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Transesophageal echocardiogram (TEE) is the preferred imaging modality to guide transcatheter left atrial appendage closure (LAAC). Intracardiac echocardiography (ICE) has evolved as a less invasive alternative to TEE. Several observational studies have shown similar success rates and perioperative complications between TEE and ICE for LAAC.We sought to examine the temporal trends and patient characteristics of TEE versus ICE use in LAAC using a national database. We also evaluated hospital outcomes including periprocedural complications, mortality, and length of hospital stay.This is a retrospective analysis of data from the National Readmission Database, collected from 2016 to 2018. The primary outcome was major adverse events (MAE) defined as in-hospital mortality, cardiac arrest, pericardial effusion with or without tamponade, pericardiocentesis or window pericardiocentesis and pericardial window, pericardial effusion and tamponade, and hemorrhage requiring transfusion.Trend analysis showed that TEE-guided LAAC increased from 96.6% in 2016 to 98.4% in 2018 (relative increase, 1.9%), while ICE-guided LAAC decreased from 3.4% to 1.6% during the same period (relative decrease, 53%, p for trend = 0.08). In the unmatched cohorts, the MAE was significantly lower in TEE-guided LAAC compared to ICE-guided LAAC (6.5% vs. 9.3%, p = 0.022). In the propensity score matching analysis, MAE remained significant (5.6% vs. 9.4%, p 0.001). The incidence of pericardial effusion with or without tamponade remained significantly lower in the TEE group (2.3% vs. 5.8%, p 0.001). Length of stay (3.4 vs. 1.9 days, p 0.001) and hospitalization cost ($34,826 vs. $20,563, p 0.001) remained significantly lower for TEE-guided LAAC.Compared to ICE, the incidence of MAE was significantly lower for TEE-guided LAAC, driven mainly by less pericardial effusion events. Large-scale randomized trials are needed to confirm the findings of the current and previous studies.

We present a rare case of iatrogenic pneumopericardium, pneumoperitoneum, and Escherichia coli pericarditis after emergency pericardiocentesis for pericardial tamponade. The patient had profound bowel distention at the time of the procedure that led to iatrogenic pericardioperitoneal fistula formation along with transverse colon perforation, which manifested later after pericardial drain removal. This condition required repeat pericardiocentesis, laparoscopic colon repair, a long course of antibiotics, and an eventual pericardial window. (Level of Difficulty: Intermediate.), Central Illustration

Background There is limited data on complications associated with the use of coronary embolic protection devices (EPDs). Methods We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA). Results We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX. Conclusions The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications.

The cardiovascular and renal systems share an intimate physiological relationship, wherein a perturbance in one system may have an adverse effect on the other. Since the burden of renal disease increases with age, there is a considerable interest in the pathophysiology of kidney disease in the geriatric patient population. This review will explore the physiological dynamics behind the increased susceptibility to kidney disease in this population. A better understanding of these pathophysiological changes may lead to improved prevention and management strategies.

We describe a patient with recurrent embolic strokes who was found to have a persistent left superior vena cava draining into a pulmonary vein. Transcatheter placement of a vascular plug resulted in successful occlusion of the superior vena cava. Repeat bubble study on follow-up imaging was negative for a right-to-left shunt. (Level of Difficulty: Advanced.), Graphical abstract, We describe a patient with recurrent embolic strokes who was found to have a persistent left superior vena cava draining into a pulmonary vein…

Background Autopsy studies suggest that implanting stents in lipid-rich plaque (LRP) may be associated with adverse outcomes. Objectives The purpose of this study was to evaluate the association between LRP detected by near-infrared spectroscopy (NIRS) and clinical outcomes in patients with coronary artery disease treated with contemporary drug-eluting stents. Methods In this prospective, multicenter registry, NIRS was performed in patients undergoing coronary angiography and possible percutaneous coronary intervention (PCI). Lipid core burden index (LCBI) was calculated as the fraction of pixels with the probability of LRP >0.6 within a region of interest. MaxLCBI4mm was defined as the maximum LCBI within any 4-mm-long segment. Major adverse cardiac events (MACE) included cardiac death, myocardial infarction, definite or probable stent thrombosis, or unplanned revascularization or rehospitalization for progressive angina or unstable angina. Events were subcategorized as culprit (treated) lesion–related, nonculprit (untreated) lesion–related, or indeterminate. Results Among 1,999 patients who were enrolled in the COLOR (Chemometric Observations of Lipid Core Plaques of Interest in Native Coronary Arteries Registry), PCI was performed in 1,621 patients and MACE occurred in 18.0% of patients, of which 8.3% were culprit lesion–related, 10.7% were nonculprit lesion–related, and 3.1% were indeterminate during 2-year follow-up. Complications from NIRS imaging occurred in 9 patients (0.45%), which resulted in 1 peri-procedural myocardial infarction and 1 emergent coronary bypass. Pre-PCI NIRS imaging was obtained in 1,189 patients, and the 2-year rate of culprit lesion–related MACE was not significantly associated with maxLCBI4mm (hazard ratio of maxLCBI4mm per 100: 1.06; 95% confidence interval: 0.96 to 1.17; p = 0.28) after adjusting clinical and procedural factors. Conclusions Following PCI with contemporary drug-eluting stents, stent implantation in NIRS-defined LRPs was not associated with increased periprocedural or late adverse outcomes compared with those without significant lipid.

Objectives The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis. Background Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated. Methods The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients. Results The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: −3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (−1.4% difference; Bayesian credible interval: −5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences. Conclusions The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.

Background Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF. Objective The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort. Methods At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days. Results A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%). Conclusions Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.

MitraClip is approved for treatment of both degenerative and functional mitral regurgitation (MR). The landmark trials for this device included only patients with A2P2 location of MR. Initial commercial experience showed A2P2 location was associated with higher technical success as compared with non-A2P2 location. We intended to compare technical success of A2P2 vs non-A2P2 MitraClip procedures in terms of residual MR and transmitral gradient (TMG) in the contemporary setting as the operator experience has increased. A total of 159 patients with complete data were included in the study. A total of 129 patients were in the A2P2 MitraClip group and 30 patients were in the non-A2P2 MitraClip group. Post implantation, there was a significant increase in TMG in both A2P2 and non-A2P2 groups (0.73 ± 1.42 and 0.94 ± 1.85, respectively; both P.01). However, postimplantation TMG was not different between the 2 groups (3.6 ± 1.9 A2P2 vs 3.7 ± 1.7 non-A2P2; P=.56) and there was no difference in residual MR (P=.40). At 1-month follow-up of 82 patients (64 A2P2 and 18 non-A2P2), the results were similar; TMG (3.7 ± 1.6 A2P2 vs 3.7 ± 2.1 non-A2P2; P=.96) and residual MR (P=.41). Our data showed similar technical success of MitraClip procedures in both types of MR.

Despite more than 80% of interventional operators reporting one or more orthopedic injuries attributed to the X-ray laboratory, there has been limited adoption of various strategies and equipment to minimize these injuries. A comprehensive review of these methods to reduce musculoskeletal strain is lacking in the current literature, and is essential in order to ensure a long, healthy, and productive interventional career.

Background There is a paucity of literature on safety and efficacy of various transseptal puncture (TSP) needles. Objectives To assess the reported mechanisms of failure, complications, and outcomes among the most frequently used transseptal needles in the United States. Methods We queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and January 2021 for reports on the most commonly used transseptal needles: NRG (Baylis Medical, Montreal, Canada), and BRK (St. Jude, Saint Paul, MN)]. The primary outcome was the mechanism of failure. Secondary outcomes included clinical consequences of device failure. Results The final analysis included 306 reports of failure/complication with TSP needles (NRG n = 70, BRK n = 236). The most commonly reported mode of failure was detachment of the needle component (i.e., clip, hub, stopcock, shaft, spring, or needle tip) (14.7% overall; 17.8% BRK; and 4.3% NRG). Among these reports, cardiac perforation was the most common complication (69.9% overall; 69.1% for BRK; and 72.9% for NRG). Pericardiocentesis was the second most commonly reported complication (45.1% overall; 48.3% for BRK; and 34.3% for NRG). The procedure was successfully completed in 33.3% of all cases (36.4% for BRK and 22.9% for NRG), while surgical conversion was needed in (13.4% overall; 14% for BRK and 11.4% for NRG) of the reports. Death occurred in 3.9% of all cases overall (3.4% for BRK and 5.7% for NRG). Conclusions Needle detachment was the most common mode of failure, and cardiac perforation was the most common complication reported with TSP needles. Future efforts should focus on innovative TSP needle design, best practice guidelines, including role of imaging guidance, and increased TSP training.

Background The modes of failure of coronary polymer-jacketed guidewires have received limited study. Methods We queried the Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and December 2020 for reports on coronary polymer-jacketed guidewires and retrieved 254 reports. Results The most common failure mode was failure of the guidewire to cross (36.2%), followed by guidewire fracture (35%), peeling of the polymer jacket (13.8%), failure to retrieve the guidewire (13.8%), and guidewire unraveling (4.7%). Guidewire fracture was more common with soft (37.3%) compared with stiff (23.8%) guidewires. Failure of retrieval was only reported with soft guidewires (9%). Coronary perforation and dissection occurred in 19.7% and 7.9% of the reports, with more reports with stiff as compared with soft guidewires (45.2% vs. 14.6% for perforation and 21.4% vs. 5.3% for dissection). Conclusions The most common failure modes of polymer-jacketed guidewires during percutaneous coronary intervention are failure to cross the lesion, guidewire fracture, and peeling of the polymer jacket. Coronary perforations were more common with stiff whereas wire fracture was more common with soft polymer-jacketed guidewires.

Background: Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device. Methods: Patients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points. Results: A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=–0.14 [95% CI, –3.42 to 3.13]; P P P P =0.32 for superiority). LAA occlusion was higher for the Amulet occluder than for the Watchman device (98.9% versus 96.8%; difference=2.03 [95% CI, 0.41–3.66]; P P =0.003 for superiority). Conclusions: The Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02879448.

The authors describe a patient with hypertrophic cardiomyopathy with concomitant left ventricular outflow tract obstruction and aortic stenosis. Detailed haemodynamic assessment of the serial lesions was performed. Alcohol septal ablation resulted in a significant reduction of gradients across the left ventricular outflow tract.

Transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) is an increasingly prevalent treatment in patients who are intermediate or high risk for surgical intervention. In nonagenarian patients undergoing TAVR, symptomatic relief and quality of life (QoL) outcomes have not been well established. This study explores these outcomes in this patient population that has been underrepresented in landmark clinical trials.All patients who underwent TAVR between January 1, 2015 and December 31, 2018 at Delray Medical Center were included. The 12-item Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score was used to assess QoL prior to and 30 days following TAVR in two patient groups: the nonagenarian group (patients ≥90 years old) and the younger group (patients90 years old). KCCQ-OS scores were compared between these two groups. Frailty assessment included grip strength, gait speed, and activities of daily living. Unadjusted and adjusted analyses (baseline KCCQ-OS score, frailty, and Society of Thoracic Surgery perioperative risk of mortality [STS-PROM] score) were performed to assess the impact of age on QoL outcomes in both groups.Of the total 223 patients included in this study, a total of 46 (20.6%) were nonagenarians and 118 (52.7%) were men. KCCQ-OS scores were lower at baseline and 30-day follow-up in nonagenarians compared with the younger group (P=.70). Age was a significant predictor of 30- day KCCQ-OS in unadjusted and adjusted analyses (adjusted for baseline KCCQ-OS, frailty, and STS-PROM score). Nonagenarians had an average 6.45 points lower 30-day KCCQ-OS scores than the younger patients in adjusted analysis. However, there was a significant clinical improvement in the 30-day KCCQ-OS score in both groups (P.001).Our data suggest that with appropriate patient selection, a significant clinical improvement may be expected with TAVR in nonagenarians.

BACKGROUND: Post-operative atrial fibrillation (POAF) is common after aortic valve replacement (AVR) and is associated with worse outcomes. We performed a meta-analysis of randomized controlled trials comparing Surgical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) for incidence of POAF at 30 days. METHODS: We searched databases from 1/1/1990 to 1/1/2020 for randomized studies comparing TAVR and SAVR. POAF was defined as either worsening or new-onset atrial fibrillation. Random effects model was used to estimate the risk of POAF with TAVR vs SAVR in all trials, and in subgroups (low, intermediate, high risk, and in self-expandable vs balloon expandable valves). Sensitivity analysis was performed including only studies reporting new-onset atrial fibrillation. RESULTS: Seven RCTs were identified that enrolled 7,934 patients (3,999 to TAVR and 3,935 to SAVR). The overall incidence of POAF was 9.7% after TAVR and 33.3% after SAVR. TAVR was associated with a lower risk of POAF compared with SAVR (OR 0.21 [0.18-0.24]; P < 0.0001). Compared with SAVR, TAVR was associated with a significantly lower risk of POAF in the high-risk cohort (OR 0.37 [0.27-0.49]; P < 0.0001), in the intermediate-risk cohort (OR 0.23 [0.19-0.28]; P < 0.0001), low-risk cohort (OR 0.13 [0.10-0.16]; P < 0.0001). Sensitivity analysis of 4 trials including only new-onset POAF showed similar summary estimates (OR 0.21, 95% CI [0.18-0.25]; P< 0.0001). CONCLUSIONS: TAVR is associated with a significantly lower risk of post-operative atrial fibrillation compared with SAVR in all strata. Further studies are needed to identify the contribution of post-operative atrial fibrillation to the differences in clinical outcomes after TAVR and SAVR.

The Impella percutaneous ventricular assist device (PVAD) rapidly deploys mechanical circulatory support (MCS) in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS). We present findings from a quality improvement (IQ) registry for US patients with AMICS who received Impella devices.From January 2009 to December 2016, 46,949 patients from 1010US hospitals were entered into the IQ registry; of these, 15,259 had AMICS. Limited de-identified patient information, product performance, and survival to explantation were recorded. Of those with AMICS, 51% survived to explantation of PVAD. There was a significant difference between survival at explantation with quintile volume at hospitals (range: 0-100%; 30% survival rate in lowest quintile vs. 76% in top quintile; P.0001). Use of the Impella device as first-line treatment pre-PCI was associated with a 59% survival rate, compared with 52% when used as a salvage strategy (P.001). The survival rate among those who received hemodynamic monitoring with pulmonary artery catheters was 63% as compared with 49% in those who did not (P.0001). Overall institutional Impella volume was related to survival (56% survival at sites with7/year vs. 51% at sites with ≤1; P.001).In this early clinical experience with Impella support for AMICS, wide variation in outcomes existed across centers. Survival was higher when Impella was used as first support strategy, when invasive hemodynamic monitoring was used, and at centers with higher Impella implantation volume.

Objectives Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single-arm CoreValve US Expanded Use Study. Methods The primary end point was all-cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10-point decrease from baseline. Results There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All-cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year. Conclusions Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation.

Coronavirus Disease 2019 (COVID-19) has had an unprecedented impact on healthcare systems both globally and in the United States. To avoid unnecessary exposure to the staff, and to preserve limited...

Background: Migraine is a prevalent and disabling disorder. Patent foramen ovale (PFO) has been associated with migraine, but its role in the disorder remains poorly understood.Objectives: ...

Background End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined. Methods The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year. Results Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% ± 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm 2 , mean gradient 9.33 mm Hg) Conclusions Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year.

The role and timing of percutaneous mechanical circulatory support (MCS) devices in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) are not well understood. We sought to evaluate patient characteristics and predictors of outcomes in patients presenting with AMICS supported with an axial flow percutaneous MCS device; 287 consecutive unselected patients enrolled in the catheter-based ventricular assist device registry presenting with AMICS who underwent percutaneous coronary intervention (PCI) were included in this analysis. All patients were supported with either the Impella 2.5 or Impella CP. Mean patient age was 66 ± 12.5 years, 76% were men, and mean left ventricular ejection fraction was 25 ± 12%. Before receiving MCS, 80% of patients required inotropes or vasopressors and 40% were supported with intra-aortic balloon pump; 9% of patients were under active cardiopulmonary resuscitation at the time of MCS implantation. Survival to discharge was 44%. In a multivariate analysis, early implantation of a MCS device before PCI (p = 0.04) and before requiring inotropes and vasopressors (p = 0.05) was associated with increased survival. Survival was 66% when MCS was initiated1.25 hours from shock onset, 37% when initiated within 1.25 to 4.25 hours, and 26% when initiated after 4.25 hours (p = 0.017). Survival was 68%, 46%, 35%, 35%, and 26% for patients requiring 0, 1, 2, 3, and ≥4 inotropes before MCS support, respectively (p 0.001). In conclusion, MCS implantation early after shock onset, before initiation of inotropes or vasopressors and before PCI, is independently associated with improved survival in patients presenting with AMICS.

BACKGROUND Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. METHODS We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. RESULTS A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. CONCLUSIONS TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

A 73-year-old woman presented with recurrent dyspnea on exertion, fatigue, oxygen dependency, and New York Heart Association (NYHA) Class III symptoms. She has a history of pulmonary embolism and a...

Contrast-induced acute kidney injury (CI-AKI) is an important consideration in patients undergoing cardiac catheterization. There has been a continuous strive to decrease morbidity and improve procedural safety. This review will address the pathophysiology, predictors, and clinical management of CI-AKI with a concise overview of the pathophysiology and a suggested association with left atrial appendage closure. Minimizing contrast administration and intravenous fluid hydration are the cornerstones of an effective preventive strategy. A few adjunctive pharmacotherapies hold promise, but there are no consensus recommendations on prophylactic therapies.

BACKGROUND: Fluoroscopy and transesophageal echocardiography (TEE) are used to guide transcatheter left atrial appendage (LAA) closure in patients with atrial fibrillation to prevent thromboembolic events. This study examines whether real-time three-dimensional volume ICE guidance (4D volume ICE) can be used as an alternative to TEE during LAA closure (LAAC). METHODS AND RESULTS: Fifteen patients with atrial fibrillation (AF), who had high risk for stroke and contraindication for long-term warfarin therapy, were enrolled in the study. The WATCHMAN device was used for transcatheter LAAC under fluoroscopy. LAA and device sizing was performed using TEE and volume ICE guidance from the right heart. Intraprocedural ICE measurements were consistent with TEE; LAA maximal width and depth, and maximal diameter of the implanted device were moderately correlated (Pearson's coefficient: 0.63, 0.65, and 0.71 respectively; p

In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery.This study sought to determine whether this clinical benefit was sustained over time.Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure.A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p0.001). There was no clinical evidence of valve thrombosis in either group.Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve(®) System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis may have concomitant mitral stenosis (MS). Hemodynamic impact of TAVR on mitral gradient is unclear, and there is no consensus strategy for treatment of MS in this patient population. The aim of this study

Atrial Fibrillation and Atrial Flutter (AF) are a major burden on public health. The prevalence of AF increases with age, but representative national data about AF associated mortality are limited. We sought to examine the trends of deaths due to AF in the United States (U.S). A retrospective

Periprocedural imaging assessment for percutaneous Left Atrial Appendage (LAA) transcatheter occlusion can be obtained by utilizing different imaging modalities including fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT), and ultrasound imaging. Given the complex and variable morphology of the left atrial appendage, it is crucial to obtain the most accurate LAA dimensions to prevent intra-procedural device changes, recapture maneuvers, and prolonged procedure time. We therefore sought to examine the accuracy of the most commonly utilized imaging modalities in LAA occlusion. Institutional Review Board (IRB) approval was waived as we only reviewed published data. By utilizing PUBMED which is an integrated online website to list the published literature based on its relevance, we retrieved thirty-two articles on the accuracy of most commonly used imaging modalities for pre-procedural assessment of the left atrial appendage morphology, namely, two-dimensional transesophageal echocardiography, three-dimensional transesophageal echocardiography, computed tomography, and three-dimensional printing. There is strong evidence that real-time three-dimensional transesophageal echocardiography is more accurate than two-dimensional transesophageal echocardiography. Three-dimensional computed tomography has recently emerged as an imaging modality and it showed exceptional accuracy when merged with three-dimensional printing technology. However, real time three-dimensional transesophageal echocardiography may be considered the preferred imaging modality as it can provide accurate measurements without requiring radiation exposure or contrast administration. We will present the most common imaging modality used for LAA assessment and will provide an algorithmic approach including preprocedural, periprocedural, intraprocedural, and postprocedural.

Patients with prior coronary artery bypass grafting (CABG) represent a high-risk cohort given associated medical conditions and worse outcome of saphenous vein graft compared with native vessel percutaneous coronary intervention (PCI). The goal of the current analysis was to compare clinical outcomes in 591 patients with and without prior CABG and multivessel coronary artery disease or unprotected left main disease and severely reduced left ventricular systolic function underwent Impella supported PCI from the PROTECT II randomized trial and the cVAD Registry. Patients with prior CABG surgery (n = 201) were compared with those without prior CABG surgery (n = 390). The primary end point of this analysis was overall mortality at 30 days. Patients with prior CABG surgery had greater Society of Thoracic Surgery mortality score compared with patients without prior CABG surgery, 7.6 ± 6.4 versus 5.1 ± 5.5, respectively, p0.001. Saphenous vein graft PCI was performed in 17% of patients with prior CABG surgery. Number of vessels treated was lower in patients with prior CABG surgery compared with patients without prior CABG surgery, 1.66 ± 0.56 versus 1.89 ± 0.64, respectively, p0.001. Achievement of TIMI 3 flow post PCI and overall PCI success was similar in the two groups. Overall mortality at 30 days was similar in patients with prior CABG surgery compared with patients without prior CABG surgery, 6.75% versus 6.61%, respectively, p = 1.0. In conclusion, in this high-risk cohort of patients underwent hemodynamically supported PCI, prior CABG surgery was not associated with worse outcome. The use of hemodynamic support appears to mitigate the increased risk of PCI associated with prior CABG.

Background: In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation. Methods: We studied the device arms of 4 prospective Food and Drug Administration trials: PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA 2 DS 2 -VASC and HAS-BLED scores. Results: Of 1739 patients who received an implant (7159 patient-years follow-up; CHA 2 DS 2 -VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18–5.79; P P P =0.007), permanent atrial fibrillation (OR, 2.24; 95% CI, 1.19–4.20; P =0.012); vascular disease (OR, 2.06; 95% CI, 1.08–3.91; P =0.028); left atrial appendage diameter (OR, 1.06 per mm increase; 95% CI, 1.01–1.12; P =0.019); left ventricular ejection fraction (OR, 0.96 per 1% increase; 95% CI, 0.94–0.99; P =0.009). DRT and SSE both occurred in 17 of 65 patients (26.2%). Of the 19 SSE events in these patients with DRT, 9 of 19 (47.4%) and 12 of 19 (63.2%) occurred within 1 and 6 months of DRT detection. Conversely, after left atrial appendage closure, most SSEs (123/142, 86.62%) occurred in patients without DRT. Conclusions: After left atrial appendage closure with Watchman, DRT (≈3.7%) is not frequent but, when present, is associated with a higher rate of stroke and systemic embolism.

Migraine is a prevalent and disabling disorder. Patent foramen ovale (PFO) has been associated with migraine, but its role in the disorder remains poorly understood.This study examined the efficacy of percutaneous PFO closure as a therapy for migraine with or without aura.The PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management) was a double-blind study investigating migraine characteristics over 1 year in subjects randomized to medical therapy with a sham procedure (right heart catheterization) versus medical therapy and PFO closure with the Amplatzer PFO Occluder device (St. Jude Medical, St. Paul, Minnesota). Subjects had 6 to 14 days of migraine per month, had failed at least 3 migraine preventive medications, and had significant right-to-left shunt defined by transcranial Doppler. Primary endpoints were responder rate defined as 50% reduction in migraine attacks and adverse events. Secondary endpoints included reduction in migraine days and efficacy in patients with versus without aura.Of 1,653 subjects consented, 230 were enrolled. There was no difference in responder rate in the PFO closure (45 of 117) versus control (33 of 103) groups. One serious adverse event (transient atrial fibrillation) occurred in 205 subjects who underwent PFO closure. Subjects in the PFO closure group had a significantly greater reduction in headache days (-3.4 vs. -2.0 days/month, p = 0.025). Complete migraine remission for 1 year occurred in 10 patients (8.5%) in the treatment group versus 1 (1%) in the control group (p = 0.01).PFO closure did not meet the primary endpoint of reduction in responder rate in patients with frequent migraine. (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management [PREMIUM]; NCT00355056).

Management of patients requiring temporary, mechanical hemodynamic support during high- risk percutaneous coronary intervention (PCI) or in cardiogenic shock is rapidly evolving. With the availability of the Impella 2.5, CP, 5.0, LD, and RP percutaneous mechanical circulatory support devices, there is a need for continued surveillance of outcomes. Three factors underline the importance of a registry for these populations. First, large randomized trials of hemodynamic support, involving cardiogenic shock, are challenging to conduct. Second, there is increasing interest in the use of registries to provide “real-world” experience and to allow the flexibility to evaluate individual patient uses and outcomes. Third, current, large databases have not captured the specific impact of mechanical support treatment of cardiogenic shock. The predecessor to the catheter-based ventricular assist devices registry, known as USpella, began in 2009 with paper data acquisition but beginning in 2011 transferred to electronic data capture, enrolling 3,339 patients through 2016. Throughout, registry data have been used to assess the outcomes of Impella therapy, leading to 8 publications and 4 Food and Drug Administration premarket approvals covering multiple indications and Impella devices. Going forward, the registry will continue to assess not only in-hospital outcomes but long-term follow-up to 1 year. In addition, data management will be enhanced to assess quality and clinical experiences. The registry will also provide a mechanism for postmarketing surveillance. This manuscript reviews the ongoing catheter-based ventricular assist devices registry design, management, and contributions of the registry data. The upgraded registry will provide a more robust opportunity to assess acute and late outcomes of current and future device use worldwide. Condensed abstract The current catheter-based ventricular assist devices registry is an international database documenting outcomes with temporary Impella hemodynamic support. The registry has supported 8 publications and 4 Food and Drug Administration premarket approvals since its inception in 2009. The current registry is more robust containing outcomes up to 1 year postprocedure.

BACKGROUND We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, −0.4; P

Objectives This study evaluates the cost-effectiveness of percutaneous cardiac assist device (pVAD) therapy in the emergent setting compared with traditional surgical hemodynamic support alternatives. Background: Previous research has demonstrated the cost-effectiveness of pVAD hemodynamic support for patients undergoing high-risk percutaneous coronary intervention. For patients in cardiogenic shock (CS), use of pVAD therapy has been shown to reduce length of stay (LOS). Methods: National utilization and outcome data from the 2010–2011 MedPAR and state-sponsored all-payer databases were collected for patients with an acute myocardial infarction complicated by CS who were treated with either a pVAD (n = 883) or with traditional surgical hemodynamic support alternatives (ECMO and extracorporeal VAD) (n = 305). Results: Discharge survival was greater with pVADs than with surgical alternatives (56% vs. 42%, P

Objectives To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre-PCI) versus those who received it after PCI (post-PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI). Background Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized. Methods Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end-point was survival to discharge. Secondary end-points included assessment of patients’ hemodynamics and in-hospital complications. A multivariate regression model was used to identify independent predictors for mortality. Results Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre-PCI group. Patients in the pre-PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post-PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre-PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in-hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17–0.79, P = 0.01) in multivariate analysis. The incidence of in-hospital complications included in the secondary end-point was similar between the 2 groups. Conclusions The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI.