Extravascular protrusion of the Alterra adaptive prestent identified on surveillance computed tomography imaging.

BACKGROUND: The Alterra adaptive prestent is a novel self-expanding device designed to provide a landing zone for the 29 mm SAPIEN 3 valve to treat pulmonary regurgitation in patients with a right ventricular outflow tract that is too large for a balloon expandable valve alone. The mechanism of fixation for the Alterra prestent is radial force from the self-expanding stent frame, combined with a unique set of flared "tines" that protrude from both ends of the stent. AIMS, METHODS, AND RESULTS: In this report, we describe 6 patients who underwent uncomplicated transcatheter pulmonary valve replacement with an Alterra adaptive prestent and SAPIEN 3 valve and had surveillance chest computed tomography (CT) scans performed 1 day to 21 months after implant. In each patient, the CT scan demonstrated extravascular extension of a portion of the Alterra prestent, without clinical sequelae, but with extension into the ascending aorta in 1 patient and contact with the ascending aorta, left pulmonary vein, or left atrial appendage in 3 others. CONCLUSIONS: Surveillance CT imaging shows that the Alterra prestent can perforate the pulmonary artery and/or right ventricle. Although no sequelae were seen in these patients, prestent perforation has the potential to be clinically important. Implanters should be aware of this finding and its potential implications. As experience with the Alterra prestent grows, it will be important to further define the risk factors, incidence, and implications of this phenomenon.

Transcatheter pulmonary valve replacement after arterial switch operation.

BACKGROUND: Patients with d-transposition of the great arteries (d-TGA) who have undergone an arterial switch operation (ASO) can develop right ventricular outflow tract (RVOT) dysfunction with pulmonary regurgitation (PR) or stenosis. In these patients, treatment may include transcatheter pulmonary valve replacement (TPVR). Coronary compression is a contraindication occurring in 5% of typical TPVR cases. After ASO, there are various anatomical considerations that can confound TPVR, including potential coronary artery compression. Our goal is to understand feasibility of TPVR in patients following ASO. METHODS: This was a retrospective multicenter cohort study of patients with RVOT dysfunction after ASO who underwent cardiac catheterization with intention to perform TPVR from 2008 to 2020. RESULTS: Across nine centers, 33 patients met inclusion criteria. TPVR was successful in 22 patients (66%), 19 receiving a Melody valve and 3 a SAPIEN valve. RVOT stenosis in isolation or with PR dictated need for TPVR in nearly all patients. One serious adverse event occurred with valve embolization. After TPVR, the RVOT peak gradient decreased from 43 to 9 mm Hg (p < 0.001); PR was trivial/none in all but one patient, in whom it was mild. Coronary compression prohibiting TPVR occurred in eight patients (24%) and two patients (6%) had severe aortic regurgitation from aortic root deformation precluding TPVR. Seven patients underwent RVOT reintervention with a median of 5.3 years post-TPVR. CONCLUSIONS: TPVR in patients with d-TGA after ASO is feasible, but in this cohort, coronary compression or aortic root distortion precluded TPVR in one-third of patients. The rate of RVOT reintervention after TPVR was higher in this cohort of ASO patients that in prior studies.

PDA Stenting for Ductal-Dependent Pulmonary Blood Flow: Management of Prostaglandin E1 Infusion.

Newborns with ductal-dependent pulmonary blood flow require PGE1 infusion prior to ductal stenting to ensure patency of the PDA. There is no consensus, however, on management of PGE in the peri-procedural period in terms of timing of discontinuation of the drug. This review will focus on the rationale for continuing or discontinuing PGE, a brief review of some of the published recommendations, and will make some final recommendations regarding PGE management. Reasons to continue PGE include ensuring the patient is stable and has adequate oxygenation prior to the stenting procedure. In addition, continuation of PGE makes the procedure logistically easier since the timing for the intervention is not dependent upon ductal constriction. The rationale for discontinuation of PGE is to ensure there is adequate ductal constriction to securely place a stent and minimize the risk of stent embolization. Decision-making regarding the discontinuation of PGE must be individualized and is primarily dependent upon PDA morphology.

Right ventricular outflow tract obstruction associated with neointimal tissue accumulation and distortion of the Harmony TPV25 stent frame: Potential mechanisms and treatment.

BACKGROUND: The Harmony TPV25 transcatheter pulmonary valve (Medtronic Inc.) is constructed with a self-expanding stent frame comprising six zigged nitinol wires sewn together and covered with knitted polyester fabric, with flared inflow and outflow ends and a porcine pericardial valve sutured to the central portion of the device. It was approved for treatment of pulmonary regurgitation after prior right ventricular outflow tract repair in 2021. Early outcomes of this procedure have been excellent, but little is known about valve durability or ultimate mechanisms of dysfunction. METHODS: We collected data on patients who underwent reintervention for TPV25 dysfunction and described findings related to distortion of the stent frame and tissue accumulation. RESULTS: We describe six patients who underwent valve-in-valve implant for TPV25 obstruction (peak catheterization gradient peak 28-73 mmHg) 10-28 months after implant. In all cases, there was tissue accumulation within the inflow and valve-housing segments of the device and deformation of the self-expanding valve frame characterized by variable circumferential narrowing at the junction between the valve housing and the inflow and outflow portions of the device, with additional geometric changes in all segments. All six patients underwent valve-in-valve implant that results in a final peak gradient ≤10 mmHg and no regurgitation. DISCUSSION: The occurrence of short-term Harmony TPV25 dysfunction in multiple patients with a similar appearance of frame distortion and tissue accumulation within the inflow and valve housing portions of the device suggests that this may be an important failure mechanism for this valve. Potential causes of the observed findings are discussed. It is possible to treat this mechanism of TPV25 dysfunction with valve-in-valve implant using balloon expandable transcatheter valves.

Safety and Short-Term Outcomes for Infants < 2.5 kg Undergoing PDA Device Closure: A C3PO Registry Study.

To evaluate short-term procedural outcomes and safety for infants < 2.5 kg who underwent catheterization with intended patent ductus arteriosus (PDA) device closure in a multi-center registry, as performance of this procedure becomes widespread. A multi-center retrospective review was performed using data from the Congenital Cardiac Catheterization Project on Outcomes (C3PO) registry. Data were collected for all intended cases of PDA closure in infants < 2.5 kg from April 2019 to December 2020 at 13 participating sites. Successful device closure was defined as device placement at the conclusion of the catheterization. Procedural outcomes and adverse events (AE) were described, and associations between patient characteristics, procedural outcomes and AEs were analyzed. During the study period, 300 cases were performed with a median weight of 1.0 kg (range 0.7-2.4). Successful device closure was achieved in 98.7% of cases with a 1.7% incidence of level 4/5 AEs, including one periprocedural mortality. Neither failed device placement nor adverse events were significantly associated with patient age, weight or institutional volume. Higher incidence of adverse events associated with patients who had non-cardiac problems (p = 0.017) and cases with multiple devices attempted (p = 0.064). Transcatheter PDA closure in small infants can be performed with excellent short-term outcomes and safety across institutions with variable case volume.

Incorporation of the CardioMEMS™ System During an Exercise Physiology Test in a Pediatric Congenital Heart Disease Patient Contributing to Medical Decision-Making.

Exercise testing among the pediatric congenital heart disease population continues to transform and expand the way patients are evaluated and managed. We describe a case where a stress echocardiogram was performed while successfully collecting data from a previously implanted CardioMEMS™ HF system which helped guide decision-making.

Interpreting Quality Improvement When Introducing New Technology: A Collaborative Experience in ASD Device Closures.

The objective of this study was to evaluate the impact of the regular introduction of new technologies into interventional cardiac catheterization procedures, in this case new atrial septal defect (ASD) closure devices, while conducting a multi-center collaborative initiative to reduce radiation usage during all procedures. Data were collected prospectively by 8 C3PO institutions between January 1, 2014 and December 31, 2017 for ASD device closure procedures in the cardiac catheterization lab during a quality improvement (QI) initiative aimed at reducing patient radiation exposure. Radiation exposure was measured in dose area product per body weight (µGy*m2/kg). Use of proposed practice change strategies at the beginning and end of the QI intervention period was assessed. Radiation exposure was summarized by institution and by initial type of device used for closure. This study included 602 ASD device closures. Without changes in patient characteristics, total fluoroscopy duration, or number of digital acquisitions, median radiation exposure decreased from 37 DAP/kg to 14 DAP/kg from 2014 to 2017. While all individual centers decreased overall median DAP/kg, the use of novel devices for ASD closure correlated with a temporary period of worsening institutional radiation exposure and increased fluoroscopy time. The introduction of new ASD closure devices resulted in increased radiation exposure during a QI project designed to reduce radiation exposure. Therefore, outcome assessment must be contextualized in QI projects, hospital evaluation, and public reporting, to acknowledge the expected variation during innovation and introduction of novel therapies.

Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve.

OBJECTIVE: We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. BACKGROUND: As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a "real-world" environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. METHODS: The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan-Meier curves and log-rank testing. RESULTS: 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p = .61) or any reintervention (p = .74) over time did not differ between trials. Freedom from stent fracture (p = .003) and transcatheter reintervention (p = .010) were longer in PAS, whereas freedom from explant (p = .020) and TPV endocarditis (p = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p = .056); the incidence of any particular event was low in both. CONCLUSIONS: Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.

Total Transcatheter Stage 1: A Word of Caution.

For patients with single ventricle physiology, being able to initially establish systemic blood flow and control pulmonary blood flow is critical to their long-term health. Recently, there have been descriptions in achieving this by a purely transcatheter approach with stenting of the ductus arteriosus and implanting pulmonary flow restrictors, a very appealing prospect. We review a case series of 6 patients who underwent a percutaneous modified stage 1 approach using modified Microvascular plugs (MVP) at our center between September 2019 and December 2019. The initial procedure was technically successful in all patients with single-stage ductal stenting and placement of bilateral modified MVP via femoral access. Four patients underwent repeat cardiac catheterization prior to subsequent surgery that demonstrated elevated Qp:Qs (> 2:1) in 3 of the 4 patients with an elevated mean distal PA pressure > 20 mmHg in all patients. In some patients, the device migrated into the distal right pulmonary artery. One patient after Glenn shunt was found to have significant LPA stenosis requiring stenting. While the percutaneous modified stage 1 approach is a promising approach, we offer a word of caution against widespread adoption of this technique with the currently available devices.

Modified delivery of SAPIEN 3 valve in the pulmonary position: Evolution of technique or dire need?

Transcatheter pulmonary valve replacement (TPVR) is now common practice in patients with significant pulmonary regurgitation (PR), stenosis (PS), or mixed pulmonary valve disease. While the Melody valve (Medtronic, Inc.) and its delivery system were specifically designed for use in the right ventricular outflow tract (RVOT), Sapien valves (XT and S3, Edwards Lifesciences, Inc.) and their delivery systems (Novaflex and Commander) were not. As a result, placement of Sapien valves in the RVOT can be challenging secondary to the stiffness of the current delivery system. Manipulating a stiff delivery system within the RV also introduces risk to the tricuspid valve and its chordal attachments. We report a novel delivery technique for the Sapien S3 valve which has greatly simplified valve delivery into the RVOT and may potentially reduce the risk of tricuspid valve injury.

Surgical Versus Percutaneous Closure of PDA in Preterm Infants: Procedural Charges and Outcomes.

BACKGROUND: Studies comparing percutaneous closure of patent ductus arteriosus (PDA) with surgical ligation tend to exclude premature infants and have not assessed procedural charges. We compared our contemporary outcomes and charges of device closure to surgical ligation of PDA in preterm infants. MATERIAL AND METHODS: Preterm infants who underwent isolated PDA closure during their newborn hospitalization (January 2014 to September 2017) were grouped based on intention to treat (surgery versus device closure). Patient demographics, procedural details, and immediate postprocedural outcomes were compared. Procedural charges for device closure versus surgical ligation were compared. RESULTS: Compared with the device group (n = 33), patients undergoing surgical ligation (n = 39) were younger, smaller, and required more preoperative support (P < 0.05). The procedure time was shorter for surgical ligation (P < 0.01). Although there was no procedural mortality in either group, the complication rate was higher for device closure than for surgical ligation (15.2% versus 0%; P = 0.02). The proportion of patients returning to preprocedural respiratory support by 48 h after procedure was similar. There was a higher proportion of surgical patients who required increased inotropic support in the first 24 h after procedure (P = 0.19). The procedural charges for transcatheter device closure were twice as expensive as those for surgical ligation. CONCLUSIONS: In our early experience with percutaneous PDA closure, we found a percutaneous approach in preterm infants feasible and well tolerated. Both surgical ligation and device closure were associated with perioperative or postoperative complications. Procedural charges were higher for percutaneous closure, driven by device charge and catheterization room utilization. Further investigation is needed to establish guidelines for first-line therapy for PDA closure in preterm infants, including cost-benefit analysis.

Fracturing a dysfunctional Edwards Perimount bioprosthetic valve to facilitate percutaneous valve-in-valve placement of SAPIEN 3 valve with modified delivery system.

Pulmonary valve replacement via surgical implantation of a bioprosthetic valve (BPV) is a well-established treatment for patients with dysfunctional RV outflow tracts. BPVs are prone to structural deterioration, and will eventually require replacement. Recently, percutaneous valve-in-valve (VIV) placement of transcatheter valves has established itself as a safe and effective alternative to surgical revision. Unfortunately, VIV therapy is inherently limited by the inner diameter of the BPV, which restricts the number of eligible patients. Other centers have reported on the feasibility of cracking certain BPVs with ultra high-pressure balloons in bench testing. We now report cracking an Edwards Perimount BPV in the pulmonary position to facilitate VIV placement of an Edwards SAPIEN 3. The ability to crack the Perimount valve allowed placement of a larger valve than previously considered and minimized the final valve gradient. In an effort to avoid the morbidity and mortality of surgical pulmonary valve replacement, this new strategy will expand the number of patients eligible for percutaneous VIV therapy.

Percutaneous transcatheter pulmonary valve replacement in children weighing less than 20 kg.

BACKGROUND: Since FDA approval of the Melody valve, transcatheter pulmonary valve replacement (TPVR) has been offered to an expanding population. Limited data exist regarding the safety and feasibility of TPVR in smaller patients. METHODS: All patients weighing <20 kg who underwent catheterization for percutaneous TPVR at four centers were reviewed. RESULTS: Of the 51 patients reviewed, 43 (84%) had successful valve implantation and 8 (16%) were found not to be candidates due to access veins too small (n = 3), coronary artery/aortic root compression (n = 3), and RVOT too large (n = 2). The 43 patients who underwent successful percutaneous TPVR had a median age and weight of 5.8 years (3.3-10) and 17.7 kg (13.5-19.8), and most had tetralogy of Fallot (TOF). TPVR was performed via femoral vein (FV) access in 24 patients and internal jugular vein (IJV) access in 19 patients. Median weight in patients with IJV implant was 1.1 kg lower than those who underwent transfemoral implant (17.0 vs. 18.1 kg, P = 0.05). There were four adverse events: one iliac vein injury, one contained MPA tear, and two patients with post-procedure femoral vein bleeding. All patients were alive at recent follow-up, a median of 2.0 years (0.1-6.0) after TPVR. There was excellent valve function with mean Doppler gradients of 3-20 mm Hg, and trivial or mild pulmonary regurgitation in all but one patient. There were no RVOT reinterventions and no cases of endocarditis. CONCLUSIONS: Percutaneous TPVR can be safely performed in patients <20 kg. The procedure frequently requires IJV access, and access site/bleeding complications may be more common in this cohort.

Post-operative Catheterization Interventions at the Site of Surgery: An Application of the CRISP Scoring System.

Catheter-based interventions in the early post-operative period are performed with caution due to concerns for increased procedural risk, particularly across fresh suture lines. The recently published CRISP scoring system provides prospective risk stratification based on pre-procedural criterion. In an effort to refine the assessment of risk in patients undergoing post-operative catheter-based interventions, the predicted risk of an adverse event based on CRISP scores was compared to actual adverse event rates. A single-center, retrospective review of patients undergoing catheterization interventions within 6 weeks of cardiac surgery was conducted between Jan 2004 and Dec 2014. Patients who underwent dilation interventions across fresh suture lines (group 1) were compared to patients who underwent interventional procedures at other sites (group 2), and a CRISP score was calculated for all patients. Patients receiving only surveillance biopsies were excluded. Sixty-eight patients underwent 100 interventional procedures. Group 1 was composed of 44 patients receiving 64 interventions, while group 2 had 24 patients who underwent 36 interventions. Group 1 was comprised significantly more single ventricles and patients were smaller/younger. Group 1 had a significantly higher median CRISP score, but both groups were within Category 4. The rates of adverse events were similar between groups and comparable to predicted rates with the CRISP scoring system. Catheter-based interventions in the early post-operative period can be performed with no significant increase in the risk of serious adverse events when intervening across fresh suture lines. The CRISP scoring system can be a valuable tool in pre-procedural counseling of high-risk post-operative patients.

Circulatory support using the impella device in fontan patients with systemic ventricular dysfunction: A multicenter experience.

BACKGROUND: There are limited mechanical circulatory support options for patients with single ventricle (SV) anatomy. This is a multicenter, retrospective study of the Impella pump to support the systemic ventricle in a cohort of SV patients with Fontan circulation. METHODS: Patients with SV anatomy supported with an Impella device from 2012 to 2015 were included. Demographic information, indication for support, adverse events and short-term outcome data were collected. RESULTS: Ten patients were included. The median age and weight at implant was 26 years (4-38 years) and 64 kg (15-102 kg). Indications for support were systemic ventricular failure with cardiogenic shock (n = 8) or high-risk electrophysiology (EP) procedures (n = 2). The median duration of support was 49 hr (2.7-264 hr). Support was discontinued for ventricular recovery in five patients, transition to another device in two patients, completion of EP procedure in two patients and death in one patient. Survival to hospital discharge was 80%. Adverse events occurred in 4 patients. There were two cases of hemolysis, one case of increasing aortic valve insufficiency with implant and one asymptomatic access site thrombus. There were no bleeding or thromboembolic events. CONCLUSIONS: Impella devices can provide temporary support for the systemic ventricle in SV patients as a bridge to recovery or additional device. Procedural survival and adverse event profiles are favorable. © 2017 Wiley Periodicals, Inc.

Percutaneous carotid artery access in infants < 3 months of age.

BACKGROUND: Carotid artery access in infants with congenital heart disease undergoing cardiac catheterization via a surgical cut down has been well described. There is a paucity of information regarding percutaneous carotid artery (CA) access in infants <3 months. METHODS: A retrospective review of infants <3 months of age undergoing cardiac catheterization via percutaneous CA approach was performed after IRB approval. Between January 2012 and May 2015, 18 patients underwent 20 procedures; median age 13 days (2-77); median weight 3.3 kg (1.6-5). Procedures performed were patent ductus arteriosus (PDA) stenting (8), modified blalock taussig (BT) shunt stenting (3), balloon aortic valvuloplasty (6), and balloon angioplasty of coarctation (3). RESULTS: Percutaneous access was obtained with a Doppler needle under ultrasound guidance into the right (16) and left CA (4). Sheath size used was 4 Fr (17), 5 Fr (2), and 6 Fr (1). Median time to sheath insertion was 6.5 min (2-20). Percutaneous access was obtained successfully in all cases. There were no major procedural complications. There were two minor complications; hypotension, and ductal spasm. Hemostasis was achieved by manual compression; median time was 14.5 min (8-36). There were two post-procedural complications involving development of CA pseudo aneurysms that were repaired surgically. Post-procedure CA patency was documented by angiography (3), MRA (3), or vascular ultrasound (14). There were no documented arterial occlusions. CONCLUSION: Our experience suggests that percutaneous CA access in infants <3 months of age is safe and feasible with preserved vascular patency and no neurological adverse events.

Transcatheter implantation of SAPIEN 3 valve in native right ventricular outflow tract for severe pulmonary regurgitation following tetralogy of fallot repair.

Pulmonary valve replacement (PVR) is indicated in patients with significant pulmonary regurgitation (PR), stenosis (PS), or mixed pulmonary valve disease. While once an exclusively surgical procedure, many patients can undergo transcatheter PVR (TPVR) with excellent early outcomes (Haas et al. 2013, Clin. Res. Cardiol. Off. J. German Cardiac Soc. 102:119-128; Kenny et al. 2011, J. Am. Coll. Cardiol. 58:2248-2256; Cheatham et al. Circulation 2015, 131:1960-1970). The available transcatheter options continue to expand, but the majority of cases performed in the United States involve the use of FDA approved Melody valve (Medtronic; Minneapolis, MN) or the SAPIEN (Edwards Lifesciences; Irvine, CA) family of valves. The SAPIEN 3 valve (S3) recently received FDA approval for transcatheter aortic valve replacement. We report the first S3 implantation in the pulmonary position for treatment of chronic pulmonary regurgitation and progressive right ventricular dilation in an 18 year old male with repaired Tetralogy of Fallot. © 2016 Wiley Periodicals, Inc.

Radiation Exposure by Three-Dimensional Rotational Angiography (3DRA) During Trans-catheter Melody Pulmonary Valve Procedures (TMPV) in a Pediatric Cardiac Catheterization Laboratory.

This retrospective study aims to evaluate radiation exposure by three-dimensional rotational angiography (3DRA) during trans-catheter Melody pulmonary valve (TMPV) procedures. 3DRA has been reported to have added value in the management of complex congenital heart disease aiding in the performance of interventional procedures albeit with concerns of higher radiation exposure. We test the hypothesis that 3DRA does not cause additional radiation exposure during TMPV procedures. We analyzed all 81 TMPV procedures performed at St. Louis Children's Hospital, MO, USA, from January 1, 2011 to December 31, 2014. Dose-area product (DAP), DAP indexed to body weight (DAP/BW), fluoroscopy time (FT), and weight-fluoroscopy time product of each procedure were recorded. We reviewed each procedure's images to determine whether additional interventions were performed (e.g., pulmonary artery angioplasty or treatment of conduit pseudo-aneurysm). 3DRA was used in 36 % of the procedures. 3DRA group had a higher number of additional procedures performed. The 3DRA group did not differ from the non-3DRA group in DAP, DAP/BW, and weight-fluoroscopy time product. 3DRA does not cause greater radiation exposure during TMPV procedures.

Sedation and Anesthesia in Pediatric and Congenital Cardiac Catheterization: A Prospective Multicenter Experience.

Sedation/anesthesia is critical to cardiac catheterization in the pediatric/congenital heart patient. We sought to identify current sedation/anesthesia practices, the serious adverse event rate related to airway, sedation, or anesthesia, and the rate of intra-procedural conversion from procedural sedation to the use of assisted ventilation or an artificial airway. Data from 13,611 patients who underwent catheterization at eight institutions were prospectively collected from 2007 to 2010. Ninety-four (0.69 %) serious sedation/airway-related adverse events occurred; events were more likely to occur in smaller patients (<4 kg, OR 4.4, 95 % CI 2.3-8.2, p < 0.001), patients with non-cardiac comorbidities (OR 1.7, 95 % CI 1.1-26, p < 0.01), and patients with low mixed venous oxygen saturation (OR 2.3, 95 % CI 1.4-3.6, p < 0.001). Nine thousand three hundred and seventy-nine (69 %) patients were initially managed with general endotracheal anesthesia, LMA, or tracheostomy, whereas 4232 (31 %) were managed with procedural sedation without an artificial airway, of which 75 (1.77 %) patients were converted to assisted ventilation/general anesthesia. Young age (<12 months, OR 5.2, 95 % CI 2.3-11.4, p < 0.001), higher-risk procedure (category 4, OR 10.1, 95 % CI 6.5-15.6, p < 0.001), and continuous pressor/inotrope requirement (OR 11.0, 95 % CI 8.6-14.0, p < 0.001) were independently associated with conversion. Cardiac catheterization in pediatric/congenital patients was associated with a low rate of serious sedation/airway-related adverse events. Smaller patients with non-cardiac comorbidities or low mixed venous oxygen saturation may be at higher risk. Patients under 1 year of age, undergoing high-risk procedures, or requiring continuous pressor/inotrope support may be at higher risk of requiring conversion from procedural sedation to assisted ventilation/general anesthesia.

Incidence and management of life-threatening adverse events during cardiac catheterization for congenital heart disease.

Continued advancements in congenital cardiac catheterization and interventions have resulted in increased patient and procedural complexity. Anticipation of life-threatening events and required rescue measures is a critical component to preprocedural preparation. We sought to determine the incidence and nature of life-threatening adverse events in congenital and pediatric cardiac catheterization, risk factors, and resources necessary to anticipate and manage events. Data from 8905 cases performed at the 8 participating institutions of the Congenital Cardiac Catheterization Project on Outcomes were captured between 2007 and 2010 [median 1,095/site (range 133-3,802)]. The incidence of all life-threatening events was 2.1 % [95 % confidence interval (CI) 1.8-2.4 %], whereas mortality was 0.28 % (95 % CI 0.18-0.41 %). Fifty-seven life-threatening events required cardiopulmonary resuscitation, whereas 9 % required extracorporeal membrane oxygenation. Use of a risk adjustment model showed that age <1 year [odd ratio (OR) 1.9, 95 % CI 1.4-2.7, p < 0.001], hemodynamic vulnerability (OR 1.6, 95 % CI 1.1-2.3, p < 0.01), and procedure risk (category 3: OR 2.3, 95 % CI 1.3-4.1; category 4: OR 4.2, 95 % CI 2.4-7.4) were predictors of life-threatening events. Using this model, standardized life-threatening event ratios were calculated, thus showing that one institution had a life-threatening event rate greater than expected. Congenital cardiac catheterization and intervention can be performed safely with a low rate of life-threatening events and mortality; preprocedural evaluation of risk may optimize preparation of emergency rescue and bailout procedures. Risk predictors (age < 1, hemodynamic vulnerability, and procedure risk category) can enhance preprocedural patient risk stratification and planning.