The prognostic significance of single-lead ST-segment resolution in ST-segment elevation myocardial infarction patients treated with primary PCI - A substudy of the randomized TOTAL trial.

BACKGROUND: ST-segment elevation myocardial infarction (STEMI) is associated with high morbidity and mortality worldwide. Simple electrocardiogram (ECG) tools, including ST-segment resolution (STR) have been developed to identify high-risk STEMI patients after primary percutaneous coronary intervention (PCI). SUBJECTS AND METHODS: We evaluated the prognostic impact of STR in the ECG lead with maximal baseline ST-segment elevation (STE) 30-60 minutes after primary PCI in 7,654 STEMI patients included in the TOTAL trial. Incomplete or no STR was defined as < 70% STR and complete STR as ≥ 70% STR. The primary outcome was the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, or new or worsening New York Heart Association (NYHA) class IV heart failure at 1-year follow-up. RESULTS: Of 7,654 patients, 42.9% had incomplete or no STR and 57.1% had complete STR. The primary outcome occurred in 341 patients (10.4%) in the incomplete or no STR group and in 234 patients (5.4%) in the complete STR group. In Cox regression analysis, adjusted hazard ratio for STR < 70% to predict the primary outcome was 1.56 (95% confidence interval 1.32-1.89; P < .001) (model adjusted for all baseline comorbidities, clinical status during hospitalization, angiographic findings, and procedural techniques). CONCLUSION: In a large international study of STEMI patients, STR < 70% 30-60 minutes post primary PCI in the ECG lead with the greatest STE at admission was associated with an increased rate of the composite of cardiovascular death, recurrent MI, cardiogenic shock, or new or worsening NYHA class IV heart failure at 1-year follow-up. Clinicians should pay attention to this simple ECG finding.

Effects of complete revascularization according to age in patients with ST-segment elevation myocardial infarction and multivessel disease (COMPLETE-AGE).

BACKGROUND: In ST-segment elevation myocardial infarction (STEMI), complete revascularization with percutaneous coronary intervention (PCI) reduces major cardiovascular events compared with culprit-lesion-only PCI. Whether age influences these results remains unknown. METHODS: COMPLETE was a multinational, randomized trial evaluating a strategy of staged complete revascularization, consisting of angiography-guided PCI of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only PCI. In this prespecified subgroup analysis, treatment effect according to age (≥65 years vs <65 years) was determined for the first coprimary outcome of cardiovascular (CV) death or new myocardial infarction (MI) and the second coprimary outcome of CV death, new MI, or ischemia-driven revascularization (IDR). Median follow-up was 35.8 months (interquartile range [IQR]: 27.6-44.3 months). RESULTS: Of 4,041 patients randomized in COMPLETE, 1,613 were aged ≥ 65 years (39.9%). Higher event rates were observed for both coprimary outcomes in patients aged ≥ 65 years comparted with those aged < 65 years (11.2% vs 7.9%, HR 1.49, 95% CI 1.22-1.83; 14.4% vs 11.8%, HR 1.28, 95% CI 1.07-1.52, respectively). Complete revascularization reduced the first coprimary outcome in patients ≥ 65 years (9.7% vs 12.5%, HR 0.77; 95% CI, 0.58-1.04) and < 65 years (6.7% vs 9.1%, HR 0.72; 95% CI, 0.54-0.96)(interaction P = .74). The second coprimary outcome was reduced in those ≥ 65 years (HR 0.56, 95% CI, 0.43-0.74) and < 65 years (HR 0.48, 95% CI, 0.37-0.61 (interaction P = .37). A sensitivity analysis was performed with consistent results demonstrated using a 75-year threshold (albeit attenuated). CONCLUSIONS: In patients with STEMI and multivessel CAD, complete revascularization compared with culprit-lesion-only PCI reduced major cardiovascular events regardless of patient age and could be considered as a revascularization strategy in older adults.

Complete Revascularization Versus Culprit-Lesion-Only PCI in STEMI Patients With Diabetes and Multivessel Coronary Artery Disease: Results From the COMPLETE Trial.

BACKGROUND: In the COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multivessel Disease After Early PCI for STEMI), a strategy of complete revascularization reduced the risk of major cardiovascular events compared with culprit-lesion-only percutaneous coronary intervention in patients presenting with ST-segment-elevation myocardial infarction (STEMI) and multivessel coronary artery disease. Patients with diabetes have a worse prognosis following STEMI. We evaluated the consistency of the effects of complete revascularization in patients with and without diabetes. METHODS: The COMPLETE trial randomized a strategy of complete revascularization, consisting of angiography-guided percutaneous coronary intervention of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only percutaneous coronary intervention (guideline-directed medical therapy alone). In prespecified analyses, treatment effects were determined in patients with and without diabetes on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. Interaction P values were calculated to evaluate whether there was a differential treatment effect in patients with and without diabetes. RESULTS: Of the 4041 patients enrolled in the COMPLETE trial, 787 patients (19.5%) had diabetes. The median HbA1c (glycated hemoglobin) was 7.7% in the diabetes group and 5.7% in the nondiabetes group. Complete revascularization consistently reduced the first coprimary outcome in patients with diabetes (hazard ratio, 0.87 [95% CI, 0.59-1.29]) and without diabetes (hazard ratio, 0.70 [95% CI, 0.55-0.90]), with no evidence of a differential treatment effect (interaction P=0.36). Similarly, for the second coprimary outcome, no differential treatment effect (interaction P=0.27) of complete revascularization was found in patients with diabetes (hazard ratio, 0.61 [95% CI, 0.43-0.87]) and without diabetes (hazard ratio, 0.48 [95% CI, 0.39-0.60]). CONCLUSIONS: Among patients presenting with STEMI and multivessel disease, the benefit of complete revascularization over a culprit-lesion-only percutaneous coronary intervention strategy was consistent regardless of the presence or absence of diabetes.

The prognostic significance of Q waves and T wave inversions in the ECG of patients with STEMI: A substudy of the TOTAL trial.

BACKGROUND: The prognostic significance of Q waves and T-wave inversions (TWI) combined and separately in STEMI patients undergoing primary PCI has not been well established in previous studies. METHODS: We included 7,831 patients from the TOTAL trial and divided the patients into categories based on Q waves and TWIs in the presenting ECG. The primary outcome was a composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock or new or worsening NYHA class IV heart failure within one year. The study evaluated the effect of Q waves and TWI on the risk of primary outcome and all-cause death, and whether patient benefit of aspiration thrombectomy differed between the ECG categories. RESULTS: Patients with Q+TWI+ (Q wave and TWI) pattern had higher risk of primary outcome compared to patients with Q-TWI- pattern [33 (10.5%) vs. 221 (4.2%); adjusted hazard ratio (aHR) 2.10; 95% CI, 1.45-3.04; p<0.001] within 40-days' period. When analyzed separately, patients with Q waves had a higher risk for the primary outcome compared to patients with no Q waves in the first 40 days [aHR 1.80; 95% CI, 1.48-2.19; p<0.001] but there was no additive risk after 40 days. Patients with TWI had a higher risk for primary outcome only after 40 days when compared to patients with no TWI [aHR 1.63; 95% CI, 1.04-2.55; p=0.033]. There was a trend towards a benefit of thrombectomy in patients with the Q+TWI+ pattern. CONCLUSIONS: Q waves and TWI combined (Q+TWI+ pattern) in the presenting ECG is associated with unfavourable outcome within 40-days. Q waves tend to affect short-term outcome, while TWI has more effect on long-term outcome.

No-reflow after primary percutaneous coronary intervention in patients with ST-elevation myocardial infarction: an angiographic core laboratory analysis of the TOTAL Trial.

BACKGROUND: The optimal strategy to prevent no-reflow in ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary intervention (PCI) is unknown. AIMS: We aimed to examine the effect of thrombectomy on the outcome of no-reflow in key subgroups and the adverse clinical outcomes associated with no-reflow. METHODS: We performed a post hoc analysis of the TOTAL Trial, a randomised trial of 10,732 patients comparing thrombectomy versus PCI alone. This analysis utilised the angiographic data of 1,800 randomly selected patients. RESULTS: No-reflow was diagnosed in 196 of 1,800 eligible patients (10.9%). No-reflow occurred in 95/891 (10.7%) patients randomised to thrombectomy compared with 101/909 (11.1%) in the PCI-alone arm (odds ratio [OR] 0.95, 95% confidence interval [CI]: 0.71-1.28; p-value=0.76). In the subgroup of patients who underwent direct stenting, those randomised to thrombectomy compared with PCI alone experienced less no-reflow (19/371 [5.1%] vs 21/216 [9.7%], OR 0.50, 95% CI: 0.26-0.96). In patients who did not undergo direct stenting, there was no difference between the groups (64/504 [12.7%] vs 75/686 [10.9%)], OR 1.18, 95% CI: 0.82-1.69; interaction p-value=0.02). No-reflow patients had a significantly increased risk of experiencing the primary composite outcome (cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA Class IV heart failure) at 1 year (adjusted hazard ratio 1.70, 95% CI: 1.13-2.56; p-value=0.01). CONCLUSIONS: In patients with STEMI treated by PCI, thrombectomy did not reduce no-reflow in all patients but may be synergistic with direct stenting. No-reflow is associated with increased adverse clinical outcomes.

Reperfusion Delays and Outcomes Among Patients With ST-Segment-Elevation Myocardial Infarction With and Without Cardiogenic Shock.

BACKGROUND: Mortality remains high in patients with ST-segment-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS), and early reperfusion has been shown to improve outcomes. We analyzed the association between first medical contact (FMC)-to-percutaneous coronary angiography time with mortality and major adverse cardiovascular events among patients with STEMI with and without CS. METHODS: We performed a retrospective analysis of the Vancouver Coastal Health Authority STEMI registry, including all patients with STEMI who received primary percutaneous coronary angiography between January 1, 2010, and December 31, 2020, and stratified them by presence or absence of CS at hospital arrival. The primary outcome was in-hospital mortality, the secondary outcome was in-hospital major adverse cardiovascular events, defined as a composite of the first occurrence of mortality, cardiac arrest, heart failure, intracerebral hemorrhage, cerebrovascular accident, or reinfarction. Mixed effects logistic regression with restricted cubic splines was used to estimate the relationships between FMC-to-device time and the outcomes in the CS and non-CS groups. RESULTS: 2929 patients were included, 9.4% (n=275) had CS. Median FMC-to-device time was 113.5 (interquartile range, 93.0-145.0) and 103.0 (interquartile range, 85.0-130.0) minutes for patients with CS and without CS, respectively. More patients with CS had FMC-to-device times above guideline recommendations (76.6% versus 54.1%, P<0.001). Between 60 and 90 minutes, for each 10-minute increase in FMC-to-device time, absolute mortality for patients with CS increased by 4% to 7%, whereas for patients without CS, it increased by <0.5%. CONCLUSIONS: Among patients with STEMI undergoing primary percutaneous coronary angiography, reperfusion delays among patients with CS are associated with significantly worse outcomes. Strategies to reduce FMC-to-device times for patients with STEMI presenting with CS are required.

Temporal Trends in Reperfusion Delivery and Clinical Outcomes Following Implementation of a Regional STEMI Protocol: A 12-Year Perspective.

Background: The Vancouver Coastal Health (VCH) ST-elevation myocardial infarction (STEMI) program aimed to increase access to primary percutaneous coronary intervention (PPCI) and reduce first-medical-contact-to-device times (FMC-DTs). We evaluated the long-term program impact on PPCI access and FMC-DT, and overall and reperfusion-specific in-hospital mortality. Methods: We analyzed all VCH STEMI patients between June 2007 and November 2019. The primary outcome was the proportion of patients receiving PPCI over 4 program implementation phases over 12 years. We also evaluated overall changes in median FMC-DT and the proportion of patients achieving guideline-mandated FMC-DT, in addition to overall and reperfusion-specific in-hospital mortality. Results: A total of 3138 of 4305 VCH STEMI patients were treated with PPCI. PPCI rates increased from 40.2% to 78.7% from 2007 to 2019 (P < 0.001). From phase 1 to 4, median FMC-DT improved from 118 to 93 minutes (percutaneous coronary intervention [PCI]-capable hospitals, P < 0.001) and from 174 to 118 minutes (non-PCI-capable hospitals, P < 0.001), with a concomitant increase in those achieving guideline-mandated FMC-DT (35.5% to 66.1%, P < 0.001). Overall in-hospital mortality was 9.0% (P = 0.20 across phases), with mortality differing significantly by reperfusion strategy (4.0% fibrinolysis, 5.7% PPCI, 30.6% no reperfusion therapy, P < 0.001). Mortality significantly decreased from phase 1 to phase 4 at non-PCI-capable centres (9.6% to 3.9%, P = 0.022) but not at PCI-capable centres (8.7% vs 9.9%, P = 0.27). Conclusions: A regional STEMI program increased the proportion of patients who received PPCI and improved reperfusion times over 12 years. Although no statistically significant decrease occurred in overall regional mortality incidence, mortality incidence was decreased for patients presenting to non-PCI-capable centres.

Contexte: Le programme sur l'infarctus du myocarde avec élévation du segment ST (STEMI) de la régie régionale de santé Vancouver Coastal Health (VCH) visait à améliorer l'accès à des interventions coronariennes percutanées primaires (ICPP) et à réduire le temps entre le premier contact médical et l'intervention. Nous avons évalué les effets à long terme du programme sur l'accès aux ICPP, sur le temps entre le premier contact médical et l'intervention, ainsi que sur le taux global de mortalité hospitalière et le taux de mortalité hospitalière lié à la reperfusion. Méthodologie: Nous avons analysé les cas de tous les patients admis au programme STEMI de la VCH entre juin 2007 et novembre 2019. Le critère d'évaluation principal était la proportion de patients recevant une ICPP pendant les 4 phases du programme, qui se sont étalées sur 12 ans. Nous avons aussi évalué la variation totale du temps médian entre le premier contact médical et l'intervention, et de la proportion de patients chez qui le temps recommandé entre le premier contact médical et l'intervention a été respecté ainsi que la variation du taux global de mortalité hospitalière et du taux de mortalité hospitalière lié à la reperfusion. Résultats: Au total, 3138 des 4305 patients du programme STEMI de la VCH ont été traités par une ICPP. Les taux d'ICPP sont passés de 40,2 % à 78,7 % entre 2007 et 2019 (p < 0,001). De la phase 1 à la phase 4 du programme, le temps médian entre le premier contact médical et l'intervention s'est amélioré, passant de 118 minutes à 93 minutes (hôpitaux en mesure d'effectuer une intervention coronarienne percutanée [ICP]; p < 0,001) et de 174 à 118 minutes (hôpitaux n'étant pas en mesure d'effectuer une ICP; p < 0,001), avec une augmentation du nombre de personnes pour qui le temps recommandé entre le premier contact médical et l'intervention a été respecté (35,5 % à 66,1 %; p < 0,001). Le taux global de mortalité hospitalière était de 9,0 % (p = 0,20 pour toutes les phases), et le taux de mortalité hospitalière lié à la reperfusion différait de manière significative selon la stratégie adoptée (fibrinolyse : 4,0 %; ICPP : 5,7 %; aucune reperfusion : 30,6 %; p < 0,001). Le taux de mortalité a diminué de manière significative entre la phase 1 et la phase 4 dans les centres qui n'étaient pas en mesure d'effectuer une ICP (9,6 % à 3,9 %; p = 0,022), mais pas dans les centres en mesure d'effectuer une ICP (8,7 % c. 9,9 %; p = 0,27). Conclusions: Le programme STEMI régional a permis d'augmenter la proportion de patients qui ont reçu une ICPP et d'améliorer les temps de reperfusion sur 12 ans. Bien qu'aucune diminution statistiquement significative n'ait été observée quant au taux global de mortalité dans la région, le taux de mortalité a diminué chez les patients se présentant dans un centre qui n'était pas en mesure d'effectuer une ICP.

Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study.

BACKGROUND: The 3M-TAVR trial (3M-Transcatheter Aortic Valve Replacement) demonstrated the feasibility and safety of next-day hospital discharge after transfemoral TAVR with implementation of a minimalist pathway. However, the economic impact of this approach is unknown. Therefore, we evaluated costs for patients undergoing minimalist TAVR compared with conventional TAVR. METHODS: We used propensity matching to compare resource utilization and costs (from a US health care system perspective) for patients in the 3M-TAVR trial with those for transfemoral TAVR patients enrolled in the contemporaneous S3i trial (PARTNER SAPIEN-3 Intermediate Risk). Procedural costs were estimated using measured resource utilization for both groups. For the S3i group, all other costs through 30-day follow-up were assessed by linkage with Medicare claims; for 3M, these costs were assessed using regression models derived from S3i cost and resource utilization data. RESULTS: After 1:1 propensity matching, 351 pairs were included in our study (mean age 82, mean Society of Thoracic Surgery risk score 5.3%). There were no differences in death, stroke, or rehospitalization between the 3M-TAVR and S3i groups through 30-day follow-up. Index hospitalization costs were $10 843/patient lower in the 3M-TAVR cohort, driven by reductions in procedure duration, anesthesia costs, and length of stay. Between discharge and 30 days, costs were similar for the 2 groups such that cumulative 30-day costs were $11 305/patient lower in the 3M-TAVR cohort compared with the S3i cohort ($49 425 versus $60 729, 95% CI for difference $9378 to $13 138; P<0.001). CONCLUSIONS: Compared with conventional transfemoral TAVR, use of a minimalist pathway in intermediate-risk patients was associated with similar clinical outcomes and substantial in-hospital cost savings, which were sustained through 30 days. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02287662.

Complete Revascularization vs Culprit Lesion-Only Percutaneous Coronary Intervention for Angina-Related Quality of Life in Patients With ST-Segment Elevation Myocardial Infarction: Results From the COMPLETE Randomized Clinical Trial.

Importance: In patients with multivessel coronary artery disease (CAD) presenting with ST-segment elevation myocardial infarction (STEMI), complete revascularization reduces major cardiovascular events compared with culprit lesion-only percutaneous coronary intervention (PCI). Whether complete revascularization also improves angina-related health status is unknown. Objective: To determine whether complete revascularization improves angina status in patients with STEMI and multivessel CAD. Design, Setting, and Participants: This secondary analysis of a randomized, multinational, open label trial of patient-reported outcomes took place in 140 primary PCI centers in 31 countries. Patients presenting with STEMI and multivessel CAD were randomized between February 1, 2013, and March 6, 2017. Analysis took place between July 2021 and December 2021. Interventions: Following PCI of the culprit lesion, patients with STEMI and multivessel CAD were randomized to receive either complete revascularization with additional PCI of angiographically significant nonculprit lesions or to no further revascularization. Main Outcomes and Measures: Seattle Angina Questionnaire Angina Frequency (SAQ-AF) score (range, 0 [daily angina] to 100 [no angina]) and the proportion of angina-free individuals by study end. Results: Of 4041 patients, 2016 were randomized to complete revascularization and 2025 to culprit lesion-only PCI. The mean (SD) age of patients was 62 (10.7) years, and 3225 (80%) were male. The mean (SD) SAQ-AF score increased from 87.1 (17.8) points at baseline to 97.1 (9.7) points at a median follow-up of 3 years in the complete revascularization group (score change, 9.9 [95% CI, 9.0-10.8]; P < .001) compared with an increase of 87.2 (18.4) to 96.3 (10.9) points (score change, 8.9 [95% CI, 8.0-9.8]; P < .001) in the culprit lesion-only group (between-group difference, 0.97 points [95% CI, 0.27-1.67]; P = .006). Overall, 1457 patients (87.5%) were free of angina (SAQ-AF score, 100) in the complete revascularization group compared with 1376 patients (84.3%) in the culprit lesion-only group (absolute difference, 3.2% [95% CI, 0.7%-5.7%]; P = .01). This benefit was observed mainly in patients with nonculprit lesion stenosis severity of 80% or more (absolute difference, 4.7%; interaction P = .02). Conclusions and Relevance: In patients with STEMI and multivessel CAD, complete revascularization resulted in a slightly greater proportion of patients being angina-free compared with a culprit lesion-only strategy. This modest incremental improvement in health status is in addition to the established benefit of complete revascularization in reducing cardiovascular events.

Association of pre-hospital time intervals and clinical outcomes in ST-elevation myocardial infarction patients.

Study Objectives: Timely coronary reperfusion is critical for favorable outcomes after ST-elevation myocardial infarction (STEMI). A substantial proportion of the total ischemic time is patient related, occurring before first medical contact (FMC). We aimed to expand the limited current understanding of the associations between prehospital intervals and clinical outcomes. Methods: We conducted a retrospective analysis of consecutive STEMI patients who underwent primary percutaneous coronary intervention (pPCI) (January 2009-March 2016) and assessed the associations between prehospital intervals and the incidence of new heart failure, cardiogenic shock, and hospital length of stay (LOS), adjusting for important clinical variables. Results: A total of 773 patients (77% men, median age 65 years) met eligibility criteria. The median pre-911 activation interval was 29 minutes (interquartile range: 11, 89); the median 911 call to FMC interval was 12 minutes (interquartile range: 9, 15). In multivariable analysis, there was a V-shaped relationship between the pre-911 activation interval and outcomes: a lower likelihood of new heart failure (odds ratio [OR] 0.51; 95% confidence interval [CI]: 0.30, 0.87), cardiogenic shock (OR 0.40; 95% CI: 0.21, 0.75) and prolonged LOS (OR 0.24; 95% CI: 0.14, 0.42) for midrange intervals (11-88 minutes) when compared to the early (< 11-minute) interval. There was no statistically significant relationship between total pre-FMC time and FMC to device activation time. Conclusions: Among ambulance-transported STEMI patients receiving pPCI, the shortest and longest pre-911 activation time intervals were associated with poorer outcomes. However, variation in post-FMC interval alone was not associated with outcomes, suggesting that interventions to reduce pre-FMC intervals must be prioritized.

Prospective long-term follow-up of silicone-polyurethane-insulated implantable cardioverter-defibrillator leads.

BACKGROUND: St Jude Medical (now Abbott) Optim-insulated implantable cardioverter-defibrillator (ICD) leads were expected to overcome problems with insulation abrasion and externalized conductors in earlier models. Long-term follow-up is essential to the evaluation of lead performance. OBJECTIVE: To determine, in a prospective cohort of Optim-insulated ICD leads, the rates of all-cause mechanical failure and its subtypes (conductor fracture, insulation abrasion, externalized conductors, and other mechanical failures) and electrical dysfunction adjudicated as nonmechanical failure. METHODS: Abbott established 3 prospective registries, enrolling 11,155 leads among 10,872 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reporting, and documentation of lead revision or inactivation, study withdrawal, and death or transplant. The Population Health Institute (McMaster University) reviewed database functions, adjudicated all potential mechanical lead failures, and conducted independent data analyses. RESULTS: During a median follow-up of 4.6 years, there were 171 mechanical failures (1.53%, 95.4% freedom from failure by 12 years). There were no significant differences in survival among Durata DF4 and DF1 and Riata ST Optim leads. The year-to-year rate of failure of leads increased over time. There were 69 electrical dysfunctions (0.62%, 98.8% freedom from failure by 12 years) adjudicated as nonmechanical failure. CONCLUSION: During follow-up as long as 12 years (median 4.6 years), Optim-insulated leads had low rates of mechanical failure and electrical dysfunction. Independent analyses provide reliable data on the long-term outcomes essential to analyzing ICD lead performance.

Quality of life among women with symptomatic, screen-detected, and interval breast cancer, and for women without breast cancer: a retrospective cross-sectional study from Norway.

PURPOSE: Breast cancers detected at screening need less aggressive treatment compared to breast cancers detected due to symptoms. The evidence on the quality of life associated with screen-detected versus symptomatic breast cancer is sparse. This study aimed to compare quality of life among Norwegian women with symptomatic, screen-detected and interval breast cancer, and women without breast cancer and investigate quality adjusted life years (QALYs) for women with breast cancer from the third to 14th year since diagnosis. METHODS: This retrospective cross-sectional study was focused on women aged 50 and older. A self-reported questionnaire including EQ-5D-5L was sent to 11,500 women. Multivariable median regression was used to analyze the association between quality of life score (visual analogue scale 0-100) and detection mode. Health utility values representing women's health status were extracted from EQ-5D-5L. QALYs were estimated by summing up the health utility values for women stratified by detection mode for each year between the third and the 14th year since breast cancer diagnosis, assuming that all women would survive. RESULTS: Adjusted regression analyses showed that women with screen-detected (n = 1206), interval cancer (n = 1005) and those without breast cancer (n = 1255) reported a higher median quality of life score using women with symptomatic cancer (n = 1021) as reference; 3.7 (95%CI 2.2-5.2), 2.3 (95%CI 0.7-3.8) and 4.8 (95%CI 3.3-6.4), respectively. Women with symptomatic, screen-detected and interval cancer would experience 9.5, 9.6 and 9.5 QALYs, respectively, between the third and the 14th year since diagnosis. CONCLUSION: Women with screen-detected or interval breast cancer reported better quality of life compared to women with symptomatic cancer. The findings add benefits of organized mammographic screening.

The Association of Atrial Fibrillation Before Percutaneous Coronary Intervention With 1-Year Outcome in ST-Elevation Myocardial Infarction Patients.

BACKGROUND: We aimed to determine the association of atrial fibrillation (AF) with 1-year outcome in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). METHODS: Patients (n = 8830) enrolled in the Trial of Routine Aspiration Thrombectomy with PCI vs PCI Alone in Patients With STEMI (TOTAL) were followed for 1 year. The primary outcome was a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening class IV heart failure. The presence or absence of AF was determined from a single pre-PCI electrocardiogram. RESULTS: Patients with AF (n = 437; 4.9%) were older, and more often had a history of stroke, hypertension, or myocardial infarction. The rate of the primary outcome was higher in the AF group than in the sinus rhythm (SR) group (17.4% vs 7.4%, P < 0.001), as was the rate of cardiovascular death (9.8% vs 3.3%, P < 0.001). In multivariable analysis, AF was independently predictive of the primary outcome (adjusted hazard ratio [aHR] 1.68; 95% confidence interval [CI], 1.30-2.16, P < 0.001), cardiovascular death (aHR 1.69; 95% CI, 1.19-2.40, P = 0.003), all-cause mortality (aHR 1.63; 95% CI, 1.18-2.24, P = 0.003), and severe heart failure (aHR 1.96; 95% CI, 1.25-3.07, P = 0.003). Among patients who were in SR, the primary outcome occurred in 307 of 4252 (7.2%) in the thrombectomy group and 310 of 4141 (7.5%) in the PCI alone group, and among those with AF, these rates were respectively 42 of 218 (19.3%) and 34 of 219 (15.5%) (P interaction = 0.26). CONCLUSIONS: In STEMI patients, AF on the pre-PCI electrocardiogram is associated with a higher risk of the primary composite cardiovascular outcome, all-cause and cardiovascular death, and severe heart failure during 1-year follow-up than it is in patients with SR.

CONTEXTE: Notre objectif était de déterminer le lien entre la fibrillation auriculaire (FA) et le résultat à un an de patients ayant subi un infarctus du myocarde avec élévation du segment ST (STEMI) puis une intervention coronarienne percutanée (ICP) primaire. MÉTHODOLOGIE: Les patients (n = 8 830) admis à l'étude TOTAL ( T rial o f Routine Aspiration T hrombectomy with PCI vs PCI Al one in Patients With STEMI) ont été suivis pendant une année. Le principal critère d'évaluation était composé des décès d'origine cardiovasculaire, de l'infarctus du myocarde récurrent, du choc cardiogénique ou de l'apparition/aggravation d'une insuffisance cardiaque de classe IV. La présence ou l'absence de FA était établie à partir d'un seul électrocardiogramme effectué avant l'ICP. RÉSULTATS: Les patients atteints de FA (n = 437; 4,9 %) étaient âgés, et la plupart avaient des antécédents d'AVC, d'hypertension ou d'infarctus du myocarde. La fréquence des manifestations liées au principal critère d'évaluation était plus élevée dans le groupe FA que dans le groupe en rythme sinusal (17,4 % vs 7,4 %, p < 0,001); il en était de même pour le taux de décès d'origine cardiovasculaire (9,8 % vs 3,3 %, p < 0,001). Dans une analyse multivariée, la FA était indépendamment prédictive des manifestations liées au principal critère d'évaluation (rapport des risques instantanés ajusté [RRIa] : 1,68; intervalle de confiance [IC] à 95 % : 1,30-2,16, p < 0,001), décès d'origine cardiovasculaire (RRIa : 1,69; IC à 95 % : 1,19-2,40, p = 0,003), mortalité toutes causes confondues (RRIa : 1,63; IC à 95 % : 1,18-2,24, p = 0,003) et insuffisance cardiaque grave (RRIa : 1,96; IC à 95 % : 1,25-3,07, p = 0,003). Parmi les patients en rythme sinusal, les manifestations du principal critère d'évaluation sont survenues chez 307 patients sur les 4 252 (7,2 %) du groupe ayant subi une thrombectomie, et chez 310 patients sur les 4 141 (7,5 %) du groupe ayant subi une ICP sans thrombectomie; parmi ceux atteints de FA, ces taux étaient respectivement de 42 sur 218 (19,3 %) et de 34 sur 219 (15,5 %) (p interaction = 0,26). CONCLUSIONS: Chez les patients ayant subi un STEMI, la détection d'une FA à l'électrocardiogramme réalisé avant l'ICP est associée à un risque accru de manifestation cardiovasculaire liée au principal critère d'évaluation composé, de décès toutes causes confondues et d'origine cardiovasculaire, et d'insuffisance cardiaque grave, pendant la première année de suivi comparativement aux patients en rythme sinusal.

The prognostic significance of grade of ischemia in the ECG in patients with ST-elevation myocardial infarction: A substudy of the randomized trial of primary PCI with or without routine manual thrombectomy (TOTAL trial).

BACKGROUND: The importance of the grade of ischemia (GI) ECG classification in the risk assessment of patients with STEMI has been shown previously. Grade 3 ischemia (G3I) is defined as ST-elevation with distortion of the terminal portion of the QRS complex in two or more adjacent leads, while Grade 2 ischemia (G2I) is defined as ST-elevation without QRS distortion. Our aim was to evaluate the prognostic impact of the GI classification on the outcome in patients with STEMI. METHODS: 7,211 patients from the TOTAL trial were included in our study. The primary outcome was a composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year. RESULTS: The primary outcome occurred in 153 of 1,563 patients (9.8%) in the G3I group vs. 364 of 5,648 patients (6.4%) in the G2I group (adjusted HR 1.27; 95% CI, 1.04 - 1.55; p=0.022). The rate of cardiovascular death (4.8% vs. 2.5%; adjusted HR 1.48; 95% CI 1.09 - 2.00; p=0.013) was also higher in patients with G3I. CONCLUSIONS: G3I in the presenting ECG was associated with an increased rate of the composite of cardiovascular death, recurrent MI, cardiogenic shock, or NYHA class IV heart failure within one year compared to patients with G2I. Patients with G3I also had a higher cardiovascular death compared to patients with G2I.

Access-Site vs Non-Access-Site Major Bleeding and In-Hospital Outcomes Among STEMI Patients Receiving Primary PCI.

BACKGROUND: Major bleeding (MB) is an independent predictor of mortality among ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (pPCI). Prevention of access-site MB has received significant attention. However, limited data have been obtained on the influence of access-site MB vs non-access-site MB and association with subsequent adverse in-hospital outcomes in the STEMI population undergoing pPCI. METHODS: We identified 1494 STEMI patients who underwent pPCI between 2012 and 2018. Unadjusted and adjusted differences among patients with no MB, access-site MB, non-access-site MB, and in-hospital clinical outcomes were assessed. The use of bleeding-avoidance strategies and their effects on MB were also evaluated. RESULTS: MB occurred in 121 (8.1%) patients. Access-site MB occurred in 34 (2.3%) patients, and non-access-site MB occurred in 87 (5.8%). The median reduction in hemoglobin was 31 g/L (interquartile range: 19-43) with access-site MB, and 44 g/L (interquartile range: 29-62) with non-access-site MB. After multivariable adjustment, non-access-site MB was independently associated with in-hospital death (adjusted odds ratio [aOR] 4.21; 95% confidence interval [CI] 2.04-8.68), cardiogenic shock (aOR 10.91; 95% CI 5.67-20.98), and cardiac arrest (aOR 5.63; 95% CI 2.88-11.01). Conversely, access-site MB was not associated with adverse in-hospital outcomes. Bleeding-avoidance strategies were used frequently; however, after multivariable adjustment, no single bleeding-avoidance strategy was significantly associated with reduced MB. CONCLUSIONS: In STEMI patients undergoing pPCI, non-access-site MB was independently associated with adverse in-hospital outcomes, whereas access-site MB was not. Additional study of strategies to reduce the incidence and impact of non-access-site MB appears to be warranted.

CONTEXTE: Le saignement majeur (SM) est un facteur prédictif indépendant de la mortalité chez les patients ayant eu un infarctus du myocarde avec élévation du segment ST (STEMI) qui subissent une intervention coronarienne percutanée primaire (ICPp). La prévention du SM lié à l'accès vasculaire a fait l'objet de nombreuses études. Toutefois, rares sont les données sur l'influence du SM lié à l'accès vasculaire par rapport au SM non lié à cet élément et sur son association avec des résultats indésirables intrahospitaliers subséquents chez des patients ayant subi une ICPp après un STEMI. MÉTHODOLOGIE: Nous avons répertorié 1 494 patients ayant subi une ICPp après un STEMI entre 2012 et 2018. Nous avons évalué les différences non ajustées et ajustées entre les cas sans SM, les cas de SM liés à l'accès vasculaire et les cas de SM non liés à l'accès vasculaire, et les résultats cliniques intrahospitaliers. L'utilisation de stratégies d'évitement des saignements et leurs effets sur le SM ont également été évalués. RÉSULTATS: Un SM a été observé chez 121 (8,1 %) patients. Le SM lié à l'accès vasculaire touchait 34 (2,3 %) patients, et le SM non lié à l'accès vasculaire 87 (5,8 %) patients. La réduction médiane du taux d'hémoglobine était de 31 g/L (intervalle interquartile : 19 à 43) dans le cas du SM lié à l'accès vasculaire, et de 44 g/L (intervalle interquartile : 29 à 62) pour le SM non lié à l'accès vasculaire. Après ajustement multivarié, une association indépendante a été observée entre le SM non lié à l'accès vasculaire et le décès (rapport de cotes ajusté [RRa] 4,21; intervalle de confiance [IC] à 95 % : de 2,04 à 8,68), le choc cardiogénique (RRa 10,91; IC à 95 % : de 5,67 à 20,98), et l'arrêt cardiaque (RRa 5,63; IC à 95 % : de 2,88 à 11,01) intrahospitaliers. Inversement, le SM lié à l'accès vasculaire n'était associé à aucun résultat indésirable intrahospitalier. Les stratégies d'évitement des saignements avaient été utilisées fréquemment; toutefois, après ajustement multivarié, aucune stratégie particulière d'évitement des saignements n'était associée de façon significative à une réduction du SM. CONCLUSIONS: Chez les patients subissant une ICPp après un STEMI, le SM non lié à l'accès vasculaire était associé de façon indépendante aux résultats indésirables intrahospitaliers, alors que le SM lié à l'accès vasculaire ne l'était pas. La poursuite des recherches sur les stratégies permettant de réduire l'incidence et les conséquences du SM non lié à l'accès vasculaire semble donc justifiée.

Predictors of the Use of Mineralocorticoid Receptor Antagonists in Patients With Left Ventricular Dysfunction Post-ST-Segment-Elevation Myocardial Infarction.

Background Guidelines recommend mineralocorticoid receptor antagonist (MRA) use in patients with left ventricular ejection fraction ≤40% following a myocardial infarction plus heart failure or diabetes mellitus, based on mortality benefit in the EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study) trial. The objective of this study was to evaluate the real-world utilization of MRAs for patients with ST-segment-elevation myocardial infarction (STEMI) with left ventricular dysfunction. Methods and Results The prospective, population-based, Vancouver Coastal Health Authority STEMI database was linked with local outpatient cardiology records from 2007 to 2018. EPHESUS criteria were used to define post-STEMI MRA eligibility (left ventricular ejection fraction ≤40% plus clinical heart failure or diabetes mellitus, and no dialysis-dependent renal dysfunction). The primary outcome was MRA prescription among eligible patients at discharge and the secondary outcome was MRA prescription within 3 months postdischarge. Of 2691 patients with STEMI, 317 (12%) were MRA eligible, and 70 (22%) eligible patients were prescribed an MRA at discharge. Among eligible patients with no MRA at discharge, 12/126 (9.5%) with documented postdischarge follow-up were prescribed an MRA within 3 months. In multivariable analysis, left ventricular ejection fraction (odds ratio [OR], 1.55 per 5% left ventricular ejection fraction decrease; 95% CI, 1.26-1.90) and calendar year (OR, 1.23 per year, 95% CI, 1.11-1.37) were associated with MRA prescription at discharge. Other prespecified variables were not associated with MRA prescription. Conclusions In this contemporary STEMI cohort, only 1 in 4 MRA-eligible patients were prescribed an MRA within 3 months following hospitalization despite high-quality evidence for use. Novel decision-support tools are required to optimize pharmacotherapy decisions during hospitalization and follow-up to target this gap in post-STEMI care.

Complete Revascularization in Patients Undergoing a Pharmacoinvasive Strategy for ST-Segment-Elevation Myocardial Infarction: Insights From the COMPLETE Trial.

[Figure: see text].

Impact of regionalizing ST-elevation myocardial infarction care on sex differences in reperfusion times and clinical outcomes.

BACKGROUND: Women with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention historically experience worse in-hospital outcomes compared to men. HYPOTHESIS: Implementation of a regional STEMI system will reduce care gaps in reperfusion times and in-hospital outcomes between women and men. METHODS: 1928 patients (413 women, 21.4%) presented with an acute STEMI between June 2007 and March 2016. The population was divided into an early cohort (n = 728 patients, 2007-May 2011), and a late cohort (n = 1200 patients, June 2011-2016). The primary endpoints evaluated were reperfusion times and in-hospital outcomes. RESULTS: Compared to men, women experienced significant delays in first medical contact (FMC) to arrival at the emergency room (26.0 vs. 22.0 min, p < 0.001) and FMC-to-device (109 vs. 101 min p = 0.001). Women had higher incidences of post-PCI heart failure and death compared to men (p < 0.05). Following multivariable adjustment, no mortality difference was observed for women versus men (adjusted OR; 0.82; 95% confidence interval [CI], 0.51-1.34; p = 0.433) or for early versus late cohorts (adjusted OR; 1.04; 95% CI, 0.68-1.60; p = 0.856). CONCLUSION: Following STEMI regionalization, women continued to experience significantly longer reperfusion times, although there was no difference in adjusted mortality. These results highlight the ongoing disparity of STEMI care between women and men, and suggest that regionalization alone is insufficient to close sex-based care gaps.

The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation.

The Canadian Cardiovascular Society (CCS) atrial fibrillation (AF) guidelines program was developed to aid clinicians in the management of these complex patients, as well as to provide direction to policy makers and health care systems regarding related issues. The most recent comprehensive CCS AF guidelines update was published in 2010. Since then, periodic updates were published dealing with rapidly changing areas. However, since 2010 a large number of developments had accumulated in a wide range of areas, motivating the committee to complete a thorough guideline review. The 2020 iteration of the CCS AF guidelines represents a comprehensive renewal that integrates, updates, and replaces the past decade of guidelines, recommendations, and practical tips. It is intended to be used by practicing clinicians across all disciplines who care for patients with AF. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system was used to evaluate recommendation strength and the quality of evidence. Areas of focus include: AF classification and definitions, epidemiology, pathophysiology, clinical evaluation, screening and opportunistic AF detection, detection and management of modifiable risk factors, integrated approach to AF management, stroke prevention, arrhythmia management, sex differences, and AF in special populations. Extensive use is made of tables and figures to synthesize important material and present key concepts. This document should be an important aid for knowledge translation and a tool to help improve clinical management of this important and challenging arrhythmia.