Amulet device implantation following incomplete left atrial appendage closure with Watchman legacy device.

Peri-device leak after left atrial appendage closure (LAAC) is often treated with endovascular coils, plugs, or second occluders. This is the first study reporting the Amulet device used for peri-device leak. An 80-year-old male with paroxysmal atrial fibrillation and recurrent falls with head trauma who underwent LAAC with a 24 mm Watchman 2.5 device 3 years ago at another institution was referred to our clinic for management of the peri-device leak. Transesophageal echocardiogram showed persistent residual peri-device leak with 5 mm width along the Coumadin ridge aspect of the device. Computed tomography (CT) also showed the peri-device leak with width of 6 mm and complete opacification of left atrial appendage (LAA). Importantly, CT demonstrated that the Watchman 2.5 device was deployed at distal LAA, leaving the proximal part of LAA with length of 10 mm from ostium. Under general anesthesia, a 22 mm Amulet device was deployed successfully with complete sealing of LAA. Procedure planning is the key to minimize the risk of peri-device leak or device-related thrombosis. Careful assessment of LAA anatomy using multimodality images for peri-device leak after LAAC helped optimal treatment strategy including second LAAC with different type of devices.

Midterm follow-up after computed tomography angiography planned left atrial appendage closure.

BACKGROUND: While studies have shown the advantages of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) in left atrial appendage closure (LAAC) preprocedural planning for WATCHMAN™ legacy and FLX devices, there has been no reported long-term data for this approach. OBJECTIVES: We sought to evaluate long-term outcomes using CTA-based preprocedural planning for LAAC using the WATCHMAN™ device. METHODS: A prospective analysis of 231 consecutive patients who underwent LAAC in a single, large academic hospital in the United States was conducted over a 5-year period. CTA-guided preprocedural planning was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. Rates of death, cerebral embolism, systemic embolism, and major and minor bleeding were recorded. Adjusted predicted stroke and major bleeding rates were derived from CHA2DS2-Vasc and HAS-BLED scores, respectively. RESULTS: From January 26, 2017, to November 23, 2021, 231 patients underwent LAAC with CTA preprocedural planning by two operating physicians. The mean age of patients was 76.5 ± 8.4. 59.7% of patients were male. Mean CHA2DS2VASc and HAS-BLED scores were 4.5 ± 1.4 and 3.9 ± 0.9, respectively. All procedures were performed with intracardiac echo (100%). The procedural success rate was 99.1%. The CTA sizing strategy accurately predicted the implant size in 93.5% of patients. Mean number of devices used was 1.10 ± 0.3. Peri-procedural complication rate was 2.2%. 6 patients were lost to follow-up. Mean follow-up was 608.94 days with a total of 377.04 patient years. Median follow-up period of 368 days (interquartile range: 209-1067 days). There were 51 deaths from all causes (13.52 per 100 patient-years), 10 cases of cerebral embolism (2.65 per 100 patient-years), 2 cases of systemic embolism (0.53 per 100 patient-years), 17 cases of major bleeding (4.50 per 100 patient-years), and 31 cases of minor bleeding (8.2 per 100 patient-years). All-cause mortality at 1, 2, and 3 years was 12.7%, 20.9%, and 29.2%, respectively. CV event rates at 1, 2, and 3 years were 2.1%, 6.6%, and 10.5%, respectively. CONCLUSIONS: CTA-based preprocedural planning is accurate in predicting device size for LAAC and associated with excellent clinical outcomes at 5 years.

Incidence, progression, and predictors of left atrial appendage sealing after Watchman FLX device implantation with computed tomographic assessment.

BACKGROUND: Limited data exists regarding incidence, progression, and predictors of left atrial appendage (LAA) sealing after transcatheter LAA closure. We aimed to evaluate the incidence, progression, and predictive factors associated with LAA sealing after LAA closure. METHODS: This study includes patients who underwent successful LAA closure with Watchman FLX device and had both pre- and postprocedural computed tomography (CT). Postprocedural CT was performed 45 days after LAA closure and used to evaluate residual LAA patency. Patient who had residual LAA patency at 45 days underwent 1-year follow-up CT. RESULTS: A total of 105 patients (mean age: 75.2 ± 9.6 years; 53.3% female) who underwent successful LAA closure with Watchman FLX device and had pre- and postprocedural CT at 45 days were included. Residual patency was observed in 35 (33.3%) patients: 21 (20.0%) patients showed complete contrast opacification in LAA (complete LAA patency) while 14 (13.3%) patients showed contrast opacification only in the distal LAA (distal LAA patency). Among patients with residual LAA patency at 45 days, the rate of LAA sealing at 1 year was significantly higher in the distal LAA patency group than in the complete LAA patency group (75.0% vs. 16.7%; p = 0.019). Increased depth oversizing was associated with both distal LAA patency and complete LAA patency. CONCLUSION: Postprocedural CT at 45 days detected patent LAA in one-third of patients after LAA closure. LAA sealing was more frequently observed at 1 year among the distal LAA patency group than the complete LAA patency group.

Elevated myocardial extracellular volume fraction is associated with the development of conduction pathway defects following transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established method of aortic stenosis treatment but suffers from the risk of heart block and pacemaker requirement. Risk stratification for patients who may develop heart block remains imperfect. Simultaneously, myocardial fibrosis as measured by cardiac magnetic resonance imaging (CMR) has been demonstrated as a prognostic indicator of ventricular recovery and mortality following TAVR. However, the association of CMR-based measures of myocardial fibrosis with post-TAVR conduction disturbances has not yet been explored. AIMS: We evaluated whether myocardial fibrosis, as measured by late gadolinium enhancement and extracellular volume (ECV) from CMR would be associated with new conduction abnormalities following TAVR. METHODS: One hundred seventy patients who underwent CMR within 2 months before TAVR were retrospectively reviewed. Septal late gadolinium enhancement (LGE) and ECV measurements were made as surrogates for replacement and interstitial fibrosis respectively. New conduction abnormalities were defined by the presence of transient or permanent atrioventricular block, new bundle branch blocks, and need for permanent pacemaker. Association of myocardial fibrosis and new conduction derangements were tested using receiver operator curve (ROC) and regression analysis in patients with and without pre-existing conduction issues. RESULTS: Forty-six (27.1%) patients developed post-TAVR conduction deficits. ECV was significantly higher among patients who experienced new conduction defects (26.2 ± 3.45% vs. 24.7% ± 4.15%, p value: 0.020). A greater fraction of patients that had new conduction defects had an elevated ECV of ≥26% (54.3% vs. 36.3%, p value: 0.026). ECV ≥ 26% was independently associated with the development of new conduction defects (odds ratio [OR]: 2.364, p value: 0.030). ROC analysis revealed a significant association of ECV with new conduction defects with an area under the receiver operating characteristic curve (AUC) of 0.632 (95% confidence interval: 0.555-0.705, p value: 0.005). The combination of prior right bundle branch block (RBBB) and ECV revealed a greater AUC of 0.779 (0.709-0.839, p value: <0.001) than RBBB alone (Delong p value: 0.049). No association of LGE/ECV with new conduction defects was observed among patients with pre-existing conduction disease. Among patients without baseline conduction disease, ECV was independently associated with the development of new conduction deficits (OR: 3.685, p value: 0.008). CONCLUSION: The present study explored the association of myocardial fibrosis, as measured by LGE and ECV with conduction deficits post-TAVR. Our results demonstrate an association of ECV, and thereby interstitial myocardial fibrosis, with new conduction derangement post-TAVR and introduce ECV as a potentially new risk stratification tool to identify patients at higher risk for needing post-TAVR surveillance and/or permanent pacemaker.

Novel computed tomography angiography-based sizing methodology for WATCHMAN FLX device in left atrial appendage closure.

BACKGROUND: While there is recent data suggesting an advantage of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) for preprocedural left atrial appendage closure (LAAC) planning, there is limited published experience for sizing strategies. Device sizing for LAAC may be challenging and noninvasive algorithms that improve this selection process are warranted. OBJECTIVES: We sought to evaluate the safety and the feasibility for the implementation of a novel CTA-based sizing methodology for WATCHMAN™ FLX device in a series of patients undergoing LAAC using the TruPlan™ software package. METHODS: A prospective analysis of 136 consecutive patients who underwent LAAC over a 12-month period in a single, large academic hospital in the United States was conducted. CTA-guided preprocedural planning and intracardiac echocardiography (ICE) was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. RESULTS: A total of 136 patients who underwent LAAC procedure with WATCHMAN™ FLX platform between October 1, 2020 until September 30, 2021 were included. The pre-specified protocol using CTA and ICE was implemented in all patients (100%). Mean CHA2 DS2 VASc score was 4.4 ± 1.3 and the mean HAS-BLED score was 3.9 ± 0.8. ICE-guided 100% transseptal puncture success rate was 100% with 98.5% of overall procedural success rate. Preprocedural CTA sizing strategy accurately predicted the implanted size in 91.1% of patients. Ten patients (7.4%) required another sized device and 2 cases were aborted. At 45-day follow-up, only 1 patient (0.7%) had significant peri-device leak (≥5 mm) on TEE. CONCLUSIONS: CTA-based preprocedural sizing methodology for WATCHMAN™ FLX in LAAC was safe, feasible and associated with excellent procedural outcomes. Further studies are warranted to confirm if the features specific to TruPlan™ may reduce the number of deployment attempts, the number of devices utilized in the procedure, and the risk of complications.

Endovascular therapeutic hypothermia adjunctive to percutaneous coronary intervention in acute myocardial infarction: realistic simulation as a game changer.

BACKGROUND: Endovascular therapeutic hypothermia (ETH) reduces the damage by ischemia/reperfusion cell syndrome in cardiac arrest and has been studied as an adjuvant therapy to percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI). New available advanced technology allows cooling much faster, but there is paucity of resources for training to avoid delays in door-to-balloon time (DTB) due to ETH and subsequently coronary reperfusion, which would derail the procedure. The aim of the study was to describe the process for the development of a simulation, training & educational protocol for the multidisciplinary team to perform optimized ETH as an adjunctive therapy for STEMI. METHODS AND RESULTS: We developed an optimized simulation protocol using modern mannequins in different realistic scenarios for the treatment of patients undergoing ETH adjunctive to PCI for STEMIs starting from the emergency room, through the CathLab, and to the intensive care unit (ICU) using the Proteus® Endovascular System (Zoll Circulation Inc™, San Jose, CA, USA). The primary endpoint was door-to-balloon (DTB) time. We successfully trained 361 multidisciplinary professionals in realistic simulation using modern mannequins and sham situations in divisions of the hospital where real patients would be treated. The focus of simulation and training was logistical optimization and educational debriefing with strategies to reduce waste of time in patient's transportation from different departments, and avoiding excessive rewarming during transfer. Afterwards, the EHT protocol was successfully validated in a trial randomizing 50 patients for 18 minutes cooling before coronary recanalization at the target temperature of 32 ± 1.0 ∘C or PCI-only. A total of 35 patients underwent ETH (85.7% [30/35] in 90 ± 15 minutes), without delays in the mean door-to-balloon time for primary PCI when compared to 15 control group patients (92.1 minutes versus 87 minutes, respectively; p = 0.509). CONCLUSIONS: Realistic simulation, intensive training and educational debriefing for the multidisciplinary team propitiated feasible endovascular therapeutic hypothermia as an adjuvant therapy to primary PCI in STEMI. CLINICALTRIALS: gov: NCT02664194.

Extra-plaque rotational atherectomy for treating a balloon uncrossable ostial right coronary artery chronic total occlusion.

Performing atherectomy in the subintimal space remains controversial. We describe a case of successful ostial right coronary artery CTO recanalization using rotational atherectomy in subintimal space.

Percutaneous left atrial appendage occlusion in mitral valve disease: A Nationwide Readmission Database analysis.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) has emerged as a non-pharmacologic alternative to oral anticoagulation in reducing stroke risk in AF patients. However, patients with mitral valve disease (MVD), who are expected to have a significantly greater risk of left atrium (LA) thrombus formation and embolic stroke were excluded from randomized trials examining percutaneous LAAO. To address this gap, we present a national registry analysis of the use of LAAO among patients with MVD. METHODS: Using the National Readmissions Database, we performed a retrospective review of all hospitalizations for LAAO identified between September 2015 and November 2019. Of these, patients with ICD-10 codes for MVD were identified. Propensity matched (PSM) analysis was used to compare patients with MVD with a matched sample of patients undergoing LAAO with non-valvular AF. Outcomes examined included all-cause mortality, stroke, major bleeding, pericardial effusion (PE), and tamponade. RESULTS: 51,540 patients who underwent LAAO without a history of MVD and 3777 with a history of MVD were identified. Crude analysis demonstrated the odds of mortality, PE, and cardiac tamponade during index hospitalization to be higher in the MVD group. The length of stay and cost of index hospitalization were also slightly greater for the MVD group. A sample of 7649 patients (MVD: 3777 MVD and no MVD: 3872) were selected for PSM analysis with similar comorbidities across the two groups. In the PSM comparison, MVD was associated with higher risk of PE. The MVD group had a slightly higher rate of readmissions the association with PE remained at 30-day readmission (OR: 2.099 [1.360-3.238], p-value: <0.001). CONCLUSION: To our knowledge, this is the first study examining the use of LAAO among MVD patients. Our findings suggest that patients with MVD who underwent LAAO had a higher risk of post-procedural PE without an increase in mortality, stroke, or major bleeding. These results provide a rationale for considering LAAO as part of the stroke prevention strategy among patients with valvular AF.

Left Atrial Appendage Closure Outcomes in Patients With Cancer at a Single Tertiary Center.

Atrial fibrillation is the most common arrhythmia in patients with underlying malignancy. Patients with cancer have a higher risk of bleeding, and at the same time, carry an elevated risk of thromboembolism related to the hypercoagulable state, type of cancer, and anticancer treatment, rendering safe anticoagulation challenging in this population. Left atrial appendage closure is an alternative treatment option in patients with atrial fibrillation and high bleeding risk; however, the data on patients with cancer are limited. Our study aimed to compare the long-term outcomes in patients with cancer receiving left atrial appendage closure using the WATCHMAN device. This is a prospective, single-center study comparing outcomes in 389 patients who underwent percutaneous left atrial appendage closure using the WATCHMAN device over 5 years in a single, large academic hospital in the United States. The postprocedural outcomes of mortality, stroke, and major bleeding were evaluated in patients with and without cancer. Our study included 57 patients with cancer and 332 without cancer. The baseline characteristics were similar between the 2 groups. Metastatic disease was present in 16.4% of patients, and 25% were receiving active treatment at the time of the procedure. The median follow-up time was 354 (interquartile range 85 to 790) days. There was no difference in mortality (hazard ratio [HR] 1.3, 95% confidence interval [CI] 0.72 to 2.35, p = 0.38), major bleeding episodes (HR 1.2, 95% CI 0.45 to 3.33, p = 0.68), and stroke (HR 0.64, 95% CI 0.19 to 2.21, p = 0.49) at 3 years after the procedure in patients with and without cancer. There was no difference in the composite outcome (postprocedural mortality, stroke, and major bleeding) between the 2 groups (HR 1.25, CI 0.75 to 2.07, p = 0.38). Percutaneous left atrial appendage closure in patients with cancer appears to be safe and has a similar long-term risk compared with patients without cancer.

Delayed Pericardial Effusion Following Left Atrial Appendage Closure: A 5-Year Single-Center Experience.

BACKGROUND: Though uncommon, pericardial effusion and cardiac tamponade are serious complications of left atrial appendage closure (LAAC). There are few data related to delayed pericardial effusions from this procedure. METHODS: This is a single-center prospective analysis of 369 patients who underwent LAAC from December 2016 to March 2022 at a large teaching hospital. We compared patients who developed effusion (n = 5) to patients who did not (n = 364) to determine if there were any factors that predispose patients to developing acute (AEs) or delayed pericardial effusions (DEs). We compared patient characteristics, procedural data, and complications. Unadjusted, stepwise multivariate logistic regression was performed. RESULTS: A total of 369 patients underwent LAAC. Of these, 5 patients (1.4%) developed pericardial effusion. Patients in both groups (pericardial effusion vs non-effusion) had similar patient and procedural characteristics. Patients in both groups were older (mean age, 78.4 ± 7.8 years in the effusion group vs 76.3 ± 8.5 years in the non-effusion group; P=.50) and white (60% in the effusion group vs 90.1% in the non-effusion group). CHA2DS2-VASc (4.2 ± 1.1 vs 4.5 ± 1.4; P=.67) and HAS-BLED (3.4 ± 0.5 vs 3.7 ± 0.9; P=.53) scores were similar in the effusion group vs the non-effusion group, respectively. Gastrointestinal bleeding was the most common procedural indication in both groups (80% in the effusion group vs 53.6% in the non-effusion group; P=.23). The majority of the patients in both groups had successful implantation in the first attempt, with the 27-mm device the most commonly used size. There was no significant difference in procedural duration (67 minutes in the effusion group vs 75 minutes in the non-effusion group; P=.16). Among patients who received the Watchman Legacy device, 2 patients developed AEs and no patients had DEs. Of those receiving the Watchman FLX device, 1 patient developed AE and 2 patients developed DEs. All of the patients with effusions had successful recovery. CONCLUSION: In this 5-year, single-center experience, DEs were uncommon and potentially related to LAA device anchor microperforation. No statistically significant risk factors predisposing patients to pericardial effusions were identified in our analysis.

Permanent Pacemaker Insertion Reduction and Optimized Temporary Pacemaker Management After Contemporary Transcatheter Aortic Valve Implantation With Self-Expanding Valves (from the Pristine TAVI Study).

Permanent pacemaker implantation (PPMI) reduction and optimal management of newly acquired conduction disturbances after transcatheter aortic valve implantation (TAVI) are crucial. We sought to evaluate the relation between transcatheter heart valve (THV) implantation depth and baseline and newly acquired conduction disturbances on PPMI after TAVI. This study included 1,026 consecutive patients with severe symptomatic aortic stenosis (mean age 79.7 ± 8.4 years; 47.4% female) who underwent TAVI with the newer-generation self-expanding THVs Primary outcomes were early and late PPMI defined as the need for PPMI during the index admission and between discharge and 30 days, respectively. Early and late PPMI was required for 115 (11.2%) and 21 patients (2.0%), respectively. Early PPMI rates decreased from 26.7% in 2015 and 2016 to 5.7% in 2021, and so did the mean THV depth from 4.4 ± 2.4 mm to 1.8 ± 1.6 mm. Receiver operator characteristics curve analyses showed THV depth had significant discriminatory value for early and late PPMI with cutoff values of 3.0 and 2.2 mm, respectively. Rates of early and late PPMI were significantly lower for patients with shallower compared with deeper implantations (5.1% vs 22.6% and 0.4% vs 4.1%, p <0.001 for both, respectively). Furthermore, rates of early PPMI were lower with shallower implantations in patients with new left bundle branch block after TAVI (2.4% vs 15.9%; p <0.001) and those with baseline right bundle branch block (7.5% vs 29.6%; p = 0.017). Lower rates of PPMI with shallower THV implantation were consistently observed, including in patients with baseline and newly acquired conduction disturbances. Our findings might help optimize the management of a temporary pacemaker after TAVI.

Safety, Efficacy, and Cost-Effectiveness of Same-Day Discharge for Left Atrial Appendage Occlusion.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) with the Watchman device is FDA approved for stroke prevention in patients with nonvalvular atrial fibrillation who have an appropriate indication. During the COVID-19 pandemic, a same-day discharge protocol (SDDP) was employed to improve resource utilization, relieve hospital occupation, and reduce the possible risk of in-hospital virus transmission. OBJECTIVES: We sought to analyze the safety, feasibility, and cost effectiveness for SDDP in patients receiving LAAO. METHODS: A prospective analysis of 142 consecutive patients, 119 treated prior to SDDP and 23 who underwent SDDP following LAAO with cardiac computed tomography angiography (CTA)-guided pre-procedural planning and intracardiac echocardiogram (ICE). Procedures were performed in a single, large academic hospital in the United States. In-hospital and 45-day procedural success, adverse events, length of procedure, and length-of-stay were evaluated. RESULTS: Baseline patient characteristics including mean CHA2DS2VASc scores and mean HAS-BLED scores were similar in both groups. All procedures were successful. There was no significant difference in rates of procedural complications or in-hospital adverse events. The mean procedure time in the SDDP group was 11 minutes longer than in the conventional group (62.1 ± 5.9 vs 51.1 ± 21; P=.01). Outcomes at 45-day follow-up were similar. SDDP was associated with a reduced length of stay compared with conventional strategy and a 15% reduction in total costs. CONCLUSIONS: Same-day discharge strategy for LAAO appears safe, feasible and could become the new standard approach for LAAO. A protocol including CTA pre-procedural planning, ICE-guided deployment and conscious sedation reduces hospital occupation and lowers costs.

Risk Stratification of New Persistent Left Bundle Branch Block After Transcatheter Aortic Valve Implantation.

Previous studies reported that new-onset persistent left bundle branch block (NOP-LBBB) was related to worse outcomes after transcatheter aortic valve implantation (TAVI). However, these results can be confounded by the presence of permanent pacemaker (PPM) implantation before and after TAVI. Long-term outcomes and the risk stratification of NOP-LBBB not having PPM implantation before and after TAVI have not been fully investigated. This is an international, multicenter, retrospective study of patients who underwent TAVI from July 31, 2007, to May 8, 2020. A total of 2,240 patients were included, and 17.5% of patients developed NOP-LBBB. NOP-LBBB was associated with cardiac mortality (adjusted hazard ratio [aHR] 1.419, 95% confidence interval [CI] 1.014 to 1.985, p = 0.041) and the composite outcomes of cardiac mortality and/or heart failure readmission (aHR 1.313, 95% CI 1.027 to 1.678, p = 0.030). Patients who developed NOP-LBBB with pre-TAVI left ventricular ejection fraction (LVEF) <40% were significantly associated with cardiac mortality (aHR 2.049, 95% CI 1.039 to 4.041, p = 0.038), heart failure (aHR 3.990, 95% CI 2.362 to 6.741, p <0.001), and the composite outcome (aHR 2.729, 95% CI 1.703 to 4.374, p <0.001). Although NOP-LBBB with pre-TAVI LVEF >40% had a significant decrease in LVEF 6 to 12 months after TAVI (-1.8 ± 9.7% vs +0.6 ± 8.1%, p = 0.003), NOP-LBBB with pre-TAVI LVEF <40% had a significant increase in LVEF 6 to 12 months after TAVI (+9.7 ± 13.6% vs +13.0 ± 11.7%, p = 0.157). In conclusion, patients with NOP-LBBB without pre-TAVI and post-TAVI PPM developed significantly worse long-term outcomes, especially in patients with pre-TAVI LVEF <40%. Further prospective investigation should be undertaken.

Multivessel Woven Coronary Artery Disease.

Woven coronary disease is a rare pathology with unknown etiology. Although initially considered benign, recent publications report myocardial ischemia caused by the affected vessel. Since most patients are asymptomatic, long-term follow-up to understand its behavior is mandatory. We report a multivessel woven disease case with documented ischemia that was submitted to coronary artery bypass grafting and remained asymptomatic for two years of follow-up.

Pericardial-Peritoneal Window as an Alternative Treatment for Large and Recurrent Pericardial Effusion Post-Pericardiotomy.

INTRODUCTION: The presence of mild to moderate pericardial effusion after cardiac surgery is common and oral medical therapy is usually able to treat it. Larger effusions are less frequent and surgical intervention is usually necessary. However, there are some rare cases of large effusions that are recurrent even after intervention and become challenging to treat. METHODS: We describe the case of a patient submitted to coronary artery bypass grafting (CABG) without any intraoperative complications, who was regularly discharged from the hospital. She was referred to our emergency department twice after surgery with large pericardial effusion that was drained. Even after those two interventions and with adequate oral medication, the large effusion recurred. RESULTS: During follow-up, the patient had her symptoms resolved, with no need for further hospital admission. Her echocardiograms after the last intervention showed no pericardial effusion. The present surgical technique demonstrated to be easy to perform, thus it should be considered as a treatment option for these rare cases of large and repetitive effusions, which do not respond to the traditional methods. CONCLUSIONS: In challenging cases of recurrent and large pericardial effusions, the pericardial-peritoneal window is an alternative surgical technique that brings clinical improvement and diminishes the risk of cardiac tamponade.

Comparison of Stent Expansion Using a Volumetric Versus the Conventional Method Through Optical Coherence Tomography in an All-Comers Population.

INTRODUCTION: A volumetric approach to measure stent expansion derived from optical coherence tomography (OCT) is superior in regards to clinical outcomes when compared to the conventional method. The current software already performs a semi-automatic assessment and it is available as a clinical tool, however data is still scarce. We evaluated the stent expansion analysis that uses a volumetric vessel model, called minimum expansion index - MEI and compared to the conventional model, which utilizes the minimum stent area expansion (MSAx) indexed to the references, and its potential impact on procedural decision-making strategy in percutaneous coronary intervention. METHODS: This was a prospective, all-comers single center study, from all patients undergoing OCT-guided PCI between September 2018 and May 2019. We utilized the APTIVUE™ OPTIS 5.2 software (Abbott, Santa Clara, CA) to evaluate MEI and MSAx measurements after reference adjustments. RESULTS: We included 100 patients with mean age of 64 ± 12.5 years, 68% were men, and the main arteries analyzed through OCT were LAD (48%), RCA (31%) and LCx (21%). The mean MEI was 77.6% ± 16.7% and the mean MSAx was 71.6% ± 16.9%. MEI location differed from MSAx in 70% of cases, and in those cases the mean distance between MEI and MSAx was 15.3 mm ± 12.4 mm. In 53% of the times, the stent underexpansion based on MEI was located proximally to the MSAx by 18.1 mm ± 11.8 mm. Furthermore, in 42% of the total cases, MEI would change the intervention strategy based on the stent underexpansion being in a different location ≥10 mm in comparison to MSAx (34%) associated with the discrepancy between expansion indexes for MEI and MSAx (22%). CONCLUSION: We concluded that MEI location did not correlate to the conventional MSAx in two thirds of the cases. Moreover, compared to MEI, the MSAx assessment yielded lower expansion values in different stent positions, potentially changing the appropriate post-stent optimization, which thus would impact the decision-making strategy in almost half of the patients.

Left Atrial Appendage Occlusion Using Cardiac CT Angiography and Intracardiac Echocardiography: A Prospective, Single-Center Study.

OBJECTIVES: We reviewed the periprocedural events, accuracy of device selection, and outcomes of a series of patients receiving percutaneous left atrial appendage occlusion (LAAO) with cardiac computed tomography angiography (CTA)-guided preprocedural planning and intracardiac echocardiography (ICE)-guided device deployment. BACKGROUND: Percutaneous LAAO with the Watchman device (Boston Scientific) is approved by the United States Food and Drug Administration for stroke prevention in patients with non-valvular atrial fibrillation with a demonstrated contraindication to oral anticoagulation. Cardiac CTA preprocedural planning with utilization of an ICE-guided deployment may be associated with favorable outcomes. METHODS: A prospective analysis of 71 non-consecutive patients who underwent LAAO over an 18-month period with cardiac CTA-guided preprocedural planning and ICE was conducted. Procedures were performed in a single large, academic hospital in the United States. Procedural success, correlation of CTA preprocedural device sizing with final device size utilization, adverse events, length of procedure, and length of stay were evaluated. RESULTS: Preprocedural cardiac CTA-guided device sizing was consistent with the final deployed device in 69 patients (97.2%) evaluated in this case series. Procedure success rate was 100%. All implants were performed using Watchman devices, 45 (63.4%) with the original 2.5 platform and 26 (36.6%) with the Watchman FLX platform. All patients were treated with conscious sedation and the mean length of stay was 1.45 ± 0.72 days. Only 2 adverse events occurred and both resolved. CONCLUSIONS: Cardiac CTA-guided preprocedural planning resulted in accurate device sizing in this patient sample and may be used in conjunction with ICE and conscious sedation for a same-day discharge strategy in select patients.

Cooling as an Adjunctive Therapy to Percutaneous Intervention in Acute Myocardial Infarction: COOL-MI InCor Trial.

Endovascular Therapeutic hypothermia (ETH) reduces the damage caused by postischemia reperfusion injury syndrome in cardiopulmonary arrest and has already established its role in patients with sudden death; however, its role in ST-segment elevation myocardial infarction (STEMI) remains controversial. The objectives of this study were to investigate the safety, feasibility, and 30-day efficacy of rapid induction of therapeutic hypothermia as adjunctive therapy to percutaneous coronary intervention (PCI) in patients with anterior and inferior STEMIs. This was a prospective, controlled, randomized, two-arm, prospective, interventional study of patients admitted to the emergency department within 6 hours of angina onset, with anterior or inferior STEMI eligible for PCI. Subjects were randomized to the hypothermia group (primary PCI+ETH) or to the control group (primary PCI) at a 4:1 ratio. The ETH was induced by 1 L cold saline (1-4°C) associated with the Proteus™ System, by cooling for at least 18 minutes before coronary reperfusion with a target temperature of 32°C ± 1°C. Maintenance of ETH was conducted for 1-3 hours, and active reheating was done at a rate of 1°C/h for 4 hours. Primary safety outcomes were the feasibility of ETH in the absence of (1) door-to-balloon (DTB) delay; (2) major adverse cardiac events (MACE) within 30 days after randomization. The primary outcomes of effectiveness were infarct size (IS) and left ventricular ejection fraction (LVEF) at 30 days. An as-treated statistical analysis was performed. Fifty patients were included: 35 (70%) randomized to the hypothermia group and 15 (30%) to the control group. The mean age was 58 ± 12 years; 78% were men; and associated diseases were 60% hypertension, 42% diabetes, and 72% dyslipidemia. The compromised myocardial wall was anterior in 38% and inferior in 62%, and the culprit vessels were left anterior descending artery (LAD) (40%), right coronary artery (38%), and left circumflex (18%). All 35 patients who attempted ETH (100%) had successful cooling, with a mean endovascular coronary reperfusion temperature of 33.1°C ± 0.9°C. The mean ischemic time was 375 ± 89.4 minutes in the hypothermia group and 359.5 ± 99.4 minutes in the control group. The mean DTB was 92.1 ± 20.5 minutes in the hypothermia group and 87 ± 24.4 minutes in the control group. The absolute difference of 5.1 minutes was not statistically significant (p = 0.509). The MACE rates were similar between both groups (21.7% vs. 20% respectively, p = 0.237). In the comparison between the hypothermia and control groups, no statistically significant differences were observed at 30 days between mean IS (13.9% ± 8% vs. 13.8% ± 10.8%, respectively, p = 0.801) and mean final LVEF (43.3% ± 11.2% vs. 48.3 ± 10.9%, respectively; p = 0.194). Hypothermia as an adjunctive therapy to primary PCI in STEMI is feasible and can be implemented without delay in coronary reperfusion. Hypothermia was safe regarding the incidence of MACE at 30 days. However, there was a higher incidence of arrhythmia and in-hospital infection in the hypothermia group, with no increase in mortality. Regarding efficacy, there was no difference in IS or LVEF at 30 days that would suggest additional myocardial protection with ETH. ClinicalTrials.gov: NCT02664194.

Segmentation of Coronary Calcified Plaque in Intravascular OCT Images Using a Two-Step Deep Learning Approach.

We developed a fully automated, two-step deep learning approach for characterizing coronary calcified plaque in intravascular optical coherence tomography (IVOCT) images. First, major calcification lesions were detected from an entire pullback using a 3D convolutional neural network (CNN). Second, a SegNet deep learning model with the Tversky loss function was used to segment calcified plaques in the major calcification lesions. The fully connected conditional random field and the frame interpolation of the missing calcification frames were used to reduce classification errors. We trained/tested the networks on a large dataset comprising 8,231 clinical images from 68 patients with 68 vessels and 4,320 ex vivo cadaveric images from 4 hearts with 4 vessels. The 3D CNN model detected major calcifications with high sensitivity (97.7%), specificity (87.7%), and F1 score (0.922). Compared to the standard one-step approach, our two-step deep learning approach significantly improved sensitivity (from 77.5% to 86.2%), precision (from 73.5% to 75.8%), and F1 score (from 0.749 to 0.781). We investigated segmentation performance for varying numbers of training samples; at least 3,900 images were required to obtain stable segmentation results. We also found very small differences in calcification attributes (e.g., angle, thickness, and depth) and identical calcium scores on repetitive pullbacks, indicating excellent reproducibility. Applied to new clinical pullbacks, our method has implications for real-time treatment planning and imaging research.