Improving efficiency and operator proficiency during percutaneous coronary interventions utilizing a standardized optical coherence tomography workflow.

OBJECTIVES: This study was designed to compare efficiency and quality metrics between percutaneous coronary intervention (PCI) procedures using optical coherence tomography (OCT) guided by a variable workflow versus a standardized workflow in a real-world population. BACKGROUND: The LightLab (LL) Initiative was designed to evaluate the impact of a standardized OCT workflow during PCI to address barriers to adoption. METHODS: The LL Initiative was a multicenter, prospective, observational study. PCI efficiency data were collected from 1/21/19 to 1/8/21 from 45 physicians at 17 US centers. OCT-guided PCIs were compared between baseline phase (variable workflow; N = 383) and the LL workflow utilization phase (N = 447). The LL workflow uses OCT to assess lesion Morphology, Length and Diameter, and then optimize outcomes by correcting for Medial dissection, stent mal-Apposition, and under-eXpansion (MLD MAX). Matching based on propensity scores was used to control for differences between PCIs. RESULTS: After propensity matching, 291 paired procedures were included. Integration of the LL versus variable workflow resulted in no difference in procedure time (51 min vs. 51 min, p = 0.93). There was a reduction in radiation exposure (1124 mGy vs. 1493 mGy, p < 0.0001) and contrast volume (160 cc vs. 172 cc, p < 0.001). The LL workflow decreased the proportion of underexpanded lesions (34% vs. 54%, p < 0.0001) and improved minimum stent expansion (85% vs. 79%, p < 0.0001). Number of noncompliant balloons used was reduced with the LL workflow. (2.0 vs. 1.7, p < 0.01). CONCLUSIONS: These data suggest that standardizing imaging with the LL workflow may overcome barriers to imaging and improve PCI outcomes without prolonging procedures.

Distal arteriovenous fistula formation after percutaneous coronary intervention: An old complication of a new access site.

Dorsal or distal transradial artery access has recently gained popularity due to several perceived benefits that include favorable ergonomics, the potential for rapid hemostasis and lower rates of vascular complications. Still, no vascular access site is free of complications and reports of hematoma and pseudoaneurysm formation related to distal radial artery access have been reported in the literature. We present a case of a 71-year-old male who developed an arteriovenous fistula (AVF) involving the distal left radial artery following repeated access of the artery. This rare complication is likely avoidable with a comprehensive understanding of the surrounding anatomy and proper procedural technique, including the routine use of ultrasound for access.

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.

A systematic review of mobility/immobility in thromboembolism risk assessment models for hospitalized patients.

Hospitalized patients are at risk of venous thromboembolism (VTE) and prophylaxis is often suboptimal due to difficulty in identifying at-risk patients. Simple and validated risk-assessment models (RAMs) are available to assist clinicians in identifying patients who have a high risk for developing VTE. Despite the well-documented association of immobility with increased risk of thrombosis, immobility is not consistently defined in clinical studies. We conducted a systematic review of published VTE RAMs and used objective criteria to determine how the term immobility is defined in RAMs. We identified 17 RAMs with six being externally validated. The concept of immobility is vaguely described in different RAMs, impacting the validity of these models in clinical practice. The wide variability in defining mobility in RAMs precluded its accurate clinical application, further limiting generalization of published RAMs. Externally validated RAMs with clearly defined qualitative or quantitative terms of immobility are needed to assess VTE risk in real-time at the point-of-care.

Suture-Mediated Intermediate and Terminal Closure When Using the Aortix Percutaneous Mechanical Circulatory Support Device.

Background: The Aortix percutaneous mechanical circulatory support (pMCS) 18F micromechanical axial impeller-driven pump is percutaneously placed and retrieved from the descending aorta above the renal arteries. Pump deployment and retrieval use defined steps to allow suture-mediated closure around the exiting power lead and for terminal hemostasis after device retrieval after therapy. The overall procedure was validated preclinically in ovine and porcine models and has since proven reliable in a recently completed IDE feasibility study (NCT04145635). This study describes the steps of a novel technique for reliable suture-mediated vessel closure when using the Aortix pMCS device. Methods: The principal steps associated with the procedure comprised ultrasound-guided access of the femoral artery, preclose placement of 4 Perclose (Abbott) sutures, achievement of intermediate hemostasis by locking 3 of the 4 sutures around the 6F exiting power lead, breaking the 3 locked sutures to permit vessel reentry for device removal, and finally, vessel closure using the fourth preclose suture along with 1 or more postclose suture(s) to close the femoral artery using a hybrid dual-sheath technique. Results: The standardized steps described have been developed and used over the course of 21 clinical cases by 12 operators who were initially procedurally naïve but experienced in large-bore access. Conclusions: Preclose and postclose suture-mediated closure is a reliable means of managing the exiting power lead of the Aortix pMCS and closing the large-bore arteriotomy after pump retrieval. The steps outlined in this study may have applicability to other procedures requiring large-bore access or using suture-mediated closure.

Early Utilization of Mechanical Circulatory Support in Acute Myocardial Infarction Complicated by Cardiogenic Shock: The National Cardiogenic Shock Initiative.

BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is associated with significant morbidity and mortality. Mechanical circulatory support (MCS) devices increase systemic blood pressure and end organ perfusion while reducing cardiac filling pressures. METHODS AND RESULTS: The National Cardiogenic Shock Initiative (NCT03677180) is a single-arm, multicenter study. The purpose of this study was to assess the feasibility and effectiveness of utilizing early MCS with Impella in patients presenting with AMI-CS. The primary end point was in-hospital mortality. A total of 406 patients were enrolled at 80 sites between 2016 and 2020. Average age was 64±12 years, 24% were female, 17% had a witnessed out-of-hospital cardiac arrest, 27% had in-hospital cardiac arrest, and 9% were under active cardiopulmonary resuscitation during MCS implantation. Patients presented with a mean systolic blood pressure of 77.2±19.2 mm Hg, 85% of patients were on vasopressors or inotropes, mean lactate was 4.8±3.9 mmol/L and cardiac power output was 0.67±0.29 watts. At 24 hours, mean systolic blood pressure improved to 103.9±17.8 mm Hg, lactate to 2.7±2.8 mmol/L, and cardiac power output to 1.0±1.3 watts. Procedural survival, survival to discharge, survival to 30 days, and survival to 1 year were 99%, 71%, 68%, and 53%, respectively. CONCLUSIONS: Early use of MCS in AMI-CS is feasible across varying health care settings and resulted in improvements to early hemodynamics and perfusion. Survival rates to hospital discharge were high. Given the encouraging results from our analysis, randomized clinical trials are warranted to assess the role of utilizing early MCS, using a standardized, multidisciplinary approach.

Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study.

BACKGROUND: Mechanisms responsible for anti-ischemic benefits of enhanced external counterpulsation (EECP) remain unknown. This was the first randomized sham-controlled study to investigate the extracardiac effects of EECP on peripheral artery flow-mediated dilation. METHODS AND RESULTS: Forty-two symptomatic patients with coronary artery disease were randomized (2:1 ratio) to thirty-five 1-hour sessions of either EECP (n=28) or sham EECP (n=14). Flow-mediated dilation of the brachial and femoral arteries was performed with the use of ultrasound. Plasma levels of nitrate and nitrite, 6-keto-prostaglandin F(1α), endothelin-1, asymmetrical dimethylarginine, tumor necrosis factor-α, monocyte chemoattractant protein-1, soluble vascular cell adhesion molecule, high-sensitivity C-reactive protein, and 8-isoprostane were measured. EECP increased brachial (+51% versus +2%) and femoral (+30% versus +3%) artery flow-mediated dilation, the nitric oxide turnover/production markers nitrate and nitrite (+36% versus +2%), and 6-keto-prostaglandin F(1α) (+71% versus +1%), whereas it decreased endothelin-1 (-25% versus +5%) and the nitric oxide synthase inhibitor asymmetrical dimethylarginine (-28% versus +0.2%) in treatment versus sham groups, respectively (all P<0.05). EECP decreased the proinflammatory cytokines tumor necrosis factor-α (-16% versus +12%), monocyte chemoattractant protein-1 (-13% versus +0.2%), soluble vascular cell adhesion molecule-1 (-6% versus +1%), high-sensitivity C-reactive protein (-32% versus +5%), and the lipid peroxidation marker 8-isoprostane (-21% versus +1.3%) in treatment versus sham groups, respectively (all P<0.05). EECP reduced angina classification (-62% versus 0%; P<0.001) in treatment versus sham groups, respectively. CONCLUSIONS: Our findings provide novel mechanistic evidence that EECP has a beneficial effect on peripheral artery flow-mediated dilation and endothelial-derived vasoactive agents in patients with symptomatic coronary artery disease.

An intravascular ultrasound analysis in women experiencing chest pain in the absence of obstructive coronary artery disease: a substudy from the National Heart, Lung and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation (WISE).

AIMS: Using intravascular ultrasound (IVUS), we sought to characterize coronary morphology in women with chest pain without major epicardial obstructive coronary artery disease (CAD). We have previously observed an unexpectedly high rate of adverse outcomes among women with chest pain and normal or insignificant obstructive CAD. Information about the presence and characteristics of coronary atherosclerosis in these women could provide insight into the mechanisms related to increased risk, as well as improved diagnosis, prevention, and treatment. METHODS: Women (n = 100) with suspected ischemia without obstructive CAD (>50% stenosis) underwent IVUS of a left coronary segment with measurements by a core lab masked to clinical and angiographic findings. RESULTS: Angiograhic core lab analysis found 69.6% of patients had no (≤20%) and 30.4% had minimal (20-<50%) CAD. IVUS segmental images were interpretable by the core lab in 92 women, with 19 (21%) having no atherosclerosis (intimal-medial thickness <0.5 mm). In the remaining 73 women (79%), percent atheroma volume was 27 ± 8% and mean maximum plaque thickness was 0.53 ± 0.22 mm. Thirty-eight women with atherosclerosis (53%) had ≥30% of interrogated vessel involved. The average vessel involvement was 40%, and the maximum plaque thickness was 1.27 mm. The number of risk factors strongly correlated with percent atheroma volume (r = 0.53, P < 0.0001) and percent vessel involvement (r = 0.51, P < 0.0001), with the strongest independent predictor of both being age. Remodeling was assessed in 59/73 women (81%), and 73% had evidence of positive remodeling. CONCLUSIONS: In symptomatic women without significant luminal obstructive CAD, we observed a high prevalence of atherosclerosis with positive remodeling and preserved lumen size. These findings may help explain increased risk and emphasize need for improved diagnostic and treatment options for women with concealed CAD.

Effect of enhanced external counterpulsation on inflammatory cytokines and adhesion molecules in patients with angina pectoris and angiographic coronary artery disease.

Cardiovascular disease is associated with chronic low-level inflammation, as evidenced by elevated circulating proinflammatory cytokines. Experimental evidence suggests that inflammation can be suppressed under conditions of high shear stress. This study was conducted to examine the effects of enhanced external counterpulsation (EECP), a noninvasive therapy that increases endothelial shear stress, on circulating levels of inflammatory biomarkers and adhesion molecules in patients with angina pectoris. Twenty-one patients were randomly assigned to either 35 1-hour treatments at cuff pressures of 300 mm Hg (EECP; n=12) or 75 mm Hg (sham; n=9). Plasma tumor necrosis factor-alpha, monocyte chemoattractant protein-1, and soluble vascular cell adhesion molecule-1 were measured before and after 35 1-hour sessions of treatment or sham. Patients in the EECP group demonstrated reductions in tumor necrosis factor-alpha (6.9+/-2.7 vs 4.9+/-2.5 pg/ml, p<0.01; -29%) and monocyte chemoattractant protein-1 (254.9+/-55.9 vs 190.4+/-47.6 pg/ml, p<0.01; -19%) after treatment, whereas there was no change in the sham group. Changes in soluble vascular cell adhesion molecule-1 were not observed in either group. In conclusion, 35 sessions of EECP decreased circulating levels of proinflammatory biomarkers in patients with symptomatic coronary artery disease.

Giant Left Ventricular Thrombus in a Patient with Acute Ischemic Stroke: A Case Report and Minireview.

A 56-year-old healthy male with no obvious risk factors or significant past medical history was admitted to the emergency room with acute ischemic stroke. On his transthoracic echocardiography (TTE), an extremely large thrombus was detected at the apex involving the distal anterior wall. The thrombus was predominantly adherent but with a mobile tip. The patient was subsequently managed with dual antiplatelet therapy. In this report, we present an interesting case of an acute ischemic stroke secondary to a giant left ventricular thrombus in a patient with no past significant cardiac or neurologic medical history.

Effects of enhanced external counterpulsation on arterial stiffness and myocardial oxygen demand in patients with chronic angina pectoris.

Enhanced external counterpulsation (EECP) is a noninvasive technique for treatment of symptomatic coronary artery disease in patients not amenable to revascularization procedures. However, the mechanisms underlying the benefits of EECP remain unknown. We hypothesized that decreases in arterial stiffness and aortic wave reflection are a therapeutic target for EECP. Patients with coronary artery disease and chronic angina pectoris were randomized (2:1 ratio) to 35 1-hour sessions of EECP (n = 28) or sham EECP (n = 14). Central and peripheral arterial pulse-wave velocity and aortic wave reflection (augmentation index) were measured using applanation tonometry before, and after 17 and 35 1-hour treatment sessions. Wasted left ventricular pressure energy and aortic systolic tension-time index, markers of left-ventricular myocardial oxygen demand, were derived from the synthesized aortic pressure wave. Exercise duration, anginal threshold, and peak oxygen consumption were measured using a graded treadmill test. Central arterial stiffness and augmentation index were decreased after 17 and 35 sessions in the treatment group. Measurements of peripheral arterial stiffness were decreased after 35 sessions in the treatment group. Changes in aortic pressure wave reflection resulted in decreased measurements of myocardial oxygen demand and wasted left ventricular energy. No changes in central or peripheral arterial stiffness were observed in the sham group. Furthermore, measurements of exercise capacity were improved in the EECP group but unchanged in the sham group. In conclusion, EECP therapy decreases central and peripheral arterial stiffness, which may explain improvements in myocardial oxygen demand in patients with chronic angina pectoris after treatment.