Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT)

Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve (EASE-IT) A Two-armed Registry

There is limited experience for the balloon expandable THV (transcatheter heart valve) on the need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify results of a small case series published by Wendler et. al. to examine hard endpoints such as the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a multicenter registry.

We aim to compare the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: BAV; Procedure: without BAV

Detailed Description

Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is usually performed under rapid right ventricular pacing (burst >180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation is aiming at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects, such as:

• Functional cardiac arrest induced by rapid pacing leads to transient coronary, cerebral, and renal ischemia.
• In patients with a reduced left ventricular ejection fraction (LVEF), prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (SIRS). Both are associated with a high periprocedural mortality.
• BAV has been identified as a major source of thrombotic and valvular material and increases the risk for coronary obstruction with subsequent myocardial infarction and stroke.
• The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg
  • Bad Neustadt an der Saale, Germany, 97615
    • Herz- und Gefäß-Klinik GmbH Bad Neustadt
  • Bad Rothenfelde, Germany, 49214
    • Schüchtermann-Schiller'sche Kliniken
  • Essen, Germany, 45147
    • Uniklinik Essen
  • Köln, Germany, D-50937
    • Uniklinik Koln
  • Baden-Württemberg
    • Karlsruhe, Baden-Württemberg, Germany, 76185
      • Clinic for Cardiac Surgery Karlsruhe
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44789
      • Klinik für Herz- und Thoraxchirurgie, BG-Uniklinikum Bergmannsheil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from aortic Stenosis undergoing transapical trans-catheter heart valve implantation

Description

Inclusion Criteria:

• Patients with an indication for TAVI as to the Edwards THV IFU
• Eligible for TABI with AND without BAV
• Signed informed consent

Exclusion Criteria:

• Logistic EuroSCORE I >50%
• Mitral or tricuspid valvular insufficiency (> grade II)
• Previous aortic valve replacement
• Uncontrolled atrial fibrillation
• Left ventricular or atrial thrombus by echocardiography
• Recent cerebrovascular event (within the last 3 months)
• High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
with BAV; Patients undergoing TA-TAVI WITH predilation of the AV (Group A)	Procedure: BAV
without BAV; Patients undergoing TA-TAVI WITHOUT predilation of the AV	Procedure: without BAV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VARC2 criteria	comparison of the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).	3 months

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Investigators: Principal Investigator: Holger Schröfel, MD, Clinic for Cardiac Surgery Karlsruhe; Principal Investigator: Justus Strauch, Prof., Klinik für Herz- und Thoraxchirurgie

Publications and helpful links

General Publications

• Strauch J, Wendt D, Diegeler A, Heimeshoff M, Hofmann S, Holzhey D, Oertel F, Wahlers T, Kurucova J, Thoenes M, Deutsch C, Bramlage P, Schrofel H. Balloon-expandable transapical transcatheter aortic valve implantation with or without predilation of the aortic valve: results of a multicentre registry. Eur J Cardiothorac Surg. 2018 Apr 1;53(4):771-777. doi: 10.1093/ejcts/ezx397.
• Bramlage P, Strauch J, Schrofel H. Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve - rationale and design of a multicenter registry (EASE-IT). BMC Cardiovasc Disord. 2014 Nov 18;14:160. doi: 10.1186/1471-2261-14-160.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: pre-dilation; Aortic valve stenosis; BAV; THV
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: EASE-IT