Background Prosthesis-patient mismatch (PPM), routinely used to characterize the degree of hemodynamic obstruction caused by a prosthetic heart valve, is associated with adverse patient outcomes... Show moreBackground Prosthesis-patient mismatch (PPM), routinely used to characterize the degree of hemodynamic obstruction caused by a prosthetic heart valve, is associated with adverse patient outcomes after aortic valve replacement (AVR). In the common definition of PPM, the opening area of the valve is related to the patients' cardiac output, by indexing effective orifice area (EOA) with body surface area (BSA). The aim of this study is to assess the implications of using BSA as a proxy for cardiac output. Methods 744 patients with normal LV function underwent echocardiographic assessment after surgical AVR. To validate the use of BSA as a proxy for cardiac output, the relation between these variables was analyzed. The effects of BSA on the classification of PPM (EOAi < 0.85 cm(2)/m(2)) and the presence of hemodynamic obstruction (mean gradient >= 20 mmHg and/or Doppler velocity index < 0.35) were estimated. Results There was a weak correlation between BSA and cardiac output (r: 0.29, 95% CI: 0.22;0.35), and cardiac output was not proportional to BSA (Cardiac output = 1.5 x BSA +1.9). As a result, the increased risk of patients with a large BSA to be labelled with PPM (OR: 5.2, 95% CI: 2.5,11 per m(2) BSA), was not reflected by a significantly higher risk of hemodynamic obstruction (OR: 1.5, 95% CI: 0.5,4.9 per m(2) BSA). Conclusions The current definition of PPM results in a systematic overestimation of hemodynamic obstruction in patients with a larger BSA, and we recommend cautious use in this subgroup. Show less
Aim Although referral to phase 2 cardiac rehabilitation (CR) following open-heart surgery is recommended in professional guidelines, according to the literature, participation rates are suboptimal.... Show moreAim Although referral to phase 2 cardiac rehabilitation (CR) following open-heart surgery is recommended in professional guidelines, according to the literature, participation rates are suboptimal. This study investigates the referral and enrolment rates, as well as determinants for these rates, for phase 2 CR following open-heart surgery via sternotomy. Methods A cross-sectional survey study was conducted among patients who underwent open-heart surgery via sternotomy in a university hospital. Data on referral and enrolment rates and possible factors associated with these rates (age, sex, type of surgery, educational level, living status, employment, income, ethnicity) were collected by a questionnaire or from the patient's medical file. Univariate logistic regression analysis (odds ratio) was used to study associations of patient characteristics with referral and enrolment rates. Results Of the 717 eligible patients, 364 (51%) completed the questionnaire. Their median age was 68 years (interquartile range 61-74) and 82 (23%) were female. Rates for referral to and enrolment in phase 2 CR were 307 (84%) and 315 (87%), respectively. Female sex and older age were independently associated with both non-referral and non-enrolment. Additional factors for non-enrolment were surgery type (coronary artery bypass grafting with valve surgery and miscellaneous types of relatively rare surgery), living alone and below-average income. Conclusion Phase 2 CR referral and enrolment rates for patients following open-heart surgery were well over 80%, suggesting adequate adherence to professional guidelines. During consultation, physicians and specialised nurses should pay more attention to certain patient groups (at risk of non-enrolment females and elderly). In addition, in-depth qualitative research to identify reasons for non-referral and/or non-enrolment is needed. Show less
ObjectivesPreoperative anticoagulation management (PAM) is a complex, multidisciplinary process important to patient safety. The Functional Resonance Analysis Method (FRAM) is a novel method to... Show moreObjectivesPreoperative anticoagulation management (PAM) is a complex, multidisciplinary process important to patient safety. The Functional Resonance Analysis Method (FRAM) is a novel method to study how complex processes usually go right at the frontline (labeled Safety-II) and how this relates to predefined procedures. This study aimed to assess PAM in everyday practice and explore the usability and utility of FRAM. MethodsThe study was conducted at an Australian and European Cardiothoracic Surgery Department. A FRAM model of work-as-imagined was developed using (inter)national guidelines. Semistructured interviews with 18 involved professionals were used to develop models reflecting work-as-done at both sites, which were presented to staff for validation. Workload in hours was estimated per process step. ResultsIn both centers, work-as-done differed from work-as-imagined, such as in the division of tasks among disciplines (e.g., nurses/registrars rather than medical specialists), but control mechanisms had been developed locally to ensure safe care (e.g., crosschecking with other clinicians). Centers had organized the process differently, revealing opportunities for improvement regarding patient information and clustering of clinic visits. Presenting FRAM models to staff initiated discussion on improvement of functions in the model that are vital for success. Overall workload was estimated at 47 hours per site. ConclusionsThis FRAM analysis provided insight into PAM from the perspective of frontline clinicians, revealing essential functions, interdependencies and variability, and the relation with guidelines. Future studies are warranted to study the potential of FRAM, such as for guiding improvements in complex systems. Show less
Aims Indexed effective orifice area (EOAi) charts are used to determine the likelihood of prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR). The aim of this study is to... Show moreAims Indexed effective orifice area (EOAi) charts are used to determine the likelihood of prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR). The aim of this study is to validate whether these EOAi charts, based on echocardiographic normal reference values, can accurately predict PPM.Methods and results In the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial, 986 patients with aortic valve stenosis/regurgitation underwent AVR with an Avalus valve. Patients were randomly split (50:50) into training and test sets. The mean measured EOAs for each valve size from the training set were used to create an Avalus EOAi chart. This chart was subsequently used to predict PPM in the test set and measures of diagnostic accuracy (sensitivity, specificity, and negative and positive predictive value) were assessed. PPM was defined by an EOAi <= 0.85 cm(2)/m(2) and severe PPM was defined as EOAi <= 0.65 cm(2)/m(2). The reference values obtained from the training set ranged from 1.27 cm(2) for size 19 mm up to 1.81 cm(2) for size 27 mm. The test set had an incidence of 66% of PPM and 24% of severe PPM. The EOAi chart inaccurately predicted PPM in 30% of patients and severe PPM in 22% of patients. For the prediction of PPM, the sensitivity was 87% and the specificity 37%. For the prediction of severe PPM, the sensitivity was 13% and the specificity 98%.Conclusion use of echocardiographic normal reference values for EOAi charts to predict PPM is unreliable due to the large proportion of misclassifications. Show less
Background: Atrial fibrillation (AF), sternal wound infection, and cardiac decompensation are complications that can occur after cardiac surgery. Early detection of these complications is... Show moreBackground: Atrial fibrillation (AF), sternal wound infection, and cardiac decompensation are complications that can occur after cardiac surgery. Early detection of these complications is clinically relevant, as early treatment is associated with better clinical outcomes. Remote monitoring with the use of a smartphone (mobile health [mHealth]) might improve the early detection of complications after cardiac surgery.Objective: The primary aim of this study is to compare the detection rate of AF diagnosed with an mHealth solution to the detection rate of AF diagnosed with standard care. Secondary objectives include detection of sternal wound infection and cardiac decompensation, as well as assessment of quality of life, patient satisfaction, and cost-effectiveness.Methods: The Box 2.0 is a study with a prospective intervention group and a historical control group for comparison. Patients undergoing cardiac surgery at Leiden University Medical Center are eligible for enrollment. In this study, 365 historical patients will be used as controls and 365 other participants will be asked to receive either The Box 2.0 intervention consisting of seven home measurement devices along with a video consultation 2 weeks after discharge or standard cardiac care for 3 months. Patient information will be analyzed according to the intention-to-treat principle. The Box 2.0 devices include a blood pressure monitor, thermometer, weight scale, step count watch, single-lead electrocardiogram (ECG) device, 12-lead ECG device, and pulse oximeter.Results: The study started in November 2018. The primary outcome of this study is the detection rate of AF in both groups. Quality of life is measured with the five-level EuroQol five-dimension (EQ-5D-5L) questionnaire. Cost-effectiveness is calculated from a society perspective using prices from Dutch costing guidelines and quality of life data from the study. In the historical cohort, 93.9% (336/358) completed the EQ-5D-5L and patient satisfaction questionnaires 3 months after cardiac surgery.Conclusions: The rationale and design of a study to investigate mHealth devices in postoperative cardiac surgery patients are presented. The first results are expected in September 2020. Show less
OBJECTIVES: To improve haemodynamic performance, design modifications of prosthetic valves have been proposed with each new generation of valves. These different designs also impact the amount of... Show moreOBJECTIVES: To improve haemodynamic performance, design modifications of prosthetic valves have been proposed with each new generation of valves. These different designs also impact the amount of mechanical wear, because mechanical stresses are distributed differently. Because long-term evidence for new prosthetic valves is lacking, this in vitro study compared hydrodynamic performance and durability among 3 currently available bioprosthetic valves with internally (IMLV) or externally mounted leaflets (EMLV).METHODS: Prostheses of the internally mounted Medtronic Avalus and Carpentier-Edwards Perimount Magna Ease valves were compared to prostheses of the externally mounted Abbott Trifecta valve. For each labelled size (e.g. 19, 21 and 23) of the 3 types, 3 valves underwent accelerated wear testing for up to 600 million cycles, corresponding to similar to 15 years of simulated wear. The valves underwent hydrodynamic testing and visual inspection.RESULTS: EMLV had the largest effective orifice area and lowest pressure gradient for each labelled size at baseline and 600 million cycles; the effective orifice area and the pressure gradient were equivalent for the 2 types of IMLV. Five of 9 EMLVs had at least 1 hole or tear in the leaflet tissue around the stent posts, which resulted in severe regurgitation at 500 million cycles in 2 cases. All IMLVs were intact at 600 million cycles with minimal tissue wear.CONCLUSIONS: EMLV showed superior hydrodynamic performance but inferior mechanical durability compared to IMLV after 600 million cycles of testing. The primary failures were because of significant mechanical abrasion in the commissural region, which may warrant close monitoring of EMLV during long-term follow-up. Show less
