Mechanical aortic valve replacement in non-elderly adults: meta-analysis and microsimulation.

AIMS: To support decision-making regarding prosthetic valve selection in non-elderly adults, we aim to provide a detailed overview of outcome after contemporary mechanical aortic valve replacement (AVR). METHODS AND RESULTS: A systematic review was conducted for papers reporting clinical outcome after AVR with bileaflet mechanical valves with a mean patient age ≥18 and ≤55 years, published between 1 January 1995 and 31 December 2015. Through meta-analysis outcomes were pooled and entered into a microsimulation model to calculate (event-free) life expectancy and lifetime event risk. Twenty-nine publications, encompassing a total of 5728 patients with 32 515 patient-years of follow-up (pooled mean follow-up: 5.7 years), were included. Pooled mean age at surgery was 48.0 years. Pooled early mortality risk was 3.15% (95% confidence interval (CI):2.37-4.23), late mortality rate was 1.55%/year (95%CI:1.25-1.92); 38.7% of late deaths were valve-related. Pooled thromboembolism rate was 0.90%/year (95%CI:0.68-1.21), major bleeding 0.85%/year (95%CI:0.65-1.12), nonstructural valve dysfunction 0.39%/year (95%CI:0.21-0.76), endocarditis 0.41%/year (95%CI:0.29-0.57), valve thrombosis 0.14%/year (95%CI:0.08-0.25), structural valve deterioration 0.00%/year (zero events observed), and reintervention 0.51%/year (95%CI:0.37-0.71), mostly due to nonstructural valve dysfunction and endocarditis. For a 45-year-old, for example, this translated to an estimated life expectancy of 19 years (general population: 34 years) and lifetime risks of thromboembolism, bleeding and reintervention of 18%, 15%, and 10%, respectively. CONCLUSION: 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.

Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial.

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.

Quality of life and prosthetic aortic valve selection in non-elderly adult patients.

OBJECTIVES: This study assesses quality of life in relation to prosthetic aortic valve selection and preferences for shared decision-making among non-elderly adult patients after aortic valve replacement (AVR). METHODS: A single-centre consecutive cohort of 497 AVR patients who underwent AVR between the age of 18 and 60 years was cross-sectionally surveyed 1-10 years after AVR. Health-related quality of life (Short-Form Health Survey, SF-36), valve-specific quality of life, patient experience with and preferences for involvement and final decision in prosthetic valve selection were investigated. RESULTS: Two-hundred and forty patients (48%) responded. The median age was 57 years (range 26-70). Compared with the general age-matched Dutch population, AVR patients reported worse physical health, but better mental health. Biological valve recipients reported lower general health than mechanical valve recipients. Mechanical valve recipients had more doubts about the decision to undergo surgery, were more bothered by valve sound, the frequency of doctor visits and blood tests, and possible bleeding, but were less afraid of a possible reoperation. Eighty-nine percent were of the opinion that it is important to be involved in prosthetic valve selection, whereas 64% agreed that they actually had been involved. A better patient experience with involvement in prosthetic valve selection was associated with better mental health (P = 0.036). CONCLUSIONS: Given the observed suboptimal patient involvement in prosthetic valve selection, the broad patient support for shared decision-making, and the positive association between patient involvement in prosthetic valve selection and mental health, tools to support shared decision-making would be useful in the setting of heart valve replacement.

Bentall Procedure: A Systematic Review and Meta-Analysis.

BACKGROUND: The Bentall procedure is considered the gold standard in the treatment of patients requiring aortic root replacement. An up-to-date overview of outcomes after the Bentall procedure is lacking. METHODS: We conducted a systematic review and meta-analysis of characteristics of and long-term outcome after the Bentall procedure with a mechanical valve prosthesis. Pooling was performed using the inverse variance method within a random-effects model. Outcome events are reported as linearized occurrence rates (percentage per patient year) with 95% confidence intervals. RESULTS: In total, 46 studies with 7,629 patients (mean age, 50 years; 76% men) were selected. Pooled early mortality was 6% (422 patients). During a mean follow-up of 6 years (49,175 patient-years), the annual linearized occurrence rate for late mortality was 2.02% (1.77%- 2.31%; 892 patients), for aortic root reoperation it was 0.46% (0.36%-0.59%), for hemorrhage it was 0.64% (0.47%-0.87%), for thromboemboli it was 0.77% (0.60%-1.00%), for endocarditis it was 0.39% (0.33%-0.46%), and for major adverse valve-related events it was 2.66% (2.17%-3.24%). Operations performed in more recent years were associated with lower rates of aortic root reoperation (beta = -0.452; p = 0.015). CONCLUSIONS: This systematic review illustrates that rates of aortic root reoperation after the Bentall procedure have decreased over the years. However, late mortality, major bleeding, and thromboembolic complications remain a concern. This report may be used to benchmark the potential therapeutic benefit of novel surgical approaches, such as valve-sparing aortic root replacement.

Prosthetic aortic valve selection: current patient experience, preferences and knowledge.

OBJECTIVE: Current clinical practice guidelines advocate shared decision-making (SDM) in prosthetic valve selection. This study assesses among adult patients accepted for aortic valve replacement (AVR): (1) experience with current clinical decision-making regarding prosthetic valve selection, (2) preferences for SDM and risk presentation and (3) prosthetic valve knowledge and numeracy. METHODS: In a prospective multicentre cohort study, AVR patients were surveyed preoperatively and 3 months postoperatively. RESULTS: 132 patients (89 males/43 females; mean age 67 years (range 23-86)) responded preoperatively. Decisional conflict was observed in 56% of patients, and in 25% to such an extent that it made them feel unsure about the decision. 68% wanted to be involved in decision-making, whereas 53% agreed that they actually were. 69% were able to answer three basic knowledge questions concerning prosthetic valves correctly. 56% were able to answer three basic numeracy questions correctly. Three months postsurgery, 90% (n=110) were satisfied with their aortic valve prosthesis, with no difference between mechanical and bioprosthetic valve recipients. CONCLUSIONS: In current clinical practice, many AVR patients experience decisional conflict and suboptimal involvement in prosthetic valve selection, and exhibit impaired knowledge concerning prosthetic valves and numeracy. Given the broad support for SDM among AVR patients and the obvious need for understandable information, to-be-developed tools to support SDM in the setting of prosthetic valve selection will help to improve quality of decision-making, better inform and actively involve patients, and reduce decisional conflict. TRIAL REGISTRATION NUMBER: NTR3618.