Use of Mechanical Circulatory Support in Chronic Total Occlusion Percutaneous Coronary Intervention.

The use of mechanical circulatory support (MCS) in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has received limited study. We analyzed the clinical and angiographic characteristics, and procedural outcomes of 7,171 CTO PCIs performed between 2012 and 2021 at 35 international centers. Mean age was 64.5 ± 10 years, mean left ventricular ejection fraction was 50 ± 13%. MCS was used in 4.5%, prophylactically in 78.7%, and urgently in 21.3%. The most common type of MCS overall was Impella CP (Abiomed) (55.5%), followed by intra-aortic balloon pump (14.8%) and TandemHeart (LivaNova Inc.) (10.0%). Prophylactic MCS patients were more likely to have diabetes mellitus (55% vs 42%, p <0.001) and had more complex lesions compared with cases without prophylactic MCS (Japan-CTO score: 2.80 ± 1.22 vs 2.39 ± 1.27, p <0.001). Cases with prophylactic MCS had similar technical (86% vs 87%, p = 0.643) but lower procedural (80% vs 86%, p = 0.028) success rates and higher rates of periprocedural major cardiac adverse events compared with no prophylactic MCS use (6.55% vs 1.68%, p <0.001). Urgent MCS use was associated with lower technical (68% vs 87%, p <0.001) and procedural (39% vs 86%, p <0.001) success rates and higher major cardiac adverse events compared with no-MCS use (32.26% vs 1.68%, p <0.001). The differences persisted in multivariable analyses. In summary, in this contemporary multicenter registry, MCS was used in 4.5% of CTO PCIs, mostly prophylactically (78.7%). Elective MCS cases had similar technical success but a higher risk of complications. Urgent MCS cases had lower technical and procedural success and higher periprocedural major complication rates.

Combined Coronary Orbital Atherectomy and Intravascular Lithotripsy for the Treatment of Severely Calcified Coronary Stenoses: The First Case Series.

OBJECTIVE: Severely calcified coronary stenoses remain a significant challenge during contemporary percutaneous coronary intervention (PCI), often requiring advanced therapies to circumvent suboptimal lesion preparation and major adverse cardiac events (MACEs). Recent reports suggest combined coronary atherectomy and intravascular lithotripsy (IVL) may achieve superior preparation of severely calcified coronary stenoses during PCI. We sought to evaluate the safety and utility of combined orbital atherectomy (OA) and IVL for the modification of coronary artery calcification (CAC) prior to drug-eluting stent (DES) implantation in PCI. METHODS: We performed a retrospective review of all patients who underwent coronary OA and IVL within a single PCI procedure at our institution. The primary outcome was procedural success, defined as successful DES implantation with a residual percent diameter stenosis of <30% and Thrombolysis in Myocardial Infarction (TIMI) 3 flow following PCI without occurrence of in-hospital MACE (cardiac death, myocardial infarction, or target-vessel revascularization). MACE was additionally assessed at 30 days post intervention. RESULTS: Eight patients underwent combined coronary OA and IVL within a single PCI procedure. The mean percent diameter stenosis prior to intervention was 80.5 ± 8.3%, with a mean calcific arc of 338 ± 42°. Procedural success was achieved in 7 of 8 cases (87.5%). Both in-hospital and 30-day MACE rates were 0%. CONCLUSION: We report the safe and effective use of combined coronary OA and IVL for the preparation of severely calcified coronary stenoses during PCI. Through their distinct yet complementary mechanisms of action, the combined use of these therapies may achieve superior preparation of severely calcified coronary stenoses during PCI.

Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients With Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study.

BACKGROUND: Reducing congestion remains a primary target of therapy for acutely decompensated heart failure. The VENUS-HF EFS (VENUS-Heart Failure Early Feasibility Study) is the first clinical trial testing intermittent occlusion of the superior vena cava with the preCARDIA system, a catheter mounted balloon and pump console, to improve decongestion in acutely decompensated heart failure. METHODS: In a multicenter, prospective, single-arm exploratory safety and feasibility trial, 30 patients with acutely decompensated heart failure were assigned to preCARDIA therapy for 12 or 24 hours. The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events through 30 days. Secondary end points included technical success defined as successful preCARDIA placement, treatment, and removal and reduction in right atrial and pulmonary capillary wedge pressure. Other efficacy measures included urine output and patient-reported symptoms. RESULTS: Thirty patients were enrolled and assigned to receive the preCARDIA system. Freedom from device- or procedure-related major adverse events was observed in 100% (n=30/30) of patients. The system was successfully placed, activated and removed after 12 (n=6) or 24 hours (n=23) in 97% (n=29/30) of patients. Compared with baseline values, right atrial pressure decreased by 34% (17±4 versus 11±5 mm Hg, P<0.001) and pulmonary capillary wedge pressure decreased by 27% (31±8 versus 22±9 mm Hg, P<0.001). Compared with pretreatment values, urine output and net fluid balance increased by 130% and 156%, respectively, with up to 24 hours of treatment (P<0.01). CONCLUSIONS: We report the first-in-human experience of intermittent superior vena cava occlusion using the preCARDIA system to reduce congestion in acutely decompensated heart failure. PreCARDIA treatment for up to 24 hours was well tolerated without device- or procedure-related serious or major adverse events and associated with reduced filling pressures and increased urine output. These results support future studies characterizing the clinical utility of the preCARDIA system. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03836079.

The Utility of Peripheral Intravascular Lithotripsy in Calcific Coronary Artery Disease: A Case Series.

BACKGROUND: Coronary intravascular lithotripsy (IVL) is an emerging therapy for the modification of coronary artery calcification (CAC). Data on its use in several clinical and lesion subsets are limited due to their exclusion from preapproval trials. METHODS: We performed a retrospective review of patients who were excluded from preapproval trials of coronary IVL and underwent CAC modification with the off-label use of a peripheral IVL system. The primary outcome was a composite of procedural success, defined as residual stenosis <10%, and no major adverse cardiac event (MACE), ie, cardiac death, myocardial infarction, or target- vessel revascularization, in hospital and at 30 days. RESULTS: Between June 2019 and April 2020, a total of 9 patients who underwent off-label coronary IVL were identified. Exclusion criteria from preapproval trials included a target lesion within an unprotected left main coronary artery (ULMCA; n = 3) and/or ostial location (n = 5), a target lesion involving in-stent restenosis (n = 3), a second target-vessel lesion with >50% stenosis (n = 1), and/or New York Heart Association class III/IV heart failure (n = 5). The primary outcome was achieved in 8 patients. MACE rate was 0% in hospital and at 30 days. For ULMCA lesions (n = 3), residual stenosis was 0% in 2 patients and 10% in 1 patient. For right coronary artery lesions (n = 3), residual stenosis was 0% in 2 patients and 40% in 1 patient. For left anterior descending coronary artery lesions (n = 3), residual stenosis was 0% in all patients. CONCLUSION: Coronary IVL with a peripheral IVL system may be an effective therapy for CAC modification within ULMCA disease, ostial disease, in-stent restenosis, and New York Heart Association class III/IV heart failure.

Fulminant myocarditis in a patient with coronavirus disease 2019 and rapid myocardial recovery following treatment.

Coronavirus disease 2019 (COVID-19) is a global pandemic increasingly encountered in the clinical setting. It typically manifests as a respiratory illness, although cardiac involvement is common and portends a worse prognosis. We present the case of a 56-year-old male admitted with COVID-19 fulminant myocarditis and cardiogenic shock. We discuss important aspects of the multidisciplinary and interventional care involved in treating cardiogenic shock as well as the likely mechanisms of, and potential treatment for, COVID-19 myocarditis. The various pathways of myocardial injury, including direct viral damage, macrophage activation, and lymphocytic infiltration, are outlined in detail in addition to associated pathology such as cytokine release syndrome. COVID-19 is a complex and multisystem disease process; in addition to supportive care, specific consideration should be given to the underlying mechanism of injury for each patient.

Catheter-based embolectomy prior to right ventricular mechanical circulatory support placement after heart transplantation.

Severe acute isolated right ventricular failure has limited dedicated percutaneous temporary mechanical circulatory support options, especially after orthotopic heart transplantation. The advent of the Impella RP device provides a newer option, though an absolute contraindication to device placement is thrombus within the right heart. We present a novel case where catheter-based embolectomy was used to evacuate right heart thrombus before Impella RP placement in a patient with severe acute right ventricular failure due to primary graft dysfunction after orthotopic heart transplantation.

Reproducibility and observer variability of tissue phase mapping for the quantification of regional myocardial velocities.

To systematically investigate the reproducibility of global and segmental left ventricular (LV) velocities derived from tissue phase mapping (TPM). Breath held and ECG synchronized TPM data (spatial/temporal resolution = 2 × 2 mm(2)/20.8 ms) were acquired in 18 healthy volunteers. To analyze scan-rescan variability, TPM was repeated in all subjects during a second visit separated by 16 ± 5 days. Data analysis included LV segmentation, and quantification of global and regional (AHA 16-segment modal) metrics of LV function [velocity-time curves, systolic and diastolic peak and time-to-peak (TTP) velocities] for radial (Vr), long-axis (Vz) and circumferential (VΦ) LV velocities. Mean velocity time curves in basal, mid-ventricular, and apical locations showed highly similar LV motion patterns for all three velocity components (Vr, VΦ, Vz) for scan and rescan. No significant differences for both systolic and diastolic peak and TTP myocardial velocities were observed. Segmental analysis revealed similar regional peak Vr and Vz during both systole and diastole except for three LV segments (p = 0.045, p = 0.033, and p = 0.009). Excellent (p < 0.001) correlations between scans and rescan for peak Vr (R(2) = 0.92), peak Vz (R(2) = 0.90), radial TTP (R(2) = 0.91) and long-axis TTP (R(2) = 0.88) confirmed good agreement. Bland-Altman analysis demonstrated excellent intra-observer and good inter-observer analysis agreement but increased variability for long axis peak velocities. TPM based analysis of global and regional myocardial velocities can be performed with good reproducibility. Robustness of regional quantification of long-axis velocities was limited but spatial velocity distributions across the LV could reliably be replicated.

Extracellular volume fraction is more closely associated with altered regional left ventricular velocities than left ventricular ejection fraction in nonischemic cardiomyopathy.

BACKGROUND: Nonischemic cardiomyopathy is a common cause of left ventricular (LV) dysfunction and myocardial fibrosis. The purpose of this study was to noninvasively evaluate changes in segmental LV extracellular volume (ECV) fraction, LV velocities, myocardial scar, and wall motion in nonischemic cardiomyopathy patients. METHODS AND RESULTS: Cardiac MRI including pre- and postcontrast myocardial T1 mapping and velocity quantification (tissue phase mapping) of the LV (basal, midventricular, and apical short axis) was applied in 31 patients with nonischemic cardiomyopathy (50±18 years). Analysis based on the 16-segment American Heart Association model was used to evaluate the segmental distribution of ECV, peak systolic and diastolic myocardial velocities, scar determined by late gadolinium enhancement, and wall motion abnormalities. LV segments with scar or impaired wall motion were significantly associated with elevated ECV (rs =0.26; P<0.001) and reduced peak systolic radial velocities (r=-0.43; P<0.001). Regional myocardial velocities and ECV were similar for patients with reduced (n=12; ECV=0.28±0.06) and preserved left ventricular ejection fraction (n=19; ECV=0.30±0.09). Patients with preserved left ventricular ejection fraction showed significant relationships between increasing ECV and reduced systolic (r=-0.19; r=-0.30) and diastolic (r=0.34; r=0.26) radial and long-axis peak velocities (P<0.001). Even after excluding myocardial segments with late gadolinium enhancement, significant relationships between ECV and segmental LV velocities were maintained indicating the potential of elevated ECV to identify regional diffuse fibrosis not visible by late gadolinium enhancement, which was associated with impaired regional LV function. CONCLUSIONS: Regionally elevated ECV negatively affected myocardial velocities. The association of elevated regional ECV with reduced myocardial velocities independent of left ventricular ejection fraction suggests a structure-function relationship between altered ECV and segmental myocardial function in nonischemic cardiomyopathy.

Eptifibatide-induced thrombocytopenia: with thrombosis and disseminated intravascular coagulation immediately after left main coronary artery percutaneous coronary angioplasty.

Early clinical trials of eptifibatide did not show a significant association between eptifibatide and the development of thrombocytopenia, thrombosis, or disseminated intravascular coagulation. However, more recent literature has suggested a significant association between eptifibatide and the development of thrombocytopenia and thrombosis. Although the true incidence and the pathophysiology of these associations are unknown, the development of these events can be life-threatening. Herein, we describe the case of a patient who experienced acute onset of profound thrombocytopenia, developing thrombosis, pulmonary emboli, and disseminated intravascular coagulation. This paper adds to the few previous reports of cases that suggested an association between thrombocytopenia, thrombosis, and the administration of eptifibatide. To the best of our knowledge, this is the first case report in the medical literature that associates the new onset of thrombocytopenia, thrombosis, and disseminated intravascular coagulation with the administration of eptifibatide. We also provide a subject review.

Clinical experience and patient outcomes associated with the TandemHeart percutaneous transseptal assist device among a heterogeneous patient population.

There is a paucity of literature describing the outcomes associated with the use of TandemHeart percutaneous ventricular assist device (PVAD). The literature is limited by analyzing only subsets of patients. We present the clinical outcomes and safety associated with the use of TandemHeart among a series of heterogeneous patients requiring PVAD support. We reviewed the clinical experience, hemodynamic variables, survival outcomes, and complications associated with the implantation of TandemHeart support device among 25 patients presenting to our institution. Indications for PVAD implantation were cardiogenic shock (56%), ST-segment elevation myocardial infarction (STEMI) (20%), postpericardiotomy (16%), and high-risk percutaneous coronary interventions (PCI) or ventricular tachycardia (VT) ablation (8%). TandemHeart was used for an average of 4.8 ± 2.1 days and demonstrated significant hemodynamic improvements (pre- and postimplantation left ventricular ejection fractions were 21.5% ± 15% and 24.5% ± 10.5%, respectively [p = 0.06]). The cardiac index improved from a mean 2.04 ± 075 L/min/m² to 2.45 ± 073 L/min/m² (p = 0.09). The mixed venous oxygen saturation (SVO2) increased from 55.14 ± 13.34 to 66.43 ± 7.43 (p = 0.008) after implantation. TandemHeart was used as a bridge to left ventricular assist device implantation (44%) or recovery (20%). Thirty-six percent of patients died on support or shortly after PVAD removal. Thirty, 90-day, and long-term (>90 days) survival rates were 56%, 52%, and 36%, respectively. Procedure-related complications were reported in 13 patients (56%), and the majority (90%) was related to vascular access (bleeding or pseudoaneurysm). The TandemHeart device is a safe therapeutic option as a bridge-to-recovery or bridge-to-bridge for patients with hemodynamic compromise regardless of the etiology. The favorable hemodynamic profile, postimplantation survival rates, and manageable complications support its use to assist hemodynamic recovery in patients refractory to conventional therapy.

Late stent fractures after endoluminal treatment of ostial supraaortic trunk arterial occlusive lesions.

PURPOSE: Percutaneous catheter-based treatment of supraaortic trunk arterial occlusive lesions obviates the need for extraanatomic bypass or median sternotomy. Although early results have been encouraging, late outcomes have yet to be defined. Reported are long-term outcomes of supraaortic trunk stent placement with particular attention to structural failures. MATERIALS AND METHODS: This was a retrospective review of 27 ostial supraaortic trunk lesions managed with balloon-expandable or self-expandable stents. Treated vessels were innominate (n = 9), common carotid (n = 8), and subclavian (n = 10). Access to the target lesion was achieved either antegrade via the femoral artery (n = 13), retrograde through the brachial artery (n = 2), or through a cutdown on the common carotid artery (n = 12). Restenosis and stent integrity were detected with duplex imaging, computed tomography, conventional arteriography, and plain radiography. Mean follow-up time is 34 months. RESULTS: Mean age was 68 years (eight men and 19 women), and mean stenosis was 85%. Preprocedural symptoms, including stroke, transient ischemic attack, arm fatigue, digital ischemia, and angina were present in 85% (23 of 27) of the group. At 30 days, there were no deaths, myocardial infarctions, or strokes. During follow-up, three type IV stent fractures in the innominate were detected as well as two midbody stent crush deformities with significant restenosis (one innominate and one common carotid). All stent failures were identified in heavily calcified lesions. CONCLUSIONS: Endoluminal stent placement in supraaortic trunk lesions is a viable early solution; however, mid- to long-term restenosis caused by bare metal fatigue and fractures, particularly in cases of calcified innominate artery lesions, are a worrisome finding.

Outcomes and complications associated with off-label and untested use of drug-eluting stents.

CONTEXT: Limited data exist regarding use of drug-eluting stents outside of approved indications in real-world settings. OBJECTIVES: To determine the frequency, safety, and effectiveness of drug-eluting stents for off-label (restenosis, bypass graft lesion, long lesions, vessel size outside of information for use recommendation) and untested (left main, ostial, bifurcation, or total occlusion lesions) indications in percutaneous coronary intervention (PCI). DESIGN, SETTING, AND PATIENTS: Observational, prospective, multicenter registry to evaluate in-hospital, 30-day, and 1-year outcomes among patients undergoing PCI between January and June 2005 in 140 US academic and community medical centers. Of 7752 PCI-treated patients, 6993 (90%) received drug-eluting stents; of these, 5851 (84%) received no other devices. Standard, off-label, and untested use was determined in 5541 (95%) of these 5851 patients, constituting the study cohort. MAIN OUTCOME MEASURES: Frequency of off-label and untested use, 1-year repeat target vessel revascularization, and composite of death, myocardial infarction (MI), or stent thrombosis at in-hospital follow-up and during 1 year of follow-up. RESULTS: Of 5541 patients receiving drug-eluting stents, 2588 (47%) received stents for off-label or untested indications. Adjusted in-hospital risk of death, MI, or stent thrombosis was not statistically different with off-label or untested vs standard use. At 30 days, the risk of this composite end point was significantly higher with off-label use (adjusted hazard ratio [HR], 2.08; 95% confidence interval [CI], 1.24-3.48; P = .005) but not untested use (adjusted HR, 1.45; 95% CI, 0.79-2.67; P = .23). Excluding early events, this end point was not different at 1 year with off-label use (adjusted HR, 1.10; 95% CI, 0.79-1.54; P = .57) or untested use (adjusted HR, 0.91; 95% CI, 0.60-1.38; P = .66). At 1 year, compared with standard use, significantly higher rates of target vessel revascularization were associated with off-label use (adjusted HR, 1.49; 95% CI, 1.13-1.98; P = .005) and untested use (adjusted HR, 1.49; 95% CI, 1.10-2.02; P = .01), although absolute rates were low (standard, 4.4% [n = 113]; off-label, 7.6% [n = 95]; untested, 6.7% [n = 72]). CONCLUSIONS: In contemporary US practice, off-label and untested use of drug-eluting stents is common. Compared with standard use, relative early safety is lower with off-label use, and the long-term effectiveness is lower with both off-label and untested use. However, the absolute event rates remain low.

A comparison of arterial closure devices to manual compression in liver transplantation candidates undergoing coronary angiography.

Whether arterial closure devices can be used safely in a coagulopathic population undergoing cardiac catheterization and at high risk for groin complications, such as liver transplant candidates, is unknown. In this prospective, non-randomized consecutive series of 80 liver transplant candidates undergoing coronary angiography, manual compression and arterial closure devices were compared. Ilio-femoral angiography was performed to determine suitability for use of the closure device. Bleeding and vascular complications were recorded along with time to ambulation. Arterial closure devices were used in 31 patients (39%), whereas manual compression was used in 49 patients (50 procedures) (61%). There were no significant differences between the two groups with respect to age, sex, cardiac risk factors, peripheral vascular disease, baseline platelet count or baseline INR. There were 10 total vascular complications out of 50 procedures (20%) in the manual compression group compared to 2 vascular complications out of 31 procedures in the arterial closure device group (6%; p = 0.12). The time to ambulation was significantly less in the group receiving arterial closure devices versus manual compression (4.2 1.8 hours versus 6.6 3.7 hours, respectively; p = 0.0003). In coagulopathic patients at higher risk for groin complications, arterial closure devices can be safely used and decrease time to ambulation compared to manual compression.