Ramzi Nicolas

Device therapy for atrial septal defects in a multicenter cohort: Acute outcomes and adverse events

Background: Secundum atrial septal defect (ASD) closure devices were granted approval based on industry‐sponsored, prospective, nonrandomized, single device studies, demonstrating acceptable efficacy and safety in selected patients. We sought to report community practice and outcomes. Methods and Results: Procedure specific data was collected on cases considered for ASD closure in the congenital cardiac catheterization project on outcomes (C3PO) between February 1, 2007 and June 31, 2010. Eight centers contributed data during this time period. All adverse events (AE) were independently reviewed and classified by a five level severity scale. In 40 months (2/07–6/10), 653 of 688 ASDs were occluded with a single device using an AMPLATZER® Septal Occluder (ASO) in 566 (87%), GORE® HELEX® Septal Occluder (HSO) in 33 (5%), and a CardioSEAL® or STARFlex™ device (CSD) in 54 (8%). Most patients had an isolated ASD (93%). 85% were >2 years of age. The ASD median diameter was 12 mm [8,16] for ASO, with smaller diameters in HSO 8 mm [7,10] and CSD 8 mm [5,10] (P < 0.001). AE (n = 82) were recorded in 76 cases, 11.5% (95% CI 9.2%, 14.1%) and classified as high severity in 4.7% (95% CI 3.2%, 6.5%), with no mortality. A new conduction abnormality was detected during 15 cases and did not resolve in one. Transcatheter device retrieval was possible in 7 of 10 device embolizations. Device erosion occurred in 3 of 566, 0.5% (95% CI 0.1%, 1.5%), ASO implants. Conclusion: Although device closure of ASDs is associated with low morbidity and rare mortality, ongoing assessment of device safety profiles are warranted, and registries offer opportunities to facilitate the required surveillance.

Endovascular stent placement for right ventricle to pulmonary artery conduit stenosis in the Norwood with Sano modification.

OBJECTIVE Conduit obstruction is increasingly recognized as a complication of the Sano modified Norwood procedure. We report our experience with stent placement to ameliorate conduit stenoses and prevent premature surgical intervention. DESIGN Records for all patients having undergone a Sano modified Norwood between September 2003 and December 2006 were reviewed. All patients with Sano conduit obstruction requiring stent placement were included. Sites of obstruction, method of stenting, pre- and poststent oxygen saturations, reinterventions, age at next surgery, and complications were collected and reviewed. RESULTS Forty-one patients underwent a Sano modified Norwood procedure, and 9 patients had stents deployed for conduit stenoses. The patients presented a median of 52 days following Norwood palliation. Twelve stents were successfully placed in 9 patients. In 8 patients, saturations improved from a median of 67.5% to 81% after stent placement (P = .0005). Arterial saturations were unavailable in 1 patient requiring extracorporeal membrane oxygenation. No patients required reintervention after stent placement. The median age at their next surgery was 144 days. Seven patients underwent a successful bidirectional Glenn, 1 patient underwent a modified Blalock-Taussig shunt, and 1 expired. Complications included hypotension during stent deployment and 1 episode of transient complete heart block. CONCLUSIONS Transcatheter treatment of Sano conduit obstruction can be performed safely and results in immediate improvement in oxygenation, thereby allowing substantial delay of the cavo-pulmonary shunt.

Percutaneous carotid artery access in infants < 3 months of age

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.

Percutaneous Pulmonary Valve Implantation Alters Electrophysiologic Substrate

Background Percutaneous pulmonary valve implantation (PPVI) is first‐line therapy for some congenital heart disease patients with right ventricular outflow tract dysfunction. The hemodynamics improvements after PPVI are well documented, but little is known about its effects on the electrophysiologic substrate. The objective of this study is to assess the short‐ and medium‐term electrophysiologic substrate changes and elucidate postprocedure arrhythmias. Methods and Results A retrospective chart review of patients undergoing PPVI from May 2010 to April 2015 was performed. A total of 106 patients underwent PPVI; most commonly these patients had tetralogy of Fallot (n=59, 55%) and pulmonary insufficiency (n=60, 57%). The median follow‐up time was 28 months (7‐63 months). Pre‐PPVI, 25 patients (24%) had documented arrhythmias: nonsustained ventricular tachycardia (NSVT) (n=9, 8%), frequent premature ventricular contractions (PVCs) (n=6, 6%), and atrial fibrillation/flutter (AF/AFL) (n=10, 9%). Post‐PPVI, arrhythmias resolved in 4 patients who had NSVT (44%) and 5 patients who had PVCs (83%). New arrhythmias were seen in 16 patients (15%): 7 NSVT, 8 PVCs, and 1 AF/AFL. There was resolution at medium‐term follow‐up in 6 (86%) patients with new‐onset NSVT and 7 (88%) patients with new‐onset PVCs. There was no difference in QRS duration pre‐PPVI, post‐PPVI, and at medium‐term follow‐up (P=0.6). The median corrected QT lengthened immediately post‐PPVI but shortened significantly at midterm follow‐up (P<0.01). Conclusions PPVI reduced the prevalence of NSVT. The majority of postimplant arrhythmias resolve by 6 months of follow‐up.

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.

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.