Predicting the development of in-hospital cardiogenic shock in patients with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention: the ORBI risk score.

Aims: To derive and validate a readily useable risk score to identify patients at high-risk of in-hospital ST-segment elevation myocardial infarction (STEMI)-related cardiogenic shock (CS). Methods and results: In all, 6838 patients without CS on admission and treated by primary percutaneous coronary intervention (pPCI), included in the Observatoire Régional Breton sur l'Infarctus (ORBI), served as a derivation cohort, and 2208 patients included in the obseRvatoire des Infarctus de Côte-d'Or (RICO) constituted the external validation cohort. Stepwise multivariable logistic regression was used to build the score. Eleven variables were independently associated with the development of in-hospital CS: age >70 years, prior stroke/transient ischaemic attack, cardiac arrest upon admission, anterior STEMI, first medical contact-to-pPCI delay >90 min, Killip class, heart rate >90/min, a combination of systolic blood pressure <125 mmHg and pulse pressure <45 mmHg, glycaemia >10 mmol/L, culprit lesion of the left main coronary artery, and post-pPCI thrombolysis in myocardial infarction flow grade <3. The score derived from these variables allowed the classification of patients into four risk categories: low (0-7), low-to-intermediate (8-10), intermediate-to-high (11-12), and high (≥13). Observed in-hospital CS rates were 1.3%, 6.6%, 11.7%, and 31.8%, across the four risk categories, respectively. Validation in the RICO cohort demonstrated in-hospital CS rates of 3.1% (score 0-7), 10.6% (score 8-10), 18.1% (score 11-12), and 34.1% (score ≥13). The score demonstrated high discrimination (c-statistic of 0.84 in the derivation cohort, 0.80 in the validation cohort) and adequate calibration in both cohorts. Conclusion: The ORBI risk score provides a readily useable and efficient tool to identify patients at high-risk of developing CS during hospitalization following STEMI, which may aid in further risk-stratification and thus potentially facilitate pre-emptive clinical decision making.

Prognostic impact of permanent pacemaker implantation after transcatheter aortic valve replacement.

BACKGROUND: Conduction disturbances requiring permanent pacemaker implantation (PPI) remain a common complication of transcatheter aortic valve replacement (TAVR). OBJECTIVE: The purpose of this study was to determine the prognostic impact of PPI after TAVR according to the timing of implantation relative to TAVR. METHODS: A total of 1199 patients (median age 83 years; interquartile range 78-86 years; 549 [45.8%] female) were included in the analysis, of whom 894 (70.8%) had not undergone PPI, 130 (10.8%) had undergone previous PPI, 116 (9.7%) had undergone in-hospital PPI, and 59 (4.9%) had undergone PPI during follow-up. Median follow-up was 2.94 years (1.42-4.32 years). The primary outcome was the composite of all-cause mortality and hospitalization for heart failure. RESULTS: PPI during follow-up was associated with a higher occurrence of the primary outcome (hazard ratio [HR] 2.11; 95% confidence interval [CI] 1.39-3.20) whereas previous PPI and in-hospital PPI were not (HR 0.96; 95% CI 0.71-1.29 and HR 1.26; 95% CI 0.88-1.81, respectively). PPI during follow-up was associated with a higher risk of hospitalization for heart failure (sub-HR 3.21; 95% CI 2.02-5.11), while this relationship was only borderline significant for previous PPI (sub-HR 1.51; 95% CI 0.99-2.29). In contrast, there was no relationship between in-hospital PPI and the subsequent risk of hospitalization for heart failure. CONCLUSION: Previous PPI and in-hospital PPI had no long-term prognostic impact on the risk of all-cause mortality and hospitalization for heart failure, whereas PPI during follow-up was associated with a higher risk of hospitalization for heart failure. The present study questions the deleterious influence of periprocedural post-TAVR PPI, which has previously been suggested by certain studies.

Early and late ventricular arrhythmias complicating ST-segment elevation myocardial infarction.

BACKGROUND: Ventricular arrhythmias can be life-threatening complications of ST-segment elevation myocardial infarction (STEMI). AIMS: To describe the incidence, predictors and in-hospital impact of early ventricular arrhythmia (EVA, occurring

Electrophysiological Study-Guided Permanent Pacemaker Implantation in Patients With Conduction Disturbances Following Transcatheter Aortic Valve Implantation.

Conduction disturbances remain common following transcatheter aortic valve implantation (TAVI). Aside from high-degree atrioventricular block (HAVB), their optimal management remains elusive. Invasive electrophysiological studies (EPS) may help stratify patients at low or high risk of HAVB allowing for an early discharge or permanent pacemaker (PPM) implantation among patients with conduction disturbances. We evaluated the safety and diagnostic performances of an EPS-guided PPM implantation strategy among TAVI recipients with conduction disturbances not representing absolute indications for PPM. All patients who underwent TAVI at a single expert center from June 2017 to July 2020 who underwent an EPS during the index hospitalization were included in the present study. False negative outcomes were defined as patients discharged without PPM implantation who required PPM for HAVB within 6 months of the initial EPS. False positive outcomes were defined as patients discharged with a PPM with a ventricular pacing percentage <1% at follow-up. A total of 78 patients were included (median age 83.5, 39% female), among whom 35 patients (45%) received a PPM following EPS. The sensitivity, specificity, positive and negative predictive values of the EPS-guided PPM implantation strategy were 100%, 89.6%, 81.5%, and 100%, respectively. Six patients suffered a mechanical HAVB during EPS and received a PPM. These 6 patients showed PPM dependency at follow-up. In conclusion, an EPS-guided PPM implantation strategy for managing post-TAVI conduction disturbances appears effective to identify patients who can be safely discharged without PPM implantation.

Determinants and Impact of Heart Failure Readmission Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Heart failure (HF) readmission is common post-transcatheter aortic valve replacement (TAVR). Nonetheless, limited data are available regarding its predictors and clinical impact. This study evaluated the incidence, predictors, and impact of HF readmission within 1-year post-TAVR, and assessed the effects of the prescription of HF therapies at discharge on the risk of HF readmission and death. METHODS: Patients included in the TAVR registry of a single expert center from 2009 to 2017 were analyzed. Competing-risk and Cox regressions were performed to identify predictors of HF readmission and death. RESULTS: Among 750 patients, 102 (13.6%) were readmitted for HF within 1-year post-TAVR. Overall, 53 patients (7.1%) experienced late readmissions (>30 days post-TAVR), and 17 (2.3%) had multiple readmissions. In ≈30% of readmissions, no trigger could be identified. Predominant causes of readmissions were changes in medication/nonadherence and supraventricular arrhythmia. Independent predictors of HF readmission included diabetes mellitus, chronic lung disease, previous acute HF, grade III or IV aortic regurgitation, and pulmonary hypertension both at discharge from the index hospitalization but not HF therapies. Overall, HF readmission did not significantly impact all-cause mortality (hazard ratio [HR], 1.36 [95% CI, 0.99-1.85]). However, late (HR, 1.90 [95% CI, 1.30-2.78]) and multiple HF readmissions (HR, 2.10 [95% CI,1.17-3.76]) were significantly associated with all-cause mortality. Prescription of renin-angiotensin system inhibitors at discharge was associated with a lower rate of all-cause mortality, especially among patients receiving doses of 25% to <50% (HR, 0.67 [95% CI, 0.48-0.94]) and 75% to 100% (HR, 0.61 [95% CI, 0.37-0.98]) of the optimal daily dose. CONCLUSIONS: HF readmission is common within 1-year of TAVR. Late and multiple HF readmissions associate with an increased risk of long-term all-cause mortality. Baseline comorbidities (diabetes, chronic lung disease, previous acute HF) and echocardiographic findings at discharge (grade III or IV aortic regurgitation, pulmonary hypertension) identified patients at high risk of HF readmission.

Immediate complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel disease treated by primary percutaneous coronary intervention: Insights from the ORBI registry.

BACKGROUND: Recent studies demonstrated the superiority of complete revascularization (CR) in patients treated by primary percutaneous coronary intervention (pPCI) in ST-elevation myocardial infarction (STEMI). AIM: To evaluate whether immediate CR improves in-hospital outcomes in patients with STEMI with multivessel disease. METHODS: Data from a prospective multicentre registry including 9365 patients with STEMI were analysed. Patients with multivessel disease and treated with pPCI (n=3412) were included and separated into two groups according to whether immediate CR was performed during the index procedure. The primary endpoint was in-hospital major adverse cardiovascular events (MACE), defined as a composite of all-cause death, non-fatal myocardial infarction, stroke and definite stent thrombosis. Secondary endpoints were individual components of MACE and major bleeding. Multivariable Cox regression and propensity-score adjustment were performed to account for confounders. RESULTS: Immediate CR was performed in 98 patients (2.9%), whereas 3314 patients (97.1%) were incompletely revascularized. The prevalence of severe heart failure (Killip class III or IV) and significant lesions of the left main coronary artery were higher in the immediate CR group (21.6% vs. 13.5% and 24.5% vs. 6.7%, respectively; P<0.001 for both). After adjustment, immediate CR was not associated with reduced rates of MACE (hazard ratio [HR] 0.64, 95% confidence interval [CI]: 0.31-1.35; P=0.24) or all-cause death (HR: 0.52, 95% CI: 0.23-1.16; P=0.11), but with increased risks of definite stent thrombosis (HR: 3.93, 95% CI: 1.12-13.75; P=0.03) and major bleeding (HR: 17.46, 95% CI: 2.29-133.17; P=0.006). CONCLUSION: Immediate CR did not improve in-hospital outcomes of patients with STEMI with multivessel disease in this analysis. Randomized studies are warranted to elucidate the optimal timing of CR in patients with STEMI.

Incidence, timing, predictors and impact of acute heart failure complicating ST-segment elevation myocardial infarction in patients treated by primary percutaneous coronary intervention.

BACKGROUND: Acute heart failure (AHF) complicating ST-segment elevation myocardial infarction (STEMI) is recognized as an ominous complication. Previous studies mostly reported outcomes of heterogeneous, non-contemporary population. Moreover, few studies assessed the prognosis of AHF according to its timing. This study evaluated incidence, predictors and impact of AHF according to its timing in a homogeneous STEMI patients population treated by primary percutaneous coronary intervention (pPCI). METHODS: Data from 6282 patients included in a prospective multicenter registry were analyzed. Patients with AHF (Killip class>I) were compared to patients without AHF and patients with admission AHF were compared to patients who developed in-hospital AHF. In-hospital mortality was the primary endpoint of the study. Propensity-score matching and multivariable regression were used to adjust for confounders. RESULTS: A total of 1328 patients (21.1%) presented AHF: 739 on admission and 589 during hospitalization. AHF was associated with a markedly increased in-hospital mortality rate (19.9% vs. 0.8%, p<0.001). There was a gradual excess risk with each Killip class and admission AHF patients displayed the highest crude mortality rate (24.1%). By multivariable analysis, AHF was the strongest independent predictor of in-hospital mortality (HR=3.852 (2.303-6.442), p<0.001) without evidence of any difference according to its timing (HR=0.947 (0.638-1.372), p=0.767). These results were consistent after extensive adjustment on baseline characteristics in the matched cohorts. Among other predictors, pPCI beyond guidelines-recommended delays and stent thrombosis were independently associated with AHF. CONCLUSION: AHF regardless of its timing remains a common and dreadful complication of STEMI in the contemporary era.

Safety of prasugrel in real-world patients with ST-segment elevation myocardial infarction: 1-year results from a prospective observational study (Bleeding and Myocardial Infarction Study).

BACKGROUND: Antiplatelet therapies, including prasugrel, are a cornerstone in the treatment of ST-segment elevation myocardial infarction (STEMI), but are associated with a bleeding risk. This risk has been evaluated in randomized trials, but few data on real-world patients are available. AIM: To evaluate prasugrel safety in real-world patients with STEMI. METHODS: Consecutive patients with STEMI were recruited over 1 year. Follow-up was done at 3 months and 1 year to evaluate prasugrel safety from hospital discharge to the STEMI anniversary date. The primary outcome was occurrence of any major bleeding according to the Bleeding Academic Research Consortium (BARC) 3 or 5 definitions, or minor bleeding according to the BARC 2 definition. RESULTS: Overall, 1083 patients were recruited. Compared to patients treated with aspirin+clopidogrel, patients treated with aspirin+prasugrel had fewer BARC 3 or 5 bleedings (two [0.4%] patients vs. nine [1.8%] patients; P=0.04), but more BARC 2 bleedings (45 [9.3%] patients vs. 20 [4.0%] patients; P<0.001). The baseline characteristics of prasugrel- and clopidogrel-treated patients differed because the former were carefully selected (younger, higher body mass index, less frequent history of stroke). In the overall population, rates of in-hospital and out-of-hospital major bleeding were 2.6% (n=28) and 1.3% (n=13), respectively. CONCLUSION: The rate of major bleeding, particularly out-of-hospital bleeding, in patients treated with prasugrel is low within 1 year after a STEMI. Accurate selection of patient candidates for prasugrel is likely to have reduced the risk of bleeding.

High-degree atrioventricular block complicating ST segment elevation myocardial infarction in the contemporary era.

BACKGROUND: High-degree atrioventricular block (HAVB) is a common complication of ST segment elevation myocardial infarction (STEMI). HAVB in STEMI is historically considered as a marker of worse outcome but overall data about HAVB in the contemporary era of mechanical reperfusion and potent antiplatelet therapies are scarce. AIM: Analysing incidence, clinical correlates and impact on inhospital outcomes of HAVB in a large prospective registry (Observatoire Régional Breton sur l'Infarctus, ORBI) of modern management of STEMI with a special focus on potential differences between patients with HAVB on admission and those who developed HAVB during hospitalisation. METHODS: All patients enrolled in ORBI between June 2006 and December 2013 were included in the present analysis and were divided into 3 groups: patients without HAVB at any time, patients with HAVB on admission and those who developed HAVB during hospitalisation. RESULTS: A total of 6662 patients (age: 62.0 (52.0-74.0) years; male: 76.3%) were included in the present analysis. HAVB was documented in 3.5% of patients, present on admission in 63.7% of patients and occurring during hospitalisation in 36.3%. Patients with HAVB on admission or occurring during the first 24 h of hospitalisation had higher inhospital mortality rates (18.1% and 28.6%, respectively) than patients without (4.5%) or with HAVB occurring beyond the first 24 h of hospitalisation (8.0%). However by multivariable analysis, HAVB was not independently associated with inhospital mortality contrarily to age, presentation as cardiac arrest, anterior STEMI location, reperfusion therapy, cardiogenic shock, mechanical ventilation and occurrence of sustained ventricular tachyarrhythmias or mechanical complication. CONCLUSIONS: Patients with HAVB had a higher mortality rate than patients without. However HAVB is not an independent predictor of inhospital mortality.

Efficacy and safety of prehospital administration of unfractionated heparin, enoxaparin or bivalirudin in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Insights from the ORBI registry.

BACKGROUND: Despite numerous studies in recent years, the best anticoagulant option for primary percutaneous coronary intervention (PCI) remains a matter of debate. AIMS: To compare in-hospital outcomes after prehospital administration of low-dose unfractionated heparin (UFH)±glycoprotein IIb/IIIa inhibitors (GPIs), enoxaparin±GPIs, or bivalirudin in patients undergoing primary PCI for ST-segment elevation myocardial infarction (STEMI). METHODS: A total of 1720 patients (median age 62.0 years, 79.2% male) who had been enrolled in a prospective registry and received an injectable anticoagulant in physician-staffed mobile intensive care units before primary PCI were included in the study. The main outcomes were in-hospital major adverse cardiovascular events (MACE) (a composite of all-cause mortality, non-fatal myocardial infarction, stroke or definite stent thrombosis) and in-hospital major bleeding (Bleeding academic research consortium type 3 or 5). RESULTS: UFH was administered in 420 (24.4%) patients, enoxaparin in 1163 (67.6%) patients and bivalirudin in 137 patients (8.0%). Rates of in-hospital MACE were 7.4% with UFH, 6.0% with enoxaparin and 6.6% with bivalirudin, with no significant differences between groups (P=0.628). In-hospital major bleeding occurred in 1.7% of patients on UFH, 1.4% on enoxaparin and 1.5% on bivalirudin (P=0.851). By multivariable analysis, the prehospital anticoagulant used was not an independent predictor of MACE or major bleeding. CONCLUSION: In this prospective registry, there were no significant differences in the rates of in-hospital MACE or major bleeding after prehospital initiation of UFH, enoxaparin or bivalirudin in patients treated by primary PCI for STEMI.

Efficacy of pre-hospital use of glycoprotein IIb/IIIa inhibitors in ST-segment elevation myocardial infarction before mechanical reperfusion in a rapid-transfer network (from the Acute Myocardial Infarction Registry of Brittany).

Previous studies investigating prehospital use of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with ST-segment elevation myocardial infarction reached conflicting conclusions. The benefit of this strategy in addition to in-ambulance loading of dual-antiplatelet therapy remains controversial. The aim of this study was to analyze data from a prospective registry of patients with ST-segment elevation myocardial infarctions admitted <24 hours after symptom onset (July 2006 to May 2012). A total of 2,052 patients managed in a physician-staffed mobile intensive care unit (MICU)<12 hours after symptom onset and scheduled for primary percutaneous coronary intervention (PPCI) were retrospectively included. Patients who received GPIs in the MICU were compared with those who did not. The primary end point was infarct-related artery patency, defined as pre-PPCI Thrombolysis In Myocardial Infarction (TIMI) flow grade 3. GPIs were administered in the MICU to 737 patients (36%), including 430<2 hours after symptom onset, and 1,315 patients (64%) did not received prehospital GPIs. Pre-PPCI TIMI flow grade 3 rate was lower in patients treated in the MICU (17.2% vs 21.3%, p=0.03) because of patients treated >2 hours after symptom onset, of whom only 12.7% reached the primary end point. There was no significant difference between groups in the rate of in-hospital major adverse cardiac events. In conclusion, prehospital GPI use in patients with ST-segment elevation myocardial infarctions<12 hours after symptom onset scheduled for PPCI neither improved pre-PPCI infarct-related artery patency nor reduced in-hospital major adverse cardiac events.

Gender differences in presentation, management and inhospital outcome in patients with ST-segment elevation myocardial infarction: data from 5000 patients included in the ORBI prospective French regional registry.

BACKGROUND: Gender differences in presentation, management and outcome in patients with ST-segment elevation myocardial infarction (STEMI) have been reported. AIM: To determine whether female gender is associated with higher inhospital mortality. METHODS: Data from ORBI, a regional STEMI registry of 5 years' standing, were analysed. The main data on presentation, management, inhospital outcome and prescription at discharge were compared between genders. Various adjusted hazard ratios were then calculated for inhospital mortality (women versus men). RESULTS: The analysis included 5000 patients (mean age 62.6±13 years), with 1174 women (23.5%). Women were on average 8 years older than men, with more frequent co-morbidities. Median ischaemia time was 215 minutes (26 minutes longer in women; P<0.05). Reperfusion strategies in women less frequently involved fibrinolysis, coronary angiography, radial access and thrombo-aspiration. Female gender, especially in patients aged<60 years, was associated with poorer inhospital prognosis (including higher inhospital mortality: 9% vs. 4% in men; P<0.0001), and underutilization of recommended treatments at discharge. Moreover, excess female inhospital mortality was independent of presentation, revascularization time and reperfusion strategy (hazard ratio for women 1.33, 95% confidence interval 1.01-1.76; P=0.04). CONCLUSIONS: One in four patients admitted for STEMI was female, with significant differences in presentation. Female gender was associated with less-optimal treatment, both in the acute-phase and at discharge. Efforts should be made to reduce these differences, especially as female gender was independently associated with an elevated risk of inhospital mortality.