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1.
Pediatr Cardiol ; 44(4): 951-954, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36912925

ABSTRACT

Coronary artery-to-pulmonary artery fistulae are a not uncommon finding in patients with Tetralogy of Fallot (TOF) and collateral-dependent pulmonary blood flow. Management for these fistulae is often primary surgical ligation or unifocalization at the time of complete repair, dependent on the presence of dual blood flow to the involved areas. We present the case of a 32-week premature boy weighing 1.79 kg with TOF, confluent branch pulmonary arteries, major aortopulmonary collaterals, and right coronary artery to main pulmonary artery fistula. The patient demonstrated evidence of coronary steal into the pulmonary vasculature with an elevation in the troponin level without hemodynamic instability, and subsequently underwent successful transcatheter occlusion of the fistula via right common carotid access using a Medtronic 3Q microvascular plug. This case demonstrates the realistic potential for early coronary steal in this physiology and possibility of transcatheter therapy even in a small neonate.


Subject(s)
Fistula , Tetralogy of Fallot , Male , Infant, Newborn , Humans , Infant , Tetralogy of Fallot/surgery , Coronary Vessels/diagnostic imaging , Coronary Vessels/surgery , Collateral Circulation , Pulmonary Artery/diagnostic imaging , Pulmonary Artery/surgery
2.
Cardiol Young ; 32(12): 1952-1956, 2022 Dec.
Article in English | MEDLINE | ID: mdl-35152927

ABSTRACT

BACKGROUND: Recurrent laryngeal nerve injury leading to vocal cord paralysis is a known complication of cardiothoracic surgery. Its occurrence during interventional catheterisation procedures has been documented in case reports, but there have been no studies to determine an incidence. OBJECTIVE: To establish the incidence of left recurrent laryngeal nerve injury leading to vocal cord paralysis after left pulmonary artery stenting, patent ductus arteriosus device closure and the combination of the procedures either consecutively or simultaneously. METHODS: Members of the Congenital Cardiovascular Interventional Study Consortium were asked to perform a retrospective analysis to identify cases of recurrent laryngeal nerve injury after the aforementioned procedures. Twelve institutions participated in the analysis. They also contributed the total number of each procedure performed at their respective institutions for statistical purposes. RESULTS: Of the 1337 patients who underwent left pulmonary artery stent placement, six patients (0.45%) had confirmed vocal cord paralysis. 4001 patients underwent patent ductus arteriosus device closure, and two patients (0.05%) developed left vocal cord paralysis. Patients who underwent both left pulmonary artery stent placement and patent ductus arteriosus device closure had the highest incidence of vocal cord paralysis which occurred in 4 of the 26 patients (15.4%). Overall, 92% of affected patients in our study population had resolution of symptoms. CONCLUSION: Recurrent laryngeal nerve injury is a rare complication of left pulmonary artery stent placement or patent ductus arteriosus device closure. However, the incidence is highest in patients undergoing both procedures either consecutively or simultaneously. Additional research is necessary to determine contributing factors that might reduce the risk of recurrent laryngeal nerve injury.


Subject(s)
Ductus Arteriosus, Patent , Recurrent Laryngeal Nerve Injuries , Vocal Cord Paralysis , Humans , Recurrent Laryngeal Nerve Injuries/etiology , Recurrent Laryngeal Nerve Injuries/complications , Vocal Cord Paralysis/epidemiology , Vocal Cord Paralysis/etiology , Ductus Arteriosus, Patent/epidemiology , Ductus Arteriosus, Patent/surgery , Ductus Arteriosus, Patent/complications , Incidence , Retrospective Studies , Catheterization/adverse effects
3.
Pediatr Cardiol ; 42(4): 918-925, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33590324

ABSTRACT

Pericardiocentesis is traditionally performed using a subxiphoid approach. Hepatomegaly or loculated and noncircumferential effusions warrant nonstandard approaches to drain effusions; echocardiographic guidance has made these less traditional, non-subxiphoid approaches feasible. The study is aimed at comparing clinical outcomes of the subxiphoid and non-subxiphoid approaches to percutaneous pericardiocentesis in a pediatric population. This is a retrospective chart review of all children undergoing percutaneous pericardiocentesis from August 2008 to December 2019 at a single-center. A total of 104 patients underwent echocardiography-guided pericardiocentesis during the timeframe. Additionally, fluoroscopy was also used in 80 patients. Hematopoietic stem cell transplantation was the most common underlying diagnosis (n = 53, 50.9%). A non-subxiphoid approach was used in 58.6% (n = 61) of patients. The fifth and sixth intercostal spaces were the most commonly used (n = 17 each). The non-subxiphoid group tended to be older (95.9 vs. 21.7 months, p = 0.006) and weighed more (23.6 vs. 11.2 kgs, p = 0.013) as compared to the subxiphoid group. Non-subxiphoid approach was associated with shorter procedure times (21 vs. 37 min, p = 0.005). No major complications were seen. Five minor complications occurred and were equally distributed in the two groups. Complications were more likely in younger patients (p = 0.047). The technique and anatomic approach to pericardiocentesis, and the location or size of effusion did not influence the risk of complications. Echocardiography-guided percutaneous pericardiocentesis in children was associated with low complication rates in this single-center pediatric experience. The use of a non-traditional, non-subxiphoid approach was associated with shorter procedure times and did not significantly affect complication rates.


Subject(s)
Pericardial Effusion/surgery , Pericardiocentesis/methods , Child , Child, Preschool , Drainage/methods , Echocardiography/methods , Female , Fluoroscopy/methods , Hematopoietic Stem Cell Transplantation , Humans , Infant , Male , Postoperative Complications/epidemiology , Retrospective Studies , Treatment Outcome
5.
J Pediatr Hematol Oncol ; 42(4): 256-260, 2020 05.
Article in English | MEDLINE | ID: mdl-32149865

ABSTRACT

Although rare in the general pediatric population, the incidence of pericardial effusion is significantly higher in pediatric patients undergoing hematopoietic stem cell transplant (HCT) with a reported incidence of up to 16.9%. The development of pericardial effusion in this setting is associated with higher mortality. Although pericardiocentesis is a relatively safe procedure for treating pericardial effusion, it is invasive, painful, and exposes an immunosuppressed patient to the risks of infection, bleeding, and injury to surrounding structures. Given the procedural risks of pericardiocentesis, systemic steroids are often administered for the treatment of pericardial effusion given their use for pericarditis in the general population. However, the effectiveness of systemic steroids for the treatment of pericardial effusion in the pediatric HCT population has not been confirmed. We studied the role of systemic steroids, administered at the time of initial pericardiocentesis performed for pericardial effusion, in preventing repeat pericardiocentesis. A total of 37 pericardiocenteses after HCT were performed during the study period with 25 patients undergoing first-time pericardiocentesis and 15 of those patients receiving systemic steroids. Eight patients required repeat pericardiocentesis; 5 of 15 (33%) received steroids and 3 of 10 (30%) did not receive steroids. Our data in this small cohort of pediatric HCT patients did not show a significant difference in the need for repeat pericardiocentesis with the use of systemic steroids, initiated within 48 hours of pericardiocentesis.


Subject(s)
Hematopoietic Stem Cell Transplantation , Pericardial Effusion , Pericardiocentesis , Steroids/administration & dosage , Allografts , Child , Child, Preschool , Female , Humans , Infant , Male , Pericardial Effusion/drug therapy , Pericardial Effusion/epidemiology , Pericardial Effusion/etiology , Recurrence
6.
Ann Noninvasive Electrocardiol ; 25(5): e12742, 2020 09.
Article in English | MEDLINE | ID: mdl-31994780

ABSTRACT

Wrist-worn devices are popular for heart rate monitoring, including use of photoplethysmography. The Apple Watch series 4 can identify atrial fibrillation. We describe a case of identification re-entrant supraventricular tachycardia not identified by outpatient rhythm monitoring, however, was identified by the Apple Watch series 4, which lead to electrophysiology study and successful ablation of atrioventricular nodal re-entrant tachycardia.


Subject(s)
Heart Rate Determination/instrumentation , Heart Rate Determination/methods , Photoplethysmography/instrumentation , Photoplethysmography/methods , Tachycardia, Atrioventricular Nodal Reentry/diagnosis , Wearable Electronic Devices , Adolescent , Catheter Ablation/methods , Female , Humans , Tachycardia, Atrioventricular Nodal Reentry/surgery
7.
Postepy Kardiol Interwencyjnej ; 16(4): 460-465, 2020 Dec.
Article in English | MEDLINE | ID: mdl-33598020

ABSTRACT

INTRODUCTION: The Nit-Occlud PDA device is a newer coil-type device with a high degree of efficacy and safety. There are concerns about the high incidence of immediate angiographic residual shunt with this device. AIM: To compare immediate angiographic residual shunts and their outcomes following PDA device closure with the Nit-Occlud device. MATERIAL AND METHODS: A single-institution, retrospective chart review of PDA closures was performed. Thirty patients who underwent Nit-Occlud PDA closure were compared with 34 patients who underwent PDA closure with an Amplatzer Duct Occluder-1 (ADO-1) and 25 patients who underwent PDA closure with coils. RESULTS: The three groups were similar in age, weight, and procedural characteristics. The PDA dimensions were smaller in the coils group. Technical success in the ADO-1 and Nit-Occlud groups was 100%. A small angiographic residual shunt was seen more often in the Nit-Occlud group (70%) than in the ADO-1 (59%) and coils (26%) groups (p = 0.005). Most residual shunts in the Nit-Occlud group disappeared in the echocardiogram performed 4 h later (90% echocardiographic closure). Echocardiographic closure (100%) was seen at 2 months and 6 months in the Nit-Occlud group. No correlation was noted between the angiographic residual shunt and Nit-Occlud device orientation with respect to the ductus, the device-ductal angle or the number of loops at the pulmonary artery end. CONCLUSIONS: Despite the higher immediate angiographic residual shunt rate in the Nit-Occlud group than the other groups, high echocardiographic closure rates were seen within hours after device closure, which persisted at follow-up. The angiographic residual shunt is not related to the device orientation and should not be a deterrent in using this device.

8.
Echocardiography ; 36(5): 944-947, 2019 05.
Article in English | MEDLINE | ID: mdl-31006919

ABSTRACT

OBJECTIVES: To report the usefulness of harmonic imaging in echocardiography to visualize and direct the implantation of the Medtronic micro vascular plug (MVP). BACKGROUND: Off label use of the MVP was reported for transcatheter occlusion of patent ductus arteriosus (PDA) in premature infants. The device is poorly visible on fluoroscopy and echocardiography. METHODS: In 9 consecutive premature infants, the MVP was used for transcatheter closure of the PDA. In each, the ability of conventional echocardiographic imaging was compared to harmonic imaging, and the device was deployed in the PDA using echocardiography. RESULTS: In each subject, harmonic imaging proved superior to conventional echocardiography to visualize the MVP in premature infants using 12 and 8 MHz probes. Once the delivery, catheter was across the PDA into the descending aorta, and the MVP advanced to the catheter tip, positioning, and deployment of the device was possible without fluoroscopy. All devices were deployed appropriately with immediate occlusion and no obstruction to the left pulmonary artery or aorta. CONCLUSIONS: The MVP can be accurately imaged using harmonic imaging, even in the near field in premature infants. Precise implantation of the MVP in the PDA of premature infants is possible with echocardiographic imaging of the device and vascular structures.


Subject(s)
Ductus Arteriosus, Patent/diagnostic imaging , Ductus Arteriosus, Patent/surgery , Echocardiography/methods , Infant, Premature, Diseases/diagnostic imaging , Infant, Premature, Diseases/surgery , Septal Occluder Device , Humans , Infant, Newborn , Infant, Premature , Prosthesis Design , Retrospective Studies , Treatment Outcome
9.
Semin Cardiothorac Vasc Anesth ; 22(4): 383-394, 2018 Dec.
Article in English | MEDLINE | ID: mdl-30095030

ABSTRACT

The term "coronary artery anomalies" encompasses a large and heterogeneous group of disorders that may affect origin, intrinsic anatomy, course, location, and termination of the coronary arteries. With these different anatomies, presentation, symptoms, and outcomes are heterogeneous as well. While significant efforts are directed toward improving diagnosis and risk-stratification, best evidence-guided practices remain in evolution. Data about anesthetic management of patients with coronary anomalies are lacking as well. This review aims to provide the anesthesiologist with a better understanding of an important subgroup of coronary artery anomalies: anomalous aortic origin of a coronary artery. We will discuss classification, pathophysiology, incidence, evaluation, management, and anesthetic implications of this potentially fatal disease group.


Subject(s)
Anesthesia/methods , Anesthetics/administration & dosage , Coronary Vessel Anomalies/complications , Anesthesiologists/organization & administration , Anesthesiology/methods , Aorta/abnormalities , Coronary Vessel Anomalies/physiopathology , Humans
10.
Echocardiography ; 34(9): 1347-1352, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28833533

ABSTRACT

BACKGROUND: Ultrasound imaging of adults with heart failure and increased central venous pressure (CVP) has shown significant thoracic duct (TD) dilation from impedance in lymphatic drainage. Elevated CVP and abnormal lymphatic drainage are implicated in severe Fontan complications, including protein losing enteropathy (PLE) and plastic bronchitis (PB). Systematic studies of TD and lymphatic circulation in children are limited, and their cervical TD normative values have not been established. METHODS: Thoracic duct imaging was attempted prospectively during routine echocardiograms performed 7/2014-9/2016 in children 5-21 years old with normal cardiovascular physiology and Fontan palliation. TD insertion to the central venous system (lympho-venous junction) was assessed with an S12-4 MHz transducer. For the first 34 patients, only TD ostia were measured, but ostium shape variability at the lympho-venous junction led to including the TD arch 5-10 mm proximal to the ostium for the remaining cohort. RESULTS: Seventy-nine total subjects were studied: 58 controls, 13 Fontan patients with normal systemic ventricular ejection fraction (EF) (>50%), and 8 Fontan patients with decreased EF (≤50%). Combined Fontan subjects had larger TD ostial diameters compared to controls when normalized by body surface area (median 2.6 mm/m2 vs. 2 mm/m2 ) (P=.04). CONCLUSION: To our knowledge, this is the first systematic study of ultrasonographic TD imaging in children. Fontan patients have larger TD diameters, reflecting the impaired lymphatic circulation in patients with this physiology. Further research may provide important associations between sonographic TD features with the functional status of patients with Fontan circulation.


Subject(s)
Central Venous Pressure/physiology , Fontan Procedure/adverse effects , Heart Defects, Congenital/surgery , Postoperative Complications/diagnostic imaging , Thoracic Duct/diagnostic imaging , Ultrasonography/methods , Adolescent , Child , Child, Preschool , Female , Follow-Up Studies , Humans , Male , Postoperative Complications/physiopathology , Prospective Studies , Thoracic Duct/physiopathology , Time Factors , Young Adult
11.
Pediatr Cardiol ; 36(7): 1376-81, 2015 Oct.
Article in English | MEDLINE | ID: mdl-25851170

ABSTRACT

Antenatal diagnosis of right heart enlargement has a wide spectrum of differential diagnosis from maternal, placental and fetal causes, and outcomes of all are not known. Coarctation of the aorta is in the differential diagnosis of right heart enlargement. In our study, we focused to measure multiple cardiac dimensions in fetuses with right heart enlargement to identify the fetus with coarctation of the aorta utilizing echocardiographic measurements. Ten cardiovascular dimensions were measured from fetal studies between 20- and 34-week gestation, and six were measured on postnatal echocardiograms. Z-scores for the cardiac dimensions were calculated, and each variable for fetuses and infants was tested using a two-sample t test between patients with and without coarctation. We excluded fetuses with TAPVR, Shone complex, interrupted aortic arch, Ebstein anomaly or HLHS. Of the 31 fetuses with in utero right heart enlargement, 11 had coarctation postnatally and 20 did not have coarctation. We compared the fetal and newborn cardiac dimensions between the groups. The mean fetal carotid-subclavian index (CS Index) was 0.7 mm with coarctation compared with 1.1 mm without coarctation (p < 0.0001). The mean difference in diameter z-scores for fetal aortic isthmus (p < 0.0001), mitral valve (<0.001) and aortic valve (p < 0.009) was also significantly different. Similar significant differences were noted postnatally in the diameters of the cardiac dimensions between the coarctation and no-coarctation group: CS index (p < 0.0001), aortic isthmus (p < 0.0002) and aortic valve annulus (p < 0.007). A spectrum of diagnoses was found postnatally in fetuses with right heart enlargement, including a normal heart. The likelihood of identifying fetuses with coarctation of the aorta and planning for postnatal management can be refined by noninvasive screening measurements. A smaller CS index and smaller diameters of the aortic isthmus, mitral valve and aortic valve were significantly associated prenatally (p < 0.05) with coarctation of the aorta versus without coarctation and might be useful in prenatally diagnosing coarctation of the aorta. Postnatally, these measurements are reproducible. This is the first study utilizing these specific measurements to diagnose coarctation prenatally.


Subject(s)
Aorta, Thoracic/abnormalities , Aortic Coarctation/diagnostic imaging , Fetal Heart/diagnostic imaging , Hypertrophy, Right Ventricular/diagnostic imaging , Echocardiography, Doppler, Color , Female , Gestational Age , Humans , Infant , Infant, Newborn , Pregnancy , Prenatal Diagnosis , Retrospective Studies , Ultrasonography, Prenatal
12.
Catheter Cardiovasc Interv ; 83(2): 250-5, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24446324

ABSTRACT

OBJECTIVES: This study assessed the feasibility and efficacy of implanting a new miniaturized nitinol device to occlude the patent ductus arteriosus (PDA) in a newborn porcine model. BACKGROUND: Transcatheter device closure is the standard of care for PDA in older children and adults. Currently available technology is not designed for the newborn infant. METHODS: The Amplatzer Duct Occluder II 0.5 is a new transcatheter Nitinol device without fabric designed to close the PDA with small aortic and pulmonary artery structures. The device was implanted in 8 infant pigs (average weight 2,400 g) after balloon dilation of PDA (average diameter 2.7 mm, average length 5.8 mm) with immediate, ∼ 7, ∼ 30, and ∼ 90 day follow-up by echocardiography, angiography, and final pathological examination. Half were implanted arterial, and half venous. RESULTS: The device was successfully implanted in all animals. There was complete occlusion of the PDA in all cases without obstruction of the pulmonary arteries or aorta. There was complete late endothelialization without thrombus. The only complication was transection of a femoral artery accessed by cutdown. CONCLUSIONS: The success of this animal study confirms safety and feasibility of the Amplatzer Duct Occluder II 0.5 (now known as the ADO II AS) for use when the aorta and pulmonary arteries are small. Consideration can be given to transcatheter closure of the PDA in preterm and other small infants with this device.


Subject(s)
Cardiac Catheterization/instrumentation , Ductus Arteriosus, Patent/therapy , Septal Occluder Device , Alloys , Animals , Animals, Newborn , Aorta/diagnostic imaging , Aortography , Cardiac Catheterization/adverse effects , Ductus Arteriosus, Patent/diagnostic imaging , Feasibility Studies , Materials Testing , Miniaturization , Models, Animal , Prosthesis Design , Pulmonary Artery/diagnostic imaging , Swine , Time Factors , Ultrasonography
13.
Catheter Cardiovasc Interv ; 83(4): 571-80, 2014 Mar 01.
Article in English | MEDLINE | ID: mdl-23703890

ABSTRACT

OBJECTIVES: To describe the initial world experience and mid-term follow-up of perimembranous ventricular septal defect (pmVSD) closure with a newly designed occluder. BACKGROUND: Transcatheter closure of pmVSDs has been associated with a substantial risk of complete heart block, prompting many centers to abandon this intervention. METHODS: A prospective multicenter cohort study was conducted on patients with pmVSD undergoing catheter closure using the Amplatzer(®) Membranous VSD Occluder 2 in the initial 4 pilot centers. RESULTS: Nineteen patients, median age 6 years (range 1.4-62 years), were enrolled and followed for 14 ± 3 months (range 8-20 months). The median weight was 26 kg (range 9.3-96 kg) and the mean Qp/Qs ratio was 1.8 ± 0.7. The defect on left ventricular side measured 9.9 ± 3.5 mm and the orifice on right ventricular side was 8.1 ± 2.8 mm by echocardiography. Mean device size was 9.4 ± 2.4 mm (range 5-14 mm). An eccentric device was employed in 9 patients (47%) and a concentric device in 10 (53%). Overall, 18 patients (95%) had successful device implants. Procedural time was 122 ± 39 min. There were no procedural complications. Mild residual shunting was initially observed in 14 (78%) patients. At last follow-up, mild residual shunting persisted in only 3 (17%) patients. There was no significant increase in aortic or tricuspid regurgitation. No patient had any degree of AV block, although one developed a transient left anterior fascicular block. Holter evaluation, obtained in all patients, was unremarkable in all. CONCLUSIONS: This early cohort experience using a novel adapted transcatheter closure device for pmVSD suggests that the procedure is feasible, safe, and effective.


Subject(s)
Cardiac Catheterization , Heart Septal Defects, Ventricular/therapy , Humans
14.
Pediatr Transplant ; 17(3): 294-9, 2013 May.
Article in English | MEDLINE | ID: mdl-23464863

ABSTRACT

PE can occur following HCT. However, the incidence, etiology, risk factors, and treatment remain unclear. We performed a retrospective study evaluating 355 pediatric recipients of HCT treated at a single institution between January 2005 and August 2010. No cases of PE were identified in the autologous HCT (auto-HCT) recipients (0/43), while 19% (57/296) of allogeneic HCT (allo-HCT) developed PE. Among the 57 PE patients, 40 (70%) were males; the median age at transplantation was 6.6 yr (0.1-17.3 yr). Thirty-six patients (63%) had significant PE with 23 patients (40%) treated by pericardiocentesis, and 19 (33%) experiencing recurrent PE. OS rates for patients who developed PE were 84% at 100 days and 65% at three yr after HCT. Risk factors associated with PE on multivariate analysis included myeloablative conditioning (p = 0.01), delayed neutrophil engraftment (p < 0.01), and CMV + serostatus of the recipient (p = 0.03). Recipients with non-malignant diseases were significantly less likely to die after development of PE (p = 0.02 and 0.004 when comparing with standard and high-risk diseases, respectively). In summary, PE is a common and significant complication of pediatric allo-HCT. Prospective studies are needed to better determine the etiology and optimal method of PE treatment after HCT.


Subject(s)
Hematopoietic Stem Cell Transplantation/adverse effects , Pericardial Effusion/diagnosis , Adolescent , Child , Child, Preschool , Cytomegalovirus Infections/complications , Female , Hematopoietic Stem Cell Transplantation/methods , Humans , Infant , Male , Neutrophils/cytology , Pericardiocentesis/methods , Recurrence , Retrospective Studies , Risk Factors , Seasons , Time Factors , Transplantation Conditioning/adverse effects , Transplantation Conditioning/methods , Treatment Outcome
15.
Catheter Cardiovasc Interv ; 79(7): 1153-60, 2012 Jun 01.
Article in English | MEDLINE | ID: mdl-22162409

ABSTRACT

OBJECTIVES: This study assessed the feasibility and efficacy of implanting a new nitinol device for closure of perimembranous ventricular septal defects in a swine model. BACKGROUND: Perimembranous ventricular septal defect occurs in 80% of patients requiring treatment for congenital heart disease. METHODS: The Amplatzer perimembranous ventricular septal occluder device (pmVSO2 device, AGA Medical Company, Plymouth MN) is a new transcatheter Nitinol device containing polyester fabric designed to close the perimembranous ventricular septal defect (VSD). The device has 75% reduction in radial force, 45% reduction in clamping force, and increased stability as compared to the previous version. The device was implanted in six swine with naturally occurring perimembranous VSD with immediate, 1, 7, ∼30, and ∼90 day followup by echocardiography, angiography, and final pathological examination. RESULTS: The device was successfully implanted in all animals and was retrievable and repositionable. There was complete occlusion of the VSD in five of six cases without embolization. There was no thrombus formation on the device or occurrence of complete heart block. A single instance of a tiny residual shunt was attributed to capture of tricuspid valve apparatus. CONCLUSIONS: The success of this animal study confirms safety and feasibility of the Amplatzer pmVSO2 device. Human trials are planned.


Subject(s)
Cardiac Catheterization/instrumentation , Heart Septal Defects, Ventricular/therapy , Septal Occluder Device , Alloys , Animals , Cardiac Catheterization/adverse effects , Coronary Angiography , Echocardiography, Doppler, Color , Feasibility Studies , Heart Septal Defects, Ventricular/diagnosis , Materials Testing , Prosthesis Design , Swine , Swine, Miniature , Time Factors
16.
Catheter Cardiovasc Interv ; 76(2): 181-5, 2010 Aug 01.
Article in English | MEDLINE | ID: mdl-20665856

ABSTRACT

OBJECTIVES: This study assessed the feasibility and efficacy of implanting a new nitinol device in the left atrial appendage (LAA) in a canine model. BACKGROUND: Left atrial thrombus occurs in the LAA in 90% of humans with nonvalvular atrial fibrillation (AF). METHODS: The Amplatzer Left Atrial Appendage Occluder Device now known as the Amplatzer Cardiac Plug (Amplatzer Medical LLC, Plymouth MN) is a new transcatheter Nitinol device containing polyester fabric designed to seal the LAA. The device was implanted in 10 canines with immediate, approximately 30 and approximately 90-day follow-up by echocardiography, angiography, and final pathological examination. RESULTS: The device was successfully implanted in all animals and found to be retrievable and repositionable. There was complete occlusion of the LAA in all cases without embolization. There was no thrombus formation on the device and no pericardial effusion or impingement on the circumflex coronary artery, mitral valve, or left pulmonary vein. A single instance of tiny left atrial mural thrombus at device end screw contact was attributed to the small canine left atrium. CONCLUSIONS: The success of this animal study confirms safety and feasibility of the Amplatzer Cardiac Plug. Human trials are warranted.


Subject(s)
Atrial Appendage , Cardiac Catheterization/instrumentation , Septal Occluder Device , Alloys , Animals , Atrial Appendage/diagnostic imaging , Atrial Appendage/pathology , Cardiac Catheterization/adverse effects , Dogs , Feasibility Studies , Materials Testing , Polyesters , Prosthesis Design , Radiography , Thrombosis/etiology , Time Factors , Ultrasonography
17.
Echocardiography ; 27(5): 575-9, 2010 May.
Article in English | MEDLINE | ID: mdl-20374268

ABSTRACT

OBJECTIVE: Echocardiographic analysis of patent ductus arteriosus (PDA), proximal left main pulmonary artery (LPA) and descending thoracic aorta (Ao) dimensions in preterm infants who undergo surgical ligation of the PDA. A discussion for percutaneous ductal occlusion in preterm infants. METHODS: Echocardiographic analysis of the LPA diameter, PDA diameter, PDA length, and descending thoracic aorta diameter in 55 preterm infants who underwent surgical ligation of the PDA from 2004 to 2008. Patients were stratified by weight into four groups: those less than 750 g, 751-1,000 g, 1,001-1,250 g, and those greater than 1,250 g. Mean and standard deviation for each structure dimension was calculated in each weight group. Structural dimensions were compared between groups using ANOVA for multiple comparisions. RESULTS: The mean patient weight was 1,018 g (560-2,400 g). The mean ductal length was 4.1 mm (2.5-5.3 mm). The mean ductal diameter was 2.2 mm (1.5-3.6 mm). The mean LPA diameter was 3 mm (1.5-4.5 mm). The mean aortic diameter was 4.3 mm (2.7-7.8 mm). The alpha value for between weight groups for PDA length was 0.21, PDA diameter 0.16, LPA diameter 0.39, and aortic diameter 0.1. DISCUSSION: No statistical significance was seen when comparing structure dimension by weight. This suggests uniform structural dimensions across a broad weight distribution in this patient population. To date, there has been no attempt to standardize dimensions of these vascular structures. The information gathered in this study may be useful in developing an implantable device for ductal occlusion in preterm infants. (ECHOCARDIOGRAPHY 2010;27:575-579).


Subject(s)
Aorta, Thoracic/diagnostic imaging , Ductus Arteriosus, Patent/diagnostic imaging , Echocardiography, Doppler, Color/methods , Infant, Premature , Pulmonary Artery/diagnostic imaging , Analysis of Variance , Body Weight , Ductus Arteriosus, Patent/surgery , Female , Humans , Infant, Newborn , Male
18.
Catheter Cardiovasc Interv ; 74(3): 482-7, 2009 Sep 01.
Article in English | MEDLINE | ID: mdl-19405162

ABSTRACT

OBJECTIVES: To describe a new percutaneous PDA device. BACKGROUND: The ADO II was developed by AGA Medical for closure of small-moderate sized PDAs via a small delivery catheter from an antegrade or retrograde catheter approach. The objective of this study was to evaluate the technical feasibility, safety, and efficacy of the ADO II in a canine PDA model. METHODS: The ADO-II consists of multi-layer nitinol wire braid with symmetric retention disks and an articulating connecting center waist, without sewn-in polyester, that can be delivered though a 4-5F catheter. A PDA was surgically created in nine dogs. Transcatheter occlusion of the PDA was performed using the ADO II. Angiographic and hemodynamic data were obtained at 7, 30, 60, and 90 days post-procedure. The devices were then harvested for pathology. RESULTS: Devices were placed transarterially (n = 8) and transvenously (n = 1). All PDAs were occluded and there were no significant pressure gradients (P > 0.05) at the immediate and 90 post-implant evaluations. Pathology found endothelial coverage on all aortic and pulmonary disks, except at the tip of the microscrew. There were no procedural complications. One canine was euthanized 4 hr after device implant because of a clinical deterioration. The staff veterinarian and pathologist concluded that the animal's illness was not device related. CONCLUSIONS: The Amplatzer ADO II devices can be safely deployed in animal models of PDAs, with complete resolution of the PDA shunt. The lower profile and symmetry of the ADO II allows for venous or arterial approach and smaller delivery catheter size. The ADO-II is expected to be a preferred alternative for closure of small-moderate PDAs.


Subject(s)
Cardiac Catheterization/instrumentation , Ductus Arteriosus, Patent/therapy , Animals , Aorta/physiopathology , Aortography , Cardiac Catheterization/adverse effects , Disease Models, Animal , Dogs , Ductus Arteriosus, Patent/diagnostic imaging , Ductus Arteriosus, Patent/physiopathology , Equipment Design , Feasibility Studies , Female , Hemodynamics , Male , Materials Testing , Pulmonary Artery/diagnostic imaging , Pulmonary Artery/physiopathology , Time Factors
19.
Catheter Cardiovasc Interv ; 72(1): 74-9, 2008 Jul 01.
Article in English | MEDLINE | ID: mdl-18546236

ABSTRACT

OBJECTIVES: To evaluate all complications that occurred during or after cardiac catheterizations for Amplatzer PFO device closure of patent foramen ovale (PFO), determine the cause of the complications and recommend techniques to minimize complications in the future. BACKGROUND: Rare complications were reported to the manufacturer of the Amplatzer PFO occluder since the introduction of the device. METHODS: A panel of independent physicians reviewed all complications reported to the manufacturer to determine whether the complication was related to the device or related to the cardiac catheterization procedure. Demographic data, echocardiograms, operative reports, and time to occurrence of complications were reviewed. RESULTS: A total of 11 events were reported. Only two patients had device related complications (erosion), an incidence of 0.018%. Two patients were found to have additional atrial septal defect after PFO closure. Two patients were thought to have an inflammatory reaction without any serious sequelae. Five complications were related to the cardiac catheterization procedure (atrial appendage perforation). CONCLUSIONS: Device related complications after Amplatzer PFO occluder placement are extremely rare. Cardiac catheterization related complications appear to be the most common cause of the hemodynamic compromise. Careful manipulation of catheters and wires, recognition of the location of the catheter by fluoroscopy and echocardiography will decrease the risk of such complications.


Subject(s)
Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Foramen Ovale, Patent/therapy , Registries , Equipment Design , Equipment Failure/statistics & numerical data , Foramen Ovale, Patent/diagnostic imaging , Humans , Postoperative Complications/epidemiology , Product Surveillance, Postmarketing , Radiography , Retrospective Studies , Time Factors , Ultrasonography
20.
Congenit Heart Dis ; 3(2): 149-54, 2008.
Article in English | MEDLINE | ID: mdl-18380767

ABSTRACT

The presence of a large patent ductus arteriosus (PDA) may result in significant pulmonary hypertension, which may not be reversible. We present the case of a 35-year-old man with pulmonary hypertension who had successful percutaneous closure of a large PDA with an Amplatzer muscular ventricular septal defect occluder and resolution of his pulmonary hypertension. The use of prior balloon test occlusion of the PDA suggested that the procedure would be successful, despite the lack of an immediate fall in the pulmonary artery pressure.


Subject(s)
Ductus Arteriosus, Patent/complications , Ductus Arteriosus, Patent/therapy , Hypertension, Pulmonary/etiology , Hypertension, Pulmonary/therapy , Prosthesis Implantation/methods , Adult , Balloon Occlusion , Cardiac Catheterization/methods , Ductus Arteriosus, Patent/diagnosis , Echocardiography , Equipment Design , Humans , Hypertension, Pulmonary/diagnosis , Magnetic Resonance Angiography , Male , Prosthesis Implantation/instrumentation
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