SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure.

Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.

SCAI/HRS expert consensus statement on transcatheter left atrial appendage closure.

Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices.

Prospective Evaluation of Autonomic Dysfunction in Post-Acute Sequela of COVID-19.

BACKGROUND: Patients with post-acute sequela of COVID-19 (PASC) often report symptoms of orthostatic intolerance and autonomic dysfunction. Numerous case reports link postural orthostatic tachycardia syndrome (POTS) to PASC. No prospective analysis has been performed. OBJECTIVES: This study performed head-up tilt table (HUTT) testing in symptomatic patients with PASC to evaluate for orthostatic intolerance suggestive of autonomic dysfunction. METHODS: We performed a prospective, observational evaluation of patients with PASC complaining of poor exertional tolerance, tachycardia with minimal activity or positional change, and palpitations. Exclusion criteria included pregnancy, pre-PASC autonomic dysfunction or syncope, or another potential explanation of PASC symptoms. All subjects underwent HUTT. RESULTS: Twenty-four patients with the described PASC symptoms were included. HUTT was performed a mean of 5.8 ± 3.5 months after symptom onset. Twenty-three of the 24 had orthostatic intolerance on HUTT, with 4 demonstrating POTS, 15 provoked orthostatic intolerance (POI) after nitroglycerin, 3 neurocardiogenic syncope, and 1 orthostatic hypotension. Compared with those with POTS, patients with POI described significantly earlier improvement of symptoms. CONCLUSIONS: This prospective evaluation of HUTT in patients with PASC revealed orthostatic intolerance on HUTT suggestive of autonomic dysfunction in nearly all subjects. Those with POI may be further along the path of clinical recovery than those demonstrating POTS.

Safety gaps in medical team communication: Closing the loop on quality improvement efforts in the cardiac catheterization lab.

Closed-loop communication (CLC) is a fundamental aspect of effective communication, critical in the cardiac catheterization laboratory (cath lab) where physician orders are verbal. Complete CLC is typically a hospital and national mandate. Deficiencies in CLC have been shown to impair quality of care. Single center observational study, CLC for physician verbal orders in the cath lab were assessed by direct observation during a 5-year quality improvement effort. Performance feedback and educational efforts were used over this time frame to improve CLC, and the effects of each intervention assessed. Responses to verbal orders were characterized as complete (all important parameters of the order repeated, the mandated response), partial, acknowledgment only, or no response. During the first observational period of 101 cases, complete CLC occurred in 195 of 515 (38%) medication orders and 136 of 235 (50%) equipment orders. Complete CLC improved over time with various educational efforts, (p < 0.001) but in the final observation period of 117 cases, complete CLC occurred in just 259 of 328 (79%) medication orders and 439 of 581 (76%) equipment orders. Incomplete CLC was associated with medication and equipment errors. CLC of physician verbal orders was used suboptimally in this medical team setting. Baseline data indicate that physicians and staff have normalized weak, unreliable communication methods. Such lapses were associated with errors in order implementation. A subsequent 5-year quality improvement program resulted in improvement but a sizable minority of unacceptable responses. This represents an opportunity to improve patient safety in cath labs.

The 40th Anniversary of Percutaneous Balloon Valvuloplasty for Mitral Stenosis: Current Status.

Percutaneous balloon mitral valvuloplasty (PBMV), once the most complex of percutaneous cardiac procedures and essentially the first adult structural heart intervention, set the stage for a host of new technologies. Randomized studies comparing PBMV to surgery were the first to provide a high-level evidence base in structural heart. The devices used have changed little in 40 years, but the advent of improved imaging and the expertise gained in interventional cardiology has provided some additional procedural safety. However, with the decline in rheumatic heart disease, PBMV is being performed in fewer patients in industrialized nations; in turn, these patients have more comorbidities, less favorable anatomy, and thus a higher rate of procedure-related complications. There remain relatively few experienced operators, and the procedure is distinct enough from the rest of the structural heart intervention world that it has its own steep learning curve. This article reviews the use of PBMV in a variety of clinical settings, the influence of anatomic and physiologic factors on outcomes, the changes in the guidelines, and alternative approaches. PBMV remains the procedure of choice in patients with mitral stenosis with ideal anatomy and a useful tool in patients with less than ideal anatomy who are poor surgical candidates. In the 40 years since its first performance, PBMV has revolutionized the care of mitral stenosis patients in developing countries and remains an important option for suitable patients in industrialized nations.

Hemodynamic Profiles of Shock in Patients With COVID-19.

Patients with serious COVID infections develop shock frequently. To characterize the hemodynamic profile of this cohort, 156 patients with COVID pneumonia and shock requiring vasopressors had interpretable echocardiography with measurement of ejection fraction (EF) by Simpson's rule and stroke volume (SV) by Doppler. RV systolic pressure (RVSP) was estimated from the tricuspid regurgitation peak velocity. Patients were divided into groups with low or preserved EF (EFL or EFP, cutoff ≤45%), and low or normal cardiac index (CIL or CIN, cutoff ≤2.2 L/min/m2). Mean age was 67 ± 12.0, EF 59.5 ± 12.9, and CI 2.40 ± 0.86. A minority of patients had depressed EF (EFLCIL, n = 15, EFLCIN, n = 8); of those with preserved EF, less than half had low CI (EFPCIL, n = 55, EFPCIN, n = 73). Overall hospital mortality was 73%. Mortality was highest in the EFLCIL group (87%), but the difference between groups was not significant (p = 0.68 by ANOVA). High PEEP correlated with low CI in the EFPCIL group (r = 0.44, p = 0.04). In conclusion, this study reports the prevalence of shock characterized by EF and CI in patients with COVID-19. COVID-induced shock had a cardiogenic profile (EFLCIL) in 9.6% of patients, reflecting the impact of COVID-19 on myocardial function. Low CI despite preservation of EF and the correlation with PEEP suggests underfilling of the LV in this subset; these patients might benefit from additional volume. Hemodynamic assessment of COVID patients with shock with definition of subgroups may allow therapy to be tailored to the underlying causes of the hemodynamic abnormalities.

Stitching your way to venous hemostasis.

Venous compression using a purse string suture is a potential alternative to device suture of the venotomy or to the more extensively described Figure of 8 closure technique. The technique is likely to prove cost effective although the optimal methodology and overall risk remain to be determined. A general comment regarding the common femoral vein: it is a fragile structure. All venous closure techniques require special care not to obstruct, lacerate or sever the vein and operators should be vigilant for both bleeding and thrombosis.

Closing up after TAVR.

Techniques for vascular access and closure are highly heterogeneous and continue to evolve. The combination of suture and collagen plug closure has theoretical benefits but also potential additive risk. It is, however, hard to state firmly that there is promising safety and efficacy claims should be made with caution when based on small single site series.

The NCDR Left Atrial Appendage Occlusion Registry.

BACKGROUND: Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited. OBJECTIVES: The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years. METHODS: The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates. RESULTS: A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare. CONCLUSIONS: The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.

Safety gaps in medical team communication: Results of quality improvement efforts in a cardiac catheterization laboratory.

OBJECTIVES: To assess closed-loop communications (readback), a fundamental aspect of effective communication, among cardiovascular teams and assess improvement efforts. BACKGROUND: Effective communication within teams is essential to assure safety and optimal outcomes. Readback of verbal physician orders is a hospital and national requirement. METHODS: Single-center observational study, where the readback responses to physician verbal orders in the catheterization laboratory were characterized over three distinct time intervals from 2015 to 2017. Performance feedback and focused education on the value of readbacks was provided to the teams in two waves, with subsequent remeasurement. Responses to verbal orders were characterized as complete (all important parameters of the order repeated for verification), partial, acknowledgement only, or no response. Changes in readback performance after quality interventions were assessed. RESULTS: During the first-observational period of 101 cases, complete readback occurred in 195 of 515 (38%) medication orders and 136 of 235 (58%) equipment orders. After initial quality improvement efforts, 102 cases were observed. In these, 298 of 480 (62%) medication orders had complete readback, and 210 of 420 (50%) equipment orders had complete readback. After additional quality improvement efforts, 168 cases were observed. In these, 506 of 723 (70%) medication orders had complete readback, and 630 of 1,061 (59%) equipment orders had complete readback. Overall, medication order readback improved over time (correlation = 0.26 [-0.30, -0.21]; p < 0.001), but equipment order readback did not (correlation = 0.02 [-0.07, 0.03]; p = 0.44). CONCLUSIONS: Closed-loop communication of physician verbal orders was used infrequently in this medical team setting and proved difficult to fully improve. This is an important safety gap.

A match not made in heaven-TAVR prosthesis-patient mismatch with contemporary valves.

Prosthesis-patient mismatch (PPM) in TAVR is relatively common Valve oversizing can potentially prevent both paravalvular leak and PPM PPM may be avoidable if the expected Effective Orifice Area/Body Surface Area ratio is considered in decision making pre-TAVR.

The under-appreciated and still under-investigated consequences of "supersized" access and closure.

Large bore access and closure of the femoral artery has the potential to cause or accelerate local vascular disease The implications of accelerated disease could be substantial Further investigation is needed to assess the true short- and long-term effects.

Clip versus suture toe to toe: Perspectives on and beyond the evidence base.

The evidence that StarClose is associated with a higher complication rate than Perclose is reasonable if less than robust. Closure results are affected by access technique. The rationale for using closure devices in small hole puncture is questionable both from a clinical as well as financial standpoint.

Moving beyond Seldinger, a vascular access and closure smorgasbord, "safe zone" or not.

This paper describes a quality improvement initiative featuring the adoption of multiple access and closure techniques to assess "real world" outcomes. Although the study does not provide a scientific evidence base, it does highlight the changing platforms being adopted. Radial, micropuncture, and image guided access will hopefully become near universal in the coming decade.

ACC/AATS/AHA/ASE/EACTS/HVS/SCA/SCAI/SCCT/SCMR/STS 2017 Appropriate Use Criteria for the Treatment of Patients With Severe Aortic Stenosis: A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons.

The American College of Cardiology collaborated with the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons to develop and evaluate Appropriate Use Criteria (AUC) for the treatment of patients with severe aortic stenosis (AS). This is the first AUC to address the topic of AS and its treatment options, including surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). A number of common patient scenarios experienced in daily practice were developed along with assumptions and definitions for those scenarios, which were all created using guidelines, clinical trial data, and expert opinion in the field of AS. The 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines(1) and its 2017 focused update paper (2) were used as the primary guiding references in developing these indications. The writing group identified 95 clinical scenarios based on patient symptoms and clinical presentation, and up to 6 potential treatment options for those patients. A separate, independent rating panel was asked to score each indication from 1 to 9, with 1-3 categorized as "Rarely Appropriate," 4-6 as "May Be Appropriate," and 7-9 as "Appropriate." After considering factors such as symptom status, left ventricular (LV) function, surgical risk, and the presence of concomitant coronary or other valve disease, the rating panel determined that either SAVR or TAVR is Appropriate in most patients with symptomatic AS at intermediate or high surgical risk; however, situations commonly arise in clinical practice in which the indications for SAVR or TAVR are less clear, including situations in which 1 form of valve replacement would appear reasonable when the other is less so, as do other circumstances in which neither intervention is the suitable treatment option. The purpose of this AUC is to provide guidance to clinicians in the care of patients with severe AS by identifying the reasonable treatment and intervention options available based on the myriad clinical scenarios with which patients present. This AUC document also serves as an educational and quality improvement tool to identify patterns of care and reduce the number of rarely appropriate interventions in clinical practice.

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis.

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

Ending "poke until you get a gusher": Part II-the evidence based approach to vascular access revisited.

Puncture above the common femoral bifurcation and below the inguinal ligament is optimal A vast majority of femoral bifurcations occur below the middle third of the femoral head while the inferior epigastric artery rarely descends below the middle third Fluoroscopy or if possible, ultrasound, should be used for femoral access to optimize safe puncture.