Prosthesis Failure, Prosthetic Valve Malfunction, Structural Valve Degeneration, Structural Valve Deterioration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure
Conditions
Keywords
Transcatheter Aortic Valve Implantation (TAVI), Structural Valve Deterioration, redo-TAVI, THV-in-THV, TAV-in-TAV, TAVR-in-TAVR, Redo-TAVR, Revalve
Brief summary
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger & lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. 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, 3 years and 5 years.
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.
Interventions
PROCEDUREElective 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)
Sponsors
Edwards Lifesciences
Institut für Pharmakologie und Präventive Medizin
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Consecutive patients fulfilling the following criteria: 1. Consenting adult patient (≥18 years) 2. Procedural success of the first TAVI 3. TAVI device failure of the index THV, irrespective of SVD severity 4. Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV) 5. The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI 6. Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)
Exclusion criteria
1. Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC) 2. Life expectancy below 12 months 3. Patients with largely incomplete data with respect to the aims of the project 4. Pregnant women at the time of the redo-TAVI Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Durability of the second aortic THV (5 years) | 5 years | Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at 5 years (when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at 5 years * All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at 5 years For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. |
| Durability of the second aortic THV (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. |
| Durability of the second aortic THV (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. |
| Durability of the second aortic THV (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 II or III structural valve degeneration according to VARC 3 definitions at twelve months (stage I may be documented) * 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. |
| Durability of the second aortic THV (3 years) | 3 years | Determine the durability of the second aortic THV: * Subclinical transcatheter heart valve thrombosis at 3 years (when it becomes apparent, but no systematic screening) * Clinical transcatheter heart valve thrombosis at 3 years * All-cause mortality, stroke, myocardial infarction, and cardiovascular hospitalization at 3 years For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. |
| Efficacy: VARC-3 defined device success at 30 days | 30 days | Determine VARC-3 defined device success at 30 days * 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. |
| Technical success: 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. |
| Safety: VARC-3 defined early safety at 30 days | 30 days | Determine VARC-3 defined early safety at 30 days: * 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. |
| Procedural Outcomes (30 days) | 30 days | Procedural outcomes at 30 days, defined as: * 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 * Valve performance, including residual mean gradient * Risk and predictors of coronary obstruction Number and percentage of subjects with above specified outcomes at 30 days , along with individual component of the success, will be presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Impact 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 For the definition of transcatheter cardiac valve thrombosis, please refer to Outcome 5. 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) * Early and late THV failure predictors (after TAVI and redo-TAVI procedures) * CT findings related to THV failure (SVD) |
| Compliance with recommendation | 12 months | It will be assessed and percentages determined whether participating centers follow the published recommendation (itemized, compliance being voluntary). |
Countries
Austria, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, Switzerland
Contacts
Primary ContactClaudia Lüske, PhD
Backup ContactDaniel Greinert
Outcome results
None listed