A formalized shared decision-making process with individualized decision aids for older patients referred for cardiac surgery.

BACKGROUND: Comprehension of risks, benefits and alternative treatment options is poor among patients referred for cardiac surgery interventions. We sought to explore the impact of a formalized shared decision-making (SDM) process on patient comprehension and decisional quality among older patients referred for cardiac surgery. METHODS: We developed and evaluated a paper-based decision aid for cardiac surgery within the context of a prospective SDM design. Surgeons were trained in SDM through a Web-based program. We acted as decisional coaches, going through the decision aids with the patients and their families, and remaining available for consultation. Patients (aged ≥ 65 yr) undergoing isolated valve, coronary artery bypass graft (CABG) or CABG and valve surgery were eligible. Participants in the non-SDM phase followed standard care. Participants in the SDM group received a decision aid following cardiac catheterization, populated with individualized risk assessment, personal profile and comorbidity status. Both groups were assessed before surgery on comprehension, decisional conflict, decisional quality, anxiety and depression. RESULTS: We included 98 patients in the SDM group and 97 in the non-SDM group. Patients who received decision aids through a formalized SDM approach scored higher in comprehension (median 15.0, interquartile range [IQR] 12.0-18.0) than those who did not (median 9.0, IQR 7.0-12.0, p < 0.001). Decisional quality was greater in the SDM group (median 82.0, IQR 73.0-91.0) than in the non-SDM group (median 76.0, IQR 62.0-82.0, p < 0.05). Decisional conflict scores were lower in the SDM group (mean 1.76, standard deviation [SD] 1.14) than in the non-SDM group (mean 5.26, SD 1.02, p < 0.05). Anxiety and depression scores showed no significant difference between groups. CONCLUSION: Institution of a formalized SDM process including individualized decision aids improved comprehension of risks, benefits and alternatives to cardiac surgery, as well as decisional quality, and did not result in increased levels of anxiety.

Structural valve deterioration of bioprosthesis in the aortic position: A single-center experience.

BACKGROUND: Aortic valve replacement (AVR) is one of the most common open-heart surgical procedures. The durability of the tissue valve in the aortic position is crucial in AVR and transcatheter AVR. We reviewed structural valve deterioration using echocardiographic follow-up in three types of surgical aortic tissue valves. METHODS: A retrospective analysis was conducted where hemodynamic deterioration was evaluated and compared using transthoracic echocardiography, including pressure gradients and effective orifice area. Kaplan-Meier analyses were used to summarize the time to failure. RESULTS: The study included 133 Trifecta, 156 Epic, and 321 Magna Ease valves. Seventy-six percent (1941/2551) of patients had to be excluded due to insufficient echo data. Through univariate analysis, 34% (216/610) of valves met deterioration criteria after 24 months. Unadjusted survival curves showed a significant difference between valves (p ≤ .001), with a longer mean time to deterioration for the Magna Ease versus Trifecta and Epic of 68.9 versus 50.1 and 38.2 months, respectively. A Cox proportional hazard analysis found worse hazard ratios of 1.69 (p ≤ .04) and 2.4 (p ≤ .01) for Trifecta versus Magna and Epic versus Trifecta, respectively. CONCLUSION: All three valve types demonstrated structural valve deterioration on echocardiographic follow-up with significant differences in rate. The Magna Ease appeared to have the highest durability, and the Epic the lowest. Further investigation is warranted to confirm the results in a larger multicenter study.

Six-year follow-up of aortic valve reoperation rates: Carpentier-Edwards Perimount versus St. Jude Medical Trifecta.

BACKGROUND: The Carpentier-Edwards Perimount valves have a proven track record in aortic valve replacement: good durability, hemodynamic performance, rates of survival, and low rates of valve-related complications and prosthesis-patient mismatch. The St. Jude Medical Trifecta is a newer valve that has shown comparable early and midterm outcomes. Studies show reoperation rates of Trifecta are comparable with Perimount valves, with a few recent studies bringing into focus early structural valve deterioration (SVD), and increased midterm SVD in younger patients. Given that midterm data for Trifecta is still sparse, we wanted to confirm the early low reoperation rates of Trifecta persist over time compared with Perimount. METHODS: The Maritime Heart Centre Database was searched for AVR between 2011 and 2016, inclusive. The primary endpoint of the study was all-cause reoperation rate. RESULTS: In total, 711 Perimount and 453 Trifecta implantations were included. The reoperation hazards were determined for age: 0.96 (0.92-0.99; p = .02), female (vs. male): 0.35 (0.08-1.53; p = .16), smoker (vs. nonsmoker): 2.44 (0.85-7.02; p = .1), and Trifecta (vs. Perimount): 2.68 (0.97-7.39; p = .06). Kaplan-Meier survival analysis in subgroups-age <60, age ≥60, male, female, smoker, and nonsmoker-showed Perimount having lower reoperation rates than Trifecta in patients younger than 60 (p = .02) and current smokers (p < .01). CONCLUSIONS: The rates of reoperation of Perimount and Trifecta were comparable, with Trifecta showing higher rates in patients younger than 60 years, and current smokers. Continued diligence and further independent reporting of midterm reoperation and SVD rates of the Trifecta, including detailed echocardiographic follow-up, are needed to confirm these findings.

Impact of Clopidogrel Stop Interval on Major Adverse Bleeding Events in Cardiac Surgery.

BACKGROUND: Major societal guidelines recommend a 5-day stop interval before cardiac surgery for patients with acute coronary syndrome receiving clopidogrel. Yet, many such patients present with high acuity, generating surgeon inclination toward use of shorter stop intervals. Thus, this study aimed to determine the impact of the duration and timing of the interval of clopidogrel cessation on adverse bleeding events. METHODS: Patients who underwent cardiac surgery between 2009 and 2016 at a tertiary-care centre were included in this retrospective cohort study. Multivariable logistic regression models adjusted for clopidogrel stop interval, age, urgency of procedure, and procedure type were used to quantify the effect of clinically relevant baseline demographic characteristics on incidence of massive transfusion as well as hemorrhagic complication outcomes. RESULTS: A total of 5748 patients underwent cardiac surgery. In this cohort, 1743 patients (30.3%) received clopidogrel preoperatively, and 884 (50.7%) of these patients discontinued clopidogrel 5 days before presenting to the operating room. The administration of clopidogrel 1-2 days before surgery (odds ratio 1.97; 95% confidence interval: 1.18 to 3.29) was an independent predictor for massive transfusions and hemorrhagic complications (odds ratio 1.85; 95% confidence interval: 1.01 to 3.37). The 3-4 day group did not have an increased risk of major bleeding complications. The risk for both massive transfusions and hemorrhagic complications also increased with the urgency and complexity of surgery. CONCLUSION: A clopidogrel stop interval of 3-4 days preoperatively was not associated with an increased risk for major bleeding complications.

INTRODUCTION: Les grandes lignes directrices sociétales recommandent une interruption de cinq jours avant l'intervention chirurgicale du cœur des patients atteints d'un syndrome coronarien aigu qui prennent du clopidogrel. Toutefois, comme il s'agit pour plusieurs d'entre eux de patients de haute acuité, le chirurgien penche vers l'utilisation d'une interruption plus courte. Par conséquent, la présente étude avait pour objectif de déterminer les conséquences de la durée et du moment de la cessation du clopidogrel sur les événements hémorragiques indésirables. MÉTHODES: La présente étude de cohorte rétrospective portait sur les patients qui avaient subi une intervention chirurgicale au cœur entre 2009 et 2016 dans un centre de soins tertiaires. Nous avons utilisé les modèles multivariés de régression logistique ajustés à l'interruption du clopidogrel, à l'âge, à l'urgence de l'intervention chirurgicale et au type d'intervention chirurgicale pour quantifier les effets des caractéristiques démographiques initiales cliniquement pertinentes sur la fréquence des transfusions massives ainsi que sur les issues des complications hémorragiques. RÉSULTATS: Un total de 5 748 patients ont subi une intervention chirurgicale au cœur. Dans cette cohorte, parmi les 1 743 patients (30,3 %) qui avaient reçu du clopidogrel avant l'opération, 884 (50,7 %) avaient cessé le clopidogrel cinq jours avant leur admission à la salle d'opération. L'administration du clopidogrel un à deux jours avant l'intervention chirurgicale (ratio d'incidence approché 1,97; intervalle de confiance [IC] à 95 % : de 1,18 à 3,29) était un prédicteur indépendant des transfusions massives et des complications hémorragiques (ratio d'incidence approché 1,85; [IC] à 95 % : de 1,01 à 3,37). Le groupe de l'interruption de trois à quatre jours n'a pas montré de risque accru de complications hémorragiques graves. Le risque de transfusions massives et de complications hémorragiques a aussi contribué à l'augmentation de l'urgence et de la complexité de l'intervention chirurgicale. CONCLUSION: Une interruption du clopidogrel de trois à quatre jours avant l'opération n'a pas été associée à un risque accru de complications hémorragiques graves.

The Role of Response-Shift in Studies Assessing Quality of Life Outcomes Among Cancer Patients: A Systematic Review.

Objective: Response-shift has been cited as an important measurement consideration when assessing patient reported quality of life (QoL) outcomes over time among patients with severe chronic conditions. Here we report the results of a systematic review of response shift in studies assessing QoL among cancer patients. Methods: A systematic review using MEDLINE, EMBASE, and PsychINFO along with a manual search of the cited references of the articles selected, was conducted. A quality review was performed using STROBE criteria and reported according to PRISMA guidelines. Results: A systematic review of 1,487 records published between 1,887 and December 2018 revealed 104 potentially eligible studies, and 35 studies met inclusion criteria for content and quality. The most common cancer patient populations investigated in these studies were breast (18 studies), lung (14 studies), prostate (eight studies), and colorectal (eight studies). Response shift was identified among 34 of the 35 studies reviewed. Effect sizes were reported in 17 studies assessing QoL outcomes among cancer patients; 12 of which had negligible to small effect sizes, four reported medium effect sizes which were related to physical, global QoL, pain, and social (role) functioning and one reported a large effect size (fatigue). The most prevalent method for assessing response shift was the then-test, which is prone to recall bias, followed by the pre-test and post-test method. Given the heterogeneity among the characteristics of the samples and designs reviewed, as well as the overall small to negligible effect sizes for the effects reported, conclusions stating that changes due to internal cognitive shifts in perceived QoL should account for changes observed in cancer patients' QoL outcomes should be interpreted with caution. Conclusion: Further work is needed in this area of research. Future studies should control for patient characteristics, time elapsed between diagnosis and baseline assessment and evaluate their contribution to the presence of response shift. Time between assessments should include short and longer periods between assessments and evaluate whether the presence of response shift holds over time. Possible avenues for inquiry for future investigation are discussed.

Toward Optimal Decision Making among Vulnerable Patients Referred for Cardiac Surgery: A Qualitative Analysis of Patient and Provider Perspectives.

OBJECTIVES: Comprehension of risks, benefits, and alternative treatment options has been shown to be poor among patients referred for cardiac interventions. Patients' values and preferences are rarely explicitly sought. An increasing proportion of frail and older patients are undergoing complex cardiac surgical procedures with increased risk of both mortality and prolonged institutional care. We sought input from patients and caregivers to determine the optimal approach to decision making in this vulnerable patient population. METHODS: Focus groups were held with both providers and former patients. Three focus groups were convened for Coronary Artery Bypass Graft (CABG), Valve, or CABG +Valve patients ≥ 70 y old (2-y post-op, ≤ 8-wk post-op, complicated post-op course) (n = 15). Three focus groups were convened for Intermediate Medical Care Unit (IMCU) nurses, Intensive Care Unit (ICU) nurses, surgeons, anesthesiologists and cardiac intensivists (n = 20). We used a semi-structured interview format to ask questions surrounding the informed consent process. Transcribed audio data was analyzed to develop consistent and comprehensive themes. RESULTS: We identified 5 main themes that influence the decision making process: educational barriers, educational facilitators, patient autonomy and perceived autonomy, patient and family expectations of care, and decision making advocates. All themes were influenced by time constraints experienced in the current consent process. Patient groups expressed a desire to receive information earlier in their care to allow time to identify personal values and preferences in developing plans for treatment. Both groups strongly supported a formal approach for shared decision making with a decisional coach to provide information and facilitate communication with the care team. CONCLUSIONS: Identifying the barriers and facilitators to patient and caretaker engagement in decision making is a key step in the development of a structured, patient-centered SDM approach. Intervention early in the decision process, the use of individualized decision aids that employ graphic risk presentations, and a dedicated decisional coach were identified by patients and providers as approaches with a high potential for success. The impact of such a formalized shared decision making process in cardiac surgery on decisional quality will need to be formally assessed. Given the trend toward older and frail patients referred for complex cardiac procedures, the need for an effective shared decision making process is compelling.

The changing face of cardiac surgery: practice patterns and outcomes 2001-2010.

BACKGROUND: Advances in cardiac surgical care have allowed for successful surgery in high-risk elderly patients. Advances in percutaneous coronary intervention (PCI) techniques and expanded indications for PCI have resulted in a decrease in referrals for coronary artery bypass grafting (CABG). Our objective was to document changes in practice patterns and outcomes in a single tertiary cardiac surgery centre serving a large geographic area. METHODS: For all cardiac surgery cases performed from 2001-2010 we examined its use, patient clinical characteristics, and outcomes. Frailty was assessed using a measure we have previously demonstrated to be associated with adverse outcomes. RESULTS: During the study period, annual case volume decreased by 13%. The number of isolated CABG cases declined, and valve surgery and other complex procedures increased. The proportion of patients aged ≥ 80 years rose from 7%-12%, and the proportion of frail patients increased from 4%-10%. Although unadjusted in-hospital mortality remained relatively unchanged, intensive care unit (ICU) stays and prolonged institutional care increased. Older age and frailty were associated with mortality, prolonged ICU stays, prolonged institutional care, and a composite of mortality and major morbidities. CONCLUSIONS: Our findings showed a decline in CABG, an increase in more complex operations, and an increase in prolonged ICU stays and prolonged institutional care. The proportion of frail and elderly patients increased over time and these patient groups were at higher risk of adverse postoperative outcomes. Particular attention is required in the decision for surgery and perioperative management of these patients.