N/A
N=71
Portico Valve-in-Valve Retrospective Registry
Aortic Valve Stenosis · Aortic Valve Failure · Aortic Insufficiency · Aortic Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT05002088 ↗Enrolled (actual)
71
Serious AEs
76.1%
Results posted
Feb 2025
Primary outcome: Primary: Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication. — 2; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Transcatheter Aortic Valve Replacement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication. |
2; 0 | — |
| PRIMARY Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke. |
7; 0 | — |
| SECONDARY Number of Participants With Procedural Success |
53; 12 | — |
| SECONDARY Evaluation of Adverse Event Rates (Descriptive Endpoint) |
45.8; 15.6; 19.0; 0.0; 3.5; 7.1 | — |
| SECONDARY Evaluation of Adverse Event Rates (Descriptive Endpoint) |
45.8; 15.6; 19.0; 0.0; 3.5; 7.1 | — |
| SECONDARY Evaluation of Adverse Event Rates (Descriptive Endpoint) |
45.8; 15.6; 19.0; 0.0; 3.5; 7.1 | — |
| SECONDARY Evaluation of Adverse Event Rates (Descriptive Endpoint) |
45.8; 15.6; 19.0; 0.0; 3.5; 7.1 | — |
| SECONDARY Evaluation of Adverse Event Rates (Descriptive Endpoint) |
45.8; 15.6; 19.0; 0.0; 3.5; 7.1 | — |
| SECONDARY Evaluation of Adverse Event Rates (Descriptive Endpoint) |
45.8; 15.6; 19.0; 0.0; 3.5; 7.1 | — |
| SECONDARY Assessment of Clinical Benefit Endpoint - NYHA Class |
100.0; 0.0; 0.0; 0.0; 0.0; 100.0 | — |
| SECONDARY Assessment of Clinical Benefit Endpoint - NYHA Class |
100.0; 0.0; 0.0; 0.0; 0.0; 100.0 | — |
| SECONDARY Assessment of Clinical Benefit Endpoint - NYHA Class |
100.0; 0.0; 0.0; 0.0; 0.0; 100.0 | — |
| SECONDARY Assessment of Clinical Benefit Endpoint - NYHA Class |
100.0; 0.0; 0.0; 0.0; 0.0; 100.0 | — |
| SECONDARY Assessment of Clinical Benefit Endpoint - NYHA Class |
100.0; 0.0; 0.0; 0.0; 0.0; 100.0 | — |
| SECONDARY Assessment of Clinical Benefit Endpoint - NYHA Class |
100.0; 0.0; 0.0; 0.0; 0.0; 100.0 | — |
| SECONDARY Paravalvular Leak as Measured by Core Lab Echocardiography |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Paravalvular Leak as Measured by Core Lab Echocardiography |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Paravalvular Leak as Measured by Core Lab Echocardiography |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Paravalvular Leak as Measured by Core Lab Echocardiography |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Paravalvular Leak as Measured by Core Lab Echocardiography |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Paravalvular Leak as Measured by Core Lab Echocardiography |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Mean Transvalvular Gradient as Measured by Core Lab Echocardiography |
9.15; 14.00 | — |
| SECONDARY Mean Transvalvular Gradient as Measured by Core Lab Echocardiography |
9.15; 14.00 | — |
| SECONDARY Mean Transvalvular Gradient as Measured by Core Lab Echocardiography |
9.15; 14.00 | — |
| SECONDARY Mean Transvalvular Gradient as Measured by Core Lab Echocardiography |
9.15; 14.00 | — |
| SECONDARY Mean Transvalvular Gradient as Measured by Core Lab Echocardiography |
9.15; 14.00 | — |
| SECONDARY Mean Transvalvular Gradient as Measured by Core Lab Echocardiography |
9.15; 14.00 | — |
| SECONDARY Aortic Valve Area as Measured by Core Lab Echocardiography |
2.09; 1.26 | — |
| SECONDARY Aortic Valve Area as Measured by Core Lab Echocardiography |
2.09; 1.26 | — |
| SECONDARY Aortic Valve Area as Measured by Core Lab Echocardiography |
2.09; 1.26 | — |
| SECONDARY Aortic Valve Area Measured by Core Lab Echocardiography |
1.63; 1.48 | — |
| SECONDARY Aortic Valve Area as Measured by Core Lab Echocardiography |
2.09; 1.26 | — |
| SECONDARY Aortic Valve Area as Measured by Core Lab Echocardiography |
2.09; 1.26 | — |
| SECONDARY New Pacemaker Implant |
1.8; 0.0 | — |
| SECONDARY New Pacemaker Implant |
1.8; 0.0 | — |
Summary
The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.
Eligibility Criteria
Inclusion Criteria
- Subject had a degenerated surgical aortic bioprosthetic valve with severe aortic stenosis, severe regurgitation, or a combination of at least moderate stenosis with at least moderate regurgitation per EAPCI-ESC-EACTS standardized criteria.
- Surgical bioprosthesis true inner diameter (true ID) was ≥ 19 mm and ≤ 27 mm and was confirmed by either CT or confirmed by the Valve in Valve Aortic App. Refer to the PCR website https://www.pcronline.com/PCR-Publications/PCR-mobile-apps/Valve-in-Valve-Aortic-app Note: if CT was contraindicated and/or not possible to be obtained, a transesophageal echocardiogram (TEE) will be accepted for sizing.
- Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery to replace the surgical aortic bioprosthetic valve.
- Subject provided written informed consent prior to performing data collection for study specific visits. For patients that are deceased at the time of enrollment, all institutional/local legal and regulatory requirements for consent must be met prior to enrollment and data collection.
- Subject is ≥ 18 years of age or legal age in host country at the time of consent.
- Prior to the Portico ViV index procedure, the subject had New York Heart Association (NYHA) class II, III, or IV.
- Subject had a minimum vessel diameter of 6.0 mm for Portico™ delivery system access or a minimum of 5.0 mm for the FlexNav™ delivery system.
- Subject had the Portico or FlexNav delivery system enter their vasculature
Exclusion Criteria
- Subject had evidence of an acute MI, percutaneous intervention, or a peripheral intervention ≤30 days prior to Portico ViV index procedure (MI defined as: ST Segment Elevation as evidenced on 12 Lead ECG).
- Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC 3.0 mg/dL (265.5μmol/L)) and/or end stage renal disease requiring chronic dialysis.
- Subject had active bacterial endocarditis or ongoing sepsis ≤ 6 months prior to the index procedure.
- Surgical aortic bioprosthetic valve was unstable or rocking.
- Subject had a vascular condition (i.e. stenosis, tortuosity, or severe calcification) that made insertion and endovascular access to the aortic valve impossible.
- Subject was unable to tolerate antiplatelet or anticoagulant therapy
Data sourced from ClinicalTrials.gov (NCT05002088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.