Diagnosis
Our focus is on patients diagnosed with:
- Aortic valve insufficiency;
- Aortic root aneurysm;
- Connective tissue disease (preventive operation).
Clinical consensus is that valve repair is preferable over valve replacement. Repair preserves the native aortic valve, whereby lifelong anticoagulation therapy is avoided, quality of life improves, the risk of complications is reduced and (re-) replacement is less frequent.
The current procedure
- Arrest heart and connect patient to heart-lung machine, then
- Perform valve sparing aortic root repair (stitches), then
- Re-pace heart, disconnect from heart-lung machine, then
- Evaluation using transoesophageal echocardiogram (TOE) informs on general functioning leakage, not geometry.
When TOE indicates sufficient heart performance, then finalize the operation.
When TOE indicates (partial) failure, then:
-Reconnect to heart-lung machine, re-arrest heart, re-repair valve (without new geometry information), or
-In case of insufficient repair specifications or time restraints, replace with prosthetic valve, disconnect, re-pace the heart, re-measure with TOE, &c.
-Finalize the operation
Unmet clinical need
Cardiothoracic surgeons in some cases prefer replacement over valve-sparing because of elevated technical and perceived risks in-operation
The AVP Device offers :
- Relief of a burdensome and costly procedure for the team by providing a direct intra-operative method to visually check and actively measure the valve condition;
- Reduction of significant uncertainty of duration of the clinically preferred route;
- Reduction risks of sub optimal results or patient complications in-operation and post-operation;
- Increase frequency of repair over replacement through reduction of perceived risk.
Major benefits for Patient and Team
- Surgical team is enabled to visually assess and evaluate the valve functioning.
- Availability of improved quality of valve geometry information.
- Facilitation of localizing the locus of intervention.
- Supports fast decision making.
- Shortens operation time by enabling performance testing in-operation.
- Improves result of the procedure with lower risk of technical complications.
- Avoiding reiterating procedure provides access to valve sparing operations, thereby decreasing the perceived risk.