Multicenter Registry Of Patients Research Articles

Abstract 17638: Left Atrial Scar Burden Among Patients With Persistent Atrial Fibrillation Undergoing Catheter Ablation and Its Association With Patient Risk Factors and Risk of Recurrence

Introduction: Left atrial (LA) scar at time of catheter ablation (CA), assessed by bipolar voltage <0.5mV may indicate more advanced AF substrate. It is not known which risk factors are associated with scar burden and whether this is linked to worse clinical outcomes. Hypothesis: We hypothesized that patient demographics and comorbidities are associated with greater scar burden at time of CA and predispose to AF recurrence. Methods: The Real-AF registry is a prospective, observational, multicenter registry of patients undergoing CA with follow-up at 6 and 12 months. LA scar burden was calculated from CARTO as total % LA area < 0.50mV bipolar using the Pentaray catheter at first CA for persistent AF. We evaluated 1503 patients among this cohort using logistic regression modeling of age, sex, CHA2DS2-VASc and LVEF <= 35%, BMI and their association with LA scar burden categorized as 0 to 5% vs >= 6%. In 783 patients with 12-month clinical outcomes a Kaplan-Meier estimator was used to analyze risk of AF recurrence in these two cohorts. Results: Each additional year in age is associated with 1.07 greater odds (p<0.001, 95% CI=1.05, 1.08) of scar area >= 6%. Women had 2.08 greater odds (p<0.001, 95% CI=1.63, 2.65) of abnormal scar area compared to men, while patients with CHF had 1.67 greater odds (p<0.001, 95% CI=1.30, 2.16). Patients with LA scar burden >= 6% experienced significantly higher recurrence of AF compared to those with a lower scar burden (HR=1.8, p=0.0094) including after controlling for operator-specific effects (HR=1.9, p=0.0088), see figure 1. Conclusions: In a large multicenter registry of persistent AF patients undergoing CA, LA scar >=6% was associated with female sex, greater age, and CHF. An increased scar burden is associated with worse 12 month clinical outcomes from CA.

Abstract 16259: Sex Related Differences in Clinical Presentation and Outcomes in Left Ventricular Thrombus

Introduction: Sex related differences in the etiology, clinical characteristics and outcomes in patients with left ventricular thrombus (LVT) are not well understood. Methods: We developed a multi-center registry of patients diagnosed with LV thrombus by echocardiography between 1/1/2014-12/30/2020. Cases were retrospectively identified and baseline clinical characteristics, thrombus features, treatment, resolution and long-term outcomes were studied. Results: Women constituted 27% of all patients (n=271, 29% African American). Compared to men, there were no significant differences in age at presentation (median age 60 years) or median LVEF at presentation (25%). Women were more likely to have nonischemic cardiomyopathy (52.6% vs 32.2%, p=0.02) and presented with thromboembolic event at time of diagnosis of LVT (27.3% vs 13.6%, p=0.008). There was no difference in use of vitamin K antagonists during the study period. During a median follow-up of 72 months, there was no significant difference in all-cause mortality or risk of stroke or arterial thromboembolism (figure 1A-B). In Cox regression analysis, age and LVEF at presentation, chronic kidney disease, malignancy and LVEF at presentation were significant predictors of long-term mortality. Conclusions: There was no significant difference in all-cause mortality or risk of stroke or thromboembolism between men and women after diagnosis of LV thrombus.

Efficacy and Safety of Dapsone in Primary Immune Thrombocytopenia. Results of a Randomized, Placebo-Controlled Multicenter Trial and of a Single-Arm, Emulated Trial in the Prospective, Multicenter Carmen-France Registry

Introduction: Adults treated for immune thrombocytopenia (ITP) usually respond to 1 st-line therapy but the majority of them eventually relapse and need a second-line treatment to spare corticosteroids. Dapsone is an antibiotic drug with immunomodulatory properties that has shown some efficacy in various autoimmune diseases including ITP in several retrospective studies. The aim of this study was to assess the efficacy and the safety of dapsone given as second-line for primary ITP. Methods DAPS-ITP was a prospective multicenter randomized open-label controlled trial aimed to assess the efficacy and safety of dapsone as a second-line option in adult ITP. Adult patients with primary and newly diagnosed or persistent ITP with previous transient response to corticosteroids and/or IVIg and a platelet count ≤30x10 9/L (or <50x10 9/L with bleeding manifestations) were eligible. After randomization (1/1 ratio), patients received either dapsone at 100 mg/day in combination with prednisone for 3 weeks (arm A) or just the 3 weeks course of prednisone (arm B). The primary outcome was the overall response rate (R + CR) in intention to treat at week 52 in the absence of any rescue therapy after week 6 and/or any other treatment for ITP over the study period. Complete response (CR) was defined by a platelet count >100x 10 9/L on dapsone (arm A) or off treatment (arm B) and response (R) by a platelet count >30x10 9/L with a least a doubling of the baseline count. We also conducted a single-arm, emulated trial in the prospective, multicenter CARMEN-France registry to provide real world evidence about the efficacy and the safety of dapsone in ITP. The CARMEN-France is a prospective, multicenter registry of adult patients with a new diagnosis of ITP in France. We selected the patients included in the registry between 2013 and 2022 with a primary ITP, exposed to dapsone, who met the inclusion criteria of the DAPS-ITP trial. We assessed the same outcomes than in the DAPS-ITP trial. Results In total, 93 patients (51% of females, median age 51 years [range: 33-66]) were included and randomized (46 in arm A and 47 in arm B) in DAPS-ITP trial. Median platelet count at inclusion was 25x 10 9/L [17-36], median ITP duration was 0.31 years [0.18-0.90]. Forty-two (arm A) and 45 patients (arm B) were followed up to week 52. In intention to treat (see figure), the overall response-rate (ORR) was respectively 8.70% [2.78%-18.93%] (arm A) and 4.26% [0.78%-12.81%] (arm B) at week 52 (primary outcome, p value = 0.78)). At week 24, the ORR was 25% [11.06%-41.78%] in arm A and 12.77% [5.18%-23.89%] in arm B (p value = 0.57). One death (intracranial hemorrhage) occurred in arm A, none in arm B; 36/46 patients (78%) from arm A had to discontinue prematurely dapsone, mostly for inefficacy with the need of other ITP treatment (n =10/36, 27.7%) or for various safety issues (n=26/36, 72%) including anemia ± gastro-intestinal manifestations (n=6); high methemoglobinemia (n=4); toxidermia (n=3) and others miscellaneous causes (n =13). In the CARMEN registry, 127 patients were exposed to dapsone. Among them, 50 met the inclusion criteria of the DAPS-ITP trial and had a 52-week follow-up after the initiation of dapsone. Patients characteristics were similar to those included in the DAPS-ITP trial. Three patients had no platelet count measured at W52 ± 4 weeks and were withdrawn from the primary outcome assessment. Overall, 5/47 achieved R or CR at W52 without any concomitant ITP treatment, resulting in an ORR of 10.6%; 95% CI: 3.5-23.1. At W24, 9/45 patients achieved R or CR (ORR: 20.0%; 95% CI: 9.6 -34.6; 5 patients had no platelet count at W24 ± 4 weeks in the real world). Seventeen (34.0%) experienced 19 adverse drug reactions (ADRs) including 8 hemolytic anemia, 4 methemoglobinemia and 3 cutaneous rash. Twelve patients discontinued dapsone due to an ADR. Conclusion Among adult patients with primary ITP and a platelet count <30 x 10 9/L treated with dapsone as a second-line treatment, only a minority of patients achieved a sustained response at W52. The low rate of durable response may be at least in part due to an unexpectedly high rate of early discontinuation observed in the dapsone arm (DAPS-ITP trial) due to the occurrence of ADRs, some of which could have been easily manageable outside a clinical trial. Further studies are needed to better define who are the few patients who may still benefit from dapsone, in a cost-effectiveness perspective.

Latin-American Registry of Cardiovascular Disease and COVID-19: Final Results.

Socioeconomic factors contribute to a more severe impact of COVID-19 in Latin American and Caribbean (LA&C) countries than in developed countries. Patients with a severe or critical illness can develop respiratory and cardiovascular complications. To describe a LA&C population with COVID-19 to provide information related to this disease, in-hospital cardiovascular complications, and in-hospital mortality. The CARDIO COVID-19-20 Registry is an observational, multicenter, prospective, and hospital-based registry of patients with confirmed COVID-19 infection that required in-hospital treatment in LA&C. Enrollment of patients started on May 01, 2020, and ended on June 30, 2021. The CARDIO COVID-19-20 Registry included 3260 patients from 44 institutions of 14 LA&C countries. 63.2% patients were male and median age was 61.0 years old. Most common comorbidities were overweight/obesity (49.7%), hypertension (49.0%), and diabetes mellitus (26.7%). Most frequent cardiovascular complications during hospitalization or reported at discharge were cardiac arrhythmia (9.1%), decompensated heart failure (8.5%), and pulmonary embolism (3.9%). The number of patients admitted to the Intensive Care Unit (ICU) was 1745 (53.5%), and median length of their stay at the ICU was 10.0 days. Support required in ICU included invasive mechanical ventilation (34.2%), vasopressors (27.6%), inotropics (10.3%), and vasodilators (3.7%). Rehospitalization after 30-day post discharge was 7.3%. In-hospital mortality and 30-day post discharge were 25.5% and 2.6%, respectively. According to our findings, more than half of the LA&C population with COVID-19 assessed required management in ICU, with higher requirement of invasive mechanical ventilation and vasoactive support, resulting in a high in-hospital mortality and a considerable high 30-day post discharge rehospitalization and mortality.

Machine-learning-based prediction of fractional flow reserve after percutaneous coronary intervention

Background and aimsPost-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) reflects residual atherosclerotic burden and is associated with future events. How much post-PCI FFR can be predicted based on baseline basic information and the clinical relevance have not been investigated. MethodsWe compiled a multicenter registry of patients undergoing pre- and post-PCI FFR. Machine-learning (ML) algorithms were designed to predict post-PCI FFR levels from baseline demographics, quantitative coronary angiography, and pre-PCI FFR. FFR deviation was defined as actual minus ML-predicted post-PCI FFR levels, and its association with incident target vessel failure (TVF) was evaluated. ResultsMedian (IQR) pre- and post-PCI FFR values were 0.71 (0.61, 0.77) and 0.88 (0.84, 0.93), respectively. The Spearman correlation coefficient of the actual and predicted post-PCI FFR was 0.54 (95% CI: 0.52, 0.57). FFR deviation was non-linearly associated with incident TVF (HR [95% CI] with Q3 as reference: 1.65 [1.14, 2.39] in Q1, 1.42 [0.98, 2.08] in Q2, 0.81 [0.53, 1.26] in Q4, and 1.04 [0.69, 1.56] in Q5). A model with polynomial function of continuous FFR deviation indicated increasing TVF risk for FFR deviation ≤0 but plateau risk with FFR deviation >0. ConclusionsAn ML-based algorithm using baseline data moderately predicted post-PCI FFR. The deviation of post-PCI FFR from the predicted value was associated with higher vessel-oriented event.

High-risk patent foramen ovale and elderly in cryptogenic stroke

BackgroundHigh-risk patent foramen ovale (PFO) could be pathological in cryptogenic stroke (CS), but its clinical characteristics have not been fully studied, especially in elderly patients. MethodsPatients with CS were enrolled in the CHALLENGE ESUS/CS registry, a multicenter registry of CS patients undergoing transesophageal echocardiography. Clinical characteristics were compared among three groups: high-risk PFO group, large shunt PFO (≥25 microbubbles) or PFO with atrial septal aneurysm (ASA); right-to-left shunt (RLS) group, RLS including PFO with <25 microbubbles or without ASA; and no-RLS group. ResultsIn total, 654 patients were analyzed: 91, 221, and 342 in the high-risk PFO, RLS, and no-RLS groups, respectively. In multinomial logistic regression analysis, the male sex (odds ratio [OR] 1.825 [1.067–3.122]) was independently associated with high-risk PFO, but hypertension (OR, 0.562 [0.327–0.967]), multiple infarctions (OR, 0.601 [0.435–0.830]), and other cardioaortic embologenic risks (OR, 0.514 [0.294–0.897]) were inversely associated with high-risk PFO compared with non-RLS. In 517 patients aged ≥60 years, multiple infarctions (OR, 0.549 [0.382–0.788]) and other cardioaortic embologenic risks (OR, 0.523 [0.286–0.959]) were inversely associated with high-risk PFO. ConclusionsHigh-risk PFO had specific clinical characteristics and possible mechanistic associations, and this trend was consistent among CS patients aged ≥60 years. Clinical Trial Registration Informationhttp://www.umin.ac.jp/ctr/ (UMIN000032957).

Outcome of patients supported with the HeartMate 3 after extracorporeal life support: On behalf of the Durable Mechanical Circulatory Support After Extracorporeal Life Support Study Group

ObjectivesThe Durable Mechanical Circulatory Support System After Extracorporeal Life Support registry is a multicenter registry of patients who were bridged from extracorporeal life support to a durable mechanical circulatory support system. Although numerous studies have highlighted the favorable outcomes after implantation of the HeartMate 3 (Abbott), the objective of our study is to examine the outcomes of patients who received HeartMate 3 support after extracorporeal life support. MethodsData of patients undergoing HeartMate 3 implantation from January 2016 to April 2022 at 14 centers were collected and evaluated. Inclusion criteria were patients with extracorporeal life support before HeartMate 3 implantation. The outcome was reported and compared with patients receiving other types of pumps. ResultsA total of 337 patients were bridged to durable mechanical circulatory support system after extracorporeal life support in the study period. Of those patients, 140 were supported with the HeartMate 3. The other types of pumps included 170 HeartWare HVADs (Medtronic) (86%), 14 HeartMate II devices (7%), and 13 (7%) other pumps (7%). Major postoperative complications included right heart failure requiring temporary right ventricular assist device in 60 patients (47%). Significantly lower postoperative stroke (16% vs 28%, P = .01) and pump thrombosis (3% vs 8%, P = .02) rates were observed in the patients receiving the HeartMate 3. The 30-day, 1-year, and 3-year survivals in patients receiving the HeartMate 3 were 87%, 73%, and 65%, respectively. ConclusionsIn this critically ill patient population, the survivals of patients who were transitioned to the HeartMate 3 are deemed acceptable and superior to those observed when extracorporeal life support was bridged to other types of durable mechanical circulatory support systems.

Prognostic accuracy of initial and 24-h maximum SOFA scores of septic shock patients in the emergency department

BackgroundWe compared the prognostic accuracy of in-hospital mortality of the initial Sequential Organ Failure Assessment (SOFAini) score at the time of sepsis recognition and resuscitation and the maximum SOFA score (SOFAmax) using the worst variables in the 24 h after the initial score measurement in emergency department (ED) patients with septic shock. MethodsThis was a retrospective observational study using a multicenter prospective registry of septic shock patients in the ED between October 2015 and December 2019. The primary outcome was in-hospital mortality. The prognostic accuracies of SOFAini and SOFAmax were evaluated using the area under the receiver operating characteristic (AUC) curve. ResultsA total of 4860 patients was included, and the in-hospital mortality was 22.1%. In 59.7% of patients, SOFAmax increased compared with SOFAini, and the mean change of total SOFA score was 2.0 (standard deviation, 2.3). There was a significant difference in in-hospital mortality according to total SOFA score and the SOFA component scores, except cardiovascular SOFA score. The AUC of SOFAmax (0.71; 95% confidence interval [CI], 0.69–0.72) was significantly higher than that of SOFAini (AUC, 0.67; 95% CI, 0.66–0.69) in predicting in-hospital mortality. The AUCs of all scores of the six components were higher for the maximum values. ConclusionThe prognostic accuracy of the initial SOFA score at the time of sepsis recognition was lower than the 24-h maximal SOFA score in ED patients with septic shock. Follow-up assessments of organ failure may improve discrimination of the SOFA score for predicting mortality.

Multicentric, observational, longitudinal study for the evaluation of nutritional management implications in newly diagnosed Italian cancer patients: the Italian Registry of Malnutrition in Oncology (IRMO)

BackgroundMalnutrition is a frequent problem in oncology and is associated with reduced response to cancer treatments, increased drug-related toxicity, higher rates of clinical complications, reduced quality of life (QoL) and...

Optical Coherence Tomography–Guided Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction: Rationale and Design of the ATLAS-OCT Study

Even after successful revascularization with primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), subsequent adverse events still occur. Previous studies have suggested potential benefits of intravascular imaging, including optical coherence tomography (OCT). However, the feasibility of OCT-guided primary PCI has not been systematically examined in these patients. The ATLAS-OCT (ST-elevation Acute myocardial infarcTion and cLinicAl outcomeS treated by Optical Coherence Tomography-guided percutaneous coronary intervention) trial was designed to investigate the feasibility of OCT guidance during primary PCI for STEMI in experienced centers with expertise on OCT-guided PCI as a prospective, multicenter registry of consecutive patients with STEMI who underwent a primary PCI. The sites' inclusion criteria are as follows: (1) acute care hospitals providing 24/7 emergency care for STEMI, and (2) institutions where OCT-guided PCI is the first choice for primary PCI in STEMI. All patients with STEMI who underwent primary PCI at participating sites will be consecutively enrolled, irrespective of OCT use during PCI. The primary end point will be the rate of successful OCT imaging during the primary PCI. As an ancillary imaging modality to angiography, OCT provides morphologic information during PCI for the assessment of plaque phenotypes, vessel sizing, and PCI optimization. Major adverse cardiac events, defined as a composite of all-cause death, myocardial infarction, and target vessel revascularization at 1year, will also be recorded. The ATLAS-OCT study will clarify the feasibility of OCT-guided primary PCI for patients with STEMI and further identify a suitable patient group for OCT-guided primary PCI.

COVID‐19 Affects Short‐Term, But Not 90‐Day, Outcome in Patients With Stroke Treated With Mechanical Thrombectomy

Background COVID‐19 is associated with an increased stroke risk. Moreover, outcome at discharge was worse in patients with large‐vessel occlusion stroke with concomitant COVID‐19 receiving endovascular treatment (ET). We aimed to investigate the impact of concomitant COVID‐19 on later functional outcome in patients with large‐vessel occlusion stroke treated with ET. Methods We analyzed patients from the GSR‐ET (German Stroke Registry–Endovascular Treatment), an observational multicenter registry of patients with large‐vessel occlusion stroke receiving ET. Baseline characteristics, procedural parameters, discharge parameters, and functional outcome at 90 days were compared between patients with concomitant COVID‐19 and propensity score–matched controls (ratio, 1:4; matched for age, sex, prestroke modified Rankin Scale score, and stroke severity), and multivariable ordinal regression analysis was performed. Results Among 4010 patients receiving ET between February 2020 and December 2021, 72 (1.8%) had concomitant COVID‐19. Compared with 224 matched patients without COVID‐19, they (n=56) were more severely affected, with a higher median National Institutes of Health Stroke Scale (NIHSS) score after 24 hours (NIHSS score, 14.5 [interquartile range {IQR}, 9–22] versus 12 [IQR, 6–18.75]; P =0.015), and NIHSS score and modified Rankin Scale score at discharge (NIHSS score, 12 [IQR, 6.75‐16.75] versus 6 [IQR, 2–13]; P =0.001; and modified Rankin Scale score, 5 [IQR, 4–5] versus 4 [IQR, 2–5]; P =0.023), but functional outcome at 90‐day follow‐up was similar (modified Rankin Scale score, 4 [IQR, 4–6] versus 4 [IQR, 2–6]; P =0.34). After adjustment for prespecified confounders, COVID‐19 was associated with worse functional outcome at discharge (common odds ratio [OR], 0.40 [95% CI, 0.19–0.80]; P =0.011), but not at 90‐day follow‐up (common OR, 0.72 [95% CI, 0.32–1.60]; P =0.43). Conclusions COVID‐19 affected short‐term, but not 90‐day, functional outcome in patients with large‐vessel occlusion stroke treated with ET. Hence, ET should not be withheld in patients with concomitant COVID‐19.

Cardiogenic Shock in the Setting of Acute Coronary Syndromes in Argentina: Results from the ARGEN SHOCK 2 Registry

Background: Cardiogenic shock (CS) is a life-threatening complication of acute myocardial infarction (AMI) and constitutes one of the leading causes of death. Objective: The aim of this study was to investigate the clinical characteristics, treatment strategies, hospital outcome and 30-day mortality of CS in Argentina. Methods: We conducted a prospective, and multicenter registry of patients with acute coronary syndromes (ACS) with and without ST-segment elevation complicated with CS that were hospitalized in 23 centers in Argentina for 14 months (between August 1, 2021, and September 30, 2022). Results: The cohort was made up of 114 patients; median age was 64 years (58-73) and 72% were women; 76.3% corresponded to ST-segment elevation ACS, 12.3% to non-ST-segment elevation ACS, 7% had right ventricular infarction and 4.4% had mechanical complications. In 66.6% of cases CS was present on admission. Revascularization: 91.1%, use of inotropic agents: 98.2%, mechanical ventilation (MV): 59.6%, Swan-Ganz catheter: 33.3%, intra-aortic balloon pump: 30.1%. Overall in-hospital mortality was 60.5%, with no differences between ACS with or without ST-segment elevation, and was 62.6% at 30 days. Conclusion: Morbidity and mortality of CS are high despite the high rate of reperfusion therapy used.

Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results.

Mechanical thrombectomy provides rapid hemodynamic improvements after acute pulmonary embolism (PE), but long-term benefits are uncertain. FlowTriever All-comer Registry for Patient Safety and Hemodynamics is a prospective, single-arm, multicenter registry of patients with acute PE treated with the FlowTriever System (Inari Medical). Six-month outcomes including modified Medical Research Council dyspnea scores(MMRCD), right ventricular (RV) function, 6-minute walk test distances, and PE quality-of-life scores(QoL) were assessed. In total, 799 patients were enrolled and 75% completed the study with a mean follow-up of 204±46 days. Demographic characteristics included 54.1% men, mean age of 61.2 years, 77.1% intermediate-high-risk PE, and 8.0% high-risk PE. All-cause mortality was 4.6% at study completion. The proportion of patients with normal echocardiographic RV function increased from 15.1% at baseline to 95.1% at 6 months (P< .0001). MMRCD score improved from 3.0 at baseline to 0.0 at 6 months (P< .0001). 6-minute walk test distances increased from 180 m at 48 hours to 398 m at 6 months (P< .001). Median PE QoL total scores were 9.38 at 30 days and 4.85 at 6 months (P< .001). Prevalence of site-reported chronic thromboembolic pulmonary hypertension was 1.0% and chronic thromboembolic disease was 1.9%. In this large diverse group of PE patients, 6-month all-cause mortality, chronic thromboembolic pulmonary hypertension, and chronic thromboembolic disease were low following thrombectomy with the FlowTriever system. Significant improvements in RV function, patient symptoms, exercise capacity, and QoL were observed at 6 months, suggesting that rapid extraction of thrombus may prevent long-term sequelae in patients with PE.

Long-term outcomes of the Coordinated Care Program inPatients after Myocardial Infarction (KOS-MI).

The Coordinated Care in Myocardial Infarction Program (KOS-MI) was introduced to improve prognosis for patients after myocardial infarction (MI). The program includes complete revascularization followed by unrestricted access to rehabilitation, electrotherapy, and cardiac care. This study aimed to assess major adverse cardiac and cerebrovascular events (MACCE) of patients enrolled in the KOS-MI at 3-year follow-up. This is a retrospective, multicenter registry of patients treated for MI. The study group (KOS-MI) of 963 patients was compared to the control group (standard care) of 1009 patients. At 3-year follow-up, MACCE including death, MI, stroke, and repeated revascularization were reported. Additionally, hospitalization for heart failure (HF) was analyzed. Propensity score matching (PSM) was utilized for group baseline characteristic adjustment. Patients in the KOS-MI group were younger (65 vs. 68 years; P <0.001), mostly men (70% vs. 62.9%; P <0.001), admitted with ST-segment elevation myocardial infarction (STEMI) (44.6% vs. 36.2%; P <0.001). Patients in the control group had more comorbidities and were admitted more often with non-ST-segment elevation myocardial infarction (63.8% vs. 55.4%; P <0.001) and acute HF (5.1% vs. 2.7%; P = 0.007). Following PSM, 530 well matched pairs were selected. At three years (92.3% follow-up completeness), the relative risk reduction was: 25% in MACCE (P = 0.008), 38% in mortality (P = 0.008), 29% in repeated revascularization (P = 0.04), and 28% (P = 0.0496) in hospitalization for HF in the KOS-MI group. The combination of contemporary invasive techniques, complete revascularization, cardiac rehabilitation, and ambulatory care included in the KOS-MI Program improves long-term prognosis of patients after MI in 3-year follow-up.

Surgical Explantation of Failed Transcatheter Aortic Valve Replacement

BackgroundRecent reports have demonstrated worse than expected outcomes of surgical explantation after transcatheter aortic valve replacement (TAVR). However in-depth analysis of the short- and mid-term risk of concomitant cardiac surgery at the time of TAVR explant is lacking. MethodsData from the multicenter EXPLANT-TAVR registry of patients undergoing TAVR-explant between November 2009 and September 2020 were retrospectively analyzed. Patients undergoing concomitant procedures were included, but explants performed during the same admission as the initial TAVR or concomitant procedures performed on the aortic root, ascending aorta, or arch were excluded. Outcomes were evaluated between the isolated surgical aortic valve replacement (SAVR) and concomitant SAVR groups. Median follow-up was 6.6 months. ResultsAmong 199 patients, concomitant SAVR was performed in 94 patients (47.2%), primarily with mitral valve surgery (n = 45) followed by coronary artery bypass grafting (n = 23). Despite similar mean ages between groups (72.8 vs 73.4 years), concomitant SAVR had a higher median Society of Thoracic Surgeons Predicted Risk of Mortality score at the index TAVR (5.9% vs 3.7%, P = .001). There were no differences in median time-to-explant between groups (12.9 vs 8.7 months, P = .78). However concomitant SAVR had longer mean cardiopulmonary bypass (166 vs 114 minutes, P = .001) and cross-clamp times (123 vs 81 minutes, P = .001). Both 30-day (16.7% vs 9.9%) and 1-year mortality (36.1% vs 22.1%) were higher with concomitant SAVR but did not reach statistical significance (both P > .05). On Kaplan-Meier analysis, actuarial estimates of cumulative survival were significantly lower with concomitant SAVR at 3 years (56.8% vs 81.1%, P = .020). ConclusionsFor surgical explantation after TAVR failure, concomitant SAVR is associated with increased mortality. Further studies with longer follow-up are warranted to examine the benefit from earlier intervention before concomitant disease develops.

Intracoronary physiology-guided percutaneous coronary intervention in patients with diabetes

ObjectiveThe risk of vessel-oriented cardiac adverse events (VOCE) in patients with diabetes mellitus (DM) undergoing intracoronary physiology-guided coronary revascularization is poorly defined. The purpose of this work is to evaluate the risk of VOCE in patients with and without DM in whom percutaneous coronary intervention (PCI) was performed or deferred based on pressure-wire functional assessment.MethodsThis is a retrospective analysis of a multicenter registry of patients evaluated with fractional flow reserve (FFR) and/or non-hyperaemic pressure ratio (NHPR). Primary endpoint was a composite of VOCE including cardiac death, vessel-related myocardial infarction (MI), and ischemia-driven target vessel revascularization (TVR).ResultsA large cohort of 2828 patients with 3353 coronary lesions was analysed to assess the risk of VOCE at long-term follow-up (23 [14–36] months). Non-insulin-dependent-DM (NIDDM) was not associated with the primary endpoint in the overall cohort (adjusted Hazard Ratio [aHR] 1.18, 95% CI 0.87–1.59, P = 0.276) or in patients with coronary lesions treated with PCI (aHR = 1.30, 95% CI 0.78–2.16, P = 0.314). Conversely, insulin-dependent diabetes mellitus (IDDM) demonstrated an increased risk of VOCE in the overall cohort (aHR 1.76, 95% CI 1.07–2.91, P = 0.027), but not in coronary lesions undergoing PCI (aHR 1.26, 95% CI 0.50–3.16, P = 0.621). Importantly, in coronary lesions deferred after functional assessment IDDM (aHR 2.77, 95% CI 1.11–6.93, P = 0.029) but not NIDDM (aHR = 0.94, 95% CI 0.61–1.44, P = 0.776) was significantly associated with the risk of VOCE. IDDM caused a significant effect modification of FFR-based risk stratification (P for interaction < 0.001).ConclusionOverall, DM was not associated with an increased risk of VOCE in patients undergoing physiology-guided coronary revascularization. However, IDDM represents a phenotype at high risk of VOCE.Graphical abstract

Impact of anemia on major bleeding in patients taking oral anticoagulants for nonvalvular atrial fibrillation.

Anemia is encountered in patients with nonvalvular atrial fibrillation (NVAF) on oral anticoagulants (OACs) but the prognostic impact was not well scrutinized in real-world settings. We conducted a historical multicenter registry of patients with NVAF taking OACs at 71 centers in Japan. Those with mechanical heart valves or a history of pulmonary thrombosis or deep venous thrombosis were excluded. Anemic patients were divided into three groups of hemoglobin (Hb) level: moderate/severe (Hb < 11.0 g/dL), mild (men: Hb of 11.0-12.9 g/dL; women: Hb of 11.0-11.9 g/dL), and no anemia. The endpoints included major bleeding, hemorrhagic stroke, ischemic events, ischemic stroke, and all-cause mortality. Among 7558 consecutive patients (mean age, 73 years; men 67%) registered in February 2013 and followed until February 2017, 2100 (28%) patients had anemia. The anemic patients were older (moderate/severe: 79 years; mild: 77 years; no anemia: 71 years, p < .001), and HAS-BLED score was significantly higher in the anemic patients (p < .001). The cumulative incidences at 4 years of major bleeding in moderate/severe, mild, and no anemia group, were 14.9%, 10.7%, and 6.4%, respectively. The adjusted hazard ratios (HRs) (95% confidential intervals (CIs)) of major bleeding of moderate/severe and mild anemia group were 1.96 (1.49-2.58) and 1.48 (1.17-1.87) compared to no anemia group. The adjusted HRs (95% CIs) for ischemic events were 0.63 (0.39-0.99) and 1.03 (0.76-1.39). The severity of anemia in the patients with NVAF on OACs was associated with major bleeding.

PEDS7: Balloon Atrial Septostomy versus Left Atrial Cannulation for Left Heart Decompression in Children with Dilated Cardiomyopathy and Myocarditis on Extracorporeal Membrane Oxygenation

Purpose: To describe the association of left heart decompression with balloon atrial septostomy (BAS) compared to left atrial (LA) cannulation with survival in children with myocarditis or dilated cardiomyopathy (DCM) on veno-arterial extracorporeal membrane oxygenation (ECMO). Methods: Retrospective study of the Extracorporeal Life Support Organization (ELSO) multicenter registry of patients ≤ to 18 years old with myocarditis or DCM on ECMO who underwent LA decompression. Only index ECMO run within a hospitalization was included. Descriptive and univariate statistics assessed association of patient factors with decompression type. Multivariable logistic regression sought independent associations with outcomes. Results: 321 pediatric ECMO runs were identified. 57% myocarditis (n=183) and 43% DCM (n=138). Survival overall was 74%. 67% underwent balloon atrial septostomy (BAS) and 33% underwent left atrial cannulation. Patient demographics including age, weight, gender, race/ethnicity, diagnosis, pre-ECMO pH, mean airway pressure, and arrest status were similar between groups. Median ECMO duration was longer in the BAS group compared to LA cannulation (7.2 versus 5.7 days respectively, p=0.002). 82 (78%) were centrally versus peripherally (22%, n=23) cannulated on ECMO in the LA cannulation group, versus 19 (9%) centrally versus 194 (91%) peripherally cannulated in the BAS group. On multivariable analysis, we found LA cannulation (OR 3.68; 95% CI, 1.86-7.31; p<0.001), neurologic complication (OR 5.25; 95% CI, 2.38-11.58; p<0.001), renal complication (OR 2.74; 95% CI, 1.41-5.29; p=0.003), and cardiac complication (OR 2.64; 95% CI, 1.30-5.38; p=0.007) were associated with greater odds of mortality. There were more episodes of pulmonary hemorrhage in the BAS group (n=17) compared to the LA cannulation group (n=2). Conclusions: Our findings indicate better left heart decompression with an LA cannula compared to BAS given a lower incidence of pulmonary hemorrhage in the LA cannulation group. There was a three times greater likelihood for mortality in children with myocarditis and DCM on ECMO who undergo LA cannulation compared to BAS, however, they appear to be fundamentally different cohorts. Further prospective evaluation with adjustment for severity of illness is warranted.

ID: 198132 Tremor Reduction Using DBS: Outcomes of a Real-World, Prospective, Multicenter Essential Tremor Registry

Essential Tremor (ET) is one of the most common neurological diseases affecting about 0.9% of the world population.1 ET treatment is focused on medical management of motor symptoms and includes pharmacotherapy and ventral intermediate nucleus (VIM) thalamotomy, which is being largely replaced by thalamic Deep Brain Stimulation (DBS) as the surgical treatment of choice. DBS of the VIM thalamus is recommended as a therapeutic option for appropriate subjects with ET.2 New insights regarding the real-world, clinical use of VIM DBS may be acquired through the implementation of large, multi-center patient registries. Here, we describe the initiation of a new ET patient registry for patients implanted with a multiple-source, constant- current DBS system capable of providing directionality for use in the management of Essential Tremor motor symptoms.

Prediction of new onset atrial fibrillation in patients with acute coronary syndrome undergoing percutaneous coronary intervention using the C2HEST and mC2HEST scores: A report from the multicenter REALE-ACS registry

BackgroundNew onset atrial fibrillation (NOAF) is associated with worse clinical outcomes after acute coronary syndrome (ACS). Identification of ACS patients at risk of NOAF remains challenging. To test the value of the simple C2HEST score for predicting NOAF in patients with ACS. MethodsWe studied patients from the prospective ongoing multicenter REALE-ACS registry of patients with ACS. NOAF was the primary endpoint of the study. The C2HEST score was calculated as coronary artery disease or chronic obstructive pulmonary disease (1 point each), hypertension (1 point), elderly (age ≥ 75 years, 2 points), systolic heart failure (2 points), thyroid disease (1 point). We also tested the mC2HEST score. ResultsWe enrolled 555 patients (mean age 65.6 ± 13.3 years; 22.9% women), of which 45 (8.1%) developed NOAF. Patients with NOAF were older (p < 0.001) and had more prevalent hypertension (p = 0.012), chronic obstructive pulmonary disease (p < 0.001) and hyperthyroidism (p = 0.018). Patients with NOAF were more frequently admitted with STEMI (p < 0.001), cardiogenic shock (p = 0.008), Killip class ≥2 (p < 0.001) and had higher mean GRACE score (p < 0.001). Patients with NOAF had a higher C2HEST score compared with those without (4.2 ± 1.7 vs 3.0 ± 1.5, p < 0.001). A C2HEST score > 3 was associated with NOAF occurrence (odds ratio 4.33, 95% confidence interval 2.19–8.59, p < 0.001). ROC curve analysis showed good accuracy of the C2HEST score (AUC 0.71, 95%CI 0.67–0.74) and mC2HEST score (AUC 0.69, 95%CI 065–0.73) in predicting NOAF. ConclusionsThe simple C2HEST score may be a useful tool to identify patients at higher risk of developing NOAF after presentation with ACS.