First and recurrent events after percutaneous coronary intervention: implications for survival analyses.

Objectives. Using composite endpoints and/or only first events in clinical research result in information loss and alternative statistical methods which incorporate recurrent event data exist. We compared information-loss under traditional analyses to alternative models. Design. We conducted a retrospective analysis of patients who underwent percutaneous coronary intervention (Jan2010-Dec2014) and constructed Cox models for a composite endpoint (readmission/death), a shared frailty model for recurrent events, and a joint frailty (JF) model to simultaneously account for recurrent and terminal events and evaluated the impact of heart failure (HF) on the outcome. Results. Among 4901 patients, 2047(41.8%) experienced a readmission or death within 1 year. Of those with recurrent events, 60% had ≥1 readmission and 6% had >4; a total of 121(2.5%) patients died during follow-up. The presence of HF conferred an adjusted Hazard ratio (HR) of 1.32 (95% CI: 1.18-1.47, p < .001) for the risk of composite endpoint (Cox model), 1.44 (95% CI: 1.36-1.52, p < .001) in the frailty model, and 1.34 (95% CI:1.22-1.46, p < .001) in the JF model. However, HF was not associated with death (HR 0.87, 95% CI: 0.52-1.48, p = .61) in the JF model. Conclusions. Using a composite endpoint and/or only the first event yields substantial loss of information, as many individuals endure >1 event. JF models reduce bias by simultaneously providing event-specific HRs for recurrent and terminal events.

Comparison of Echocardiographic and Catheter Mean Gradient to Assess Stenosis After Transcatheter Aortic Valve Implantation.

Discordance exists between Doppler-derived and left heart catheterization (LHC)-derived mean gradient (MG) in transcatheter aortic valve implantation (TAVI). We compared echocardiographic parameters of prosthetic valve stenosis and LHC-derived MG in new TAVIs. In a retrospective, single-center study, intraoperative transesophageal echocardiogram (TEE)-derived MG, LHC-derived MG, and acceleration time (AT) were obtained before and after TAVI in 362 patients. Discharge MG, AT, and Doppler velocity index (DVI) using transthoracic echocardiogram (TTE) were also obtained. MG ≥10 mm Hg was defined as abnormal. During native valve assessment with pre-TAVI TEE and pre-TAVI LHC, Pearson correlation coefficient revealed a nearly perfect linear relation between both methods' MGs (r = 0.97, p <0.0001). Intraoperatively, after TAVI, Spearman correlation coefficient revealed a weak-to-moderate relation between post-TAVI TEE and LHC MGs (r = 0.33, p <0.0001). Significant differences were observed in categorizations between post-TAVI TEE MG and post-TAVI AT (McNemar test p = 0.0003) and between post-TAVI TEE MG and post-TAVI LHC MG (signed-rank test p <0.0001), with TEE MG more likely to misclassify a patient as abnormal. At discharge, 30% of patients had abnormal TTE MG, whereas 0% and 0.8% of patients had abnormal DVI and AT, respectively. Discharge TTE MG was not associated with death or hospitalization for heart failure at a median follow-up of 862 days. Post-TAVI Doppler-derived MG by intraoperative TEE was higher than LHC, despite being virtually identical before implantation. At discharge, patients were more likely to be classified as abnormal using MG than DVI and AT. Elevated MG at discharge was not associated with death or hospitalization for heart failure.

Delays in Presentation in Patients With Acute Myocardial Infarction During the COVID-19 Pandemic.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, has had a major impact on the behavior of patients, as well as on the delivery of healthcare services. With older and more medically vulnerable people tending to stay at home to avoid contracting the virus, it is unclear how the behavior of people with acute myocardial infarction (AMI) has changed. The aim of this study was to determine if delays in presentation and healthcare service delivery for AMI exist during the COVID-19 pandemic compared to the same period a year prior. METHODS: In this single-center, retrospective study, we evaluated patients admitted with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) during early months of the COVID-19 pandemic (March 11, 2020 to April 20, 2020) compared to patients admitted with same diagnosis during the same period a year prior. RESULTS: There were 30 and 62 patients who presented with NSTEMI in the pandemic and pre-pandemic eras, respectively. The median pain-to-door time was significantly larger during the pandemic compared to pre-pandemic era (1,885 (880, 5,732) vs. 606 (388, 944) min, P < 0.0001). There was a significant delay in door-to-reperfusion time during the pandemic with a median time of 332 (182, 581) vs. 194 (92, 329) min (P = 0.0371). There were 24 (80%) and 25 (42%) patients who presented after 12 h of pain onset in pandemic and pre-pandemic eras, respectively (P = 0.0006). There were 47 and 60 patients who presented with STEMI during the pandemic timeframe of study and pre-pandemic timeframe, respectively. The median pain-to-door time during the pandemic was significantly larger than that of the pre-pandemic (620 (255, 1,500) vs. 349 (146, 659) min, P = 0.0141). There were 22 (47%) and 14 (24%) patients who presented after 12 h of pain onset in the pandemic and pre-pandemic eras, respectively (P = 0.0127). There was not a significant delay in door-to-reperfusion time (P = 0.9833). There were no differences in in-hospital death, stroke, or length of hospitalization between early and late presenters, as well as between pandemic and pre-pandemic eras. CONCLUSIONS: In conclusion, this study found that patients waited significantly longer during the pandemic to seek medical treatment for AMI compared to before the pandemic, and that pandemic-specific protocols may delay revascularization for NSTEMI patients. These findings resulted in more than a threefold increase from the onset of symptoms to revascularization increasing the risks for future complications such as left ventricular dysfunction and cardiovascular death. Efforts should be made to increase patients' awareness regarding consequences of delayed presentation, and to find a balance between hospital evaluation strategies and goals of minimizing total ischemic time.

Frequency of abnormal fractional flow reserve measurements among major coronary arteries.

BACKGROUND: Fractional flow reserve(FFR) is a validated tool for evaluating functional severity and guiding the revascularization of angiographically moderate coronary artery lesions. OBJECTIVE: To study if there is a higher frequency of positive FFR measurements in the left anterior descending(LAD) versus other major coronary arteries and also evaluate the differences in the total length of the stent placed. METHODS: A retrospective cohort study including all subjects (January 2011 to December 2015) who had fractional flow reserve (FFR) measured during coronary catheterization was conducted. Coronary catheterizations with FFR at a single tertiary care center were reviewed and FFR ≤ 0.80 post adenosine was deemed positive. The differences in the baseline characteristics and the degree of stenosis were compared between the different vessel groups. RESULTS: Of the 758 vessels included in the analysis, the majority were LAD(51.3%) followed by right coronary artery(RCA)(22.8%), Circumflex(22.2%), Left main(2.2%), and Ramus intermedius(1.5%). 25.1% of 758 vessels were FFR positive. The proportion of positive FFR were higher among LAD versus other vessels(33.2%vs.16.5%,p < 0.001), while no differences were noted between RCA and circumflex(p = 0.87) or other vessels excluding LAD(p = 0.69). Of 175 patients who received stents, no statistical difference was noted in the median[range] total length of the stent between LAD(22[9-64]) and the other coronary arteries (18[8-42])(p = 0.19). In patients with an FFR <0.75, we found that the stent length(median [range]) was significantly longer in LAD(28[9-42]) than the other coronary arteries(18[8-42])(p = 0.03). CONCLUSION: In our study, FFR was almost twice as likely to be positive in the LAD when compared to other major coronary arteries. Furthermore, there was a trend towards FFR positive LAD lesions needing longer stents than other coronary arteries. This data should encourage operators to evaluate moderate, long lesions in the LAD with FFR, as they have a higher probability of functional significance.

Event dependence in the analysis of cardiovascular readmissions postpercutaneous coronary intervention.

Recurrent hospitalizations are common in longitudinal studies; however, many forms of cumulative event analyses assume recurrent events are independent. We explore the presence of event dependence when readmissions are spaced apart by at least 30 and 60 days. We set up a comparative framework with the assumption that patients with emergency percutaneous coronary intervention (PCI) will be at higher risk for recurrent cardiovascular readmissions than those with elective procedures. A retrospective study of patients who underwent PCI (January 2008-December 2012) with their follow-up information obtained from a regional database for hospitalization was conducted. Conditional gap time (CG), frailty gamma (FG) and conditional frailty models (CFM) were constructed to evaluate the dependence of events. Relative bias (%RB) in point estimates using CFM as the reference was calculated for comparison of the models. Among 4380 patients, emergent cases were at higher risk as compared with elective cases for recurrent events in different statistical models and time-spaced data sets, but the magnitude of HRs varied across the models (adjusted HR [95% CI]: all readmissions [unstructured data]-CG 1.16 [1.09 to 1.22], FG 1.45 [1.33 to 1.57], CFM 1.24 [1.16 to 1.32]; 30-day spaced-CG1.14 [1.08 to 1.21], FG 1.28 [1.17 to 1.39], CFM 1.17 [1.10 to 1.26]; and 60-day spaced-CG 1.14 [1.07 to 1.22], FG 1.23 [1.13 to 1.34] CFM 1.18 [1.09 to 1.26]). For all of the time-spaced readmissions, we found that the values of %RB were closer to the conditional models, suggesting that event dependence dominated the data despite attempts to create independence by increasing the space in time between admissions. Our analysis showed that independent of the intercurrent event duration, prior events have an influence on future events. Hence, event dependence should be accounted for when analyzing recurrent events and challenges contemporary methods for such analysis.

Measurement of right ventricular volumes before and after atrial septal defect closure using multislice computed tomography.

Volumetric measurements of the right ventricle are helpful in patients with atrial septal defects (ASDs) in estimating the degree of right ventricular (RV) failure. They also may be important in following patients postoperatively after ASD closure. Traditional imaging modalities used to obtain such measurements have had limitations in measuring the complex shape of the right ventricle. Multislice computed tomography (MSCT) is a technique that provides excellent spatial resolution of the moving heart. This study was conducted to assess whether MSCT could be used to evaluate RV end-diastolic volume (EDV) before and after the closure of an ASD. From June 2004 to March 2006, 10 patients with ASDs underwent MSCT to calculate their RV volumes. The patients then had their ASDs closed by either a percutaneous or a surgical approach. Three months later, the patients' MSCT scans were repeated, and RV volumes were recalculated. EDV was approximated using 3-dimensional volume-rendered models of the right ventricle. At a mean follow-up of 3 months, a significant reduction in mean RV EDV, indexed for body surface area, was demonstrated, from 131 +/- 31 to 83 +/- 22 cm(3)/m(2) (p = 0.0007). In conclusion, this report is the first to describe the utility of MSCT to demonstrate RV EDV reduction after ASD closure.

Probability of Accurate Heart Failure Diagnosis and the Implications for Hospital Readmissions.

Heart failure (HF) is a complex syndrome with inherent diagnostic challenges. We studied the scope of possibly inaccurately documented HF in a large health care system among patients assigned a primary diagnosis of HF at discharge. Through a retrospective record review and a classification schema developed from published guidelines, we assessed the probability of the documented HF diagnosis being accurate and determined factors associated with HF-related and non-HF-related hospital readmissions. An arbitration committee of 3 experts reviewed a subset of records to corroborate the results. We assigned a low probability of accurate diagnosis to 133 (19%) of the 712 patients. A subset of patients were also reviewed by an expert panel, which concluded that 13% to 35% of patients probably did not have HF (inter-rater agreement, kappa = 0.35). Low-probability HF was predictive of being readmitted more frequently for non-HF causes (p = 0.018), as well as documented arrhythmias (p = 0.023), and age >60 years (p = 0.006). Documented sleep apnea (p = 0.035), percutaneous coronary intervention (p = 0.006), non-white race (p = 0.047), and B-type natriuretic peptide >400 pg/ml (p = 0.007) were determined to be predictive of HF readmissions in this cohort. In conclusion, approximately 1 in 5 patients documented to have HF were found to have a low probability of actually having it. Moreover, the determination of low-probability HF was twice as likely to result in readmission for non-HF causes and, thus, should be considered a determinant for all-cause readmissions in this population.

Effect on right ventricular volume of percutaneous Amplatzer closure of atrial septal defect in adults.

In adult patients with atrial septal defects (ASDs), right ventricular (RV) cavity size may return to normal after operative closure. This study demonstrated improved RV volumes and right atrial areas in 20 adult patients after successful transcatheter closure of large ASDs. RV volumes decreased by 22%, 30%, and 41% at 1 day, 1 month, and 6 months, respectively, after the procedure. Right atrial areas decreased by 5%, 23%, and 26%, respectively, over the same time.

Effect of bivalirudin on length of stay in the recovery area after percutaneous coronary intervention compared with heparin alone, heparin + abciximab, or heparin + eptifibatide.

Three hundred nine patients were followed during their recovery area stay after percutaneous coronary intervention. Recovery area times for patients who received bivalirudin during percutaneous coronary intervention showed an average reduction in total recovery area length of stay of 36 minutes (p <0.0001) compared with patients who received heparin alone. This reduction was also seen when compared with the heparin + abciximab group (46-minute reduction, p = 0.0007), and the heparin + eptifibatide group (35-minute reduction, p = 0.0005). Patients who received bivalirudin took significantly less time for the activated clotting time (ACT) to normalize despite significantly higher average ACTs and significantly fewer subtherapeutic ACTs.

Validation of the i-STAT handheld activated clotting time for use with bivalirudin.

Bivalirudin is being used more frequently as an anticoagulant in the cardiac catheterization laboratory. Newer devices, used to measure activated clotting time (ACT), have not been thoroughly tested for use with bivalirudin. One such device, the i-STAT ACT, measures the generation of activated thrombin to determine the level of anticoagulation. Our study demonstrated a high level of agreement between the i-STAT ACT and the Hemochron ACT in patients anticoagulated with bivalirudin. In addition, the i-STAT was shown to have an extremely high degree of reproducibility.

Percutaneous closure of multiple atrial septal defects with three Amplatzer septal occluder devices.

We report on the successful closure of three atrial septal defects with three Amplatzer septal occluders in a 55-year-old woman.

Massive bloody pericardial effusion as an initial manifestation of chronic kidney disease.

We describe a 35-year-old man with a massive bloody pericardial effusion, which was his initial manifestation of chronic kidney disease. Pericardiocentesis and hemodialysis restored cardiac function and relieved the associated massive anasarca.

Management of a single coronary artery aneurysm by use of a stent.

A 36-year-old man is described with aneurysmal coronary artery disease successfully treated with a Jomed covered stent. This technique obviates the need for surgical exclusion or ligation of the aneurysm.