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JACC

Lots of interesting abstracts and cases were submitted for TCTAP 2025. Below are the accepted ones after a thorough review by our official reviewers. Don’t miss the opportunity to expand your knowledge and interact with authors as well as virtual participants by sharing your opinion in the comment section!

TCTAP A-005

Early Outcomes With Three TAVI Valves in Women - Insight of LANDMARK Trial

By Ignacio Amat-Santos, Akihiro Tobe, Patrick Serruys, Niels van Royen, Martin Hudec, Alexander Ijsselmuiden, Peep Laanmets, Daniel Unic, Bela Merkely, Renicus Hermanides, Vlasis Ninios, Marcin Protasiewicz, Benno Rensing, Pedro Martin, Fausto Feres, Manuel Almeida, Eric van Belle, Axel Linke, Alfonso Ielasi, Matteo Montorfano, Konstantinos Toutouzas, Francesco Bedogni, Michiel Voskuil, Manuel Pan, Oskar Angreas, Won-Keum Kim, Jurgen Rothe, Ivica Kristic, Vicente Peral, Mohamed Abdel-Wahab, Udita Chandra, Ashokkumar Thakkar, Marie-Claude Morice, Osama Soliman, Yoshinobu Onuma, Andreas Baumbach, Mark Webster, Emmanuel Teiger

Presenter

Marcin Protasiewicz

Authors

Ignacio Amat-Santos1, Akihiro Tobe2, Patrick Serruys3, Niels van Royen3, Martin Hudec4, Alexander Ijsselmuiden5, Peep Laanmets6, Daniel Unic7, Bela Merkely8, Renicus Hermanides9, Vlasis Ninios10, Marcin Protasiewicz11, Benno Rensing12, Pedro Martin13, Fausto Feres14, Manuel Almeida15, Eric van Belle16, Axel Linke17, Alfonso Ielasi18, Matteo Montorfano19, Konstantinos Toutouzas20, Francesco Bedogni21, Michiel Voskuil22, Manuel Pan23, Oskar Angreas24, Won-Keum Kim25, Jurgen Rothe26, Ivica Kristic27, Vicente Peral28, Mohamed Abdel-Wahab29, Udita Chandra30, Ashokkumar Thakkar30, Marie-Claude Morice31, Osama Soliman2, Yoshinobu Onuma2, Andreas Baumbach32, Mark Webster33, Emmanuel Teiger34

Affiliation

Centro de Investigacion Biomedica en Red, Spain, Spain1, University of Galway, Ireland, Ireland2, Radboud University Hospital, Netherlands, Netherlands3, Middle-Slovak Institute of Cardiovascular Diseases, Slovak Republic4, Slovak Republic4, University Medical Centre Ljubljana, Slovenia, Slovenia5, North Estonia Medical Centre, Estonia, Slovenia6, University Hospital Dubrava, Croatia, Croatia7, Semmelweis University Heart and Vascular Centre, Hungary, Hungary8, Isala Hospital, Netherlands, Netherlands9, European Interbalkan Medical Center, Greece, Greece10, Wrocław Medical University, Poland, Poland11, St Antonius Hospital, Netherlands, Netherlands12, University Hospital of Gran Canaria Dr Negrin, Spain, Spain13, Instituto Dante Pazzanese, Brazil, Brazil14, NOVA University, Portugal, Portugal15, Lille University, France, France16, University of Technology Dresden, Germany, Germany17, IRCCS Galeazzi Sant’Ambrogio Hospital, Italy, Italy18, Vita-Salute San Raffaele University, Italy, Italy19, Hippokration Hospital, Greece, Greece20, San Donato Hospital, Italy, Italy21, University Medical Center Utrecht, Netherlands, Netherlands22, University Hospital Reina Sofia, Spain, Spain23, Gothenburg University, Sweden, Sweden24, University of Giessen and Marburg, Germany, Germany25, , University Medical Center Freiburg, Germany, Germany26, University Hospital of Split, Croatia, Croatia27, Son Espases University Hospital, Spain, Spain28, University Hospital Leipzig, Germany, Germany29, Meril Life Sciences Pvt. Ltd., India, India30, Cardiovascular European Research Center, France, France31, Queen Mary University of London, United Kingdom, United Kingdom32, Auckland City Hospital, New Zealand, New Zealand33, Henri-Mondor University Hospital, France, France34
View Study Report
TCTAP A-005
Minimalist TAVR

Early Outcomes With Three TAVI Valves in Women - Insight of LANDMARK Trial

Ignacio Amat-Santos1, Akihiro Tobe2, Patrick Serruys3, Niels van Royen3, Martin Hudec4, Alexander Ijsselmuiden5, Peep Laanmets6, Daniel Unic7, Bela Merkely8, Renicus Hermanides9, Vlasis Ninios10, Marcin Protasiewicz11, Benno Rensing12, Pedro Martin13, Fausto Feres14, Manuel Almeida15, Eric van Belle16, Axel Linke17, Alfonso Ielasi18, Matteo Montorfano19, Konstantinos Toutouzas20, Francesco Bedogni21, Michiel Voskuil22, Manuel Pan23, Oskar Angreas24, Won-Keum Kim25, Jurgen Rothe26, Ivica Kristic27, Vicente Peral28, Mohamed Abdel-Wahab29, Udita Chandra30, Ashokkumar Thakkar30, Marie-Claude Morice31, Osama Soliman2, Yoshinobu Onuma2, Andreas Baumbach32, Mark Webster33, Emmanuel Teiger34

Centro de Investigacion Biomedica en Red, Spain, Spain1, University of Galway, Ireland, Ireland2, Radboud University Hospital, Netherlands, Netherlands3, Middle-Slovak Institute of Cardiovascular Diseases, Slovak Republic4, Slovak Republic4, University Medical Centre Ljubljana, Slovenia, Slovenia5, North Estonia Medical Centre, Estonia, Slovenia6, University Hospital Dubrava, Croatia, Croatia7, Semmelweis University Heart and Vascular Centre, Hungary, Hungary8, Isala Hospital, Netherlands, Netherlands9, European Interbalkan Medical Center, Greece, Greece10, Wrocław Medical University, Poland, Poland11, St Antonius Hospital, Netherlands, Netherlands12, University Hospital of Gran Canaria Dr Negrin, Spain, Spain13, Instituto Dante Pazzanese, Brazil, Brazil14, NOVA University, Portugal, Portugal15, Lille University, France, France16, University of Technology Dresden, Germany, Germany17, IRCCS Galeazzi Sant’Ambrogio Hospital, Italy, Italy18, Vita-Salute San Raffaele University, Italy, Italy19, Hippokration Hospital, Greece, Greece20, San Donato Hospital, Italy, Italy21, University Medical Center Utrecht, Netherlands, Netherlands22, University Hospital Reina Sofia, Spain, Spain23, Gothenburg University, Sweden, Sweden24, University of Giessen and Marburg, Germany, Germany25, , University Medical Center Freiburg, Germany, Germany26, University Hospital of Split, Croatia, Croatia27, Son Espases University Hospital, Spain, Spain28, University Hospital Leipzig, Germany, Germany29, Meril Life Sciences Pvt. Ltd., India, India30, Cardiovascular European Research Center, France, France31, Queen Mary University of London, United Kingdom, United Kingdom32, Auckland City Hospital, New Zealand, New Zealand33, Henri-Mondor University Hospital, France, France34

Background

Nearly 50% of severe aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) are women, yet they are under-represented in clinical trials. SMART trial reported that in women with small annulus area, self-expanding transcatheter heart valve (THV) showed better hemodynamic outcomes than balloon-expandable THV. In the LANDMARK trial comparing three types of THVs, outcomes in women were investigated.

Methods

In a multicenter, non-inferiority LANDMARK trial (n=768), 369 women with severe AS were randomized to Myval THV series(n=193), Sapien THV series (n=86), and Evolut THV series (n=90). The primary endpoint at 30 days was a composite of all-cause death, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation (PVR), and new permanent pacemaker implantation as per the Valve Academic Research Consortium-3 consensus.

Results

Mean age (Myval: 81, Sapien: 81.7, andEvolut 79.8 years old) and median Society of Thoracic Surgeons scores (3.1%,3.5%, 3.1%) were comparable in three arms. More than 50% of women had smallaortic annuli (55.4%, 60.5%, 54.4%). In the Myval arm, 49% of patientsreceived intermediate sizes (21.5, 24.5 and 27.5 mm).
At 30 days, Myval had a lower aortic valve mean pressure gradient (MPG, Myval:8.7mmHg; Sapien: 11.1mmHg, p<0.001) and a higher effective orifice area(EOA) compared to Sapien (1.88cm2, 1.61cm2, p<0.001),while having a higher MPG  (Evolut: 5.4mmHg, p<0.001) and lower EOAthan Evolut (2.37cm2, p<0.001).
Myval was non-inferior to Sapien  (Myval: 19% vs Sapien: 20%, Riskdifference [95%Cl]: -0.6 [NA, 9.6], pnoninferiority=0.01) and Evolut(19% vs 30%; risk difference [95%CI]: -10.9% [NA, 0.1],  pnoninferiority<0.0001)for the primary endpoint. There was no statistically significant differencebetween Myval versus Sapien for itemized events of the primary compositeendpoint, whereas there were lower rates of moderate-severe PVR (Myval 2% vs.Evolut 9%, p=0.01) and major vascular complications (2% vs. 7%, p=0.03) inMyval than Evolut.

Conclusion

In the women subset of the LANDMARK trial, Myvalhad a lower aortic valve mean pressure gradient and a higher effectiveorifice area than Sapien, whereas superior hemodynamics of Evolut to Myvalentails a significantly higher risk of PVR at 30 days.  TAVI withthe Myval series in women patients with severe AS is non-inferior to boththe Sapien and Evolut series for the primary composite endpoint at 30 days.

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