Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR

Overview

About this study

The purpose of this study is to compare the changes in quality of life following valve-invalve TAVR guided by Doppler-echocardiography vs. catheterization measurements.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team.

- Surgical stented bioprosthetic valve (label size ≤ 25 mm).

- TAVR with the SAPIEN 3 Ultra valve.

Exclusion Criteria:

- Stentless or sutureless surgical valves.

- Trifecta bioprosthesis.

- Hancock II bioprosthesis.

- High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT < 4 mm or based on the criterion of the heart team responsible for the procedure).

- Impossibility to obtain written informed consent.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/7/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mackram Eleid, M.D.

Open for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

  • The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. Read More on PubMed
  • The use of valve-in-valve–transcatheter aortic valve replacement (VIV-TAVR) in degenerated aortic bioprosthesis has been increasing, but the Food and Drug Administration approval is limited to high-risk patients. We analyzed the real-world experience of SAPIEN 3 VIV-TAVR, especially in lower-risk patients, based on the Society of Thoracic Surgeons (STS) score. Read More on PubMed
  • Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV. Read More on PubMed
  • The limited durability of surgical bioprostheses, combined with an ageing population, has led to an increasing demand for replacing degenerated bioprosthetic surgical heart valves, which is projected to increase. Valve-in-valve transcatheter aortic valve implantation involves implanting a transcatheter heart valve within a degenerated bioprosthetic surgical heart valve. A significant minority of patients, however, are left with a suboptimal haemodynamic result with high residual gradients. This is more common with smaller surgical bioprostheses, and may be associated with a worse prognosis. The novel concept of fracturing the previously implanted bioprosthetic surgical heart valve during valve-in-valve transcatheter aortic valve implantation to create a more favourable haemodynamic profile has shown great promise, particularly in smaller valves. Herein, we describe the benefits, limitations and potential complications of this novel approach. Read More on PubMed
  • Transcatheter aortic valve replacement (TAVR) for degenerated surgical bioprosthetic aortic valves is associated with favorable early outcomes. However, little is known about the durability and longer-term outcomes associated with this therapy. Read More on PubMed
  • We sought to investigate the procedural and hemodynamic outcome after valve-in-valve transcatheter aortic valve replacement (VinV-TAVR) for different surgical (SBV) and transcatheter (TAVR) bioprosthetic valves. Read More on PubMed
  • Data on long-term outcomes after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) are scarce. The objective of this study was to determine the long-term clinical outcomes and structural valve degeneration (SVD) over time in patients undergoing ViV-TAVR. Read More on PubMed
  • Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) has been established as a safe and effective means of treating failed surgical bioprosthetic valves (BPVs) in patients at high risk for complications related to reoperation. Patients who undergo VIV TAVR are at risk of patient-prosthesis mismatch, as the transcatheter heart valve (THV) is implanted within the ring of the existing BPV, limiting full expansion and reducing the maximum achievable effective orifice area of the THV. Importantly, patient-prosthesis mismatch and high residual transvalvular gradients are associated with reduced survival following VIV TAVR. Bioprosthetic valve fracture (BVF) is as a novel technique to address this problem. During BPV, a non-compliant valvuloplasty balloon is positioned within the BPV frame, and a highpressure balloon inflation is performed to fracture the surgical sewing ring of the BPV. This allows for further expansion of the BPV as well as the implanted THV, thus increasing the maximum effective orifice area that can be achieved after VIV TAVR. This review focuses on the current evidence base for BVF to facilitate VIV TAVR, including initial bench testing, procedural technique, clinical experience and future directions. Read More on PubMed
  • Bioprosthetic valve use has increased significantly. Considering their limited durability, there will remain an ongoing clinical need for repairing or replacing these prostheses in the future. The current standard of care for treating bioprosthetic valve degeneration involves redo open-heart surgery. However, repeat cardiac surgery may be associated with significant morbidity and mortality. With the rapid evolution of transcatheter heart valve therapies, the feasibility and safety of implanting a transcatheter heart valve within a failed tissue valve has been established. We review the historical perspective of transcatheter valve-in-valve therapy, as well as the main procedural challenges and clinical outcomes associated with this new less invasive treatment option. Read More on PubMed
  • Owing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed. Read More on PubMed
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CLS-20554436

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