Novel tech throws knock-out punch to ECG improving GP referral decisions to cardiology.

PURPOSE: In a comparator study, designed with assistance from the Food and Drug Administration, a State-of-the-Art (SOTA) ECG device augmented with automated analysis, the comparator, was compared with a breakthrough technology, Cardio-HART (CHART). METHODS: The referral decision defined by physician reading biosignal-based ECG or CHART report were compared for 550 patients, where its performance is calculated against the ground truth referral decision. The ground truth was established by cardiologist consensus based on all the available measurements and findings including echocardiography (ECHO). RESULTS: The results confirmed that CHART analysis was far more effective than ECG only analysis: CHART reduced false negative rates 15.8% and false positive (FP) rates by 5%, when compared with SOTA ECG devices. General physicians (GP's) using CHART saw their positive diagnosis rate significantly increased, from ~10% to ~26% (260% increase), and the uncertainty rate significantly decreased, from ~31% to ~1.9% (94% decrease). For cardiology, the study showed that in 98% of the cases, the CHART report was found to be a good indicator as to what kind of heart problems can be expected (the 'start-point') in the ECHO examination. CONCLUSIONS: The study revealed that GP use of CHART resulted in more accurate referrals for cardiology, resulting in fewer true negative or FP-healthy or mildly abnormal patients not in need of ECHO confirmation. The indirect benefit is the reduction in wait-times and in unnecessary and costly testing in secondary care. Moreover, when used as a start-point, CHART can shorten the echocardiograph examination time.

A novel algorithm for the computation of the diastolic pressure ratio in the invasive assessment of the functional significance of coronary artery disease.

BACKGROUND: Invasive functional assessment is a mainstay in the management of patients with coronary artery disease (CAD), but there is uncertainty on the comparative accuracy of diagnostic indices of functional significance. We aimed to validate the diagnostic performance of a novel non-hyperemic diastolic pressure ratio (dPR). METHODS: We performed a retrospective analysis including two separate registries (VERIFY 2, Latina, Italy) of patients in whom functional indices were measured for lesions with angiographically moderate severity. On top of fractional flow reserve, distal coronary pressure (Pd)/aortic pressure (Pa) ratio, instantaneous wave-free ratio (iFR) and diastolic pressure ratio (dPR) were computed using a novel dedicated algorithm over 4 consecutive beats. Agreement/discrepancy between indexes was appraised Bland-Altman analysis, area under the receiver operating characteristic curve (AUC), and unsupervised machine learning. RESULTS: A total of 525 lesions from 479 patients were included. The novel dPR was highly correlated with iFR (R2=0.99, P<0.001), with a mean difference of -0.004±0.014. The diagnostic performance of dPR (best cutoff value: ≤0.89) against iFR was as follows: accuracy =96%; sensitivity =94%; specificity =97%; positive-predictive value =94%; and negative-predictive value =96%. Additionally, AUC to predict iFR≤0.89 was 0.99, which was significantly higher than that of Pd/Pa (0.97, P<0.001). In the iFR range of 0.85-0.93 ("grey zone"), the diagnostic performance was well maintained (accuracy =91%; sensitivity =87%; specificity =93%; and AUC=0.96). Results were supported also by unsupervised learning analysis. CONCLUSIONS: This multicenter registry suggests this novel dPR algorithm provides results that are numerically equivalent to iFR. Pending further studies, physicians may consider using this novel dPR algorithm to gauge the functional significance of a coronary lesion.

Incidence, Management, Immediate and Long-Term Outcome of Guidewire and Device Related Grade III Coronary Perforations (from G3CAP - Cardiogroup VI Registry).

Ellis grade III coronary artery perforations (G3-CAP) remain a life-threatening complication of percutaneous coronary intervention (PCI), with high morbidity and mortality and lack of consensus regarding optimal treatment strategies. We reviewed all PCIs performed in 10 European centers from 1993 to 2019 recording all G3-CAP along with management strategies, in-hospital and long-term outcome according to Device-related perforations (DP) and Guidewire-related perforations (WP). Among 106,592 PCI (including 7,773 chronic total occlusions), G3-CAP occurred in 311 patients (0.29%). DP occurred in 194 cases (62.4%), more commonly in proximal segments (73.2%) and frequently secondary to balloon dilatation (66.0%). WP arose in 117 patients (37.6%) with chronic total occlusions guidewires involved in 61.3% of cases. Overall sealing success rate was 90.7% and usually required multiple maneuvers (80.4%). The most commonly adopted strategies to obtain hemostasis were prolonged balloon inflation (73.2%) with covered stent implantation (64.4%) in the DP group, and prolonged balloon inflation (53.8%) with coil embolization (41%) in the WP group.  Procedural or in-hospital events arose in 38.2% of cases: mortality was higher after DP (7.2% vs 2.6%, p = 0.05) and acute stent thrombosis 3-fold higher (3.1% vs 0.9%, p = 0.19). At clinical follow-up, median 2 years, a major cardiovascular event occurred in one-third of cases (all-cause mortality 8.2% and 7.1% respectively, without differences between groups). In conclusion, although rare and despite improved rates of adequate perforation sealing G3-CAP cause significant adverse events. DP and WP result in different patterns of G3-CAP and management strategies should be based on this classification.