TAVI, TMVI, TEVAR, EVAR: The end of standard Cardiovascular Surgery? Perspectives of a Cardiac Surgeon

Daniel Fink MDDept. of Cardiothoracic SurgeryShaare Zedek Medical Center

Jerusalem, Israel

Disclosures

Just a plain Cardiothoracic Surgeon

KISS Principle( keep it simple s…..)

I have no conflicts of interest

Historical Background

Traditional Aortic Valve Replacement and Open Thoracoabdominal Aneurym Repair are well established and long standing therapies.

Both procedures have excellent long term effects with acceptable risk factors.Operative risk is affected by both age and comorbidies( EUROSCORE, STS score).

With increase in aged and sicker population CONVENTIONAL SURGERY is being avoided!!!

WHAT DO WE DO???

Development of lesser invasive therapies!!

Catheter based Valve implantation

Endovascular Stent Implantation

Transcatheter Valve

Endovascular Stent Grafting

TEVAR

Benefits of TAVI

Excellent Hemodynamic- low transvalvulargradients!!!!

Percutaneous

Multiple Applications- “ Valve in Valve”; Calcified MV – native??; Trans Apical & Aortic

Drawbacks

Paravalvular Leak

Pacemaker Requirement

Non suitability in BAV

COST!!!!!!!!!!

DURABILITY??????

Two-Year Outcomes in Patients With Severe Aortic

Valve Stenosis Randomized to Transcatheter Versus

Surgical Aortic Valve Replacement

by Lars Søndergaard, Daniel Andreas Steinbrüchel, Nikolaj Ihlemann, Henrik

Nissen, Bo Juel Kjeldsen, Petur Petursson, Anh Thuc Ngo, Niels Thue

Olsen, Yanping Chang, Olaf Walter Franzen, Thomas Engstrøm, Peter

Clemmensen, Peter Skov Olsen, and Hans Gustav Hørsted Thyregod

Circ Cardiovasc Interv

Volume 9(6):e003665

June 13, 2016

Copyright © American Heart Association, Inc. All rights reserved.

Kaplan–Meier curves depicting (A) a composite rate of all-cause mortality, all stroke,

and myocardial infarction (MI); (B) all-cause mortality; (C) composite rate of all-cause

mortality, all stroke, and MI in transcatheter aortic valve replacement (TAVR) and

surgical aortic valve replacement (SAVR) patients with Society of Thoracic Surgeons

Predicted Risk of Mortality (STS-PROM) <4%; and (D) composite rate of all-cause

mortality, stroke, and MI in TAVR and SAVR patients with STS-PROM ≥4%.

Lars Søndergaard et al. Circ Cardiovasc Interv.

2016;9:e003665

Copyright © American Heart Association, Inc. All rights reserved.

Date of download: 9/7/2016 Copyright © The American College of Cardiology. All rights reserved.

From: Transcatheter Aortic Valve Replacement in Europe: Adoption Trends and

Factors Influencing Device Utilization

J Am Coll Cardiol. 2013;62(3):210-219. doi:10.1016/j.jacc.2013.03.074

TAVR Adoption in Europe

(A) Cumulative transcatheter aortic value replacement (TAVR) implants in 11 Western European

nations between 2007 and 2011. (B) TAVR implants per annum and percentage annual increase

(solid line).

Figure Legend:

Date of download: 9/7/2016 Copyright © The American College of Cardiology. All rights reserved.

From: Transcatheter Aortic Valve Replacement in Europe: Adoption Trends and

Factors Influencing Device Utilization

J Am Coll Cardiol. 2013;62(3):210-219. doi:10.1016/j.jacc.2013.03.074

TAVR Implants per Million Population in the Study Nations

TAVR implant dynamics in the study nations between 2007 and 2011. (A) TAVR implants per million

population. (B) TAVR implants per million population age ≥75 years. Broken line represents mean.

Abbreviation as in Figure 1.

Figure Legend:

TAVI vs. sAVR in Israel 2015

0

200

400

600

800

1000

2015

Cas

es

surgical AVR

TAVI

Cost per case:sAVR 15,480 €TAVI 48,000 €

Number of procedures

0

10

20

30

40

50

60

70

80

2011 2012 2013 2014 2015

surgical AVR TAVI

(%) Operative Mortality

0

5

10

15

20

25

2011 2012 2013 2014 2015

surgical AVR

TAVI

Is this the end of sAVR?

Figure 2. University of Alabama at Birmingham isolated aortic valve replacement volume from 2009 through 2014. SAVR, surgical

aortic valve replacement; TAVR, transcatheter aortic valve replacement.

James E. Davies Jr., William W. McAlexander, Mark F. Sasse, Massoud A. Leesar, Spencer J. Melby, Satinder P. Singh, Lindsey

B. Jernigan, Oscar J. Booker, Oluseun O. Alli

Impact of Transcatheter Aortic Valve Replacement on Surgical Volumes and Outcomes in a Tertiary Academic Cardiac

Surgical Practice

Journal of the American College of Surgeons, Volume 222, Issue 4, 2016, 645–655

http://dx.doi.org/10.1016/j.jamcollsurg.2015.12.054

sAVR in Transcatheter Era

Sutureless Tissue Valves

Benefits of Sutureless Valves

Excellent Hemodynamics

Easy Deployment

Minimally Invasive Technique

Short CPB

Durability?

Costs- lower than TAVI

BEST OF ALL WORLDS

Minimally Invasive Aortic Valve Replacement( MIAVR)

ENDOVASCULAR REPAIR- Advantages

Minimally Invasive

Less Morbidity & Complications

LOS

Disadvantages

Suitabilty- Proper Landing Zones; CTD

Endoleaks

Migration & Graft Collapse

Durability ?

Fenestrated/Branched Thoracic Endovascular Aneurysm Repair

Author, Year

Number of Patients

Mortality

Paraplegia and Paraparesis

Renal Failure

Technical Success

Endoleak Re-Intervention

Roselli2007

73 5.5 2.7 1.4 93 18 29

Haulon2009

33 9 15 9 - 15 3

Verhoeven2009

30 6.7 16.7 3.2 93 - 6.7

Guillou2012

89 10 7.8 6.7 96.6 21 4.2

Kitagawa 2013

30 0 0 0 100 66.7 33.3

Oikonomou 2014

31 9.6 12.9 3.2 93.5 38.7 32.3

Open Repair of ThoracoabdominalAneurysms

Author, Year Number of Patients

Extent 1 and 2

Mortality Paraplegia and

Paraparesis

Renal Failure

Svennson1993

1,509 54.3 8.3 15.5 17.8

Safi 2003 1,004 41.6 14 3.6 NA

Coselli 2007 2,286 64.2 5 3.8 5.6

Acher 2008 637 37.9 2.7 5.5 2.6

Girardi 2015 675 48.5 5.6 2.8 5.2

Endovascular Repair-Recommendations

Acute Complicated Type B Aortic Dissection

Blunt Traumatic Aortic Injury

Penetrating Aortic Ulcers

Ruptured Descending Thoracic or TAA- high risk

Avoid

CTD

Mycotic Aneurysms

Infected Grafts

Aortic Fistulae

Ascending Aorta & Arch???? / Type A Dissections ?

HYBRID

www.escardio.org/guidelines

Class Level

TAVIshouldonlybeundertakenwithamultidisciplinary“heartteam”including

cardiologistsandcardiacsurgeonsandotherspecialistsifnecessary.I C

TAVIshouldonlybeperformedinhospitalswithcardiacsurgeryon-site. I C

TAVIisindicatedinpatientswithseveresymptomaticASwhoarenotsuitablefor

AVRasassessedbya“heartteam”andwhoarelikelytogainimprovementintheir

qualityoflifeandtohavealifeexpectancyofmorethan1yearafterconsideration

oftheircomorbidities.

I B

TAVIshouldbeconsideredinhighriskpatientswithseveresymptomaticASwho

maystillbesuitableforsurgery,butinwhomTAVIisfavouredbya“heartteam”

basedontheindividualriskprofileandanatomicsuitability.

IIa B

www.escardio.org/guidelines

Indications fortranscatheter aortic valve implantation

doi:10.1093/ejcts/ezs455).

« In the absence of a perfect quantitative score, the risk assessment

should mostly rely on the clinical judgement of the ‘heart team’, in addition

to the combination of scores. »

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs109 &European Journal of Cardio-Thoracic Surgery 2012 -

www.escardio.org/guidelines

High Surgical Risk?Decision between TAVI and AVR?

EuroScore ≥ 20%

STS score > 10%

Fraility

Chest radiation

Porcelain aorta

Re-operation

Conclusions

TVR, TEVAR, EVAR- established and effective therapies

Indications, Durability, Costs are evolving issues that need further studies.Designated Multidisciplinary Heart & Aortic Team are probably the most effective tool to develop the future applications of these technologies and establishing practice guidelines.RCT and “real life” registries are essential to determine long term resultsExtension of TVR to other Heart Valves is still unknown

CONCLUSIONS

Sutureless Valves and Minimally Invasive Surgery is a promising evolving option that may further extend the pool of patients for Surgical Valve Replacement

Hybrid approaches, Improved Stent Graft Technologies ( Branched Grafts) may be the future!!

SURGEONS MUST MASTER CATHETER BASED SKILLS!!!( “cath or perish”!!!)

THANK YOU!