Damien Kenny

Percutaneous Implantation of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position: Early Phase 1 Results From an International Multicenter Clinical Trial

OBJECTIVES The purpose of this study was to evaluate the safety and effectiveness of the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position in patients with moderate to severe pulmonary regurgitation with or without stenosis. BACKGROUND Transcatheter pulmonary valve replacement is evolving, but to date, experience has been limited to the Melody valve (Medtronic Inc., Minneapolis, Minnesota). METHODS Eligible patients with dysfunctional right ventricle-to-pulmonary artery conduits were screened if body weight was ≥35 kg and the in situ conduit diameter was ≥16 mm and ≤24 mm. Standardized implantation and follow-up protocols were used. RESULTS Thirty-six patients from 4 centers were recruited between April 2008 and May 2010. Mean body weight was 73.4 ± 22.9 kg. Successful valve deployment was achieved in 33 of 34 attempts (97.1%). Valve migration occurred in 3 patients, with 2 requiring surgical retrieval; however, 1 patient underwent successful perventricular valve implantation. Further intraprocedure complications included pulmonary hemorrhage (n = 2), ventricular fibrillation (n = 1), and stent migration (n = 1). Pullback gradient across the conduit decreased from 26.8 ± 18.4 mm Hg to 11.7 ± 8.0 mm Hg (p < 0.001). The right ventricular/aortic pressure ratio decreased from 0.6 ± 0.2 to 0.4 ± 0.1 (p < 0.001). Peak Doppler gradient across the right ventricular outflow tract decreased from 41.9 ± 27.9 mm Hg to 19.1 ± 13.3 mm Hg (p < 0.001). At 6-month follow-up, all patients were alive. The number of patients with New York Heart Association functional class I increased from 5 at baseline to 27 at follow-up. Pulmonary regurgitation was ≤2+ in 97% of patients. Freedom from reintervention was 97% with 1 patient undergoing elective placement of a second valve due to conduit-induced distortion of the initial implant. CONCLUSIONS Transcatheter pulmonary valve replacement using the Edwards SAPIEN transcatheter heart valve is safe and effective in patients with dysfunctional right ventricle-to-pulmonary artery conduits.

Feeding difficulties and growth delay in children with hypoplastic left heart syndrome versus d-transposition of the great arteries.

The objective of this study was to identify the incidence of feeding difficulties in infants with hypoplastic left heart syndrome (HLHS) and d-transposition of the great arteries (d-TGA). Congenital heart disease is a risk factor for growth failure. The etiologies include poor caloric intake, inability to utilize calories effectively, and increased metabolic demands. The goals of our study were to (1) identify feeding difficulties in infants with HLHS and d-TGA and (2) assess their growth in the first year of life. We performed a chart review of 27 consecutive infants with HLHS and 26 with d-TGA. Descriptive statistics were generated for demographic and clinical variables within each group and are presented as means ± standard deviations. HLHS and d-TGA groups were compared on time to achieving nutritional goals using the log rank test, on complication rate using the chi-square test, and on weight using the t-test. A significance level of 0.05 was used for all tests. Birth weight was similar for both the HLHS and d-TGA groups (3.19 ± 0.69 vs 3.35 ± 0.65 kg, respectively; p = 0.38). Infants with HLHS weighed less than those with d-TGA at l month (3.29 ± 0.58 vs 3.70 ± 0.60 kg, respectively; p = 0.021), 6 months (6.27 ± 1.06 vs 7.31 ± 1.02 kg, p = 0.003), and 12 months of age (8.40 ± 1.11 vs 9.49 ± 1.01 kg, p = 0.006). Time to achieving full caloric intake (at least 100 kcal/kg/day) for the HLHS group (24 ± 11.9 days) was significantly longer than for the d-TGA group (12.0 ± 11.2 days, p < 0.001). In addition, infants with HLHS had a higher incidence of feeding-related complications that those with d-TGA (48 vs 4%, respectively; p = 0.001). Compared to the d-TGA group, infants with HLHS weighed less at follow-up, took longer to reach nutritional goals, and had a much higher incidence of feeding-related complications.

Balloon expandable stent implantation for native and recurrent coarctation of the aorta—prospective computed tomography assessment of stent integrity, aneurysm formation and stenosis relief

Background Stenting for aortic coarctation is known to be effective in the medium term. Aneurysm formation following stent implantation is a recognised complication. However, data regarding aortic wall injury and stent integrity following stent placement are sparse. Objectives We report comprehensive clinical, echocardiographic and prospective CT follow-up data following stenting for aortic coarctation from a single centre. Methods Full data analysis of all patients undergoing balloon expandable stent implantation and follow-up procedures in a single tertiary congenital cardiac unit. Results Between October 2002 and April 2008, we performed 102 coarctation stent procedures on 88 patients. Median age was 20.6 years (range 8.5–65) and median weight 65 kg (range 34–101). 94 stents (26 covered) were implanted. 12 procedures were re-dilatations. Stenting resulted in a reduction of the gradient across the site of coarctation, from a median of 20 mm Hg to 4 mm Hg. There were no procedure-related deaths. Four patients had immediate complications (one requiring emergency surgery). During median follow-up of 34.5 months (range 4.2–72.8), two patients had late complications requiring additional stent procedures. Follow-up CT data are available in 84 patients with MRI in one patient (96.5%). Only one patient developed a procedure-related aortic aneurysm. All stent fractures (n=7) occurred with a single stent design. Conclusions Stenting for aortic coarctation and re-coarctation is effective with low immediate complication rates. CT is useful in the longer term for assessment of stent integrity and post-procedural aneurysm formation. Overall incidence of post-procedural aneurysm is rare and stent fractures were not seen with newer generation stents.

Self‐expanding and balloon expandable covered stents in the treatment of aortic coarctation with or without aneurysm formation

Objectives: We describe our complete experience with covered stent implantation for aortic coarctation including short‐ to medium‐term outcomes. Background: Coarctation of the aorta is a heterogeneous disease process with multiple associated complications both with and without treatment. Covered stents have evolved to provide greater support to the aortic wall and a varied approach with choice of stent tailored to the anatomy of the patient is required. Methods: We retrospectively analyzed consecutive patient data from two congenital heart centers from March 2003 to October 2007. Results: We implanted 38 covered stents in 37 patients (20 female) of which three were self‐expanding stents. Median age was 29.6 years (9–65) with median weight of 71.5 kg (35–95). The indications for stent placement were native coarctation (n = 13); recurrent coarctation following surgical treatment (n = 11); aneurysm associated with previous coarctation surgery (n = 7); aorto‐bronchial fistula leading to acute hemoptysis (n = 2); stent fracture (n = 1); associated arterial duct (n = 2). One patient had a combination of acquired coarctation and false aneurysm. The median screening time was 10 min (3–22). The median systolic gradient of 26 mm Hg (10–60) was reduced to 4 mm Hg (0–20) postprocedure (P < 0.001). There were no deaths on median follow up of 11.5 months (1–56). One patient developed aortic rupture during the procedure and required emergency surgery. Conclusion: Covered stent implantation for treatment of aortic coarctation is safe and highly effective in selected patients. Self‐expanding stent grafts may be preferable to balloon expandable stents when there is aneurysm formation in the setting of aortopathy.

Early clinical experience with a novel self-expanding percutaneous stent-valve in the native right ventricular outflow tract

Balloon expandable transcatheter pulmonary valve systems are not applicable to the large majority of patients with chronic severe pulmonary regurgitation (PR) following surgical right ventricular outflow tract (RVOT) rehabilitation. This report describes the clinical use and short‐term follow‐up of a novel transcatheter self‐expanding pulmonary valve system (Venus P Valve) for rehabilitation of the RVOT in patients with chronic severe PR.

Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves: An International, Multicenter Registry Study.

Background— Off-label use of transcatheter aortic and pulmonary valve prostheses for tricuspid valve-in-valve implantation (TVIV) within dysfunctional surgical tricuspid valve (TV) bioprostheses has been described in small reports. Methods and Results— An international, multicenter registry was developed to collect data on TVIV cases. Patient-related factors, procedural details and outcomes, and follow-up data were analyzed. Valve-in-ring or heterotopic TV implantation procedures were not included. Data were collected on 156 patients with bioprosthetic TV dysfunction who underwent catheterization with planned TVIV. The median age was 40 years, and 71% of patients were in New York Heart Association class III or IV. Among 152 patients in whom TVIV was attempted with a Melody (n=94) or Sapien (n=58) valve, implantation was successful in 150, with few serious complications. After TVIV, both the TV inflow gradient and tricuspid regurgitation grade improved significantly. During follow-up (median, 13.3 months), 22 patients died, 5 within 30 days; all 22 patients were in New York Heart Association class III or IV, and 9 were hospitalized before TVIV. There were 10 TV reinterventions, and 3 other patients had significant recurrent TV dysfunction. At follow-up, 77% of patients were in New York Heart Association class I or II (P<0.001 versus before TVIV). Outcomes did not differ according to surgical valve size or TVIV valve type. Conclusions— TVIV with commercially available transcatheter prostheses is technically and clinically successful in patients of various ages across a wide range of valve size. Although preimplantation clinical status was associated with outcome, many patients in New York Heart Association class III or IV at baseline improved. TVIV should be considered a viable option for treatment of failing TV bioprostheses.

Early clinical experience with the new Amplatzer Ductal Occluder II for closure of the persistent arterial duct.

Objectives: To describe the early single‐center clinical experience with the Amplatzer Ductal Occluder II (ADO II). Methods: All patients undergoing attempted transcatheter closure of persistent arterial duct (PDA) with the ADO II were included. Data collected included demographic, clinical, and echocardiographic parameters. Results: From March until September 2008, 29 procedures were undertaken in 27 patients (21 female). Median age was 1.4 years (range 0.4–76 years) with median weight 9.4 kg (range 4.7–108 kg). A transarterial approach was used in 2 patients. The median minimum ductal diameter was 2.7 mm (range 1.7–5). ADO II was released in 25 patients (92.5%). Two patients had significant residual shunting following deployment of ADO II and underwent closure with Amplatzer ductal occluder (ADO I). Postprocedural echocardiography identified one occluder had changed position with development of a significant leak and one occluder had embolized to the left pulmonary artery. Both occluders were retrieved successfully at a second catheter procedure. Complete occlusion was noted predischarge in 22 of the remaining 23 occluders (96%). One patient had mild flow acceleration in the left pulmonary artery which has resolved. Conclusions: The ADO II is highly effective at providing rapid occlusion of morphologically varied PDAs. Occluder design allows closure with arterial or venous approach and delivery with 4 or 5 F delivery catheters. Stable occluder position is dependent on correct positioning of both aortic and pulmonary discs. A larger range of sizes and configurations of this occluder may be required to successfully occlude all ductal sizes and morphologies.

Relationship of aortic pulse wave velocity and baroreceptor reflex sensitivity to blood pressure control in patients with repaired coarctation of the aorta

BACKGROUND Increased aortic stiffness and reduced baroreceptor reflex sensitivity have been described independently after coarctation of the aorta (CoA) repair. This study sought to determine the relationship between these variables and blood pressure control in adolescents after early CoA repair. METHODS Spontaneous baroreceptor reflex sensitivity (sBRS) and aortic pulse wave velocity (PWV) were measured in 29 adolescents after CoA repair and compared with 20 age-matched controls. Patients treated for hypertension or having residual aortic narrowing were excluded. Ambulatory blood pressure (ABP), heart rate variability, and cardiac output were also recorded. After ABP measurement, CoA subjects were classified as normotensive or hypertensive. RESULTS Nine patients (31%) were hypertensive according to standard definitions, and this subgroup had higher aortic PWV than the normotensive subgroup (P = .004). There was a significant positive correlation between ABP and PWV seen in the whole CoA group (r(2) = 0.5, P < .01). The normotensive subgroup had increased sBRS compared with controls (P = .02). This difference was not seen between the hypertensive subgroup and controls. There was a significant inverse relationship between sBRS and aortic PWV in the whole CoA group (r(2) = 0.25, P = .01). The normotensive subgroup had a significant reduction in stroke index compared with controls (P = .02), which was not seen in the hypertensive subgroup (P = .96). CONCLUSIONS Adolescents with hypertension after CoA repair have increased aortic PWV and a relative reduction in sBRS compared with normotensive CoA patients. Thus, failure of the baroreceptor reflex to compensate for increasing arterial stiffness may herald the onset of hypertension in these patients.

Erosions, erosions, and erosions! Device closure of atrial septal defects: how safe is safe?

Secundum atrial septal defect (ASD) accounts for approximately 6 to 10% of all CHD in children and 30% in adult patients [1,2]. Although surgical closure of ASDs is associated with very low mortality (0–3%), the use of transcatheter device techniques has become widely accepted as an alternative therapy to surgery. Device closure is considered safe and offers many intuitive advantages over surgical closure. Such advantages may include avoidance of cardiopulmonary bypass (CPB) and its potential adverse neurologic sequelae, avoidance of sternotomy scar, a potentially lower incidence of post-procedure complications, and a shorter hospital stay [3,4]. Currently, there are two devices approved by the United States Food and Drug Administration (FDA) for ASD closure: the Amplatzer Septal Occluder (ASO) (AGA/St. Jude Medical Corporation, St. Paul, Minnesota), approved in December 2001 [5]; and the Gore Helex Septal Occluder (HSO) (W.L. Gore & Associates, Flagstaff, Arizona), approved in August 2006 [6]. Lately, there has been an increasing concern regarding device erosion with the ASO. Although this is a very rare complication, it presents particular concerns. First, it is potentially fatal if not promptly recognized; second, it can unpredictably occur early or late (days to years) after the procedure making close follow-up difficult; third, there are no definite identifiable risk factors and the etiology is multifactorial (patients factors, device size, rim deficiency, septal malalignment). Recently at the PICS AICS 2012 meeting, there was a special session on this topic with a panel of experts including interventional cardiologists, cardiac surgeons, and FDA representative. In addition, the FDA held a panel meeting on May 24, 2012 to discuss this issue and came up with some recommendations that may help identify the true incidence of erosions and may shed some light as to the mechanism of erosions. Below is an overview on this life-threatening complication as well as a review of the available data and an update on the latest recommendations provided by the advisory panel to the FDA in order to assist in further understanding the causes and incidence of erosion and subsequently how to avoid/minimize its occurrence.

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.