Allison K. Cabalka

Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease

OBJECTIVES To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD). STUDY DESIGN A randomized, double-blind, placebo-controlled trial included 1287 children with CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of 15 mg/kg palivizumab or placebo. Children were followed for 150 days. The primary efficacy end point was antigen-confirmed respiratory syncytial virus (RSV) hospitalization. RESULTS Palivizumab recipients had a 45% relative reduction in RSV hospitalizations (P=.003), a 56% reduction in total days of RSV hospitalization per 100 children (P=.003), and a 73% reduction in total RSV hospital days with increased supplemental oxygen per 100 children (P=.014). Adverse events were similar in the treatment groups; no child had drug discontinued for a related adverse event. Serious adverse events occurred in 55.4% of palivizumab recipients and 63.1% of placebo recipients (P<.005); none were related to palivizumab. Twenty-one children (3.3%) in the palivizumab group and 27 (4.2%) in the placebo group died; no deaths were attributed to palivizumab. The rates of cardiac surgeries performed earlier than planned were similar in the treatment groups. CONCLUSIONS Monthly palivizumab (15 mg/kg IM) was safe, well-tolerated, and effective for prophylaxis of serious RSV disease in young children with hemodynamically significant CHD.

Long-term follow-up of percutaneous repair of paravalvular prosthetic regurgitation.

OBJECTIVES The goal of this study was to determine the long-term clinical efficacy of percutaneous repair of paravalvular prosthetic regurgitation. BACKGROUND Percutaneous repair has emerged as an effective therapy for patients with paravalvular prosthetic regurgitation. METHODS We retrospectively identified 126 patients who underwent catheter-based treatment of symptomatic prosthetic paravalvular regurgitation. Patients were contacted for symptoms, clinical events, and vital status. RESULTS The 3-year estimate for survival was 64.3% (95% confidence interval: 52.1% to 76.8%). Mortality occurred due to cardiac, noncardiac, and unknown causes in 9.5%, 7.1%, and 5.6% of patients, respectively. Among survivors, 72% of patients who had presented with heart failure were free of severe symptoms and need for cardiac surgery. Severity of residual regurgitation was not related to overall survival but was an important determinant of other clinical events. For those with no, mild, or moderate or severe residual regurgitation, 3-year estimate of survival free of death or need for surgery was 63.3%, 58.3%, and 30.3% (p = 0.01), respectively. CONCLUSIONS Percutaneous repair of paravalvular prosthetic regurgitation can lead to durable symptom relief in selected patients. Nonetheless, mortality remains significant in symptomatic patients with paravalvular prosthetic regurgitation. Long-term clinical efficacy is highly dependent on residual regurgitation.

Principles of percutaneous paravalvular leak closure.

Paravalvular regurgitation affects 5% to 17% of all surgically implanted prosthetic heart valves. Patients who have paravalvular regurgitation can be asymptomatic or present with hemolysis or heart failure, or both. Reoperation is associated with increased morbidity and is not always successful because of underlying tissue friability, inflammation, or calcification. Comprehensive echocardiographic imaging with transthoracic and real-time 3-dimensional transesophageal echocardiography is key for characterizing the defect location, size, and shape. For paramitral defects, an antegrade transseptal approach can usually be guided by biplane fluoroscopy, and real-time 3-dimensional transesophageal echocardiography can usually be performed successfully. Alternative approaches to paramitral defects include retrograde transaortic cannulation or transapical access and retrograde cannulation. For oblong or crescentic defects, the simultaneous or sequential deployment of 2 smaller devices, as opposed to 1 large device, results in a higher degree of procedural success and safety because the risk of impingement on the prosthetic leaflets is minimized. Most para-aortic defects can be approached in a retrograde manner and closed with a single device. With careful anatomical assessment, procedural planning, and procedural execution, successful closure rates of 90% or more should be attainable with a low risk of device impingement on the prosthetic valve or embolization.

Percutaneous Repair of Paravalvular Prosthetic Regurgitation Acute and 30-Day Outcomes in 115 Patients

Background— Percutaneous repair has emerged as a potential therapy for patients with prosthetic paravalvular regurgitation. However, there is a relative paucity of data on the feasibility and outcome of this procedure. Methods and Results— All patients in whom percutaneous paravalvular regurgitation closure was attempted at our hospital were identified and included. Under echocardiographic and fluoroscopic guidance, patients underwent implantation of ≥1 an Amplatzer Septal Occluder, Duct Occluder, Muscular Ventricular Septal Defect Occluder, or Vascular Plug II. Percutaneous repair of 141 paravalvular defects was attempted in 115 patients (age, 67±12 years; men, 53%) with heart failure, hemolytic anemia, or both and who were at high risk of open surgery (mean estimated Society of Thoracic Surgeons mortality, 6.9%). Devices were implanted in 125 defects (89% of total defects), including in 19 patients with multiple defects. Because of the complexity of the procedures, wire exteriorization was required in 29 patients. Overall, successful percutaneous closure (defined as ≤1+ residual regurgitation) was achieved in 88 (77%) patients. Procedural time decreased with increasing case experience for percutaneous repair of both perimitral and periaortic defects. Overall, the 30-day complication rate was 8.7% (sudden and unexplained death, 1.7%; stroke, 2.6%; emergency surgery, 0.9%; bleeding, 5.2%). Two devices embolized during the procedure and were retrieved without sequelae. No procedural deaths occurred, but 2 (1.7%) patients died by 30 days. Conclusions— Percutaneous repair of paravalvular prosthetic regurgitation can be performed with a reasonable rate of procedural success and may be an initial therapeutic option, particularly in patients at significant risk for open surgery. Increased case experience is associated with shorter procedural time.Background—Percutaneous repair has emerged as a potential therapy for patients with prosthetic paravalvular regurgitation. However, there is a relative paucity of data on the feasibility and outcome of this procedure. Methods and Results—All patients in whom percutaneous paravalvular regurgitation closure was attempted at our hospital were identified and included. Under echocardiographic and fluoroscopic guidance, patients underwent implantation of ≥1 an Amplatzer Septal Occluder, Duct Occluder, Muscular Ventricular Septal Defect Occluder, or Vascular Plug II. Percutaneous repair of 141 paravalvular defects was attempted in 115 patients (age, 67±12 years; men, 53%) with heart failure, hemolytic anemia, or both and who were at high risk of open surgery (mean estimated Society of Thoracic Surgeons mortality, 6.9%). Devices were implanted in 125 defects (89% of total defects), including in 19 patients with multiple defects. Because of the complexity of the procedures, wire exteriorization was required in 29 patients. Overall, successful percutaneous closure (defined as ⩽1+ residual regurgitation) was achieved in 88 (77%) patients. Procedural time decreased with increasing case experience for percutaneous repair of both perimitral and periaortic defects. Overall, the 30-day complication rate was 8.7% (sudden and unexplained death, 1.7%; stroke, 2.6%; emergency surgery, 0.9%; bleeding, 5.2%). Two devices embolized during the procedure and were retrieved without sequelae. No procedural deaths occurred, but 2 (1.7%) patients died by 30 days. Conclusions—Percutaneous repair of paravalvular prosthetic regurgitation can be performed with a reasonable rate of procedural success and may be an initial therapeutic option, particularly in patients at significant risk for open surgery. Increased case experience is associated with shorter procedural time.

Percutaneous Repair of Paravalvular Prosthetic RegurgitationClinical Perspective

Background— Percutaneous repair has emerged as a potential therapy for patients with prosthetic paravalvular regurgitation. However, there is a relative paucity of data on the feasibility and outcome of this procedure. Methods and Results— All patients in whom percutaneous paravalvular regurgitation closure was attempted at our hospital were identified and included. Under echocardiographic and fluoroscopic guidance, patients underwent implantation of ≥1 an Amplatzer Septal Occluder, Duct Occluder, Muscular Ventricular Septal Defect Occluder, or Vascular Plug II. Percutaneous repair of 141 paravalvular defects was attempted in 115 patients (age, 67±12 years; men, 53%) with heart failure, hemolytic anemia, or both and who were at high risk of open surgery (mean estimated Society of Thoracic Surgeons mortality, 6.9%). Devices were implanted in 125 defects (89% of total defects), including in 19 patients with multiple defects. Because of the complexity of the procedures, wire exteriorization was required in 29 patients. Overall, successful percutaneous closure (defined as ≤1+ residual regurgitation) was achieved in 88 (77%) patients. Procedural time decreased with increasing case experience for percutaneous repair of both perimitral and periaortic defects. Overall, the 30-day complication rate was 8.7% (sudden and unexplained death, 1.7%; stroke, 2.6%; emergency surgery, 0.9%; bleeding, 5.2%). Two devices embolized during the procedure and were retrieved without sequelae. No procedural deaths occurred, but 2 (1.7%) patients died by 30 days. Conclusions— Percutaneous repair of paravalvular prosthetic regurgitation can be performed with a reasonable rate of procedural success and may be an initial therapeutic option, particularly in patients at significant risk for open surgery. Increased case experience is associated with shorter procedural time.Background—Percutaneous repair has emerged as a potential therapy for patients with prosthetic paravalvular regurgitation. However, there is a relative paucity of data on the feasibility and outcome of this procedure. Methods and Results—All patients in whom percutaneous paravalvular regurgitation closure was attempted at our hospital were identified and included. Under echocardiographic and fluoroscopic guidance, patients underwent implantation of ≥1 an Amplatzer Septal Occluder, Duct Occluder, Muscular Ventricular Septal Defect Occluder, or Vascular Plug II. Percutaneous repair of 141 paravalvular defects was attempted in 115 patients (age, 67±12 years; men, 53%) with heart failure, hemolytic anemia, or both and who were at high risk of open surgery (mean estimated Society of Thoracic Surgeons mortality, 6.9%). Devices were implanted in 125 defects (89% of total defects), including in 19 patients with multiple defects. Because of the complexity of the procedures, wire exteriorization was required in 29 patients. Overall, successful percutaneous closure (defined as ⩽1+ residual regurgitation) was achieved in 88 (77%) patients. Procedural time decreased with increasing case experience for percutaneous repair of both perimitral and periaortic defects. Overall, the 30-day complication rate was 8.7% (sudden and unexplained death, 1.7%; stroke, 2.6%; emergency surgery, 0.9%; bleeding, 5.2%). Two devices embolized during the procedure and were retrieved without sequelae. No procedural deaths occurred, but 2 (1.7%) patients died by 30 days. Conclusions—Percutaneous repair of paravalvular prosthetic regurgitation can be performed with a reasonable rate of procedural success and may be an initial therapeutic option, particularly in patients at significant risk for open surgery. Increased case experience is associated with shorter procedural time.

Transcatheter Amplatzer device closure of atrial septal defect and patent foramen ovale in patients with presumed paradoxical embolism.

OBJECTIVE To review our experience with, and profile the safety and efficacy of, the Amplatzer PFO (patent foramen ovale) occluder (APO) and Amplatzer septal occluder (ASO) used to close PFO and/or atrial septal defect (ASD) in patients with paradoxical embolism (PE). PATIENTS AND METHODS Between April 1998 and November 2002, 103 patients at the Mayo Clinic in Rochester, Minn, and Scottsdale, Ariz, mean age 52.4 years, with presumed PE (transient ischemic attack [n=22], stroke [n=77], or peripheral emboli [n=4]) underwent transcatheter device closure of PFO (n=81), ASD (n=12), and ASD/PFO (n=10) with 106 devices (APO [n=22] or ASO [n=84]). RESULTS All devices deployed successfully, and no patients died. Procedural complications included atrial fibrillation (n=2), vessel injury (n=3), profound sinus node dysfunction (n=1), and device embolization with successful retrieval (n=1). At 3 months, 7 of 95 monitored patients had trivial residual shunt; at 12 months, 2 of 28 monitored patients had trivial residual shunt. Three patients had recurrent events--2 transient ischemic attacks and 1 retinal artery occlusion--at a mean +/- SD follow-up of 8.3 +/- 8.1 months (range, 1-34 months). None of these 3 patients had residual shunt or evidence of intracardiac thrombus. The average annual recurrence of all events was 3.6% at 23 months. The overall mean +/- SD freedom from recurrence of all events was 98.9% +/- 1.2% and 83.8% +/- 10.2% at 12 and 29 months of follow-up, respectively. CONCLUSIONS Transcatheter device closure of PFO and/or ASD with use of APO/ASO in patients with presumed PE is effective and safe. Recurrent events may occur in the absence of a residual shunt.

Successful percutaneous repair of perivalvular prosthetic regurgitation

To examine the feasibility and outcome of percutaneous transcatheter repair of perivalvular regurgitation.

Intracardiac echocardiographic guidance during transcatheter device closure of atrial septal defect and patent foramen ovale.

OBJECTIVES To describe our experience with intracardiac echocardiographic (ICE) guidance during transcatheter device closure of atrial septal defect (ASD) and patent foramen ovale (PFO) and to describe a detailed stepwise approach for performing ICE examinations. PATIENTS AND METHODS We reviewed the ICE results of all patients who underwent transcatheter device closure of ASD/PFO at the Mayo Clinic in Rochester, Minn, between October 2000 and November 2002. Conscious sedation was used, and all ICE studies were performed using a diagnostic ultrasound catheter. RESULTS Ninety-four patients (47 male; median age, 51 years [range, 17-81 years]) underwent ICE during transcatheter device closure of ASD/PFO. Total procedure time was 128 minutes (range, 27-320 minutes). ICE identified a previously unrecognized anatomical diagnosis in 32 of 94 patients. An additional ASD or PFO was found in 16 patients; a redundant atrial septum or an atrial septal aneurysm was found in 12 patients. There were few ICE complications (4%): 3 patients developed atrial fibrillation, and 1 developed supraventricular tachycardia; of these 4, 2 resolved spontaneously, and 2 required cardioversion with no recurrence. CONCLUSION ICE provides anatomical detail of ASD/PFO and cardiac structures facilitating congenital cardiac interventional procedures. ICE eliminates major drawbacks related to the use of transesophageal echocardiographic guidance for transcatheter device closure of ASD/PFO, specifically problems related to airway management. Finally, ICE gives the interventional cardiologist the ability to control all aspects of imaging without relying on additional echocardiographic support. We believe that ICE should be considered the preferred imaging technique for guidance of transcatheter device closure of ASD/PFO in adults and larger pediatric patients.

Prophylactic indomethacin therapy in the first twenty-four hours of life for the prevention of patent ductus arteriosus in preterm infants treated prophylactically with surfactant in the delivery room

OBJECTIVE To determine whether a course of low-dose indomethacin therapy, when initiated within 24 hours of birth, would decrease ductal shunting in premature infants who received prophylactic surfactant in the delivery room. DESIGN Ninety infants, with birth weights of 600 to 1250 gm, were entered into a prospective, randomized, controlled trial to receive either indomethacin, 0.1 mg/kg per dose, or placebo less than 24 hours and again every 24 hours for six doses. Echocardiography was performed on day 1 before treatment and on day 7, 24 hours after treatment. A hemodynamically significant patent ductus arteriosus (PDA) was confirmed with an out-of-study echocardiogram, and the nonresponders were treated with standard indomethacin or ligation. RESULTS Forty-three infants received indomethacin (birth weight, 915 +/- 209 gm; gestational age, 26.4 +/- 1.6 weeks; 25 boys), and 47 received placebo (birth weight, 879 +/- 202 gm; gestational age, 26.4 +/- 1.8 weeks; 22 boys) (P = not significant). Of 90 infants, 77 (86%) had a PDA by echocardiogram on the first day of life before study treatment; 84% of these PDAs were moderate or large in size in the indomethacin-treated group compared with 93% in the placebo group. Nine of forty indomethacin-treated infants (21%) were study-dose nonresponders compared with 22 (47%) of 47 placebo-treated infants (p < 0.018). There were no significant differences between both groups in any of the long-term outcome variables, including intraventricular hemorrhage, duration of oxygen therapy, endotracheal intubation, duration of stay in neonatal intensive care unit, time to regain birth weight or reach full caloric intake, incidence of bronchopulmonary dysplasia, and survival. No significant differences were noted in the incidence of oliguria, elevated plasma creatinine concentration, thrombocytopenia, pulmonary hemorrhage, or necrotizing enterocolitis. CONCLUSION The prophylactic use of low doses of indomethacin, when initiated in the first 24 hours of life in low birth weight infants who receive prophylactic surfactant in the delivery room, decreases the incidence of left-to-right shunting at the level of the ductus arteriosus.

Results of transcatheter Fontan fenestration to treat protein losing enteropathy

Transcatheter fenestration to create an interatrial communication has been used to treat patients with protein losing enteropathy (PLE) after Fontan operation. No systematic data have been reported assessing the results of this procedure. Our institutional database was queried to identify patients after Fontan operation who had transcatheter fenestration to treat PLE. Clinical notes, laboratory data, echocardiograms, and cardiac catheterization data were reviewed. From 1995 to 2005, 16 transcatheter fenestration procedures were performed in seven patients. Median age at fenestration was 18 years (range 13–41 years). Median duration of follow‐up was 3.6 years (range 0.2–10.4 years). Techniques for fenestration included blade/balloon septostomy, stent placement, Amplatzer‐fenestrated ASD device, and balloon dilation of previous stent. Size of the fenestration created was 5.2 ± 1.1 mm. Systemic venous pressure remained unchanged after fenestration. Cardiac index increased significantly. Reduction of ascites and edema was noted after 9 of the 16 procedures. Ten of 16 (63%) of fenestrations spontaneously occluded. Three patients are free of ascites although recurrence of PLE occurred in all. One patient with a patent fenestration continues to have ascites. Two patients had Fontan takedown. One patient had conversion to a fenestrated extracardiac conduit Fontan and died postoperatively. The results of transcatheter Fontan fenestration are often disappointing. Maintaining fenestration patency is difficult. Even after “successful” fenestration, resolution of PLE may be incomplete and recurrences have occurred in all. Early consideration should be given to Fontan takedown or cardiac transplant in severely symptomatic patients with PLE who do not respond to fenestration. Transcatheter fenestration may be a bridge to a definitive procedure.