Radoslaw Pracon

BACKGROUND: The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) demonstrated greater health status benefits with an initial invasive strategy, as compared with a conservative one, for patients with chronic coronary disease and moderate or severe ischemia. Whether these benefits vary globally is important to understand to support global adoption of the results. METHODS: We analyzed participants’ disease-specific health status using the validated 7-item Seattle Angina Questionnaire (SAQ: >5-point differences are clinically important) at baseline and over 1-year follow-up across 37 countries in 6 international regions. The average effect of initial invasive versus conservative strategies on 1-year SAQ scores was estimated using Bayesian proportional odds regression and compared across regions. RESULTS: Considerable regional variation in baseline health status was observed among 4617 participants (mean age=64.4±9.5 years, 24% women), with the mean SAQ summary scores of 67.4±19.5 in Eastern Europe participants (17% of the total), 71.4±15.4 in Asia-Pacific (18%), 74.9±16.7 in Central and South America (10%), 75.5±19.5 in Western Europe (26%), and 78.6±19.2 in North America (28%). One-year improvements in SAQ scores were greater in regions with lower baseline scores with initial invasive management (17.7±20.9 in Eastern Europe and 11.4±19.3 in North America), but similar in the conservative arm. Adjusting for baseline SAQ scores, similar health status benefits of an initial invasive strategy on 1-year SAQ scores were observed (ranging from 2.38 points [95% CI, 0.04–4.50] in North America to 4.66 points [95% CI, 2.46–6.94] in Eastern Europe), with an 88.3% probability that the difference in benefit across regions was <5 points. CONCLUSIONS: In patients with chronic coronary disease and moderate or severe ischemia, initial invasive management was associated with a consistent health status benefit across regions, with modest regional variability, supporting the international generalizability of health status benefits from invasive management of chronic coronary disease. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01471522

Background: No data currently exist comparing the contemporary iterations of balloon‐expandable (BE) Edwards SAPIEN 3/Ultra and the self‐expanding (SE) Medtronic Evolut PRO/R34 valves. The aim of the study was the comparison of these transcatheter heart valves with emphasis on patients with small aortic annulus. Methods and Results: In this retrospective registry, periprocedural outcomes and midterm all‐cause mortality were analyzed. A total of 1673 patients (917 SE versus 756 BE) were followed up for a median of 15 months. A total of 194 patients died (11.6%) during follow‐up. SE and BE groups showed similar survival at 1 (92.6% versus 90.6%) and 3 (80.3% versus 85.2%) years ( P _log‐rank =0.136). Compared with the BE group, patients treated with the SE device had lower peak (16.3±8 mm Hg SE versus 21.9±8 mm Hg BE) and mean (8.8±5 mm Hg SE versus 11.5±5 mm Hg BE) gradients at discharge. Conversely, the BE group demonstrated lower rates of at least moderate paravalvular regurgitation postoperatively (5.6% versus 0.7% for SE and BE valves, respectively; P P _log‐rank =0.042). In propensity‐matched patients treated with small transcatheter heart valve, there remained a trend for higher survival among the SE group at both 1 (97% SE versus 92.3% BE) and 3 years (91.8% SE versus 78.7% BE), P _log‐rank =0.096). Conclusions: Real‐world comparison of the latest‐generation SE and BE devices demonstrated similar survival up to 3 years’ follow‐up. In patients with small transcatheter heart valves, there may be a trend for improved survival among those treated with SE valves.

Introduction Advanced Clinical Practice (ACP) is an established structured university training programme available to registered non-medical healthcare professionals preparing them to safely manage clinical patient care incorporating complex clinical decisions and high degree of autonomy. Aim To assess the service impact, safety and efficiency of a clinical cardiology pharmacist with ACP training providing a sustainable, holistic and independent clinical care to non-predefined cohort of patient within a consultant-led cardiology clinic environment. Methods A pharmacist-prescriber undertaking ACP course within a tertiary cardiac centre autonomously reviewed randomly selected patients, face-to-face or virtually, in two consultant-led outpatient cardiology clinics, interventional and heart rhythm clinic, twice weekly over 12-month period. Clinical examination, diagnostic skills and IRMER training were completed prior to commencing. Data was collected from each clinic capturing number of patients reviewed, time spent per patient and consultation outcomes. Clinical decisions made for every patient were timely discussed with the relevant consultant to assess the safety of this service concept. Results A total of 358 patients were reviewed: 217 (60.6%) in the heart rhythm and 141 (39.4%) in the interventional cardiology clinic, 86 (24%) were newly referred, 196 (54.7%) were routine follow-up patients and 76 (21.3%) were booked for their first post-intervention cardiology outpatient review. Mean number of patients reviewed per clinic was 6.03 (+/-1.63) with 17.7 (+/-2.4) minutes spent per patient. Outcome data revealed 227 (63.4%) had further diagnostic tests organised, 127(35.5%) had their medications optimised, 63 (17.6%) were discharged, 44 (12.3%) patients were referred to a different specialist and 38 (10.6%) were referred for elective cardiac intervention e.g. coronary angiography, DCCV, or catheter ablation. No patients were admitted to hospital directly from clinic. 16 patients (4.5%) had their plan changed following consultant oversight safety discussion. Over the 12-month period ACP total discharge rate was 14.3% compared to 14.7% (p=0.88) by consultant, in the heart rhythm clinic and 22.7% compared to 50% (pConclusion Our ACP-Physician Hybrid Clinic model is a safe, efficient and sustainable service that allows effective management of cardiology outpatients within a tertiary cardiac centre. It demonstrates that an ACP pharmacist can apply their ACP training programme derived skillsets to make safe and appropriate clinical decisions supporting the cardiac services. This model may improve the use of NHS staff resource and patient access to specialist services. ACP combined patient outcome data(total of 358 patients reviewed over a 12-month period) Conflict of Interest None

Background: ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches—Chronic Kidney Disease) reported an initial invasive treatment strategy did not reduce the risk of death or nonfatal myocardial infarction (MI) compared with a conservative treatment strategy in patients with advanced chronic kidney disease, stable coronary disease, and moderate or severe myocardial ischemia. The cumulative frequency of different MI type after randomization and subsequent prognosis have not been reported. Methods: MI classification was based on the Third Universal Definition for MI. For procedural MI, the primary MI definition used creatine kinase-MB as the preferred biomarker, whereas the secondary MI definition used cTn (cardiac troponin); both definitions included elevated biomarker-only events with higher thresholds than nonprocedural MIs. The cumulative frequency of MI type according to treatment strategy was determined. The association of MI with subsequent all-cause death and new dialysis initiation was assessed by treating MI as a time-dependent covariate. Results: The 3-year incidence of type 1 or 2 MI with the primary MI definition was 11.2% in invasive treatment strategy and 13.6% in conservative treatment strategy (hazard ratio [HR], 0.66 [95% CI, 0.42–1.02]). Procedural MIs were more frequent in invasive treatment strategy and accounted for 9.8% and 28.3% of all MIs with the primary and secondary MI definitions, respectively. Patients had an increased risk of all-cause death after type 1 MI (adjusted HR, 4.35 [95% CI, 2.73–6.93]) and after procedural MI with the primary (adjusted HR, 2.75 [95% CI, 0.99–7.60]) and secondary MI definitions (adjusted HR, 2.91 [95% CI, 1.73–4.88]). Dialysis initiation was increased after a type 1 MI (HR, 6.45 [95% CI, 2.59–16.08]) compared with patients without an MI. Conclusions: In ISCHEMIA-CKD, the invasive treatment strategy had higher rates of procedural MIs, particularly with the secondary MI definition, and lower rates of type 1 and 2 MIs. Procedural MIs, type 1 MIs, and type 2 MIs were associated with increased risk of subsequent death. Type 1 MI increased the risk of dialysis initiation. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01985360.

Objectives This study aimed to find imaging risk features for device related-pulmonary artery (PA) injury (DR-PAI) in patients after left atrial appendage closure (LAAC). Background Cardiac tamponade resulting from DR-PAI is a rare but life-threatening complication of LAAC. Methods In vitro analysis of Amplatzer (TM) Amulet (TM) (Abbott, MN) device was done. Measurements of the distance between PA and Amplatzer lobe at its middle part, distal part, and along the stabilizing wires' trajectory (wires-to-PA distance) were taken in 100 consecutive patients on post-LAAC computed tomography (CT) studies. Clinical outcomes were collected. Results In vitro analysis indicated that both middle and distal lobe had to be in close PA proximity (<1.5 mm) for the stabilizing wires to cause risk for DR-PAI, configuration called ''cuddling lobe orientation''. On CT measurements middle lobe-PA distance was 4.7 mm (IQR = 2.7-9.5), with close proximity in 4 (4%) patients, and distal lobe-PA distance was 3.2 mm (IQR = 1.8-7.2 mm), with close proximity in 17 (17%) patients. Stabilizing wires were pointing toward PA in 47 patients (47%) with median wire-to-PA distance 5.7 mm (IQR = 3.6-8.5 mm). ''Cuddling'' was found in 2 (2%) patients and resulted in shorter wires-to-PA distance vs no ''cuddling'' group (2.3 vs 5.8 mm p <.01). At 2.9 +/- 1.0 yrs of follow-up, the two patients with ''cuddling lobe orientation'' on post-LAAC CT scan developed late cardiac tamponades (p <.001). One of those required surgery, which confirmed DR-PAI. Conclusions ''Cuddling lobe orientation'' of Amulet device with the PA was associated with short wires-to-PA distance and late pericardial effusions, including DR-PAI. Hence, such device-to-PA configuration should be avoided.

Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease.

Background—: Device-related thrombus (DRT) after left atrial appendage occlusion is a worrisome finding with little knowledge about when to expect it and how to prevent it. This study sought to investigate correlates of DRT after left atrial appendage occlusion, its time of diagnosis, and particularly, association with postimplantation dual antiplatelet therapy duration. Methods and Results—: Consecutive patients (n=102) after left atrial appendage occlusion with AMPLATZER Cardiac Plug/Amulet (n=59) or WATCHMAN (n=43) were included in a prospective registry (October 2011–May 2016). Follow-up was done at 1.5, 3 to 6, and 12 months postimplantation. DRT was classified as early (at 1.5 month), late (at 3–6 month), or very late (at 12-month follow-up). Postimplantation dual antiplatelet therapy was recommended for 30 to 180 days and decided independently by attending physicians. Final analysis included 99 patients, 42 (42.4%) females, with median CHA ₂ DS ₂ -VASc of 4.0 (interquartile range [IQR], 3.0–5.0) and median HAS-BLED score of 2.0 (IQR, 1.0–3.0). DRTs were observed in 7 (7.1%) patients: 2 (28.6%) early, 2 (28.6%) late, and 3 (42.9%) very late. When compared with patients without DRT, those with DRT presented more often with a history of prior thromboembolism (5 [71.4%] versus 28 [30.4%]; P =0.04), had lower left ventricular ejection fraction (50.0 [IQR, 35.0–55.0] versus 60.0 [IQR, 55.0–66.0]; P P =0.04) and with larger devices implanted (30.0 mm [IQR, 27.0–33.0] versus 25.0 mm [IQR, 24.0–28.0]; P P =0.77). Conclusions—: In this real-world series, DRT was observed early, late, and very late after left atrial appendage occlusion. It was related to patient and procedural characteristics but not to postimplantation dual antiplatelet therapy duration.