The International Trifecta and Epic Valve-in-Valve Registry: Insights Into Clinical & Hemodynamic Outcomes.

Matthias Raschpichler, Mohamed Abdel-Wahab, Nick Curzen, Manuel Wilbring, Christoph Dubois, Kayan Lam, Gloria Faerber, Jana Nagel, Holger Thiele, Michael A Borger
Author Information
  1. Matthias Raschpichler: Leipzig Heart Center, University Clinic of Cardiac Surgery, Leipzig, Germany. ORCID
  2. Mohamed Abdel-Wahab: Department of Internal Medicine/Cardiology, Leipzig Heart Center, Leipzig, Germany.
  3. Nick Curzen: Wessex Cardiothoracic Centre, University Hospital Southampton, Southampton, UK.
  4. Manuel Wilbring: Heart Center Dresden, University Hospital Dresden, Dresden, Germany.
  5. Christoph Dubois: University Hospital Leuven, Leuven, Belgium.
  6. Kayan Lam: Heartcentre Catharina Hospital, Eindhoven, Netherlands.
  7. Gloria Faerber: University Clinic of Cardiothoracic Surgery, Jena, Germany.
  8. Jana Nagel: Helios Health Institute, Heart Center Leipzig, Leipzig, Germany.
  9. Holger Thiele: Department of Internal Medicine/Cardiology, Leipzig Heart Center, Leipzig, Germany.
  10. Michael A Borger: Leipzig Heart Center, University Clinic of Cardiac Surgery, Leipzig, Germany.

Abstract

BACKGROUND: Little is known about the clinical and hemodynamic outcome of valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) for failed Trifecta surgical aortic bioprotheses.
AIMS: We aimed to compare outcomes of valve-in-valve transcatheter aortic valve replacement (ViV-TAVR into failed Trifecta vs. ViV-TAVR into a standard aortic bioprosthetic valve with internally mounted leaflets (Epic, Abbott, Minneapolis, MN).
METHODS: Data of consecutive patients who underwent ViV-TAVR into either failed Trifecta or Epic bioprostheses between October 2015 and June 2020 were retrospectively collected within the International Trifecta and Epic Valve-in-Valve Registry, and analyzed for a primary composite outcome of 30-day mortality and/or coronary obstruction (CO), defined as: (1) CO resulting in myocardial infarction and/or cardiogenic shock, or (2) CO requiring emergent coronary intervention.
RESULTS: A total of 76 patients (49 Trifecta, 27 Epic) with a median age of 80 years (interquartile range [IQR] 75.0; 82.0]) and a median Society of Thoracic Surgeons-score of 5.4 (IQR 4.0; 9.8) were identified. Coronary protection techniques were more frequently performed in Trifecta than Epic patients (29.6% vs. 0%, p���=���0.01). The primary composite outcome was observed in three Trifecta versus five Epic cases (6.1% vs. 20%, p���=���0.1), which included one case of CO following ViV-TAVR into Epic requiring stenting. Increased rates of patient-prosthesis mismatch (PPM) following valve-in-Epic were found (41.7% vs. 75%, p���=���0.08). Survival at a median of 365 days was 86.2% and did not differ between groups (log-rank p���=���0.37).
CONCLUSIONS: Compared to a stented prosthesis without increased risk of CO, ViV-TAVR into Trifecta prostheses can be performed with low risk of CO and acceptable short-term clinical outcomes. As the rate of post-ViV PPM is substantial for both prostheses, careful patient selection is warranted. (NCT05389631).

Keywords

Associated Data

ClinicalTrials.gov | NCT05389631

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Grants

  1. /Financial support was provided by the Abbott Structural Heart.

Word Cloud

Created with Highcharts 10.0.0TrifectaEpicViV-TAVRCOaorticvalvevsp���=���0outcometranscatheterreplacementfailedpatientscoronarymedianclinicalvalve-in-valveoutcomesmountedleafletsInternationalValve-in-Valveprimarycompositeand/orobstruction1requiring04performedfollowingPPMriskprosthesesBACKGROUND:LittleknownhemodynamicsurgicalbioprothesesAIMS:aimedcomparestandardbioprostheticinternallyAbbottMinneapolisMNMETHODS:DataconsecutiveunderwenteitherbioprosthesesOctober2015June2020retrospectivelycollectedwithinRegistryanalyzed30-daymortalitydefinedas:resultingmyocardialinfarctioncardiogenicshock2emergentinterventionRESULTS:total764927age80yearsinterquartilerange[IQR]75820]SocietyThoracicSurgeons-score5IQR98identifiedCoronaryprotectiontechniquesfrequently296%0%01observedthreeversusfivecases61%20%includedonecasestentingIncreasedratespatient-prosthesismismatchvalve-in-Epicfound417%75%08Survival365days862%differgroupslog-rank37CONCLUSIONS:Comparedstentedprosthesiswithoutincreasedcanlowacceptableshort-termratepost-ViVsubstantialcarefulpatientselectionwarrantedNCT05389631Registry:InsightsClinical&HemodynamicOutcomesEpicTM���valveTrifectaTM���valveexternallyvalve���in���valve

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