Blinded, randomized trial of sonographer versus AI cardiac function assessment.

Artificial intelligence (AI) has been developed for echocardiography1-3, although it has not yet been tested with blinding and randomization. Here we designed a blinded, randomized non-inferiority clinical trial (ClinicalTrials.gov ID: NCT05140642; no outside funding) of AI versus sonographer initial assessment of left ventricular ejection fraction (LVEF) to evaluate the impact of AI in the interpretation workflow. The primary end point was the change in the LVEF between initial AI or sonographer assessment and final cardiologist assessment, evaluated by the proportion of studies with substantial change (more than 5% change). From 3,769 echocardiographic studies screened, 274 studies were excluded owing to poor image quality. The proportion of studies substantially changed was 16.8% in the AI group and 27.2% in the sonographer group (difference of -10.4%, 95% confidence interval: -13.2% to -7.7%, P < 0.001 for non-inferiority, P < 0.001 for superiority). The mean absolute difference between final cardiologist assessment and independent previous cardiologist assessment was 6.29% in the AI group and 7.23% in the sonographer group (difference of -0.96%, 95% confidence interval: -1.34% to -0.54%, P < 0.001 for superiority). The AI-guided workflow saved time for both sonographers and cardiologists, and cardiologists were not able to distinguish between the initial assessments by AI versus the sonographer (blinding index of 0.088). For patients undergoing echocardiographic quantification of cardiac function, initial assessment of LVEF by AI was non-inferior to assessment by sonographers.

Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP).

The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged >55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with >300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p = 0.39). In patients with low baseline OACA (<90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p < 0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.

Successful weaning and explantation of the Heartmate II left ventricular assist device.

BACKGROUND: Ventricular assist devices (VADs) are used in cases of heart failure refractory to medical therapy. Most VADs are used as a bridge to heart transplantation; however, in certain cases, myocardial function recovers and VADs can be explanted after the patient is weaned. The objectives of this study were to describe patients who required Heartmate II VAD insertion, followed by myocardial recovery and explanation in a quaternary heart centre. METHODS: Patients who had a VAD explanted were identified in the mechanical support institutional database and their outcomes were analyzed. Clinical examinations, biochemical markers, and serial echocardiograms were used to demonstrate myocardial recovery. RESULTS: Seventeen patients had a Heartmate II VAD inserted between 2008 and 2010. Four patients underwent successful weaning and subsequent VAD explantation. Etiology of decompensated heart failure was idiopathic dilated cardiomyopathy (n = 1), ischemic (n = 1), or myocarditis (n = 2). Mean age was 35.3 years. Patients were supported for 213 days (range 70-293 days) and were in New York Heart Association class I in the community before explantation. The devices were explanted via a minimally invasive approach, without cardiopulmonary bypass. All patients survived explantation and were discharged alive from hospital after an average of 5.7 ± 1.5 days post pump explantation. No adverse events were reported after explantation. Only one patient required allogenic blood transfusion after the procedure. CONCLUSIONS: Patients requiring VAD support for myocardial failure can undergo significant reverse remodelling. Explantation can lead to optimal outcome with minimal morbidity. Methods for assessment of reverse remodelling, weaning protocol, and optimal timing of explantation remain under evaluation.

Transatrial transcatheter tricuspid valve-in-valve implantation of balloon expandable bioprosthesis.

Transcatheter valve-in-valve implantation into failing mitral and aortic bioprosthetic valves have been reported. This strategy avoids performing high-risk repeat cardiac surgery in elderly patients with multiple comorbidities. Tricuspid valve-in-valve implantation has not been described. We report a case of failing bioprosthetic tricuspid valve in a 48-year-old woman with carcinoid syndrome. We attempted a transatrial transcatheter approach and we successfully deployed a 26-mm Edwards Sapien balloon expandable bioprosthesis (Edwards Lifesciences, Irvine, CA) into a severely stenotic tricuspid bioprosthesis. This case demonstrates the technical feasibility and safety of this approach. Therefore, tricuspid valve-in-valve implantation may be a viable treatment alternative in carefully selected patients.

The efficacy and safety of intensive statin therapy: a meta-analysis of randomized trials.

BACKGROUND: Recent lipid guidelines recommend aggressive low-density lipoprotein (LDL) cholesterol lowering in patients with coronary artery disease. To clarify the evidence for this recommendation, we conducted a meta-analysis of randomized controlled trials that compared different intensities of statin therapy. METHODS: We searched electronic databases (MEDLINE, EMBASE, Cochrane Central Registery of Controlled Trials, Web of Science) for randomized controlled trials published up to July 19, 2007, that compared statin regimens of different intensities in adults with coronary artery disease and that reported cardiovascular events or mortality. Data were pooled using random-effects models to calculate odds ratios (OR). RESULTS: A total of 7 trials (29 395 patients) were included. Compared with less intensive statin regimens, more intensive regimens further reduced LDL levels (0.72 mmol/L reduction, 95% confidence interval [CI] 0.60-0.84 mmol/L), and reduced the risk of myocardial infarction (OR 0.83, 95% CI 0.77-0.91) and stroke (OR 0.82, 95% CI 0.71-0.95). Although there was no effect on mortality among patients with chronic coronary artery disease (OR 0.96, 95% CI 0.80-1.14), all-cause mortality was reduced among patients with acute coronary syndromes treated with more intensive statin regimens (OR 0.75, 95% CI 0.61-0.93). Compared with lower intensity regimens, more intensive regimens were associated with small absolute increases in rates of drug discontinuation (2.5%), elevated levels of aminotransferases (1%) and myopathy (0.5%), and there was no difference in noncardiovascular mortality. All 7 trials reported events by randomization arm rather than by LDL level achieved. About half of the patients treated with more intensive statin therapy did not achieve an LDL level of less than 2.0 mmol/L, and none of the trials tested combination therapies. INTERPRETATION: Our analysis supports the use of more intensive statin regimens in patients with established coronary artery disease. There is insufficient evidence to advocate treating to particular LDL targets, using combination lipid-lowering therapy to achieve these targets or for using more intensive regimens in patients without established coronary artery disease.

Cholesterol lowering for secondary prevention: what statin dose should we use?

Over the past decade, 17 large placebo-controlled trials have established that statin therapy lowers LDL cholesterol and prevents cardiovascular events and death in patients with coronary disease or at high risk for atherosclerotic events. Nine trials of higher dose vs. lower dose statins (reporting data from 29,853 patients with coronary artery disease and 486 patients with other indications for statin therapy) have established that higher dose statin therapy is more efficacious than lower dose therapy in reducing myocardial infarctions/coronary death (by 16%) and stroke (by 18%) in patients with coronary disease but only reduces all-cause mortality in patients at high risk for coronary death (such as patients immediately after acute coronary syndrome). Higher dose statins are associated with statistically significantly increased risks of myopathy and elevated transaminases compared to lower dose statins; while relative risks for these outcomes are 1.2 and 4.0, the absolute increases are small (0.5% and 1%). Secondary analyses of these trials using individual patient data and multivariate adjustment will be needed to appropriately examine the incremental benefits of different LDL targets, and trials are needed to determine whether combinations of low dose statins plus other lipid lowering agents may achieve better clinical outcomes than higher dose statin therapy alone.