Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Malposition of left atrial disc and feasibility of recapturing Figulla-II Occlutech septal occluder.

We report a case of Figulla-II Occlutech septal occluder malposition with residual shunt at posteriosuperior margin of an atrial septal defect. Improvising its bioptome type delivery cable, same system was used to recapture the device and redeploy it successfully. This report highlights a potential malfunction of Figulla-II Occlutech disc and the advantage of its delivery system for retrieval of the device.

SCAI expert consensus statement on operator and institutional requirements for PFO closure for secondary prevention of paradoxical embolic stroke: The American Academy of Neurology affirms the value of this statement as an educational tool for neurologists.

Until recently, evidence to support Patent Foramen Ovale (PFO) closure for secondary prevention of recurrent stroke has been controversial. Publication of high-quality evidence from randomized clinical trials and the subsequent FDA approval of two devices for percutaneous PFO closure is expected to increase the volume of PFO closure procedures not only in the United States but worldwide. As this technology is disseminated broadly to the public, ensuring the safe and efficacious performance of PFO closure is essential to mitigate risk and avoid unnecessary procedures. This document, prepared by a multi-disciplinary writing group convened by the Society for Cardiovascular Angiography and Interventions and including representatives from the American Academy of Neurology, makes recommendations for institutional infrastructure and individual skills necessary to initiate and maintain an active PFO/stroke program, with emphasis on shared decision making and patient-centered care.

Variable Treatment Approaches for Extracorporeal Membrane Oxygenation Complications in Neonates: A Case Series.

Extracorporeal membrane oxygenation complications involving vascular injury or intracardiac thrombosis in neonates are rare. We present a series of unique complications and describe their variable treatments.

Anchor balloon, buddy wire, and wire and sheath techniques to deploy percutaneous pulmonary valves in tetralogy of fallot patients.

Advances in surgical techniques in tetralogy of Fallot (TOF) patients have improved survival of these patients into adulthood. The procedure requires right ventricular outflow tract or trans-annular patch with resultant pulmonary stenosis and/or regurgitation. As such, adult patients seen with this condition may have increasing right ventricular hypertrophy and/or right ventricular dilation. Recently, the Sapien XT valve (Edwards Lifesciences, CA) was approved by the FDA for pulmonary implantation. In some cases, advancing the valve in right ventricular outflow tract is difficult. This is a case series of delivering Sapien XT valves in TOF patients with severe pulmonary regurgitation and/or stenosis, using the anchor balloon, buddy wire, and the novel, wire and sheath techniques. © 2017 Wiley Periodicals, Inc.

Use of Amplatzer vascular plugs and Amplatzer duct occluder II additional sizes for occlusion of patent ductus arteriosus: A multi-institutional study.

BACKGROUND: Variable patent ductus arteriosus (PDA) morphology and the need to close PDAs in small size patients has led physicians to use Amplatzer Vascular Plugs (AVP) and recently available Amplatzer Duct Occluder II - Additional Sizes (ADO II AS). The purpose of this study was to analyze the safety, efficacy, and complication rates of the ADO II AS and AVPs, specifically AVP II. METHODS: All patients undergoing PDA closure with an AVP or ADO II AS from 2011 to 2016 were included. Clinical, echocardiographic, and angiographic data were collected and reviewed. RESULTS: Four hundred and sixty-nine patients were included. Median age was 27 months (0.75-852) and the median weight was 11.4 kg (1-92). There were 51 patients ≤5 kg. Type A PDA was most common in 48% (n = 225), followed by type E (27.5%, n = 129), type D (13%, n = 61), type C (10.2%, n = 48), and type B (1.3%, n = 6). Devices included AVP II (n = 421), ADO II AS (n = 30), and AVP IV (n = 18), left pulmonary artery stenosis occurred in 4.3% (n = 20). One patient required surgery for severe stenosis; the remaining cases were mild and required no intervention. Device embolization occurred in 3 patients (10%) with the ADO II AS. Successful device closure was achieved in 98.9% of cases. CONCLUSIONS: The AVP II was highly effective for closing PDAs in smaller babies with varying morphologies and is safe when used in small sized patients with relatively low risk of complications. More studies are warranted to clarify the risks of ADO II AS.

Percutaneous pulmonary valve implantation with anomalous left anterior descending coronary artery.

Percutaneous pulmonary valve placement in patients with an anomalous coronary artery is rare and can be complicated by coronary artery compression. We report successful implantation of a percutaneous pulmonary valve in a patient with an anomalous left anterior descending artery.

Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects: A Case-Control Study.

BACKGROUND: Transcatheter closure of secundum atrial septal defects (ASD) using the Amplatzer septal occluder is generally safe and effective, but erosion into the pericardial space or aorta has been described. Although the absolute risk of this complication is low, there has been no assessment of relative risk factors. METHODS AND RESULTS: All erosions reported to St. Jude Medical after ASD closure with an Amplatzer septal occluder (cases) were compared with controls (matched 2:1) who underwent ASD closure but did not develop an erosion. A total of 125 erosions were reported between 2002 and 2014, including 95 with an available echocardiogram. The median duration from implant to erosion was 14 days, but was >1 year in 16 patients. Nine patients (all age ≥17 years) who died were more likely to have an oversized device, and to have erosion into the aorta, than survivors. Aortic or superior vena cava rim deficiencies were more common in cases than in controls. In addition, larger balloon-sized ASD diameter, Amplatzer septal occluder device size, and device size-ASD diameter difference, and smaller weight:device size ratio were associated with erosion. On multivariable analysis, deficiency of any rim, device >5 mm larger than ASD diameter, and weight:device size ratio were associated with erosion. CONCLUSIONS: In addition to aortic rim deficiency, which was almost universal among erosion cases, there were several relative risk factors for erosion after ASD closure with the Amplatzer septal occluder device. To understand the mechanisms of and absolute risk factors for this uncommon but serious complication, an adequately powered prospective study with thorough echocardiographic evaluation will be critical.

Safety, Feasibility, Results, and Economic Impact of Common Interventional Procedures in a Low-Volume Region of the United States.

The aim of the study was to evaluate the safety, feasibility, and economic benefit of a high-volume operator performing common interventional procedures in a rural region of the United States (U.S.). Rural areas of the U.S., even with well-equipped cardiac catheterization laboratories, may not have a full-time pediatric interventional cardiologist (PIC); this requires patients to travel out of state even for simple interventions. Since 2005, we have adopted a policy of performing cardiac catheterizations and common interventional procedures with a visiting PIC. We reviewed data of all patients who underwent cardiac catheterizations from May 2005 through March 2015 at our center. Variables analyzed were type of procedure, results, and follow-up six months after procedure. 197 catheterizations were performed, of which 80 were for single atrial septal defect (ASD), 29 for fenestrated ASD, 49 for patent ductus arteriosus (PDA), and 39 for other procedures. Device closure of single ASD was successful in 75 of 79 attempts and in 27 of 28 attempts for fenestrated ASD. PDA closure was successful in 45 of 46 attempts. Follow-up data of 6 months or more were available for 127 patients. All but two patients had no cardiovascular symptoms at 6 months. There were four minor complications and no major complications. With a technical success rate of 94.9% for single ASD closure, 97.8% for PDA closure, and results comparable to those of multi-institutional registries, cardiac catheterization and interventions can be performed safely with excellent results. Performing procedures in such an arrangement is safe, feasible, and economically beneficial.

Initial Experience with Elective Perventricular Melody Valve Placement in Small Patients.

Perventricular Melody valve placement has been described as a bailout approach or alternative RVOT approach in patients >30 kg. We present three patients <20 kg and two patients with limited venous access, where we electively performed the perventricular approach. Retrospective analysis of patients <30 kg and vascular access limitation undergoing elective hybrid pulmonary valve replacement were reviewed. The subcostal approach was performed without sternotomy with the sheath introduced through the diaphragmatic surface of the right ventricle. Diagnoses included tetralogy of Fallot (n = 3) and truncus arteriosus (n = 2). Mean weight was 16.2 kg (range 4.7-28.1 kg). Four patients had RV-PA conduits (size: 14-21 mm), and the fifth patient had a transannular patch. All patients met criteria for surgical valve replacement. Technical success was 100%. In two patients with absent pulmonary valve, the stent migrated during advancement of the delivery sheath. These stents were anchored in the distal main pulmonary artery (n = 1) or branch pulmonary artery (n = 1) without sequela. Tricuspid valve chordal injury occurred in one patient, where transesophageal echocardiogram (TEE) was not utilized. No patient required conversion to cardiopulmonary bypass. One patient with absent pulmonary valve died on follow-up as a consequence of severe airway compromise. Our initial experience demonstrates that the perventricular valve can be placed safely in small-sized patients. Advancement of the melody ensemble may be difficult and may cause stent migration. We conclude that the technique is feasible in small-sized patients and that prevention of complications includes placement of the stent at the time of the valve and TEE assistance in reducing tricuspid valve injury.

Retrograde percutaneous repair of aortic coarctation utilizing trans-septal puncture in patients with complex anatomy.

Coarctation of the aorta (COA) is one of the more common congenital anomalies, occurring in four in ten thousand live births and accounting for five to eight percent of all congenital heart defects. COA lesions can be challenging to treat percutaneously, especially if complex vascular anatomy is a barrier to crossing the lesion. We present two cases of COA that utilized a trans-septal approach to cross the lesion in anterograde fashion, subsequently facilitating retrograde stenting of the lesions after snaring and externalizing the wire. In both cases, the trans-septal approach was employed because traditional femoral and radial approaches failed due to complex anatomy, and the trans-septal approach allowed for effective intervention without the need for surgery.

Extended Application of the Hybrid Procedure in Neonates with Left-Sided Obstructive Lesions in an Evolving Cardiac Program.

The hybrid approach to management of hypoplastic left heart syndrome (HLHS) was developed as an alternative to neonatal Norwood surgery, providing a less invasive initial palliation for HLHS. We describe our experience in extending the concept of the hybrid procedure to palliate neonates with anatomically compromised systemic arterial blood flow in a variety of congenital cardiac anomalies and supporting its application as first-line palliation in centers developing their HLHS programs. Retrospective review of patients undergoing therapy for HLHS at a single institution from June 2008 to December 2014 was performed. Subject demographics, clinical and procedural data, along with follow-up, were collected. Thirteen patients had initial hybrid palliation for HLHS during the time frame indicated at a median age of 8 days (range 1-29 days) and median weight of 3.4 kg (range 2.4-4.6 kg). Diagnoses included typical HLHS (n = 6), right-dominant unbalanced atrioventricular septal defect with arch hypoplasia (n = 4), double outlet right ventricle [subpulmonic VSD (n = 1) and intact ventricular septum (n = 1)] with hypoplastic transverse aortic arch and borderline left ventricular dimensions. Standard approach with bilateral pulmonary artery banding and ductal stenting was carried out in all thirteen patients. Two patients required two ductal stents at the time of index procedure. There were no intraprocedural complications. Median intubation length post-procedure was 4 days (range 1-74 days). Median hospital stay post-procedure was 47 days (range 15-270 days). The overall mortality rate on follow-up through comprehensive stage 2 over the 6-year experience was 38 % (5 out of 13). Of note, the mortality rate was significantly lower in the latter 3 years of the study period when the procedure was adopted as a primary palliation for HLHS (14 % or 1 out of 7) compared to the initial 3-year period when it was reserved for higher risk cohorts (67 % or 4 out of 6). Median time to subsequent surgery was 3 months (range 1-4 months). One patient required further ductal stenting on follow-up and developed subsequently airway compression. On median follow-up of 24 months, two patients required pulmonary artery arterioplasty. The hybrid procedure may be used for palliation for a variety of cardiac lesions to avoid high-risk surgery in the neonatal period. This approach may be also an alternative in centers performing lower number of Norwood surgery, which has been associated with higher mortality.

Perventricular closure of pulmonary stump in a 16-kg child.

Blind pouch formation of the pulmonary artery (PA) in patients having undergone a Fontan operation can present a serious risk for thromboembolic events. Either primary or secondary closure of this stump is necessary to reduce this risk. Unfortunately, secondary closure is oftentimes difficult due to the size and anatomy of the presenting patient. We describe the insertion of a muscular ventricular septal defect (VSD) device via a perventricular approach for successful closure of a pulmonary stump in a 3-year old, 16-kg child. To our knowledge, this is the first report of a perventricular approach for successful closure of a PA stump.

Transcatheter Closure of Coronary Artery Fistulae: Considerations and Approaches Based on Fistula Origin.

OBJECTIVES: To investigate technical approaches for transcatheter closure of coronary artery fistula based on anatomic type of the fistula. BACKGROUND: The variability in coronary artery fistulae (CAF) anatomy that necessitates different transcatheter closure (TCC) approaches has not been well documented. METHODS: Records of patients with CAF who underwent TCC at 2 centers were reviewed for technical details and procedural outcome. CAF were classified as proximal and distal. TCC approaches employed were arterio-venous or arterio-arterial loop, retrograde arterial, and antegrade venous. RESULTS: Eighteen patients with CAF, mean age 12.6 years (0.07-60), 11 male (61%), underwent TCC. All CAF drained predominantly into the right side of the heart. Types of CAF were proximal in 15 and distal in 3 patients. CAF calibers were large in 7, medium in 9, and small in 2 patients. The arterio-venous loop approach was used in the majority of the cases (11 patients) and the CAF size were medium to large. The retrograde arterial approach was used in 4; of these, 3 patients had small to medium sized CAF. In 2 patients with long tortuous CAF an antegrade venous approach was employed. TCC was successful in 17 of the 18 patients (94.4%). There were no peri-procedural deaths or vascular complications. CONCLUSIONS: This study documents transcatheter closure approaches for CAF and device selection based on fistula origin. The choices of TCC technique and device selection vary, and are primarily determined by the heterogeneous anatomic characteristics of the fistulae.

Echocardiographic predictors of cardiac erosion after Amplatzer septal occluder placement.

UNLABELLED: The risk of erosion after Amplatzer septal occluder (ASO) device placement in atrial septal defects is well described. Aortic rim deficiency and use of over-sized device increase the risk of erosion. This study attempts to describe device characteristics, anatomical features and echocardiographic predictors that increase the risk of erosion. METHODS: From 2005 through 2012, 12 new cases, with nine confirmed and three suspected device erosions where pre-procedural, intra-procedural, and/or post-procedural echocardiograms were available and, were reviewed. Following parameters were evaluated: ASD location (high or low), rims deficiency and consistency, septal mal-alignment, dynamic nature of the defect; device edge relationship toward the transverse sinus (TS), atrial free wall tenting and the size of the defect compared with the size of the device used for closure. RESULTS: We found poor posterior rim consistency, aortic rim absence (in multiple views) and absent aortic rim at O degree in 100% of the patients. Septal mal-alignment and dynamic ASD was present in nearly 50% of the cases. The device was over-sized in three patients only. A 26-mm device was the most common device that resulted in erosion. In cases, where patient had experienced bloody pericardial effusion and the device was in place, device tenting in the TS was observed. Surgical explantation of the device confirmed presence of erosion in all cases. CONCLUSION: Aortic rim absence in multiple views, poor posterior rim consistency, septal mal-alignment, and dynamic ASD appear to be factors where erosion risk increases significantly. A thorough assessment of the device edge by echocardiography in short-axis may show device tenting of the atrial free wall into the TS. This finding should be a strong indictor to recommend surgical removal of device after occurrence of pericardial effusion.

Single-center outcome analysis comparing reintervention rates of surgical arterioplasty with stenting for branch pulmonary artery stenosis in a pediatric population.

Although catheter-based intervention is generally accepted as the treatment of choice for branch pulmonary artery (PA) stenosis, there are no data directly comparing both the need for reintervention and time to reintervention in patients undergoing transcatheter stenting versus surgical arterioplasty. We compared children who underwent surgical branch pulmonary arterioplasty and branch PA stent placement between January 2008 and May 2012 at a single tertiary center. Need for reintervention and mean time to reintervention were assessed using chi-square and independent sample Student t test. Thirty-seven patients were included (surgery n = 18, stent n = 19). Mean weight at initial intervention was 11.3 ± 8.8 kg for surgical and 20.1 ± 15.5 kg for stent (p = 0.041). Intervention was performed on the left PA in 17 patients, the right PA in 12 patients, and both PAs in 8 patients. Five patients had undergone previous intervention. On mean follow-up of 807 ± 415 days, 50% (9 of 18) of the surgery cohort and 5.3% (1 of 19) of the stent cohort required reintervention (p = 0.002). In all but one case reintervention was catheter-based. Mean time to reintervention for the surgery cohort was 272 ± 162 days and for the single stent cohort it was 150 days. When comparable age and weight groups were analyzed, reintervention was still more common in the surgery cohort (p = 0.007). Children undergoing surgical branch pulmonary arterioplasty are more likely to require reintervention than those undergoing stent placement.

Perventricular Melody valve implantation in a 12 kg child.

Transcatheter pulmonic valve implantation has emerged as a safe and effective alternative to valve surgery in patients with surgically corrected congenital heart disease. In cases where the transcatheter approach has failed, or was thought to be technically challenging, a hybrid approach to pulmonic valve implantation has been described. This approach involves a small subxyphoid incision made by the cardiac surgeon and implantation of the pulmonic valve through the appropriate delivery sheath through this incision. Here we describe a case of a successful implantation of a Melody valve in a 12 kg child with tetralogy of Fallot. To our knowledge this is the smallest child to have undergone this procedure reported.

Single-center comparative outcomes of the Edwards SAPIEN and Medtronic Melody transcatheter heart valves in the pulmonary position.

BACKGROUND: Two transcatheter pulmonary valve replacement (tPVR) systems (Edwards SAPIEN and Medtronic Melody) are available; however, comparative studies evaluating outcome data are lacking. The aim of this study was to compare short- with medium-term outcome data of these valves in the pulmonary position from a single institution. METHODS: Retrospective data analysis of all patients undergoing tPVR from April 2008 until April 2012. Pre-procedural investigations, patient demographics, procedural hemodynamics, and clinical and echocardiographic follow-up data were included. Data are presented as mean ± standard deviation. RESULTS: Thirty-three patients underwent successful tPVR (SAPIEN (S) n = 20, Melody (M) n = 13). Patient age and weight were similar between the two groups. Primary indication included regurgitation (S (n = 2), M (n = 3)), stenosis (S (n = 13), M (n = 7)), or mixed (S (n = 5), M (n = 3)). There was no difference in pre-procedural peak Doppler gradients across the pulmonary outflow (S = 47.73 ± 21.14 mm Hg, M = 42.62 ± 15.59 mm Hg, P = 0.46). All but one patient underwent pre-stenting prior to valve implantation. Immediately following valve deployment, the transvalvar gradient was not statistically different between the two groups (S = 11.5 ± 8.07 mm Hg, M = 8.15 ± 4.56 mm Hg, P = 0.18). There were no procedural deaths. Follow-up mean pulmonary Doppler gradients were higher with the SAPIEN cohort (18.43 ± 9.06 mm Hg (S) and 11.17 ± 5.24 mm Hg (M), P = 0.016); however, no differences were seen when similar procedural epochs were assessed. All but one patient remained with PR grade = 2. CONCLUSIONS: In a single-center series, the SAPIEN and Melody valves demonstrated comparable medium-term valve function. Greater residual gradients with the SAPIEN valve may represent a more conservative early pre-stenting approach with this valve.

New design of the Amplatzer membranous VSD occluder: a step forward?

Closure of perimembranous ventricular septal defects (PmVSDs) [4] with the original Amplatzer membranous VSD occluder (mVSD1) has been associated with an increased risk of complications, the most notable of which has been complete heart block. This has led to the introduction of a new device to close PmVSDs. The authors describe their experience with the new Amplatzer membranous VSD occluder (mVSD2) in two patients and critique the new device design and delivery system, comparing it with the mVSD1 occluder. Two patients underwent attempted closure of PmVSDs with the new mVSD2 device. One patient had successful closure of the defect with no residual shunt and no evidence of heart block at follow-up evaluation. Trace to mild aortic insufficiency was observed at the time of closure and at the last follow-up visit. The rhythm remained sinus. In the second patient, the device was placed but removed before release because of inability to orient the device in optimal position. Percutaneous closure of PmVSD is feasible with the new mVSD2 occluder. The change in the design may reduce the incidence of complete heart block. It remains to be seen whether the device will be suitable for smaller patients.