Retiro de dispositivo de oclusión septal transcateterismo en una paciente con comunicación interventricular / Removal of Transcatheter Septal Occlusion Device in a Patient with Ventricular Septal Defect

Introducción: Las complicaciones asociadas al procedimiento de colocación de un dispositivo de oclusión septal se presentan en menos del 10 por ciento de los casos. La embolización requiere de cirugía cardíaca, por lo que se incrementa el riesgo de la mortalidad. Objetivo: Presentar el caso en una paciente con comunicación interventricular e hipertensión pulmonar severa que se le retiró el dispositivo de oclusión septal transcateterismo. Presentación de caso: Se presentó una mujer de 24 años de edad con comunicación interventricular, insuficiencia cardíaca (New York Heart Association) clase IV e hipertensión pulmonar tipo 2, que se programó para la colocación de dispositivo de oclusión septal, sin embargo, presentó fallo en la colocación del dispositivo y defecto residual de 7 mm, por lo que se realizó el retiro de este 48 h después sin presentar complicaciones. Conclusiones: Aunque el cierre transcateterismo de la comunicación interventricular es una alternativa segura y efectiva a la cirugía, no está exento de complicaciones. En caso de translocación del dispositivo de oclusión septal este debe ser retirado durante el mismo procedimiento, ya que el riesgo de embolización es elevado y en caso de presentarse, el riesgo de muerte se incrementa(AU)

Introduction: Complications associated with the placement procedure of a septal occlusion device occur in less than 10percent of cases. Embolization requires cardiac surgery, which increases the risk of mortality. Objective: To report the case of a patient with ventricular septal defect and severe pulmonary hypertension who had the transcatheter septal occlusion device removed. Case report: We report the case report of a 24-year-old woman with ventricular septal defect, heart failure (New York Heart Association) class IV and type 2 pulmonary hypertension. She was scheduled for placement of a septal occlusion device, however, the placement of the device failed and had a residual defect of 7 mm, so the placement was removed 48 hours later without complications. Conclusions: Although transcatheter closure of the ventricular septal defect is a safe and effective alternative to surgery, it is not free of complications. In case of translocation of the septal occlusion device, it must be removed during the same procedure, since the risk of embolization is high and if it occurs, the risk of death increases(AU)

Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial / 中华医学杂志(英文版)

BACKGROUND@#Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD).@*METHODS@#One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.@*RESULTS@#At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P  0.05).@*CONCLUSIONS@#The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.

Comparison of postoperative changes in inflammatory marker levels between transthoracic and transcatheter device closures of atrial septal defects in children

Abstract Objective: To explore the postoperative changes in inflammatory markers in children who underwent device closure of an atrial septal defect (ASD) via a transthoracic or transcatheter approach. Methods: The experimental and clinical data were retrospectively collected and analyzed for a total of 53 pediatric patients between September 2018 and December 2018. According to the different treatments, 19 patients who underwent transthoracic device closure were assigned to group A, and the remaining 34 patients who underwent a transcatheter approach were assigned to group B. Results: All patients were successfully occluded without any device-related severe complication. Compared with the preoperative levels, the postoperative levels of most inflammatory cytokines in both groups were significantly increased and reached a peak on the first day after the procedure. The level of postoperative inflammatory cytokines was significantly lower in group B than in group A. In addition, there was no significant difference in procalcitonin before and after the transcatheter approach. Conclusion: Systemic inflammatory reactions occurred after transthoracic or transcatheter device closure of ASDs in pediatric patients. However, these inflammatory reactions were more significant in patients who underwent a transthoracic approach than in patients who underwent a transcatheter approach.

Endocarditis tardía en un portador de un Amplatzer: Manejo conservador en un paciente pediátrico / Late onset endocarditis in Amplatzer carrier: Conservative management in a pediatric patient

Desde su aparición, las técnicas percutáneas han ido sustituyendo la cirugía convencional como tratamiento de primera línea en los defectos septales interauriculares. Los dispositivos Amplatzer fueron los primeros aprobados por la Food and Drug Administration, y su colocación se ha convertido en un procedimiento habitual en cardiología pediátrica. La aparición de endocarditis bacteriana sobre este tipo de dispositivos es muy infrecuente. Se presenta el caso de una endocarditis bacteriana en un paciente pediátrico portador de un dispositivo Amplatzer, que se manejó de forma conservadora con antibioterapia intravenosa, con evolución satisfactoria.

Since their introduction, percutaneous techniques have been replacing conventional surgery as a first-line treatment for septal defects. Amplatzer devices were the first to be approved by the Food and Drug Administration, and their placement has become a standard procedure in pediatric cardiology. Bacterial endocarditis of intracardiac devices such as the Amplatzer septal occluder is very infrequent. We report a case of bacterial endocarditis in a pediatric patient with an Amplatzer device, who developed an infectious endocarditis six years after its placement and received conservative management with intravenous antibiotics, with satisfactory evolution.

Anterior minithoracotomy: a safe approach for surgical asd closure & asd device retrieval

Abstract Objective: Midline sternotomy is the preferred approach for device migration following transcatheter device closure of ostium secundum atrial septal defect. Results of patients operated for device migration were retrospectively reviewed after transcatheter closure of atrial septal defect. Methods: Among the 643 patients who underwent atrial septal defect with closure device, 15 (2.3%) patients were referred for device retrieval and surgical closure of atrial septal defect. Twelve patients underwent device retrieval and surgical closure of atrial septal defect through right antero-lateral minithoracotomy with femoral cannulation. Three patients were operated through midline sternotomy. Results: Twelve patients operated through minithoracotomy did not require conversion to sternotomy. Due to device migration to site of difficult access through thoracotomy, cardiac tamponade and hemodynamic instability, respectively, three patients were operated through midline sternotomy. Mean aortic cross-clamp time and cardiopulmonary bypass time were 28.1±17.7 and 58.3±20.4 minutes, respectively. No patient had surgical complication or mortality. Mean intensive care unit and hospital stay were 1.6±0.5 days and 7.1±2.2 days, respectively. Postoperative echocardiography confirmed absence of any residual defect and ventricular dysfunction. In a mean follow-up period of six months, no mortality was observed. All patients were in New York Heart Association class I without wound or vascular complication. Conclusion: Minithoracotomy with femoral cannulation for cardiopulmonary bypass is a safe-approach for selected group of patients with device migration following transcatheter device closure of atrial septal defect without increasing the risk of cardiac, vascular or neurological complications and with good cosmetic and surgical results.

Erosión muy tardía de la aurícula derecha con dispositivo Amplatzer®; reporte de un caso / Very late erosion of the right atrium with Amplatzer® device

Resumen La erosión tardía de la pared auricular y de la aorta es una causa infrecuente, pero potencialmente mortal en los pacientes que han sido sometidos al cierre percutáneo de un defecto del septum auricular, en especial cuando existe una alta relación entre el tamaño del dispositivo escogido con el tamaño del defecto y la presencia de bordes insuficientes. Presentamos el caso de un hombre de 70 años con un episodio de colapso hemodinámico secundario a taponamiento cardiaco debido a erosión muy tardía de la aurícula derecha por un Amplatzer® implantado 4 años atrás para el cierre de un defecto septal auricular. Conclusión La erosión tardía de los dispositivos de cierre percutáneo para los defectos atriales, aunque infrecuente, deberá ser tenida en cuenta en los pacientes que presentan colapso hemodinámico.

Abstract Late atrial wall and aorta erosion is a rare cause of potential fatallity in patients who have undergone percutaneous closure of an atrial septal defect, especially when a high ratio device to defect is chosen, and an insufficient aortic rim is present. We report the case of a 70 year old male with an episode of hemodinamic collapse secondary to cardiac tamponade due to a late erosion of a 4 years ago implanted Amplatzer® used to close an atrial septal defect. Conclusion Very late wall erosion of an atrial septal closure device, although uncommon, should be suspected in patients presenting with hemodynamic collapse.

Comparison of Outcomes after Device Closure and Medication Alone in Patients with Patent Foramen Ovale and Cryptogenic Stroke in Korean Population

PURPOSE: To compare the effectiveness of device closure and medical therapy in prevention of recurrent embolic event in the Korean population with cryptogenic stroke and patent foramen ovale (PFO). MATERIALS AND METHODS: Consecutive 164 patients (men: 126 patients, mean age: 48.1 years, closure group: 72 patients, medical group: 92 patients) were enrolled. The primary end point was a composite of death, stroke, transient ischemic attack (TIA), or peripheral embolism. RESULTS: Baseline characteristics were similar in the two groups, except age, which was higher in the medical group (45.3±9.8 vs. 50.2±6.1, p<0.0001), and risk of paradoxical embolism score, which was higher in the closure group (6.2±1.6 vs. 5.7±1.3, p=0.026). On echocardiography, large right-to-left shunt (81.9% vs. 63.0%, p=0.009) and shunt at rest/septal hypermobility (61.1% vs. 23.9%, p<0.0001) were more common in the closure group. The device was successfully implanted in 71 (98.6%) patients. The primary end point occurred in 2 patients (2 TIA, 2.8%) in the closure group and in 2 (1 death, 1 stroke, 2.2%) in the medical group. Event-free survival rate did not differ between the two groups. CONCLUSION: Compared to medical therapy, device closure of PFO in patients with cryptogenic stroke did not show difference in reduction of recurrent embolic events in the real world's setting. However, considering high risk of echocardiographic findings in the closure group, further investigation of the role of PFO closure in the Asian population is needed.

complication following the transcatheter closure of a muscular ventricular septal defect

Today, congenital heart diseases may be treated without surgery through advances in interventional cardiology. However, complications such as infection and thrombus formation may develop due to foreign materials used during these procedures. Surgical intervention may be required for the removal of the device utilized for the procedure. In this case report, we present the surgical treatment of a residual ventricular septal defect [VSD] that had developed in a 6-year-old patient with an apical muscular VSD closed with the Amplatzer muscular VSD device. The patient was admitted to the emergency room with complaints of abdominal pain and high fever 5 days after discharge without any cardiac symptoms. When she arrived at our clinic, she had a heart rate of 95 bpm, blood pressure of 110/70 mmHg, and temperature of 38.5 [degree]C. Examinations of the other systems were normal, except for a 3/6 pan-systolic murmur at the mesocardiac focus on cardiac auscultation. Echocardiography showed a residual VSD, and the total pulmonary blood flow to the total systemic blood flow ratio [Qp/Qs] of the residual VSD was 1.8. In the operating room, the Amplatzer device was removed easily with a blunt dissection. The VSD was closed with an autologous fresh pericardial patch. Following the pulmonary artery debanding procedure, the postoperative period was uneventful. The condition of the patient at the time of discharge and in the first postoperative month's follow-up was good. There was no residual VSD or infection

Percutaneous Retrieval of Embolized Amplatzer Septal Occluder after Treatment of Double Atrial Septal Defect: A Case Report

Embolization of the occlusion device after percutaneous closure of atrial septal defect (ASD) is a potential disastrous complication. The usual site of embolization is the right side of the heart including pulmonary artery, but the device embolization to the extracardiac aorta is extremely rare. Here, we report a successful percutaneous retrieval case of the embolized Amplatzer Septal Occluder (ASO) to the descending thoracic aorta after the successful deployment of two ASO devices in a patient with double ASD. Competition between the two devices to obtain a stable position may be an explanation for the migration of ASO.

Oclusão percutânea da persistência do ducto arterioso / Percutaneous occlusion of patent ductus arteriosus

Introdução: A persistência do ducto arterioso é uma condição congênita de alta morbidade, especialmente em recém-nascidos prematuros de extremo baixo peso, representando 5 a 10% das cardiopatias congênitas. Nosso objetivo foi descrever as abordagens realizadas em hospital de referência para o tratamento da persistência do ducto arterioso com o método percutâneo de oclusão. Métodos: Foi realizado estudo retrospectivo do tratamento transcateter da persistência do ducto arterioso no período de abril de 2008 a abril de 2010. Resultados: Foram revisados 47 casos, a maioria (78,8%) tratada com molas Flipper®; os demais tratados com a prótese Amplatzer®. A configuração morfológica ductal foi do tipo A de Krichenko em 89,4% (34 no grupo molas Flipper® e 8 no grupo Amplatzer®), tipo D em 6,4% (2 no grupo molas Flipper® e 1 no grupo Amplatzer®) e tipo E em 4,2% (1 em cada grupo) dos pacientes. Os diâmetros mínimos pré-cateterismo foram de 2,6 ± 0,8 mm e 3,8 ± 1,6 mm para os grupos de molas Flipper® e Amplatzer®, respectivamente. Obteve-se oclusão imediata total do defeito na angiografia de controle em 72,3% dos pacientes tratados. Sete pacientes tratados com molas Flipper® receberam molas adicionais e os tratados com prótese Amplatzer® mostraram apenas shunts residuais mínimos em dois casos. Não ocorreram complicações do procedimento. No acompanhamento após a alta, um paciente permaneceu com mínimo shunt residual à ecografia, 45 dias após o cateterismo. Conclusões: A oclusão da persistência do ducto arterioso por método percutâneo tem-se mostrado segura e efetiva na maioria dos casos...

Background: Patent ductus arteriosus is a congenital condition with high morbidity, especially in preterm infants of extremely low birth weight, representing 5% to 10% of congenital heart diseases. Our objective was to describe the approaches used at a reference hospital for the percutaneous occlusion of PDA. Methods: We conducted a retrospective study on the transcatheter treatment of patent ductus arteriosus from April of 2008 to April of 2010. Results: Forty-seven cases were reviewed and most of them (78.8%) were treated with FlipperTM coils while the remaining patients received the AmplatzerTM device. Ductal morphological configuration was Krichenko type A in 89.4% (34 in the FlipperTM coil group and 8 in the AmplatzerTM group), type D in 6.4% (2 in the FlipperTM coil group and 1 in the AmplatzerTM group) and type E in 4.2% (1 in each group) of patients. Pre-catheterization minimum diameters were 2.6 ± 0.8 mm and 3.8 ± 1.6 mm for the FlipperTM coil and AmplatzerTM groups, respectively. Immediate total occlusion of the defect was obtained in the control angiography in 72.3% of the patients. Seven patients treated with the FlipperTM coil received additional coils and two patients treated with the AmplatzerTM device presented minimal residual shunts. There were no procedure-related complications. In the follow-up after hospital discharge, one patient presented minimal residual shunt at the echography, 45 days after catheterization. Conclusions: Percutaneous patent ductus arteriosus occlusion has proven to be safe and effective in most cases...

Outcome of Transcatheter Closure of Oval Shaped Atrial Septal Defect with Amplatzer Septal Occluder

PURPOSE: For the successful completion of transcatheter closure of atrial septal defects with the Amplatzer septal occluder, shape of the defects should be considered prior to selecting the device. The purpose of this study is to evaluate the results of a transcatheter closure of oval shaped atrial septal defect. MATERIALS AND METHODS: From November 2009 until November 2011, cardiac computed tomography was performed on 69 patients who needed a transcatheter closure of atrial septal defect. We defined an oval shaped atrial septal defect as the ratio of the shortest diameter to the longest diameter 0.05). The differences between the device size to the longest diameter of the defect and the ratios of the device size to the longest diameter were significantly smaller in the ovoid group (1.8+/-2.8 vs. 3.7+/-2.6 and 1.1+/-0.1 vs. 1.2+/-0.2). CONCLUSION: Transcatheter closure of an oval shaped atrial septal defect was found to be safe with the smaller Amplatzer septal occluder device when compared with circular atrial septal defects.

Oclusão do apêndice atrial esquerdo com o Amplatzer Cardiac Plug em pacientes com fibrilação atrial / Left atrial appendage closure with the Amplatzer Cardiac Plug in patients with atrial fibrillation

FUNDAMENTO: A oclusão percutânea do apêndice atrial esquerdo (OAAE) surgiu como alternativa à anticoagulação oral (AO) para prevenção do acidente vascular cerebral (AVC) em pacientes com fibrilação atrial não-valvular (FANV). OBJETIVO: Relatar os resultados imediatos e o seguimento clínico de pacientes submetidos a OAAE com o Amplatzer Cardiac Plug (ACP) em um único centro de referência. MÉTODOS: Oitenta e seis pacientes consecutivos com FANV, contra-indicação à AO e escore CHADS2= 2,6±1,2 foram submetidos a OAAE com implante de ACP. Realizou-se seguimento clínico e ecocardiográfico no mínimo 4 meses após o implante. RESULTADOS: Todos os implantes foram guiados apenas por angiografia. O sucesso do procedimento foi de 99% (1 insucesso por tamponamento cardíaco e consequente suspensão da OAAE). Houve 4 complicações maiores (o tamponamento já referido, 2 AVCs transitórios e uma embolização com retirada percutânea da prótese) e duas menores (um derrame pericárdico sem tamponamento e uma pequena comunicação interatrial evidenciada no seguimento). Houve 1 óbito hospitalar após 6 dias, não relacionado à intervenção. Todos os outros pacientes receberam alta sem AO. Após seguimento de 25,9 pacientes-ano (69 pacientes) não houve AVCs nem embolizações tardias de próteses. O AAE estava completamente ocluído em 97% dos casos. Seis pacientes apresentaram evidência de trombo sobre a prótese, que desapareceram após reinstituição de AO por 3 meses. CONCLUSÃO: OAAE se associa a um alto índice de sucesso, um índice aceitável de complicações e resultados promissores a médio prazo, podendo ser considerada uma alternativa válida à OA na prevenção do AVC em pacientes com FANV.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OA) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation (NVAF). OBJECTIVE: To describe the immediate results and short- to medium-term clinical follow-up (FU) of patients that underwent LAAC with Amplatzer Cardiac Plug (ACP) implantation in a single reference center. METHODS: Eighty-six consecutive patients with NVAF, contraindication to OA, and CHADS2 score=2.6±1.2 underwent LAAC with ACP implantation. Clinical and echocardiographic FU was performed at least four months after the procedure. RESULTS: All implants were guided by angiography alone. Procedural success was 99% (one patient suffered a cardiac tamponade requiring pericardiocentesis, and the procedure was waived). There were four major complications (the already mentioned cardiac tamponade, two transient ischemic attacks and one device embolization with percutaneous retrieval) and two minor complications (one pericardial effusion without clinical significance and one non-significant ASD evidenced at FU). There was one in-hospital death after six days, unrelated to the procedure. All other patients were discharged without OA. After 25.9 patient-years of FU (69 patients), there were no strokes and no late device embolization. The LAA was completely closed in 97% of the cases. Six patients showed evidence of thrombus formation on the device, which resolved after three months of OA. CONCLUSION: LAAC is associated with high success, acceptable complication rates, and promising FU results, and may be considered a valuable alternative or complement to OA for stroke prevention in patients with NVAF.

Oclusão percutânea do apêndice atrial esquerdo com o Amplatzer Cardiac PlugTM na fibrilação atrial / Percutaneous occlusion of left atrial appendage with the Amplatzer Cardiac PlugTM in atrial fibrillation

Fundamento: A fibrilação atrial está associada a acidentes vasculares embólicos que frequentemente resultam em morte ou invalidez. Eficaz na redução desses eventos, a anticoagulação possui várias limitações e vem sendo amplamente subutilizada. Mais de 90 por cento dos trombos identificados nos portadores de fibrilação atrial sem doença valvar se originam no apêndice atrial esquerdo, cuja oclusão é investigada como uma alternativa à anticoagulação. Objetivo: Determinar a viabilidade da oclusão percutânea do apêndice atrial esquerdo em pacientes com alto risco de eventos embólicos e limitações ao uso de anticoagulação. Métodos: Relatamos a experiência inicial com o Amplatzer Cardiac PlugTM (St. Jude Medical Inc., Saint Paul, Estados Unidos) em pacientes com fibrilação atrial não valvar. Foram selecionados pacientes com alto risco de tromboembolia, sangramentos maiores e contraindicações ao uso ou grande labilidade na resposta ao anticoagulante. Os procedimentos foram realizados por via percutânea, sob anestesia geral e com ecocardiografia transesofágica. O desfecho primário foi a presença de complicações periprocedimento e o seguimento programado incluiu reavaliação clínica e ecocardiográfica em 30 dias e por contato telefônico após nove meses. Resultados: Nos cinco pacientes selecionados se conseguiu a oclusão do apêndice atrial esquerdo sem complicações periprocedimento. Não houve eventos clínicos no seguimento. Conclusão: Ensaios clínicos controlados são necessários antes que o fechamento percutâneo do apêndice atrial esquerdo constitua uma alternativa à anticoagulação na fibrilação atrial não associada a doença valvar. Mas o dispositivo se mostrou promissor em pacientes com alto risco de embolia e restrições ao uso de anticoagulantes.

Background: Atrial fibrillation is associated with embolic strokes that often result in death or disability. Effective in reducing these events, anticoagulation has several limitations and has been widely underutilized. Over 90 percent of thrombi identified in patients with atrial fibrillation without valvular disease originate in the left atrial appendage, whose occlusion is investigated as an alternative to anticoagulation. Objective: To determine the feasibility of percutaneous occlusion of the left atrial appendage in patients at high risk of embolic events and limitations to the use of anticoagulation. Methods: We report our initial experience with Amplatzer Cardiac PlugTM (St. Jude Medical Inc., Saint Paul, Estados Unidos) in patients with nonvalvular atrial fibrillation. We selected patients at high risk of thromboembolism, major bleeding, contraindications to the use or major instability in response to the anticoagulant. The procedures were performed percutaneously under general anesthesia and transesophageal echocardiography. The primary outcome was the presence of periprocedural complications and follow-up program included clinical and echocardiographic review within 30 days and by telephone contact after nine months. Results: In five selected patients it was possible to occlude the left atrial appendage without periprocedural complications. There were no clinical events in follow-up. Conclusion: Controlled clinical trials are needed before percutaneous closure of the left atrial appendage should be considered an alternative to anticoagulation in nonvalvular atrial fibrillation. But the device has shown to be promissory in patients at high risk of embolism and restrictions on the use of anticoagulants.

Intermediate and long term outcome of patients after device closure of ASD with special reference to complications

Device closure of Secundum atrial septal defect [ASD] is an accepted mode of treatment in selected patients with a suitable defect. The major initial concern over the long term outcome has been erosions and more recently development of aortic regurgitation. Objective was to assess the intermediate and long term outcome of patients with device closure of ASD with special reference to complications. Two hundred and four patients with significant Secundum ASD, 16 months to 55 years [median 8 years] were considered for transcatheter closure with the Amplatzer septal occluder from October 1999 to April 2009 with follow up examinations at 1, 3, 6, and 12 months and thereafter at yearly interval. Device closure of ASD was done successfully in 202/204 patients. The immediate [first 24-hour] major complications included device embolization [n=4], pericardial effusion [n=1] and 2:1 heart block [n=1]. At a mean follow up of 4.9 years [90 days to 9.6 years, median 5.3 years] complete closure was documented in all patients. Two patients [1%] had developed mild aortic regurgitation. A trial fibrillation occurred in 3 adult patients [1.5%] at a mean of 2 weeks post procedure with complete recovery within 6 months. There were no late embolizations, erosions or thromboembolic events on long term follow up. Device closure of secundum ASD using Amplatzer septal occluder is safe and effective in intermediate and long term follow up with extremely low mortality rate. The risk of development of aortic regurgitation or atrial fibrillation is also very low