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.

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.

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.

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.

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.

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.

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.

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.

Revisiting Femoral vs. Radial access-do vascular closure devices level the playing field?

Previous large randomized multicenter trials have shown superiority of radial to femoral access in reducing major bleeding, vascular complications, and in some cohorts, mortality Vascular closure devices improve time to hemostasis and ambulation, as well as patient comfort, but have not been shown to reduce major complications or mortality consistently in the high level evidence base. The combination of optimal femoral access and closure with a vascular closure device has the potential to narrow the gap between the radial and femoral approaches in high risk patients, but unfortunately this study was too limited to confirm either non-inferiority or equivalence.

Life in the left atrial appendage fast lane after FDA approval: Moving forward on new technology at last.

FDA approval of the WATCHMAN is expected to spur development and availability of a range of evolutionary and revolutionary technologies for left atrial appendage occlusion. The fourth generation WATCHMAN described in this article has multiple features that will potentially streamline the deployment process and have the potential to make left atrial appendage occlusion safer. The population studied was too small to compare the relatively high adverse event rate with the known outcomes associated with existing WATCHMAN technology. Going forward, in part because of improvements in technology, it is likely that late ischemic stroke will supplant pericardial effusion as a key outcome measure for ongoing assessment of WATCHMAN safety and efficacy.

Does a vascular closure device affect the imbalance in complications between radial and femoral access?

There exists a robust evidence base of superior outcomes in ST-Elevation Myocardial Infarction (STEMI) with radial as opposed to femoral access Benefit of vascular closure devices to decrease femoral access complications remains a matter of contention; the evidence base is largely incomplete Vascular site complications and access site related bleeding may be as much, or more affected by access technique as by method of vascular closure.

One step forward or eight needles back: A retro(grade) approach to femoral hemostasis for TAVR.

Percutaneous approach rather than surgical cutdown is the procedure of choice for TAVR patients to minimize morbidity and procedure time. ProGlide has been shown to have noninferior outcomes versus surgical cutdown with shorter procedure time and less pain; noninferiority was not demonstrated by single Prostar XL in a randomized trial of "preclosure" for endovascular aortic aneurysm repair. The current study did not include a ProGlide arm. As the size of Transcatheter Aortic Valve Replacement devices continues to decrease, the need for large bulky 4-needle devices like the Prostar XL is likely to become obsolete.

Cutting down on the cutdown: Time to remove the training wheels for transfemoral access for TAVR.

Percutaneous transfemoral access is replacing cutdowns, even in the absence of a high level evidence base The evolution of smaller profile TAVR sheaths will make cutdowns largely obsolete Patient comfort, early ambulation, and shorter length of stay, along with improved methodologies will continue to drive the move to percutaneous access and closure for TAVR.

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.

The "bladder sign"--an important early marker of retroperitoneal hemorrhage.

Retroperitoneal hemorrhage remains one of the major complications of cardiac and peripheral vascular catheterization. Its high associated morbidity and mortality require vigilance and early intervention. We report six cases of retroperitoneal hemorrhage featuring a "bladder sign." The compression of the bladder described in this series can be visualized on the incidental cystogram that results from contrast given during catheterization. Its significance as a highly specific marker of retroperitoneal hemorrhage should be appreciated.