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ABSTRACT: The difficult performance of certain percutaneous interventions in the field of congenital heart disease is well known. Crossing pulmonary arteries in patients who have previously undergone surgical repair or stenotic pulmonary veins in infants can be typical examples of these technical challenges in the catheterization laboratory. The Venture wire 6 Fr control catheter (St Jude Medical) is compatible with a steerable tapered radiopaque tip that can be manually angulated (up to 90°) by clockwise rotation of a knob located in the proximal handle. This mechanism directs any 0.014″ guidewire and provides back-up support. This catheter has been successfully used in coronary artery intervention for crossing severely tortuous vessels, extreme angulations of side-branch ostia, jailed stents, saphenous vein graft anastomoses, and chronic total occlusions. We report the first use of the Venture wire control catheter (St Jude Medical) in the field of congenital heart disease. Patient #1 was diagnosed with pulmonary atresia and ventricular septal defect and had a proximally migrated stent in the pulmonary trunk and severe left pulmonary artery stenosis. We have used this catheter in order to cross this stent and perform left pulmonary artery stent placement. Patient #2 had postoperative vein restenosis after surgery. The Venture catheter was used to reach the obstructed insertion of the right medium lobe pulmonary vein from a transseptal approach. Techniques from coronary interventional colleagues can help interventional cardiologists in the field of congenital heart disease to treat complex situations.
The Journal of invasive cardiology 07/2012; 24(7):E148-52. · 1.84 Impact Factor
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ABSTRACT: Tetralogy of Fallot (TOF) is the most common form of cyanotic congenital heart disease. If left untreated, it carries a 33% mortality in the first year of life and a 50% mortality in the first 3 years of life. Since the introduction of the first open-heart repair by Lillehei and Varco in 1954, surgical management of TOF has evolved to be the primary repair during infancy in the majority of patients. Surgical management of TOF results in anatomic and functional abnormalities in the majority of patients, such as chronic pulmonary valve regurgitation and right ventricular (RV) dysfunction. Long-standing chronic pulmonary valve regurgitation can result in RV dilatation and failure, increasing tricuspid regurgitation, impaired exercise performance and supraventricular or ventricular arrhythmias. A timely reoperation may prevent these consequences, with a complete RV-function recovery. This article provides insight into the questions of when to perform a pulmonary valve implantation and in whom.
Expert Review of Cardiovascular Therapy 07/2012; 10(7):917-23.
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ABSTRACT: BACKGROUND AND AIMS: Percutaneous implantation of pulmonary valve has been recently introduced in the clinical practice. Our aim was to analyse data of patients treated in Italy by using the Melody Medtronic valve. METHODS: Prospective, observational, multi-centric survey by means of a web-based database registry of the Italian Society of Pediatric Cardiology (SICP). RESULTS: Between October 2007 and October 2010, 63 patients were included in the registry (median age: 24 years; range 11-65 years). Forty subjects were in NYHA class I-II while 23 were in NYHA class III-IV. Patients included had a history of a median 3 previous surgeries (range 1-5) and a median of 1 previous cardiac catheterization (range 0-4). A cono-truncal disease was present in 39 patients, previous Ross operation in 9, other diagnosis in 15. Indication to valve implantation was pure stenosis in 21 patients, pure regurgitation in 12, association of stenosis and regurgitation in 30. Implantation was performed in 61 subjects (97%). Pre-stenting was performed in 85% of cases. Median procedure time was 170 minutes (range 85-360). No significant regurgitation was recorded after procedure while the trans-pulmonary gradient reduced significantly. Early major complications occurred in 7 subjects (11%). One death occurred in the early post-operative period in a severely ill subject. At a median follow-up of 30 months (range 12-48 months) three patients died due to underlying disease. Major complications occurred in 6 patients during follow-up (external electric cardioversion: 1 pt; herpes virus encephalitis: 2 pts; Melody valve endocarditis needing surgical explant: 2 pts; major fractures of the stent and need second Melody valve implantation: 2 pts). Freedom from valve failure at latest follow-up was 81.4%?9%. CONCLUSION: Early results of the SICP registry on transcatheter Melody pulmonary valve implantation show that the procedure is safe and successful. Major concerns are related to the occurrence of stent fracture and bacterial endocarditis. Longer follow-up and larger series are needed. © 2012 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions 06/2012; · 2.29 Impact Factor
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ABSTRACT: Aortic coarctation comprises approximately 7% of all known congenital heart defects. Surgery and balloon angioplasty have been performed for many years but are associated with a significant incidence of recoarctation and aneurysm formation. Although bare-stent implantation decreases the incidence of recoarctation, the risk of aortic dissection or aneurysm formation is not eliminated. Described initially to treat patients with coexistent aneurysm of the aortic wall, we currently believe that covered-stent implantation for aortic coarctation should play a more important role. Our increasing experience from expanding their indication to deal with complications from previous interventions, associated defects or particular anatomical situations has led us to conclude that most of cases of aortic coarctation in adolescents and adults should be treated by the implantation of covered stents.
Expert Review of Medical Devices 03/2012; 9(2):123-30. · 2.63 Impact Factor
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Claudio Bussadori,
Pedro Oliveira,
Carmelo Arcidiacono,
Antonio Saracino,
Elisa Nicolosi,
Diana Negura, Luciane Piazza,
Angelo Micheletti,
M Chessa,
Gianfranco Butera,
Jaspal S Dua,
Mario Carminati
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ABSTRACT: To evaluate acute change of right and left ventricle after percutaneous closure of isolated atrial septal defect (ASD) 21 adult patients (13 F; 8 M) aged 28 ± 9.5 range 18-49 years have been examined by echocardiography before and 24 hours after percutaneous closure of ASD. Twenty-one normal adult subjects, as control group were included. A MyLab25 echo machine equipped with a multifrequency 2.5-3.5 MHz transducer was used. Offline computer-based analysis for strain and SR were performed using XStrain software based on a feature tracking algorithm. All patients had ASD OS2 with right ventricular dilatation and diastolic areas were larger than in controls: P = 0.0158. Global right ventricular longitudinal strain was higher P = 0.0438. Twenty-four hours after ASD closure, right ventricular diastolic and systolic areas were significantly reduced. Right ventricular global longitudinal systolic strain decreased: P = 0.00016, as well as global right ventricular longitudinal SR -1.56/sec ± 0.57 vs. -1.28/sec ± 0.31, P = 0.02646. At the mean time left ventricular end diastolic volume and left ventricular cardiac output measured by two-dimensional echocardiography both increased significantly P = 0.002145 and 0.013409. Global circumferential strain at mitral level augmented significantly -20.3%± 4.64 vs. -25.39%± 5.22, P = 0.00003. Longitudinal strain of the right ventricle works as indicator of right ventricular function dependent on loading conditions while SR seems to be less dependent on it. Circumferential strain could be used as an indicator of left ventricular response to normalized loading conditions.
Echocardiography 05/2011; 28(7):730-7. · 1.24 Impact Factor
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ABSTRACT: Objectives. To evaluate the recurrence of congenital heart disease (CHD) in pregnant women with familial risk who had been referred for fetal echocardiography. Material and Methods. 1634 pregnancies from 1483 women with familial history of CHD in one or more relatives were studied. Fetal cardiologic diagnosis was compared with postnatal findings at 6 months or at autopsy. Results. Total recurrence rate of CHD was 3.98%, 4.06% in single familial risk, 2.9% in double, and 5% in multiple risk. It was 3.5% in case of one previously affected child; 4.5% with 2 children; 5.2% with the mother alone affected and 7,5% with father alone affected and 3.5% with a single distant relative. Exact concordance of CHD was found in 21.5% and a partial concordance in 20% of cases. Conclusions. Our data show a higher recurrence rate of CHD than previously published data and high relative risk ratios compared to normal population.
Journal of pregnancy 01/2011; 2011:368067.
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ABSTRACT: Different devices are used for transcatheter occlusion of patent ductus arteriosus (PDA), each with its own limitations and complications. We report our initial single-center experience with the new Amplatzer Duct Occluder II (ADO II), which has been designed to address some of these issues.
From April until October 2008, 10 consecutive patients with PDA (minimal diameter > or = 2 mm) were enrolled for intention-to-treat with ADO II. The median age was 10.2 years (7 months to 51.4 years); the median weight was 35.5 kg (6.3-70 kg).
ADO II implantation was attempted in 10/10 patients. The mean PDA diameter was 3.1 mm (+/- 1.0 mm), and the mean device waist diameter was 4.0 mm (+/- 1.3 mm). In 1 patient, the ADO II encroached upon the left pulmonary artery, hence it was changed to an Amplatzer Duct Occluder I. In another patient, the shape and size of the duct necessitated the use of a Cook detachable coil. Complete angiographic closure was achieved in 8/8 ADO II implantations (100%) and in the patient with the coil. In the patient with an ADO I, complete echocardiographic closure was demonstrated at 24 hours. No device embolization or complications related to implantation occurred.
This initial experience demonstrates the feasibility and efficacy of the ADO II to occlude PDA with a minimum diameter > or = 2 mm. It is especially useful in smaller children with larger duct diameters. Longer-term follow up in a larger cohort of patients is required to establish safety and long-term results.
The Journal of invasive cardiology 09/2009; 21(8):401-5. · 1.84 Impact Factor
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ABSTRACT: The incidence of residual ventricular septal defects (VSDs) after surgery is 5-25%. Redo surgery is associated with higher risks.
Between January 2000 to December 2008, 170 patients underwent percutaneous VSD closure in our centre: 22(16M) of these had 23 closures for residual VSDs. Median age was 32.5 yrs (1.4-79). All patients had echocardiographic signs of left ventricle volume overload (Q(p)/Q(s) >or= 1.5). Nine patients had previous VSD closure, 6 tetralogy of Fallot repair, and 7, other procedures. There were 15 muscular, 6 perimembranous and 2 apical VSDs.
Amplatzer VSD devices were used in all. Median VSD size was 8 mm (4.3-16). Median fluoroscopy time was 33 minutes (15-130). There were three adverse events: 1 ventricular fibrillation requiring DC cardioversion; 1 transient complete atrio-ventricular block reverting to sinus rhythm at 24-hours; one patient had transient atrial flutter during the procedure. All procedures were successful; no additional procedures were required. Trivial residual shunts were seen in 3 patients at follow-up. There were no late events. One patient experienced arrhythmic death 5-yrs after procedure. One patient was reoperated due to dehiscence of VSD patch 2-yrs after the second successful percutaneous closure.
Transcatheter closure of postsurgical residual VSD is safe and efficacious management option and obviates the need for further surgery and by-pass.
Catheterization and Cardiovascular Interventions 09/2009; 75(2):246-55. · 2.29 Impact Factor
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ABSTRACT: To evaluate the course of migraine in migraine headache patients undergoing patent foramen ovale (PFO) transcatheter closure.
Migraine has an important impact on the quality of life, and it seems to be one of the most disabling medical illnesses. In several studies, a high prevalence of right-to-left shunt has been described in patients with migraine, especially migraine with aura. The presence of right-to-left shunt, whatever the mechanism, may be the most potent trigger of migraine attacks in both migraine with aura and migraine without aura and the main determinant of aura in migraine with aura.
A cohort of 42 patients (nine men/33 women; mean age 39 +/- 11.2 years), current migraineurs, underwent PFO percutaneous closure in our centre between January 2004 and December 2007. All patients rated the severity of their migraine preoperatively and 6 months postoperatively, indicating the frequency, duration, and intensity of the attacks and the occurrence of the aura in the prodromal phase, during the past 6 months, according to the migraine severity score.
Baseline severity of migraine was higher in migraine with aura patients than in migraine without aura ones (8.8 vs. 7.5; P = 0.037). The resolution of migraine was verified in 11 patients (26%) after the closure of the PFO. A reduction in the frequency of the attacks (>=50%) was observed in 22 patients (52%). Multiple logistic regression analysis showed that the improvement in migraine with aura and migraine without aura was independent of migraine type, sex, age, cerebrovascular risk factors and cerebrovascular events, type of cardiac defect, and thrombophilic conditions.
The consistent observations of this and other studies are provocative and worthy of evaluation with a prospective randomized trial using objective measures of migraine frequency and severity. However, it seems too early to recommend PFO closure for all patients who suffer from migraine until the results of ongoing large randomized trials are available.
Journal of Cardiovascular Medicine 06/2009; 10(5):401-5. · 1.51 Impact Factor
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Gianfranco Butera,
Enrico Romagnoli,
Mario Carminati,
Massimo Chessa, Luciane Piazza,
Diana Negura,
Alessandro Giamberti,
Raul Abella,
Giuseppe Pomè,
Claudia Condoluci,
Alessandro Frigiola
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ABSTRACT: Percutaneous closure of atrial septal defect (ASD) is a valid alternative to surgical approach. Current device has significantly improved the success rate also in complex cases. The aim of this study is to assess the impact of age, defect size, and morphologic features on successfully percutaneous ASD closure.
Between January 2000 and September 2004, 1,013 consecutive patients underwent closure of an isolated type II ASD at our institution. The following outcomes have been evaluated: (1) role of percutaneous ASD closure as alternative to surgical repair, in current daily practice; (2) impact of age on the selected closure approach; (3) analysis of morphologic variety of ASD and its effect on the closure technique; (4) possible role of specific device selection according to ASD morphology to improve procedural success.
During the study period, up to 80% of secundum ASDs were suitable for percutaneous closure with the currently available devices. Need for surgical ASD closure was more common in pediatric patients, likely reflecting the more frequent diagnosis of larger and complex defects at a young age. Accurate ADS morphology assessment and appropriate device selection are key elements to obtain procedural success. In particular, among all the ASD characteristics, the rim absence is the main limiting factor to a successful percutaneous ASD closure. A trend of reduction in peri-procedural adverse events was observed during the study period, with complications needing immediate cardiac surgery occurred only in 1% of cases.
Percutaneous ASD closure is feasible and associated with low complication rate. A thorough analysis of morphologic aspects is mandatory in order to select the appropriate device and the optimal approach. Surgical closure remains the treatment of choice in selected patients.
American heart journal 11/2008; 156(4):706-12. · 4.65 Impact Factor
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ABSTRACT: There are limited data in the literature about the use of covered stent in patients with aortic coarctation.
Between January 2004 and September 2006, we implanted covered Cheatham-Platinum stents in 33 patients with complex aortic coarctation (23 men, median age 13 years, range 6-66 years). Twenty subjects had native aortic coarctation, whereas 13 had recoarctation. All procedures were performed under general anesthesia and orotracheal intubation.
The stents used ranged from 22 to 45 mm in length. The mean fluoroscopy and procedure times were 14 +/- 6 and 74 +/- 15 minutes, respectively. After implantation, the gradient across the stenosis decreased significantly (pre stent: median value 39 mm Hg [range 20-75 mm Hg] vs post stent: median value 0 mm Hg [range 0-12 mm Hg] [P < .0001]). Vessel diameter increased from a median value of 5 mm (range 0-11) to a median value of 15 mm (range 10-25) (P < .0001). The stents were placed in the correct position in all subjects. No complications occurred, and on angiographic control, the stenoses had been relieved and the aneurysms completely excluded. During a median follow-up of 12 months (1-40 months), the results were stable without complications. One patient developed intrastent restenosis due to a significant endothelial proliferation that was successfully treated by high-pressure balloon angioplasty.
Covered Cheatham-Platinum stents are promising tools for the treatment of complex aortic coarctation.
American heart journal 10/2007; 154(4):795-800. · 4.65 Impact Factor
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ABSTRACT: We sought to analyze safety, efficacy, and follow-up results of percutaneous closure of perimembranous ventricular septal defects (pmVSD).
Results of pmVSD transcatheter closure have been reported in the literature; however, follow-up data are still limited.
Between January 1999 and June 2006, 104 patients underwent percutaneous closure of a pmVSD at our institution. An Amplatzer VSD device (muscular or eccentric) (AGA Medical Corp., Golden Valley, Minnesota) was used in all subjects.
The mean age at closure was 14 years (range 0.6 to 63 years). The attempt to place a device was successful in 100 patients (96.2%). The median device size used was 8 mm (range 4 to 16 mm). No deaths occurred. Total occlusion rate was 47% at completion of the procedure, rising to 84% at discharge and 99% during the follow-up. A total of 13 early complications occurred (11.5%), but in all but 2 subjects (1.9%) these were transient. The median follow-up was 38.5 months. The most significant complication was complete atrioventricular block (cAVB), which required pacemaker implantation in 6 subjects (5.7%; 2 in the early phase and 4 during the follow-up). Cox proportional hazards regression analysis showed that the only variable significantly associated with the occurrence of this complication was age at the time of the procedure (p = 0.028; relative risk 0.25). All subjects experiencing this problem were <6 years old.
In the current era and in experienced hands, pmVSD closure can be performed safely and successfully. The major concern is the occurrence of cAVB; therefore, very careful monitoring of rhythm is mandatory during follow-up.
Journal of the American College of Cardiology 09/2007; 50(12):1189-95. · 14.16 Impact Factor
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ABSTRACT: To compare surgical as opposed to percutaneous interventional closure of isolated atrial septal defects in the oval fossa in terms of hospital stay, efficacy, and complications, and to study the respective role of the two techniques in current practice.
Between January 1998 and April 2004, 126 out of 1210 patients treated at our institution for closure of an isolated defect in the oval fossa were aged less than 6 years. The mean age of these 126 patients at procedure was 4.2 plus or minus 1 year. The ratio of females to males was 74 to 52.
Of the patients, 62% were treated successfully using a percutaneous approach. The groups treated surgically or percutaneously did not differ for age, gender, or indications for treatment. No deaths occurred. The rates of total and major complications were higher in the group undergoing surgical closure, at 34% versus 9%, p less than 0.0001, and 10.5% versus 1%, p equal to 0.01, respectively. Embolisation of the device requiring subsequent surgery occurred in 1% of patients. The stay in hospital was shorter in those closed percutaneously, at 3.2 plus or minus 0.9 days versus 6.8 plus or minus 2.8 days, p equal to 0.0001. During a mean follow-up of 3.4 plus or minus 1.9 years, no major complications occurred in either group, and symptoms improved significantly in both groups. Additional sequels occurred in 2 patients who had major complications subsequent to surgical closure.
Even in young children, it is both feasible and safe to close defects in the oval fossa percutaneously. Compared to surgical closure, the transcatheter approach allows a shorter stay in hospital, and has a lower rate of complications. Early and mid-term follow-up has confirmed the safety and efficacy of both techniques.
Cardiology in the Young 03/2007; 17(1):35-41. · 0.76 Impact Factor
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Gianfranco Butera,
Mario Carminati,
Massimo Chessa, Luciane Piazza,
Raul Abella,
Diana Gabriella Negura,
Alessandro Giamberti,
Bussadori Claudio,
Angelo Micheletti,
Youssef Tammam,
Alessandro Frigiola
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ABSTRACT: The aim of the article is to study the safety, efficacy, and follow-up of percutaneous closure of muscular ventricular septal defect (mVSD) and perimembranous ventricular septal defect (pmVSD) in children.
Between January 2000 and June 2005, among 140 patients who underwent percutaneous closure of an mVSD or a pmVSD, 88 were aged lt;12. Two different Amplatzer devices were used: the mVSD occluder and the pmVSD occluder. Mean age and weight at procedure were 4.5+/-3.3 years and 18.7+/-11.2 kg, respectively. Percutaneous closure was successfully achieved in 83 subjects (94%). No deaths occurred. Thirteen patients (14.7%) had early complications: device embolization (n=4), vascular complications (n=3), and rhythm abnormalities (n=6). These were transient complications in all but one case [1.1% complete atrioventricular block (cAVB) needing pacemaker implantation]. During a median follow-up of 24 months, three subjects treated for a pmVSD needed pacemaker implantation due to the occurrence of cAVB. Multivariable analysis using Cox's proportional hazard regression showed that age was the only risk factor associated with the occurrence of cAVB (P=0.028; relative risk: 0.25).
Percutaneous closure of mVSD and pmVSD in children can be performed safely and successfully. The occurrence of cAVB is a major concern in young children with pmVSD.
European Heart Journal 01/2007; 27(23):2889-95. · 10.48 Impact Factor
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Circulation 12/2006; 114(20):e581-2. · 14.74 Impact Factor
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ABSTRACT: A 4-year-old child with patent ductus arteriosus, perimembranous ventricular septal defect and ostium secundum atrial septal defect was successfully treated with the use of a simultaneous transcatheter for all of the anomalies present. The patent ductus arteriosus was closed first by using a coil, then the perimembranous ventricular septal defect was closed by using a 10-mm Amplatzer eccentric device. Finally, a 10-mm Amplatzer atrial septal defect device was implanted to treat the atrial septal defect.
Journal of Cardiovascular Medicine 11/2006; 7(10):775-8. · 1.51 Impact Factor
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ABSTRACT: Isolated ventricular septal defect is the most common form of congenital heart disease. Surgery has been performed for many years and is considered the gold standard for the treatment of ventricular septal defects. However, it is associated with morbidity and mortality. Less invasive techniques have been developed and currently percutaneous closure of muscular and perimembranous ventricular septal defects has to be considered a possible alternative to the standard surgical approach.
Expert Review of Cardiovascular Therapy 10/2006; 4(5):671-80.
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ABSTRACT: To evaluate the role of covered Cheatham-Platinum stents in patients with congenital heart disease.
There are limited data in the literature about the use of covered stent in patients with congenital heart disease.
Between January 2004 and September 2005, covered Cheatham-Platinum stents were implanted into 18 patients with congenital heart defects (9 males, median age 19 years, range 8-45 years). Sixteen had aortic coarctation or recoarctation (8 with associated aneurysm, 1 with patent ductus arteriosus, 3 with an irregular wall, 4 with subatretic native aortic coarctation) (group 1). Two subjects with univentricular heart circulation were treated because of complex right-to-left shunting (Group 2).
Group 1: The stents used ranged from 34 to 45 mm in length. The mean fluoroscopy and procedure times were 12+/-8 and 70+/-15 minutes, respectively. After implantation, the gradient across the stenosis decreased significantly (prestent median value 37 mmHg) (range 20-50 mmHg) versus poststent: median value 0 mmHg (range 0-10 mmHg) (P<0.0001). Vessel diameter increased from a median value of 6 mm (range 0-11) to a median value of 14 mm (range 10-23) (P<0.0001). Stents were placed in the correct position in all subjects. No complications occurred and on angiographic control the stenoses had been relieved and the aneurysms completely excluded. Group 2: Implantation of the covered stents successfully abolished right-to-left shunting in both patients. Both had significant increases in oxygen saturation and no complications occurred. Follow-up: During a median follow-up of 7 months (1-19 months), the results were stable without any complications.
Covered Cheatham-Platinum stents are very useful tools for treating various congenital cardiovascular malformations.
Catheterization and Cardiovascular Interventions 04/2006; 67(3):466-72. · 2.29 Impact Factor
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ABSTRACT: The objective of this study is to assess the impact of interventional cardiology procedures for the management of ACHD. The interventional approach to the management of CHD in the adult population is becoming increasingly recognized as the preferred treatment option for a wide number of congenital cardiac conditions. The files of all consecutive patients over 18 years of age who were hospitalized in our department from January 2000 to December 2004 were reviewed. Over the study period, 1,115 ACHD (583 women; mean age 41 +/- 13.8, years, range 18-72 years) were hospitalized in our department; 752 patients underwent cardiac catheterization and 82.4% of them had an interventional procedure carried out. ASD (329/620) and PFO (159/620) closure account for 78% of all the procedures carried out, with a 2.7% of major complications incidence (all of them closing ASDs). Other procedures such as stenting aortic coarctation (40/620), ventricular septal defect closure (33/620), patent ductus arteriosus embolization (30/620), pulmonary valvuloplasty (12/620), stenting pulmonary artery branches (8/620), etc (5/620) were carried out. The most important complication was one death, which occurred in the case of a 22-year-old woman after stent implantation for a recurrent aortic coarctation. A trivial residual shunt was detected in only 5% of the patients who had a 6-month follow-up after VSD closure; no residual shunt was found after PDA embolization during the 12-month follow-up. In conclusion, we believe that the interventional approach is a safe and successful treatment option for a wide number of congenital cardiac conditions. The increasing use of catheter interventions for these patients will be responsible for an increase of complex cases in surgery.
Catheterization and Cardiovascular Interventions 03/2006; 67(2):258-64. · 2.29 Impact Factor
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ABSTRACT: This study reports on experience with transcatheter closure of congenital ventricular septal defects (VSDs) with Amplatzer septal occluders. From January 2000 to April 2005, transcatheter Amplatzer device implantation was attempted in 122 patients with congenital VSD (30 with muscular, 87 with perimembranous, and 5 with residual postsurgical repair of conotruncal malformations). Patient mean age was 15 years (range, 6 months to 64 years), and mean weight was 35 kg (range, 5.8 to 102 kg). The VSD mean size was 7 mm (range, 4 to 16 mm), mean Qp/Qs was 2.1 (range, 1.3 to 4), and mean fluoroscopy time was 32 minutes (range, 5 to 129 minutes). All procedures were performed with the patient under general anesthesia and guided by fluoroscopy and transesophageal echocardiography. The device size chosen was usually 1- to 2-mm larger than the maximum defect size as assessed by either the echocardiographic or angiographic views that were judged most reliable. Amplatzer muscular devices were placed in 47 patients, and the membranous devices were placed in 72 patients. The procedure was not performed in 3 patients with perimembranous VSD because of the impossibility of achieving an adequate long sheath position in 1 patient, onset of complete atrioventricular (AV) block during catheter manipulation in 1 patient, and the presence of aortic valve prolapse preventing a safe device placement in 1 patient. Satisfactory device implantation was achieved in 119 of 122 patients (97.5%): a tiny smoke-like residual flow through the device was often seen immediately after the procedure (50%); residual shunting was detectable in 19% after 24 hours and in only 4% at 6 months. The following additional catheter interventions were performed simultaneously: balloon pulmonary valvuloplasty in 3 patients, device closure of atrial septal defects in 2 patients, coil occlusion of the arterial duct in 1 patient, stenting coarctation in 1 patient, and stenting of the right pulmonary artery in 1 patient. Minimal aortic regurgitation developed in 3 patients, and minimal tricuspid regurgitation in 3 patients; no patient required additional treatment. Device embolization occurred in 3 patients (1 patient with muscular VSD, 2 with perimembranous VSD); catheter retrieval and implantation of a second device was successfully performed in all patients. Transient left bundle branch block occurred in 2 patients, and transient first-degree AV block in 1 patient. Among the perimembranous VSD cases, complete AV block occurred acutely (within 48 hours) in 3 patients, requiring a pacemaker in 1 patient; complete heart block occurred in the other 2 patients after 5 and 12 months, requiring pacemakers. There was no mortality. Transcatheter closure of muscular and perimembranous VSDs offers encouraging results: 96% complete closure at midterm follow-up. Complications are limited; the most relevant appears to be device-related complete heart block in perimembranous VSD. Greater experience and long-term follow-up are required to assess the safety and effectiveness of this procedure as an alternative to conventional surgery.
The American Journal of Cardiology 01/2006; 96(12A):52L-58L. · 3.37 Impact Factor
