Pediatric Catheterization Laboratory Research Articles

First record of pediatric cardiovascular interventional procedures performed in a state pediatric catheterization laboratory in El Salvador

First record of pediatric cardiovascular interventional procedures performed in a state pediatric catheterization laboratory in El Salvador

The Burden of Radiation Exposure During Transcatheter Closure of Atrial Septal Defect

Radiation reduction in the pediatric cardiac catheterization laboratory is well-suited for targeted quality improvement (QI) interventions. Transcatheter atrial septal defect (ASD) closure was chosen for this QI project based on a homogenous procedural population and inter-operator variability in radiation usage, with the aim to reduce radiation exposure during ASD device closure by 50% over 1 year. The aim for this project was defined and a Key Driver Diagram (KDD) was created with three domains for change: modification of procedural practice, reporting and monitoring/feedback, and team engagement. All patients undergoing attempted transcatheter ASD closure were considered for inclusion. The primary outcome, % reduction in median radiation dose (DAP/Kg), was determined through comparison with a historical cohort. Additional radiation metrics, procedural characteristics, and adverse events (AE) were compared to the historical cohort. Radiation exposure (DAP/kg) was reduced by 55% with a median dose reduction from 26 (15, 61) in a historical cohort to 12 (6, 22) in the intervention population (p <0.001). Fluoroscopy time and cine acquisition utilization significantly decreased. Procedure time, procedural success (defined as successful delivery of the device) and AE did not increase in the QI cohort. Successful practice changes included standardized procedural strategies to limit fluoroscopy and cine acquisition, improved fluoroscopic practice, engagement of the multidisciplinary team, and feedback with data reporting by electronic and in-person reminders. In conclusion, application of QI methodologies such as KDD with engagement of a multidisciplinary team can effectively reduce radiation in the pediatric catheterization laboratory.

Interventional catheterization in pediatric catheterization laboratories for congenital and structural heart defects during 2009-2018 in Poland. Report of the National Consultant of Pediatric Cardiology.

Interventional catheterization in pediatric catheterization laboratories for congenital and structural heart defects during 2009-2018 in Poland. Report of the National Consultant of Pediatric Cardiology.

Complex Decision Making in the Pediatric Catheterization Laboratory: Catheterizer, Know Thyself and the Data.

Optimal outcomes are as much influenced by critical decision making pathways as by the technical skill of the operator. The complexity and potential cognitive traps underlying critical decision making has long been recognized in the aviation and business communities, however, remains a largely subconscious, unexamined discipline amongst congenital cardiac interventionalists. Challenges to making good decisions in the catheterization laboratory include heuristics, biases, and cognitive traps. In this paper we discuss some of the more common decision making challenges encountered and we address potential solutions to such decision making with particular focus towards standardization.

Organ doses in pediatric patients undergoing cardiac-centered fluoroscopically guided interventions: Comparison of three methods for computational phantom alignment.

To assess various computational phantom alignment techniques within Monte Carlo radiation transport models of pediatric fluoroscopically guided cardiac interventional studies. Logfiles, including all procedure radiation and machine data, were extracted from a Toshiba infinix-I unit in the University of Florida Pediatric Catheterization Laboratory for a cohort of 10 patients. Two different alignment methods were then tested against a ground truth standard based upon identification of a unique anatomic reference point within images co-registered to specific irradiation events within each procedure. The first alignment method required measurement of the distance from the edge of the exam table to the top of the patient's head (table alignment method). The second alignment method fixed the anatomic reference point to be the geometric center of the heart muscle, as all 10 studies were cardiac in nature. Monte Carlo radiation transport simulations were performed for each patient and intervention using morphometry-matched hybrid computational phantoms for the reference and two tested alignment methods. For each combination, absorbed doses were computed for 28 organs and root mean square organ doses were assessed and compared across the alignment methods. The percent error in root mean square organ dose ranged from -57% to +41% for the table alignment method, and from -27% to +22% for the heart geometric centroid alignment method. Absorbed doses to specific organs, such as the heart and lungs, demonstrated higher accuracy in the heart geometric centroid alignment method, with average percent errors of 10% and 1.4%, respectively, compared to average percent errors of -32% and 24%, respectively, using the table alignment method. Of the two phantom alignment methods investigated in this study, the use of an anatomical reference point - in this case the geometric centroid of the heart - provided a reliable method for radiation transport simulations of organ dose in pediatric interventional cardiac studies. This alignment method provides the added benefit of requiring no physician input, making retrospective calculations possible. Moving forward, additional anatomical reference methods can be tested to assess the reliability of anatomical reference points beyond cardiac centered procedures.

Transcatheter Intervention of Coronary Obstructions in Infants, Children, and Young Adults.

This study assesses the characteristics of coronary obstructions that underwent transcatheter intervention in a pediatric catheterization laboratory, the procedural details, and patient outcomes. Acute cardiac failure due to coronary obstructions in children is rare. The role of catheter based intervention is largely unreported. Single center retrospective review between January 2000 and December 2016. Thirty-three patients (median age 2y/o [0-38], weighing 9.6kg [2.2-91]) underwent 39 transcatheter interventions on 39 lesions, mainly left main coronary (16/39; 39%) and right coronary (9/39; 23%) arteries. Most patients had congenital heart disease (29/33; 88%). Cath indications included ventricular dysfunction (17), cardiac arrest (7), failure to wean from cardiopulmonary bypass (5), and other (4). Almost half (18/39; 46%) were performed on ECMO support. Obstructions were post-surgical (16; 4 with coronary manipulation), thrombotic (13; 5 < 30days from cardiac surgery), and miscellaneous lesions (10). Interventions included 25 bare metal stents implanted in 22 lesions in 17 patients (mainly post-surgical lesions; 3at Damus-Kaye-Stansel anastomosis), nine balloon angioplasty only, four lytic therapy ± mechanical disruption of thrombus, and four technical failures. There were no procedure-related deaths. Most patients survived to discharge or transplant (24/33; 73%). Six patients who received stents had follow-up catheterization (median 15.5months [1-106]); all were without restenosis. Most coronary obstructions intervened upon in a pediatric cath lab were on young, critically ill patients with congenital heart disease secondary to surgical manipulation/injury or thrombosis. Transcatheter intervention should be considered a potential treatment strategy in this population.

Noninvasive Cardiac Output Estimation by Inert Gas Rebreathing in Mechanically Ventilated Pediatric Patients

To assess the feasibility and accuracy of inert gas rebreathing (IGR) pulmonary blood flow (Qp) estimation in mechanically ventilated pediatric patients, potentially providing real-time noninvasive estimates of cardiac output. In mechanically ventilated patients in the pediatric catheterization laboratory, we compared IGR Qp with Qp estimates based upon the Fick equation using measured oxygen consumption (VO2) (FickTrue); for context, we compared FickTrue with a standard clinical short-cut, replacing measured with assumed VO2 in the Fick equation (FickLaFarge, FickLundell, FickSeckeler). IGR Qp and breath-by-breath VO2 were measured using the Innocor device. Sampled pulmonary arterial and venous saturations and hemoglobin concentration were used for Fick calculations. Qp estimates were compared using Bland-Altman agreement and Spearman correlation. The final analysis included 18 patients aged 4-23 years with weight >15 kg. Compared with the reference FickTrue, IGR Qp estimates correlated best and had the least systematic bias and narrowest 95% limits of agreement (results presented as mean bias ±95% limits of agreement): IGR -0.2 ± 1.1 L/min, r = 0.90; FickLaFarge +0.7 ± 2.2 L/min, r = 0.80; FickLundell +1.6 ± 2.9 L/min, r = 0.83; FickSeckeler +0.8 ± 2.5 L/min, r = 0.83. IGR estimation of Qp is feasible in mechanically ventilated patients weighing >15 kg, and agreement with FickTrue Qp estimates is better for IGR than for other Fick Qp estimates commonly used in pediatric catheterization. IGR is an attractive option for bedside monitoring of Qp in mechanically ventilated children.

Abstract 19722: Cardiac Output Estimation by Inert Gas Rebreathing is Accurate in Mechanically Ventilated Children With Heart Disease

Introduction: Real time estimates of pulmonary (Qp) and systemic blood flow (Qs) could improve pediatric cardiac care. Current generation inert gas rebreathing (IGR) devices are safe, portable, and easy to use; can estimate Qp and Qs rapidly at the bedside; and can now be adapted for use in intubated patients. We compared IGR and two types of Fick Qp estimates, those using measured (FickM) and assumed (FickA) oxygen consumption (VO2) values, in mechanically ventilated pediatric cardiac patients with no shunt lesion or exclusive right-to-left shunt. Secondarily, we compared measured VO2 with assumed values and values back-calculated from the Fick equation (using measured saturations, hemoglobin and IGR Qp). Methods: In 18 intubated patients in the pediatric catheterization laboratory, the modified ventilator-compatible InnocorTM device was used to measure IGR Qp and breath-by-breath VO2; assumed VO2 was taken from LaFarge tables. Sampled pulmonary arterial and venous saturations were used to calculate FickM and FickA. Bland-Altman agreement and Spearman correlation were assessed for IGR Qp with FickA Qp and FickM Qp. Secondarily, agreement was analyzed between measured VO2, assumed VO2, and VO2 calculated from the Fick equation. Results: Subjects were aged 4-23 years, with a range of cardiac diagnoses. The figure shows Bland-Altman plots for Qp. Compared with FickA, IGR Qp had mean bias -0.9 L/min, 95% limits of agreement (=±1.96 SD) -2.8 to +1.0 L/min, and r=0.75. Compared with FickM, IGR Qp had mean bias -0.2 L/min, 95% limits of agreement -1.3 to +1.0 L/min, and r=0.90. Agreement of assumed and measured VO2 was poor (bias +23%, ±55%); measured VO2 agreed better with Fick calculated VO2 than assumed VO2. Conclusions: IGR Qp estimates agree well with Fick Qp estimates. This agreement improves when VO2 is measured, as assumed VO2 agrees poorly with measured VO2. IGR is an attractive option for bedside monitoring of Qp in intubated children.

How Slow Can We Go? 4 Frames Per Second (fps) Versus 7.5 fps Fluoroscopy for Atrial Septal Defects (ASDs) Device Closure.

Radiation exposure remains a significant concern for ASD device closure. In an effort to reduce radiation exposure, the default fluoroscopy frame rate in our Siemens biplane pediatric catheterization laboratory was reduced to 4 fps in November 2013 from an earlier 7.5 fps fluoro rate. This study aims to evaluate the components contributing to total radiation exposure and compare the procedural success and radiation exposure during ASD device closure using 4 versus 7.5 fps fluoroscopy rates. Twenty ASD device closures performed using 4 fps fluoro rate were weight-matched to 20 ASD closure procedures using 7.5 fps fluoro rate. Baseline characteristics, procedure times and case times were similar in the two groups. Device closure was successful in all but one case in the 4 fps group. The dose area product (DAP), normalized DAP to body weight, total radiation time and fluoro time were lower in the 4 fps group but not statistically different than the 7.5 fps. The number of cine images and cine times were identical in both groups. Fluoroscopy and cineangiography contributed equally to radiation exposure. Fluoroscopy at 4 fps can be safe and effective for ASD device closure in children and adults. There was no increase in procedure time, cine time, fluoro time or complications at this slow fluoro rate. There was a trend toward decreased radiation exposure as measured by indexed DAP although not statistically significant in this small study. Further study with multiple operators using 4 fps fluoroscopy for simple interventional procedures is recommended.

心臓カテーテル検査によって得られた結果をどう解釈するか

心エコー，CT，MRIなどの非侵襲的検査法の進歩に従い，心臓カテーテル造影検査はカテーテル治療の目的で施行されることが多くなり，多くの先天性心疾患（以下CHD）の術前のルーチンの検査として施行していた時代と比較してその適応は大きく変わった．現在の診断カテーテルの適応は，1）大動脈弁，僧房弁狭窄の重症度やFontan型手術適応など，より正確な血行動態評価が必要な時，2）心奇形の形態異常が非侵襲的検査法では充分に描出されず評価できない時，3）カテーテル治療を計画し，その前に施行する場合，4）肺動脈閉塞性病変の有無を決定するなど，血行動態評価が治療方針の決めてとなる時，5）電気生理学的検査，または生検が必要な時，などである．このように以前と診断カテーテルの適応は変わったが，未だCHDの，特に複雑心奇形の形態，血行動態を評価する“Gold Standard”な検査として施行されている．このReviewでは酸素飽和度，圧などから計算される血行動態の指標や造影所見などをいかに得て，どう解釈するかについて概説した．

Ultrasound- Versus Landmark-Guided Femoral Catheterization in the Pediatric Catheterization Laboratory: A Randomized-Controlled Trial

Ultrasound (US) is the standard of care for vascular access in many clinical scenarios. Limited data exist regarding the benefits of US- versus landmark (LM)-guided femoral vascular access in the pediatric catheterization laboratory. This study aimed to compare US- and LM-guided vascular access in the pediatric catheterization laboratory. A single operator randomized 95 patients (201 vessels) to undergo either LM- or US-guided vascular access. The primary end point was the access success rate. Number of attempts, inadvertent access, time to sheath placement, and complications also were compared between the two groups. No difference was seen in the overall access success rate: 98 % with US versus 93 % with LM (p = 0.17). The success rate for the targeted vessel was higher with US (89 %) than with LM (67 %) (p = 0.012). US facilitated fewer attempts (1.1 ± 0.4 vs 1.4 ± 0.9; p = 0.048) and improved the first-attempt success rate (87 vs 77 %; p = 0.049). The time to access did not differ significantly between the two groups (US 2:55 ± 4:03 vs LM 3:37 ± 2:54; p = 0.28). No differences in complication rates were noted. The benefits of US were accentuated in the subgroup weighing less than 10 kg. In this study, US access in the pediatric catheterization laboratory did not improve overall success. However, US improved accuracy and reduced the number attempts necessary for access without prolonging the access time of the procedure. Small children realized the greatest benefit of US-guided access.

Heart Rythm Society expert consensus statement on electrophysiology laboratory standards: process, protocols, equipment, personnel, and safety.

ABBREVIATIONS CIED = cardiovascular implantable electronic device; CT=computed tomography; EP=electrophysiology; FDA= U.S. Food and Drug Administration; ICD=implantable cardioverterdefibrillator; MRI = magnetic resonance imaging; QA = quality assurance; QI = quality improvement; RF = radiofrequency; VT = ventricular tachycardia (Heart Rhythm 2014;11:e9–e51)

Patient Radiation Exposure in a Modern, Large-Volume, Pediatric Cardiac Catheterization Laboratory

Radiation exposure from pediatric cardiac catheterization may be substantial, although published estimates vary. We sought to report patient radiation dose across a range of diagnostic and interventional cases in a modern, high-volume pediatric catheterization laboratory. We retrospectively reviewed diagnostic and interventional cases performed in our pediatric catheterization laboratory from 1 April 2009 to 30 September 2011 for which radiation usage data were available as reported by the Artis Zee(®) (Siemens Medical Solutions) system. Electrophysiology cases were excluded. Radiation dose was quantified as air kerma dose (mGy) and dose-area product (DAP; μGy m(2)). The DAP was converted to an effective dose millisievert (mSv) using the Monte Carlo method. Radiation usage data were available from 2,265 diagnostic and interventional cases with an overall median air kerma dose of 135 mGy [interquartile range (IQR) 59-433], median DAP of 760 μGy m(2) (IQR 281-2,810), of which 75 % (IQR 59-90 %) was derived from fluoroscopy, and median effective dose of 6.2 mSv (IQR 2.7-14.1). Air kerma dose from a single camera >2,000 mGy occurred in 1.8 % of cases. Significant differences in all measures of radiation exposure existed based on procedural and interventional types (p = 0.0001), with interventional cases associated with the highest effective dose after adjusting for patient weight category (p < 0.001). Patient weight, age, fluoroscopy time, and proportional use of digital acquisition were independent predictors of exposure (p ≤ 0.001; R (2) = 0.59-0.64). In a modern, large-volume pediatric catheterization laboratory, the median effective dose is 6.2 mSv with a wide range of exposure based on patient- and procedure-specific factors. Radiation monitoring is an important component of a pediatric laboratory and further dose reduction strategies are warranted.

Ductal spasm during performance of transcatheter ductal occlusion

Transcatheter patent ductus arteriosus (PDA) occlusion is a staple of pediatric catheterization laboratories. We present the phenomenon of significant PDA spasm to prevent failure to occlude a hemodynamically significant duct. Transcatheter techniques have evolved, allowing safe and effective occlusion of PDAs in younger and smaller patients. Neonatal care is evolving with increasing survival at younger gestational ages. Premature infants often have PDAs, so the proportion of formerly premature children referred for transcatheter ductal occlusion will likely rise. We reviewed all transcatheter PDA occlusions performed at our institution since 2001 (N = 331). Retrospective data included: gestational age, age at catheterization, precatheterization echocardiographic parameters, PDA size (after spasm relief), device specifications, and most recent follow-up data. Seven cases were identified. Median age was 12 months, median gestational age was 28 weeks. All were born prematurely. All PDAs were restrictive and six had left-heart volume overload. All patients were examined by the interventional cardiologist and had ductal murmurs. When reauscultated (three of seven), murmurs were absent during spasm. Once spasm relieved, PDA diameters ranged from 1.5 to 8 (median 2) mm. All patients accommodated a 6-mm-or larger-Amplatzer device. No significant complications occurred and all patients were well at follow-up. Ductal spasm occurs during transcatheter occlusion and may be an unrecognized cause of procedural failure. The phenomenon seems to occur in children born prematurely, and can occur after infancy. Loss of a continuous murmur confirms the diagnosis. Care should be taken to avoid device under-sizing when spasm occurs.

Effective Radiation Dosages in 3D Rotational Angiography in Children

Background: Three-dimensional rotational angiography (3DRA) is a relatively new but promising imaging technique in the pediatric catheterization laboratory. However, data on the effective dose (E) of this technique are lacking, since they are very time consuming to obtain. The purpose of our study is to provide E of 3DRA and to correlate Ed to parameters readily available in daily practice.

2012 American college of cardiology foundation/society for cardiovascular angiography and interventions expert consensus document on cardiac catheterization laboratory standards update: American college of cardiology foundation task force on expert consensus documents society of thoracic surgeons society for vascular medicine

2012 American college of cardiology foundation/society for cardiovascular angiography and interventions expert consensus document on cardiac catheterization laboratory standards update: American college of cardiology foundation task force on expert consensus documents society of thoracic surgeons society for vascular medicine

Pediatric catheterization laboratory anticoagulation with bivalirudin

Pediatric physicians regularly face the problem of uncertain procedural anticoagulation in children, especially in neonates. We sought to evaluate the safety, plasma concentration (pharmacokinetics, PK), pharmacodynamics (PD), and dosing guidelines of bivalirudin when used as a procedural anticoagulant in pediatric percutaneous intravascular procedures. Pediatric subjects undergoing percutaneous intravascular procedures for congenital heart disease were enrolled and received the current weight-based dose used in percutaneous coronary interventions (0.75 mg/kg bolus, 1.75 mg/kg/hr infusion). Blood samples for PK/PD analyses were drawn, and safety was evaluated by monitoring bleeding and thrombosis events. A total of 110 patients (11 neonates, 33 infants, 32 young children, and 34 older children) were enrolled; 106 patients received the protocol dose. The PK/PD response of bivalirudin was predictable and behaved in a manner similar to that in adults. Weight-normalized bivalirudin clearance rates were more rapid in neonates and decreased with increasing age. Bivalirudin concentrations were slightly lower in neonates, with a trend to an increase with age. Activating clotting time response was consistent with adult studies and prolonged in all age groups, and there was reasonable correlation between activating clotting time and bivalirudin plasma concentrations across all age groups. There were few major bleeding (2 of 110, 1.8%) or thrombotic events (9 of 110, 8.2%) reported. PK/PD response of bivalirudin in the pediatric population is predictable and behaves in a manner similar to that in adults. Using adult dosing, bivalirudin safely provided the expected anticoagulant effect in the pediatric population undergoing intravascular procedures for congenital heart disease.

Assessment of pulmonary hypertension in the pediatric catheterization laboratory: current insights from the Magic registry.

To assess protocols, demographics, and hemodynamics in pediatric patients undergoing catheterization for pulmonary hypertension (PH). Pediatric specific data is limited on PH. Review of the Mid-Atlantic Group of Interventional Cardiology (MAGIC) collaboration PH registry dataset. Between November 2003 and October 2008, seven institutions submitted data from 177 initial catheterizations in pediatric patients with suspected PH. Pulmonary arterial hypertension associated with congenital heart disease (APAH-CHD) (n = 61, 34%) was more common than idiopathic PAH (IPAH) (n = 36, 20%). IPAH patients were older with higher mean pulmonary arterial pressures (mPAP) (P < 0.01). Oxygen lowered mPAP in patients with IPAH (P < 0.01) and associated PAH not related to congenital heart disease (APAH-non CHD) (P < 0.01). A synergistic effect was seen with inhaled nitric oxide (iNO) (P < 0.01). Overall 9/30 (29%) patients with IPAH and 8/48 (16%) patients with APAH-non CHD were reactive to vasodilator testing. Oxygen lowered pulmonary vascular resistance index (PVRI) in patients with APAH-CHD (P < 0.01). There was no additive effect with iNO but a subset of patients required iNO to lower PVRI below 5 WU·m(2). General anesthesia (GA) lowered systemic arterial pressure (P < 0.01) with no difference between GA and procedural sedation on mPAP or PVRI. Adverse events were rare (n = 7) with no procedural deaths. Pediatric patients with PH demonstrate a higher incidence of APAH-CHD and neonatal specific disorders compared to adults. Pediatric PH patients may demonstrate baseline mPAP < 40 mm Hg but > 50% systemic illustrating the difficulty in applying adult criteria to children with PH. Catheterization in children with PH is relatively safe.

Is it safe to perform cardiac catheterizations on adults with congenital heart disease in a pediatric catheterization laboratory?

To determine the complication rate during the catheterization in adults with congenital heart disease (CHD) in a pediatric catheterization laboratory (PCL). An increasing number of patients with CHD are surviving into adulthood, with diagnostic and interventional cardiac catheterization being essential for the management of their disease. The complication rate during the catheterization of adults with CHD has not been reported. A retrospective chart review was performed on all adult patients (>18 years) with CHD who underwent diagnostic or interventional catheterization in our PCL within the past 8.5 years. A total of 576 procedures were performed on 436 adult patients (median age 26 years). Complex heart disease was present in 387/576 (67%) procedures. An isolated atrial septal defect or patent foramen ovale was present in 115/576 (20%) procedures, and 51/576 (9%) procedures were performed on patients with structurally normal hearts with arrhythmias. Interventional catheterization was performed in 378/576 (66%) procedures. There were complications during 61/576 (10.6%) procedures; 19 were considered major and 42 minor. Major complications were death (1), ventricular fibrillation (1), hypotension requiring inotropes (7), atrial flutter (3), retroperitoneal hematoma, pneumothorax, hemothorax, aortic dissection, renal failure, myocardial ischemia and stent malposition (1 each). The most common minor complications were vascular entry site hematomas and hypotension not requiring inotropes. Procedures performed on patients > or = 45 years of age had a 19% occurrence of complications overall compared with 9% occurrence rate in patients of age < 45 years (P < 0.01). The complication rate during the catheterization of adults with CHD in a PCL is similar to the complication rate of children with CHD undergoing cardiac catheterization. The older subset of patients are more likely to encounter complications overall. The encountered complications could be handled effectively in the PCL. With screening in place, it is safe to perform cardiac catheterization on most adults with CHD in a PCL.

Pediatric cardiac catheterization in the era of transcatheter intervention and partnership with surgery

Pediatric cardiac catheterization has entered an era of intervention. Most cases are performed to treat the patients’ heart defects. Catheterization laboratory interventions may either be the patients’ definitive treatments or treatments aimed at improving surgical outcomes. Compared with their predecessors, modern pediatric operators need more training and experience in order to perform a greater number and complexity of procedures using larger inventories of techniques, catheters and devices. Pediatric catheterization laboratories need to be state-of-the-art, preferably digital, in order to support safe and efficacious procedures. Laboratory staff and administration is optimal if designed specifically for pediatric patients and procedures. Hospital environments, which support pediatric catheterization programs, should have appropriate intensive care and pediatric cardiac surgery services available. Increasingly, professional guidelines and administrative regulations are playing important roles in defining the characteristics of pediatric cardiac catheterization programs.