First Experience of Transcatheter Leak Occlusion With Detachable Coils Following Left Atrial Appendage Closure

ObjectivesThe aim of this study was to assess the feasibility and efficacy of transcatheter leak closure with detachable coils in patients with incomplete left atrial appendage (LAA) closure.BackgroundIncomplete LAA closure is common after interventional therapies targeting the LAA, potentially hindering effective thromboembolic prevention. Detachable coils have found a wide range of applications for transcatheter vascular occlusion and embolization procedures.MethodsThirty consecutive patients at high thromboembolic risk with clinically relevant residual leaks (mean age 72 ± 9 years, 73.3% men, mean CHA₂DS₂-VASc score 4.4 ± 1.4, mean HAS-BLED score 3.6 ± 0.8) underwent percutaneous closure of the LAA patency using embolization coils. Transesophageal echocardiography was performed at 60 ± 15 days post-procedure.ResultsLAA closure had been previously attempted with the Watchman device in 25 patients, the Amulet device in 2 patients, and the LARIAT device in 3 patients. Baseline transesophageal echocardiography documented moderate and severe leaks in 20 (66.7%) and 10 (33.3%) patients, respectively. After a single procedure, 25 patients (83.3%) showed complete LAA sealing or minimal leaks. Five patients (16.7%) had moderate residual leaks; 3 patients of them were offered repeat procedures. Mean procedure and fluoroscopy times were 76 ± 41 min and 21 ± 14 min, respectively; the mean volume of iodinated contrast medium used was 80 ± 47 ml. Coil deployment was successful in all cases. The overall complication rate was 6.1%. After a median follow-up period of 54 days (range 43 to 265 days) and an average of 1.1 procedures/patient, transesophageal echocardiography revealed complete LAA sealing or negligible residual leaks in 28 patients (93.3%; 25 with no residual leak, 3 patients with minimal to mild residual leaks) and moderate residual leaks in 2 patients (6.7%).ConclusionsTranscatheter LAA leak occlusion using endovascular coils appears to be a safe, effective, and promising approach in patients at high echo time risk with incomplete LAA closure. (Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures [TREASURE]; NCT03503253)     

Peridevice Leak Following Amplatzer Left Atrial Appendage Occlusion: Cardiac Computed Tomography Classification and Clinical Outcomes

ObjectivesThis study aimed to investigate cardiac computed tomography (CT) and transesophageal echocardiography (TEE) peridevice leak (PDL) assessments, and the clinical relevance of PDL.BackgroundPDL assessment is integral during follow-up after left atrial appendage (LAA) occlusion. Comparative studies of TEE and cardiac CT are sparse, and the clinical relevance of PDL is uncertain.MethodsThis was a single-center observational study of consecutive patients undergoing LAA occlusion with Amplatzer devices (Amplatzer Cardiac Plug/Amulet) between 2010 and 2018 (N = 415). Patients with both 8-week CT and TEE were included for analysis (n = 346). Images were analyzed by blinded investigators (K.K. and A.S.). PDL on cardiac CT was classified from grade 1 to 3, based on PDL at the device disc, device lobe, and LAA contrast patency. Primary clinical outcome was a composite of ischemic stroke, transient ischemic attack, systemic embolism, or all-cause death.ResultsPDL was present in 110 patients (32%) by TEE, with 29 (8%) >3 mm. By cardiac CT, 210 patients (61%) had PDL at the disc, with contrast patency in 204 patients (59%). A grade 3 PDL (gap at disc, lobe, and LAA contrast patency) was present in 63 patients (18%). Bland-Altman analysis showed poor agreement between CT and TEE for leak sizing. CT and TEE detected PDL was not significantly associated with worse outcome, hazard ratio: 1.82 (95 % confidence interval: 0.95 to 3.50); p = 0.07 and hazard ratio: 1.43 (95% confidence interval: 0.74 to 2.76); p = 0.28, respectively.ConclusionsPDL occurrence is substantially higher with CT compared with TEE, with a large discrepancy between modalities in leak quantification. A novel CT-based classification is proposed, yet PDL was not associated with worse clinical outcome.     

Peridevice Leak After Transcatheter Left Atrial Appendage Occlusion: An Analysis of the Amulet IDE Trial

BackgroundPeridevice leak (PDL) is a limitation of left atrial appendage occlusion.ObjectivesThe aim of this study was to assess the incidence of and outcomes associated with PDL in the Amulet IDE (AMPLATZER? Amulet? LAA Occluder Trial) randomized controlled trial.MethodsPatients with atrial fibrillation at increased stroke risk were randomly assigned to undergo either Amulet (dual occlusive mechanism) or Watchman 2.5 (single occlusive mechanism) device implantation. Transesophageal echocardiography was performed at 45 days and 12 months postprocedure. Clinically significant PDL was defined as ≥3 mm. The primary endpoint was ischemic stroke or systemic embolism, and the secondary endpoint was stroke, systemic embolism, or cardiovascular death. The Kaplan-Meier method was used to estimate 18-month cumulative event rates landmarked at day 45 postprocedure.ResultsA total of 1,593 patients underwent successful left atrial appendage occlusion and had an evaluable transesophageal echocardiographic studies at 45 days. The dual–occlusive mechanism device provided superior closure (defined as leak <3 mm) compared with the single–occlusive mechanism device at 45 days (88.9% vs 74.1%; P < 0.01) and 12 months (90.5% vs. 78.3%; P < 0.01). Through 18 months, PDL was associated with a higher, but not statistically significant, risk for the primary endpoint (3.6% vs 1.8%; adjusted HR: 1.98; 95% CI: 0.93-4.19; P = 0.07) and a statistically significantly higher risk for the secondary endpoint (8.1% vs. 4.7%; adjusted HR: 1.66; 95% CI: 1.02-2.69; P = 0.04).ConclusionsThe dual–occlusive mechanism device provided superior closure compared with the single–occlusive mechanism device at both 45 days and 1 year postprocedure. PDL ≥3 mm was associated with a significantly increased 18-month risk for the composite of stroke, systemic embolism, or cardiovascular death. Completeness of closure of the left atrial appendage has important implications for patient outcomes. (AMPLATZER? Amulet? LAA Occluder Trial [Amulet IDE]; NCT02879448)     

Watchman Occlusion in Long-Standing Persistent Atrial Fibrillation: Larger Left Atrial Appendages With Greater Residual Leak

ObjectivesThis study sought to compare patients with and without long-standing persistent atrial fibrillation (LSPAF) undergoing Watchman left atrial appendage (LAA) occlusion.BackgroundAn increased burden of atrial fibrillation is associated with progressive left atrial remodeling and enlargement.MethodsTransesophageal echocardiography (TEE) measures of LAA ostial diameter and depth, device compression, and residual leak were evaluated in 101 consecutive Watchman cases. The patients were categorized into LSPAF (n = 48) or non-LSPAF (n = 53) groups and compared.ResultsThe average LAA ostial diameter for LSPAF versus non-LSPAF by TEE omniplane at 0° was 21.1 ± 4.1 mm versus 18.2 ± 3.6 mm (p = 0.0002); at 45° was 18.7 ± 3.4 mm versus 16.3 ± 3.1 mm (p = 0.0004); at 90° was 19.6 ± 3.8 mm versus 16.2 ± 3.4 mm (p = 0.00001); and at 135° was 21.0 ± 4.1 mm versus 18.0 ± 4.1 mm (p = 0.0005). The average LAA depth for LSPAF versus non-LSPAF by TEE at 0° was 28.1 ± 6.4 mm versus 25.2 ± 4.9 mm (p = 0.02); at 45° was 27.9 ± 5.8 mm versus 25.1 ± 4.3 mm (p = 0.007); at 90° was 27.2 ± 5.2 mm versus 22.8 ± 3.7 mm (p = 0.0001); and at 135° was 25.6 ± 5.4 mm versus 21.5 ± 3.8 mm (p = 0.0001). In successfully treated patients, 77% of the LSPAF group received larger device (27, 30, or 33 mm) implants versus only 46% in the non-LSPAF group (p = 0.003). While both groups had similar rates of moderate (3 to 5 mm) leaks at implant (2% vs. 0%; p = 0.14), 27% of the LSPAF vs. 4% of the non-LSPAF group had moderate leaks (p = 0.04) on 6-week follow-up TEE.ConclusionsPatients with LSPAF have significantly larger LAA sizes, require larger devices, and have more residual leak on follow-up TEE. LSPAF may represent a higher risk group that warrants more stringent long-term follow-up.     

Incidence,Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study

ObjectivesThis study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota).BackgroundDRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized.MethodsA total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation.ResultsDevice implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04).ConclusionsFollowing LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events.     

The Association of Chronic Kidney Disease With Outcomes Following Percutaneous Left Atrial Appendage Closure

ObjectivesThe aim of this study was to investigate the associations of chronic kidney disease (CKD) and end-stage renal disease (ESRD) with in-hospital and short-term outcomes using a large national database representative of contemporary clinical practice.BackgroundCKD and ESRD are associated with increased risk for stroke and bleeding in patients with atrial fibrillation on oral anticoagulation. Left atrial appendage closure (LAAC) may provide a reasonable alternative for these patients; however, the impact of CKD and ESRD on in-hospital and short-term outcomes following LAAC remain largely unknown.MethodsThe Nationwide Readmissions Database was used to identify LAAC procedures from 2016 to 2017 in patients with no CKD, CKD (stages I-V), and ESRD. Multivariable logistic regression models were used to assess in-hospital and short-term outcomes. The primary outcome was in-hospital mortality.ResultsOf 21,274 patients who underwent LAAC during the study period, 3,954 (18.6%) had CKD and 571 (2.7%) had ESRD. ESRD was associated with increased risk for in-hospital mortality compared with no CKD (3.3% vs 0.4%; adjusted odds ratio: 6.48; 95% confidence interval: 3.35-12.50; P < 0.001) and CKD (3.3% vs 0.5%; adjusted odds ratio: 11.43; 95% confidence interval: 4.77-27.39; P < 0.001). CKD was associated with increased risk for in-hospital acute kidney injury or hemodialysis and stroke or transient ischemic attack. ESRD and CKD were associated with increased readmissions extending to 90 days compared with no CKD, and ESRD was associated with increased readmissions compared with CKD. There was no difference with respect to other in-hospital outcomes.ConclusionsESRD is associated with higher in-hospital mortality, and CKD is associated with higher rates of stroke or transient ischemic attack in patients undergoing LAAC. Further research is needed to assess the impact of CKD and ESRD on long-term outcomes in these patients.     

The Hypertrophic Cardiomyopathy Phenotype Viewed Through the Prism of Multimodality Imaging: Clinical and Etiologic Implications

Noninvasive contemporary imaging with echocardiography and cardiovascular magnetic resonance (CMR) provide comprehensive characterization of the hypertrophic cardiomyopathy (HCM) heart including precise definition of left ventricle (LV) wall thickness and reliable identification of morphologic abnormalities of the mitral valve, LV chamber, and myocardial tissue characterization with late gadolinium enhancement (LGE) (fibrosis). Imaging also contributes to identification of patients at risk for sudden death including novel high-risk features such as LV apical aneurysm and extensive LGE. Exercise (stress) echocardiography should be considered to demonstrate physiologic provocation of LV outflow gradients and to distinguish from patients with nonobstructive HCM. Multimodality imaging identifies patients who are optimal candidates for invasive septal reduction therapy and directs preoperative planning for extended myectomy and to optimize alcohol septal ablation. Contemporary imaging interwoven with current management strategies have resulted in a low HCM-related mortality rate.     

Procedural and Short-Term Results With the New Watchman FLX Left Atrial Appendage Occlusion Device

ObjectivesThis study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts).BackgroundThe new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis.MethodsA total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program.ResultsMean age was 75.4 ± 8.9 years, and CHA₂DS₂-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ≥5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred.ConclusionsLAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.     

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States

ObjectivesThe aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States.BackgroundThe National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of “real-world” patients have not been previously reported.MethodsPatients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates.ResultsThe study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA₂DS₂-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier–estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure.ConclusionsThis study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.     

Heart and Lung Multimodality Imaging in COVID-19

The severe acute respiratory syndrome-coronavirus-2 outbreak has rapidly reached pandemic proportions and has become a major threat to global health. Although the predominant clinical feature of coronavirus disease-2019 (COVID-19) is an acute respiratory syndrome of varying severity, ranging from mild symptomatic interstitial pneumonia to acute respiratory distress syndrome, the cardiovascular system can be involved in several ways. As many as 40% of patients hospitalized with COVID-19 have histories of cardiovascular disease, and current estimates report a proportion of myocardial injury in patients with COVID-19 of up to 12%. Multiple pathways have been suggested to explain this finding and the related clinical scenarios, encompassing local and systemic inflammatory responses and oxygen supply-demand imbalance. From a clinical point of view, cardiac involvement during COVID-19 may present a wide spectrum of severity, ranging from subclinical myocardial injury to well-defined clinical entities (myocarditis, myocardial infarction, pulmonary embolism, and heart failure), whose incidence and prognostic implications are currently largely unknown because of a significant lack of imaging data. Integrated heart and lung multimodality imaging plays a central role in different clinical settings and is essential in the diagnosis, risk stratification, and management of patients with COVID-19. The aims of this review are to summarize imaging-oriented pathophysiological mechanisms of lung and cardiac involvement in COVID-19 and to provide a guide for integrated imaging assessment in these patients.     

Impact of Echocardiographic Guidance on Safety and Efficacy of Left Atrial Appendage Closure: An Observational Study

ObjectivesThe aim of this study was to evaluate the impact of echocardiographic guidance on the safety and efficacy of left atrial appendage closure (LAAC).BackgroundExpert consensus documents recommend intraprocedural imaging by means of either transesophageal echocardiography or intracardiac echocardiography to guide LAAC. However, no evidence exists that intraprocedural echocardiographic guidance in addition to fluoroscopy improves the safety and efficacy of LAAC.MethodsConsecutive LAAC procedures performed at a high-volume center between January 2009 and October 2020 were stratified on the basis of intraprocedural imaging modalities, including fluoroscopic guidance (FG) only or intraprocedural echocardiographic guidance (EG) in addition to fluoroscopy. The primary safety endpoint was the composite of procedure-related complications occurring within 7 days after the procedure. Technical success at 7 days and at follow-up were secondary endpoints.ResultsAmong 811 LAAC procedures, 549 (67.7%) and 262 (32.3%) were assigned to the FG and EG groups, respectively. After adjusting for confounders, EG remained associated with a lower rate of the primary safety endpoint (3.4% vs 9.1%; P = 0.004; adjusted odds ratio [OR]: 0.31; 95% CI: 0.11-0.90; P = 0.030). Technical success trended higher at 7 days (92.1% vs 87.2%; P = 0.065; adjusted OR: 1.68; 95% CI: 0.95-3.01; P = 0.079) and was significantly improved with EG compared with FG (87.6% vs 79.9%; P = 0.018; OR: 4.06; 95% CI: 1.60-10.27; P = 0.003) after a median follow-up period of 4.9 months (interquartile range: 3.4 months-6.2 months).ConclusionsIn a large cohort of consecutive LAACs, the use of intraprocedural echocardiography to guide intervention in addition to standard fluoroscopy was associated with lower risks for procedural complications and higher mid-term technical success rates.     

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use

ObjectivesThe authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device.BackgroundThe CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation.MethodsPatients with atrial fibrillation at high stroke risk (CHA₂DS₂-VASc score ≥2) were recruited using standard selection criteria. The LAAC procedure was guided by transesophageal echocardiography with patients under general anesthesia. The CLAAS device is composed of a foam cup, with a Nitinol endoskeleton with an expanded polytetrafluoroethylene cover, delivered with a standard delivery system using a tether for full recapture. All patients received dual-antiplatelet therapy for 6 months, followed by aspirin alone. Transesophageal echocardiographic follow-up was scheduled for 45 days and 1 year.ResultsTwenty-two patients (63.7% with CHA₂DS₂-VASc scores ≥3, 76.2% with HAS-BLED scores ≥3) were enrolled. The device was successfully implanted in 18 patients and unsuccessfully in 4 patients. There were no serious procedural complications. On transesophageal echocardiography performed at 45 days, 1 significant leak (≥5 mm) was seen, which was due to a large posterior lobe not appreciated at the time of implantation, and 1 device-related thrombus was noted, which resolved on oral anticoagulation. There were no periprocedural strokes, major pericardial effusions, or systemic or device embolization.ConclusionsThis first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC.     

Contemporary Issues in Chronic Total Occlusion Percutaneous Coronary Intervention

Remarkable progress has been achieved in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in recent years, with refinement of the indications and technical aspects of the procedure, imaging, and complication management. Randomized controlled trials and rigorous prospective registries have provided high-quality data on the benefits and risks of CTO PCI. Global collaboration has led to an agreement on nomenclature, indications, endpoint definition, and principles of clinical trial design that have been distilled in global consensus documents such as the CTO Academic Research Consortium. Increased use of preprocedural coronary computed tomography angiography and intraprocedural intravascular imaging, as well as development of novel techniques and structured CTO crossing and complication management algorithms, allow a systematic, stepwise approach to this difficult lesion subset. This state-of-the-art review provides a comprehensive discussion about the most recent developments in the indications, preprocedural planning, technical aspects, complication management, and future directions of CTO PCI.     

Iatrogenic Atrial Septal Defects Following Transcatheter Mitral Valve Repair and Implications of Interventional Closure

ObjectivesThe authors investigated whether iatrogenic atrial septal defect (iASD) closure post-transcatheter mitral valve edge-to-edge repair (TMVR) is superior to conservative therapy (CT) and whether outcomes (death/heart failure [HF] hospitalization) differ between patients with and without an iASD post-TMVR.BackgroundTransseptal access for TMVR can create an iASD, which is associated with impaired outcomes. Controversially, the creation of an iASD in HF has been linked to improved hemodynamics.Methods80 patients with an iASD and relevant left-to-right shunting (Qp:Qs ≥1.3) 30 days following TMVR were randomized to CT or interventional closure of the iASD (MITHRAS [Closure of Iatrogenic Atrial Septal Defect Following Transcatheter Mitral Valve Repair] cohort), and 235 patients without an iASD served as a comparative cohort.ResultsAll patients of the MITHRAS cohort (mean age 77 ± 9 years, 39% women) received their allocated treatment, and follow-up was completed for all MITHRAS and comparative cohort (mean age 77 ± 8 years, 47% women) patients. Twelve months post-TMVR, there was no significant difference in the combined endpoint of death or HF hospitalization within the MITHRAS cohort (iASD closure: 35% vs CT 50%; P = 0.26). The combined endpoint was more frequent among patients within the MITHRAS cohort as opposed to the comparative cohort (43% vs 17%; P < 0.0001), primarily driven by a higher rate of HF hospitalization (34% vs 8%; P = 0.004).ConclusionsIn this randomized controlled trial, interventional closure of a relevant iASD 1 month after TMVR did not result in improved clinical outcomes at 12 months post-TMVR. Patients with an iASD are at higher risk for HF hospitalization independent of iASD management and warrant close follow-up. (Closure of Iatrogenic Atrial Septal Defect Following Transcatheter Mitral Valve Repair [MITHRAS]; NCT03024268)     

Transcatheter Interventions for Mitral Regurgitation: Multimodality Imaging for Patient Selection and Procedural Guidance

Transcatheter therapies to treat mitral regurgitation are rapidly developing. Currently, there are several devices commercially available to treat mitral regurgitation. The underlying cause of mitral regurgitation and specific anatomical aspects of the mitral valve and surrounding structures are considered when patients with symptomatic severe mitral regurgitation for transcatheter mitral valve therapies are selected. Multimodality imaging plays an important central role in the selection of patients, providing information about the mechanism of mitral regurgitation, the anatomy of the mitral valve and spatial relationships with the coronary sinus, the circumflex coronary artery and left ventricular outflow tract and to predict the procedural outcomes. During the transcatheter procedure, transesophageal echocardiography and fluoroscopy are key for monitoring the procedural steps to maximize the outcomes and minimize the complications. This paper provides a comprehensive review of the most important aspects to visualize in order to appropriately select patients for transcatheter mitral valve repair and replacement and to guide the procedure for the different transcatheter devices.     

Expert Recommendations on Cardiac Computed Tomography for Planning Transcatheter Left Atrial Appendage Occlusion

Transcatheter left atrial appendage occlusion is an increasingly used alternative to oral anticoagulation in selected patients with atrial fibrillation. Pre-procedural imaging is a prerequisite to a successful intervention, with transesophageal echocardiography as the current gold standard. However, cardiac computed tomography offers improved imaging with high-quality multiplanar and 3-dimensional reconstructed images. Nevertheless, the lack of a standardized imaging protocol has slowed the adoption of cardiac computed tomography into clinical practice. On the basis of current research and expert consensus, this paper provides a protocol for the preparation, acquisition, and interpretation of cardiac computed tomographic imaging in pre-procedural planning of left atrial appendage occlusion.     

Multimodality Intravascular Imaging of High-Risk Coronary Plaque

The majority of coronary atherothrombotic events presenting as myocardial infarction (MI) occur as a result of plaque rupture or erosion. Understanding the evolution from a stable plaque into a life-threatening, high-risk plaque is required for advancing clinical approaches to predict atherothrombotic events, and better treat coronary atherosclerosis. Unfortunately, none of the coronary imaging approaches used in clinical practice can reliably predict which plaques will cause an MI. Currently used imaging techniques mostly identify morphological features of plaques, but are not capable of detecting essential molecular characteristics known to be important drivers of future risk. To address this challenge, engineers, scientists, and clinicians have been working hand-in-hand to advance a variety of multimodality intravascular imaging techniques, whereby 2 or more complementary modalities are integrated into the same imaging catheter. Some of these have already been tested in early clinical studies, with other next-generation techniques also in development. This review examines these emerging hybrid intracoronary imaging techniques and discusses their strengths, limitations, and potential for clinical translation from both an engineering and clinical perspective.     

Clinical Outcomes Associated With Left Atrial Appendage Occlusion Versus Direct Oral Anticoagulation in Atrial Fibrillation

ObjectivesThis study sought to investigate clinical outcomes associated with left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs) in patients with high-risk atrial fibrillation (AF).BackgroundLAAO has been shown to be noninferior to warfarin for stroke prevention in AF. However, anticoagulation with DOACs is now preferred over warfarin as thromboprophylaxis in AF.MethodsPatients with AF enrolled in the Amulet Observational Registry (n = 1,088) who had successful LAAO with the Amplatzer Amulet device (n = 1,078) were compared with a propensity score–matched control cohort of incident AF patients (n = 1,184) treated by DOACs identified from Danish national patient registries. Propensity score matching was based on the covariates of the CHA₂DS₂-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65–74 years, sex category) and HAS-BLED (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores for predicting stroke and bleeding. The primary outcome was a composite of ischemic stroke, major bleeding (Bleeding Academic Research Consortium ≥3), or all-cause mortality, and follow-up was 2 years.ResultsAF patients treated with LAAO had a significantly lower risk of the primary composite outcome as compared with patients treated with DOACs (hazard ratio [HR]: 0.57; 95% confidence interval [CI]: 0.49 to 0.67). Total events and event rates per 100 patient-years were (LAAO vs. DOACs) 256 vs. 461 and 14.5 vs. 25.7, respectively. The risk of ischemic stroke was comparable between groups (HR: 1.11; 95% CI: 0.71 to 1.75), while risk of major bleeding (HR: 0.62; 95% CI: 0.49 to 0.79) and all-cause mortality (HR: 0.53; 95% CI: 0.43 to 0.64) were significantly lower in patients treated with LAAO.ConclusionsAmong high-risk AF patients, LAAO in comparison with DOACs may have similar stroke prevention efficacy but lower risk of major bleeding and mortality.     

Comprehensive Evaluation of Left Ventricle Dysfunction by a New Computed Tomography Scanner: The E-PLURIBUS Study

BackgroundAlthough cardiac magnetic resonance (CMR) is considered the gold standard for myocardial fibrosis detection, cardiac computed tomography (CCT) is emerging as a promising alternative.ObjectivesThe purpose of this study was to assess feasibility and diagnostic accuracy of a comprehensive functional and anatomical evaluation with CCT as compared with CMR in patients with newly diagnosed left ventricular dysfunction (LVD).MethodsA total of 128 consecutive patients with newly diagnosed LVD were screened. Based on the exclusion criteria, 28 cases were excluded. CCT was performed within 10 days from CMR. Biventricular volumes and ejection fraction, and presence and pattern of delayed enhancement (DE), were determined, along with evaluation of coronary arteries among patients undergoing invasive angiography in the 6 months after CCT.ResultsSix cases were excluded because of claustrophobia at CMR. Among the 94 patients who formed the study population, the concordance between CCT and CMR in suggesting the cause of the LVD was high (94.7%, 89/94 patients) in the overall population and was 100% for identifying ischemic cardiomyopathy. The CCT diagnostic rate for DE assessment was also high (96.7%, 1,544/1,598 territories) and similar to that of CMR (97.4%; P = 0.345, CCT vs CMR). Moreover, CCT showed high diagnostic accuracy in the detection of DE (94.8%, 95% CI: 93.6%-95.8%) in a territory-based analysis. Biventricular volumes and function parameters as measured by CCT and CMR were similar, without significant differences with the exception of a modest difference in RV volume. CCT was confirmed to be accurate for assessing arterial coronary circulation. The mean radiation exposure of the whole CCT was 7.78 ± 2.53 mSv (0.84 ± 0.24 mSv for DE).ConclusionsCCT performed with low-dose whole-heart coverage scanner and high-concentration contrast agent appears an effective noninvasive tool for a comprehensive assessment of patients with newly diagnosed LVD.