Background: Combined valvular and coronary artery bypass grafting (CAB G) surgery requires a long period of cardioplegic arrest (CA) that predisposes the heart to ischaemiareperfusion injury, low cardiac output syndrome, reperfusion dysrhythmias, inhospital mortality and increased costs. Procedures that can reduce the duration of CA would be expected to reduce intraoperative and postoperative complications. Mehods: Adults undergoing combined valvular and CABG surgery were randomized to either coronary surgery performed on the beating heart with cardiopulmonary bypass (CPB) support followed by CA for the valvular procedure (hybrid group) or surgery with both procedures carried out under CA (conventional group). The primary outcome was a composite of in-hospital death, postoperative myocardial infarction, cardiac dysrhythmias, requirements for cardiac pacing for more than 12 hours and/or inotropic support for more than 12 hours postoperativeiy. Results: One hundred and sixty patients (80 hybrid, 80 conventional) were randomized between March 2008 and July 2012. Mean age was 66.5 years and 74% were male. Valvular procedures included aortic (61.8%) and mitral (33.1%) alone or in combination (5.l %). The primary outcome occurred in 64/80 of the conventional group patients and 67/80 of the hybrid group patients (odds ratio 1.24, 95% Cl 0.54 to 2.86, p=0.61). The CA time was, on average, 16% shorter in the hybrid group (median 98 minutes vs. 89 minutes, geometric mean ration (GMR) 0.84, 95% Cl 0.77 to 0.93 , p=0.0004), but the overall duration of CPB was on average 7% longer in the hybrid group (GMR 1.07, 95% Cl 0.98 to 1.16, p=0.12). Cardiac troponin T plasma concentrations and levels of metabolites measured in heart biopsies were similar between the two treatment groups. Conclusion: The hybrid technique reduced the CA time, but this did not result in a significant reduction in the frequency of the primary outcome. In this trial the clinical outcomes and the extent of the myocardial injury were similar between the two surgical methods.

ObjectifsL’objectif de ce travail a été d’évaluer la faisabilité d’utiliser le gel LeGoo pour occlure temporairement les artères coronaires afin de réaliser des pontages coronariens à cœur battant initialement chez le porc puis chez l’humain. Les objectifs secondaires ont été d’étudier l’impact de l’injection du gel sur l’endothélium et le myocarde.MéthodesLa première étude a eu pour but d’évaluer la possibilité de réaliser chez le cochon des pontages coronariens sur l’artère interventriculaire antérieure ou l’artère coronaire droite avec une artère thoracique interne, et d’évaluer la fonction endothéliale des artères coronariennes au niveau de la zone d’injection du gel.La deuxième étude a analysé chez le porc la fonction endothéliale des artères thoraciques internes au niveau de la zone d’occlusion par du gel LeGoo chez le porc.Après l’obtention du marquage CE, la troisième étude a permis de prouver la faisabilité de l’utilisation de LeGoo dans la réalisation de pontages coronariens à cœur battant chez l’humain et d’évaluer l’impact myocardique de cette utilisation.La dernière étude était une étude randomisée, multicentrique, internationale, comparant l’utilisation du gel pour la réalisation des anastomoses, versus les occlusions conventionnelles par élastiques péri-coronaires. RésultatsPour la première étude, 14 cochons ont été pontés à cœur battant et sacrifiés à la 3ème h (n=8) ou au 3ème jour (n=6). L’étude de la réactivité endothéliale n’a pas mis en évidence de différence entre les artères coronaires occluses par le gel et l’artère coronaire circonflexe qui servait de témoin. L’endothélium ne présentait pas de lésions histologiques en microscopie. Les mêmes résultats ont été obtenus dans la deuxième étude, sur les 9 artères thoraciques internes qui avaient été occluses durant 15 minutes avec le gel LeGoo.Les premières utilisations humaines ont permis de réaliser 99 anastomoses chez 50 patients. Le taux de satisfaction sur la qualité de l’hémostase obtenue a été de 91%. Un patient a présenté une arythmie, qui a nécessité de dissoudre le gel et de mettre en place un shunt intra-coronaire. Un autre patient a présenté un infarctus du myocarde à J1 lié à une sténose sur l’artère thoracique interne en amont de l’anastomose, nécessitant une réfection du pontage. Les autres complications étaient identiques aux séries de la littérature.Au cours de l’étude randomisée, les temps d’anastomoses étaient plus courts dans le groupe LeGoo que dans le groupe élastiques (12,8 ± 4,7 min vs 15,4 ± 6 min, p<0,001). Les écarts étaient de 2 minutes environ pour les territoires antérieurs et de 4 minutes pour les territoires latéraux et postérieurs. Le taux de satisfaction pour l’hémostase était de 88% avec le gel alors qu’il était de 60% avec les élastiques (p<0,0001). Les autres critères péri- opératoire étaient statistiquement identiques. Conclusions L’utilisation du gel LeGoo (Poloxamer 407) permet de réaliser des anastomoses en diminuant les temps d’occlusion et de manière sécuritaire sans altérer les fonctions de l’endothélium coronarien. / ObjectifsThe objective of this work is to assess the feasibility of using the LeGoo gel to occlude the coronary arteries temporarily, to facilitate the performance of coronary bypass (off-pump technique), initially in pigs then in human. A Secondary objective was to evaluate the impact of the injection on the endothelium and myocardium.MethodesThe first study evaluated in pigs the feasibility of using LeGoo, while performing coronary bypass on the left anterior descending or on the right coronary artery and to evaluate the endothelial function of coronary arteries occluded by the gel.The second study analyzed endothelial function of internal thoracic arteries, in the area occluded by the gel.After obtaining the CE mark, a third study demonstrated the feasibility of the utilisation of LeGoo for temporary coronary artery occlusion during the performance of beating heart coronary bypass surgery in human.The last study was a randomized, multicenter and international clinical study that compared the gel with conventional vessel loop during the performance of off-pump coronary artery bypass anastomoses.ResultsIn the first study 14 pigs received coronary bypass and were sacrificed after 3 hours (n=8) or 3 days (n=6). The study of endothelial reactivity did not reveal any difference between the coronary arteries occluded by the gel and the circumflex coronary artery, which served as a control. The endothelium showed no histological damage. Identical observations were made on the 9 internal thoracic arteries, used in the second study and occluded during 15 minutes by a LeGoo plug.In the first human use, 99 anatomoses were performed in 50 patients. The level of satisfaction on the quality of haemostasis was 91%. One patient presented arrhythmia which required the introduction of an intracoronary shunt after rapid dissolution of the gel. Another patient had a myocardial infarct on day 1 associated with stenosis on the internal thoracic artery upstream of the anastomosis, requiring a refection of this bypass (new off pump procedure). Other complications were identical to what is reported in the literature.In the randomised study, anastomoses times were shorter in LeGoo group than with vessel loops (12,8 ± 4,7 min vs 15,4 ± 6 min, p<0,001). The differences were 2 minutes for anterior bypass and 4 minutes for the lateral and posterior territories.The satisfaction rate of haemostasis was 88% with the gel against it was 60.7% with the vessel loop (p<0,0001). Other peri-operative measurements were statistically identical between the 2 groups.ConclusionsLeGoo (a poloxamer based formulation) can be used safely for the performance of coronary anastomoses. Anastomotic times are shorter than with traditional vessel loops, without any alteration of the endothelial function.

Mild cognitive deficits that negatively impact self-management education-related outcomes may be present in a proportion of cardiac rehabilitation patients and the degree of impairment may vary by the type of coronary revascularization procedure. The purpose of this study was to compare cognitive function, as measured by the Montreal Cognitive Assessment (MoCA), between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) patients, and to determine independent variables of MoCA score. In a cross-sectional study, 78 cardiac rehabilitation patients (CABG n = 38, PCI n = 40) completed the MoCA. Demographics were collected and disease burden was calculated using the age-adjusted Charlson Comorbidity Index (ACCI). Mild cognitive deficits (MoCA ≤26) were present in 55.3% CABG and 30.0% PCI patients. An independent Student’s t test showed that MoCA scores were significantly lower among CABG patients (mean = 24.5, SD = 3.3) compared to PCI patients (M = 26.7, SD = 2.7), t (76) = 3.15, p < 0.01. Descriptive analyses of cognitive domain scores indicated that deficits in short-term memory and language were present among CABG patients. Using a backward regression, coronary revascularization procedure (CABG vs. PCI) (p = 0.006) and disease burden (ACCI) (p = 0.015) remained significant, while heart failure diagnosis became non-significant and was removed from the model (F (2, 75) = 8.382, p < 0.001). The final model explained 16.1% of the total variance in MoCA score (adjusted R2 = 0.161). Results indicate that cognitive deficits were present in cardiac rehabilitation participants and associated with the type of coronary revascularization procedure, suggesting the need for formal cognitive screening and adaptation of education interventions in cardiac rehabilitation. A future prospective cohort study is required to establish temporality, and to measure education-related outcomes, such as health-related quality of life (HRQOL) and self-management. / Thesis / Master of Science (MSc) / Cardiac rehabilitation (CR) is a multifaceted program consisting of exercise and education that is essential to the care of post-coronary revascularization patients. While exercise has shown to improve health outcomes, education has demonstrated inconsistent effects. Since education has imposed cognitive demands, this discrepancy in outcomes may, in part, be due to cognitive deficits present in a proportion of program attendees: the degree of impairment may vary by type of coronary revascularization procedure prior to CR. This study compared cognitive function between two groups of coronary revascularization patients, post-coronary bypass surgery and post-coronary angioplasty, and determined independent variables for cognitive function. Results showed that coronary bypass surgery patients had significantly lower cognitive function than coronary angioplasty patients at program intake. Coronary bypass surgery and accumulated disease burden were weakly associated with decreased cognitive function. Cognitive screening and adapted education for patients with cognitive deficits should be considered to improve CR outcomes.

Aims: Coronary Revascularization (CR) has increased patients' survival rate globally. However, the lack of a consensus definition of Health Related Quality of Life (HRQoL) and the different methodological and conceptual approaches adopted by researchers in the cardio-revascularization field create an incomplete picture of the influence of CR on individuals' HRQoL. By using mixed methodology, the current research aimed to explore Greek CHD patients' perspectives of their HRQoL after CR (Coronary Artery Bypass Grafting (CABG) or Percutaneous Coronary Interventions (PCI)), as well as detect and explain individual disparities. Method: Two studies were conducted with a total sample of 487 individuals: (1) The translation and validation of the Coronary Revascularization Outcome Questionnaire (CROQ) into Greek and (2) The longitudinal mixed methods study, the main study of the thesis, following a sequential explanatory design with two research components: a) the longitudinal quantitative component aimed to detect changes in patients' HRQoL (both overall and its subdomains) following CR over a 12-month period based on individuals' subjective evaluation as captured by the CROQ, detect the influence of CR type on the outcome and to explore potential predictors (individuals' demographic, clinical and behavioural features). Data were analysed using multilevel modelling; b) the qualitative component aimed to capture individuals' lived experience, their view and understanding of themselves and their life approximately 12 months after treatment using Interpretive Phenomenological Analysis (IPA). Results/findings: Based on participants' subjective evaluations as captured by the validated Greek version of the CROQ, one year after CR Greek Coronary Heart Disease (CHD) patients experience an increase in their HRQoL level compared to prior to CR. The pattern of change though is not constant; initially HRQoL increases with time, and then decreases again, however, remaining much greater compared to prior to CR one year after CR. Regarding the influence of the CR type of treatment on patients' HRQoL level, a year after CR mixed findings are revealed. In the symptoms and physical functioning subdomain, patients treated with CABG demonstrate a greater increase compared to patients treated with PCI. In the psychosocial functioning subdomain no difference is found. In the cognitive functioning subdomain, patients treated with CABG demonstrate a decline compared to their cognitive functioning prior to the CR. Various demographic, clinical and behavioural features are demonstrated to be predictors of the outcome though not consistent for all subdomains. The main predictors associated with larger positive changes following CR seem to be sex, BMI and smoking; females with low BMI that do not smoke tend to demonstrate a greater increase in HRQoL after CR. According to individuals' lived experience, participants, reflecting on their experience one year after treatment, perceive CR as a simple process and their negative experience is mostly related to medical care. Many participants with no symptoms or adverse effects tend to misperceive CHD, viewing their health condition as an acute disease treated with CR. Trying to understand disease causality they tend to adopt medical discourse especially in relation to stress as a factor that can be controlled by themselves and reflect on their own responsibility as a causal factor. Feeling grateful for being alive, sensing a different body, a 'revitalized body' as many participants suggest, as well as a fear of re-occurrence or disease progression motivate individuals to work on aspects of the self related to the CHD development in an effort to regain control over their life which has been reduced after the CHD diagnosis. In effect a dramatic change in how the self and life are viewed is reported, highlighting a positive growth; a greater appreciation of life, a personal growth and effort to build more meaningful relationships. Challenges that participants face in modification of their lifestyle are attributed to both external and internal factors. Concerning smoking participants' accounts point to a lack of knowledge regarding the relationship between smoking and CHD, a lack of support (by experts or family members) and conscious denial as a way to cope with every day anxiety and stress, but also a pleasure in everyday life. The findings provide a complementary insight into perceptions of individuals with CHD about their quality of life one year after CR, suggesting that other factors beyond CR may influence their perspectives. Conclusions/implications: This study highlights the benefits of using a mixed methods longitudinal design in exploring HRQoL. Both the quantitative and qualitative findings support the notion that HRQoL is a multidimensional, continuously changing concept, providing support for the Wold Health Organization's definition. Also, the findings suggest that CR has a positive influence on individuals' HRQoL. The effect of the CR type needs further investigation as mixed findings are observed in the present thesis. Moreover, it seems difficult to investigate the pure effect of CR on individuals' HRQoL without taking into consideration individuals' adjustment processes and positive growth triggered by the CR. The self regulation model (SRM) might be considered a useful theoretical framework for developing theory-based interventions aiming to alter patients' false beliefs since individuals' making-meaning process seems to be aligned with it. Finally, the complementary insights concerning smoking may help health care providers to develop smoking cessation interventions tailored to cardiac patients.