Hagler, Donald J.

ObjectivesTo describe medium‐ to long‐term follow‐up of patients undergoing device closure of patent foramen ovale (PFO) for stroke or transient ischemic attack (TIA).BackgroundTranscatheter device closure of PFO continues to be used for secondary prevention of cryptogenic stroke or TIA, but data are lacking regarding long‐term outcomes.MethodsWe reviewed the Mayo Clinic Rochester PFO database for patients who underwent device closure of PFO for secondary prevention of stroke/TIA from December 2001 to June 2012. Demographic, clinical, procedural, and follow‐up data were reviewed. Recurrence rate of stroke/TIA were calculated. Data were analyzed to identify risk factors of recurrent neurologic events.ResultsSeven hundred and thirty patients (mean age 53 years; 40% female) were included in our study. Most patients (72%) had cryptogenic stroke as their qualifying event for PFO closure. There were no procedure‐related deaths or strokes. The most commonly used device was the Amplatzer Septal Occluder (82%). Median follow‐up was 6 years. A 3.9% of patients had documented residual right‐to‐left shunting at last echocardiogram. Recurrent stroke and/or TIA were reported in 45 patients, (6.3% of patients with follow‐up data). Patients who experienced recurrent stroke/TIA were older and had a higher rate of diabetes and hypertension than those who did not. The presence of residual shunt did not correlate with risk of recurrent events.ConclusionsDevice closure of PFO can be performed safely with very good long‐term resolution of atrial shunting. Recurrent neurologic events after PFO closure may reflect additional comorbid risk factors unrelated to the potential for paradoxical embolism. © 2016 Wiley Periodicals, Inc.

ObjectivesWe sought to develop a scoring system that predicts the risk of serious adverse events (SAE's) for individual pediatric patients undergoing cardiac catheterization procedures.BackgroundSystematic assessment of risk of SAE in pediatric catheterization can be challenging in view of a wide variation in procedure and patient complexity as well as rapidly evolving technology.MethodsA 10 component scoring system was originally developed based on expert consensus and review of the existing literature. Data from an international multi‐institutional catheterization registry (CCISC) between 2008 and 2013 were used to validate this scoring system. In addition we used multivariate methods to further refine the original risk score to improve its predictive power of SAE's. Results: Univariate analysis confirmed the strong correlation of each of the 10 components of the original risk score with SAE attributed to a pediatric cardiac catheterization (P < 0.001 for all variables). Multivariate analysis resulted in a modified risk score (CRISP) that corresponds to an increase in value of area under a receiver operating characteristic curve (AUC) from 0.715 to 0.741.ConclusionThe CRISP score predicts risk of occurrence of an SAE for individual patients undergoing pediatric cardiac catheterization procedures. © 2015 Wiley Periodicals, Inc.

Objectives To determine event‐free survival after transcatheter closure of ventricular septal defect (VSD), and to identify predictors of adverse events (AE) in post myocardial infarction VSD (post‐MI VSD) subgroup. Background There are limited data on mid‐term follow‐up after transcatheter VSD closure. Methods Retrospective review of 27 cases of transcatheter VSD closure (post‐MI = 18 and non‐ischemic = 9) performed from 1999 to 2013. We defined AE as death, device embolization, hemolysis requiring blood transfusion, heart block and reintervention. Results In the post‐MI VSD subgroup, mean age and follow‐up was 69 ± 11 and 7.3 ± 7 years, respectively. AE occurred in 8 (44%) patients (death‐3, device embolization‐1, hemolysis‐1, surgical VSD closure‐2, reintervention‐1). Event‐free survival was 56% at 1 month and 5 years, and all AE occurred in the periprocedural period. Cardiogenic shock (HR: 3.21, CI: 1.82–5.41, P = 0.002), and VSD closure in acute phase (HR: 2.14, CI: 1.12–4.31, P = 0.004) were independent predictors of AE. In the non‐ischemic VSD subgroup, mean age and follow‐up was 49 ± 15 and 8.7 ± 8 years, respectively. AE occurred in 3 (33%) patients (late death‐1, surgical VSD closure‐2). For the entire cohort, freedom from death was 89% and 85% at 1 month and 5 years, and event‐free survival was 70% and 61% at 1 month and 5 years. Conclusions Transcatheter closure of post‐MI VSD carries a moderate risk of periprocedural complications but low event rates afterwards. By comparison, device closure of non‐ischemic VSD has lower periprocedural morbidity but some patients continued to experience AE during follow‐up. © 2015 Wiley Periodicals, Inc.

ObjectiveTo describe the effects of percutaneously implanted valve‐in‐valve in the tricuspid position for patients with pre‐existing transvalvular device leads.MethodsIn this case series, we describe implantation of the Melody valve and SAPIEN XT valve within dysfunctional bioprosthetic tricuspid valves in three patients with transvalvular device leads.ResultsIn all cases, the valve was successfully deployed and device lead function remained unchanged. In 1/3 cases with 6‐month follow‐up, device lead parameters remain unchanged and transcatheter valve‐in‐valve function remains satisfactory.ConclusionsTranscatheter tricuspid valve‐in‐valve is feasible in patients with pre‐existing transvalvular devices leads. Further study is required to determine the long‐term clinical implications of this treatment approach. © 2015 Wiley Periodicals, Inc.

BackgroundPatent foramen ovale (PFO) is common and may predispose to paradoxical embolism. Transcatheter device closure of PFO can be challenging in certain cases of “long‐tunnel” PFO morphology. We report our experience with device closure of long‐tunnel PFO using transseptal puncture.MethodsWe retrospectively reviewed all cases of PFO device closure using transseptal puncture at the Mayo Clinic from January 1, 2010 to September 30, 2013. We arbitrarily defined a PFO tunnel configuration as a tunnel length ≥ 12 mm as observed in intracardiac echocardiography (ICE) at the time of device closure.ResultsTwelve patients (mean age 40.8 [range 15–67] years; 7 males [58%]) underwent PFO device closure with transseptal puncture. The most common indication for PFO closure was previous stroke (n = 7, 58%). Median tunnel length measured by ICE was 15 mm (12–20 mm). GORE® HELEX® Septal Occluder was used for closure in all but one patient. The only significant procedural complication was a minor perforation of the left atrial wall during attempted septal puncture, which resulted in a trivial pericardial effusion that resolved without intervention. At latest follow‐up (mean 543 days, [range 170–1162]) one patient had a residual shunt and subsequently died due to complications during surgical PFO closure. No recurrent strokes or TIAs were reported.ConclusionThough not without risk, transseptal puncture can be a valuable tool for facilitating device closure of long‐tunnel type PFOs. GORE® HELEX® Septal Occluder may be an effective option for facilitating device closure for patients with long‐tunnel type PFO. © 2014 Wiley Periodicals, Inc.

BackgroundLong‐term follow‐up after stent dilation of native and acquired pulmonary artery stenosis is scarce in the pediatric population. Most cohorts include a myriad of anatomies and associated conditions.MethodIn order to establish objective performance criteria, we performed a retrospective review of all patients who underwent unilateral pulmonary artery stenting in biventricular physiology at three centers from June 2006 to June 2011.ResultsFifty‐eight patients received 60 stents with Palmaz Genesis stent used most commonly (78%). Average age at implantation was 10.4 ± 10.3 years and weight 31.6 ± 21.8 kg. The immediate success rate was 98%, with improvement in minimal diameter from 5.1 ± 2 cm to 10.6 ± 3 cm (P < 0.01). There were 10 complications (7 major and 3 minor) and no acute mortality. One‐year follow‐up studies were available in 48 patients (83%), including echocardiogram (60%), catheterization (28%), MRI (29%), and lung perfusion (31%). Follow‐up echocardiogram showed mild increase in stent gradient, from 5.7 ± 6.7 mm Hg post‐procedure to 17.1 ± 11.7 mm Hg. Follow‐up catheterization showed no significant change in minimal stent diameter (8.8 ± 2.6 to 7.8 ± 2.3 mm), gradient (7.7 ± 8.4 to 12.6 ± 12.2 mm Hg), or right ventricular pressures (43.7 ± 9 to 47.7 ± 10.5 mm Hg). Nine patients (16%) underwent scheduled stent redilation over a period of 12 days to 25 months.ConclusionIn conclusion, stent implantation shows excellent immediate and 1‐year follow‐up results with maintenance of improved caliber of the stented vessel and lowered right ventricular systolic pressures. © 2014 Wiley Periodicals, Inc.

Pediatric and Congenital Interventional Cardiology is the practice of catheter‐based techniques that improve cardiac physiology and circulation through the treatment of heart disease in children and adults with congenital or acquired heart defects. Over the last decade, and since last published training guidelines for pediatric cardiac catheterization and interventional cardiology were published in 2005 [1] the field of Pediatric and Congenital Cardiac Catheterization has evolved into a predominantly interventional discipline. As there is no sub‐specialty certification for interventional cardiac catheterization in pediatrics, the Congenital Heart Disease Committee of the Society of Cardiovascular Angiography and Interventions has put together this consensus statement for advanced training in pediatric and congenital interventional cardiac catheterization. The statement puts forth recommendations for program infrastructure in terms of teaching, personnel, equipment, facilities, conferences, patient volume and trainee assessment. This is meant to set a standard for training programs as well as giving applicants a basis on which to judge and compare programs. © 2014 Wiley Periodicals, Inc.