s

7. Patient undergoes transfemoral TAVI with ‘Sapien’ valve, immediate post procedure angio noticed to have moderate AR, SBP-100 mm Hg; first response would be

a) Rapid RV Pacing

b) Gentle probing with catheter

c) Prepare for urgent AVR

d) IABP

Dr. Nithin P G

MCQ’s

8. Patient undergoes successful transfemoral TAVR with ‘CoreValve’ device, immediate post procedure angio & TTE good device position and function, after sheath removal and shifting to ICU pt goes into shock, most likely cause

a) RV pacing induced VF

b) Vascular complications

c) Device malposition

d) Moderate AR

Dr. Nithin P G

MCQ’s

9. For TAVR optimum annulus to coronary artery distance should be

a) >4mm

b) >5mm

c) >8mm

d) >10mm

Dr. Nithin P G

MCQ’s

10. After uncomplicated TAVR routine post-op care and discharge advice does not include

a) Early extubation and ambulation

b) Control of Post-op hypertension

c) Pre-discharge TTE

d) OAC

Dr. Nithin P G

MCQ’s

11. Which is false regarding TAVI

a) PPM is less likely compared to surgical bioprosthesis

b) ‘Valve in valve’ implantation is an acceptable option in patients with high risk for surgical AVR and post procedural moderate AR

c) AR after TAVR is usually paravalvular

d) Patients with post procedural AR at 1 year follow up 90% of pts show a gradual increase in severity