Procedural Complications During Congenital Cardiac Catheterization

Objective. We sought to identify complications that occurred during congenital cardiac catheterization (CCC) and determine factors that could improve the quality of care provided to patients with congenital heart disease during this procedure. Design. We reviewed the electronic medical record for 903 CCC cases, (455 female; mean age = 29 ± 22 years, range = birth to 91 years) performed in our catheterization laboratory from 2005 to 2007. Included in this cohort are 342 cases performed on patients less than 18 years of age. Clinical follow-up data were reviewed for 3 months postcatheterization. Complications were assigned a grade from 1 to 4 based on severity. Results. The indication for catheterization was diagnostic in 459 (51%) patients, interventional in 386 (43%) patients, and endomyocardial biopsy in 58 (6%) patients. Mean intravenous contrast dose = 1.9 ± 1.8 mL/kg. Mean fluoroscopy exposure = 22 ± 13 minutes. Mean procedure duration = 122 ± 42 minutes. Although 806 cases (89%) were performed without complication, 102 complications were observed in 97 cases. There were no deaths. Emergent surgery was performed in four patients. One patient notified us 16 days after catheterization that she was pregnant. The result of that pregnancy was normal. Thirty complications occurred during the CCC procedure and a first year fellow was involved in 17. Patient age, weight, gender, attending physician, or type of procedure (diagnostic vs. intervention) did not impact risk of complications. Conclusions. Patients of all ages with congenital heart disease can expect a safe procedure with minimal risk of serious complications. Procedural changes that have been implemented include pregnancy testing on all menstruating females prior to CCC regardless of history of sexual activity, and first-year fellows are now directly supervised by the attending physician rather than a more senior fellow throughout the procedure.     

Use and Performance of Premounted Stents Compared to Nonpremounted Stents in Pediatric and Adult Congenital Cardiac Catheterization

Objectives

We sought to characterize the use, efficacy, and performance characteristics of premounted stents relative to nonpremounted stents when used during congenital cardiac catheterization.

Background

Endovascular stent implantation is an effective means of relieving vascular obstruction in patients with congenital heart disease. However, stent implantation is technically challenging and important complications occur. Premounted stents appear to offer many advantages relative to their nonpremounted counterparts, and it has been suggested that the use of premounted stents is associated with fewer complications. However, translation of these potential benefits into procedural or clinical success has been poorly examined and the data are conflicting.

Methods

All stent placements performed between January 1, 1999 and December 31, 2009 were reviewed. Analysis of technical success, hemodynamic success and complications was performed.

Results

416 stents were placed over the 10 year period. 158 (38%) were premounted. There was no apparent trend in the frequency of use of premounted stents over the study period. Implanted premounted stents were smaller in diameter than nonpremounted stents 4.9 mm +/? 1.8 versus 13.9 mm +/? 3.7, and the site of stent placement differed significantly. Unadjusted and adjusted analysis of technical success with respect to the precision of stent placement, hemodynamic success, and complications showed no difference between premounted and non‐premounted stents.

Conclusions

We found no difference between premounted and nonpremounted stents with respect to procedural and hemodynamic success or complications. Nevertheless, there remain practical advantages to the use of premounted stents that may justify their expanding role in congenital cardiac catheterization. (J Interven Cardiol 2013;26:58–61)

     

Adverse Event Rates in Congenital Cardiac Catheterization: A New Understanding of Risks

We sought to characterize the frequency, severity, and attributability of adverse events (AE) in congenital cardiac catheterization and identify patient and procedural characteristics associated with AE. Risk for any AE was associated with age < 1 year (odds ratio [OR] 2.3), interventional cases (OR 2.2), increasing procedure type risk group (OR 1, 2.0, 2.5), and indicator of hemodynamic vulnerability (OR 1.6), all p < 0.001. Each of these and weight were also associated with increased risk for high severity events, except for young age. Our understanding of populations at risk for adverse outcomes in congenital cardiac catheterization cases can be enhanced through the development and refinement of variables that categorize procedure types and patient characteristics by similar risk for adverse outcomes.     

Pediatric/Congenital Cardiac Catheterization Quality: An Analysis of Existing Metrics

ObjectivesThe aim of this study was to enumerate and categorize quality metrics relevant to the pediatric/congenital cardiac catheterization laboratory (PCCL).BackgroundDiagnostic and interventional catheterization procedures are an increasingly important part of the care of young patients with cardiac disease. Measurement of the performance of PCCL programs in a stringent and consistent fashion is a crucial step toward improving outcomes. To the best of our knowledge, a systematic evaluation of current quality metrics in PCCL has not been performed previously.MethodsPotential metrics were evaluated by: 1) a systematic review of peer-reviewed research; 2) a review of metrics from organizations interested in quality improvement, patient safety, and/or PCCL programs; and 3) a survey of U.S. PCCL cardiologists. Collected metrics were grouped on 2 dimensions: 1) Institute of Medicine domains; and 2) the Donabedian structure/process/outcome framework. Survey responses were dichotomized between favorable and unfavorable responses and then compared within and between categories.ResultsIn the systematic review, 6 metrics were identified (from 9 publications), all focused on safety either as an outcome (adverse events [AEs], mortality, and failure to rescue along with radiation exposure) or as a structure (procedure volume or operator experience). Four organizations measure quality metrics of PCCL programs, of which only 1 publicly reports data. For the survey, 229 cardiologists from 118 hospital programs responded (66% of individuals and 72% of hospital programs). The highest favorable ratings were for safety metrics (p < 0.001), of which major AEs, failure to rescue, and procedure-specific AEs had the highest ratings. Of respondents, 67% stated that current risk adjustment were not effective. Favorability ratings for hospital characteristics, PCCL characteristics, and quality improvement processes were significantly lower than for safety and less consistent within categories.ConclusionsThere is a limited number of PCCL quality metrics, primarily focused on safety. Confidence in current risk adjustment methodology is low. The knowledge gaps identified should guide future research in the development of new quality metrics.     

Cardiac Catheterization in the Early Post-Operative Period After Congenital Cardiac Surgery

ObjectivesThis study sought to demonstrate that early cardiac catheterization, whether used solely as a diagnostic modality or for the use of transcatheter interventional techniques, can be used effectively and with an acceptable risk in the post-operative period.BackgroundCardiac catheterization offers important treatment for patients with congenital heart disease. Early post-operative cardiac catheterization is often necessary to diagnose and treat residual anatomic defects. Experience with interventional catheterization to address post-operative concerns is limited.MethodsThis was a retrospective cohort study. The medical and catheterization data of pediatric patients who underwent a cardiac catheterization ≤30 days after congenital heart surgery between November 2004 and July 2013 were reviewed. Patients who underwent right heart catheterization and endomyocardial biopsy after heart transplantation were excluded.ResultsA total of 219 catheterizations (91 interventional procedures, 128 noninterventional catheterizations) were performed on 193 patients. Sixty-five interventions (71.43%) were dilations, either balloon angioplasty or stent implantation. There was no difference in survival to hospital discharge between those who underwent an interventional versus noninterventional catheterization (p = 0.93). One-year post-operative survival was comparable between those who underwent an intervention (66%) versus diagnostic (71%) catheterization (p = 0.58). There was no difference in the incidence of major or minor complications between the interventional and diagnostic catheterization cohorts (p = 0.21).ConclusionsCardiac catheterization, including transcatheter interventions, can be performed safely in the immediate post-operative period after congenital heart surgery.     

A Risk Adjusted Method for Comparing Adverse Outcomes among Practitioners in Pediatric and Congenital Cardiac Catheterization

Objective. We sought to develop a method to adjust for case mix diversity and allow comparison of adverse outcome rates among practitioners in pediatric and congenital cardiac catheterization. Patients and Methods. A single institutional database that captured demographic and procedural data was used to identify patient and procedural characteristics associated with adverse events (AE) and any high severity event classified as preventable or possibly preventable (P/PP). Diagnostic and procedural risk groups were created and indicators of hemodynamic vulnerability were defined. Expected event rates by the practitioners adjusting for case mix were calculated. Standardized adverse event ratios (SAER), defined as the observed rate divided by the expected rate for each practitioner were calculated with 95% confidence intervals. Results. The database included 1727 hemodynamic (30%) and interventional (70%) cases performed by seven practitioners in 18 months. During 147 cases, at least one P/PP AE occurred; among the seven practitioners observed, event rates ranged from 3.2 to 14.2%. In multivariable analysis, risk factors for all P/PP events included highest procedure risk group (odds ratio [OR] 2.1 for group 2, and 2.8 for group 3, relative to group 1, P = .001 and P < .001, respectively) and weight less than 4 kg (OR 2.8, P < .001). High severity P/PP events occurred in 67 cases with rates ranging from 2.0 to 6.6% by the practitioners. For these events, risk factors included: highest procedure risk group (OR 4.5 for group 2, and 4.9 for group 3, both P < .001) and an indicator of hemodynamic vulnerability (OR 1.8, P = .026). For the seven practitioners, the SAER ranged from 0.41 to 1.32 for any P/PP AE and from 0.69 to 1.44 for P/PP high severity events. In this cohort, we did not identify any statistically significant performance differences. Conclusion. Despite wide variations in case mix complexity in pediatric and congenital cardiac catheterization, this study demonstrates a method for risk adjustment which allows equitable comparisons among practitioners at a single institution.     

Right Pulmonary Artery Obstruction Is a Long‐term Complication of Aortopulmonary Window Repair

The early outcomes of transaortic patch repair closure for aortopulmonary window are satisfactory, but the lifelong fate of the aorta and pulmonary artery remains unknown. We describe a 40‐year‐old patient with right pulmonary artery occlusion accompanied by aneurysmal dilation of the ascending aorta 38 years after transaortic repair of an aortopulmonary window. Operative findings revealed patch shrinkage and thrombotic occlusion of the right pulmonary artery. The dilated ascending aorta firmly adhered to the right pulmonary artery. After pulmonary artery thrombectomy, the right pulmonary artery was reconstructed and the dilated ascending aorta was replaced.     

Femoral Vascular Access Complications in Adult Congenital Heart Disease Patients: Audit from a Single Tertiary Center

Objective. To determine the rate of vascular access complications in patients with adult congenital heart disease (ACHD). Background. Complications of femoral access following coronary angiography or percutaneous coronary intervention have been studied extensively, but the complication rate following catheterization and intervention in ACHD patients is poorly documented. Design, Setting, and Outcome Measures. We present a retrospective audit of vascular access complications in a large tertiary ACHD center over a 12‐month period. Complications were defined as any clinically significant hematoma, pseudoaneurysm, arteriovenous fistula, or bleeding resulting in the need for imaging, transfusion, vascular or radiological intervention, or delayed discharge. Results. Of 197 procedures (102 interventions and 95 cardiac catheterizations), a complication rate of 3.6% was identified, comparable to that of coronary angiography and percutaneous coronary intervention. The main complications were femoral artery pseudoaneurysm and hematoma resulting in delayed discharge by a mean of 2? days (range 1–4 days). Predictors of risk for vascular complications include female sex, history of diabetes, and anticoagulation; larger sheath sizes and obesity were not associated with higher complication rate. Conclusions. Adult congenital heart disease patients represent a unique and ever‐growing population with a higher incidence of catheterization as children, surgical cut‐down scars and anatomical variants. We present a low incidence of femoral access complications in interventional and diagnostic procedures in a large series of ACHD patients over a 12‐month period. Patients with risk factors for vascular complications may be considered for device closure of the venous access site.     

Congenital Left Ventricular Splint in an Adult Patient with Unrepaired Anomalous Left Coronary Artery from the Pulmonary Artery

A 24‐year‐old woman presented with a recent increase in dyspnea on exertion and development of presyncope. The patient stated that she has reproducible episodes of dizziness and near fainting when she climbs a flight of stairs and activity is limited to a slow gait.