Trends in the Incidence of Cardiogenic Shock, and Utilization of Mechanical Circulatory Support in Myocarditis: Insights from the National Inpatient Sample 2016 to 2019.

A subset of patients with myocarditis present with cardiogenic shock. There is a lack of contemporary data assessing the use of mechanical circulatory support (MCS) in these patients. Myocarditis hospitalizations were analyzed using the National Inpatient Sample between 2016 and 2019. Characteristics of patients with and without cardiogenic shock were assessed. Trends in mortality, MCS, right-sided cardiac catheterization (RHC) and endomyocardial biopsy were evaluated. The impact of RHC on consequent MCS and mortality was studied. A total of 38,300 hospitalizations for myocarditis were included in the study, of which 3,490 hospitalizations (9.1%) had cardiogenic shock. Patients with cardiogenic shock were older (p <0.001) and had more chronic kidney disease and atrial fibrillation. Between 2016 and 2019, there was an increase in myocarditis admissions but no difference in rates of cardiogenic shock and mortality and the use of extracorporeal membrane oxygenation, percutaneous ventricular assist devices, intra-aortic balloon pumps, left ventricular assist devices, and cardiac transplant. The most common form of MCS used in myocarditis was extracorporeal membrane oxygenation. The rates of RHC (p = 0.02) and endomyocardial biopsy (p = 0.03) increased over time. Patients who underwent RHC were more likely to receive mechanical support, and in patients with shock, RHC was associated with lower mortality (adjusted odds ratio 0.34, p <0.01). Myocarditis admissions increased over time but with no increase in the rates of cardiogenic shock and MCS. In patients with cardiogenic shock, RHC resulted in lower mortality.

Mortality of patients with ST-segment-elevation myocardial infarction without standard modifiable risk factors among patients without known coronary artery disease: Age-stratified and sex-related analysis from nationwide readmissions database 2010-2014.

Objective: The proportion of ST-segment elevation myocardial infarction (STEMI) patients without standard modifiable risk factors (SMuRFs: hypertension, diabetes, hypercholesterolemia and smoking) has increased over time. The absence of SMuRFs is known to be associated with worse outcomes, but its association with age and sex is uncertain. We sought to evaluate the association between age and sex with the outcomes of post-STEMI patients without SMuRFs among patients without preexisting coronary artery disease. Methods: Patients who underwent primary PCI for STEMI were identified from the Nationwide Readmission Database of the United States. Clinical characteristics, in-hospital, and 30-day outcomes in patients with or without SMuRFs were compared in men versus women and stratified into five age groups. Results: Between January 2010 and November 2014, of 474,234 patients who underwent primary PCI for STEMI, 52,242 (11.0%) patients did not have SMuRFs. Patients without SMuRFs had higher in-hospital mortality rates than those with SMuRFs. Among those without SMuRFs, the in-hospital mortality rate was significantly higher in women than men (10.6% vs 7.3%, p<0.001), particularly in older age groups. The absence of SMuRFs was associated with higher 30-day readmission-related mortality rates (0.5% vs 0.3% with SMuRFs, p<0.001). Among patients without SMuRFs, women had a higher 30-day readmission-related mortality rates than men (0.6% vs 0.4%, p<0.001). After multivariable adjustment, the increased rates of in-hospital (odds ratio 1.89 (95% CI 1.72 to 2.07) and 30-day readmission-related mortality (hazard ratio 1.30 (95% CI 1.01 to 1.67)) in patients without SMuRFs remained significant. Conclusions: STEMI patients without SMuRFs have a significantly higher risk of in-hospital and 30-day mortality than those with SMuRFs. Women and older patients without SMuRFs experienced significantly higher in-hospital and 30-day readmission-related mortality.

Early Stroke and Mortality After Percutaneous Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation.

BACKGROUND: Percutaneous endocardial left atrial appendage occlusion (LAAO) is an alternative therapy for stroke prevention in patients with atrial fibrillation who are poor candidates for oral anticoagulants. Oral anticoagulation is generally discontinued 45 days following successful LAAO. Real-world data on early stroke and mortality following LAAO are lacking. METHODS: Using International Classification of Diseases, Tenth Revision, Clinical-Modification codes, we performed a retrospective observational registry analysis to examine the rates and predictors of stroke, mortality, and procedural complications during index hospitalization and 90-day readmission among 42 114 admissions in the Nationwide Readmissions Database for LAAO between 2016 and 2019. Early stroke and mortality were defined as events occurring during index admission or 90-day readmission. Data on timing of early strokes post-LAAO were collected. Multivariable logistic regression modeling was used to ascertain predictors of early stroke and major adverse events. RESULTS: LAAO was associated with low rates of early stroke (0.63%), early mortality (0.53%), and procedural complications (2.59%). Among patients who had readmissions with strokes after LAAO, the median time from implant to readmission was 35 days (interquartile range, 9-57 days); 67% of readmissions with strokes occurred <45 days postimplant. Between 2016 and 2019, the rates of early stroke after LAAO significantly decreased (0.64% versus 0.46% P-for-trend <0.001), while early mortality and major adverse event rates were unchanged. Peripheral vascular disease and a history of prior stroke were independently associated with early stroke after LAAO. Early post-LAAO stroke rates were similar between low, medium, and high LAAO volume tertile centers. CONCLUSIONS: In this contemporary real-world analysis, the early stroke rate after LAAO was low, with the majority occurring within 45 days of device implantation. Despite an increase in LAAO procedures between 2016 and 2019, there with a significant decline in early strokes after LAAO during that period.

Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure: Placement of Aortic Transcatheter Valves 3 Aortic Valve-in-Valve Study.

Background: Transcatheter aortic valve implantation is safe and effective for high-risk patients with bioprosthetic valve failure (BVF) but has not been studied in low- and intermediate-risk patients. One year outcomes of the PARTNER 3 Aortic Valve-in-valve (AViV) Study were evaluated. Methods: This prospective, single-arm, multicenter study enrolled 100 patients from 29 sites with surgical BVF. The primary endpoint was a composite of all-cause mortality and stroke at 1 year. The key secondary outcomes included mean gradient, functional capacity, and rehospitalization (valve-related, procedure-related, or heart failure related). Results: A total of 97 patients underwent AViV with a balloon-expandable valve from 2017 to 2019. Patients were 79.4% male with a mean age of 67.1 years and Society of Thoracic Surgeons score of 2.9%. The primary endpoint occurred in 2 patients (2.1%) who had strokes; there was no mortality at 1 year. Five patients (5.2%) had valve thrombosis events, and 9 patients (9.3%) had rehospitalizations, including 2 (2.1%) for strokes, 1 (1.0%) for heart failure, and 6 (6.2%) for aortic valve reinterventions (3 explants, 3 balloon dilations, and 1 percutaneous paravalvular regurgitation closure). From baseline to 1 year, New York Heart Association class III/IV decreased from 43.3% to 4.5%, mean gradient from 39.1 ± 18.2 mm Hg to 19.7 ± 7.6 mm Hg, and ≥moderate aortic regurgitation from 41.1% to 1.1%. Conclusions: AViV with a balloon-expandable valve improved hemodynamic and functional status at 1 year and can provide an additional therapeutic option in selected low- or intermediate-risk patients with surgical BVF, although longer term follow-up is necessary.

Relative Impact of Surgical Mitral Repair and MitraClip on Annular Remodeling-A Potential Mechanism for Therapeutic Response to Mitral Repair for Degenerative Mitral Regurgitation.

OBJECTIVES: Three-dimensional transesophageal echocardiography (TEE) is widely used to guide decision-making for mitral repair. The relative impact of surgical mitral valve repair (MVr) and MitraClip on annular remodeling is unknown. The aim was to determine the impact of both mitral repair strategies on annular geometry, including the primary outcome of annular circumference and area. DESIGN: This was a retrospective observational study of patients who underwent mitral intervention between 2016 and 2020. SETTING: Weill Cornell Medicine, a single, large, academic medical center. PARTICIPANTS: The population comprised 50 patients with degenerative mitral regurgitation (MR) undergoing MVr. INTERVENTIONS: Elective MVr and TEE. MEASUREMENTS AND MAIN RESULTS: Patients undergoing MitraClip or surgical MVr were matched (1:1) for sex and coronary artery disease. Mitral annular geometry indices were quantified on intraprocedural three-dimensional TEE. Mild or less MR on follow-up transthoracic echocardiography defined optimal response. Patients undergoing MitraClip were older (80 ± eight v 66 ± six years; p < 0.001) but were otherwise similar to surgical patients. Patients undergoing MitraClip had larger baseline left atrial and ventricular sizes, increased tenting height, and volume (p < 0.01), with a trend toward increased annular area (p = 0.23). MitraClip and surgery both induced immediate mitral annular remodeling, including decreased area, circumference, and tenting height (p < 0.001), with greater remodeling with surgical repair. At follow-up (4.1 ± 9.0 months) optimal response (≤ mild MR) was ∼twofold more common with surgery than MitraClip (81% v 46%; p = 0.02). The relative reduction in annular circumference (odds ratio [OR] 1.05 [1.00-1.09] per cm; p = 0.04) and area (OR 1.03 [1.00-1.05] per cm2; p = 0.049) were both associated with optimal response. CONCLUSIONS: Surgical MVr and MitraClip both reduce annular size, but repair-induced remodeling is greater with surgery and associated with an increased likelihood of optimal response.

Impact of Socioeconomic Status on Mechanical Circulatory Device Utilization and Outcomes in Cardiogenic Shock.

Objectives: This study evaluates the impact of socioeconomic status (SES) on utilization of mechanical circulatory support (MCS) devices and outcomes in cardiogenic shock (CS). Background: CS is associated with significant mortality. There is increasing use of temporary MCS devices in CS, and its impact on outcomes is currently under investigation. There is a lack of data on the effect of SES on the utilization of MCS devices in CS. Methods: CS hospitalizations were obtained from the State Inpatient Databases in 2016 from 9 states representing various regions in the United States. The study had exempt institutional review board status as the database includes deidentified data. Hospitalizations were separated into SES cohorts based on the median household income of the patient residence zip code. Utilization of MCS devices and revascularization procedures along with clinical outcomes with CS were compared across the quartiles. Results: There were 38,520 hospitalizations identified with CS, 42.6% of which were secondary to acute myocardial infarction. Patients from higher SES areas were significantly older but had lower burden of comorbidities. Utilization of temporary MCS devices was higher for hospitalizations from higher SES regions (frequency from the lowest SES quartile to the highest SES quartile: 21.3%, 21.5%, 23.5, and 24.1%, P < .01), though revascularization rates were similar. However, there was no significant difference in overall mortality from CS among the 4 quartiles. Patients from regions of higher SES experienced increased hospital costs. Conclusions: Higher SES regions had increased use of temporary MCS. There was no difference in mortality between SES cohorts.

Thirty-Day Readmission Rates after Takotsubo Syndrome with or without Malignancy: A Nationwide Readmissions Database Analysis.

The association between malignancy and readmission after Takotsubo syndrome (TTS) hospitalization has not been fully described. We sought to examine the rates, cause, and cost of 30-day readmissions of TTS, with or without malignancy, by utilizing Nationwide Readmissions Databases from 2010 to 2014. We identified 61,588 index hospitalizations for TTS. TTS patients with malignancy tended to be older (70.6 ± 0.2 vs. 66.1 ± 0.1, p < 0.001), and the overall burden of comorbidities was higher than in those without malignancy. TTS patients with malignancy had significantly higher 30-day readmission rates than those without malignancy (15.9% vs. 11.0%; odds ratio (OR), 1.35; 95% confidence interval (CI), 1.18-1.56). Non-cardiac causes were the most common causes of readmission for TTS patients with malignancy versus without malignancy (75.5% vs. 68.1%, p < 0.001). The 30-day readmission rate due to recurrent TTS was very low in both groups (0.4% and 0.5%; p = 0.47). The total costs were higher by 25% (p < 0.001) in TTS patients with vs. without malignancy. In summary, among patients hospitalized with TTS, the presence of malignancy was associated with increased risk of 30-day readmission and increased costs. These findings highlight the importance of optimized management for TTS patients with malignancy.

Safety and Effectiveness of the SVELTE Fixed-Wire and Rapid Exchange Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study.

[Figure: see text].

Sex-Based Disparities in Outcomes With Abdominal Aortic Aneurysms.

Although abdominal aortic aneurysms (AAA) are more common in men, women with AAA have increased morbidity and mortality. Additionally, there are discrepancies among professional society guidelines for AAA screening in women. In this retrospective study from the Nationwide Inpatient Sample (NIS) database from 2003 to 2014, we compared rates of AAA repair (rupture and elective) and AAA-related mortality in men vs. women to identify predictors of death among men and women with AAA. We divided the population into 1) AAA rupture 2) elective AAA repair. The main outcomes included temporal trends in AAA rupture, rupture-related death, AAA repair, in-hospital death, and predictors of AAA-related death. There were 570,253 discharge records for AAA admissions between 2003 and 2014, including 22.8% women and 77.2% men. Women had a higher proportion of rupture (18.4% vs 12.6%, p <0.01). A smaller proportion of women underwent endovascular aortic repair (EVAR) compared with men in the ruptured AAA (13.9% vs. 20.3%, p <0.01) and elective repair (55.7% vs. 67.4%, p <0.01) cohorts. Within the ruptured cohort, a higher proportion of women did not receive repair (46.4% vs. 26.1%, p <0.01). On multivariable analysis, female gender was a significant predictor of death with rupture (OR 1.39, 95% CI 1.16 to 1.66) and elective repair (OR 1.74, 95% CI 1.36 to 2.22), with both elective EVAR (OR 2.52, 95% CI 2.06 to 3.09) and elective open aortic repair (OAR; OR 1.50, 95% CI 1.33 to 1.68). Propensity score matching confirmed a higher risk of death in women in both the rupture (OR 1.19, 95% CI 1.09 to 1.30) and elective repair (OR 1.50, 95% CI 1.35 to 1.67) cohorts. In conclusion, AAA poses significant morbidity and mortality, especially in women. Women were more likely to die before repair with AAA rupture and female gender was an independent predictor of mortality in both the rupture and elective repair groups.

Leaks after Left Atrial Appendage Closure: Ignored or Neglected?

Left atrial appendage (LAA) closure has recently been approved as an alternative management for stroke prevention in patients with chronic atrial fibrillation who have difficulties with long-term oral anticoagulation. The various shapes and sizes of LAA and orientation of the atrial ostium may contribute to the incomplete LAA closure from circular design devices and orientation of the non-steerable delivery catheter. Incomplete closure of LAA leads to a high-velocity blood flow through the peri-device gap, resulting in peri-device leak (PDL). Residual leaks are frequently diagnosed after LAA closure procedures, regardless of closure methods. There is a controversy in the clinical significance of the leaks, particularly about its association with thromboembolic events. PDL <5 mm was not associated with any increase of risk for thromboembolism. Current literatures with small study population have not been sufficient to clarify the role of the leaks after LAA closure. Nevertheless, management of severe leaks has been a challenging concern for cardiologists. Leaks after epicardial LAA closures are at the neck of the incompletely closed LAA and have shown to increase the risk of thromboembolism. Percutaneous closure of the leaks after LAA closure has been attempted with good safety and success, but long-term safety and efficacy remains unclear. Further large long-term studies which aim to assess the role of leaks or PDLs in predicting thromboembolic events and management strategies are warranted.

Impact of paravalvular leak on left ventricular remodeling and global longitudinal strain 1 year after transcatheter aortic valve replacement.

Background: New mild or persistent moderate paravalvular leak (PVL) is a known predictor of poor outcomes after transcatheter aortic valve replacement (TAVR). Its impact on left ventricular (LV) remodeling and global longitudinal strain (GLS) has not been well studied. Materials & methods: We collected echocardiographic data in 99 TAVR patients. LV remodeling and GLS were compared between patients with and without PVL. Results: Patients without PVL (n = 84) had significant LV ejection fraction, wall thickness and LV mass improvement compared with patients with PVL (n = 15; p < 0.001 for all). Diastolic function worsened in patients with PVL. Baseline GLS improved significantly regardless of PVL (p = 0.016 and p = 0.01, respectively) and was not predictive of LV ejection fraction or LV mass improvement when analyzed in tertiles. Conclusion: PVL impedes reverse LV remodeling but not GLS improvement 1-year after TAVR. Baseline GLS was not a predictor of LV remodeling.

Associations Between Hospital Length of Stay, 30-Day Readmission, and Costs in ST-Segment-Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: A Nationwide Readmissions Database Analysis.

Background Readmission after ST-segment-elevation myocardial infarction (STEMI) poses an enormous economic burden to the US healthcare system. There are limited data on the association between length of hospital stay (LOS), readmission rate, and overall costs in patients who underwent primary percutaneous coronary intervention for STEMI. Methods and Results All STEMI hospitalizations were selected in the Nationwide Readmissions Database from 2010 to 2014. From the patients who underwent primary percutaneous coronary intervention, we examined the 30-day outcomes including readmission, mortality, reinfarction, repeat revascularization, and hospital charges/costs according to LOS (1-2, 3, 4, 5, and >5 days) stratified by infarct locations. The 30-day readmission rate after percutaneous coronary intervention for STEMI was 12.0% in the anterior wall (AW) STEMI group and 9.9% in the non-AW STEMI group. Patients with a very short LOS (1-2 days) were readmitted less frequently than those with a longer LOS regardless of infarct locations. However, patients with a very short LOS had significantly increased 30-day readmission mortality versus an LOS of 3 days (hazard ratio, 1.91; CI, 1.16-3.16 [P=0.01]) only in the AW STEMI group. Total costs (index admission+readmission) were the lowest in the very short LOS cohort in both the AW STEMI group (P<0.001) and the non-AW STEMI group (P<0.001). Conclusions For patients who underwent primary percutaneous coronary intervention for STEMI, a very short LOS was associated with significantly lower 30-day readmission and lower cumulative cost. However, a very short LOS was associated with higher 30-day mortality compared with at least a 3-day stay in the AW STEMI cohort.

Impact Of Cirrhosis On 90-Day Outcomes After Percutaneous Coronary Intervention (from A Nationwide Database).

Patients with cirrhosis often have concomitant coronary artery disease and require percutaneous coronary intervention (PCI). PCI in cirrhotics can be associated with significant risks due to thrombocytopenia, possible coagulopathies, bleeding, and renal failure. Longer term risks of PCI in cirrhotics have not been well studied. Our study seeks to evaluate the 90-day outcomes of PCI in patients with cirrhosis. Patients receiving PCI were identified from the Nationwide Readmissions Database from 2010 to 2014 and stratified by the presence of co-morbid cirrhosis. The total mortality during index admission and 90-day readmissions as well as the readmissions rate were examined. Adverse events including bleeding, stroke, kidney injury, and vascular complications were also compared. Patients with cirrhosis had a significantly higher number of co-morbidities. The cirrhosis group had a higher overall 90-day mortality (10.3% vs 2.5%, p < 0.01), including during the index hospitalization (7.0% vs 1.8%, p < 0.01), as well as a higher 90-day readmission rate (38.2% vs 20.2%, p < 0.01). Patients with cirrhosis also had higher frequencies of overall 90-day adverse events (44.7% vs 17.7%, p < 0.01), including gastrointestinal bleeding (15.3% vs 2.7%, p < 0.01) and acute kidney injury (28.4% vs 10.1%, p < 0.01). In conclusion, patients with cirrhosis face a significantly higher risk of adverse outcomes including mortality, readmissions, and adverse events in the 90 days after hospitalization for PCI compared with the general population.

Mid-Term Outcomes of Transcatheter Aortic Valve Replacement in Extremely Large Annuli With Edwards SAPIEN 3 Valve.

OBJECTIVES: The aim of this study was to report the 1-year results of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 (S3) valve in extremely large annuli. BACKGROUND: Favorable 30-day outcomes of S3 TAVR in annuli >683 mm2 have previously been reported. Pacemaker implantation rates were acceptable, and a larger left ventricular outflow tract and more eccentric annular anatomy were associated with increasing paravalvular leak. METHODS: From December 2013 to December 2018, 105 patients across 15 centers with mean area 721.3 ± 36.1 mm2 (range 683.5 to 852.0 mm2) underwent TAVR using an S3 device. Clinical, anatomic, and procedural characteristics were analyzed. One-year survival and echocardiographic follow-up were reached in 94.3% and 82.1% of patients, respectively. Valve Academic Research Consortium-2 30-day and 1-year outcomes were reported. RESULTS: The mean age was 76.9 ± 10.4 years, and Society of Thoracic Surgeons predicted risk score averaged 5.2 ± 3.4%. One-year overall mortality and stroke rates were 18.2% and 2.4%, respectively. Quality-of-life index improved from baseline to 30 days and at 1 year (p < 0.001 for both). Mild paravalvular aortic regurgitation occurred in 21.7% of patients, while moderate or greater paravalvular aortic regurgitation occurred in 4.3%. Mild and moderate or severe transvalvular aortic regurgitation occurred in 11.6% and 0%, respectively. Valve gradients remained stable at 1 year. CONCLUSIONS: S3 TAVR in annular areas >683 mm2 is feasible, with favorable mid-term outcomes.

Prognostic role of diastolic dysfunction in patients undergoing transcatheter aortic valve replacement.

OBJECTIVES: Prior studies have shown that left ventricular diastolic dysfunction (DD) is associated with increased mortality after surgical aortic valve replacement but studies on transcatheter aortic valve replacement (TAVR) are limited and have not taken into account mitral annular calcification (MAC), which limits the use of mitral valve annular tissue Doppler imaging. We performed a single-center retrospective analysis to better evaluate the role of baseline DD on outcomes after TAVR. METHODS: After excluding patients with atrial fibrillation, mitral valve prostheses and significant mitral stenosis, 359 consecutive TAVR patients were included in the study. Moderate-to-severe MAC was present in 58% of the patients. We classified patients into severe versus nonsevere DD based on the evaluation of elevated left ventricular filling pressure. The outcome measure was all-cause mortality or heart failure hospitalization. RESULTS: Over a mean follow-up time of 13 months, severe DD was associated with an increased risk for the outcome measure (HR 2.02 [1.23-3.30], p = .005). However, this association was lost in a propensity-matched cohort. In multivariate analysis, STS score was the only independent predictor of all cause mortality of heart failure hospitalization (HR 1.1 [1.05-1.15], p < .001). CONCLUSIONS: We evaluated the role of baseline DD on outcomes after TAVR by taking into account the presence of MAC. Severe DD was associated with increased all-cause mortality or heart failure hospitalization but not independently of other structural parameters and known predictors of the outcome measure.

Impact of Aortomitral Continuity Calcification on Need for Permanent Pacemaker After Transcatheter Aortic Valve Replacement.

BACKGROUND: By virtue of its proximity to structures vital to cardiac conduction, aortomitral continuity calcification (AMCC) may help identify patients at highest risk for developing atrioventricular conduction disease requiring permanent pacemaker implantation (PPMI). We aim to determine the association of AMCC and need for PPMI after transcatheter aortic valve replacement. METHODS: Of 614 patients who underwent transcatheter aortic valve replacement (11.8% PPMI rate), we included 136 patients (age 85±8 years, 47% male) without a preexisting intracardiac device or prior valve surgery who underwent preprocedural computed tomography. We analyzed for the presence of AMCC, aortic valve calcification, and mitral annular calcification as well as quantified AMCC and aortic valve calcification score using the Agatston method. We further stratified AMCC score into 3 categories: 0, 1 to 300, and >300. End point was PPMI at 1 month after transcatheter aortic valve replacement. RESULTS: There were 51 (38%) new PPMIs (median time to PPMI, 5 days). Patients who underwent PPMI had a higher prevalence of AMCC than patients without PPMI (69% versus 32%; P<0.0001), as well as higher median AMCC score (263 versus 0; P<0.0001). There was no difference in aortic valve calcification and mitral annular calcification between patients with and without PPMI (all P≥0.09). Patients with AMCC had a 4-fold increase in odds for PPMI compared with those without (adjusted odds ratio, 4.0; P=0.0026). Compared with patients with an AMCC score of 0, patients with an AMCC score >300 had greater than a 5-fold increased odds for PPMI (adjusted odds ratio, 5.7; P=0.0016). CONCLUSIONS: Presence of AMCC, particularly with AMCC score >300, is associated with the need for PPMI after transcatheter aortic valve replacement.

Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study.

BACKGROUND: Near-infrared spectroscopy (NIRS) intravascular ultrasound imaging can detect lipid-rich plaques (LRPs). LRPs are associated with acute coronary syndromes or myocardial infarction, which can result in revascularisation or cardiac death. In this study, we aimed to establish the relationship between LRPs detected by NIRS-intravascular ultrasound imaging at unstented sites and subsequent coronary events from new culprit lesions. METHODS: In this prospective, cohort study (LRP), patients from 44 medical centres were enrolled in Italy, Latvia, Netherlands, Slovakia, UK, and the USA. Patients with suspected coronary artery disease who underwent cardiac catheterisation with possible ad hoc percutaneous coronary intervention were eligible to be enrolled. Enrolled patients underwent scanning of non-culprit segments using NIRS-intravascular ultrasound imaging. The study had two hierarchal primary hypotheses, patient and plaque, each testing the association between maximum 4 mm Lipid Core Burden Index (maxLCBI4mm) and non-culprit major adverse cardiovascular events (NC-MACE). Enrolled patients with large LRPs (≥250 maxLCBI4mm) and a randomly selected half of patients with small LRPs (<250 maxLCBI4mm) were followed up for 24 months. This study is registered with ClinicalTrials.gov, NCT02033694. FINDINGS: Between Feb 21, 2014, and March 30, 2016, 1563 patients were enrolled. NIRS-intravascular ultrasound device-related events were seen in six (0·4%) patients. 1271 patients (mean age 64 years, SD 10, 883 [69%] men, 388 [31%]women) with analysable maxLCBI4mm were allocated to follow-up. The 2-year cumulative incidence of NC-MACE was 9% (n=103). Both hierarchical primary hypotheses were met. On a patient level, the unadjusted hazard ratio (HR) for NC-MACE was 1·21 (95% CI 1·09-1·35; p=0·0004) for each 100-unit increase maxLCBI4mm) and adjusted HR 1·18 (1·05-1·32; p=0·0043). In patients with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 2·18 (1·48-3·22; p<0·0001) and adjusted HR was 1·89 (1·26-2·83; p=0·0021). At the plaque level, the unadjusted HR was 1·45 (1·30-1·60; p<0·0001) for each 100-unit increase in maxLCBI4mm. For segments with a maxLCBI4mm more than 400, the unadjusted HR for NC-MACE was 4·22 (2·39-7·45; p<0·0001) and adjusted HR was 3·39 (1·85-6·20; p<0·0001). INTERPRETATION: NIRS imaging of non-obstructive territories in patients undergoing cardiac catheterisation and possible percutaneous coronary intervention was safe and can aid in identifying patients and segments at higher risk for subsequent NC-MACE. NIRS-intravascular ultrasound imaging adds to the armamentarium as the first diagnostic tool able to detect vulnerable patients and plaques in clinical practice. FUNDING: Infraredx.

Predictors of Late Mortality in D-Transposition of the Great Arteries After Atrial Switch Repair: Systematic Review and Meta-Analysis.

Background Existing data on predictors of late mortality and prevention of sudden cardiac death after atrial switch repair surgery for D-transposition of the great arteries (D-TGA) are heterogeneous and limited by statistical power. Methods and Results We conducted a systematic review and meta-analysis of 29 observational studies, comprising 5035 patients, that reported mortality after atrial switch repair with a minimum follow-up of 10 years. We also examined 4 additional studies comprising 105 patients who reported rates of implantable cardioverter-defibrillator therapy in this population. Average survival dropped to 65% at 40 years after atrial switch repair, with sudden cardiac death accounting for 45% of all reported deaths. Mortality was significantly lower in cohorts that were more recent and operated on younger patients. Patient-level risk factors for late mortality were history of supraventricular tachycardia (odds ratio [OR] 3.8, 95% CI 1.4-10.7), Mustard procedure compared with Senning (OR 2.9, 95% CI 1.9-4.5) and complex D-TGA compared with simple D-TGA (OR 4.4, 95% CI 2.2-8.8). Significant risk factors for sudden cardiac death were history of supraventricular tachycardia (OR 4.7, 95% CI 2.2-9.8), Mustard procedure (OR 2.2, 95% CI 1.1-4.1), and complex D-TGA (OR 5.7, 95% CI 1.8-18.0). Out of a total 124 implantable cardioverter-defibrillator discharges over 330 patient-years in patients with implantable cardioverter-defibrillators for primary prevention, only 8% were appropriate. Conclusions Patient-level risk of both mortality and sudden cardiac death after atrial switch repair are significantly increased by history of supraventricular tachycardia, Mustard procedure, and complex D-TGA. This knowledge may help refine current selection practices for primary prevention implantable cardioverter-defibrillator implantation, given disproportionately high rates of inappropriate discharges.