cardiopatía estructural. - dr. josé maría hernández

TAVIFOP INSUFICIENCIA MITRALDENERVACIÓN RENAL

NOVEDADES EN CARDIOPATIA ESTRUCTURALJosé María HernándezHospital Universitario Virgen de la Victoria.Málaga

TAVIFOP INSUFICIENCIA MITRALDENERVACIÓN RENALDENERVACIÓN RENAL


Efecto placebo al ser incluido y mayor adherenciaa la medicación

Porcentaje mayor de antialdosterónicos

Sesgo en estudios previos al conocerse el grupoasignado

¿Efectiva sólo en hiperactividad simpática?

Catéter monopolar

DENERVACIÓN RENAL

TAVIFOP INSUFICIENCIA MITRALDENERVACIÓN RENAL FOP

TAVIFOP INSUFICIENCIA MITRALDENERVACIÓN RENAL INSUFIENCIA MITRAL


Final Results of the EVEREST II Randomized Controlled Trial of Percutaneous and Surgical

Reduction of Mitral Regurgitation

Ted Feldman, MD, FACC, FESC, FSCAI on behalf of the EVEREST II Investigators

ACC 2014 Washington, DC

PML04247 Rev. A

Kaplan-Meier Freedom From Mortality EVEREST II RCT

Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years

MitraClip # At Risk 178 165 158 154 143 133 119 58

Surgery # At Risk 80 76 70 70 65 57 52 24

93.7% 92.3% 1 year

81.2% 79.0% 5 years

MitraClip (N=178)

Surgery (N=80)

PML04247 Rev. A

Kaplan-Meier Freedom From Mortality EVEREST II RCT



Surgery # At Risk 80 76 70 70 65 57 52 24

93.7% 92.3% 1 year

81.2% 79.0% 5 years

MitraClip (N=178)

Surgery (N=80)

PML04247 Rev. A

INSUFIENCIA MITRAL




Surgery # At Risk 80 75 69 68 63 54 49 21

78.9% 97.4% 1 year 74.3%

92.5% 5 years

MitraClip (N=178)

Surgery (N=80)

Kaplan-Meier Freedom From MV Surgery in MitraClip Group or Re-operation in Surgery Group

EVEREST II RCT

PML04247 Rev. A



Surgery # At Risk 80 75 69 68 63 54 49 21

78.9% 97.4% 1 year 74.3%

92.5% 5 years

MitraClip (N=178)

Surgery (N=80)

Kaplan-Meier Freedom From MV Surgery in MitraClip Group or Re-operation in Surgery Group

EVEREST II RCT

PML04247 Rev. A





PML04247 Rev. A

INSUFIENCIA MITRAL






PML04247 Rev. A

Mitral Regurgitation Grade EVEREST II RCT All Treated Patients (N=258)

MitraClip (N=178)

2+

4+

3+

2+

1+

2+

0+ 0+ 2+

4+

3+

Surgery (N=80)

2+

4+

3+

3+ 3+

2+

2+

1+ 1+

4+

3+

81% 82%

Baseline 1 Year

0+

Baseline 1 Year

99% 98%

1+

N=149

Baseline 5 Years

N=106

p < 0.005 p < 0.005 p < 0.005 p < 0.005

N=66 Baseline 5 Years

N=41

N = survivors with paired data; p-values for descriptive purposes only PML04247 Rev. A Mitral Regurgitation Grade

EVEREST II RCT All Treated Patients (N=258)

MitraClip (N=178)

2+

4+

3+

2+

1+

2+

0+ 0+ 2+

4+

3+

Surgery (N=80)

2+

4+

3+

3+ 3+

2+

2+

1+ 1+

4+

3+

81% 82%

Baseline 1 Year

0+

Baseline 1 Year

99% 98%

1+

N=149

Baseline 5 Years

N=106

p < 0.005 p < 0.005 p < 0.005 p < 0.005

N=66

Baseline 5 Years N=41

N = survivors with paired data; p-values for descriptive purposes only PML04247 Rev. A

INSUFIENCIA MITRAL






PML04247 Rev. A

NYHA Functional Class EVEREST II RCT All Treated Patients (N=258)

MitraClip (N=178) NYHA I/II at 1 and 5 Years

I I

I V

I I I

I I I

I I

I I

I I

I I

I V

I I I

Surgery (N=80) NYHA I/II at 1 and 5 Years

I I

I V

I I I

I I I

I I

I I

I

I

I I

I V

I I I

98% 91% 88% 98%

I I I I

p < 0.005 p < 0.005 p < 0.005 p < 0.005

Baseline 1 Year

N=151

Baseline 5 Years

N=106

Baseline 1 Year

N=66 Baseline 5 Years

N=42

N = survivors with paired data; p-values for descriptive purposes only PML04247 Rev. A NYHA Functional Class

EVEREST II RCT All Treated Patients (N=258)

MitraClip (N=178) NYHA I/II at 1 and 5 Years

I I

I V

I I I

I I I

I I

I I

I

I

I I

I V

I I I

Surgery (N=80) NYHA I/II at 1 and 5 Years

I I

I V

I I I

I I I

I I

I I

I

I

I I

I V

I I I

98% 91% 88% 98%

I I I I

p < 0.005 p < 0.005 p < 0.005 p < 0.005

Baseline 1 Year

N=151

Baseline 5 Years

N=106

Baseline 1 Year

N=66

Baseline 5 Years N=42

N = survivors with paired data; p-values for descriptive purposes only PML04247 Rev. A

INSUFIENCIA MITRAL


85,4% INSUFICIENCIA MITRAL FUNCIONAL


61% UN CLIP, 35% DOS CLIPS , 4% 3 ó 4 CLIPS

TAVIFOP INSUFICIENCIA MITRALDENERVACIÓN RENAL TAVI


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CLIN ICAL RESEARCH

The German Aort ic Valve Registry

(GARY): in-hospital outcome

Chr ist ian W . Hamm*, Helge Mollmann, David Holzhey, AndreasBeckmann,

Chr istof Veit , Hans-Reiner Figulla, J. Cremer, Kar l-Heinz Kuck, Rudiger Lange,

Ralf Zahn, Stefan Sack, Gerhard Schuler , ThomasW alther , Fr iedhelm Beyersdor f,

Michael Bohm, Gerd Heusch, Anne-Kathr in Funkat , ThomasMeinertz, Till Neumann,

Konstant inosPapoutsis, Steffen Schneider , Armin W elz, and Fr iedr ich W . Mohr, for the

GARY-Execut ive Board

Department of Cardiology, Medical Clinic I, Kerckhoff Heart and Thorax Center, University of Giessen, Benekestrasse. 2-8, Bad Nauheim 61231, Germany

Received 24 May2013; revised 5 August 2013;accepted 22 August 2013

Backgr ound Aorticstenosisisafrequent valvular diseaseespecially inelderlypatients.Catheter-basedvalveimplantationhasemerged

asavaluabletreatment approachfor thesepatientsbeingeither at veryhighrisk for conventional surgeryor evendeemed

inoperable.TheGerman Aortic ValveRegistry (GARY) providesdataonconventional and catheter-based aortic proce-

dureson an all-comersbasis.

Met hods and

r esult s

A total of 13 860consecutive patientsundergoingrepair for aortic valvedisease[conventional surgeryand transvascular

(TV) or transapical (TA) catheter-based techniques] havebeenenrolledinthisregistryduring2011andbaseline,proced-

ural,and outcomedatahavebeenacquired.Theregistrysummarizestheresultsof 6523 conventional aortic valverepla-

cementswithout (AVR) and3464withconcomitant coronarybypasssurgery (AVR+ CABG) aswell as2695TVAVIand

1181 TA interventions(TA AVI).Patientsundergoingcatheter-based techniquesweresignificantly older and had higher

risk profiles.Thestrokeratewaslow in all groupswith 1.3%(AVR),1.9%(AVR+ CABG),1.7%(TVAVI), and 2.3%(TA

AVI).Thein-hospital mortality was2.1%(AVR) and 4.5%(AVR+ CABG) for patientsundergoingconventional surgery,

and 5.1%(TVAVI) and AVI 7.7%(TA AVI).

Conclusion The in-hospital outcome resultsof thisregistry show that conventional surgery yieldsexcellent results in all risk groups

and that catheter-based aortic valve replacements is an alternative to conventional surgery in high risk and elderly

patients.- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Keywor ds Aortic stenosis † Surgery † Catheter-based valve replacement † GARY

Int roduct ion

Aortic stenosis is the most frequent type of valvular heart disease

in the Western Countries and presents mostly in an advanced age

as acalcific form. The prognosis is poor once the patient becomes

symptomatic. Surgical valve replacement isthe established standard

management, which alleviates symptoms and improves survival.1

Valvuloplasty of the stenosed valve hasbeen over many yearsapal-

liative option for the short term for highly selected, inoperable

patients. Recently, catheter-based valve implantations have

become an alternative for selected, particularly elderly

patients.2–4 Smaller, randomized studies confirmed acceptable

outcomesinhighriskand inoperablepatients5,6for thetransvascu-

lar (TV) aswell as the transapical (TA) approach when compared

*Correspondingauthor. Tel: + 49 60329962202, Fax: + 49 60329962313, Email: [email protected]

& The Author 2013. Published by Oxford University Presson behalf of the European Society of Cardiology.

This isan Open Access article distributed under the termsof the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which

permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work isproperly cited. For commercial re-use, please contact

[email protected]

European Heart Journal

doi:10.1093/eurheartj/eht381

European Heart Journal Advance Access published September 10, 2013

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CLIN ICAL RESEARCH






Michael Bohm, Gerd Heusch, Anne-Kathr in Funkat , Thomas Meinertz, Till Neumann,




Received 24 May2013; revised 5 August 2013; accepted 22 August 2013

Back gr ound Aorticstenosisisafrequent valvular diseaseespecially inelderlypatients.Catheter-basedvalveimplantationhasemerged


inoperable.TheGerman Aortic ValveRegistry (GARY) providesdataonconventional and catheter-based aortic proce-

dureson an all-comers basis.

Met hods and

r esult s

A total of 13 860consecutive patientsundergoingrepair for aorticvalvedisease [conventional surgery and transvascular

(TV) or transapical (TA) catheter-based techniques] havebeenenrolled inthisregistryduring2011andbaseline,proced-

ural,and outcomedatahavebeenacquired.Theregistrysummarizestheresultsof 6523conventional aortic valverepla-



risk profiles.The strokeratewaslow in all groupswith 1.3%(AVR),1.9%(AVR+ CABG), 1.7%(TVAVI), and 2.3%(TA

AVI).The in-hospital mortality was2.1%(AVR) and 4.5%(AVR+ CABG) for patientsundergoingconventional surgery,


Conclusion The in-hospital outcome resultsof thisregistry show that conventional surgery yieldsexcellent results in all risk groups



Int roduct ion




symptomatic. Surgical valve replacement is the established standard







outcomesinhighriskand inoperablepatients5,6for thetransvascu-

lar (TV) aswell as the transapical (TA) approach when compared


& The Author 2013. Published by Oxford University Press on behalf of the European Society of Cardiology.

This isan Open Access article distributed under the terms of the Creative CommonsAttribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which


[email protected]




at Biblioteca V

irtual del Sistem

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TAVI

.....................................................................................................................................................................................

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CLINICAL RESEARCH

The German Aortic Valve Registry


Christ ian W. Hamm*, Helge Mollmann, David Holzhey, AndreasBeckmann,

Christof Veit , Hans-Reiner Figulla, J. Cremer, Karl-Heinz Kuck, Rudiger Lange,

Ralf Zahn, Stefan Sack, Gerhard Schuler, ThomasWalther, Friedhelm Beyersdorf,

Michael Bohm, Gerd Heusch, Anne-Kathrin Funkat, ThomasMeinertz, Till Neumann,

KonstantinosPapoutsis,SteffenSchneider,Armin Welz,and FriedrichW.Mohr, for the

GARY-Executive Board

Department of Cardiology, Medical Clinic I, Kerckhoff Heart and Thorax Center, University of Giessen, Benekestrasse. 2-8, Bad Nauheim61231, Germany

Received24 May2013;revised 5 August 2013;accepted 22 August 2013

Background Aorticstenosisisafrequent valvular diseaseespeciallyinelderlypatients.Catheter-basedvalveimplantationhasemerged

asavaluabletreatment approachfor thesepatientsbeingeither at veryhighriskfor conventional surgeryor evendeemed

inoperable.TheGermanAorticValveRegistry (GARY) providesdataonconventional andcatheter-based aorticproce-

duresonanall-comersbasis.

Met hods and

result s

Atotal of13860consecutivepatientsundergoingrepair for aorticvalvedisease[conventional surgeryandtransvascular

(TV) or transapical (TA)catheter-based techniques] havebeenenrolledinthisregistryduring2011andbaseline,proced-

ural,andoutcomedatahavebeenacquired.Theregistrysummarizestheresultsof6523conventional aorticvalverepla-

cementswithout (AVR) and3464withconcomitant coronarybypasssurgery(AVR+ CABG) aswell as2695TVAVIand

1181TA interventions(TA AVI).Patientsundergoingcatheter-based techniquesweresignificantlyolder andhadhigher

risk profiles.Thestrokeratewaslow inall groupswith1.3%(AVR),1.9%(AVR+ CABG),1.7%(TVAVI),and2.3%(TA

AVI).Thein-hospital mortalitywas2.1%(AVR) and4.5%(AVR+ CABG) for patientsundergoingconventional surgery,


Conclusion Thein-hospital outcomeresultsof thisregistryshow that conventional surgery yieldsexcellent resultsinall risk groups


patients.- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Keywords Aortic stenosis † Surgery † Catheter-based valvereplacement † GARY

Introduction


in the Western Countriesand presents mostly in an advanced age

asacalcific form. The prognosis ispoor once the patient becomes

symptomatic.Surgical valve replacement istheestablished standard


Valvuloplastyof thestenosed valvehasbeen over manyyearsapal-





outcomesinhighriskandinoperablepatients5,6for thetransvascu-

lar (TV) aswell asthe transapical (TA) approach when compared


& TheAuthor 2013.Published byOxford University Pressonbehalf of theEuropean Societyof Cardiology.

Thisisan Open Accessarticle distributed under the termsof theCreativeCommonsAttribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which

permitsnon-commercial re-use, distribution, and reproduction inany medium, provided theoriginal work isproperly cited. For commercial re-use, pleasecontact

[email protected]




at B

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.....................................................................................................................................................................................

.....................................................................................................................................................................................

CLINICAL RESEARCH






Michael Bohm, Gerd Heusch, Anne-Kathr in Funkat , ThomasMeinertz, Till Neumann,




Received 24 May2013; revised 5 August 2013;accepted 22 August 2013

Backgr ound Aorticstenosisisafrequent valvular diseaseespecially inelderlypatients.Catheter-basedvalveimplantationhasemerged


inoperable.TheGerman AorticValveRegistry (GARY) providesdataonconventional andcatheter-based aorticproce-

dureson an all-comersbasis.

Met hods and

r esult s

A total of 13 860consecutivepatientsundergoingrepair for aortic valvedisease[conventional surgery and transvascular

(TV) or transapical (TA) catheter-based techniques] havebeenenrolledinthisregistryduring2011andbaseline,proced-

ural,and outcomedatahavebeenacquired.Theregistrysummarizestheresultsof 6523 conventional aortic valverepla-



risk profiles.Thestrokeratewaslow in all groupswith 1.3%(AVR),1.9%(AVR+ CABG),1.7%(TVAVI), and 2.3%(TA

AVI).Thein-hospital mortality was2.1%(AVR) and 4.5%(AVR+ CABG) for patientsundergoingconventional surgery,


Conclusion The in-hospital outcome resultsof thisregistry show that conventional surgery yieldsexcellent resultsin all risk groups



Int roduct ion




symptomatic. Surgical valve replacement isthe established standard










& The Author 2013. Published by Oxford University Presson behalf of the European Society of Cardiology.

This isan Open Access article distributed under the termsof the Creative CommonsAttribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which


[email protected]




at B

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irtual d

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TAVI

.....................................................................................................................................................................................

.....................................................................................................................................................................................

CLINICAL RESEARCH

The German Aortic Valve Registry


Christ ian W. Hamm*, Helge Mollmann, David Holzhey, AndreasBeckmann,

Christof Veit , Hans-Reiner Figulla, J. Cremer, Karl-Heinz Kuck, Rudiger Lange,

Ralf Zahn, Stefan Sack, Gerhard Schuler, ThomasWalther, Friedhelm Beyersdorf,

Michael Bohm, Gerd Heusch, Anne-Kathrin Funkat, ThomasMeinertz, Till Neumann,

KonstantinosPapoutsis,SteffenSchneider,Armin Welz,and FriedrichW.Mohr, for the

GARY-Executive Board

Department of Cardiology, Medical Clinic I, Kerckhoff Heart and Thorax Center, University of Giessen, Benekestrasse. 2-8, Bad Nauheim61231, Germany

Received24 May2013;revised 5 August 2013;accepted 22 August 2013

Background Aorticstenosisisafrequent valvular diseaseespeciallyinelderlypatients.Catheter-basedvalveimplantationhasemerged

asavaluabletreatment approachfor thesepatientsbeingeither at veryhighriskfor conventional surgeryor evendeemed

inoperable.TheGermanAorticValveRegistry (GARY) providesdataonconventional andcatheter-based aorticproce-

duresonanall-comersbasis.

Met hods and

result s

Atotal of13860consecutivepatientsundergoingrepair for aorticvalvedisease[conventional surgeryandtransvascular

(TV) or transapical (TA)catheter-based techniques] havebeenenrolledinthisregistryduring2011andbaseline,proced-

ural,andoutcomedatahavebeenacquired.Theregistrysummarizestheresultsof6523conventional aorticvalverepla-

cementswithout (AVR) and3464withconcomitant coronarybypasssurgery(AVR+ CABG) aswell as2695TVAVIand

1181TA interventions(TA AVI).Patientsundergoingcatheter-based techniquesweresignificantlyolder andhadhigher

risk profiles.Thestrokeratewaslow inall groupswith1.3%(AVR),1.9%(AVR+ CABG),1.7%(TVAVI),and2.3%(TA

AVI).Thein-hospital mortalitywas2.1%(AVR) and4.5%(AVR+ CABG) for patientsundergoingconventional surgery,


Conclusion Thein-hospital outcomeresultsof thisregistryshow that conventional surgery yieldsexcellent resultsinall risk groups


patients.- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Keywords Aortic stenosis † Surgery † Catheter-based valvereplacement † GARY

Introduction


in the Western Countriesand presents mostly in an advanced age

asacalcific form. The prognosis ispoor once the patient becomes

symptomatic.Surgical valve replacement istheestablished standard


Valvuloplastyof thestenosed valvehasbeen over manyyearsapal-








& TheAuthor 2013.Published byOxford University Pressonbehalf of theEuropean Societyof Cardiology.

Thisisan Open Accessarticle distributed under the termsof theCreativeCommonsAttribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which

permitsnon-commercial re-use, distribution, and reproduction inany medium, provided theoriginal work isproperly cited. For commercial re-use, pleasecontact

[email protected]




at B

iblio

teca V

irtual d

el S

istem

a S

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PÃºb

lico

de A

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CLIN ICAL RESARCHTAVI

Advanced chronic kidney disease in pat ients

undergoing transcatheter aort ic valve

implantat ion: insights on clinical outcomes and

prognost ic markersfrom alarge cohort of pat ients

Ricardo Allende1†, John G. W ebb2, Antonio J. Munoz-Garcia3, Peter de Jaegere4,

Corrado Tambur ino5, Antonio E. Dager 6, Asim Cheema7, Vicenc Serra8,

Ignacio Amat-Santos9, James L. Velianou10, Marco Barbant i2, Danny Dvir 2,

Juan H. Alonso-Br iales3, Rutger-Jan Nuis4, Elhamula Faqir i4, Sebast iano Imme5,

Luis Miguel Benitez6, Angela Mar ia Cucalon6, Hat im Al Lawat i7,

Bruno Garcia del Blanco8, Javier Lopez9, Madhu K. Natarajan10,

Rober t DeLarochelliere1, Mar ina Urena1, Henr ique B. Ribeiro1, Er ic Dumont 1,

Luis Nombela-Franco1†, and Josep Rodes-Cabau1*

1QuebecHeart andLungInstitute,Laval University,Quebeccity,QC,Canada;2St Paul’sHospital,UniversityofBritishColumbia,Vancouver,BC,Canada;3Hospital Universitario Virgende

laVictoria, Malaga, Spain; 4Thoraxcenter-Erasmus MC, Rotterdam, The Netherlands; 5Ferrarotto Hospital, University of Catania, Catania, Italy; 6Angiografiade Occidente S.A., Cali,

Colombia; 7St-Michael’sHospital, Toronto, ON,Canada; 8Hospital General Universitari Vall d’Hebron,Barcelona, Spain; 9Hospital Clinico Universitario deValladolid, Valladolid, Spain;

and 10Hamilton General Hospital, Hamilton, ON, Canada

Received 11 August 2013; revised 9 February 2014; accepted 3 April 2014

A im Theaimofthisstudywastodeterminetheeffectsofadvancedchronickidneydisease(CKD)onearlyandlateoutcomesafter

transcatheter aorticvalve implantation (TAVI),and to evaluate thepredictive factorsof poorer outcomesin suchpatients.

Met hods

and r esult s

This was a multicentre study including a total of 2075 consecutive patients who had undergone TAVI. Patients were

grouped according the estimated glomerular filtration rate as follows: CKD stage 1-2 (≥ 60 mL/min/1.73 m2;

n¼ 950), stage 3 (30–59 mL/min/1.73 m2; n¼ 924), stage 4 (15–29 mL/min/1.73 m2; n¼ 134) and stage 5 (, 15 mL/

min/1.73 m2 or dialysis; n¼ 67). Clinical outcomes were evaluated at 30-days and at follow-up (median of 15 [6–29]

months) and defined according to the VARC criteria. Advanced CKD (stage 4–5) was an independent predictor of

30-day major/life-threateningbleeding (P¼ 0.001) and mortality (P¼ 0.027), and late overall, cardiovascular and non-

cardiovascular mortality (P, 0.01for all).Pre-existingatrial fibrillation (HR:2.29,95%CI:1.47–3.58,P¼ 0.001) anddia-

lysistherapy(HR:1.86,95%CI:1.17–2.97,P¼ 0.009) werethepredictorsof mortality inadvanced CKD patients,witha

mortality rateashigh as71%at 1-year follow-up in thosepatientswith these2 factors. Advanced CKD patientswho had

survived at 1-year follow-upexhibited bothasignificant improvement inNYHA class(P, 0.001) andno deteriorationin

valve hemodynamics (P¼NSfor changes in mean gradient and valve areaover time).

Conclusions AdvancedCKD wasassociatedwithahigher rateofearlyandlatemortalityandbleedingeventsfollowingTAVI,withAFand

dialysistherapydeterminingahigher risk inthesepatients.Themortalityrateofpatientswithbothfactorswasunacceptably

high and thisshould be taken into account in theclinical decision-makingprocessin thischallenginggroup of patients.- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Keywor ds Chronic kidney disease † Dialysis † Transcatheter aortic valve implantation † Atrial fibrillation

* Correspondingauthor. Tel: + 1 4186568711, Fax:+ 1 4186564544, Email: [email protected]

†R.A. and L.N.-F. have equally contributed to thiswork.

Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2014. For permissions please email: journals.per [email protected].


doi:10.1093/eurheartj/ehu175

European Heart Journal Advance Access published May 5, 2014

at Biblioteca Virtual del Sistem

a Sanitario PÃºblico de A

ndalucÃ-a on June 4, 2014

http://eurheartj.oxfordjournals.org/D

ownloaded from

.....................................................................................................................................................................................

.....................................................................................................................................................................................

CLIN ICAL RESARCHTAVI

Advanced chronic kidney disease in pat ients

undergoing transcatheter aort ic valve

implantat ion: insightson clinical outcomesand

prognostic markersfrom alarge cohort of pat ients


Corrado Tambur ino5, Antonio E. Dager 6, Asim Cheema7, Vicenc Serra8,

Ignacio Amat-Santos9, James L. Velianou10, Marco Barbant i2, Danny Dvir 2,

Juan H. Alonso-Br iales3, Rutger-Jan Nuis4, Elhamula Faqir i4, Sebast iano Imme5,

Luis Miguel Benitez6, Angela Mar ia Cucalon6, Hat im Al Lawat i7,


Rober t DeLarochelliere1, Mar ina Urena1, Henr ique B. Ribeiro1, Er ic Dumont 1,

Luis Nombela-Franco1†, and Josep Rodes-Cabau1*

1QuebecHeart andLungInstitute,Laval University,Quebeccity,QC,Canada;2St Paul’sHospital,UniversityofBritishColumbia,Vancouver,BC,Canada;3Hospital Universitario Virgende

laVictoria, Malaga, Spain; 4Thoraxcenter-Erasmus MC, Rotterdam, The Netherlands; 5Ferrarotto Hospital, University of Catania, Catania, Italy; 6Angiografiade Occidente S.A., Cali,

Colombia; 7St-Michael’sHospital, Toronto, ON, Canada; 8Hospital General Universitari Vall d’Hebron,Barcelona, Spain; 9Hospital Clinico Universitario deValladolid, Valladolid, Spain;


Received 11 August 2013; revised 9 February 2014;accepted 3 April 2014

A im Theaimofthisstudywastodeterminetheeffectsofadvancedchronickidneydisease(CKD)onearlyandlateoutcomesafter

transcatheter aorticvalve implantation (TAVI),and to evaluate thepredictive factorsof poorer outcomesin suchpatients.

Met hods

and r esul t s

This was a multicentre study including a total of 2075 consecutive patients who had undergone TAVI. Patients were


n¼ 950), stage 3 (30–59 mL/min/1.73 m2; n¼ 924), stage 4 (15–29 mL/min/1.73 m2; n¼ 134) and stage 5 (, 15 mL/

min/1.73 m2 or dialysis; n¼ 67). Clinical outcomes were evaluated at 30-days and at follow-up (median of 15 [6–29]


30-day major/life-threateningbleeding(P¼ 0.001) and mortality (P¼ 0.027), and late overall, cardiovascular and non-

cardiovascular mortality (P, 0.01for all).Pre-existingatrial fibrillation (HR:2.29,95%CI:1.47–3.58,P¼ 0.001) anddia-

lysistherapy(HR:1.86,95%CI:1.17–2.97,P¼ 0.009) werethepredictorsof mortality inadvanced CKD patients,witha

mortality rateashigh as71%at 1-year follow-up in thosepatientswith these2 factors.Advanced CKD patientswho had

survived at 1-year follow-upexhibited bothasignificant improvement inNYHA class(P, 0.001) andno deteriorationin

valve hemodynamics (P¼ NSfor changes in mean gradient and valve areaover time).

Conclusions AdvancedCKD wasassociatedwithahigher rateofearlyandlatemortalityandbleedingeventsfollowingTAVI,withAFand

dialysistherapydeterminingahigher risk inthesepatients.Themortalityrateofpatientswithbothfactorswasunacceptably

high and thisshould be taken into account in the clinical decision-makingprocessin thischallenginggroup of patients.- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Keywor ds Chronic kidney disease † Dialysis † Transcatheter aortic valve implantation † Atrial fibrillation

* Correspondingauthor. Tel: + 1 4186568711, Fax:+ 1 4186564544, Email: [email protected]

†R.A. and L.N.-F. have equally contributed to thiswork.

Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2014. For permissionsplease email: [email protected].




at Bib

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itario PÃºb

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4h

ttp://eu

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.....................................................................................................................................................................................

.....................................................................................................................................................................................

CLINICAL RESARCHTAVI

Advanced chronic kidney disease in patients

undergoing transcatheter aortic valve

implantation: insightson clinical outcomesand

prognosticmarkersfrom alargecohort of patients


Corrado Tamburino5, Antonio E. Dager 6, Asim Cheema7, Vicenc Serra8,

Ignacio Amat-Santos9, JamesL. Velianou10, Marco Barbant i2, Danny Dvir 2,

Juan H. Alonso-Briales3, Rutger-Jan Nuis4, Elhamula Faqir i4, Sebast iano Imme5,

LuisMiguel Benitez6, Angela Maria Cucalon6, Hat im Al Lawati7,


Robert DeLarochelliere1, Marina Urena1, Henr ique B. Ribeiro1, Eric Dumont 1,

LuisNombela-Franco1†, and Josep Rodes-Cabau1*

1QuebecHeart andLungInstitute,Laval University,Quebeccity,QC,Canada;2StPaul’sHospital,UniversityofBritishColumbia,Vancouver,BC,Canada;3Hospital Universitario Virgende

laVictoria, Malaga, Spain; 4Thoraxcenter-Erasmus MC, Rotterdam, The Netherlands;5Ferrarotto Hospital,University of Catania, Catania, Italy; 6AngiografiadeOccidente S.A., Cali,

Colombia; 7St-Michael’sHospital,Toronto, ON,Canada; 8Hospital General Universitari Vall d’Hebron,Barcelona, Spain; 9Hospital Clinico Universitario deValladolid, Valladolid, Spain;


Received11 August 2013; revised 9 February2014;accepted 3 April 2014

Aim Theaimofthisstudywastodeterminetheeffectsofadvancedchronickidneydisease(CKD)onearlyandlateoutcomesafter

transcatheter aorticvalveimplantation(TAVI),and to evaluatethepredictivefactorsofpoorer outcomesinsuchpatients.

Met hods

and result s

This was amulticentre study including a total of 2075 consecutive patients who had undergone TAVI. Patients were


n¼950), stage3 (30–59 mL/min/1.73 m2; n¼924), stage4 (15–29 mL/min/1.73 m2; n¼134) and stage 5 (, 15 mL/

min/1.73 m2 or dialysis; n¼67). Clinical outcomes were evaluated at 30-daysand at follow-up (median of 15 [6–29]


30-day major/life-threateningbleeding(P¼0.001) and mortality (P¼0.027), and lateoverall, cardiovascular and non-

cardiovascular mortality(P, 0.01for all).Pre-existingatrialfibrillation (HR:2.29,95%CI:1.47–3.58,P¼0.001) anddia-

lysistherapy(HR:1.86,95%CI:1.17–2.97,P¼0.009) werethepredictorsofmortality inadvancedCKD patients,witha

mortality rateashighas71%at 1-year follow-up inthosepatientswith these2factors.Advanced CKD patientswho had

survivedat 1-year follow-upexhibitedbothasignificant improvement inNYHAclass(P, 0.001) andnodeteriorationin

valvehemodynamics(P¼NSfor changesin mean gradient and valveareaover time).

Conclusions AdvancedCKDwasassociatedwithahigher rateofearlyandlatemortalityandbleedingeventsfollowingTAVI,withAFand

dialysistherapydeterminingahigher riskinthesepatients.Themortalityrateofpatientswithbothfactorswasunacceptably

highand thisshouldbetaken into account in theclinical decision-makingprocessin thischallenginggroup of patients.- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Keywords Chronic kidneydisease † Dialysis † Transcatheter aortic valve implantation † Atrial fibrillation

* Correspondingauthor. Tel: + 1 4186568711, Fax:+ 14186564544, Email: [email protected]

†R.A. and L.N.-F.haveequally contributed to thiswork.

Published on behalf of the European Societyof Cardiology. All rightsreserved. & The Author 2014. For permissionsplease email: [email protected].




at Bib

liotec

a Virtu

al del S

istema S

anitario

PÃºb

lico d

e Andalu

cÃ-a o

n Ju

ne 4

, 20

14

http

://eurh

eartj.oxfo

rdjo

urn

als.o

rg/

Do

wnlo

aded

from

.....................................................................................................................................................................................

.....................................................................................................................................................................................

CLINICAL RESARCHTAVI

Advanced chronic kidney disease in patients

undergoing transcatheter aortic valve

implantation: insightson clinical outcomesand

prognosticmarkersfrom alargecohort of patients


Corrado Tamburino5, Antonio E. Dager 6, Asim Cheema7, Vicenc Serra8,

Ignacio Amat-Santos9, JamesL. Velianou10, Marco Barbanti2, Danny Dvir 2,

Juan H. Alonso-Briales3, Rutger-Jan Nuis4, Elhamula Faqiri4, Sebastiano Imme5,

LuisMiguel Benitez6, Angela Maria Cucalon6, Hatim Al Lawati7,


Robert DeLarochelliere1, Marina Urena1, Henr ique B. Ribeiro1, Eric Dumont 1,

LuisNombela-Franco1†, and Josep Rodes-Cabau1*

1QuebecHeart andLungInstitute,Laval University,Quebeccity,QC,Canada;2StPaul’sHospital,UniversityofBritishColumbia,Vancouver,BC,Canada;3Hospital Universitario Virgende

laVictoria, Malaga, Spain; 4Thoraxcenter-Erasmus MC,Rotterdam, TheNetherlands;5Ferrarotto Hospital, University of Catania, Catania, Italy;6AngiografiadeOccidente S.A., Cali,

Colombia; 7St-Michael’sHospital,Toronto,ON,Canada; 8Hospital General Universitari Vall d’Hebron,Barcelona, Spain; 9Hospital Clinico Universitario deValladolid, Valladolid, Spain;


Received11 August 2013; revised 9 February2014;accepted 3 April 2014

Aim Theaimofthisstudywastodeterminetheeffectsofadvancedchronickidneydisease(CKD)onearlyandlateoutcomesafter

transcatheter aorticvalveimplantation(TAVI),and to evaluatethepredictivefactorsofpoorer outcomesinsuchpatients.

Met hods

and result s

This wasamulticentre study including a total of 2075 consecutive patients who had undergone TAVI. Patients were


n¼950), stage3 (30–59 mL/min/1.73 m2;n¼924), stage4 (15–29 mL/min/1.73 m2; n¼134) and stage5 (, 15 mL/

min/1.73 m2or dialysis; n¼67). Clinical outcomeswere evaluated at 30-daysand at follow-up (median of 15 [6–29]


30-day major/life-threateningbleeding(P¼0.001) and mortality (P¼0.027), and lateoverall, cardiovascular and non-

cardiovascular mortality(P, 0.01for all).Pre-existingatrialfibrillation(HR:2.29,95%CI:1.47–3.58,P¼0.001) anddia-

lysistherapy(HR:1.86,95%CI:1.17–2.97,P¼0.009) werethepredictorsofmortality inadvancedCKD patients,witha

mortality rateashighas71%at 1-year follow-up inthosepatientswith these2factors.AdvancedCKD patientswho had

survivedat 1-year follow-upexhibitedbothasignificant improvement inNYHAclass(P, 0.001) andnodeteriorationin

valvehemodynamics(P¼NSfor changesin mean gradient and valveareaover time).

Conclusions AdvancedCKDwasassociatedwithahigher rateofearlyandlatemortalityandbleedingeventsfollowingTAVI,withAFand

dialysistherapydeterminingahigher riskinthesepatients.Themortalityrateofpatientswithbothfactorswasunacceptably

highand thisshouldbetaken into account in theclinical decision-makingprocessin thischallenginggroupof patients.- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Keywords Chronic kidneydisease † Dialysis † Transcatheter aortic valve implantation † Atrial fibrillation

* Correspondingauthor. Tel: + 14186568711, Fax:+ 14186564544, Email: [email protected]

†R.A.and L.N.-F.haveequally contributed to thiswork.

Published onbehalf of theEuropean Societyof Cardiology. All rightsreserved. & TheAuthor 2014. For permissionsplease email: [email protected].




at B

iblio

teca V

irtual d

el S

istem

a S

anita

rio PÃºb

lico

de A

nd

alu

cÃ

-a o

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4h

ttp://e

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TAVI


Análisis post-hoc no aleatorizado

Pacientes incluidos desde 2007 a 2012 (Edwards sólo desde 2010)

Sesgos (preferencias de operador, curva de aprendizaje, patrón decalcificación anular) no corregidos pese a “propensity matching”

Superviviencia al año al año similar (88% ES, 84% MCV, p= 0,42)

No diferencias en otros estudios (FRANCE 2, UK TAVI, PRAGMATIC..)

Descenso de la “more-then-mild” IAO con el tiempo con la Corevalve(11,5% a 30 días y 4,1% al año en en US Pivotal Trial)

TAVI

Selección del tamaño de dispositivo heterogénea con pocos casos con TAC


Aunque la válvula balón expandible tiene mas tasa de éxito que la autoexpandibleno hay datos de que esto tenga impacto en el seguimiento (muerte, ACV, calidad de vida)

IAO ≥ 2 e implante de una segunda válvula fueron mayores con la válvula autoexpandible,mientras que los ACV y la oclusión coronaria fueron numerica, aunque no estadisticamente, mayores con la balón expandible

Datos recientes sugieren que la IAO disminuye en el seguimiento de la válvulaautoexpandible

La experiencia del operador es un factor crucial en el éxito del procedimiento, y debeser tenido en cuenta en la selección del tipo de válvula

En espera de resultados a un año

TAVI


6 Extreme Risk Study | Iliofemoral Pivotal Popma JACC 2014 March 19 (epub ahead of print)

On behalf of the US CoreValve Investigators

Paravalvular Regurgitation

23 Extreme Risk Study | Iliofemoral Pivotal TCT 2013 LBCT (JACC 2014)

TAVI


LIMITACIONES

Se incluyen características preprocedimiento, no complicaciones intra oPost procedimiento, que pueden incrementar la mortalidad

No tiene validación externa

FRANCE 2 no recogió datos de la capacidad cognitiva ni fragilidad

TAVI


LOTUS DIRECT FLOW

PORTICO SAPIEN 3 SAPIEN 3(APICAL)

Pacientes 120 100 (75) 83 96 54

Edad 84,4 83,1 83,8 83,6

Euroscore STS 7,1 23,5 16,3 19,8 24,9

Mortalidad(30 días) %

4,2 1,3 3,6 2,1 11,1

ACV (%) 5,8 (1,8) 4 3,6 (2,6) 1 5,6

MP (%) 29,4 17-6 10,8 12,5 14,8

IAO ≥ 2 (%) 2 2 5 2,6 5,1

IAM 1,3 1,2 2,1

2ª Válvula 0 0 1

Balón post 0 0 3,3

TAVI: NUEVOS DISPOSITIVOS (PCR 2014)

TAVI


¡ MUCHAS GRACIAS !

cardiopatía estructural. - dr. josé maría hernández

Health & Medicine