The ReDo-TAVI Prospective Observational Registry
Study Details
Study Description
Brief Summary
The evidence on redo-TAVI (where a transcatheter heart valve [THV] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations.
Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Between 1.4 and 2.8% of all patients undergoing transcatheter heart valve (THV) implantation require a second THV implanted into the previously implanted THV because of clinically significant aortic regurgitation [1-3]. 90% of THV-in-THV implants were considered successful although the mortality in the redo-TAVI group was higher at similar STS risks as in those with a successful first implant.
Redo-TAVI may also be a promising treatment strategy in degenerated THVs, but there is insufficient knowledge which strategy and valve design may result in the best outcomes [4]. Evidence so far reported is based on case reports and small case series, but not on a prospective, multicenter documentation.
Currently, ~ 5% of THV are implanted in degenerated surgical bioprosthetic valves. With the expanded use of THV for treatment of lower risk patients with severe aortic stenosis (sAS), it is estimated that the number of patients requiring re-treatment for THV failure is likely to rise within the next years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| redo-TAVI patients Patients with severe aortic stenosis (sAS) treated with TAVI developing SVD and thus an indication for redo-TAVI procedure |
Procedure: Elective redo transcatheter aortic valve implantation (redo-TAVI)
Elective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Major objective is to determine the number and percentage of subjects with Device Success as defined by VARC-3 [30 days]
Device success at 30 days based on Valve Academic Research Consortium-3 consensus (VARC-3), defined as: Technical success Freedom from mortality Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) (Different definitions, in addition to the predefined such as the consideration of higher gradients than 20 mmHg, will be explored) These events will be adjudicated. Number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
- Also, a major objective is to determine the number and percentage of subjects with technical success (at exit from procedure room) [end of intervention]
Technical success at exit from procedure room defined as: Freedom from mortality Successful access, delivery of the device, and retrieval of the delivery system Correct positioning of a single prosthetic heart valve into the proper anatomical location Freedom from surgery or intervention related to the device (excluding pacemaker) or to a major vascular or access-related, or cardiac structural complication Number and percentage of subjects with technical success at exit from procedure room, along with individual component of the success, will be presented.
- Also, a major objective is to determine Early Safety as defined by VARC-3 [30 days]
Early safety at 30 days based on Valve Academic Research Consortium-3 consensus (VARC-3), defined as: Freedom from all-cause mortality Freedom from all Stroke Freedom from all VARC type 2-4 bleeding Freedom from all major vascular, access-related, or cardiac structural complication Freedom from all acute kidney injury stage III/IV Freedom from all moderate/severe aortic regurgitation Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities Freedom from all surgery/intervention related to the device These events will be adjudicated. Number and percentage of subjects with early safety at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
- Also to determine Procedural Outcomes at 30 days [30 days]
Procedural outcomes at 30 days, defined as: Description of clinical and anatomical predictors of technical success (type of SVD [stenosis vs. regurgitation], valve size, implant depth, redo-TAVI balloon dilation, CT and echo-derived variables, etc.) Rate of central and paravalvular regurgitation at 30 days Valve performance, including residual mean gradient at 30 days Risk and predictors of coronary obstruction at 30 days Number and percentage of subjects with above specified outcomes at 30 days , along with individual component of the success, will be presented.
- Besides, the evaluation of the durability of the second aortic THV at 30 days [30 days]
Determine the durability of the second aortic THV: Subclinical transcatheter heart valve thrombosis at thirty days (when it becomes apparent, but no systematic screening) Endocarditis Definition of transcatheter heart valve thrombosis Clinical sequelae of a thromboembolic event (e.g. stroke, TIA, retinal occlusion, other evidence of systemic thromboembolism) or worsening valve stenosis/ regurgitation (e.g. signs of heart failure, syncope) and Haemodynamic valve deterioration Stage 2 or 3 or Confirmatory imaging (CT evidence of HALT† or TEE findings) In the absence of clinical sequelae, both Haemodynamic valve deterioration Stage 3 and Confirmatory imaging (CT evidence of HALT or TEE findings) Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented.
- Besides, the evaluation of the durability of the second aortic THV at 3 months [3 months]
Determine the durability of the second aortic THV: Subclinical transcatheter heart valve thrombosis at three months (if data obtained, when it becomes apparent, but no systematic screening) Clinical transcatheter heart valve thrombosis at three months (if data obtained) Endocarditis For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria at 3 months, along with individual component of the success, will be presented.
- Besides, the evaluation of the durability of the second aortic THV at 12 months [12 months]
Determine the durability of the second aortic THV: Subclinical transcatheter heart valve thrombosis at twelve months (when it becomes apparent, but no systematic screening) Clinical transcatheter heart valve thrombosis at twelve months All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at twelve months (stage I may be documented, but no specific screening) Endocarditis For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. Number and percentage of subjects with above specified criteria at 12 months , along with individual component of the success, will be presented.
Other Outcome Measures
- Evaluation of adherence to published recommendations [12 months]
It will be assessed and percentages determined as to whether and how many of the participating centers are following the published recommendations (itemized).
- Assessment of alterations to published recommendations [12 months]
The impact of potential alterations to the protocol on the procedural outcomes will be elucidated and descriptively described.
- Discretionary longer-term follow-up [up to 5 years]
Discretionary longer-term follow-up in terms of durability of the second aortic THV: Subclinical transcatheter heart valve thrombosis Clinically symptomatic transcatheter heart valve thrombosis All-cause mortality, stroke, and cardiovascular hospitalization Stage II or III structural valve degeneration according to VARC 3 definitions Number and percentage of subjects with above specified criteria with up to 5 years follow-up, along with individual component of the success, will be presented.
- Exploratory objectives [12 months]
Further, not predefined research questions will be explored based on the dataset such as: Hemodynamic outcome of the intervention Applicability of VARC-3 criteria for the redo-TAVI situation Coronary artery obstruction due to valve implantation Coronary artery cannulation (in particular in case of risk plane above ostia)
Eligibility Criteria
Criteria
Inclusion Criteria:
Consecutive patients fulfilling the following criteria:
-
Consenting adult patient (≥18 years)
-
Consecutive patients with procedural success of the first TAVI irrespective of SVD severity
-
Intention to treat the patient with a SAPIEN family valve implantation
-
The local heart team and the case review board considers the patient suitable and indicated for elective redo-TAVI
-
Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits takin place in hospital)
-
Optional/Recommended: 3 and 6 Months follow-up: hospital visit or phone call
Exclusion Criteria:
-
Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
-
Life expectancy below 12 months
-
Patients with largely incomplete data with respect to the aims of the project
Note: Patients included based on the intention to receive a SAPIEN family valve but requiring a different valve (other than SAPIEN family) or undergoing surgery will only be documented at baseline.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Institut für Pharmakologie und Präventive Medizin
- Edwards Lifesciences
Investigators
- Principal Investigator: Giuseppe Tarantini, Prof., University of Padua Medical School, Padua, Italy
- Principal Investigator: Radoslaw Parma, Dr., Medical University of Silesia, Katowice, Poland
- Study Chair: Thomas Cuisset, Prof., Centre Hospitalier Universitaire de Timone, Marseille, France
- Study Chair: Victoria Delgado, Prof., University Hospital Germans Trias i Pujol, Badalona, Spain
- Study Chair: Michael Joner, Prof., German Heart Center, Technical University of Munich, Munich, Germany
- Study Chair: Thomas Modine, Prof., Hopital Haut Levêque - Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
- Study Chair: Simon Redwood, Prof., Guy's and St Thomas' NHS Foundation Trust, St Thomas' Hospital, London, UK
- Study Chair: Francesco Saia, Prof., University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ReDo-TAVI Registry