Preoperative optimization of cardiac valve patients’ expectations: Study protocol of the randomized controlled ValvEx-trial

Abstract

IntroductionComplete recovery after surgery depends on psychological factors such as preoperative information, expectations, and surgery-associated anxiety. Prior studies have shown that even a short preoperative psychological intervention aiming at optimized expectations (EXPECT) can improve postoperative outcomes in coronary artery bypass patients. However, this intervention may benefit only a small subgroup of heart surgery patients since implementing preoperative psychological interventions into the daily clinical routine is difficult due to the additional time and appointments. It is unclear whether the EXPECT intervention can be shortened and whether heart valve patients would also benefit from interventions that optimize patients’ expectations. The multicenter ValvEx trial aims (i) to adapt an effective preoperative psychological intervention (EXPECT) to make it brief enough to be easily integrated into the preoperative routine of heart valve patients and (ii) to examine if the adapted preoperative psychological intervention improves the subjectively perceived illness-related disability (PDI) up to 3 months after surgery.Materials and analysisIn two German university hospitals, N = 88 heart valve patients who undergo heart surgery are randomized into two groups [standard of care (SOC) vs. standard of care plus interventional expectation manipulation (SOC and EXPECT)] after baseline assessment. Patients in the EXPECT group additionally to standard of care participate in the preoperative psychological intervention (30–40 min), focusing on optimizing expectations and have two booster-telephone calls (4 and 8 weeks after the surgery, approx. 15 min). Both groups have assessments again on the evening before the surgery, 4 to 6 days, and 3 months after the surgery.DiscussionThe trial demonstrates excellent feasibility in the clinical routine and a high interest by the patients.Ethics and disseminationThe Ethics Committees of the Department of Medicine of the Philipps University of Marburg and the Department of Medicine of the University of Giessen approved the study protocol. Study results will be published in peer-reviewed journals and presented at congresses.Clinical trial registrationClinicalTrials.gov, identifier NCT04502121.

Impact of cardiac rehabilitation on pre- and post-operative transcatheter aortic valve replacement prognoses

“…In addition, patients with moderate to severe anxiety before cardiac surgery present with higher postoperative pain scores and a significantly increased need for intra- and postoperative analgesia, according to Muhammad Kashif et al ( 95 ). SAVR or TAVR, though, could aid in reducing anxiety among elderly patients with AS ( 89 , 96 ) and increasing confidence in their bodily states ( 16 , 97 ), while CR could aid in improving depressive states ( 18 , 98 – 100 ). Screening for psychological disorders should be incorporated into preoperative risk stratification ( 101 ), and future research must determine whether interventions to treat psychological disorders preoperatively or postoperatively can improve outcomes.…”

Patient-centered evaluation of an expectation-focused intervention for patients undergoing heart valve surgery: a qualitative study

“…This influence remains consistent regardless of the patient's medical condition or the type of surgical procedure ( 3 ). Negative expectations are associated with more complications, lower quality of life, higher illness-related disability, depressive symptoms, and prolonged inability to work ( 4 , 5 ). Interventions to optimize patients' expectations before undergoing heart surgery have been developed in the past ( 5 – 7 ).…”

“…Negative expectations are associated with more complications, lower quality of life, higher illness-related disability, depressive symptoms, and prolonged inability to work (4,5). Interventions to optimize patients' expectations before undergoing heart surgery have been developed in the past (5)(6)(7). Former studies showed an association between expectation-focused interventions and a faster recovery, including a reduced hospital stay and quicker return to work (8)(9)(10).…”