Effect on medication adherence of applying a specialty pharmacy care model to nonspecialty medications: A quasi-experimental cohort study.

PURPOSE: Medication nonadherence is a multifactorial healthcare problem that contributes to increased healthcare costs and morbidity. To improve medication adherence, specialty pharmacies offer services not typically provided by retail pharmacies such as benefits investigation, financial assistance, medication synchronization, and proactive refill reminders. This study assessed the impact of the specialty pharmacy care model on medication adherence for patients on nonspecialty medications. METHODS: This study was a quasi-experimental cohort comparison of patients who were transferred from a health-system retail pharmacy to a health-system specialty pharmacy between April 1, 2020, and June 30, 2021. The primary endpoint in this study was the difference in mean medication adherence proportion of days covered (PDC) between the post-transfer and pretransfer periods. Secondary outcomes included the proportion of patients with PDC of greater than 80%, medication adherence by drug group, shipment volumes, number of medications per shipment, and the mean copay per medication. RESULTS: In this study of 163 patients, use of a specialty pharmacy care model led to a significant increase of 7.0% in mean PDC, a significant increase in the percentage of patients with PDC of greater than 80%, a significant decrease in the number of shipments per 30 days per patient, a significant increase in the number of medications included per shipment, and a significant reduction in the mean copay per medication. CONCLUSION: The findings in this study suggest that the application of the specialty pharmacy care model to nonspecialty pharmacy patients may improve medication adherence, decrease the number of shipments per patient sent from the pharmacy, and reduce patient copays.

Mitral Valve Repair Versus Replacement in The Elderly.

The disadvantages of mitral valve replacement with a bioprosthesis in the long-term may not play an important role if the shorter life expectancy of older patients is taken into account. This study aims to evaluate whether mitral valve replacement in the elderly is associated with similar outcome compared to repair in the short- and long-term. All patients aged 70 years and older undergoing minimally invasive mitral valve surgery were studied retrospectively. Primary outcome was 30-day complication rate, secondary outcome was long-term survival and freedom from re-operation. 223 Patients underwent surgery (124 replacement and 99 repair) with a mean age of 76.4 ± 4.2 years. 30-Day complication rate (replacement 73.4% versus repair 67.7%; p=.433), 30-day mortality (replacement 4.0% versus repair 1.0%; p=.332) and 30-day stroke rate (replacement 0.0% versus repair 1.0%; p=.910) were similar in both groups. Multivariable cox regression revealed higher age, diabetes and left ventricular dysfunction as predictors for reduced long-term survival, while a valve replacement was no predictor for reduced survival. Sub analysis of patients with degenerative disease showed no difference in long-term survival after propensity weighting (HR 1.4; 95%CI 0.84 - 2.50; p=.282). The current study reveals that mitral valve repair and replacement in the elderly can be achieved with good short- and long-term results. Long-term survival was dependent on patient related risk factors and not on the type of operation (replacement versus repair).

Decision Making during the Learning Curve of Minimally Invasive Mitral Valve Surgery: A Focused Review for the Starting Minimally Invasive Surgeon.

Minimally invasive mitral valve surgery is evolving rapidly since the early 1990's and is now increasingly adopted as the standard approach for mitral valve surgery. It has a long and challenging learning curve and there are many considerations regarding technique, planning and patient selection when starting a minimally invasive program. In the current review, we provide an overview of all considerations and the decision-making process during the learning curve.

Reoperative Mitral Valve Surgery Through Port Access.

Minimally invasive mitral valve surgery (MIMVS) has become the standard approach for mitral valve pathology in many centres. The anterolateral mini thoracotomy access is beneficial in reoperative surgery by avoiding repeat sternotomy associated risks. The aim of this study is to analyse the safety of this technique. All patients undergoing reoperative MIMVS between 2008 and 2019 were studied retrospectively. Primary endpoint was 30-day major complications and mortality; secondary outcome was long term survival, reoperation rate and rate of more than moderate recurrent regurgitation. 146 Patients underwent reoperative MIMVS with a mean age of 68 ± 8 years. The composite outcome of 30-day major complication and mortality was 29.5%. 30-Day mortality was 6.2% and stroke rate 3.4%. Survival for the whole cohort was 89.7 ± 2.5% at 1-year, 71.6 ± 4.3% at 5 year and 50.9 ± 5.9% at 8-year follow up. Cox regression analysis revealed reduced left ventricular function (HR 2.8; 95%CI 1.5 - 5.0), GFR < 60 (HR 2.1; 95%CI 1.2 - 3.7) and active endocarditis (HR 6.4; 95%CI 2.7 - 15.4) as variables associated with reduced long-term survival. The cumulative incidence of re-operation after mitral valve replacement was 11.3 ± 3.2% at 5-year and for repair 16.2 ± 7.5% at 5-year. The cumulative incidence of more than moderate recurrent regurgitation after mitral valve repair was 25.4 ± 9.0% at 3-year. Minimally invasive access in reoperative mitral valve surgery in the current study showed similar 30-day mortality and stroke rate compared to repeat sternotomy results reported in literature.

Minimally invasive mitral valve surgery: a systematic safety analysis.

OBJECTIVE: Minimally invasive surgery is increasingly adopted as an alternative to conventional sternotomy for mitral valve pathology in many centres worldwide. A systematic safety analysis based on a comprehensive list of pre-specified 30-day complications defined by the Mitral Valve Academic Consortium (MVARC) criteria is lacking. The aim of the current study was to systematically analyse the safety of minimally invasive mitral valve surgery in our centre based on the MVARC definitions. METHODS: All consecutive patients undergoing minimally invasive mitral valve surgery through right mini-thoracotomy in our institution within 10 years were studied retrospectively. The primary outcome was a composite of 30-day major complications based on MVARC definitions. RESULTS: 745 patients underwent minimally invasive mitral valve surgery (507 repair, 238 replacement), with a mean age of 62.9±12.3 years. The repair was successful in 95.8%. Overall 30-day mortality was 1.2% and stroke rate 0.3%. Freedom from any 30-day major complications was 87.2%, and independent predictors were left ventricular ejection fraction <50% (OR 1.78; 95% CI 1.02 to 3.02) and estimated glomerular filtration rate <60 mL/min/1.73 m2 (OR 1.98; 95% CI 1.17 to 3.26). CONCLUSIONS: Minimally invasive mitral valve surgery is a safe technique and is associated with low 30-day mortality and stroke rate.

McMaster RARE-Bestpractices clinical practice guideline on diagnosis and management of the catastrophic antiphospholipid syndrome.

Background The McMaster RARE-Bestpractices project group selected the catastrophic antiphospholipid syndrome (CAPS) for a pilot exercise in guideline development for a rare disease. Objectives The objectives of this exercise were to provide a proof of principle that guidelines can be developed for rare diseases and assist in clinical decision making for CAPS. Patients/Methods The GIN-McMaster Guideline Development checklist and GRADE methodology were followed throughout the guideline process. The CAPS guideline was coordinated by a steering committee, and the guideline panel was formed with representation from all relevant stakeholder groups. Systematic reviews were performed for the key questions. To supplement the published evidence, we piloted novel methods, including use of an expert-based evidence elicitation process and ad hoc analysis of registry data. Results This paper describes the CAPS guideline recommendations, including evidence appraisal and discussion of special circumstances and implementation barriers identified by the panel. Many of these recommendations are conditional, because of subgroup considerations in this heterogeneous disease, as well as variability in patient values and preferences. Conclusions The CAPS clinical practice guideline initiative met the objective of the successful development of a clinical practice guideline in a rare disease using GRADE methodology. We expect that clinicians caring for patients with suspected CAPS will find the guideline useful in assisting with diagnosis and management of this rare disease.

McMaster RARE-Bestpractices clinical practice guideline on diagnosis and management of the catastrophic antiphospholipid syndrome

Background The McMaster RARE-Bestpractices project group selected the catastrophic antiphospholipid syndrome (CAPS) for a pilot exercise in guideline development for a rare disease. Objectives The objectives of this exercise were to provide a proof of principle that guidelines can be developed for rare diseases and assist in clinical decision making for CAPS. Patients/Methods The GIN-McMaster Guideline Development checklist and GRADE methodology were followed throughout the guideline process. The CAPS guideline was coordinated by a steering committee, and the guideline panel was formed with representation from all relevant stakeholder groups. Systematic reviews were performed for the key questions. To supplement the published evidence, we piloted novel methods, including use of an expert-based evidence elicitation process and ad hoc analysis of registry data. Results This paper describes the CAPS guideline recommendations, including evidence appraisal and discussion of special circumstances and implementation barriers identified by the panel. Many of these recommendations are conditional, because of subgroup considerations in this heterogeneous disease, as well as variability in patient values and preferences. Conclusions The CAPS clinical practice guideline initiative met the objective of the successful development of a clinical practice guideline in a rare disease using GRADE methodology. We expect that clinicians caring for patients with suspected CAPS will find the guideline useful in assisting with diagnosis and management of this rare disease.

Pulmonary Vein Widening Plasty for Pulmonary Vein Stenosis and Occlusion After Catheter Ablation.

We successfully performed a pulmonary vein widening plasty in a patient with pulmonary vein stenosis and occlusion after multiple catheter ablations for paroxysmal atrial fibrillation.

Survival of transcatheter mitral valve repair compared with surgical and conservative treatment in high-surgical-risk patients.

OBJECTIVES: The goal of this study was to compare survival between transcatheter mitral valve (MV) repair using MitraClip system (Abbott Vascular, Santa Clara, California), MV-surgery, and conservative treatment in high-surgical-risk patients symptomatic with severe mitral valve regurgitation (MR). BACKGROUND: Up to 50% of patients with symptomatic severe MR are denied for surgery due to high perioperative risk. Transcatheter MV repair might be an alternative. METHODS: Consecutive patients (n = 139) treated with transcatheter MV repair were included. Comparator surgically (n = 53) and conservatively (n = 59) treated patients were identified retrospectively. Surgical risk was based on the logistic European System for Cardiac Operative Risk Evaluation (log EuroSCORE) or the presence of relevant risk factors, as judged by the heart team. RESULTS: The log EuroSCORE was higher in the transcatheter MV repair group (23.9 ± 16.1%) than in the surgically (14.2 ± 8.9%) and conservatively (18.7 ± 13.2%, p < 0.0001) treated patients. Left ventricular ejection fraction was higher in surgical patients (43.9 ± 14.4%, p = 0.003), with similar values for the transcatheter MV repair (36.8 ± 15.3%) and conservatively treated (34.5 ± 16.5%) groups. After 1 year of follow-up, the transcatheter MV repair and surgery groups showed similar survival rates (85.8% and 85.2%, respectively), whereas 67.7% of conservatively treated patients survived. The same trend was observed after the second and third years. After weighting for propensity score and controlling for risk factors, both the transcatheter MV repair (hazard ratio [HR]: 0.41, 95% confidence interval [CI]: 0.22 to 0.78, p = 0.006) and surgical (HR: 0.52, 95% CI: 0.30 to 0.88, p = 0.014) groups showed better survival than the conservatively treated group. The transcatheter MV repair and surgical groups did not differ (HR: 1.25, 95% CI: 0.72 to 2.16, p = 0.430). CONCLUSIONS: Despite a higher log EuroSCORE, high-surgical-risk patients with symptomatic severe MR treated with transcatheter MV repair show similar survival rates compared with surgically treated patients, with both displaying survival benefit compared with conservative treatment.

Added value of hybrid myocardial perfusion SPECT and CT coronary angiography in the diagnosis of coronary artery disease.

AIMS: Hybrid single photon emission computed tomography (SPECT)/coronary computed tomography angiography (CCTA) has only been evaluated for its diagnostic accuracy as a single test in patients suspected of significant coronary artery disease (CAD). Added value of hybrid SPECT/CCTA beyond usual clinical work-up, or use of each of these tests separately, remains unclear. We evaluated the added value of hybrid myocardial perfusion SPECT (SPECT) and CCTA, beyond pre-test likelihood and exercise stress ECG (X-ECG), in the diagnosis of CAD. METHODS AND RESULTS: Two hundred and five patients with stable angina pectoris and intermediate-to-high pre-test likelihood were prospectively included. All patients underwent clinical history and examination, X-ECG, stress and rest SPECT, coronary calcium scoring (CCS) and CCTA. Fractional flow reserve measurement <0.80 or a lesion >50% on coronary angiography (CA) served as reference standard for significant CAD. Multiple imputation was used to correct for missing test results (17-20%). Added value of hybrid SPECT/CCTA to the basic model of pre-test likelihood plus X-ECG was quantified using logistic regression analysis. Model differences were then assessed using differences in C-index and in net reclassification improvement (NRI). The basic model had a C-index of 0.73 (95%CI 0.66-0.80). This significantly increased to 0.85 (95%CI 0.80-0.91) by addition of only SPECT, to 0.90 (95%CI 0.85-0.94) when adding only CCTA, and to 0.96 (95%CI 0.92-0.99) when adding hybrid SPECT/CCTA. The accompanying NRIs were 0.82 (95%CI 0.62-1.02), 0.86 (95%CI 0.66-1.06) and 1.57 (95%CI 1.11-1.59) respectively. CONCLUSION: Current analysis resembles clinical routine of layered testing and shows that hybrid SPECT/CCTA imaging has a substantially higher yield than standalone SPECT or CCTA in the diagnostic workup of patients suspected of significant CAD.

Incremental diagnostic accuracy of hybrid SPECT/CT coronary angiography in a population with an intermediate to high pre-test likelihood of coronary artery disease.

AIMS: Hybrid myocardial perfusion imaging with single photon emission computed tomography (SPECT) and CT coronary angiography (CCTA) has the potential to play a major role in patients with non-conclusive SPECT or CCTA results. We evaluated the performance of hybrid SPECT/CCTA vs. standalone SPECT and CCTA for the diagnosis of significant coronary artery disease (CAD) in patients with an intermediate to high pre-test likelihood of CAD. METHODS AND RESULTS: In total, 98 patients (mean age 62.5 ± 10.1 years, 68.4% male) with stable anginal complaints and a median pre-test likelihood of 87% (range 22-95%) were prospectively included in this study. Hybrid SPECT/CCTA was performed prior to conventional coronary angiography (CA) including fractional flow reserve (FFR) measurements. Hybrid analysis was performed by combined interpretation of SPECT and CCTA images. The sensitivity, specificity, positive (PPV), and negative (NPV) predictive values were calculated for standalone SPECT, CCTA, and hybrid SPECT/CCTA on per patient level, using an FFR <0.80 as a reference for significant CAD. Significant CAD was demonstrated in 56 patients (57.9%). Non-conclusive SPECT or CCTA results were found in 32 (32.7%) patients. SPECT had a sensitivity of 93%, specificity 79%, PPV 85%, and NPV 89%. CCTA had a sensitivity of 98%, specificity 62%, PPV 77%, and NPV 96%. Hybrid analysis of SPECT and CCTA improved the overall performance: sensitivity, specificity, PPV, and NPV for the presence of significant CAD to 96, 95, 96, and 95%, respectively. CONCLUSIONS: In > 40% of the patients with a high pre-test likelihood no significant CAD was demonstrated, emphasizing the value of accurate pre-treatment cardiovascular imaging. Hybrid SPECT/CCTA was able to accurately diagnose and exclude significant CAD surpassing standalone myocardial SPECT and CCTA, vs. a reference standard of FFR measurements.

Usefulness of coronary calcium scoring to myocardial perfusion SPECT in the diagnosis of coronary artery disease in a predominantly high risk population.

Coronary calcium scoring (CCS) adds to the diagnostic performance of myocardial perfusion single-photon emission computed tomography (SPECT) to assess the presence of significant coronary artery disease (CAD). Patients with a high pre-test likelihood are expected to have a high CCS which potentially could enhance the diagnostic performance of myocardial perfusion SPECT in this specific patient group. We evaluated the added value of CCS to SPECT in the diagnosis of significant CAD in patients with an intermediate to high pre-test likelihood. In total, 129 patients (mean age 62.7 ± 9.7 years, 65 % male) with stable anginal complaints and intermediate to high pre-test likelihood of CAD (median 87 %, range 22-95) were prospectively included in this study. All patients received SPECT and CCS imaging preceding invasive coronary angiography (CA). Fractional flow reserve (FFR) measurements were acquired from patients with angiographically estimated 50-95 % obstructive CAD. For SPECT a SSS > 3 was defined significant CAD. For CCS the optimal cut-off value for significant CAD was determined by ROC curve analysis. The reference standard for significant CAD was a FFR of <0.80 acquired by CA. Significant CAD was demonstrated in 64 patients (49.6 %). Optimal CCS cut-off value for significant CAD was >182.5. ROC curve analysis for prediction of the presence of significant CAD for SPECT, CCS and the combination of CCS and SPECT resulted in an area under the curve (AUC) of 0.88 (95 % CI 81-94), 0.75 (95 % CI 66-83 %) and 0.92 (95 % CI 87-97 %) respectively. The difference of the AUC between SPECT and the combination of CCS and SPECT was 0.05 (P = 0.12). The addition of CCS did not significantly improve the diagnostic performance of SPECT in the evaluation of patients with a predominantly high pre-test likelihood of CAD.

Hybrid myocardial perfusion SPECT/CT coronary angiography and invasive coronary angiography in patients with stable angina pectoris lead to similar treatment decisions.

OBJECTIVES: To evaluate to what extent treatment decisions for patients with stable angina pectoris can be made based on hybrid myocardial perfusion single-photon emission CT (SPECT) and CT coronary angiography (CCTA). It has been shown that hybrid SPECT/CCTA has good performance in the diagnosis of significant coronary artery disease (CAD). The question remains whether these imaging results lead to similar treatment decisions as compared to standalone SPECT and invasive coronary angiography (CA). METHODS: We prospectively included 107 patients (mean age 62.8±10.0 years, 69% male) with stable anginal complaints and an intermediate to high pre-test likelihood for CAD. Hybrid SPECT/CCTA was performed prior to CA in all patients. The study outcome was the treatment decision categorised as: no revascularisation, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Treatment decisions were made by two interventional cardiologists and one cardiothoracic surgeon in two steps: first, based on the results of hybrid SPECT/CCTA; second, based on SPECT and CA. RESULTS: Revascularisation (PCI or CABG) was indicated in 54 (50%) patients based on SPECT and CA. Percentage agreement of treatment decisions in all patients based on hybrid SPECT/CCTA versus SPECT and CA on the necessity of revascularisation was 92%. Percentage agreement of treatment decisions in patients with matched, unmatched and normal hybrid SPECT/CCTA findings was 95%, 84% and 100%, respectively. CONCLUSIONS: Panel evaluation shows that patients could be accurately indicated for and deferred from revascularisation based on hybrid SPECT/CCTA.

Numerical simulation of hemodynamic changes during beating-heart surgery: analysis of the effects of cardiac position alteration in an animal model.

Hemodynamic instability, mostly due to vertical lifting of the heart, is usually observed during beating-heart surgical procedures. However, some hemodynamic parameters, such as coronary blood flow, are not routinely measured. A digital computer model of the circulation able to simulate and analyze the effects of heart lifting and the Trendelenburg maneuver, and thus supply detailed hemodynamic information to the clinicians would provide a useful analytical tool. A lumped parameters model of the circulation was applied to both beta-blocked and not beta-blocked pigs. The results confirmed a drop of cardiac output and coronary flow during heart lifting and a rise of both variables after the Trendelenburg maneuver for beta-blocked animals. In not beta-blocked pigs, the analysis was more complex but the model reproduced experimental data and permitted coronary flow to be estimated. These results showed the feasibility of numerical simulation for specific circulatory conditions encountered during beating-heart surgery.

Gastrointestinal motility during cardiopulmonary bypass: a sonomicrometric study.

Cardiopulmonary bypass (CPB) is known to impair the integrity of the gastrointestinal tract. However, little is known about the movement behavior of the gastrointestinal tract during CPB. This study was aimed to assess the gastrointestinal motility with sonomicrometry, a distance measurement using ultrasound, in a porcine model of CPB. Twelve pigs weighing 70-112 kg were having a standard hypothermic CPB for 120 min either with the nonpulsatile flow (n = 6) or the pulsatile flow (n = 6). Before CPB, piezoelectric echo crystals were placed either along the longitudinal or the circular axis of the pylorus. Patterns of gut movement and the total sonomicrometric activity (TSA) were recorded at several time intervals during experiments as qualitative and quantitative parameters of gut motility. Results showed that the intact regular rhythmic pattern of gut movement was detected before CPB. This pattern changed little when CPB started, but it disappeared at 60 min when the body temperature lowered down to 32 degrees Celsius. During the same period, the TSA reduced significantly along the longitudinal as well as the circular directions of the pylorus. There was no significant difference between the nonpulsatile and pulsatile groups. Gut blood flow reduced significantly in both groups, but it was not associated with the reduced sonomicrometric activity. In conclusion, gastrointestinal motility during CPB can be measured qualitatively and quantitatively by sonomicrometry in a large animal model. Suppression of gut motility during CPB does not seem to be associated with the mode of perfusion but with the reduced body temperature during the hypothermic phase of CPB.

Laboratory confirmation of meningococcal disease in Scotland, 1993-9.

AIMS: To describe the laboratory confirmation of meningococcal disease, using culture and non-culture based techniques, between 1993 and 1999 as part of a national service in Scotland. METHODS: Samples from patients with suspected meningococcal disease in Scotland were analysed by culture and non-culture based techniques to gain a laboratory confirmation of disease. Data were analysed to establish the number of disease cases, the serogroups of the organisms involved, and the importance of the techniques used. RESULTS: Between 1993 and 1999, there was a total of 1749 notified cases of meningococcal disease in Scotland. Culture based methods provided a laboratory confirmation of 788 cases whereas non-culture techniques confirmed 461 cases. CONCLUSIONS: Non-culture techniques were a useful addition to culture based techniques in Scotland and improved the dataset required for public health management, disease surveillance, and vaccine policy.