Right heart catheterization using metallic guidewires and low SAR cardiovascular magnetic resonance fluoroscopy at 1.5 Tesla: first in human experience.

BACKGROUND: Cardiovascular magnetic resonance (CMR) fluoroscopy allows for simultaneous measurement of cardiac function, flow and chamber pressure during diagnostic heart catheterization. To date, commercial metallic guidewires were considered contraindicated during CMR fluoroscopy due to concerns over radiofrequency (RF)-induced heating. The inability to use metallic guidewires hampers catheter navigation in patients with challenging anatomy. Here we use low specific absorption rate (SAR) imaging from gradient echo spiral acquisitions and a commercial nitinol guidewire for CMR fluoroscopy right heart catheterization in patients. METHODS: The low-SAR imaging protocol used a reduced flip angle gradient echo acquisition (10° vs 45°) and a longer repetition time (TR) spiral readout (10 ms vs 2.98 ms). Temperature was measured in vitro in the ASTM 2182 gel phantom and post-mortem animal experiments to ensure freedom from heating with the selected guidewire (150 cm × 0.035″ angled-tip nitinol Terumo Glidewire). Seven patients underwent CMR fluoroscopy catheterization. Time to enter each chamber (superior vena cava, main pulmonary artery, and each branch pulmonary artery) was recorded and device visibility and confidence in catheter and guidewire position were scored on a Likert-type scale. RESULTS: Negligible heating (< 0.07°C) was observed under all in vitro conditions using this guidewire and imaging approach. In patients, chamber entry was successful in 100% of attempts with a guidewire compared to 94% without a guidewire, with failures to reach the branch pulmonary arteries. Time-to-enter each chamber was similar (p=NS) for  the two approaches. The guidewire imparted useful catheter shaft conspicuity and enabled interactive modification of catheter shaft stiffness, however, the guidewire tip visibility was poor. CONCLUSIONS: Under specific conditions, trained operators can apply low-SAR imaging and using a specific fully-insulated metallic nitinol guidewire (150 cm × 0.035" Terumo Glidewire) to augment clinical CMR fluoroscopy right heart catheterization. TRIAL REGISTRATION: Clinicaltrials.gov NCT03152773 , registered May 15, 2017.

CMR fluoroscopy right heart catheterization for cardiac output and pulmonary vascular resistance: results in 102 patients.

BACKGROUND: Quantification of cardiac output and pulmonary vascular resistance (PVR) are critical components of invasive hemodynamic assessment, and can be measured concurrently with pressures using phase contrast CMR flow during real-time CMR guided cardiac catheterization. METHODS: One hundred two consecutive patients underwent CMR fluoroscopy guided right heart catheterization (RHC) with simultaneous measurement of pressure, cardiac output and pulmonary vascular resistance using CMR flow and the Fick principle for comparison. Procedural success, catheterization time and adverse events were prospectively collected. RESULTS: RHC was successfully completed in 97/102 (95.1%) patients without complication. Catheterization time was 20 ± 11 min. In patients with and without pulmonary hypertension, baseline mean pulmonary artery pressure was 39 ± 12 mmHg vs. 18 ± 4 mmHg (p < 0.001), right ventricular (RV) end diastolic volume was 104 ± 64 vs. 74 ± 24 (p = 0.02), and RV end-systolic volume was 49 ± 30 vs. 31 ± 13 (p = 0.004) respectively. 103 paired cardiac output and 99 paired PVR calculations across multiple conditions were analyzed. At baseline, the bias between cardiac output by CMR and Fick was 5.9% with limits of agreement -38.3% and 50.2% with r = 0.81 (p < 0.001). The bias between PVR by CMR and Fick was -0.02 WU.m2 with limits of agreement -2.6 and 2.5 WU.m2 with r = 0.98 (p < 0.001). Correlation coefficients were lower and limits of agreement wider during physiological provocation with inhaled 100% oxygen and 40 ppm nitric oxide. CONCLUSIONS: CMR fluoroscopy guided cardiac catheterization is safe, with acceptable procedure times and high procedural success rate. Cardiac output and PVR measurements using CMR flow correlated well with the Fick at baseline and are likely more accurate during physiological provocation with supplemental high-concentration inhaled oxygen. TRIAL REGISTRATION: Clinicaltrials.gov NCT01287026 , registered January 25, 2011.

Intentional right atrial exit for microcatheter infusion of pericardial carbon dioxide or iodinated contrast to facilitate sub-xiphoid access.

OBJECTIVES: We test the safety of transatrial pericardial access using small catheters, infusion of carbon dioxide (CO2 ) or iodinated contrast to facilitate sub-xiphoid access, and catheter withdrawal under full anticoagulation. BACKGROUND: Sub-xiphoid pericardial access is required for electrophysiological and structural heart interventions. If present, an effusion protects the heart from needle injury by separating the myocardium from the pericardium. However, if the pericardium is 'dry' then there is a significant risk of right ventricle or coronary artery laceration caused by the heart beating against the needle tip. Intentional right atrial exit is an alternative pericardial access route, through which contrast media could be infused to separate pericardial layers. METHODS: Transatrial pericardial access was obtained in a total of 30 Yorkshire swine using 4Fr or 2.8Fr catheters. In 16 animals, transatrial catheters were withdrawn under anticoagulation and MRI was performed to monitor for pericardial hemorrhage. In 14 animals, iodinated contrast or CO2 was infused before sub-xiphoid access was obtained. RESULTS: Small effusions (mean 18.5 ml) were observed after 4Fr (1.3 mm outer-diameter) but not after 2.8Fr (0.9 mm outer-diameter) transatrial catheter withdrawal despite full anticoagulation (mean activated clotting time 383 sec), with no hemodynamic compromise. Pericardial CO2 resorbed spontaneously within 15 min. CONCLUSIONS: Intentional transatrial exit into the pericardium using small catheters is safe and permits infusion of CO2 or iodinated contrast to separate pericardial layers and facilitate sub-xiphoid access. This reduces the risk of right ventricular or coronary artery laceration. 2.8Fr transatrial catheter withdrawal does not cause any pericardial hemorrhage, even under full anticoagulation.

Segmented nitinol guidewires with stiffness-matched connectors for cardiovascular magnetic resonance catheterization: preserved mechanical performance and freedom from heating.

BACKGROUND: Conventional guidewires are not suitable for use during cardiovascular magnetic resonance (CMR) catheterization. They employ metallic shafts for mechanical performance, but which are conductors subject to radiofrequency (RF) induced heating. To date, non-metallic CMR guidewire designs have provided inadequate mechanical support, trackability, and torquability. We propose a metallic guidewire for CMR that is by design intrinsically safe and that retains mechanical performance of commercial guidewires. METHODS: The NHLBI passive guidewire is a 0.035" CMR-safe, segmented-core nitinol device constructed using short nitinol rod segments. The electrical length of each segment is less than one-quarter wavelength at 1.5 Tesla, which eliminates standing wave formation, and which therefore eliminates RF heating along the shaft. Each of the electrically insulated segments is connected with nitinol tubes for stiffness matching to assure uniform flexion. Iron oxide markers on the distal shaft impart conspicuity. Mechanical integrity was tested according to International Organization for Standardization (ISO) standards. CMR RF heating safety was tested in vitro in a phantom according to American Society for Testing and Materials (ASTM) F-2182 standard, and in vivo in seven swine. Results were compared with a high-performance commercial nitinol guidewire. RESULTS: The NHLBI passive guidewire exhibited similar mechanical behavior to the commercial comparator. RF heating was reduced from 13 °C in the commercial guidewire to 1.2 °C in the NHLBI passive guidewire in vitro, using a flip angle of 75°. The maximum temperature increase was 1.1 ± 0.3 °C in vivo, using a flip angle of 45°. The guidewire was conspicuous during left heart catheterization in swine. CONCLUSIONS: We describe a simple and intrinsically safe design of a metallic guidewire for CMR cardiovascular catheterization. The guidewire exhibits negligible heating at high flip angles in conformance with regulatory guidelines, yet mechanically resembles a high-performance commercial guidewire. Iron oxide markers along the length of the guidewire impart passive visibility during real-time CMR. Clinical translation is imminent.

Real-time magnetic resonance imaging guidance improves the diagnostic yield of endomyocardial biopsy.

BACKGROUND: Diagnostic yield of endomyocardial biopsy is low, particularly in disease that affects the myocardium in a non-uniform distribution. We hypothesized that real-time MRI guidance could improve the yield through targeted biopsy of focal myocardial pathology. METHODS: An animal model of focal myocardial pathology was created by infusing 3mL of fluorescent microspheres (NuFlow Hydrocoat, 15µm diameter, 5 million spheres/mL) followed by 2mL of 100% ethanol to a branch coronary artery. Animals were survived for minimum 14days, before undergoing MRI guided endomyocardial biopsy using a custom 6.5Fr active visualization MRI-conditional bioptome and X-ray guided biopsy using a commercial bioptome. Specimens were analyzed using a dissecting microscope under ultraviolet light to determine the proportion of 'on-target' specimens containing fluorescent microspheres. RESULTS: A total of 77 specimens were obtained using real-time MRI guidance and 87 using X-ray guidance, in five animals. Specimens obtained with the MRI-conditional bioptome were smaller compared with the commercial X-ray bioptome. Real-time MRI guidance significantly increased the diagnostic yield of endomyocardial biopsy (82% vs. 56% on-target biopsy specimens with real-time MRI vs. X-ray guidance, p<0.01). CONCLUSIONS: Endomyocardial biopsy performed using real-time MRI guidance is feasible and significantly improves the diagnostic yield compared with X-ray fluoroscopy guidance.

Interventional-Cardiovascular MR: Role of the Interventional MR Technologist.

BACKGROUND: Interventional-cardiovascular magnetic resonance (iCMR) is a promising clinical tool for adults and children who need a comprehensive hemodynamic catheterization of the heart. Magnetic resonance (MR) imaging-guided cardiac catheterization offers radiation-free examination with increased soft tissue contrast and unconstrained imaging planes for catheter guidance. The interventional MR technologist plays an important role in the care of patients undergoing such procedures. It is therefore helpful for technologists to understand the unique iCMR preprocedural preparation, procedural and imaging workflows, and management of emergencies. The authors report their team's experience from the National Institutes of Health Clinical Center and a collaborating pediatric site.

Magnetic Resonance Imaging-Guided Transcatheter Cavopulmonary Shunt.

OBJECTIVES: The aim of this study was to test the hypothesis that real-time magnetic resonance imaging (MRI) would enable closed-chest percutaneous cavopulmonary anastomosis and shunt by facilitating needle guidance along a curvilinear trajectory, around critical structures, and between a superior vena cava "donor" vessel and a pulmonary artery "target." BACKGROUND: Children with single-ventricle physiology require multiple open heart operations for palliation, including sternotomies and cardiopulmonary bypass. The reduced morbidity of a catheter-based approach would be attractive. METHODS: Fifteen naive swine underwent transcatheter cavopulmonary anastomosis and shunt creation under 1.5-T MRI guidance. An MRI antenna-needle was advanced from the superior vena cava into the target pulmonary artery bifurcation using real-time MRI guidance. In 10 animals, balloon-expanded off-the-shelf endografts secured a proximal end-to-end caval anastomosis and a distal end-to-side pulmonary anastomosis that preserved blood flow to both branch pulmonary arteries. In 5 animals, this was achieved with a novel, purpose-built, self-expanding device. RESULTS: Real-time MRI needle access of target vessels (pulmonary artery), endograft delivery, and superior vena cava shunt to pulmonary arteries were successful in all animals. All survived the procedure without complications. Intraprocedural real-time MRI, post-procedural MRI, x-ray angiography, computed tomography, and necropsy showed patent shunts with bidirectional pulmonary artery blood flow. CONCLUSIONS: MRI guidance enabled a complex, closed-chest, beating-heart, pediatric, transcatheter structural heart procedure. In this study, MRI guided trajectory planning and reproducible, reliable bidirectional cavopulmonary shunt creation.

Intentional Laceration of the Anterior Mitral Valve Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Replacement: Pre-Clinical Findings.

OBJECTIVES: The authors propose a novel transcatheter transection of the anterior mitral leaflet to prevent iatrogenic left ventricular outflow tract (LVOT) obstruction during transcatheter mitral valve replacement (TMVR). BACKGROUND: LVOT obstruction is a life-threatening complication of TMVR caused by septal displacement of the anterior mitral leaflet. METHODS: In vivo procedures in swine were guided by biplane x-ray fluoroscopy and intracardiac echocardiography. Retrograde transaortic 6-F guiding catheters straddled the anterior mitral leaflet. A stiff 0.014-inch guidewire with polymer jacket insulation was electrified and advanced from the LVOT, through the A2 leaflet base, into the left atrium. The wire was snared and externalized, forming a loop that was energized and withdrawn to lacerate the anterior mitral leaflet. RESULTS: The anterior mitral leaflet was successfully lacerated in 7 live and 1 post-mortem swine under heparinization. Lacerations extended to 89 ± 19% of leaflet length and were located within 0.5 ± 0.4 mm of leaflet centerline. The chordae were preserved and retracted the leaflet halves away from the LVOT. LVOT narrowing after benchtop TMVR was significantly reduced with intentional laceration of the anterior mitral leaflet to prevent LVOT obstruction than without (65 ± 10% vs. 31 ± 18% of pre-implantation diameter, p < 0.01). The technique caused mean blood pressure to fall (from 54 ± 6 mm Hg to 30 ± 4 mm Hg, p < 0.01), but blood pressure remained steady until planned euthanasia. No collateral tissue injury was identified on necropsy. CONCLUSIONS: Using simple catheter techniques, the anterior mitral valve leaflet was transected. Cautiously applied in patients, this strategy can prevent anterior mitral leaflet displacement and LVOT obstruction caused by TMVR.

Transcatheter Myocardial Needle Chemoablation During Real-Time Magnetic Resonance Imaging: A New Approach to Ablation Therapy for Rhythm Disorders.

BACKGROUND: Radiofrequency ablation for ventricular arrhythmias is limited by inability to visualize tissue destruction, by reversible conduction block resulting from edema surrounding lesions, and by insufficient lesion depth. We hypothesized that transcatheter needle injection of caustic agents doped with gadolinium contrast under real-time magnetic resonance imaging (MRI) could achieve deep, targeted, and irreversible myocardial ablation, which would be immediately visible. METHODS AND RESULTS: Under real-time MRI guidance, ethanol or acetic acid was injected into the myocardium of 8 swine using MRI-conspicuous needle catheters. Chemoablation lesions had identical geometry by in vivo and ex vivo MRI and histopathology, both immediately and after 12 (7-17) days. Ethanol caused stellate lesions with patchy areas of normal myocardium, whereas acetic acid caused homogeneous circumscribed lesions of irreversible necrosis. Ischemic cardiomyopathy was created in 10 additional swine by subselective transcoronary ethanol administration into noncontiguous territories. After 12 (8-15) days, real-time MRI-guided chemoablation-with 2 to 5 injections to create a linear lesion-successfully eliminated the isthmus and local abnormal voltage activities. CONCLUSIONS: Real-time MRI-guided chemoablation with acetic acid enabled the intended arrhythmic substrate, whether deep or superficial, to be visualized immediately and ablated irreversibly. In an animal model of ischemic cardiomyopathy, obliteration of a conductive isthmus both anatomically and functionally and abolition of local abnormal voltage activities in areas of heterogeneous scar were feasible. This represents the first report of MRI-guided myocardial chemoablation, an approach that could improve the efficacy of arrhythmic substrate ablation in the thick ventricular myocardium.

Transatrial intrapericardial tricuspid annuloplasty.

OBJECTIVES: This study sought to demonstrate transcatheter deployment of a circumferential device within the pericardial space to modify tricuspid annular dimensions interactively and to reduce functional tricuspid regurgitation (TR) in swine. BACKGROUND: Functional TR is common and is associated with increased morbidity and mortality. There are no reported transcatheter tricuspid valve repairs. We describe a transcatheter extracardiac tricuspid annuloplasty device positioned in the pericardial space and delivered by puncture through the right atrial appendage. We demonstrate acute and chronic feasibility in swine. METHODS: Transatrial intrapericardial tricuspid annuloplasty (TRAIPTA) was performed in 16 Yorkshire swine, including 4 with functional TR. Invasive hemodynamics and cardiac magnetic resonance imaging (MRI) were performed at baseline, immediately after annuloplasty and at follow-up. RESULTS: Pericardial access via a right atrial appendage puncture was uncomplicated. In 9 naïve animals, tricuspid septal-lateral and anteroposterior dimensions, the annular area and perimeter, were reduced by 49%, 31%, 59%, and 24% (p < 0.001), respectively. Tricuspid leaflet coaptation length was increased by 53% (p < 0.001). Tricuspid geometric changes were maintained after 9.7 days (range, 7 to 14 days). Small effusions (mean, 46 ml) were observed immediately post-procedure but resolved completely at follow-up. In 4 animals with functional TR, severity of regurgitation by intracardiac echocardiography was reduced. CONCLUSIONS: Transatrial intrapericardial tricuspid annuloplasty is a transcatheter extracardiac tricuspid valve repair performed by exiting the heart from within via a transatrial puncture. The geometry of the tricuspid annulus can interactively be modified to reduce severity of functional TR in an animal model.

Fully percutaneous transthoracic left atrial entry and closure as a potential access route for transcatheter mitral valve interventions.

BACKGROUND: Percutaneous access for mitral interventions is currently limited to transapical and transseptal routes, both of which have shortcomings. We hypothesized that the left atrium could be accessed directly through the posterior chest wall under imaging guidance. METHODS AND RESULTS: We tested percutaneous transthoracic left atrial access in 12 animals (10 pigs and 2 sheep) under real-time magnetic resonance imaging or x-ray fluoroscopy plus C-arm computed tomographic guidance. The pleural space was insufflated with CO2 to displace the lung, an 18F sheath was delivered to the left atrium, and the left atrial port was closed using an off-the-shelf nitinol cardiac occluder. Animals were survived for a minimum of 7 days. The left atrial was accessed, and the port was closed successfully in 12/12 animals. There was no procedural mortality and only 1 hemodynamically insignificant pericardial effusion was observed at follow-up. We also successfully performed the procedure on 3 human cadavers. A simulated trajectory to the left atrium was present in all of 10 human cardiac computed tomographic angiograms analyzed. CONCLUSIONS: Percutaneous transthoracic left atrial access is feasible without instrumenting the left ventricular myocardium. In our experience, magnetic resonance imaging offers superb visualization of anatomic structures with the ability to monitor and address complications in real-time, although x-ray guidance seems feasible. Clinical translation seems realistic based on human cardiac computed tomographic analysis and cadaver testing. This technique could provide a direct nonsurgical access route for future transcatheter mitral implantation.