Pulmonary Artery Catheter Use and Mortality in the Cardiac Intensive Care Unit.

BACKGROUND: The appropriate use of pulmonary artery catheters (PACs) in critically ill cardiac patients remains debated. OBJECTIVES: The authors aimed to characterize the current use of PACs in cardiac intensive care units (CICUs) with attention to patient-level and institutional factors influencing their application and explore the association with in-hospital mortality. METHODS: The Critical Care Cardiology Trials Network is a multicenter network of CICUs in North America. Between 2017 and 2021, participating centers contributed annual 2-month snapshots of consecutive CICU admissions. Admission diagnoses, clinical and demographic data, use of PACs, and in-hospital mortality were captured. RESULTS: Among 13,618 admissions at 34 sites, 3,827 were diagnosed with shock, with 2,583 of cardiogenic etiology. The use of mechanical circulatory support and heart failure were the patient-level factors most strongly associated with a greater likelihood of the use of a PAC (OR: 5.99 [95% CI: 5.15-6.98]; P < 0.001 and OR: 3.33 [95% CI: 2.91-3.81]; P < 0.001, respectively). The proportion of shock admissions with a PAC varied significantly by study center ranging from 8% to 73%. In analyses adjusted for factors associated with their placement, PAC use was associated with lower mortality in all shock patients admitted to a CICU (OR: 0.79 [95% CI: 0.66-0.96]; P = 0.017). CONCLUSIONS: There is wide variation in the use of PACs that is not fully explained by patient level-factors and appears driven in part by institutional tendency. PAC use was associated with higher survival in cardiac patients with shock presenting to CICUs. Randomized trials are needed to guide the appropriate use of PACs in cardiac critical care.

Critical Care Cardiology Trials Network (CCCTN): a cohort profile.

AIMS: The aims of the Critical Care Cardiology Trials Network (CCCTN) are to develop a registry to investigate the epidemiology of cardiac critical illness and to establish a multicentre research network to conduct randomised clinical trials (RCTs) in patients with cardiac critical illness. METHODS AND RESULTS: The CCCTN was founded in 2017 with 16 centres and has grown to a research network of over 40 academic and clinical centres in the United States and Canada. Each centre enters data for consecutive cardiac intensive care unit (CICU) admissions for at least 2 months of each calendar year. More than 20 000 unique CICU admissions are now included in the CCCTN Registry. To date, scientific observations from the CCCTN Registry include description of variations in care, the epidemiology and outcomes of all CICU patients, as well as subsets of patients with specific disease states, such as shock, heart failure, renal dysfunction, and respiratory failure. The CCCTN has also characterised utilization patterns, including use of mechanical circulatory support in response to changes in the heart transplantation allocation system, and the use and impact of multidisciplinary shock teams. Over years of multicentre collaboration, the CCCTN has established a robust research network to facilitate multicentre registry-based randomised trials in patients with cardiac critical illness. CONCLUSION: The CCCTN is a large, prospective registry dedicated to describing processes-of-care and expanding clinical knowledge in cardiac critical illness. The CCCTN will serve as an investigational platform from which to conduct randomised controlled trials in this important patient population.

Clinical Practice Patterns in Temporary Mechanical Circulatory Support for Shock in the Critical Care Cardiology Trials Network (CCCTN) Registry.

BACKGROUND: Temporary mechanical circulatory support (MCS) devices provide hemodynamic assistance for shock refractory to pharmacological treatment. Most registries have focused on single devices or specific etiologies of shock, limiting data regarding overall practice patterns with temporary MCS in cardiac intensive care units. METHODS: The CCCTN (Critical Care Cardiology Trials Network) is a multicenter network of tertiary CICUs in North America. Between September 2017 and September 2018, each center (n=16) contributed a 2-month snapshot of consecutive medical CICU admissions. RESULTS: Of the 270 admissions using temporary MCS, 33% had acute myocardial infarction-related cardiogenic shock (CS), 31% had CS not related to acute myocardial infarction, 11% had mixed shock, and 22% had an indication other than shock. Among all 585 admissions with CS or mixed shock, 34% used temporary MCS during the CICU stay with substantial variation between centers (range: 17%-50%). The most common temporary MCS devices were intraaortic balloon pumps (72%), Impella (17%), and veno-arterial extracorporeal membrane oxygenation (11%), although intraaortic balloon pump use also varied between centers (range: 40%-100%). Patients managed with intraaortic balloon pump versus other forms of MCS (advanced MCS) had lower Sequential Organ Failure Assessment scores and less severe metabolic derangements. Illness severity was similar at high- versus low-MCS utilizing centers and at centers with more advanced MCS use. CONCLUSIONS: There is wide variation in the use of temporary MCS among patients with shock in tertiary CICUs. While hospital-level variation in temporary MCS device selection is not explained by differences in illness severity, patient-level variation appears to be related, at least in part, to illness severity.

Demographics, Care Patterns, and Outcomes of Patients Admitted to Cardiac Intensive Care Units: The Critical Care Cardiology Trials Network Prospective North American Multicenter Registry of Cardiac Critical Illness.

Importance: Single-center and claims-based studies have described substantial changes in the landscape of care in the cardiac intensive care unit (CICU). Professional societies have recommended research to guide evidence-based CICU redesigns. Objective: To characterize patients admitted to contemporary, advanced CICUs. Design, Setting, and Participants: This study established the Critical Care Cardiology Trials Network (CCCTN), an investigator-initiated multicenter network of 16 advanced, tertiary CICUs in the United States and Canada. For 2 months in each CICU, data for consecutive admissions were submitted to the central data coordinating center (TIMI Study Group). The data were collected and analyzed between September 2017 and 2018. Main Outcomes and Measures: Demographics, diagnoses, management, and outcomes. Results: Of 3049 participants, 1132 (37.1%) were women, 797 (31.4%) were individuals of color, and the median age was 65 years (25th and 75th percentiles, 55-75 years). Between September 2017 and September 2018, 3310 admissions were included, among which 2557 (77.3%) were for primary cardiac problems, 337 (10.2%) for postprocedural care, 253 (7.7%) for mixed general and cardiac problems, and 163 (4.9%) for overflow from general medical ICUs. When restricted to the initial 2 months of medical CICU admissions for each site, the primary analysis population included 3049 admissions with a high burden of noncardiovascular comorbidities. The top 2 CICU admission diagnoses were acute coronary syndrome (969 [31.8%]) and heart failure (567 [18.6%]); however, the proportion of acute coronary syndrome was highly variable across centers (15%-57%). The primary indications for CICU care included respiratory insufficiency (814 [26.7%]), shock (643 [21.1%]), unstable arrhythmia (521 [17.1%]), and cardiac arrest (265 [8.7%]). Advanced CICU therapies or monitoring were required for 1776 patients (58.2%), including intravenous vasoactive medications (1105 [36.2%]), invasive hemodynamic monitoring (938 [30.8%]), and mechanical ventilation (652 [21.4%]). The overall CICU mortality rate was 8.3% (95% CI, 7.3%-9.3%). The CICU indications that were associated with the highest mortality rates were cardiac arrest (101 [38.1%]), cardiogenic shock (140 [30.6%]), and the need for renal replacement therapy (51 [34.5%]). Notably, patients admitted solely for postprocedural observation or frequent monitoring had a mortality rate of 0.2% to 0.4%. Conclusions and Relevance: In a contemporary network of tertiary care CICUs, respiratory failure and shock predominated indications for admission and carried a poor prognosis. While patterns of practice varied considerably between centers, a substantial, low-risk population was identified. Multicenter collaborative networks, such as the CCCTN, could be used to help redesign cardiac critical care and to test new therapeutic strategies.

Duration of Dual Antiplatelet Therapy in Coronary Artery Disease: a Review Article.

Dual antiplatelet therapy (DAPT) following an acute coronary syndrome or after placement of a coronary artery stent is superior to aspirin alone for prevention of atherothrombotic events but carries an increased bleeding risk. DAPT should be continued for at least 12 months based on current guidelines. Recent randomized trials demonstrate reduced ischemic events including myocardial infarction (MI), stroke, and death with continued DAPT for up to 30 months or longer, particularly in the post-MI population. However, this clinical benefit is accompanied by an increased risk of bleeding. Additional trials show mixed safety and efficacy with duration of DAPT of less than 12 months. The current data emphasizes the need to individualize DAPT duration at the patient level to balance the clinical benefits of a reduced risk of cardiovascular ischemic events with the greater risk of clinically significant bleeding. Patients at an increased risk of ischemic events and a lower risk of bleeding should be strongly considered for prolonged DAPT beyond the 1 year currently recommended in the practice guidelines.

Carotid artery stent type influences duplex ultrasonography derived peak systolic velocity: findings of an in-vitro model.

OBJECTIVE: The goal of this study is to evaluate the effect of stenting on Doppler ultrasonography (DU) [velocity] signals in an in-vitro carotid model. BACKGROUND: Considerable debate exists about whether DU overestimates velocity signals and thus the degree of stenosis in previously stented carotid arteries. METHODS: Constant, pulsatile flow was simulated with an experimental circulatory system containing a nonstenotic ovine internal carotid artery segment. Peak systolic velocity (PSV) and peak diastolic velocity were measured with an intravascular flow wire (FW) and DU. Velocities were evaluated at five predetermined locations within the vessel immediately prior to and following stent placement. RESULTS: Eleven stents were implanted. DU-derived PSV increased significantly following placement of the X-Act stent (80+/-26 cm/sec [pre] vs. 102+/-29 cm/sec [post], P=0.02), while FW-derived PSV (65+/-23 cm/sec [pre] vs. 66+/-9 cm/sec [post], P=0.93) did not change. The Precise stent did not influence PSV with either method (DU: 76+/-28 cm/sec [pre] vs. 72+/-35 cm/sec [post], P=0.95;), while the Acculink stent showed a trend towards a reduction in DU (69+/-37 cm/sec [pre] vs. 51+/-10 cm/sec [post], P=0.075) and FW (50+/-27 cm/sec [pre] vs. 40+/-12 cm/sec [post], P=0.14) derived PSV. Peak diastolic velocity revealed similar trends as PSV signals depending on the type of stent used. CONCLUSIONS: Stent type may have significant impact on DU derived velocity signals. DU seems to overestimate PSV in carotid arteries treated with the X-Act stent, but not with the Precise or Acculink stent. Larger scale clinical comparison of various stent types and their impact on DU are needed in order to clarify the value of DU surveillance following carotid artery stenting.

Coronary revascularization in multivessel disease. Which is better, stents or surgery?

Coronary artery disease (CAD) remains the major cardiovascular health issue in contemporary clinical practice. Treatment options for multivessel CAD include medical therapy, percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG). Here, the authors review the most recent data that compare intracoronary stenting to CABG in multivessel disease. They address therapeutic issues surrounding proper selection of the optimal revascularization strategy and give special consideration to high-risk populations, such as patients with diabetes.

Intracoronary beta brachytherapy as a treatment option for high-risk refractory in-stent restenosis; Compassionate use.

BACKGROUND: Vascular (VBT) has clearly been shown in multiple clinical trials to decrease restenosis rates for in-stent restenosis (ISR). However, patients enrolled in these randomized clinical trials represent a select group, and the efficacy of VBT in patients with ISR who were excluded from these controlled trials due to more complex coronary anatomy requires further investigation. This study sought to define the angiographic and clinical profile and outcomes of these high-risk patients with ISR who were excluded from the randomized clinical trials and who received VBTusing Strontium-90 (Sr-90) using the Novoste Beta-Cath System through a Compassionate Use Protocol (CUP). METHODS: The study was designed as a single center, prospective, open label registry trial evaluating the use of VBT on complex instent restenotic lesions in patients who were excluded from the START and START 40 trials. In general, these patients included those with saphenous vein graft (SVG) lesions, long lesions (>35 mm), and patients with a history of more than three prior interventions. VBT using Sr-90 was delivered using the Novoste Beta-Cath System after successful angioplasty. The predetermined primary endpoint was freedom from target vessel revascularization (TVR) at 8 months, one and two years. The secondary endpoint was a composite of death, myocardial infarction (MI) and TVR at 8 months, one year, and two years. RESULTS: Between September 4, 1998 and December 6, 2000, 32 patients were treated with VBT under the UCP protocol. The mean duration of follow up was 15.3 +/- 8.3 months. There were 9 major cardiac events at eight months including one death, one acute myocardial infarction and 7 TVR. Excluding the one patient who died, 33 lesions were available for follow-up. The rate of TVR in this high-risk patient population was 21.1% (n = 7/33 lesions). The method of revascularization included one bypass surgery and 6 repeat percutaneous coronary interventions. CONCLUSIONS: This trial demonstrates that utilization of the Beta-Cath System using Sr-90 for the treatment of ISR in a patient population excluded from the randomized clinical trials due to unfavorable lesions characteristics is feasible appears to be associated TVR rates that compare favorably with the event rates of patients enrolled in other trials enrolling lower-risk groups.

Clinical and angiographic profile of patients with markedly elevated coronary calcium scores (>or=1000) detected by electron beam computed tomography.

OBJECTIVE: The objective of this study was to determine the clinical and angiographic profile of patients with extremely high coronary artery calcium scores (CACS; >or=1000) by electron beam computed tomography (EBCT). METHODS: All patients at Rush University Medical Center who had a calcium score >or=1000 and a coronary angiogram performed from 1997 to 2002 were identified using a prospectively collected database. The baseline demographics, symptom status, and degree of coronary stenosis by angiography and subsequent rate of coronary intervention were compared with that of patients with calcium scores <1000. RESULTS: The clinical and angiographic profile of patients with severe coronary calcification, detected by EBCT, revealed that patients with scores >or=1000 had a significantly higher prevalence of coronary stenosis >or=50% compared with patients with scores <1000 (97% vs. 57%, P<.001). The group with CACS >or=1000 was more likely to be male (90% vs. 75%, P=.027) and was older (64+/-8 vs. 59+/-10, P=.001) compared with the group with less severe calcification. Although there was a significantly higher rate of luminal stenosis detected by coronary angiography in the cohort with CACS >or=1000, there was no difference in subsequent percutaneous coronary intervention (PCI) and utilization of intracoronary stents between the two groups. CONCLUSIONS: A markedly elevated coronary calcium score (>or=1000) is correlated with increasing age and is associated with an increased likelihood of coronary stenosis >or=50%. However, the decision to perform coronary angiography in patients with severe coronary calcification should not be based solely on these findings, but should remain primarily dependent on the degree of ischemia detected by clinical and functional assessment.

The effect of percutaneous transmyocardial laser revascularization on left ventricular function in a porcine model of hibernating myocardium: a pilot study.

BACKGROUND: Hibernating myocardium is defined as a state of persistently impaired myocardial function at rest due to reduced coronary blood flow that can partially or completely be restored to normal if the myocardial oxygen supply/demand relationship is favorably altered. Percutaneous laser revascularization (PMR) is an emerging catheter-based technique that involves creating channels in the myocardium, directly through a percutaneous approach with a laser delivery system, and has been shown to reduce symptoms in patients with severe refractory angina; however, its effect on improving regional wall motion abnormalities in hibernating myocardium has not been clearly established. We sought to determine the effect of PMR using the Eclipse System (Cardiogenesis) on left ventricular function in a porcine model of hibernating myocardium. METHODS: A model of hibernating myocardium was created by placement of an ameroid constrictor in the proximal left anterior descending artery of a 35 kg male Yorkshire pig. The presence of hibernating myocardium was confirmed with dobutamine stress echocardiography (DSE) and defined as severe hypocontractility at rest, with an improvement in systolic wall thickening with low-dose dobutamine in myocardial regions with a subsequent deterioration in function at peak stress (biphasic response). After the demonstration of hibernating myocardium, PMR was performed in the area of hypocontractile function, and the serial echocardiography was performed. The echocardiograms were reviewed by an experienced echocardiologist blinded to the results, and regional wall motion was assessed using the American Society of Echocardiography Wall Motion Score. Six weeks after PMR, the animal was sacrificed and the heart sent for histopathologic studies. RESULTS: A comparison of the regional wall motion function of the area distal to the ameroid constrictor and in the contralateral wall at baseline, post-ameroid placement, and post-PMR was performed. Hibernating myocardium was demonstrated 4 weeks after ameroid placement by DSE. Coronary angiography demonstrated a discrete 90%stenosis in the proximal LAD at the site of ameroid constrictor placement without evidence of collaterals. Using PMR, 17 bursts were successfully delivered to the anterior wall distal to the ameroid constrictor. Four weeks after PMR, there was improvement in wall motion function in the region distal to the ameroid placement by echocardiography. Histopathologic analysis demonstrated the absence of myocardial infarction in the anterior wall distal to the ameroid constrictor. CONCLUSIONS: The performance of PMR in a porcine model of hibernating myocardium is feasible and is associated with an improvement regional wall motion function after 4 weeks.

One-year follow-up of direct myocardial gene transfer of vascular endothelial growth factor-2 using naked plasmid deoxyribonucleic acid by way of thoracotomy in no-option patients.

This phase I open label, dose-escalating study shows that gene transfer of vascular endothelial growth factor-2 naked deoxyribonucleic acid by direct myocardial injection by way of thoracotomy in patients with Canadian Cardiovascular Society class 3 or 4 angina is feasible and safe. The procedure is well tolerated, with few major adverse cardiac events at 1 year, and without complications directly related to gene expression. In this prospective, nonblinded study, the procedure is associated with clinical improvement; however, there was no angiographic evidence of angiogenesis and there is a great potential for a sham or placebo effect in the study patients. A randomized phase III trial is underway that will help determine the efficacy of vascular endothelial growth factor-2 gene transfer in "no-option" patients.

Predictors of late cardiac events following treatment with Sr-90 beta-irradiation for instent restenosis.

BACKGROUND: Intracoronary radiation therapy (IRT) with Sr-90 using the Novoste Beta-Cath system has been shown to be an effective therapy for instent restenosis (ISR), but the temporal occurrence of cardiac events and the predictors of late complications require further investigation. METHODS: We analyzed the demographics, lesion characteristics and clinical outcomes of 138 consecutive patients with ISR treated with IRT from September 1998 to March 2002. Major adverse cardiac events (MACE) were defined as death, myocardial infarction (MI) or target vessel revascularization (TVR). Characteristics of early (< or =8 months) and late (>8 months) failures were analyzed. RESULTS: Thirty-two (23.1%) of 138 patients had MACE on follow-up; 25% (8/32) of failures occurred late after treatment with IRT. A comparison of the clinical and angiographic profile of early and late failures using univariate analysis indicates no correlations to late failure following IRT. Duration to failure after IRT was 14.25+/-3.69 months in the late group compared to 4.63+/-2.86 months in the early group (P<.001). CONCLUSIONS: Late MACE after IRT with Sr-90 for ISR occur beyond the traditional period for clinical restenosis in 25% of cases and are difficult to predict. Further study is warranted to identify patients at risk for the development of late complications after IRT.

Correlates of failure following treatment with Sr-90 beta irradiation for in-stent restenosis.

We sought to determine the correlates of failure following intracoronary radiation therapy (IRT) with Sr-90 using the Novoste Beta-Cath system for the treatment of in-stent restenosis (ISR) in a broad range of patients. IRT has been shown to be more efficacious compared to placebo for the treatment of ISR in large randomized trials. However, even in patients treated with IRT, major adverse cardiac events occur in approximately 20% of cases on follow-up. This trial sought to elucidate the correlates of failure following successful IRT for ISR. To determine the correlates of IRT failure, we retrospectively compared the demographics, lesion characteristics, and clinical outcomes of 102 consecutive patients with ISR treated with Sr-90 from September 1998 to July 2001. IRT failure was defined as death, myocardial infarction (MI), or target vessel revascularization (TVR) due to repeat ISR on follow-up. A comparison of the clinical and angiographic profile of IRT failures (n = 16) vs. IRT successes (n = 86) revealed that a history of smoking (75% vs. 40%; P = 0.012), current use of calcium channel blockers (84% vs. 45%; P = 0.013), ostial location of target lesion (44% vs. 16%; P = 0.020), and mean posttreatment minimal luminal diameter (MLD; 1.64 +/- 0.19 vs. 2.21 +/- 0.29 mm; P < 0.001), respectively, were correlated with failure using univariate analysis. After multivariate regression analysis, the correlates of failure that remained significant were treatment of an ostial lesion (OR = 31.2; 95% CI = 2.6-382.7; P = 0.007) and final posttreatment MLD (P < 0.001). Ostial location of target lesion and smaller posttreatment MLD are correlated with subsequent death, MI, and TVR following therapy with Sr-90 for ISR.

Clinical outcomes of patients treated with the cutting balloon and Sr-90 beta-irradiation for instent restenosis.

BACKGROUND: The cutting balloon (CB) is an emerging therapy for the treatment of instent restenosis (ISR), but its impact on the clinical outcomes of patients treated with intracoronary radiation therapy (IRT) with Sr-90 compared with conventional PTCA and IRT is not clearly defined. METHODS: We compared the baseline demographics, angiographic characteristics and clinical outcomes of 102 consecutive patients with ISR treated either with CB+IRT (n=45) or with conventional PTCA+IRT (n=57). The combined endpoint was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of death, myocardial infarction (MI) or target vessel revascularization (TVR) at 6 months. RESULTS: The CB+IRT group had a shorter mean lesion length (14.3+/-6.5 vs. 21.1+/-15.7, P=.009), and greater utilization of glycoprotein IIb/IIIa inhibitors during the procedure (48.9% vs. 26.3%, P=.02) compared to the PTCA+IRT group. There were no significant differences in the baseline demographics, angiographic and procedural results, or subsequent MACE at 6 months between the two groups. CONCLUSION: The strategy of CB+IRT using Sr-90 for ISR is associated with similar procedural and clinical outcomes compared to conventional PTCA+IRT. Further study is warranted to determine which patient subgroups would derive the most benefit from this approach.

Visual assessment of procedural results following treatment with Sr-90 beta-radiation for instent restenosis.

BACKGROUND: Visual assessment (VA) of postprocedural % diameter stenosis (DS) is used routinely in clinical practice to determine the adequacy of coronary intervention. Although VA has been shown to underestimate final %DS after balloon angioplasty compared to quantitative coronary angiography (QCA), the impact of this effect on clinical outcomes following treatment with intracoronary radiation therapy (IRT) with Sr-90 for instent restenosis (ISR) is unknown. METHODS: To determine the effect of VA on the rate of major adverse cardiac events (MACEs) after IRT for ISR, we compared the clinical outcomes of 102 consecutive patients based on postprocedural %DS by QCA vs. %DS by VA. MACE was defined as death, M1 or need for target vessel revascularization (TVR). RESULTS: MACE rates for the 102 consecutive patients grouped according to postprocedural %DS by QCA and VA were compared. The mean %DS by QCA was 30.7%, while the mean %DS by VA was 12.5%. The mean %DS by VA across the QCA subgroups were 13.67%, 10.71% and 13.37%, respectively (P = .244). Fifty-two patients (51.0%) had %DS > 30% by QCA with the highest MACE percentage occurring in this subgroup. CONCLUSION: VA underestimated the %DS compared to QCA, and it was associated with worse MACE following treatment with Sr-90 for ISR.