Differences In 1-year Outcomes Research Articles

Characteristics of Central Nervous System Relapse after CD19 CAR-T Cell Therapy in R/R NHL

Background CD19-targeted chimeric antigen receptor T (CAR-T) cell therapy has shown remarkable antitumor activity against relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). However, NHL with central nervous system (CNS) relapse carries a poor prognosis and high mortality. We reported an analysis of 80 patients with NHL who underwent CAR-T cell therapy, and described the characteristics including the international prognostic index (IPI) and other clinical variables to evaluate the outcomes of CNS relapse in NHL patients treated with CAR-T cell therapy. Methods A total of 80 patients with NHL treated with CD19 CAR-T cell therapy in our center between April 2017 and November 2022 was retrospectively analyzed. Patient characteristics, laboratory parameters, and clinical outcomes were collected. CNS relapse was diagnosed by cerebrospinal fluid cytology, MRI or PET-CT. Results Baseline characteristics of all 80 patients are summarized in Table 1. The median age was 58.5 (range, 10 to 79) years, and 57.5% of patients were male. Overall, 67 (83.8%) patients achieved complete remission (CR) or partial remission (PR) after CD19 CAR-T therapy. Seven (8.43%) patients developed isolated CNS relapse after CAR-T cell therapy, all of which were heavily pre-treated with multiple lines of chemotherapy prior to CAR-T cell therapy, and one of them had received autologous stem cell transplant before infusion of CAR-T cells. Only 4 of 7 patients with isolated CNS relapse achieved CR (n=4), and the median time to isolated CNS relapse from CAR-T cell infusion was 6.3(range, 1.53 to 25.8) months. Thirty-seven patients (46.2%) developed systemic recurrence without CNS involvement, with the median time from CAR-T to relapse of 3.2 (range, 0.467-30.8) months. The other 36 patients remained in remission at the last follow-up. During the median follow-up of 13.5 months of the whole cohort, the number of recorded deaths in isolated CNS relapse, systemic only recurrence, and no relapse patients was 5 (71.4%), 22 (59.4%), 1(2.78%), respectively. The 1-year OS and 1-year PFS of patients with isolated CNS recurrence was significantly lower compared to the no relapse group (OS, 35.7% [95%CI 12.1-100] vs 97.22% [95%CI 92-100], P<0.001; PFS, 28.6% [95%CI 8.86-92.2] vs 100% [95%CI 100-100], P<0.001), but showed no difference compared to the systemic only recurrence group(OS, 53.3% [95%CI 39.3-72.4], P=0.79; PFS, 13.0% [95%CI 5.53-30.5], P=0.17). Conclusion In conclusion, patients with CNS relapse showed significant difference in 1-year outcomes with no relapse group but not systemic relapse group in our study, which suggested the importance of effective prophylaxis against CNS relapse. Further investigation is necessary to better define the characteristics of patients who will benefit from prophylaxis. Acknowledgements We gratefully thank all the participation from patients enrolled in clinical trials (ChiCTR1800015575; NCT03118180; NCT04532281; NCT04532268; NCT04213469).

Abstract 15402: Anatomic and Physiologic Classification of Adults With Congenital Heart Disease Using International Classification of Diseases (ICD) Coding

Background: The 2018 Adult Congenital Heart Disease (ACHD) Anatomic Physiologic (AP) classification scheme encompasses both anatomy and physiology to guide care management. To utilize the ACHD AP classification system in population-based research, an International Classification of Diseases (ICD) code-based classification is needed. Methods: AP classification of 240 cases, 18-65 years, with an encounter between 1/1/2010 - 12/31/2019 identified by at least one of 90 CHD codes (41 ICD-9-CM, 49 ICD-10-CM) in a tertiary adult healthcare system was performed by two methods - medical record review and a novel code-based AP classification. Cases were assigned one of four mutually exclusive AP classification categories based on complex vs. non-complex (simple plus moderate) anatomy and combined AB physiology (no/mild physiologic comorbidities) vs. CD physiology (moderate/severe physiologic comorbidities). A composite outcome of death, emergency department visit and/or hospitalization at 1-year after AP classification was evaluated. Results: Both record review and ICD code-based physiology classification methods demonstrated significant differences in 1-year outcomes between AB and CD physiology regardless of anatomic classification (Table 1), with CD physiology experiencing more adverse outcomes. Performance of AP classification by record review [PPV: 85.1% (97/114)] and ICD code-based classification [PPV: 80.7% (92/114)] (p=0.38) was similar. No differences were revealed by comparing outcome prediction within physiologic group by method, (AB by record review vs. AB by ICD codes: p=0.98; CD record review vs. CD by ICD codes: p=0.16). Conclusion: An ICD code-based classification of the ACHD AP guidelines is feasible, predictive of future adverse outcomes, and a reliable tool to use in administrative data. ICD code-based AB and CD physiology classifications are a good differentiator of outcomes for both complex and non-complex anatomic groups.

Abstract 17879: Assessing the Safety of an Early Repatriation Strategy for Uncomplicated ST-Elevation Myocardial Patients After Primary Percutaneous Intervention

Introduction: Repatriation of patients with ST-elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PPCI) is common in Canadian regional health care programs. However, the safety of early repatriation after PPCI in uncomplicated STEMI patients remains unknown. We aimed to compare the outcomes between uncomplicated STEMI patients repatriated early (transfer to home hospital ≤4hrs of PPCI completion) vs. those who remained at the PPCI-hospital until discharge. Methods: We performed a retrospective, cohort study examining consecutive, uncomplicated STEMI patients treated with PPCI between 2016-2018 in the Fraser Health Authority. Patients were designated as uncomplicated if there was no evidence of cardiogenic shock, prolonged cardiac arrest or congestive heart failure requiring mechanical ventilation. Outcomes of interest included discharge with guideline-based medical therapy (GBMT) and a composite of 1-year major cardiovascular events. Results: A total of 787 patients were included for analysis, with 62% (n=492) being repatriated early. Early repatriated patients were similar in age and baseline characteristics when compared with those discharged from the PPCI-based hospital. Interestingly, early repatriated patients were more likely to be discharged on GBMT (89% vs. 83%, p=0.015) In multivariate analysis, early repatriation was not associated with worsened 1-year cardiovascular outcomes (OR 1.05, 95% CI 0.6782,1.6521, p=0.80). Independent predictors of 1-year major cardiovascular outcomes included hypertension (OR 1.75, 95% CI 1.0918-2.8349, p=0.02) and discharge with GBMT (OR 0.49, 95% CI 0.2831-0.8465, p=0.01). Amongst the subset of early repatriated patients, primary treatment by cardiologist vs internist did not result in differences in 1-year outcomes (10% vs. 8%, p=0.23) or discharge with GBM (87% vs. 83%, p=0.09). Conclusions: Early repatriation of uncomplicated STEMI patients after PPCI was associated with outcomes similar to those having ongoing care at the PPCI-based hospital. Therefore, early repatriation serves as a safe treatment strategy for regional STEMI programs and may be particularly relevant for PPCI centres with limited bed capacity.

Delayed Ustekinumab Responders in Ulcerative Colitis Have Greater Inflammatory Burden but Similar Outcomes as Early Responders

Differences in 1-year outcomes among early compared with delayed responders to vedolizumab have been shown in ulcerative colitis. However, it is unclear whether similar differences exist with ustekinumab, and what factors differentiate delayed responders from nonresponders. This study was a post hoc analysis of patient-level data from the UNIFI clinical trial. Ustekinumab-treated patients with clinical response, defined as a reduction in total Mayo score of 30% or moreand 3 or more points from baseline with a reduction in their rectal bleeding subscore of 1 or more or a rectal bleeding subscore of 1 or less, at week 8 were deemed early responders andtheir outcomes were compared with delayed responders (week 8 nonresponders whosubsequently responded at week 16). The primary outcome assessed was 1-year clinical remission, defined as a total Mayo score of 2 or less and no subscore greater than1. We included 642 ustekinumab-treated patients, including 321 (50%) early responders, 115 (17.9%) delayed responders, and 205 (32.1%) nonresponders. No differences were observed for 1-year clinical remission among early vs delayed responders (132 of 321 [41.1%] vs 40 of 115 [34.8%]; P= .233), or for other outcomes assessed regardless of induction dose. Compared with early responders, delayed responders had more severe baseline Mayo endoscopic disease (88 of 115 [76.5%] vs 206 of 321 [64.2%]; P= .015) and abnormal baseline C-reactive protein level greater than 3 mg/L (83 of 115 [72.2%] vs 183 of 321 [57%]; P= .004). Compared with nonresponders, delayed responders had a significant decrease in C-reactive protein level (F-value [degrees of freedom, mean squares] [4, 844]; P < .0001) and fecal calprotectin level (F[4, 818]; P < .0001) through week16. Compared with early ustekinumab responders, delayed responders had a greater inflammatory burden at baseline. Early and delayed responders had similar 1-year outcomes. Biomarker decline observed in delayed responders can help differentiate them from nonresponders.

Trends in Utilization and Outcomes of Orbital, Laser, and Excisional Atherectomy for Lower Extremity Revascularization

Purpose: The aim of this study is to analyze the utilization pattern of atherectomy modalities and compare their outcomes. Materials and Methods: All patients undergoing atherectomy in the 2010–2016 Vascular Quality Initiative Database were identified. Utilization of orbital, laser, or excisional atherectomy was obtained. Characteristics and outcomes of patients treated for isolated femoropopliteal and isolated tibial disease by different modalities were compared. Results: Atherectomy use increased from 10.3% to 18.3% of all peripheral interventions (n = 122 938). Orbital atherectomy was most commonly used and increased from 59.4% in 2010 to 63.2% of all atherectomies in 2016, while laser atherectomy decreased from 19.2% to 13.1%. Atherectomy was mostly used for treatment of isolated femoropopliteal disease (51.1%), followed by combined femoropopliteal and tibial disease (25.8%) and isolated tibial disease (11.7%). In isolated femoropopliteal revascularization, excisional atherectomy was associated with higher rate of perforation (1.2%) compared with laser (0.4%) and orbital atherectomy (0.5%). The technical success of orbital atherectomy (96.7%) was lower compared with excisional atherectomy (98.7%). Concomitant stenting was significantly higher with laser atherectomy (43.0%) compared with orbital (27.2%) and excisional (26.1%) atherectomy. Nevertheless, there was no difference in 1-year primary patency, reintervention, major amputation, improvement in ambulatory status, or mortality. Multivariable analysis also demonstrated no difference in 1-year primary patency and major ipsilateral amputation among the modalities. In isolated tibial revascularization, there were no differences in perioperative outcomes among the modalities. Excisional atherectomy was associated with the highest 1-year primary patency (88.1%). After adjusting for confounders, excisional atherectomy remained associated with superior 1-year primary patency compared with orbital atherectomy (odds ratio [OR] = 2.59, 95% confidence interval [CI] = [1.18–5.68]), and excisional atherectomy remained associated with a lower rate of 1-year major ipsilateral amputation compared with laser atherectomy (OR = 0.29, 95% CI = [0.09–0.95]). Conclusion: Atherectomy use has increased, driven primarily by orbital atherectomy. Despite significant variation in perioperative outcomes, there were no differences in 1-year outcomes among the different modalities when used for treating isolated femoropopliteal disease. In isolated tibial disease treatment, excisional atherectomy was associated with higher 1-year primary patency compared with orbital atherectomy and decreased major ipsilateral amputation rates compared with laser atherectomy. These differences warrant further investigation into the comparative effectiveness of atherectomy modalities in various vascular beds.

Association of Initial Treatment With Antibiotics vs Surgery With Treatment Success and Disability in Subgroups of Children With Uncomplicated Appendicitis

This study investigates differences in 1-year outcomes by clinical and socioeconomic factors among US children with uncomplicated appendicitis who were treated with antibiotics vs surgery.

Association of Sex with Outcome in Elderly Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

BackgroundWorse outcomes have been reported for women, compared with men, after an acute coronary syndrome (ACS). Whether this difference persists in elderly patients undergoing similar invasive treatment has not been studied. We investigated sex-related differences in 1-year outcome of elderly acute coronary syndrome patients treated by percutaneous coronary intervention (PCI). MethodsPatients 75 years and older successfully treated with PCI were selected among those enrolled in 3 Italian multicenter studies. Cox regression analysis was used to assess the independent predictive value of sex on outcome at 12-month follow-up. ResultsA total of 2035 patients (44% women) were included. Women were older and most likely to present with ST-elevation myocardial infarction (STEMI), diabetes, hypertension, and renal dysfunction; men were more frequently overweight, with multivessel coronary disease, prior myocardial infarction, and revascularizations. Overall, no sex disparity was found about all-cause (8.3% vs 7%, P = .305) and cardiovascular mortality (5.7% vs 4.1%, P = .113). Higher cardiovascular mortality was observed in women after STEMI (8.8%) vs 5%, P = .041), but not after non ST-elevation-ACS (3.5% vs 3.7%, P = .999). A sensitivity analysis excluding patients with prior coronary events (N = 1324, 48% women) showed a significantly higher cardiovascular death in women (5.4% vs 2.9%, P = .025). After adjustment for baseline clinical variables, female sex did not predict adverse outcome. ConclusionsElderly men and women with ACS show different clinical presentation and baseline risk profile. After successful PCI, unadjusted 1-year cardiovascular mortality was significantly higher in women with STEMI and in those with a first coronary event. However, female sex did not predict cardiovascular mortality after adjustment for the different baseline variables.

Sex differences in 1-year clinical outcomes after percutaneous coronary intervention with COMBO stents: From the COMBO collaboration.

The COMBO drug eluting stent is a novel device with luminal endothelial progenitor cell capture technology for rapid homogeneous endothelialization. We examined for sex differences in 1-year outcomes after COMBO stenting from the COMBO collaboration, a pooled patient-level dataset from the MASCOT and REMEDEE multicenter registries. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel-myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes included stent thrombosis (ST). Adjusted outcomes were assessed using Cox regression methods. The study included 861 (23.8%) women and 2,753 (76.2%) men. Women were older with higher prevalence of several comorbidities including diabetes mellitus. Risk of 1-year TLF was similar in both sexes (3.8% vs. 3.9%, HR 0.92, 95% CI 0.59-1.42, p = .70), without sex differences in the incidence of cardiac death (1.6% vs. 1.5%, p = .78), TV-MI (1.5% vs. 1.1%, p = .32), or CD-TLR (2.0% vs. 2.2%, p = .67). Definite or probable ST occurred in 0.4% women and 1.0% men (HR 0.26, 95% CI 0.06-1.11, p = .069). Despite greater clinical risks at baseline, women treated with COMBO stents had similarly low 1-year TLF and other ischemic outcomes compared to men.

Outcomes in children undergoing posterior fossa decompression and duraplasty with and without tonsillar reduction for Chiari malformation type I and syringomyelia: a pilot prospective multicenter cohort study.

Despite significant advances in diagnostic and surgical techniques, the surgical management of Chiari malformation type I (CM-I) with associated syringomyelia remains controversial, and the type of surgery performed is surgeon dependent. This study's goal was to determine the feasibility of a prospective, multicenter, cohort study for CM-I/syringomyelia patients and to provide pilot data that compare posterior fossa decompression and duraplasty (PFDD) with and without tonsillar reduction. Participating centers prospectively enrolled children suffering from both CM-I and syringomyelia who were scheduled to undergo surgical decompression. Clinical data were entered into a database preoperatively and at 1-2 weeks, 3-6 months, and 1 year postoperatively. MR images were evaluated by 3 independent, blinded teams of neurosurgeons and neuroradiologists. The primary endpoint was improvement or resolution of the syrinx. Eight clinical sites were chosen based on the results of a published questionnaire intended to remove geographic and surgeon bias. Data from 68 patients were analyzed after exclusions, and complete clinical and imaging records were obtained for 55 and 58 individuals, respectively. There was strong agreement among the 3 radiology teams, and there was no difference in patient demographics among sites, surgeons, or surgery types. Tonsillar reduction was not associated with > 50% syrinx improvement (RR = 1.22, p = 0.39) or any syrinx improvement (RR = 1.00, p = 0.99). There were no surgical complications. This study demonstrated the feasibility of a prospective, multicenter surgical trial in CM-I/syringomyelia and provides pilot data indicating no discernible difference in 1-year outcomes between PFDD with and without tonsillar reduction, with power calculations for larger future studies. In addition, the study revealed important technical factors to consider when setting up future trials. The long-term sequelae of tonsillar reduction have not been addressed and would be an important consideration in future investigations.

Clinical characteristics and prognosis of heart failure with mid-range ejection fraction: insights from a multi-centre registry study in China

BackgroundHeart failure (HF) with mid-range ejection fraction (EF) (HFmrEF) has attracted increasing attention in recent years. However, the understanding of HFmrEF remains limited, especially among Asian patients. Therefore, analysis of a Chinese HF registry was undertaken to explore the clinical characteristics and prognosis of HFmrEF.MethodsA total of 755 HF patients from a multi-centre registry were classified into three groups based on EF measured by echocardiogram at recruitment: HF with reduced EF (HFrEF) (n = 211), HFmrEF (n = 201), and HF with preserved EF (HFpEF) (n = 343). Clinical data were carefully collected and analyzed at baseline. The primary endpoint was all-cause mortality and cardiovascular mortality while the secondary endpoints included hospitalization due to HF and major adverse cardiac events (MACE) during 1-year follow-up. Cox regression and Logistic regression were performed to identify the association between the three EF strata and 1-year outcomes.ResultsThe prevalence of HFmrEF was 26.6% in the observed HF patients. Most of the clinical characteristics of HFmrEF were intermediate between HFrEF and HFpEF. But a significantly higher ratio of prior myocardial infarction (p = 0.002), ischemic heart disease etiology (p = 0.004), antiplatelet drug use (p = 0.009), angioplasty or stent implantation (p = 0.003) were observed in patients with HFmrEF patients than those with HFpEF and HFrEF. Multivariate analysis showed that the HFmrEF group presented a better prognosis than HFrEF in all-cause mortality [p = 0.022, HR (95%CI): 0.473(0.215–0.887)], cardiovascular mortality [p = 0.005, HR (95%CI): 0.270(0.108–0.672)] and MACE [p = 0.034, OR (95%CI): 0.450(0.215–0.941)] at 1 year. However, no significant differences in 1-year outcomes were observed between HFmrEF and HFpEF.ConclusionHFmrEF is a distinctive subgroup of HF. The strikingly prevalence of ischemic history among patients with HFmrEF might indicate a key to profound understanding of HFmrEF. Patients in HFmrEF group presented better 1-year outcomes than HFrEF group. The long-term prognosis and optimal medications for HFmrEF require further investigations.

Outcomes by Gender and Ethnicity After Percutaneous Coronary Intervention

Limited data on gender differences by ethnicity after percutaneous coronary intervention (PCI) exist. In this prospective cohort study, we examined gender differences in 1-year outcomes among patients from 4 ethnic groups who underwent PCI from 2010 to 2016 at a tertiary center. The primary outcome was 1-year major adverse cardiovascular events (MACE) defined as composite of all-cause death, nonfatal myocardial infarction (MI), or target lesion revascularization. Secondary outcomes included composite of death or MI and individual components of MACE. Baseline characteristics and outcomes were compared between gender in each ethnic group. The study included 16,361 patients: 7,881 whites (26.1% women), 1,943 blacks (47.3% women), 2,621 Asians (22.6% women), and 3,916 Hispanics (39.3% women). Women were older with more co-morbidities than men. Unadjusted, women had higher incidence of 1-year MACE than men among whites and Asians but not blacks or Hispanics, which was driven by a greater incidence of death in white women and greater incidence of MI in Asian women compared with male counterparts. After adjustment, findings showed similar risk of 1-year MACE in women versus men in whites, Asians, and Hispanics (Whites: hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.78 to 1.16; Asians: HR 1.14, 95% CI 0.77 to 1.67; Hispanics: HR 0.97, 95% CI 0.74 to 1.27). Black women had lower risk of 1-year MACE compared with black men (HR 0.67, 95% CI 0.46 to 0.97), driven by lower risk of death or MI. In conclusion, this study suggests that risk factors account for adverse events in women after PCI.

Short and Stout Female Donors in Heart Transplantation: Do They Make a Difference?

Purpose Certain donor characteristics after heart transplantation (HTx) may have less optimal outcome post-HTx. One factors leading to worse outcome is female donors to male recipient possibly due to size (height and weight) mismatch relative to male donors. We try to compensate for this size mismatch by using obese female donors into male recipients. However, there have been recent concerns with obese donors, in the sense that there are commonly large fat deposits on the donor heart. It is not known whether short and obese female donors (weight oversizing) results in acceptable outcome after HTx. We sought to assess for this possibility in our large single center. Methods Between 2010 and 2017 we assessed 799 HTx patients and divided them into those male recipients who received female donors (n=246) that were short (≤ 66 inches) and obese (BMI≥30) (n=61) and short and non-obese (BMI major adverse cardiac events (NF-MACE: myocardial infarction , new congestive heart failure , percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke), and freedom from any-treated rejection, acute cellular rejection , and antibody-mediated rejection . Results There is no significant difference in 1-year outcomes between short and obese female donors, short and non-obese female donors, and male donors of similar heights and weights (see tables). Conclusion Short and stout female donors appear to be acceptable for HTx which increases the donor pool.

Balloon-Mounted versus Self-Expanding Stent Outcomes in Symptomatic Middle Cerebral Artery Stenosis Combined with Poor Collaterals in China: A Multicenter Registry Study

To compare the technical and 1-year clinical outcome in balloon-mounted versus self-expanding stenting for symptomatic severe stenosis of the middle cerebral artery combined with poor collaterals in China. Ninety-one patients with severe middle cerebral artery atherosclerotic stenosis combined with poor collaterals were recruited in the study. Balloon-mounted stent or self-expanding stent were selected to treat patients following a guideline. The baseline characteristics, cerebral angiography, and outcomes were compared between the patients treated with balloon-mounted stent and self-expanding stent. The mean degree of stenosis was 85.5% ± 6.37% in the balloon-mounted stenting group and 85.4% ± 7.73% in the self-expanding stenting group before treatment (P= 0.930). A longer operative time occurred in patients treated with self-expanding stent than in those treated with balloon-mounted stent (96.7 vs. 68.6 minutes, respectively; P= 0.002). Patients with self-expanding stent had a higher rate of residual stenosis than those with balloon-mounted stent (67.3% vs. 38.9%, respectively; P= 0.014). The patients in balloon-mounted stenting group was less likely to have restenosis (6.1% vs. 26.5%, P= 0.019) and had a lower degree of stenosis (5.0% ± 0.0% vs. 26.9% ± 29.2%, P= 0.019) compared with patients in the self-expanding stenting group. During the 1-year follow-up, the recurrence rate of ischemic stroke, transient ischemic attack, hemorrhage stroke, and death was not significantly different between the 2 groups (1/33 vs. 2/49, P= 0.804; 1/33 vs. 1/49, P= 0.776; 0/33 vs. 2/49, P= 0.240; 1/33 vs. 0/49, P= 0.220, respectively). Balloon-mounted stents may have a shorter operative time and lower restenosis occurrence than self-expanding stents. No significant difference in 1-year outcome was observed between the 2 groups.

Abstract 302: NeuroCardiac Comprehensive Care Clinic Seeks to Define and Detect Neurological, Psychiatric, and Functional Sequelae in Cardiac Arrest Survivors

Introduction: Despite improved survivability, cardiac arrest (CA) survivors face significant “extracardiac” (i.e. functional, cognitive and psychosocial) sequelae. More so, survivors and their caregivers are seemingly unaware that they will be confronted with these issues post-discharge. As a response, we have created a multidisciplinary, follow-up clinic to provide comprehensive and well-coordinated care to CA survivors. The team includes a neurointensivist, neuropsychologist, neuropsychiatrist and a chaplain. Hypothesis: CA survivors attending a follow-up clinic will have improved outcomes compared to historical controls. Methods: Fisher’s exact and Wilcoxon Rank-sum tests were used to assess differences in 1-year outcomes between survivors who had at least one follow-up visit in the NeuroCardiac clinic (2/2017-1/2018), with historical controls (9/2015 - 1/2017) who had no clinic visits. Results: Clinic patients (n= 34; median visit per patient=2), were slightly younger (49 vs 57 years, p=0.03) than historic controls (n=47), but otherwise there were no significant differences in demographic, psychosocial or functional status at hospital discharge. At 1-year, clinic patients, compared to historic controls, had significantly greater independence on the Lawton Physical Self-Maintenance Scale (mean score 7.6 vs 8.9, p=0.03) and Instrumental Activities of Daily Living scale (4.9 vs 8.8, p =.01). In clinic patients, there was a trend towards return to work (38.2% vs 23.4%), having a less negative impact on their marital status (5.9% vs 21.3%) and reduced complaints of sleep issues (29% vs 52%). Clinic patients had lower rates of depression symptoms on the Center for Epidemiological Studies-Depression scale (9.8 vs 13.4), were less fearful about the possibility of arrest recurrence (23.5% vs 31.9%), had more positive recovery perceptions (55.9% vs 38.3%), and had higher self-reported overall health ratings on a 100-point scale (84.7 vs 75.4) at one year. Conclusions: We have taken an important step in early detection of extracardiac symptoms in a systematic manner after CA. This paradigm shift could potentially be utilized to develop and implement novel interventions responsible for improving clinical outcomes and quality of life.

Health Status Benefits of Successful Chronic Total Occlusion Revascularization Across the Spectrum of Left Ventricular Function: Insights From the OPEN-CTO Registry

ObjectivesThis study sought to describe the association between chronic total occlusion (CTO) revascularization (CTO percutaneous coronary intervention [PCI]) and health status in patients with and without cardiomyopathy. BackgroundPrior PCI trials for cardiomyopathy have excluded CTO patients. Whether patients with reduced left ventricular ejection fraction (LVEF) receive similar health status benefit from CTO-PCI compared with patients with normal LVEF is unclear. MethodsWe assessed health status change, using the Seattle Angina Questionnaire (SAQ) Summary, SAQ Angina Frequency, and Rose Dyspnea Scale scores, among patients undergoing successful CTO PCI in the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion) Registry. Participants were classified by LVEF (normal, ≥50%; mild-moderate, 30% to 49%; and severe, <30%), with higher SAQ and lower Rose Dyspnea Scale scores indicating better health status. Differences in 1-year outcomes were compared using hierarchical multivariable regression. ResultsOf 762 patients, 506 (66.4%), 193 (25.3%), and 63 (8.3%) had normal, mild-moderate, and severely reduced LVEF. SAQ Summary score improvements were observed in each group (27.1 ± 20.4, 26.7 ± 21.2, and 20.3 ± 18.1, respectively). Compared with patients with LVEF ≥50%, those with LVEF <30% had less improvement in SAQ Summary Score (−5.2 points; 95% confidence interval: −9.0 to −1.5; p = 0.01) and Rose Dyspnea Scale (+0.5 points; 95% confidence interval: 0.1 to 0.8; p = 0.01), with no difference in odds of angina (odds ratio: 1.3; 95% confidence interval: 0.6 to 3.0; p = 0.48). Health status improvement was similar between patients with LVEF ≥50% and LVEF 30% to 49%. ConclusionsAlthough health status improvement was less in patients with severely reduced LVEF compared with those with normal LVEF, each group experienced large health status improvements after CTO-PCI.

Incidence, Management, and Associated Clinical Outcomes of New-Onset Atrial Fibrillation Following Transcatheter Aortic Valve Replacement: An Analysis From the STS/ACC TVT Registry

ObjectivesThe aim of this study was to evaluate incidence, care patterns, and clinical outcomes in patients developing new-onset atrial fibrillation (AF) following transcatheter aortic valve replacement (TAVR). BackgroundPre-procedural AF has been associated with adverse outcomes in patients undergoing TAVR, but the incidence of new-onset AF, associated anticoagulant management, and subsequent clinical outcomes are unclear. MethodsUsing the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry linked with Medicare claims, patients undergoing TAVR from 2011 to 2015 who developed post-procedural AF were evaluated. Patients with known AF prior to TAVR were excluded. Outcomes of interest included in-hospital mortality and stroke and all-cause mortality, stroke, and bleeding at 12 months. Multivariate adjustment was then performed to determine differences in 1-year outcomes among those with and without new post-procedural AF, stratified by anticoagulation status. ResultsWe identified 1,138 of 13,556 patients (8.4%) who developed new onset AF (4.4% of transfemoral [TF]–access patients, 16.5% of non-TF-access patients). Patients developing AF were older, more likely female, had higher Society of Thoracic Surgeons risk scores, and were often treated using non-TF access. Despite having a median CHA2DS2-VASc score of 5 (25th and 75th percentile: 5 to 6), only 28.9% of patients with new AF were discharged on oral anticoagulation. In-hospital mortality (7.8% vs. 3.4%; p < 0.01) and stroke (4.7% vs. 2.0%; p < 0.01) were higher among patients who developed post-procedural AF compared with those who did not. At 1 year, rates of death (adjusted hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.19 to 1.59), stroke (adjusted HR: 1.50; 95% CI: 1.14 to 1.98), and bleeding (adjusted HR: 1.24; 95% CI: 1.10 to 1.40) were higher among patients with new-onset AF. One-year mortality rates were highest among patients who developed new-onset AF but were not discharged on anticoagulation. ConclusionsPost-TAVR AF occurred in 8.4% of patients (4.4% with TF access, 16.5% with non-TF access), with fewer than one-third of patients receiving anticoagulation at discharge, and was associated with increased risk for in-hospital and 1-year mortality and stroke. Given the clinical significance of post-TAVR AF, additional studies are necessary to delineate the optimal management strategy in this high-risk population.

Acute coronary syndrome – Still a valid contraindication to perform rotational atherectomy? Early and one-year outcomes

BackgroundRotational atherectomy (RA) is an acknowledged method of percutaneous treatment of highly calcified or fibrotic coronary lesions. However, using the rotablator system in patients presenting with acute coronary syndromes (ACS) remains controversial and is considered as a relative contraindication. The aim of our study was to assess in-hospital and 1-year outcomes in patients undergoing RA presenting with ACS, in comparison to elective RA procedures. MethodsThis single-center observational study included all consecutive patients who underwent RA and PCI in our institution from April 2008 to October 2015. All patients were subsequently divided into two groups based on clinical presentation: stable angina group (SA) and ACS group. Primary endpoints were in-hospital and 1-year all-cause mortality and 1-year major adverse cardiac events (MACE). Secondary endpoints were procedural success and in-hospital complications. ResultsThe study included 207 patients, 164 (79%) in SA group and 43 (21%) in ACS group. In-hospital mortality was higher in patients with ACS (4.7% vs. 0%, p=0.01). Procedural success was similar in both groups, 93% in ACS groups vs. 92.7% in SA group, p=0.94. There were no significant differences in the rate of periprocedural complications (4.7% vs. 10.4%, p=0.25), however postprocedural complications were more frequent in ACS group. At 1-year follow-up MACE rate and mortality were numerically higher, however statistically not significant (25.6% vs. 16.5%, p=0.17 and 16.3% vs. 7.9%, p=0.10; respectively). ConclusionsDespite higher mortality and complication rate in ACS group observed in postprocedural period, we found no significant difference in 1-year outcomes in comparison to elective patients. Procedural success of RA in ACS patients is similar to elective patients with SA and this procedure should be considered in case of urgent indications, if no other options of treatment exist.

The Use of Decomposition Methods in Real-World Treatment Benefits Evaluation for Patients with Type 2 Diabetes Initiating Different Injectable Therapies: Findings from the INITIATOR Study

BackgroundDetermining characteristics of patients likely to benefit from a particular treatment could help physicians set personalized targets. ObjectivesTo use decomposition methodology on real-world data to identify the relative contributions of treatment effects and patients’ baseline characteristics. MethodsDecomposition analyses were performed on data from the Initiation of New Injectable Treatment Introduced after Antidiabetic Therapy with Oral-only Regimens (INITIATOR) study, a real-world study of patients with type 2 diabetes started on insulin glargine (GLA) or liraglutide (LIRA). These analyses investigated relative contributions of differences in baseline characteristics and treatment effects to observed differences in 1-year outcomes for reduction in glycated hemoglobin A1c (HbA1c) and treatment persistence. ResultsThe greater HbA1c reduction seen with GLA compared with LIRA (−1.39% vs. −0.74%) was primarily due to differences in baseline characteristics (HbA1c and endocrinologist as prescribing physician; P < 0.050). Patients with baseline HbA1c of 9.0% or more or evidence of diagnosis codes related to mental illness achieved greater HbA1c reductions with GLA, whereas patients with baseline polypharmacy (6–10 classes) or hypogylcemia achieved greater reductions with LIRA. Decomposition analyses also showed that the higher persistence seen with GLA (65% vs. 49%) was mainly caused by differences in treatment effects (P < 0.001). Patients 65 years and older, those with HbA1c of 9.0% or more, those taking three oral antidiabetes drugs, and those with polypharmacy of more than 10 classes had higher persistence with GLA; patients 18 to 39 years and those with HbA1c of 7.0% to less than 8.0% had higher persistence with LIRA. ConclusionsAlthough decomposition does not demonstrate causal relationships, this method could be useful for examining the source of differences in outcomes between treatments in a real-world setting and could help physicians identify patients likely to respond to a particular treatment.

Sex Differences in 1-Year Outcomes After Percutaneous Coronary Intervention in the Veterans Health Administration.

Advancements in percutaneous coronary intervention (PCI) for treating obstructive coronary artery disease have reduced major adverse events, including mortality. Yet, evidence as to whether women and men experience similar outcomes is mixed. The objective was to examine sex differences in 1-year major adverse cardiac outcomes for the national population of patients undergoing PCI at Veterans Health Administration (VA) cardiac catheterization laboratories. All Veterans undergoing PCI at VA hospitals between October 1, 2007 and September 30, 2013 (N = 64,757; Women = 1,040) were included. Cox proportional hazards models compared 1-year postprocedural outcomes [rehospitalization for myocardial infarction (MI), all-cause mortality, and major adverse cardiovascular events (MACE)] by sex. Women Veterans undergoing PCI were more likely to be younger, black, obese, and have chronic depression and less likely to have common cardiovascular risk factors and to have had prior cardiac events than Veteran men. One-year rates for women versus men were 2.1% and 2.5% for rehospitalization (p-value = 0.57); 3.5% and 4.9% for mortality (p-value = 0.14), and 5.4% and 6.9% for MACE (p-value = 0.18). There were no significant sex differences in any of the outcomes in Cox proportional hazards models. Despite differences in clinical risk factors at the time of PCI, women and men Veterans treated at VA cardiac catheterization laboratories experienced comparable 1-year rehospitalization for MI, mortality, and MACE post-PCI. These results demonstrated similar 1-year post-PCI outcomes for men and women in a national population of patients who have more comorbidities and mental health issues than the general population.

Eptifibatide is associated with significant cost savings and similar clinical outcomes to abciximab when used during primary percutaneous coronary intervention for ST-elevation myocardial infarction: An observational cohort study of 3863 patients.

IntroductionGlycoprotein IIb/IIIa inhibitors are recommended by guidelines in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. There are few studies directly comparing these agents. The aim of this study was to assess whether eptifibatide is a safe and cost-effective alternative to abciximab in the treatment of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.MethodsThis was an observational cohort study of 3863 patients who received a GPIIb/IIIa inhibitor whilst undergoing primary percutaneous coronary intervention from 2007 to 2014. Patients who did not receive a GPIIb/IIIa inhibitor were excluded. Time to first major adverse cardiac event defined as death, non-fatal myocardial infarction, stroke or target vessel revascularization, and total hospital costs were compared between the groups.ResultsIn all, 1741 patients received abciximab with 2122 receiving eptifibatide. Patients who received eptifibatide had higher rates of previous MI/percutaneous coronary intervention and were more likely to undergo a procedure from the radial route. Unadjusted Kaplan–Meier analysis revealed no significant difference in the 1-year event rates between patients given eptifibatide versus abciximab (p = 0.201). Age-adjusted Cox analysis demonstrated no difference in 1-year outcome between abciximab and eptifibatide (hazard ratio: 0.83; 95% confidence interval: 0.73–1.39), which persisted after multivariate adjustment (hazard ratio: 0.92; 95% confidence interval: 0.79–1.56) including the incorporation of a propensity score (hazard ratio: 0.88; 95% confidence interval: 0.71–1.44). Eptifbatide was associated with significant cost savings being 87% cheaper overall compared to abciximab (on average £650 cheaper per patient and saving approximately £950,000).ConclusionThis observational data suggest that eptifibatide is associated with similar outcomes and significant cost savings compared to abciximab when used in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.