In-hospital Bleeding Complications Research Articles

Factors affecting in-hospital clinical outcomes in patients with acute limb ischemia undergoing endovascular therapy or fogarty thrombectomy: a large-scale analysis based on the JROAD-DPC database

Abstract Background The etiology of acute limb ischemia (ALI) involves embolism as well as atherosclerotic thrombosis. Although endovascular therapy (EVT) or Fogarty thrombectomy (Fogarty TE) is the recommended revascularization method for ALI, treatment choice based on patient characteristics remains controversial. Purpose This study aimed to evaluate the differences in clinical outcomes between primary treatments and identify predictive factors affecting clinical outcomes in patients with ALI. Methods This retrospective study used data from the Japanese Registry of All Cardiac and Vascular Diseases-Diagnosis Procedure Combination (JROAD-DPC) database, from April 2012 to March 2020. We analyzed 18,701 patients with ALI and categorized them into medication and invasive treatment groups (EVT alone, Fogarty TE alone, bypass surgery alone, and hybrid treatment). The EVT-alone and Fogarty TE-alone groups were compared after propensity score matching, considering 19 clinically relevant covariates. The primary outcomes were in-hospital mortality, major amputation, and bleeding complications (anemia requiring transfusion or endoscopic hemostasis). The secondary outcomes were major adverse cardiovascular events (myocardial infarction, coronary intervention, heart failure, stroke, and cerebral hemorrhage), major amputation and/or death, hospitalization duration, and total cost during hospitalization. Results The EVT-alone group had more patients at a higher risk of atherosclerotic disease, including peripheral artery disease (PAD), chronic kidney disease (CKD), or hemodialysis. The Fogarty TE-alone group had more patients at a higher risk of embolism, including AF or AFL. After propensity score matching, in-hospital mortality (odds ratio [OR]: 1.58, 95% confidence interval [CI]: 1.29–1.92, p<.0001), bleeding complications (OR: 1.28, 95% CI: 1.12–1.46, p=0.0002), and major amputation rates (OR: 1.44, 95% CI: 1.17–1.76, p=0.0004) were significantly higher in the EVT-alone group than in the Fogarty TE-alone group. Major amputation and/or death rates and total hospitalization costs were higher in the EVT-alone group than in the Fogarty TE-alone group. In interaction analyses, EVT demonstrated a favorable trend of lower risks of death and/or major amputation in patients with PAD, CKD, and diabetes mellitus (all risk factors for atherosclerotic disease), especially in those with PAD and CKD. Conclusions Fogarty TE may be the preferred primary treatment for patients with ALI, particularly those without PAD or CKD.Study flowchartForest plot analyzing interaction effect

Reduced mortality associated with pulmonary embolism response team consultation for intermediate and high-risk pulmonary embolism: a retrospective cohort study

BackgroundThe management of acute pulmonary embolism (PE) has become increasingly complex with the expansion of advanced therapeutic options, resulting in the development and widespread adoption of multidisciplinary Pulmonary Embolism Response Teams (PERTs). Much of the literature evaluating the impact of PERTs has been limited by pre- postimplementation study design, leading to confounding by changes in global practice patterns over time, and has yielded mixed results. To address this ambiguity, we conducted a retrospective cohort study to evaluate the impact of the distinct exposures of PERT availability and direct PERT consultation.MethodsAt a single tertiary center, we conducted propensity-matched analyses of hospitalized patients with intermediate or high-risk PE. To assess the impact of PERT availability, we evaluated the changes in 30-day mortality, hospital length of stay (HLOS), time to therapeutic anticoagulation (TAC), in-hospital bleeding complications, and use of advanced therapies between the two years preceding and following PERT implementation. To evaluate the impact of direct PERT consultation, we conducted the same analyses in the post-PERT era, comparing patients who did and did not receive PERT consultation.ResultsSix hundred eighty four patients were included, of which 315 were pre-PERT patients. Of the 367 postPERT patients, 201 received PERT consultation. For patients who received PERT consultation, we observed a significant reduction in 30-day mortality (5% vs 20%, OR 0.38, p = 0.0024), HLOS.(-5.4 days, p < 0.001), TAC (-0.25 h, p = 0.041), and in-hospital bleeding (OR 0.28, p = 0.011).These differences were not observed evaluating the impact of PERT presence in pre-vs postimplementation eras.ConclusionsWe observed a significant reduction in 30-day mortality, hospital LOS, TAC, and in-hospital bleeding complications for patients who received PERT consultation without an observed difference in these metrics when comparing the pre- vs post-implementation eras. This suggests the benefits stem from direct PERT involvement rather than the mere existence of PERT. Our data supports that PERT consultation may provide benefit to patients with acute intermediate or high-risk PE and can be achieved without a concomitant increase in advanced therapies.

Ultrasound-Assisted Versus Standard Catheter-Directed Thrombolysis for Acute Pulmonary Embolism: Insights From National Inpatient Sample

BackgroundPulmonary embolism is one of the leading causes of morbidity and mortality in the United States. Catheter-directed therapies have emerged as a promising treatment for managing intermediate- and high-risk patients; however, data comparing standard catheter-directed thrombolysis (SCDT) and ultrasound-assisted thrombolysis (USAT) are limited. This study aimed to investigate trends, outcomes, and predictors of mortality of both modalities from a nationally representative sample. MethodsThis analysis used data from the National Inpatient Sample years 2016-2020. The primary outcome was in-hospital mortality. A multivariable regression model was used to compare the outcomes. ResultsAmong 39,430 patients who received catheter-directed thrombolysis, 26,710 (76.8%) received SCDT and 8060 (23.2%) received USAT. The utilization of SCDT and USAT increased during the study years except for 2020. In-hospital mortality was lower among patients who received USAT (2.7% vs 3.8%; P = .04) compared with patients who received SCDT in the unadjusted analysis. On multivariable regression analysis, there was no difference in the incidence of in-hospital mortality between USAT and SCDT (odds ratio, 0.75; 95% CI, 0.52-1.08; P = .13). There were no significant differences between SCDT and USAT groups in the rate of bleeding adverse events including intracranial hemorrhage (0.6% vs 0.4%; P = .47), and nonintracranial major bleeding (4.2% vs 4.1%; P = .72). ConclusionsUltrasound-assisted thrombolysis was associated with similar in-hospital mortality and bleeding complications compared with SCDT for acute pulmonary embolism. Further studies are warranted to confirm evaluate the long-term outcomes with both modalities.

Total Hip Arthroplasty in Hemophilic Patients: are their Results Similar to those of Nonhemophilic Patients?

Total hip arthroplasty (THA) is the mainstay therapy for patients with terminal hemophilic arthropathy of the hip. However, the largest case series published between 2017 and 2023 in the literature on THA in patients with hemophilia have found a higher 1-year infection rate (8.1% versus 3.4%) in hemophilia patients than in the general population, a higher rate of in-hospital bleeding complications (38.7% versus 16.1%), a higher length of stay (6 days versus 3 days) and a higher 30-day readmission rate (22.6% versus 4.1%). Finally, a lower 5-year survival rate has also been observed in hemophilia patients than in the general population (91.9% versus 95.3%). In the last decade there have been dramatically positive improvements in implant designs and hematological treatment, and therefore it does not seem that THA in hemophilia is so far from that in osteoarthritic patients.

Systemic Coagulation Inflammation Index Associated With Bleeding in Acute Coronary Syndrome.

Assessment of the inflammatory component of acute coronary syndrome (ACS) and the degree of activation of the coagulation cascade may provide prognostic information. The systemic coagulation-inflammation index (SCI) assesses both inflammation and the coagulation system, and it has also been found to be associated with clinical outcomes. We investigated the relationship between SCI and in-hospital clinical events (acute kidney injury, cardiogenic shock, life-threatening arrhythmia, bleeding) and mortality. The study included 396 patients aged ≥18 yrs who were hospitalized with a diagnosis of ACS. The SCI was calculated using the formula: platelet count (103 / µl) X fibrinogen (g / l) / white blood cell (WBC) count (103 / µl). Patients were divided into two groups according to whether their SCI score was &gt;100 or &lt;100, and the relationship between clinical and laboratory characteristics was analyzed accordingly. The mean age of the patients was 61.4±12.2 years and 78.3 % (n=310) were male. The type of ACS was NSTEMI in 56.1 % (n=222). The responsible vessel was the left anterior descending artery (LAD) in 42.4 % of the patients (n=168). The mean SCI score was 97.5±47.1. WBC, neutrophil, and lymphocyte counts were higher in the SCI &lt;100 group, whereas fibrinogen, C-reactive protein, and platelet count were higher in the SCI &gt;100 group. Bleeding from any cause as an in-hospital complication was significantly higher in patients with SCI &gt;100 (p&lt;0.05). Other in-hospital events were not significantly associated with SCI (p&gt;0.05). Bleeding in ACS patients was significantly more common in the group with SCI &gt;100. Thus, SCI may be a useful parameter for predicting in-hospital bleeding complications in ACS. On the other hand, SCI was not associated with mortality and other in-hospital clinical events.

Abstract 15975: Cardiogenic Shock Teams Are Associated With Lower Mortality, Bleeding and Vascular Complications: A Systematic Review and Meta-Analysis

Introduction: Short-term mortality and morbidity associated with cardiogenic shock (CS) remains high. However, observational studies suggest that CS teams improve outcomes. Our aim is to systematically evaluate the outcomes associated with CS team use by performing a meta-analysis of the published literature. Methods: A comprehensive literature search of the PubMed/EMBASE, Cochrane databases and published abstracts was performed from inception to 06/01/2023 including studies comparing CS outcomes before and after the implementation of CS teams (excluding case reports and pediatric studies). Outcomes included in-hospital mortality, bleeding, vascular complications, use of temporary mechanical circulatory support (tMCS), and renal replacement therapy (RRT). Odds ratios (OR) with 95% confidence intervals (CI) were calculated using DerSimonian-Laird method. The Eggers test was used to assess publication bias; significant heterogeneity was considered if I 2 &gt; 75%. Results: Of 524 studies screened, 5 met inclusion criteria. This included 2,331 subjects (1091 managed with a CS team and 1270 without, mean age 62.5 years, 72.1% male, 41% non-white). The implementation of CS teams was associated with lower risk of in-hospital mortality ([OR] = 0.63 [95% CI 0.49 - 0.81]; I 2 =19%; p &lt; 0.001) (Fig), major bleeding (OR = 0.69 [95% CI 0.48 - 0.99]; I 2 =0%; p = 0.042), and vascular complications (OR = 0.61 [95% CI 0.40 - 0.93]; I 2 =0%; p = 0.021) compared to management without CS teams. There were no differences in tMCS (OR = 0.81 [95% CI 0.56 - 1.17]; I 2 =52%; p = 0.26) or RRT use (OR = 0.74 [95% CI 0.44 - 1.25]; I 2 =78%; p = 0.26). There was no evidence of publication bias (p &gt; 0.05). Conclusions: In this meta-analysis, CS team implementation was associated with lower in-hospital mortality, major bleeding, and vascular complications, but no difference in the use of tMCS or RRT. These findings support further prospective studies to assess the impact of CS teams in improving outcomes.

Abstract 16830: Feasibility and Safety of Intracardiac Echocardiography Guidance in Mitral Transcatheter Edge-to-Edge Repair: Analysis of the National Inpatient Sample Data From 2015 to 2020

Introduction: Data on use of ICE guidance in TEER procedure is limited to case reports and small case series. Our study aims to assess the feasibility, safety, utilization patterns and clinical outcomes of mitral TEER procedure with ICE guidance using a nationally representative real-world cohort of patients.Hypothesis: There is no difference between ICE-guided TEER and TEE-guided TEER in the clinical outcomes and complications. Methods: This study used the National Inpatient Sample database from quarter 4 of 2015 to 2020. We used a propensity-matched analysis and adjusted odds ratios for in-hospital outcomes/complications. A P value of &lt;0.05 was considered significant. Results: A total of 38,770 weighted cases of mitral TEER were identified. Of the included patients 665 patients underwent ICE-guided TEER while 38,105 had TEE-guided TEER. There were no differences in the in-hospital mortality between both groups (2.5% vs. 3.0%, p=0.58). Adjusted odds of in-hospital mortality (aOR 0.83, 95%CI [0.42-1.64]) were not significantly different. There were no differences in periprocedural complications including cardiac (aOR 0.85, 95%CI [0.54-1.35]), bleeding (aOR 1.45, 95%CI [0.93-2.33]), respiratory (aOR 0.88, 95%CI [0.61-1.25]), and renal (aOR 0.89, 95%CI [0.66-1.20]) complications between patients undergoing ICE-guided versus TEE-guided TEER. There was no difference in GI complications between both groups (aOR 1.11, 95%CI [0.46-2.70]). The adjusted length of stay was less among ICE-guided TEER (median: 1 vs. 2, p&lt;0.01) with no differences in costs of hospitalization ($137,312 vs. $153,773, p=0.06), Conclusions: In conclusion, ICE-guided mitral TEER is safe when compared with TEE guided TEER with no significant differences in in-hospital mortality, cardiac, bleeding, respiratory, and renal complications. The length of stay in ICE group is shorter as compared with the TEE group.

Percutaneous coronary intervention with Impella support with and without intra-aortic balloon in cardiogenic shock patients

ObjectiveTo assess the clinical characteristics and in-hospital bleeding complications and major adverse cardiac and cerebrovascular events (MACCE) associated with the use of Impella alone or the combination of an intra-aortic balloon pump (IABP) with Impella in cardiogenic shock (CS) patients undergoing percutaneous coronary intervention (PCI). MethodsAll CS patients who underwent PCI and were treated with an Impella mechanical circulatory support (MCS) device were identified. Patients were divided into two groups: having MCS support with Impella alone or with both, IABP and Impella simultaneously (dual MCS group). Bleeding complications were classified by a modified Bleeding Academic Research Consortium (BARC) classification. Major bleeding was defined as BARC≥3 bleeding. MACCE was the composite of in-hospital death, myocardial infarction, cerebrovascular events and major bleeding complications. ResultsBetween 2010 and 2018 a total of 101 patients were treated at six tertiary care New York hospitals with either Impella (n = 61) or dual MCS with Impella and IABP (n = 40). Clinical characteristics were similar for both groups. Dual MCS patients presented more often with a STEMI (77.5 % vs. 45.9 %, p = 0.002) and had left main coronary artery intervention (20.3 % vs. 8.6 %, p = 0.03). Major bleeding complications (69.4 % vs. 74.1 %, p = 0.62) and MACCE rates (80.6 % vs. 79.3 %, p = 0.88) were very high but similar in both groups, however access site bleeding complications were lower in patients treated with dual MCS. In-hospital mortality was 29.5 % for the Impella group and 25.0 % for the dual MCS group (p = 062). Access site bleeding complications were lower in in patients treated with dual MCS (5.0 % vs. 24.6 %, p = 0.01). ConclusionIn CS patients undergoing PCI with either the Impella device alone or with Impella and IABP, major bleeding complications and MACCE rates were high but not significantly different between the two groups. In hospital mortality was relatively low in both MCS groups despite the high-risk characteristics of these patients. Future studies should assess the risks and benefits of the simultaneous use of these two MCS in CS patients undergoing PCI.

EKOSTM in Octogenarians: The Safety and Efficacy of Ultrasound-Accelerated Catheter-Directed Thrombolysis in Elderly Patients with Intermediate-High-Risk Pulmonary Embolism.

Pulmonary embolism (PE) is a common cardiovascular disease. Elderly patients with acute PE have very high mortality rates. Data concerning the safety and effectiveness of ultrasound-accelerated thrombolysis (USAT) in this age group are lacking. Nineteen octogenarians with acute pulmonary embolism underwent USAT between August 2020 and February 2023 at two centres in Germany and were retrospectively analysed. The main efficacy measures were the right ventricle to left ventricle diameter (RV/LV) ratio, systolic right ventricle function, and invasive and echocardiographic measured systolic pulmonary artery pressure (sPAP). The main safety measures were in-hospital death and the bleeding rate according to the GUSTO bleeding score. USAT was associated with an improved RV/LV ratio (0.36 ± 0.29, p < 0.001), systolic right ventricle function (5.0 ± 3.8, p < 0.001), and systolic pulmonary artery pressure (sPAP) at 24 h after therapy (24.2 ± 11.2 mmHg and 19 ± 13.4 mmHg, p < 0.001). No in-hospital deaths or bleeding complications occurred. USAT with EKOSTM may be a safe and effective therapeutic option for octogenarians with acute pulmonary embolism.

Peripheral artery disease and extracorporeal membrane oxygenation: Examining a high-risk cohort over time.

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a resource-intensive approach for the management of refractory cardiogenic shock. Within this population exists a substantial cohort of patients with peripheral artery disease (PAD), which independently increases the risk of complications and all-cause mortality. We studied 10-year national trends of the impact of PAD among VA-ECMO recipients to better understand the prevalence of PAD and implications on outcomes in this vulnerable population. This 10-year retrospective, propensity score-matched study identified all adult patients (≥18) who underwent VA-ECMO between 2009 and 2018, from a large US database (National Inpatient Sample). Patients with an ICD diagnosis of PAD were identified. The primary endpoints of in-hospital mortality, bleeding complications and major limb loss (above- or below-knee amputation) were compared between patients with PAD to those without. A total of 6768 patients were identified, of which 342 (5.3%) had PAD. The median age at admission was significantly higher in PAD patients [64years vs. 55years; p < .01], as was male gender [71% vs. 64%; p < .01]. Patients with PAD had higher rates of smoking (38.9% vs. 23.3%), hypertension (71.1% vs. 50%), diabetes (37.4% vs. 27.0%), chronic kidney disease (30.1% vs. 18.0%), coronary artery disease (76.0% vs. 35.0%) and dyslipidemia (76.0% vs. 35.0); all p < .01. After propensity-matching 2:1 for comorbidities, PAD patients were found to have significantly greater overall complications, including in-hospital mortality, bleeding, surgical wound infections, pseudoaneurysms, and major adverse limb events [71.9% vs. 63.9%; p < .01]. Subgroup analysis revealed greater in-hospital mortality [62.2% vs. 55.3%; p < .05], major amputations [4.1% vs. 0.3%; p < .01] and blood transfusions [32.2% vs. 26.2%; p < .05] in PAD patients. Over 2014-2018, the non-PAD group demonstrated statistically discernable trends in a 51.1% decrease in overall complications and a 28.1% increase in survival to discharge (all p < .01). Over the same time period the PAD cohort experienced a modest, nonsignificant, decrease in complications [7.0%, p = .40] and a decrease in those surviving to discharge [47.1% vs. 40.5%, p = .91]. Patients with PAD on VA-ECMO are sicker at baseline and experience significantly greater major amputations and higher in-hospital mortality. They have not benefitted from the considerable decrease in complication rates and increase in survival to discharge over time as compared to their non-PAD counterparts. These findings demonstrate the substantial frailty of the PAD population within an already high-risk cohort, and highlight the need for better procedural approaches and innovative technologies.

Comparison of Body Mass Index (Four Categories) to In-Hospital Outcomes in Patients Who Underwent Transcatheter Aortic Valve Implantation

Although obesity is often associated with adverse outcomes in cardiovascular diseases, studies have demonstrated a beneficial effect on patients who underwent transcatheter aortic valve implantation (TAVI), coining the term "obesity paradox." We sought to determine if the obesity paradox is valid when patients are studied in body mass index (BMI) groups versus simplified classification of obese and nonobese. We examined the National Inpatient Sample database from 2016 to 2019 for all patients who underwent TAVI >18 years of age using the International Classification of Diseases, 10th edition procedure codes. Patients were grouped by BMI categories of underweight, overweight, obese, and morbidly obese. They were compared with normal-weight patients to assess the relative risk of in-hospital mortality, cardiogenic shock, ST-elevation myocardial infarction, bleeding complications requiring transfusions, and complete heart blocks requiring permanent pacemaker. A logistic regression model was constructed to account for potential confounders. Of the 221,000 patients who underwent TAVI, 42,315 patients with appropriate BMI designation were stratified into BMI groups. Compared to the normal-weight group, overweight, obese, and morbid-obese TAVI patients were associated with a lower risk of in-hospital mortality (relative risk [RR] 0.48, confidence interval [CI] 0.29 to 0.77, p <0.001), (RR 0.42, CI 0.28 to 0.63, p <0.001), (RR 0.49, CI 0.33 to 0.71, p <0.001 respectively), cardiogenic shock (RR 0.27, CI 0.20 to 0.38, p <0.001), (RR 0.21, CI 0.16 to 0.27, p <0.001), (RR 0.21, CI 0.16 to 0.26, p <0.001), and blood transfusions (RR 0.63, CI 0.50 to 0.79, p <0.001), (RR 0.47, CI 0.39 to 0.58, p <0.001), (RR 0.61, CI 0.51 to 0.74, p <0.001). This study indicated that obese patients were at a significantly lower risk of in-hospital mortality, cardiogenic shock, and bleeding complications requiring transfusions. In conclusion, our study supported the existence of the obesity paradox in TAVI patients.

Pregnancy-Associated Extracorporeal Membrane Oxygenation in the United States.

The use of extracorporeal membrane oxygenation (ECMO) therapy has increased in the adult population. Studies from the H1N1 influenza pandemic suggest that ECMO deployment in pregnancy is associated with favorable outcomes. With increasing numbers of pregnant women affected by COVID-19 (coronavirus disease 2019) and potentially requiring this life-saving therapy, we sought to compare comorbidities, costs, and outcomes between pregnancy- and nonpregnancy-associated ECMO therapy among reproductive-aged female patients. We used the 2013 to 2019 National Readmissions Database. Diagnosis and procedural coding were used to identify ECMO deployment, potential indications, comorbid conditions, and pregnancy outcomes. The primary outcome was in-hospital mortality during the patient's initial ECMO stay. Secondary outcomes included length of stay and hospital charges/costs, occurrence of thromboembolic or bleeding complications during ECMO hospitalization, and mortality and readmissions up to 330 days following ECMO stay. Univariate and multivariate regression models were used to model the associations between pregnancy status and outcomes. The sample included 324 pregnancy-associated hospitalizations and 3,805 nonpregnancy-associated hospitalizations, corresponding to national estimates of 665 and 7,653 over the study period, respectively. Pregnancy-associated ECMO had lower incidence of in-hospital death (adjusted odds ratio [aOR]: 0.56, 95% confidence interval [CI]: 0.41-0.75) and bleeding complications (aOR: 0.67, 95% CI: 0.49-0.93). Length of stay was significantly shorter (adjusted rate ratio (aRR): 0.86, 95% CI: 0.77-0.96) and total hospital costs were less (aRR: 0.83, 95% CI: 0.75-0.93). Differences in the incidence of thromboembolic events (aOR: 1.04, 95% CI: 0.78-1.38) were not statistically significant. Pregnancy-associated ECMO therapy had lower incidence of in-hospital death, bleeding complications, total inpatient cost, and length of stay when compared with nonpregnancy-associated ECMO therapy without increased thromboembolic complications. Pregnancy-associated ECMO therapy should be offered to eligible patients. · Pregnancy-related ECMO use was compared with nonpregnant use.. · Outcomes were equal or favored pregnancy-related deployment.. · These data may be useful when considering ECMO use in pregnancy..

Performance of the Academic Research Consortium High Bleeding Risk Criteria in Patients With ST-Segment Elevation Myocardial Infarction: A Single Center Study.

We assessed the ability of predicting mortality and total in-hospital bleeding and adverse outcomes by the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (pPCI). A total of 1441 STEMI patients were recruited: HBR group 354 (25%) patients and non-HBR group of 1087 (75%) patients. A total of 131 patients (9%) had a bleeding complication during hospitalization. The bleeding complications were also categorized according to other conventional bleeding scores. According to these conventional scores, all bleeding categories were associated with HBR. In univariate logistic regression analysis, female gender, diabetes mellitus, hypertension (HT) and HBR were associated with in-hospital bleeding. However, in multivariable analysis only HT (Odds Ratio [OR] 1.528, 95% CI 1.020-2.290; P = .040) and HBR (OR 1.612, 95% CI 1.075-2.428; P = .022) independently predicted total in-hospital bleeding complications. Hospital duration was longer and mortality rate was significantly higher in patients with HBR (OR 8.755, 95% CI 5.864-13.074; P < .01). The ARC-HBR criteria may predict in-hospital bleeding events and adverse outcomes in STEMI patients undergoing pPCI.

Dual Loading Antiplatelet Therapy in Patients With Acute Coronary Syndrome and High Bleeding Risk Undergoing Percutaneous Coronary Intervention: Findings From the Improving Care for Cardiovascular Disease in China Project.

ObjectiveLoading dose of dual antiplatelet therapy (LD) is supported by the guidelines for patients with acute coronary syndrome (ACS). However, limited data is provided in the series of high bleeding risk (HBR) patients with ACS and percutaneous coronary intervention (PCI).MethodsUsing data from the Improving Care for Cardiovascular Disease in China—Acute Coronary Syndrome registry, conducted between 2014 and 2019, we stratified all ACS patients with HBR and PCI according to LD used within 24 h of first medical contact or not. Inverse probability of treatment weighting (IPTW) and Cox proportional hazards model with hospital as random effect were used to analyze differences in in-hospital clinical outcomes: the primary efficacy endpoint was mortality, and the primary safety endpoint was bleeding.ResultsOf 21,654 evaluable patients 14,322 (66.2%) were treated with LD, and were on average older, less likely to have comorbidities and higher hemoglobin, more often treated GPI and anticoagulant during hospitalization than those without LD. After IPTW adjustment for baseline differences, LD was associated with significantly increased risk of in-hospital mortality [1.89 vs. 1.02%; hazard ratio (HR): 1.71 (95% confidence interval 1.12, 2.42); p < 0.001] and in-hospital bleeding [3.89 vs. 3.3%; HR: 1.25 (1.03, 1.53); p = 0.03].ConclusionsIn ACS patients with HBR, LD was associated with an increased risk of in-hospital mortality and bleeding complications after PCI. Dedicated randomized trials with contemporary ACS management are needed to confirm these findings.

Sex-Related Differences in Postoperative Outcomes After Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

Aortic stenosis is the most common valvular disease of the heart and is increasing in prevalence. Previous literature has found inferior outcomes for females undergoing surgical aortic valve replacement, while recent investigations have found equivalent or superior outcomes for females undergoing transcatheter aortic valve replacement (TAVR). PubMed and Medline were systematically searched for articles published from January 1, 2010, to April 30, 2021, for retrospective and prospective studies comparing outcomes between males and females undergoing TAVR. One thousand one hundred eighty titles and abstracts were screened, and 28 were included in this review. Risk of bias was assessed using questions derived from the ROBINS-I tool and previous literature. The data were compiled and analyzed using the RevMan 5.4 software. The results of this review confirm the previously published literature and have found rates of acute kidney injury ( P = 0.05) and postoperative pacemaker insertion ( P < 0.00001) favoring females and in-hospital mortality ( P = 0.04), stroke ( P < 0.00001), bleeding complications ( P < 0.00001), and vascular complications ( P < 0.00001) favoring males. The previously published literature has demonstrated consistently inferior outcomes for females undergoing heart valve surgery when compared to males. However, contemporary literature investigating sex differences after TAVR has found comparable outcomes for females. While the postoperative outcomes after surgical aortic valve replacement and TAVR are well established, the causal factors are still unidentified. Future studies utilizing matching based on preoperative characteristics and follow-up including collection of postoperative ventricular remodeling and prosthetic valve performance data will aid in elucidating the causal factors impacting outcomes for males and females after TAVR.

Pron�stico de pacientes nonagenarios tras implante percut�neo de v�lvula a�rtica

Introduction and objectives: Nonagenarians are a fast-growing age group among cardiovascular patients, especially with aortic stenosis, but data about their prognosis after transcatheter aortic valve implantation (TAVI) is scarce. The objective of our study is to analyze the baseline characteristics of nonagenarians treated with TAVI and determine whether age 65; 90 years is associated with a worse prognosis compared to non-nonagenarian patients. Methods: We included all patients 65;75 years enrolled in the multicenter prospective Spanish TAVI registry between 2009 and 2018. Patients < 75 years were excluded. Results: A total of 8073 elderly patients (65; 75 years) from 46 Spanish centers were enrolled in the Spanish TAVI registry; 7686 were between 65; 75 and < 90 years old (95.2%), and 387 were nonagenarian patients (4.79%). A gradual increase of nonagenarians was observed. The transfemoral access was used in 91.6% of the cases, predominantly among the nonagenarian patients (91.4% frente a 95.1%, P = .01). Nonagenarians were more likely to die during their hospital stay (4.3% frente a 7.0% among nonagenarians, P = .01). However, no difference was seen in the all-cause mortality rates reported at the 1-year follow-up (8.8% frente a 11.3%, P = .07). In the multivariate analysis, age 65; 90 years was not independently associated with a higher adjusted all-cause mortality rate (HR, 1.37, 95%CI, 0.91- 1.97, P = .14). The baseline creatinine levels, and the in-hospital bleeding complications were all associated with a worse long-term prognosis in nonagenarians treated with TAVI. Conclusions: Nonagenarians are a very high-risk and growing population with severe AS in whom TAVI may be a safe and effective team is mandatory to achieve maximum efficiency in this population where baseline kidney function and bleeding complications may determine the long-term prognosis after TAVI.

Impact of Comorbidity Burden on Cardiac Implantable Electronic Devices Outcomes.

Background:There is limited data on the impact of comorbidity burden on clinical outcomes of patients undergoing cardiac implantable electronic devices (CIED) implantation.Objectives:Our aim was to assess trends in CIED implantations and explore the relationship between comorbidity burden and outcomes in patients undergoing de novo implantations.Methods:Using the National Inpatient Sample database from 2000 to 2014, we identified adults ⩾18 years undergoing de novo CIED procedures. Comorbidity burden was assessed by Charlson comorbidity Index (CCI), and patients were classified into 4 categories based on their CCI scores (CCI = 0, CCI = 1, CCI = 2, CCI ⩾3). Annual implantation trends were evaluated. Logistic regression was conducted to measure the association between categorized comorbidity burden and outcomes.Results:A total of 3 103 796 de-novo CIED discharge records were identified from the NIS database. About 22.4% had a CCI score of 0, 28.2% had a CCI score of 1, 22% had a CCI score of 2, and 27.4 % had a CCI score ⩾3. Annual de-novo CIED implantations peaked in 2006 and declined steadily from 2010 to 2014. Compared to CCI 0, CCI ⩾3 was independently associated with increased odds of in-hospital mortality, bleeding, pericardial, and cardiac complications (all P < .05). Length of stay and hospital charges increased with increasing comorbidity burden.Conclusions:CCI is a significant predictor of adverse outcomes after CIED implantation. Therefore, comorbidity burden needs to be considered in the decision-making process for CIED implant candidates.

Frequency, Etiology, and Impact of Unplanned Repeat Coronary Angiography After ST-Elevation Myocardial Infarction

Unplanned repeat coronary angiography (CAG) after balloon angioplasty for ST-elevation myocardial infarction (STEMI) was common before the advent of coronary stenting. Limited data are available regarding the role of unplanned repeat CAG in contemporary percutaneous coronary intervention (PCI) for STEMI. Therefore, we analyzed a large, 2-center prospective STEMI registry (January 2011 to June 2020) stratified by the presence or absence of unplanned repeat CAG during index hospitalization. Patients with planned CAG for staged PCI or experimental drug administration were excluded. Among 3,637 patients with STEMI, 130 underwent unplanned repeat CAG (3.6%) during index hospitalization. These patients were more likely to have cardiogenic shock (16% vs 9.8%, p=0.021), left anterior descending culprit (44% vs 31%, p <0.001), lower left ventricular ejection fraction (45% vs 52%, p <0.001), and higher peak troponin levels (22 vs 8ng/ml, p <0.001) than those without repeat CAG. At repeat CAG, 80 patients had a patent stent (62%) including 65 requiring no further intervention (50%) and 15 who underwent intervention on a nonculprit lesion (12%). Only 32 patients had stent thrombosis (25%). Repeat CAG was associated with a higher incidence of recurrent MI (19% vs 0%, p <0.001) and major bleeding (12% vs 4.5%, p <0.001), yet similar in-hospital mortality (7% vs 6.4%, p=0.93) than those without repeat CAG. In conclusion, in the era of contemporary PCI for STEMI, unplanned repeat CAG during index hospitalization was infrequent and more commonly observed in patients with left anterior descending culprit in the presence of significant left ventricular dysfunction or shock and was associated with higher in-hospital recurrent myocardial infarction and major bleeding complications.

Abstract 13630: Impella Alone vs Intra-Aortic Balloon Pump Plus Impella in Cardiogenic Shock Patients Undergoing Percutaneous Coronary Intervention: Two Are Better Than One?

Background: Cardiogenic shock (CS) is still one of the leading causes of cardiovascular mortality despite advances in therapeutic options. Aggressive management with percutaneous coronary intervention (PCI) and the use of mechanical circulatory support (MCS) devices has been associated with improved survival. The most frequently used MCS devices are the intra-aortic balloon pump (IABP) and the axial flow pump (Impella). Aim: To assess in-hospital bleeding complications and outcomes in CS patients treated with either Impella alone vs. IABP combined with Impella while undergoing PCI. Methods: Between 12/2010 and 03/2018 a total of 62 CS patients underwent PCI with Impella (n = 33) or IABP and Impella combined (n =29) at 6 hospitals in our system. Bleeding complications were classified according to the Bleeding Academic Research Consortium (BARC). BARC Type 4 (coronary bypass grafting-related) and Type 5 (fatal) bleeding events were excluded. Chi square was used for categorical values and t-test for continuous variables. P&lt;0.05 was considered significant. Results: Clinical characteristics, bleeding complications and in-hospital outcomes are shown in the Table. There was a trend towards a higher percentage of STEMI patients treated with both devices. There was a significant higher rate of BARC 2 bleeding events in patients treated with both devices (6% v 28%, p=0.02) and a higher rate of BARC 3 bleeding events in patients treated with Impella alone (70% v 38%, p=0.01). Both groups had high rates of acute kidney failure and acute neurological events. Conclusions: In a limited series of CS patients undergoing PCI: 1) the use of Impella alone was associated with a significantly higher rate of BARC 3 major bleeding events; 2) patients treated simultaneously with both devices had a significantly higher rate of BARC 2 bleeding events; and 3) in-hospital acute neurological events and mortality rates were very high but similar in both groups.

Abstract 13711: End-Stage Renal Failure and Bleeding Complications in Patients Undergoing Percutaneous Coronary Intervention: A Contemporary System-Wide Analysis

Background: Patients with chronic kidney disease (CKD) and significant impairment of kidney function (eGFR of 15-29 ml/min/1.73m 2 ) ( CKD Stage G4 ) and patients with an eGFR of &lt;15 ml/min/1.73m 2 , or who require some form of dialysis (CKD Stage G5) are often referred to as end-stage renal failure (ESRF) . These patients tend to have more severe coronary disease and worse outcomes following percutaneous coronary intervention (PCI). Aim: To compare the in-hospital bleeding complications and major adverse cardiac and cerebrovascular (MACCE) events in CKD Stage G4 with CKD Stage G5 (dialysis) patients undergoing PCI. Methods: Between 12/2010 and 03/2018 a total of 1,534 ESRF patients underwent PCI at 6 hospitals in our system. Patients were divided into two groups, those with an CKD Stage G4 (n=954) and those on dialysis CKD Stage G5 (n=580). Bleeding complications were classified according to Bleeding Academic Research Consortium (BARC). BARC 4 (coronary bypass grafting-related bleed) and BARC 5 (fatal) bleeding events were excluded. Chi square statistical analysis was used for categorical values and t-test for continuous variables. P&lt;0.05 was considered significant. Results: Clinical characteristics, bleeding complications, and in-hospital outcomes are shown in the Table. Patients with CKD Stage G4 were older, had a higher percentage of female patients and more often presented with a STEMI when compared with CKD Stage 5 (dialysis) patients. Bleeding (BARC ≤2 and 3) rates were similar between the two groups. Although mortality and MACCE (Death/MI/Stroke/Major Bleed) rates were numerically higher in Stage G4 patients, it did not reach statistical significance. Conclusion: In a contemporary analysis of ESRF patients undergoing PCI, CKD Stage G4 and CKD Stage G5 (dialysis) patients had low and comparable rates of moderate and severe bleeding complications. Furthermore, in hospital MACCE rates were low and similar in these two groups.