Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia.

BACKGROUND: A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level. METHODS: In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days. RESULTS: A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49). CONCLUSIONS: In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).

Restrictive Versus Liberal Transfusion in Patients with Type 1 or Type 2 Myocardial Infarction: A Prespecified Analysis of the Myocardial Ischemia and Transfusion (MINT) Trial.

BACKGROUND: The MINT trial raised concern for harm from a restrictive versus liberal transfusion strategy in patients with acute myocardial infarction (MI) and anemia. Type 1 and type 2 MI are distinct pathophysiological entities that may respond differently to blood transfusion. This analysis sought to determine if the effects of transfusion varied among patients with a type 1 or a type 2 MI and anemia. We hypothesized that the liberal transfusion strategy would be of greater benefit in type 2 than in type 1 MI. METHODS: We compared rates of death or MI at 30 days in patients with type 1 (n=1460) and type 2 (n=1955) MI and anemia who were randomly allocated to a restrictive (threshold of 7 to 8 g/dL) or a liberal (threshold of 10 g/dL) transfusion strategy. RESULTS: The primary outcome of death or MI was observed in 16% of type 1 MI and 15.4% of type 2 MI patients. The rate of death or MI was higher in patients with type 1 MI randomized to a restrictive (18.2%) versus liberal (13.2%) transfusion strategy (RR 1.32, 95% CI 1.04 - 1.67) with no difference observed between the restrictive (15.8% ) and liberal (15.1% ) transfusion strategies in patients with type 2 MI (RR 1.05 95% CI 0.85-1.29). The test for a differential effect of transfusion strategy by MI type was not statistically significant (P-interaction = 0.16). CONCLUSIONS: The concern for harm with a restrictive transfusion strategy in patients with acute MI and anemia raised in the MINT primary outcome manuscript may be more apparent in patients with type 1 than type 2 MI. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number, NCT02981407.

AABB recommends restrictive RBC transfusions for hospitalized adults and children.

SOURCE CITATION: Carson JL, Stanworth SJ, Guyatt G, et al. Red blood cell transfusion: 2023 AABB international guidelines. JAMA. 2023;330:1892-1902. 37824153.

Effect of Four Hemoglobin Transfusion Threshold Strategies in Patients With Acute Myocardial Infarction and Anemia : A Target Trial Emulation Using MINT Trial Data.

BACKGROUND: The optimal hemoglobin threshold to guide red blood cell (RBC) transfusion for patients with acute myocardial infarction (MI) and anemia is uncertain. OBJECTIVE: To estimate the efficacy of 4 individual hemoglobin thresholds (<10 g/dL [<100 g/L], <9 g/dL [<90 g/L], <8 g/dL [<80 g/L], and <7 g/dL [<70 g/L]) to guide transfusion in patients with acute MI and anemia. DESIGN: Prespecified secondary analysis of the MINT (Myocardial Ischemia and Transfusion) trial using target trial emulation methods. (ClinicalTrials.gov: NCT02981407). SETTING: 144 clinical sites in 6 countries. PARTICIPANTS: 3492 MINT trial participants with acute MI and a hemoglobin level below 10 g/dL. INTERVENTION: Four transfusion strategies to maintain patients' hemoglobin concentrations at or above thresholds of 10, 9, 8, or 7 g/dL. Protocol exceptions were permitted for specified adverse clinical events. MEASUREMENTS: Data from the MINT trial were leveraged to emulate 4 transfusion strategies and estimate per protocol effects on the composite outcome of 30-day death or recurrent MI (death/MI) and 30-day death using inverse probability weighting. RESULTS: The 30-day risk for death/MI was 14.8% (95% CI, 11.8% to 18.4%) for a <10-g/dL strategy, 15.1% (CI, 11.7% to 18.2%) for a <9-g/dL strategy, 15.9% (CI, 12.4% to 19.0%) for a <8-g/dL strategy, and 18.3% (CI, 14.6% to 22.0%) for a <7-g/dL strategy. Absolute risk differences and risk ratios relative to the <10-g/dL strategy for 30-day death/MI increased as thresholds decreased, although 95% CIs were wide. Findings were similar and imprecise for 30-day death. LIMITATION: Unmeasured confounding may have persisted despite adjustment. CONCLUSION: The 30-day risks for death/MI and death among patients with acute MI and anemia seem to increase progressively with lower hemoglobin concentration thresholds for transfusion. However, the imprecision around estimates from this target trial analysis precludes definitive conclusions about individual hemoglobin thresholds. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.

Anticoagulation Medications, Monitoring, and Outcomes in Patients with Cardiogenic Shock Requiring Temporary Mechanical Circulatory Support.

Cardiogenic shock (CS) is a syndrome of low cardiac output resulting in critical end-organ hypoperfusion and hypoxia. The mainstay of management involves optimizing preload, afterload and contractility. In medically refractory cases, temporary percutaneous mechanical support (MCS) is used as a bridge to recovery, surgical ventricular assist device, or transplant. Anticoagulation is recommended to prevent device-related thromboembolism. However, MCS can be fraught with hemorrhagic complications, compounded by incident multisystem organ failure often complicating CS. Currently, there are limited data on optimal anticoagulation strategies that balance the risk of bleeding and thrombosis, with most centers adopting local antithrombotic stewardship practices. In this review, we detail anticoagulation protocols, including anticoagulation agents, therapeutic monitoring, and complication mitigation in CS requiring MCS. This review is intended to provide an evidence-based framework in this population at high risk for in-hospital bleeding and mortality.

Multidisciplinary Care Teams in Acute Cardiovascular Care: A Review of Composition, Logistics, Outcomes, Training, and Future Directions.

As cardiovascular care continues to advance and with an aging population with higher comorbidities, the epidemiology of the cardiac intensive care unit has undergone a paradigm shift. There has been increasing emphasis on the development of multidisciplinary teams (MDTs) for providing holistic care to complex critically ill patients, analogous to heart teams for chronic cardiovascular care. Outside of cardiovascular medicine, MDTs in critical care medicine focus on implementation of guideline-directed care, prevention of iatrogenic harm, communication with patients and families, point-of-care decision-making, and the development of care plans. MDTs in acute cardiovascular care include physicians from cardiovascular medicine, critical care medicine, interventional cardiology, cardiac surgery, and advanced heart failure, in addition to nonphysician team members. In this document, we seek to describe the changes in patients in the cardiac intensive care unit, health care delivery, composition, logistics, outcomes, training, and future directions for MDTs involved in acute cardiovascular care. As a part of the comprehensive review, we performed a scoping of concepts of MDTs, acute hospital care, and cardiovascular conditions and procedures.

Association of social support and health status outcomes in peripheral artery disease.

OBJECTIVE: A critical goal in the care of patients with peripheral artery disease (PAD) is to optimize their health status; that is, their symptoms, function, and quality of life. Social support has been proposed to be a predictor of disease-specific health status in patients with PAD. However, the prevalence of low perceived social support, the association with health status outcomes, and the interaction with other biopsychosocial variables, is unknown. Our aim was to assess the association of baseline perceived social support with health status at 12 months in patients with PAD. METHODS: The Patient-Centered Outcomes Related Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) registry, which enrolled patients with PAD in the United States, the Netherlands, and Australia from 2011 to 2015, was used. Perceived social support was assessed at baseline with the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Social Support Inventory (ESSI), and disease-specific (Peripheral Artery Disease Questionnaire [PAQ]) and generic health status (Euro-Quality of Life Visual Analog Scale [VAS] and EQ-5D-3L Index) questionnaires were assessed at baseline and 12 months. Low social support was defined as a score of ≤3 on two items and an ESSI score of ≤18. A hierarchical mixed level linear regression model adjusting for biopsychosocial variables was used to assess the association between low perceived social support and the ESSI score with health status at 12 months. RESULTS: A total of 949 patients were included (mean age, 67.64 ± 9.32 years; 37.9% female), with low social support being present in 18.2%. Patients with low social support were more likely to not be married or to be living alone (50.0% vs 77.5%; P < .001); have more financial constraints; have more depressive, stress, and anxiety symptoms; and have lower disease-specific and generic health status at baseline and at 12 months. In the unadjusted model, low social support was associated with a -7.02 (95% confidence interval [CI], -10.97 to -3.07) point reduction in the PAQ, -7.43 (95% CI, -10.33 to -4.54) in the VAS, and -0.06 (95% CI, -0.09 to -0.03) in the EQ-5D-3L Index. Adjusting for biopsychosocial factors minimally attenuated these associations (PAQ: -6.52; 95% CI, -10.55 to -2.49; P = .002; VAS: -5.39; 95% CI, 8.36 to -2.42; P < .001; EQ-5D-3L Index: -0.04; 95% CI, -0.07 to 0.01; P = .022). The ESSI per-point score was associated with a decrease of 0.51 (95% CI, 0.18-0.85; P = .003) in PAQ and 0.46 (95% CI, 0.12-0.61; P = .004) in the VAS. CONCLUSIONS: Among patients with PAD, low social support was frequent and associated with a lower health status at 1 year independent of other biopsychosocial variables. Improving social support could improve health status and outcomes in PAD.

Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial.

Importance: Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States. Objective: To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention. Design, Setting, and Participants: AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023. Interventions: Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon. Main Outcomes and Measures: The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority. Results: Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively. Conclusions and Relevance: Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis. Trial Registration: ClinicalTrials.gov Identifier: NCT04647253.

Rationale and design for the myocardial ischemia and transfusion (MINT) randomized clinical trial.

BACKGROUND: Accumulating evidence from clinical trials suggests that a lower (restrictive) hemoglobin threshold (<8 g/dL) for red blood cell (RBC) transfusion, compared with a higher (liberal) threshold (≥10 g/dL) is safe. However, in anemic patients with acute myocardial infarction (MI), maintaining a higher hemoglobin level may increase oxygen delivery to vulnerable myocardium resulting in improved clinical outcomes. Conversely, RBC transfusion may result in increased blood viscosity, vascular inflammation, and reduction in available nitric oxide resulting in worse clinical outcomes. We hypothesize that a liberal transfusion strategy would improve clinical outcomes as compared to a more restrictive strategy. METHODS: We will enroll 3500 patients with acute MI (type 1, 2, 4b or 4c) as defined by the Third Universal Definition of MI and a hemoglobin <10 g/dL at 144 centers in the United States, Canada, France, Brazil, New Zealand, and Australia. We randomly assign trial participants to a liberal or restrictive transfusion strategy. Participants assigned to the liberal strategy receive transfusion of RBCs sufficient to raise their hemoglobin to at least 10 g/dL. Participants assigned to the restrictive strategy are permitted to receive transfusion of RBCs if the hemoglobin falls below 8 g/dL or for persistent angina despite medical therapy. We will contact each participant at 30 days to assess clinical outcomes and at 180 days to ascertain vital status. The primary end point is a composite of all-cause death or recurrent MI through 30 days following randomization. Secondary end points include all-cause mortality at 30 days, recurrent adjudicated MI, and the composite outcome of all-cause mortality, nonfatal recurrent MI, ischemia driven unscheduled coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), or readmission to the hospital for ischemic cardiac diagnosis within 30 days. The trial will assess multiple tertiary end points. CONCLUSIONS: The MINT trial will inform RBC transfusion practice in patients with acute MI.

Coronary Artery Disease and Revascularization in Patients Undergoing Transcatheter Aortic Valve Replacement.

Coronary artery disease (CAD) and aortic stenosis share similar risk factors and underlying pathophysiology. Up to half of the patient population undergoing work-up for aortic valve replacement have underlying CAD, which can affect outcomes in patients with more severe disease. As the indications for transcatheter aortic valve replacement (TAVR) have expanded to intermediate and now low risk patients, the optimal management of CAD in this patient population still needs to be determined. This includes both pre-TAVR evaluation for CAD as well as indications for revascularization in patients undergoing TAVR. There is also limited data on coronary interventions after TAVR, including the incidence, feasibility and outcomes of patients undergoing percutaneous coronary intervention (PCI) after TAVR. This review provides an updated report of the current literature on CAD in TAVR patients, focusing on its prevalence, impact on outcomes, timing of revascularization and potential challenges with coronary interventions post-TAVR.

Three versus 12-month dual antiplatelet therapy duration in patients with acute coronary syndrome undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials.

INTRODUCTION: The American Heart Association/American College of Cardiology guidelines on dual antiplatelet therapy (DAPT) recommend at least 12 months of a P2Y12 inhibitor and low dose aspirin in patients with an acute coronary syndrome (ACS) treated with a stent. Since that recommendation, several randomized controlled trials (RCTs) have studied an abbreviated duration of DAPT in ACS. Therefore, we sought to perform a meta-analysis of RCTs comparing 3- versus 12-month DAPT in patients presenting with ACS undergoing percutaneous coronary intervention (PCI). METHODS: PubMed, Embase, and Cochrane Central databases were searched until July 31, 2022, for RCTs comparing 3- versus 12-month DAPT in patients with ACS undergoing PCI. Outcomes assessed were major adverse cardiovascular events (MACE), cardiovascular mortality, all-cause mortality, myocardial infarction (MI), stent thrombosis (ST) and bleeding. A random-effects model was used to calculate pooled relative risk (RR) and 95% confidence intervals (CI). RESULTS: We included 5 trials comprising 16,781 patients with an ACS that underwent PCI. There was no significant difference in MACE (RR: 0.92; 95% CI: 0.76-1.11), cardiovascular mortality (RR: 1.26; 95% CI: 0.38-4.17), or all-cause mortality (RR: 0.92; 95% CI: 0.48-1.77) between the 2 groups. In addition, there was no difference in rates of MI (RR: 0.98; 95% CI: 0.74-1.30), or ST (RR: 1.30; 95% CI: 0.55-3.05) between 3- and 12-month DAPT. However, compared with 12-month DAPT, 3-month DAPT significantly reduced risk of major bleeding (RR: 0.53; 95% CI: 0.43-0.64). CONCLUSIONS: In patients with ACS undergoing PCI, 3-month DAPT reduced risk of bleeding without evidence of harm.

Sex-related differences in the trends and outcomes of trans-septal transcatheter mitral valve replacement: Insights from the National Readmissions Database.

BACKGROUND: There is a paucity of data regarding the sex-related differences in the trends and outcomes of trans-septal transcatheter mitral valve replacement (TS-TMVR). METHODS: The Nationwide Readmissions Database (2015-2018) was queried for admissions for TS-TMVR. Propensity matched analysis was conducted to compare outcomes with hospitalizations for TS-TMVR among women versus men. The main study outcome was in-hospital mortality. RESULTS: Our final analysis included 2063 hospitalizations for TS-TMVR; of whom, 58.1% were women. The proportion of women among those undergoing TS-TMVR increased from 50% in 2015 to 60.2% in 2018 (Ptrend = 0.04). Compared with men, women undergoing TS-TMVR were slightly younger, and had a distinct profile of comorbidities. After matching, there was no significant difference in in-hospital mortality among women versus men undergoing TS-TMVR (7.8% vs. 6.1%, OR = 1.30; 95% CI: 0.79-2.13). Subgroup analyzes showed an interaction toward higher mortality with women versus men among patients with CKD (Pinteraction = 0.07). There were no significant differences between women and men in in-hospital complications or length of stay after TS-TMVR. Compared with men, women undergoing TS-TMVR were more likely to be discharged to a nursing facility (17.7% vs. 11.5%, p = 0.01) and had higher rates of 30-day readmissions (22.4% vs. 13.6%, p = 0.01). CONCLUSION: This nationwide analysis showed an increase in the proportion of women among patients undergoing TS-TMVR during the study years. There were no differences in in-hospital mortality, in-hospital complications, or length of stay between both sexes following TS-TMVR. Women were more likely to be discharged to nursing facilities and had higher rates of readmission at 30 days even after propensity matching.

Early versus late discharge after transcatheter aortic valve replacement and readmissions for permanent pacemaker implantation.

OBJECTIVE: To examine the rate of readmission for permanent pacemaker (PPM) implantation with early versus late discharge after transcatheter aortic valve replacement (TAVR). BACKGROUND: There is a current trend toward early discharge after TAVR. However, paucity of data exists on the impact of such practice on readmissions for PPM implantation. METHODS: The Nationwide Readmission Database 2016-2018 was queried for all hospitalizations where patients underwent TAVR. Hospitalizations were stratified into early (Days 0 and 1) versus late (≥Day 2) discharge groups. Observations in which PPM was required in the index admission were excluded. Multivariable regression analyses involving patient- and hospital-related variables were utilized. The primary outcome was 90-day readmission for PPM implantation. RESULTS: The final analysis included 68,482 TAVR hospitalizations, 20,261 (29.6%) with early versus 48,221 (70.4%) with late discharge. Early discharge after TAVR increased over the study period (16.2% in 2016 vs. 37.9% in 2018, Ptrend < 0.01). Nevertheless, 90-day readmission for PPM implantation remained stable (1.8% in 2016 vs. 2.0% in 2018, Ptrend = 0.32). The 90-day readmission rate for PPM implantation (2.0% vs. 1.8%; adjusted odds ratio: 1.15; 95% confidence interval: 0.95-1.39; p = 0.15) and median time-to-readmission (5 days [interquartile range, IQR 3-9] vs. 5 days [IQR 3-14], p = 0.92) were similar with early versus late discharge. Similar rates were observed regardless of whether readmission was elective versus not. Early discharge was associated with lower hospitalization cost ($39,990 ± $13,681 vs. $46,750 ± $18,218, p < 0.01) compared with late discharge. CONCLUSION: In patients who did not require PPM during the index TAVR hospitalization, the rate of readmission for PPM implantation was similar with early versus late discharge.

Impact of sex on outcomes of percutaneous coronary intervention for chronic total occlusion: A meta-analysis.

BACKGROUND: Women are underrepresented in chronic total occlusion (CTO) trials and little is known about sex differences in the outcomes of CTO percutaneous coronary intervention (PCI). This meta-analysis aims to compare the outcomes of CTO PCI in males and females. METHODS: A comprehensive search of PubMed, EMBASE, Cochrane, Web of Science, and Google Scholar was performed for studies comparing outcomes of CTO PCI in females versus males from inception to January 26, 2021. The current statistical analysis was performed using STATA version 15.1 software (Stata Corporation, TX); P < 0.05 indicated statistical significance. RESULTS: Fourteen observational studies were included in the analysis with 75% males and 25% females. The mean age was 64.47 ± 10.5 years and 68.98 ± 9.5 years for males and females, respectively. The median follow-up duration was 2.4 years. Males had a higher Japanese-CTO (J-CTO) score compared with females (MD = -0.17; 95% CI: -0.25 to -0.10). Females had statistically higher success rates of CTO PCI (RR = 1.03; 95% CI: 1.01 to1.05), required less contrast volume (MD = -18.64: 95% CI: -30.89 to -6.39) and fluoroscopy time (MD = -9.12; 95% CI: -16.90 to -1.34) compared with males. There was no statistical difference in in-hospital (RR = 1.50; 95% CI: 0.73 to 3.09) or longer term (≥6 months) all-cause mortality (RR = 1.10; 95% CI: 0.86 to 1.42) between the two groups. CONCLUSIONS: CTO PCI is feasible and safe in female patients with comparable outcomes in female versus male patients.

Outcomes of rotational atherectomy followed by cutting balloon versus plain balloon before drug-eluting stent implantation for calcified coronary lesions: A meta-analysis.

OBJECTIVE: The aim of this study is to compare outcomes of rotational atherectomy and cutting balloon (RACB) versus rotational atherectomy and plain balloon (RAPB) before drug-eluting stent (DES) implantation in calcified coronary lesions. METHODS: Randomized controlled trials (RCT) and observational studies comparing RACB with RAPB were identified through a systematic search of published literature across multiple databases. Random effect meta-analysis was performed to compare the outcome between the two groups. RESULTS: Four studies were included in the meta-analysis (three observational and one RCT) involving a total of 315 patients. 166 patients had RACB, and 149 patients had RAPB before DES placement with a median follow-up of 11.5 months. Compared with patients who had RAPB there was no difference in MACE (composite of death, myocardial infarction, and target vessel revascularization) (odds ratio [OR]: 0.74; 95% confidence interval [CI]: 0.25-2.18], slow flow/no reflow (OR: 0.71; 95% CI: 0.23-2.16), all-cause mortality (OR: 2.02; 95% CI: 0.28-14.60), and device success rate (OR: 1.79; 95% CI: 0.28-11.18) in the RACB approach. There was a benefit towards less target lesion revascularization in the RACB group; however, this outcome was reported in two studies (OR: 0.29; 95% CI: 0.08-0.99). On meta-regression there was no association between age, sex, diabetes, or lesion location with MACE and all-cause mortality. The studies were homogenous across all outcomes. CONCLUSION: RACB, as compared with RAPB, had a similar risk of MACE, all-cause mortality, device success, and complication, but a lower risk of target lesion revascularization.

Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis.

BACKGROUND: Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. STUDY DESIGN: AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. CONCLUSION: This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

Readmission following urgent transcatheter aortic valve implantation versus urgent balloon aortic valvuloplasty in patients with decompensated heart failure or cardiogenic shock.

BACKGROUND: Urgent transcatheter aortic valve implantation (TAVI) is a feasible option for aortic stenosis (AS) patients with decompensated heart failure (HF) and cardiogenic shock (CS) as compared to the more traditional urgent balloon aortic valvuloplasty (BAV). OBJECTIVES: We conducted a retrospective analysis to compare risk and cause of readmission in these two high-risk groups. METHODS: Nationwide Readmission Database (NRD) 2011-2014 was retrospectively analyzed to identify patients with AS having either urgent TAVI or urgent BAV using appropriate ICD-9 codes. Propensity scores were used to match patients with urgent TAVI as compared to patients with urgent BAV. Statistical analysis was performed using the Stata 15.1 software. RESULTS: We identified a weighted sample of 6,670 patients with urgent BAV and 6,964 patients with urgent TAVI. The all-cause 30- and 90-day readmission was lower in the urgent TAVI group compared to urgent BAV (15.4 vs. 22.5%, (aHR): 0.92 [0.90-0.95] p < .001). 30-day readmission due to CV cause and HF was also lower in the urgent TAVI group (aHR, 0.93: p < .001 and aHR, 0.98: p = .040, respectively). The 30-day gastrointestinal (GI) bleed readmission rate was three times higher in urgent TAVI group (aHR, 3.00:95% CI (1.23-7.33), p = .016), but was not statistically significant at 90-days. Cardiac causes of readmission were the predominant cause of readmission in both groups, but more pronounced in urgent BAV group (60.3 vs. 40.5%, p < .001). CONCLUSION: Urgent TAVI appears beneficial in patients with AS and decompensated HF or CS driven by roughly 10 and 25% reductions in overall readmissions at 30 and 90 days, and marked reductions in reintervention, although offset partially by higher risk of readmission due to GI bleeding at 30 days.

30-day readmission following urgent and elective transcatheter aortic valve replacement: A Nationwide Readmission Database analysis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is being increasingly used for decompensated severe symptomatic aortic stenosis. Data on urgent and elective TAVR readmission is scarce in the literature. Here, we have performed a retrospective cohort study with the Nationwide Readmission Database of 2016 to identify the rate of 30-day all-cause readmission, common causes of readmission, and distribution of morbidity in index admission and readmission after urgent and elective TAVR. METHODS: We used International Classification of Diseases, Tenth Revision codes (02R.F38H, 02R.F38Z, 02R.F48Z) for identification of all TAVR procedures done in 2016 in patients >18 years old. We found 8379 patients who underwent urgent TAVR and 32,006 patients who underwent elective TAVR in 2016. RESULT: The mean age of patients undergoing urgent TAVR was 79 ± 9.97 years with 44.6% women. The mean age of patients undergoing elective TAVR was 80.7 ± 8.25 years with 46.2% women. We found the 30-day all-cause readmission rate of 15.5% and 9.5% in patients undergoing urgent and elective TAVR, respectively (p < 0.001). The cardiac cause was the predominant cause of readmission in both groups (43.77% vs. 42.11%, p = 0.57), followed by pulmonary cause, gastrointestinal (GI) cause, and renal cause. Among cardiac causes, congestive heart failure (CHF) was predominant cause of readmission and was similar in both groups (18.73 in urgent TAVR vs. 15.73 in elective TAVR, p = 0.12). CONCLUSION: We found that the all-cause 30-day readmission rate was higher in patients who had undergone urgent TAVR. Further studies are needed to better understand this difference.

SCAI expert consensus update on best practices in the cardiac catheterization laboratory: This statement was endorsed by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) in April 2021.

The current document commissioned by the Society for Cardiovascular Angiography and Interventions (SCAI) and endorsed by the American College of Cardiology, the American Heart Association, and Heart Rhythm Society represents a comprehensive update to the 2012 and 2016 consensus documents on patient-centered best practices in the cardiac catheterization laboratory. Comprising updates to staffing and credentialing, as well as evidence-based updates to the pre-, intra-, and post-procedural logistics, clinical standards and patient flow, the document also includes an expanded section on CCL governance, administration, and approach to quality metrics. This update also acknowledges the collaboration with various specialties, including discussion of the heart team approach to management, and working with electrophysiology colleagues in particular. It is hoped that this document will be utilized by hospitals, health systems, as well as regulatory bodies involved in assuring and maintaining quality, safety, efficiency, and cost-effectiveness of patient throughput in this high volume area.

North American lower-extremity revascularization and amputation during COVID-19: Observations from the Vascular Quality Initiative.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic's impact on vascular procedural volumes and outcomes has not been fully characterized. METHODS: Volume and outcome data before (1/2019 - 2/2020), during (3/2020 - 4/2020), and following (5/2020 - 6/2020) the initial pandemic surge were obtained from the Vascular Quality Initiative (VQI). Volume changes were determined using interrupted Poisson time series regression. Adjusted mortality was estimated using multivariable logistic regression. RESULTS: The final cohort comprised 57,181 patients from 147 US and Canadian sites. Overall procedure volumes fell 35.2% (95% CI 31.9%, 38.4%, p < 0.001) during and 19.8% (95% CI 16.8%, 22.9%, p < 0.001) following the surge, compared with presurge months. Procedure volumes fell 71.1% for claudication (95% CI 55.6%, 86.4%, p < 0.001) and 15.9% for chronic limb-threatening ischemia (CLTI) (95% CI 11.9%, 19.8%, p < 0.001) but remained unchanged for acute limb ischemia (ALI) when comparing surge to presurge months. Adjusted mortality was significantly higher among those with claudication (0.5% vs 0.1%; OR 4.38 [95% CI 1.42, 13.5], p = 0.01) and ALI (6.4% vs 4.4%; OR 2.63 [95% CI 1.39, 4.98], p = 0.003) when comparing postsurge with presurge periods. CONCLUSION: The first North American COVID-19 pandemic surge was associated with a significant and sustained decline in both elective and nonelective lower-extremity vascular procedural volumes. When compared with presurge patients, in-hospital mortality increased for those with claudication and ALI following the surge.