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JACC. Cardiovascular Interventions May 2019The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine,... (Clinical Trial)
Clinical Trial
OBJECTIVES
The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).
BACKGROUND
Catheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis.
METHODS
Patients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios ≥0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory-assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy.
RESULTS
From April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up.
CONCLUSIONS
Percutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care.
Topics: Acute Disease; Adult; Aged; Cardiac Catheters; Female; Humans; Male; Middle Aged; Prospective Studies; Pulmonary Embolism; Recovery of Function; Risk Assessment; Risk Factors; Suction; Thrombectomy; Time Factors; Treatment Outcome; United States; Ventricular Function, Left; Ventricular Function, Right
PubMed: 31072507
DOI: 10.1016/j.jcin.2018.12.022 -
Circulation. Arrhythmia and... Jun 2020The tissue selectivity of pulsed field ablation (PFA) provides safety advantages over radiofrequency ablation in treating atrial fibrillation. One-shot PFA catheters... (Clinical Trial)
Clinical Trial
BACKGROUND
The tissue selectivity of pulsed field ablation (PFA) provides safety advantages over radiofrequency ablation in treating atrial fibrillation. One-shot PFA catheters have been shown capable of performing pulmonary vein isolation, but not flexible lesion sets such as linear lesions. A novel lattice-tip ablation catheter with a compressible 9-mm nitinol tip is able to deliver either focal radiofrequency ablation or PFA lesions, each in 2 to 5 s.
METHODS
In a 3-center, single-arm, first-in-human trial, the 7.5F lattice catheter was used with a custom mapping system to treat paroxysmal or persistent atrial fibrillation. Toggling between energy sources, point-by-point pulmonary vein encirclement was performed using biphasic PFA posteriorly and either temperature-controlled irrigated radiofrequency ablation or PFA anteriorly (RF/PF or PF/PF, respectively). Linear lesions were created using either PFA or radiofrequency ablation.
RESULTS
The 76-patient cohort included 55 paroxysmal and 21 persistent atrial fibrillation patients undergoing either RF/PF (40 patients) or PF/PF (36 patients) ablation. The pulmonary vein isolation therapy duration time (transpiring from first to last lesion) was 22.6±8.3 min/patient, with a mean of 50.1 RF/PF lesions/patient. Linear lesions included 14 mitral (4 RF/2 RF+PF/8 PF), 34 left atrium roof (12 RF/22 PF), and 44 cavotricuspid isthmus (36 RF/8 PF) lines, with therapy duration times of 5.1±3.5, 1.8±2.3, and 2.4±2.1 min/patient, respectively. All lesion sets were acutely successful, using 4.7±3.5 minutes of fluoroscopy. There were no device-related complications, including no strokes. Postprocedure esophagogastroduodenoscopy revealed minor mucosal thermal injury in 2 of 36 RF/PF and 0 of 24 PF/PF patients. Postprocedure brain magnetic resonance imaging revealed diffusion-weighted imaging+/fluid-attenuated inversion recovery- and diffusion-weighted imaging+/fluid-attenuated inversion recovery+ asymptomatic lesions in 5 and 3 of 51 patients, respectively.
CONCLUSIONS
A novel lattice-tip catheter could safely and rapidly ablate atrial fibrillation using either a combined RF/PF approach (capitalizing on the safety of PFA and the years of experience with radiofrequency energy) or an entirely PF approach. Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT04141007 and NCT04194307.
Topics: Action Potentials; Aged; Atrial Fibrillation; Cardiac Catheterization; Cardiac Catheters; Catheter Ablation; Czech Republic; Electrophysiologic Techniques, Cardiac; Equipment Design; Female; Heart Rate; Humans; Lithuania; Male; Middle Aged; Prospective Studies; Pulmonary Veins; Therapeutic Irrigation; Time Factors; Treatment Outcome
PubMed: 32383391
DOI: 10.1161/CIRCEP.120.008718 -
JACC. Cardiovascular Interventions Dec 2020This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions.
BACKGROUND
Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes.
METHODS
The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months.
RESULTS
Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm.
CONCLUSIONS
In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).
Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Germany; Humans; Pharmaceutical Preparations; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome
PubMed: 33248978
DOI: 10.1016/j.jcin.2020.08.035 -
Catheterization and Cardiovascular... Apr 2020Telesupport means guidance of a procedure performed at one location by another clinician at a different location. In a pilot study, 21 percutaneous coronary...
Telesupport means guidance of a procedure performed at one location by another clinician at a different location. In a pilot study, 21 percutaneous coronary interventions and nine catheter ablations were successfully performed without complications with telesupport from a remote university hospital. Telesupport is a powerful tool that can be especially useful when urgent care is needed or when transfer is not an option, but it also has limitations, such as network failure or difficulties handling complications; judicious use is key to optimizing outcomes.
Topics: Cardiac Catheters; Catheter Ablation; Percutaneous Coronary Intervention; Pilot Projects; Treatment Outcome
PubMed: 32294328
DOI: 10.1002/ccd.28878 -
Sensors (Basel, Switzerland) Sep 2020sensors yield valuable medical information by measuring directly on the living tissue of a patient. These devices can be surface or implant devices. Electrical activity... (Review)
Review
sensors yield valuable medical information by measuring directly on the living tissue of a patient. These devices can be surface or implant devices. Electrical activity in the body, from organs or muscles can be measured using surface electrodes. For short term internal devices, catheters are used. These include cardiac catheter (in blood vessels) and bladder catheters. Due to the size and shape of the catheters, silicon devices provided an excellent solution for sensors. Since many cardiac catheters are disposable, the high volume has led to lower prices of the silicon sensors. Many catheters use a single sensor, but silicon offers the opportunity to have multi sensors in a single catheter, while maintaining small size. The cardiac catheter is usually inserted for a maximum of 72 h. Some devices may be used for a short-to-medium period to monitor parameters after an operation or injury (1-4 weeks). Increasingly, sensing, and actuating, devices are being applied to longer term implants for monitoring a range of parameters for chronic conditions. Devices for longer term implantation presented additional challenges due to the harshness of the environment and the stricter regulations for biocompatibility and safety. This paper will examine the three main areas of application for in-vivo devices: surface devices and short/medium-term and long-term implants. The issues of biocompatibility and safety will be discussed.
Topics: Electrodes; Humans; Monitoring, Physiologic; Prostheses and Implants; Silicon
PubMed: 32883011
DOI: 10.3390/s20174953 -
JACC. Cardiovascular Imaging May 2019Cardiac magnetic resonance (CMR) and cardiac CT (CCT) have evolved into powerful diagnostic tools in the evaluation of patients with cardiovascular diseases. However,... (Review)
Review
Cardiac magnetic resonance (CMR) and cardiac CT (CCT) have evolved into powerful diagnostic tools in the evaluation of patients with cardiovascular diseases. However, the use of these imaging techniques poses potential safety concerns for patients with implanted cardiac devices. These concerns result from the potential for electromagnetic interaction between the device and the CMR field or CCT x-ray radiation, which could lead to device heating, malfunction, or dislocation. Additionally, the presence of cardiac devices may induce significant image artifacts due to local magnetic field inhomogeneities (CMR) or photon starvation/beam hardening (CCT). In this review summarizes the safety issues regarding imaging in patients with cardiac devices. Optimization strategies to mitigate image artifacts and to improve imaging efficacy are discussed.
Topics: Artifacts; Cardiac Catheters; Defibrillators, Implantable; Heart Valve Prosthesis; Heart-Assist Devices; Humans; Magnetic Resonance Imaging; Pacemaker, Artificial; Predictive Value of Tests; Reproducibility of Results; Septal Occluder Device; Stents; Tomography, X-Ray Computed
PubMed: 31072517
DOI: 10.1016/j.jcmg.2018.09.030 -
Methodist DeBakey Cardiovascular Journal 2016Patients with pulmonary embolism (PE) present with highly variable clinical symptoms and often have accompanying comorbidities. Timely diagnosis and treatment are... (Review)
Review
Patients with pulmonary embolism (PE) present with highly variable clinical symptoms and often have accompanying comorbidities. Timely diagnosis and treatment are critical to help prevent recurrence and increased morbidity/mortality. While open surgical thrombectomy was once reserved only for those with massive PE and hemodynamic compromise, it has been reevaluated with a focus on careful patient selection and early intervention. Lately, there has been increased interest in catheter-based interventions and in combining these with an open surgical component to decrease the magnitude of the intervention-for example, direct placement of large-bore thrombectomy devices directly into the right ventricle via sternotomy or subxiphoid approaches. In addition, improved diagnostic capabilities have allowed for expedited diagnosis and treatment of patients with life-threatening PE. At our institution, a hybrid room allows patients suspected of having a massive or submassive PE to undergo on-table contrast-enhanced cone-beam computed tomography scan, thus creating a high-resolution 3-dimensional image of the arterial system that can provide immediate guidance for therapeutic intervention. This review highlights the array of therapeutic options currently used in our armamentarium at the Houston Methodist DeBakey Heart & Vascular Center and describes our development of a pulmonary angioplasty procedure that we believe will greatly facilitate selective thrombus removal in the acute PE setting.
Topics: Cardiac Catheterization; Cardiac Catheters; Computed Tomography Angiography; Endovascular Procedures; Humans; Imaging, Three-Dimensional; Models, Anatomic; Models, Cardiovascular; Patient-Specific Modeling; Predictive Value of Tests; Printing, Three-Dimensional; Pulmonary Artery; Pulmonary Embolism; Radiographic Image Interpretation, Computer-Assisted; Thrombectomy; Treatment Outcome
PubMed: 28289497
DOI: 10.14797/mdcj-12-4-219 -
JACC. Cardiovascular Interventions Mar 2017
Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Coronary Artery Bypass; Coronary Artery Disease; History, 20th Century; Humans; Risk Factors; Smoking; Time Factors; Treatment Outcome
PubMed: 28279324
DOI: 10.1016/j.jcin.2017.02.001 -
Open Heart Oct 2020The use of fractional flow reserve (FFR) in guiding revascularisation improves patient outcomes and has been well-established in clinical guidelines. Despite this, the... (Review)
Review
The use of fractional flow reserve (FFR) in guiding revascularisation improves patient outcomes and has been well-established in clinical guidelines. Despite this, the uptake of FFR has been limited, likely attributable to the perceived increase in procedural time and use of hyperaemic agents that can cause patient discomfort. This has led to the development of instantaneous wave-free ratio (iFR), an alternative non-hyperaemic pressure ratio (NHPR). Since its inception, the use of iFR has been supported by an increasing body of evidence and is now guideline recommended. More recently, other commercially available NHPRs including diastolic hyperaemia-free ratio and resting full-cycle ratio have emerged. Studies have demonstrated that these indices, in addition to mean distal coronary artery pressure to mean aortic pressure ratio, are mathematically analogous (with specific nuances) to iFR. Additionally, there is increasing data demonstrating the equivalent diagnostic performance of alternative NHPRs in comparison with iFR and FFR. These NHPRs are now integral within most current pressure wire systems and are commonly available in the catheter laboratory. It is therefore key to understand the fundamental differences and evidence for NHPRs to guide appropriate clinical decision-making.
Topics: Arterial Pressure; Cardiac Catheterization; Cardiac Catheters; Clinical Decision-Making; Coronary Artery Disease; Coronary Circulation; Fractional Flow Reserve, Myocardial; Humans; Percutaneous Coronary Intervention; Predictive Value of Tests; Transducers, Pressure; Treatment Outcome
PubMed: 33004619
DOI: 10.1136/openhrt-2020-001308 -
BMC Cardiovascular Disorders May 2020Right free wall accessory pathways (AP) are difficult to treat with catheter ablation as ablation catheter (AC) instability at the tricuspid annulus often precludes...
BACKGROUND
Right free wall accessory pathways (AP) are difficult to treat with catheter ablation as ablation catheter (AC) instability at the tricuspid annulus often precludes successful procedure. The aim of our study was to test a novel intra-cardiac echocardiography (ICE) guided technique for AC placement. Feasibility and success rates were observed.
METHODS
Eight consecutive patients (aged 29 ± 21 years, 4 female) with Wolff-Parkinson-White syndrome and a right free wall AP were included in the study. ICE, three-dimensional (3D) electro-anatomic mapping (EAM) system, and a steerable long sheath were used together with either an irrigated or a non-irrigated tip radio-frequency AC to achieve a "loop" manoeuvre which provided AC tip stability at the ventricular aspect of the tricuspid annulus. X-ray fluoroscopy was not used.
RESULTS
Three patients had an anterior and five had a lateral location of the right free wall AP. Procedures were successful in all patients, without recurrences during the mean follow-up of 397 ± 363 days. Average procedural duration was 90 ± 31 min. On average, 6.6 ± 5.7 ablations were needed. Average time to terminate AP conduction after the start of ablation was 4.8 ± 4.2 s. In five patients (62%) AP conduction was successfully terminated with the first ablation. There were no procedural complications.
CONCLUSIONS
The novel ICE-guided approach with concomitant use of the steerable sheath and the 3D EAM system for zero-fluoroscopy mapping and ablation of the right free wall APs proved feasible and resulted in excellent acute and long-term outcomes.
Topics: Accessory Atrioventricular Bundle; Action Potentials; Adolescent; Adult; Cardiac Catheters; Catheter Ablation; Child; Echocardiography; Feasibility Studies; Female; Heart Rate; Humans; Male; Middle Aged; Operative Time; Retrospective Studies; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Wolff-Parkinson-White Syndrome; Young Adult
PubMed: 32375635
DOI: 10.1186/s12872-020-01494-1