Navigating the Landscape of Medical Device Advisories: A Special Report from the Canadian Heart Rhythm Society Device Advisory Committee.

Cardiac implantable electronic devices (CIED) are often important for regulating cardiac rate and rhythm. Pacemakers and defibrillators are among the top 10 most-implanted medical devices, with >1.5 million devices implanted annually. While millions of patients have benefited with improved quality of life and survival, CIED-systems are increasingly complex and do not always perform according to expectations. Advisory notices communicate important information about the safety and performance of a medical device to healthcare providers and patients. Medical device recalls are common, with >35 unique device recalls in the past five years. From an ethical standpoint, CIED recalls highlight a range of considerations including the consent process, duty to report, how best to promote autonomous decision-making, trust in the healthcare system, as well as disproportionate impact of these considerations on equity-deserving groups. The purpose of the current article is to review and advise regarding the process around medical device advisory and recall, with a specific focus on clinicians caring for patients affected by these devices. We have sought the input of a lawyer, a patient advocacy group, and an ethicist to guide the clinical management of, and communications regarding, device recalls and advisories. Diligent surveillance and a clear, transparent patient consent process regarding these small but potentially serious device-anomalies is paramount in ensuring patients feel safe and informed. Meaningful patient engagement helps to ensure optimal communication and disclosure mechanisms before implant and throughout follow-up, accessibility of information both in the initial implant and recall action process, and trust in healthcare systems and providers.

Association between sodium-glucose cotransporter-2 inhibitors and arrhythmic outcomes in patients with diabetes and pre-existing atrial fibrillation.

AIMS: Prior studies suggest that sodium-glucose cotransporter-2 inhibitors (SGLT2is) may decrease the incidence of atrial fibrillation (AF). However, it is unknown whether SGLT2i can attenuate the disease course of AF among patients with pre-existing AF and Type II diabetes mellitus (DM). In this study, our objective was to examine the association between SGLT2i prescription and arrhythmic outcomes among patients with DM and pre-existing AF. METHODS AND RESULTS: We conducted a population-based cohort study of adults with DM and AF between 2014 and 2019. Using a prevalent new-user design, individuals prescribed SGLT2i were matched 1:1 to those prescribed dipeptidyl peptidase-4 inhibitors (DPP4is) based on time-conditional propensity scores. The primary endpoint was a composite of AF-related healthcare utilization (i.e. hospitalization, emergency department visits, electrical cardioversion, or catheter ablation). Secondary outcome measures included all-cause mortality, heart failure (HF) hospitalization, and ischaemic stroke or transient ischaemic attack (TIA). Cox proportional hazard models were used to examine the association of SGLT2i with the study endpoint. Among 2242 patients with DM and AF followed for an average of 3.0 years, the primary endpoint occurred in 8.7% (n = 97) of patients in the SGLT2i group vs. 10.0% (n = 112) of patients in the DPP4i group [adjusted hazard ratio 0.73 (95% confidence interval 0.55-0.96; P = 0.03)]. Sodium-glucose cotransporter-2 inhibitors were associated with significant reductions in all-cause mortality and HF hospitalization, but there was no difference in the risk of ischaemic stroke/TIA. CONCLUSION: Among patients with DM and pre-existing AF, SGLT2is are associated with decreased AF-related health resource utilization and improved arrhythmic outcomes compared with DPP4is.

Clinical Effectiveness and Utilisation of Cardiac Rehabilitation After Hospital Discharge: Data Linkage Analysis of 84,064 Eligible Discharged Patients (2016-2021).

BACKGROUND: Despite the highest levels of evidence on cardiac rehabilitation (CR) effectiveness, its translation into practice is compromised by low participation. AIM: This study aimed to investigate CR utilisation and effectiveness in South Australia. METHODS: This retrospective cohort study used data linkage of clinical and administrative databases from 2016 to 2021 to assess the association between CR utilisation (no CR received, commenced without completing, or completed) and the composite primary outcome (mortality/cardiovascular re-admissions within 12 months after discharge). Cox survival models were adjusted for sociodemographic and clinical data and applied to a population balanced by inverse probability weighting. Associations with non-completion were assessed by logistic regression. RESULTS: Among 84,064 eligible participants, 74,189 did not receive CR, with 26,833 of the 84,064 (31.9%) participants referred. Of these, 9,875 (36.8%) commenced CR, and 7,681 of the 9,875 (77.8%) completed CR. Median waiting time from discharge to commencement was 40 days (interquartile range, 23-79 days). Female sex (odds ratio [OR] 1.12; 95% CI 1.01-1.24; p=0.024), depression (OR 1.17; 95% CI 1.05-1.30; p=0.002), and waiting time >28 days (OR 1.15; 95% CI 1.05-1.26; p=0.005) were associated with higher odds of non-completion, whereas enrolment in a telehealth program (OR 0.35; 95% CI 0.31-0.40; p<0.001) was associated with lower odds of non-completion. Completing CR (hazard ratio [HR] 0.62; 95% CI 0.58-0.66; p<0.001) was associated with a lower risk of 12-month mortality/cardiovascular re-admissions. Commencing without completing was also associated with decreased risk (HR 0.81; 95% CI 0.73-0.90; p<0.001), but the effect was lower than for those completing CR (p<0.001). CONCLUSIONS: Cardiac rehabilitation (CR) attendance is associated with lower all-cause mortality/cardiovascular re-admissions, with CR completion leading to additional benefits. Quality improvement initiatives should include promoting referral, women's participation, access to telehealth, and reduction of waiting times to increase completion.

Catheter ablation for supraventricular tachycardia and health resource utilization and expenditures: A propensity-matched cohort study.

BACKGROUND: Few data are available regarding temporal patterns of health resource utilization (HRU) and expenditures among patients undergoing catheter ablation for paroxysmal supraventricular tachycardia (PSVT). This study aimed to describe expenditures and HRU in patients with PSVT who underwent catheter ablation compared to a matched cohort of patients on medical therapy alone. METHODS: Using a large US administrative database, we identified adult patients (age 18 to 65 years) with a new PSVT diagnosis between 2008 and 2016. Propensity-score matching was used to assemble a PSVT cohort treated with ablation or medical therapy alone (N = 2556). Longitudinal trends in HRU and expenditures in the 3-years preceding and following PSVT diagnosis were compared. RESULTS: There were no significant differences in expenditures between groups except within the first year after PSVT diagnosis: $48,004 ablation vs. $17,560 medical therapy (p < 0.001). This difference was driven by procedural expenditures, where the mean cost of catheter ablation was $32,057 ± SD 26,737. In Years 2 and 3 post-ablation, HRU and expenditures decreased to the levels associated with the medical therapy group, although fewer ablation patients required any prescription for beta-blockers, calcium channel blockers, or anti-arrhythmic drugs (32% ablation vs. 42% medical therapy group, p < 0.001). CONCLUSION: Catheter ablation reduces medication burden in PSVT, yet health resource use and expenditures were similar beyond 2 years post-ablation when compared to PSVT patients on medical therapy alone. Additional studies are required to better understand drivers of these sustained health expenditures, and barriers to achieving cost-savings for a potentially curative procedure.

Economic Analysis of AbClo, a Novel Abdominal Fascia Closure Device, for Patients With an Open Abdomen Following Trauma or Acute Abdominal Surgery.

BACKGROUND: Open Abdomen (OA) cases represent a significant surgical and resource challenge. AbClo is a novel non-invasive abdominal fascial closure device that engages lateral components of the abdominal wall muscles to support gradual approximation of the fascia and reduce the fascial gap. The study objective was to assess the economic implications of AbClo compared to negative pressure wound therapy (NPWT) alone on OA management. METHODS: We conducted a cost-minimization analysis using a decision tree comparing the use of the AbClo device to NPWT alone among patients with midline laparotomy for trauma or acute abdominal surgery who were ineligible for primary fascial closure. The time horizon was limited to the length of the inpatient hospital stay, and costs were considered from the perspective of the US Medicare payer. Clinical effectiveness data for AbClo was obtained from a randomized clinical trial. Cost data was obtained from the published literature. Probabilistic and deterministic sensitivity analyses were performed. The primary outcome was incremental cost. RESULTS: The mean cumulative costs per patient were $76 582 for those treated with NPWT alone and $70,582 for those in the group treated with the AbClo device. Compared to NPWT alone, AbClo was associated with lower incremental costs of -$6012 (95% CI -$19 449 to +$1996). The probability that AbClo was cost-savings compared to NPWT alone was 94%. CONCLUSIONS: The use of AbClo is an economically attractive strategy for management of OA in in patients with midline laparotomy for trauma or acute abdominal surgery who were ineligible for primary fascial closure.

Sex- and Age-Specific Differences in Risk Profiles and Early Outcomes in Adults With Acute Coronary Syndromes.

BACKGROUND: Adults <55 years of age comprise a quarter of all acute coronary syndromes (ACS) hospitalisations. There is a paucity of data characterising this group, particularly sex differences. This study aimed to compare the clinical and risk profile of patients with ACS aged <55 years with older counterparts, and measure short-term outcomes by age and sex. METHOD: The study population comprised patients with ACS enrolled in the AUS-Global Registry of Acute Coronary Events (GRACE), Cooperative National Registry of Acute Coronary Syndrome Care (CONCORDANCE) and SNAPSHOT ACS registries. We compared clinical features and combinations of major modifiable risk factors (hypertension, smoking, dyslipidaemia, and diabetes) by sex and age group (20-54, 55-74, 75-94 years). All-cause mortality and major adverse events were identified in-hospital and at 6-months. RESULTS: There were 16,658 patients included (22.3% aged 20-54 years). Among them, 20-54 year olds had the highest proportion of ST-elevation myocardial infarction compared with sex-matched older age groups. Half of 20-54 year olds were current smokers, compared with a quarter of 55-74 year olds, and had the highest prevalence of no major modifiable risk factors (14.2% women, 12.7% men) and of single risk factors (27.6% women, 29.0% men), driven by smoking. Conversely, this age group had the highest proportion of all four modifiable risk factors (6.6% women, 4.7% men). Mortality at 6 months in 20-54 year olds was similar between men (2.3%) and women (1.7%), although lower than in older age groups. CONCLUSIONS: Younger adults with ACS are more likely to have either no risk factor, a single risk factor, or all four modifiable risk factors, than older patients. Targeted risk factor prevention and management is warranted in this age group.

Could Computed Tomography Coronary Angiography Replace Invasive Coronary Angiography as a First-Line Diagnostic Investigation in Suspected Acute Coronary Syndromes? A Decision-Analytic Model.

BACKGROUND: The implementation of high-sensitivity cardiac troponin (hs-cTn) assays into clinical practice has resulted in the identification of a novel cohort of patients with modestly increased troponin concentrations. Subsequent increases in rates of coronary angiography have been observed, without significant increases in rates of coronary revascularisation. Computed tomography coronary angiography (CTCA) is a non-invasive investigation that offers the opportunity to decouple investigation from the impetus to revascularise, and may provide an alternative, more risk-appropriate initial investigative strategy for the cohort with low to moderate hs-cTn increases. This analysis seeks to define the threshold of pre-test probability of coronary revascularisation in patients with suspected acute coronary syndrome at which a strategy of initial CTCA is safe and a more cost-effective approach than standard invasive coronary angiography (ICA). METHODS: A cost-benefit evaluation was conducted using a decision-analytic model. The primary outcome measure was the incremental cost-effectiveness ratio (ICER) of CTCA in comparison with ICA as an initial diagnostic investigation for patients with hs-cTnT levels between 5 and 100 ng/L. Secondary outcome measures of costs, patient outcomes, and quality-adjusted life years were analysed. RESULTS: Median base case ICER over 1,000 trials was $17,163 AUD but demonstrated large variability. Sensitivity analysis demonstrated that CTCA was cost-effective until the probability of requiring revascularisation was ∼60%, beyond which point CTCA was associated with higher costs and poorer outcomes than ICA. CONCLUSIONS: Computed tomography coronary angiography may be a cost-effective first-line investigation for patients with moderate hs-cTnT rises until/up to a 60% pre-test probability for receiving coronary revascularisation. To objectively assess the optimal circumstances of cost-effectiveness, prospective evaluation incorporating the estimated probability of revascularisation will be required.

Microbiology of cardiac implantable electronic device infections in Calgary, Canada.

The microbiology of cardiac implantable electronic device (CIED) infections in Calgary, Alberta was described, identifying 50 infections from 2013 to 2019. The majority were Staphylococcus aureus (40.0%). There is significant economic burden, mostly related to inpatient costs, associated with CIED infections. However, there were no significant differences in costs stratified by organism.

Cardiovascular Disease and the Mediterranean Diet: Insights into Sex-Specific Responses.

Cardiovascular disease (CVD) is a leading cause of mortality and disease burden in women globally. A healthy diet is important for the prevention of CVD. Research has consistently favoured the Mediterranean diet as a cardio-protective diet. Several studies have evaluated associations between the Mediterranean diet and cardiovascular outcomes, including traditional risk factors like hypertension, type 2 diabetes mellitus, and obesity. In addition, consistent evidence suggests that the components of the Mediterranean diet have a synergistic effect on cardiovascular risk due to its anti-inflammatory profile and microbiome effects. While the benefits of the Mediterranean diet are well-established, health advice and dietary guidelines have been built on largely male-dominant studies. Few studies have investigated the beneficial associations of the Mediterranean diet in sex-specific populations, including those with non-traditional risk factors that are specific to women, for instance polycystic ovarian syndrome and high-risk pregnancies, or more prevalent in women, such as chronic inflammatory diseases. Therefore, this review aims to provide a comprehensive overview of the current evidence regarding the Mediterranean diet in women in relation to cardiovascular health outcomes.

Management and outcomes with 5-year mortality of patients with mildly elevated high-sensitivity troponin T levels not meeting criteria for myocardial infarction.

OBJECTIVES: To examine management and outcomes of patients presenting to EDs with symptoms suggestive of acute coronary syndrome, who have mild non-dynamically elevated high-sensitivity troponin T (HsTnT) levels, not meeting the fourth universal definition of myocardial infarction (MI) criteria (observation group). METHODS: Consecutive patients presenting to the ED with symptoms suggestive of acute coronary syndrome at Liverpool Hospital, Sydney, Australia, those having ≥2 HsTnT levels after initial assessment were adjudicated according to the fourth universal definition of MI, as MI ruled-in, MI ruled-out, or myocardial injury in whom MI is neither ruled-in nor ruled-out (>1 level ≥15 ng/L, called observation group); follow-up was 5 years. RESULTS: Of 2738 patients, 547 were in the observation group, of whom 62% were admitted to hospital, 52% to cardiac services, whereas 97% of MI ruled-in patients and 21% of MI ruled-out patients were admitted; P < 0.001. Non-invasive testing occurred in 42% of observation group patients (36% had echo-cardiography), and 16% had coronary angiography. Of observation group patients, MI rates were 1.5% during hospitalisation and 4% during the following year, similar to that in those with MI ruled-in, among those with MI ruled-out, the MI rate was 0.2%. The 1-year death rate was 13% among observation group patients and 11% MI ruled-in patients (P = 0.624), whereas at 5 years among observation group patients, type 1 MI and type 2 MI were 48%, 26% and 58%, respectively (P = 0.001). CONCLUSION: Very few unselected consecutive patients attending ED, with minor stable HsTnT elevation, had MI, although most had chronic myocardial injury. Late mortality rates among observation group patients were higher than those with confirmed type 1 MI but lower than those with type 2 MI.

Impact of myocardial perfusion and coronary calcium on medical management for coronary artery disease.

AIMS: Single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) remains one of the most widely used imaging modalities for the diagnosis and prognostication of coronary artery disease (CAD). Despite the extensive prognostic information provided by MPI, little is known about how this influences the prescription of medical therapy for CAD. We evaluated the relationship between MPI with computed tomography (CT) attenuation correction and prescription of acetylsalicylic acid (ASA) and statins. METHODS AND RESULTS: We performed a retrospective analysis of consecutive patients who underwent SPECT MPI at a single centre between 2015 and 2021. Myocardial perfusion abnormalities and coronary calcium burden were assessed, with attenuation correction imaging 77.8% of patients. Medication prescriptions before and within 180 days after the test were compared. Associations between abnormal perfusion and calcium burden with ASA and statin prescription were assessed using multivariable logistic regression. In total, 9908 patients were included, with a mean age 66.8 ± 11.7 years and 5337 (53.9%) males. The prescription of statins increased more in patients with abnormal perfusion (increase of 19.2 vs. 12.0%, P < 0.001). Similarly, the presence of extensive CAC led to a greater increase in statin prescription compared with no calcium (increase 12.1 vs. 7.8%, P < 0.001). In multivariable analyses, ischaemia and coronary artery calcium were independently associated with ASA and statin prescription. CONCLUSION: Abnormal MPI testing was associated with significant changes in medical therapy. Both calcium burden and perfusion abnormalities were associated with increased prescriptions of medical therapy for CAD.

Sodium-glucose co-transporter-2 inhibitors are associated with kidney benefits at all degrees of albuminuria: A retrospective cohort study of adults with diabetes.

AIM: To estimate the real-world effectiveness of sodium-glucose co-transporter-2 inhibitors (SGLT2is) versus dipeptidyl peptidase-4 inhibitors (DPP4is) at reducing loss of kidney function and adverse kidney events in adults with varying levels of albuminuria. MATERIALS AND METHODS: In this retrospective cohort study using administrative data, we matched new SGLT2i users 1:2 to DPP4i users on diabetes therapy, chronic kidney disease (CKD) stage, albuminuria and time-conditional propensity score. Albuminuria was defined by spot urine albumin or equivalent as mild, moderate or severe. Linear regression was used to model the estimated glomerular filtration rate (eGFR), and Poisson regression for a composite kidney outcome (> 40% loss of eGFR, kidney replacement therapy or death from kidney causes) and all-cause mortality. RESULTS: SGLT2i users (n = 19 238, median age 57.9 years, female 40.9%) had mostly nil/mild albuminuria (70.7%). SGLT2is were associated with a 1.36 (95% CI 0.98-1.74) mL/min/1.73m2 (P < .001) acute (≤ 60 days) decline in eGFR, relative to DPP4is. Thereafter, SGLT2is were associated with 1.04 (95% CI 0.93-1.15) mL/min/1.73m2 (P < .001) less annual eGFR loss. SGLT2i users had fewer adverse kidney outcomes (incidence rate ratio [IRR] 0.58 [0.47-0.71]; P < .001), but not all-cause mortality (IRR 0.82 [0.66-1.01]; P = .06). Outcomes were similar considering only those with nil/mild albuminuria. CONCLUSIONS: SGLT2is may prevent eGFR decline and reduce the risk of adverse kidney events in adults with diabetes and nil or non-severe albuminuria.

Pre-stroke anticoagulation for atrial fibrillation in primary English speakers and non-primary English speakers: a multicentre retrospective cohort study.

BACKGROUND: Anticoagulation can prevent most strokes in individuals with atrial fibrillation (AF); however, many people presenting with stroke and known AF are not anticoagulated. Language barriers and poor health literacy have previously been associated with decreased patient medication adherence. The association between language barriers and initiation of anticoagulation therapy for AF is uncertain. AIMS: The aims of this study were to determine whether demographic factors, including non-English primary language, were (1) associated with not being initiated on anticoagulation for known AF prior to admission with stroke, and (2) associated with non-adherence to anticoagulation in the setting of known AF prior to admission with stroke. METHODS: A multicentre retrospective cohort study was conducted for consecutive individuals admitted to the three South Australian tertiary hospitals with stroke units over a 5-year period. RESULTS: There were 6829 individuals admitted with stroke. These cases included 5835 ischaemic stroke patients, 1333 of whom had pre-existing AF. Only 40.0% presenting with ischaemic stroke in the setting of known pre-existing AF were anticoagulated. When controlling for demographics, socioeconomic status and past medical history (including the components of the CHADS2VASC score and anticoagulation contraindications), having a primary language other than English was associated with a lower likelihood of having been commenced on anticoagulant for known pre-stroke AF (odds ratio: 0.52, 95% confidence interval: 0.36-0.77, P = 0.001), but was not associated with a differing likelihood of anticoagulation adherence. CONCLUSIONS: A significant proportion of patients with stroke have pre-existing unanticoagulated AF; these rates are substantially higher if the primary language is other than English. Targeted research and interventions to minimise evidence-treatment gaps in this cohort may significantly reduce stroke burden.

Asia-Pacific Investigators and Asian Enrollment in Cardiometabolic Trials: Insights From Publications Between 2011 and 2020.

Background: A lack of geographic and racial diversity in clinical trial populations may arise from a disproportionate focus on the United States and Europe for trial leadership and conduct. Inadequate diversity may compromise the external validity to the Asia-Pacific (APAC) region, where 60% of global cardiometabolic disease exists. Objectives: This study aimed to assess the proportion and trends of Asian race participants and APAC authorship in cardiometabolic trials. Methods: We performed a systematic review of all cardiovascular, diabetes and obesity-related randomized controlled trials (phase ≥2, n = ≥100) published in these major medical journals: the New England Journal of Medicine, the Lancet, and the Journal of the American Medical Association between January 1, 2011, and December 31, 2020. Trial leadership was defined by first authorship, and any listed author was considered a trial collaborator. Temporal trends were evaluated using the Jonckheere-Terpstra proportion test and correlations using Pearson's correlation coefficient. Participant-to-prevalence ratios (PPR) were determined using Global Health Data Exchange registry data. Results: A total of 8.3% (218,613 of 2,619,710) participants identified as being of Asian race and 7.7% of total enrollment occurred in APAC. APAC lead authorship occurred in 52 of 656 (7.9%) trials and collaboration in 10.1% (1312 of 13,000 of authors), which correlated with Asian enrollment (r = 0.63 and r = 0.76, respectively). A marginal increase in the proportion of Asian race (Δ1.40% ± 6.95%/year, P = 0.003) and APAC regional (Δ1.46% ± 8.67%/year, P = 0.003) enrollment was observed; however, severe regional underrepresentation persisted (PPR <0.30). Conclusions: Despite a favorable trend over the past decade, Asian participants and authors from APAC remain significantly underrepresented in seminal cardiometabolic trials; barriers to trial conduct and leadership in this region must be addressed.

Physician Variation and the Impact of Payment Model in Cardiac Imaging.

BACKGROUND: The influence of fee-for-service reimbursement on cardiac imaging has not been compared with other payment models. Furthermore, variation in ordering practices is not well understood. METHODS AND RESULTS: This retrospective, population-based cohort study using linked administrative data from Alberta, Canada included adults with chronic heart disease (atrial fibrillation, coronary artery disease, and heart failure) seen by cardiac specialists for a new outpatient consultation April 2012 to December 2018. Generalized linear mixed-effects models estimated the association of payment model (including the ability to bill to interpret imaging tests) and the use of cardiac imaging and quantified variation in cardiac imaging. Among 31 685 adults seen by 308 physicians at 136 sites, patients received an observed mean of 0.67 (95% CI, 0.67-0.68) imaging tests per consultation. After adjustment, patients seeing fee-for-service physicians had 2.07 (95% CI, 1.68-2.54) and fee-for-service physicians with ability to interpret had 2.87 (95% CI, 2.16-3.81) times the rate of receiving a test than those seeing salaried physicians. Measured patient, physician, and site effects accounted for 31% of imaging variation and, following adjustment, reduced unexplained site-level variation 40% and physician-level variation 29%. CONCLUSIONS: We identified substantial variation in the use of outpatient cardiac imaging related to physician and site factors. Physician payment models have a significant association with imaging use. Our results raise concern that payment models may influence cardiac imaging practice. Similar methods could be applied to identify the source and magnitude of variation in other health care processes and outcomes.