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The optimal treatment for intermediate-risk pulmonary embolism (PE) remains unclear. Our goal was to describe the safety and efficacy of the EkoSonic ultrasound-assisted catheter-directed thrombolysis system (EKOS Corporation, Bothell, Washington) in a real-world registry of patients with intermediate-risk PE. Fifty-three consecutive patients with intermediate-risk PE treated with ultrasound-assisted catheter-directed thrombolysis at Brigham and Women's Hospital from 2010 to 2014 were analyzed. The primary outcome was a change in directly measured pulmonary artery pressures as assessed using logistic regression with generalized estimating equations to account for serial measurements. Patients received an average of 24.6 ± 9 mg of alteplase using the EKOS catheter with an average treatment time of 15.9 ± 3 hours. After treatment, there was a 7.2- and a 11.4-mm Hg reduction in mean and systolic pulmonary artery pressure (95% confidence interval 4.7 to 9.7 mm Hg, p <0.001, and 95% confidence interval 7.8 to 15.0 mm Hg, p <0.001), respectively. In this cohort, 9.4% had any bleeding complication noted during their hospital stay. One patient's alteplase was prematurely discontinued for access site bleeding although no other interventions were required related to bleeding complications.

Objective. To identify outcomes of patients undergoing emergency transcatheter aortic valve replacement (TAVR) and determine predictors of in-hospital mortality. Background. Emergency TAVR has emerged as a viable treatment strategy for patients with decompensated severe aortic stenosis and/or regurgitation; however, data on patients undergoing emergency TAVR are limited. Methods. All emergency TAVR procedures were identified from a single tertiary academic center between January 2015 and August 2018. Results. 31 patients underwent emergency TAVR due to cardiogenic shock (26 patients), electrical instability with incessant ventricular tachycardia (2 patients), severe refractory angina (2 patients), and decompensated heart failure with hypoxemic respiratory failure requiring mechanical ventilation (1 patient). Mechanical circulatory support (MCS) was used in 16 (51.6%). MCS initiation occurred immediately prior to TAVR in 10 patients and placed post-TAVR in 6 patients. 6 patients died before hospital discharge (in-hospital mortality 19.4%). 1-year and 2-year survival rates were 61.0% and 55.9%, respectively. Univariate predictors of in-hospital mortality were preprocedural pulmonary artery pulsatility index (PAPi) ≤1.8 (66.7% vs. 20.0%, p=0.01), intraprocedural cardiopulmonary resuscitation (CPR) (83.3% vs 4.0%, p≤0.001), acute kidney injury post-TAVR (80.0% vs. 4.2%, p≤0.001), initiation of dialysis post-TAVR (60.0% vs. 4.2%, p≤0.001), and MCS initiation post-TAVR (50.0% vs. 12.0%, p=0.03). MCS initiation before TAVR was associated with improved survival compared with post-TAVR initiation. Conclusion. Emergency TAVR in extreme risk patients with acute decompensated heart failure or cardiogenic shock secondary to severe aortic valve disease is associated with high in-hospital mortality rates. Careful patient selection taking into account right heart function, assessed by PAPi, and early utilization of MCS may improve survival following emergency TAVR.

In a randomized trial, 1000 patients with severe aortic stenosis who were at low risk for death with surgery were assigned to undergo transcatheter aortic-valve replacement with a balloon-expandable valve or surgical aortic-valve replacement. At 1 year, the rate of death, stroke, or rehospitalization was significantly lower in the TAVR group.

In the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO-I) trial, VSD was seen in 84 of 41 021 patients (0.2%) with a median time of 1 day from symptom onset to diagnosis.1 A recent retrospective analysis of Medicare beneficiaries presenting with VSD in the contemporary era of primary PCI for AMI showed a significant decrease in rates of hospitalisation for VSD from 1999 to 2014.2 Patients who develop VSD are more likely to be female, older and lack traditional cardiovascular risk factors such as hypertension, diabetes, smoking or prior history of AMI. The first, the infarctectomy and closure technique, involves thorough debridement of infarcted myocardium and either suturing the defect closed or incorporating a prosthetic patch.4 The second, the infarct exclusion technique, preserves infarcted myocardium by sewing an endocardial patch larger than the infarcted area directly onto healthy tissue.5 There have been subsequent modifications designed to minimise development of residual shunts, including reinforcement of the RV wall in addition to application of an LV patch to ‘sandwich’ the septal defect.6 For patients surviving the initial operation, a single-centre study of 110 patients showed residual shunt on TTE in over 40% of patients, 12% need for reoperation and 5-year survival of 45%.7 Percutaneous techniques Given an operative mortality in excess of 40% among patients deemed fit enough to undergo sternotomy, percutaneous techniques have emerged for less viable and higher-risk patients. A recent retrospective analysis of Medicare beneficiaries presenting with VSD in the contemporary era of primary PCI for AMI showed a decline in rates of surgical repair from 43.8% in 2006 to 28.4% in 2014.2 In contrast, rates of percutaneous repair increased from 0.3% in 2006 to 5.9% in 2014 with a total of 87 repairs performed. (A) The overlay of colour Doppler on 2D two-dimensional transthoracic echocardiography imaging helps highlight the serpiginous nature of this extensive VSD (yellow arrows).

Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve. The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT 04415047, and is ongoing. Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2–34·0]) patients (pnon-inferiority<0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3–12·3]) patients at 1 year (pnon-inferiority<0·0001). This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary. JenaValve Technology.

It is unclear if surgical exposure confers a risk advantage compared with a percutaneous approach for patients undergoing endovascular procedures requiring large-bore femoral artery access. From the randomized controlled Placement of Aortic Transcatheter Valve trials A and B and the continued access registries, a total of 1,416 patients received transfemoral transcatheter aortic valve replacement, of which 857 underwent surgical, and 559 underwent percutaneous access. Thirty-day rates of major vascular complications and quality of life scores were assessed. Propensity matching was used to adjust for unmeasured confounders. Overall, there were 116 major vascular complications (8.2%). Complication rates decreased dramatically during the study period. In unadjusted analysis, major vascular complications were significantly less common in the percutaneous access group (35 [6.3%] vs 81 [9.5%] p = 0.032). However, among 292 propensity-matched pairs, there was no difference in major vascular complications (22 [7.5%] vs 28 [9.6%], p = 0.37). Percutaneous access was associated with fewer total in-hospital vascular complications (46 [16%] vs 66 [23%], p = 0.036), shorter median procedural duration (97 interquartile range [IQR 68 to 166] vs 121 [IQR 78 to 194] minutes, p <0.0001), and median length of stay (4 [IQR 2 to 8] vs 6 [IQR 3 to 10] days, p <0.0001). There were no significant differences in quality of life scores at 30 days. Surgical access for large-bore femoral access does not appear to confer any advantages over percutaneous access and may be associated with more minor vascular complications.

The prevalence of concurrent cancer and severe aortic stenosis (AS) is increasing due to an ageing population. In addition to shared traditional risk factors for AS and cancer, patients with cancer may be at increased risk for AS due to off-target effects of cancer-related therapy, such as mediastinal radiation therapy (XRT), as well as shared non-traditional pathophysiological mechanisms. Compared with surgical aortic valve replacement, major adverse events are generally lower in patients with cancer undergoing transcatheter aortic valve intervention (TAVI), especially in those with history of mediastinal XRT. Similar procedural and short-to-intermediate TAVI outcomes have been observed in patients with cancer as compared with no cancer, whereas long-term outcomes are dependent on cancer survival. Considerable heterogeneity exists between cancer subtypes and stage, with worse outcomes observed in those with active and advanced-stage disease as well as specific cancer subtypes. Procedural management in patients with cancer poses unique challenges and thus requires periprocedural expertise and close collaboration with the referring oncology team. The decision to ultimately pursue TAVI involves a multidisciplinary and holistic approach in assessing the appropriateness of intervention. Further clinical trial and registry studies are needed to better appreciate outcomes in this population.

Prompt percutaneous coronary intervention is associated with improved survival in patients presenting with cardiac arrest. Few studies, however, have focused on patients with cardiac arrest not selected for coronary angiography. The aim of the present study was to evaluate the clinical characteristics and outcomes of patients with cardiac arrest denied emergent angiography. Patients with cardiac arrest were identified within a registry that included all catheterization laboratory activations from 2008 to 2012. Logistic regression and proportional-hazards models were created to assess the clinical characteristics and mortality associated with denying emergent angiography. Among 664 patients referred for catheterization, 110 (17%) had cardiac arrest, and 26 of these patients did not undergo emergent angiography. Most subjects (69%) were turned down for angiography for clinical reasons and a minority for perceived futility (27%). After multivariate adjustment, pulseless electrical activity as the initial arrest rhythm (adjusted odds ratio [AOR] 13.27, 95% confidence interval [CI] 1.76 to 100.12), <1.0 mm of ST-segment elevation (AOR 10.26, 95% CI 1.68 to 62.73), female gender (AOR 4.45, 95% CI 1.04 to 19.08), and advancing age (AOR 1.10 per year, 95% CI 1.04 to 1.16) were associated with increased odds of withholding angiography. The mortality rate was markedly higher for patients who were denied emergent angiography (hazard ratio 3.64, 95% CI 2.05 to 6.49), even after adjustment for medical acuity (hazard ratio 2.29, 95% CI 1.19 to 4.41). In conclusion, older subjects, women, and patients without ST-segment elevation were more commonly denied emergent angiography after cardiac arrest. Patients denied emergent angiography had increased mortality that persisted after adjustment for illness severity.

Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial. Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were “PROTECT II-like” (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days. Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P < .001) and prior myocardial infarction (40.7% vs 69.3%; P < .001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P < .001) and duration of support was longer (median 1.6 vs 1.3 hours; p<0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P < .001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P < .001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P < .001), as was procedural hypotension (2.2% vs 10.1%; P < .001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P < .001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048). The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.