In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions in Heart failure patients

Chronic total occlusion (CTO) coronary artery disease is a frequent and challenging entity that is encountered in 25%-30% of cardiac catheterizations and carries significant clinical and prognostic implications.1, 2, 3, 4, 5 CTO Percutaneous coronary interventions (PCI) are complex procedures with considerably higher complication risk compared to routine PCI, such as myocardial infarction, stroke, coronary perforation and dissection, tamponade, major bleeding, renal failure, vascular surgery interventions, urgent coronary artery bypass grafting and death.6, 7, 8 However, multiple observational studies have demonstrated feasibility and temporal improvement in procedural success that parallel technical advances and improved operator experience.9, 10, 11 Many studies compared successful CTO PCI with unsuccessful CTO PCI to make the case for positive beneficial impact of CTO PCI on survival.12, 13, 14 However, no sufficient evidence from randomized trials is available to support that CTO PCI decreases cardiovascular mortality.15 The DECISION-CTO (Drug-eluting stent implantation in patients with chronic total occlusion) trial reported no difference in MACE between routine CTO-PCI/Optimal medical management vs medical management.15 In EXPLORE (Evaluating Xience and left ventricular function in percutaneous coronary intervention on occlusions after ST-Elevation myocardial infarction) trial, routine CTO intervention did not show improvement in left ventricle function as compared to no-CTO PCI arm.16 Ischemic cardiomyopathy patients are more susceptible to complications following invasive procedures. This population represents the target for innovative approaches aiming to improve cardiac function and survival. Identifying the magnitude of the clinical problem can be pivotal in stimulating further investigations to optimize care delivery. We sought to evaluate the in-hospital outcomes of CTO PCI for stable ischemic heart disease in heart failure patients using the national inpatient database.

Data was obtained from the 2008-2014 Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS) database. Annually, the NIS collects data covering 7-8 million hospital stays, reflecting all discharges from ∼1000 hospitals. The database contains patient-level hospital discharge data provided by States that participate in the Agency for Healthcare Research and Quality's Project (n = 44 in 2013). The NIS includes U.S. non-rehabilitation, community hospitals, with the target universe being all acute care hospital discharges in the United States. A full description of the database is available on the HCUP website.1718 The National Center for Health Statistics (NCHS) and the Centers for Medicare & Medicaid Services (CMS) have issued new diagnosis and procedure codes for the International Classification of Diseases, ninth Revision, Clinical Modification (ICD-9-CM) every year since 1986. New code assignments were implemented for CTO (414.2) in October 2007. Therefore, our study sample was derived from NIS data 2008 onwards until 2014. We chose to restrict analyses up to 2014 to limit coding utilization to one coding system (ICD-9), which has been extensively validated and therefore decrease the chance of misclassification.

We used International Classification of Diseases, Ninth Edition Clinical Modification (ICD-9-CM) codes (360, 00.66,36.01, 36.02,36.04, 36.05,36.06,36.07,36.09 and 17.55) to identify patients who had percutaneous coronary interventions (PCI). We excluded patient with presenting principal diagnosis of ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and out of hospital cardiac arrest. We also excluded patients younger than 18 years old and those who were transferred from another hospital to avoid duplication of records. Then, we used ICD-9 codes 00.44 to identify patients with single vessel PCI (N = 1327,084). Finally, we combined single vessel PCI with CTO ICD-9 code (414.2). The final study sample included 112,061 patients with singe vessel CTO PCI. Similar approach was done in prior publications.19 Thereafter, the sample was divided into 3 groups: patients without heart failure, heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). This was illustrated in the study flow diagram (Supplement eFigure 1).

Inpatient outcomes of interest included: (A) In-Hospital mortality, acute renal failure and utilization of mechanical support devices [Intra-Aortic Balloon Pump (IABP), Impella, Tandem Heart, Extracorporeal Membrane Oxygenation (ECMO)] (B) Other In-hospital complications (STEMI, NSTEMI, cardiogenic shock, in-hospital arrest, cardiac tamponade, pacemaker use, acute stroke, vascular complications, gastrointestinal bleed and transfusion), (C) length of hospital stay (days), (D) total hospital charges (US $) adjusted for inflation using the 2020 consumer price index. Patients’ clinical characteristics, comorbidities and hospital characteristics were compared between groups and included: age, gender, race, hypertension, diabetes, atrial fibrillation, peripheral arterial disease, chronic renal failure, hypocoagulable state (coagulation factors deficiency, thrombocytopenia), chronic lung disease, drug abuse, alcohol use, smoking, dyslipidemia, obesity, previous myocardial infarction, previous percutaneous coronary intervention (PCI), previous coronary artery bypass grafting (CABG), hospital size, location/ teaching status and hospital region. Relevant co-morbidities that were not readily available in the NIS database were obtained using the appropriate ICD-9-CM codes (Supplemental eTable 1).

Statistical analyses were performed using Stata 16.0, accounting for survey design complexity, sampling weights, primary sampling units and strata. Subsequently, population estimates of proportions, means and regression coefficients were obtained. Standard errors were estimated using Taylor series linearization. First, patient demographics and co-morbidities were compared between groups using Pearson χ2 test for categorical variables and linear regression (1-way ANOVA) for continuous variables. Second, means and proportions of outcomes of interest were similarly compared. Third, multiple logistic regression models were conducted to examine study outcomes of in-hospital mortality, acute renal failure, and utilization of mechanical support. These models were adjusted for age, gender, race, atrial fibrillation, hypertension, diabetes, chronic renal failure, peripheral arterial disease, cardiogenic shock, septic shock, respiratory failure, acute stroke, STEMI, NSTEMI, Bleeding, hospital size, and hospital region. Fourth, proportions of in-hospital mortality in different age categories were explored using Pearson χ2 test for categorical variables. Categorical variables were expressed as n (%) and continuous variables as mean ± SEM. The OR/β coefficients and 95% confidence interval were used to report results of regression models. All P values were 2-sided and Type I error was set at 0.05.

The study included 112,061 patients who had CTO PCI and admitted to U.S hospitals from 2008 to 2014. Of those, 21,185 (19%) had HFrEF and 3,309 (3%) had HFpEF. Compared to patients without heart failure, HFrEF and HFpEF patients were older (mean age 69.2 years vs 66.3 years, 70.3 years vs 66.3 years respectively, P < 0.001), and had higher proportions of diabetes, chronic renal disease, atrial fibrillation, and chronic lung disease. Further details of demographic distributions can be found in (Table1).

In univariate analyses, heart failure patients (HFrEF and HFpEF) were more likely to develop in-Hospital complications (STEMI, NSTEMI, acute stroke, gastrointestinal bleed, vascular access complications, need for transfusion, cardiac tamponade, pacemaker placement, acute renal failure, cardiogenic shock, in-hospital arrest, use of mechanical support and mortality). They also had higher length of hospital stay and higher hospital charges (Table 2).

Compared to patients without heart failure, those with HFrEF were more likely to have higher in-hospital mortality (0.6% vs 2.9%, P < 0.001) in univariate and multivariate analyses [AOR 1.73, 95% CI (1.21-2.48)], acute renal failure [AOR 2.68, 95% CI (2.34-3.06)], and need for mechanical support [AOR 2.76, 95% CI (2.17-3.51)]. On the other hand, patients with HFpEF had similar adjusted mortality and adjusted need for mechanical support to those without heart failure, but higher incidence of acute renal failure [AOR 2.95, 95% CI (2.29-3.81)] (Table 3, Supplement eTable 2,3,4) and (Figure 1).

In-hospital mortality increased significantly with increase age, for each 1-year increase in age there was a 3% increase in adjusted in-hospital mortality [AOR 1.03, 95% CI (1.02-1.05)] (Supplement eTable 2). Such increase in mortality was more evident in those older than 80 years of age: in patient without heart failure, the in-hospital mortality increased from 0.5% in those younger than 65 years to 1.3% in patients older than 80 years. And in HFrEF patients, the in-hospital mortality increased from 1.9% in patient younger than 65 years to 4.8% in patients older than 80 years of age (Figure 2).

留言 (0)

沒有登入
gif