No abstract

This study demonstrates that outcome after mechanical AVR in non-elderly adults is characterized by suboptimal survival and considerable lifetime risk of anticoagulation-related complications, but also reoperation. Non-elderly adult patients who are facing prosthetic valve selection are entitled to conveyance of evidence-based estimates of the risks and benefits of both mechanical and biological valve options in a shared decision-making process.

Background-A Dutch online patient decision aid to support prosthetic heart valve selection was recently developed.A multicenter randomized controlled trial was conducted to assess whether use of the patient decision aid results in optimization of shared decision making in prosthetic heart valve selection. Methods and Results-In a 5-center randomized controlled trial, patients were allocated to receive either standard preoperative care (control group) or additional access to the patient decision aid (intervention group). Legally capable adult patients accepted for elective isolated or combined aortic and mitral valve replacement were included. Primary outcome was preoperative decisional conflict (Decisional Conflict Scale); secondary outcomes included patient knowledge, involvement in valve selection, anxiety and depression, (valve-specific) quality of life, and regret. Out of 306 eligible patients, 155 were randomized (78 control and 77 intervention). Preoperative decisional conflict did not differ between the groups (34% versus 33%; P=0.834). Intervention patients felt better informed (median Decisional Conflict Scale informed subscore: 8 versus 17; P=0.046) and had a better knowledge of prosthetic valves (85% versus 68%; P=0.004). Intervention patients experienced less anxiety and depression (median Hospital Anxiety and Depression Scale score: 6 versus 9; P=0.015) and better mental well-being (mean Short Form Health Survey score: 54 versus 50; P=0.032). Three months postoperatively, valve-specific quality of life and regret did not differ between the groups. Conclusions-A patient decision aid to support shared decision making in prosthetic heart valve selection does not lower decisional conflict. It does result in more knowledgeable, better informed, and less anxious and depressed patients, with a better mental well-being. Clinical Trial Registration-http://www.trialregister.nl. Unique identifier: NTR4350. In a previous study, we have shown that many patients experience decisional conflict and suboptimal involvement in prosthetic valve selection and have limited knowledge of the advantages and disadvantages of mechanical and biological valves. 5Because no tools to support SDM are available in this setting, an online patient decision aid (PDA) to support prosthetic heart valve selection was recently developed in the Netherlands. The PDA informs patients about the available treatment options, encourages participation in decision making, and helps patients to assess their prosthetic valve preferences in relation to their values and goals in life, so they are optimally prepared to participate in prosthetic valve selection with their treating physician. 6 We tested in a multicenter randomized controlled trial the hypothesis that the use of the PDA results in an improved quality of decision making in prosthetic heart valve selection compared with standard preoperative care in patients accepted for aortic and mitral valve replacement. Quality of decisionmaking measures included decisional conflict (primary outcome m...