The Amplatzer® Membranous VSD Occluder and the vulnerability of the atrioventricular conduction system

AbstractTranscatheter closure of ventricular septal defects with the Amplatzer® Membranous VSD Occluder has yielded promising initial results, but disturbances of conduction, including complete heart block, have been reported. We report our experience with the Amplatzer occluder in 35 patients with a median age 4.5 years, the defects being sized angiographically at 4.4 plus or minus 1.1 millimetres, with a range from 3 to 8 millimetres, and the size of the occluder varying from 4 to 12 millimetres. Over a median follow-up of 2.5 years, the rate of complete closure was 87% and 91%, at 1 and 2 years respectively, while 2 patients required surgical closure of the defect subsequent to the insertion of the device. Persistent regurgitation across the tricuspid valve related to the occluder was observed in 3 patients, and in 6 patients across the aortic valve. Abnormalities of conduction related to the procedure were noted in 7 patients, one-fifth of the cohort. The disturbances were transient in 1 patient, but permanent in 6, in one of the latter progressing after 6 months from left bundle branch block to intermittent Mobitz II second-degree atrioventricular block in association with expansion of the occluder. We conclude that transcatheter closure of perimembranous ventricular septal defects with the Amplatzer occluder is effective with limited complications, but the incidence of immediate and progressive disturbances of conduction related to the proximity of conduction tissues to the rims of the occluder stress the importance of larger and longer studies to assess the safety of this procedure.

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Transcatheter closure of perimembranous and muscular ventricular septal defects: short and medium-term outcome

Journal of Clinical Medicine- Hue Central Hospital ◽

10.38103/jcmhch.2020.62.1 ◽

2020 ◽

Author(s):

Anh Binh Ho

Keyword(s):

Success Rate ◽

Transcatheter Closure ◽

Central Hospital ◽

Ventricular Septal Defects ◽

Medium Term ◽

Term Outcome ◽

Surgical Closure ◽

Septal Defects ◽

First Choice

Transcatheter closure of perimembranous and muscular ventricular septal defects: short and medium-term outcome ABSTRACT Objective: This study attempted to report the initial results: the safety and efficacy of transcatheter closure of ventricular septal defects (VSDs) at Hue Central Hospital with the short and medium-term follow-up. Methods: From September 2012 to May 2017, a total of 36 patients with perimembranous or muscular VSD underwent an attempt of transcatheter closure at the Department of Interventional Cardiology, Hue Central Hospital. Results: 14 males and 26 females participated in this study, with the age of 17,29  13.72 and 24.23  12.32 respectively. Among these patients, 19.44% of them were under 6-year-old; 72.22% had perimembranous VSDs, 27.78% had muscular VSDs, and 33.33% had aneurysm. The distance to AV was 5.62 ± 4.32 mm. The device size was 15.31± 8.12 mm. Procedures lasted for 57.17 ± 26.5 min with 15.31± 8.12 min of exposure. The complete closure rates by transthoracic echocardiography after 24 hours, 1 month, 3 months and 6 months (transthoracic) were 94.44%; 94.44% ; 97.22% and 100%, respectively. Mean time of follow-up was 11.92 ± 8.36 (3-38) months. Success rate was 97.22% and no death occurred. There was 1 case of hematuria, lasting 1 month; no Atrioventricular (AV) block. Conclusions: Transcatheter closure of VSDs is a novel, feasible and safe technique with high success rate (97.22%). The transcather approach provides a less invasive alternative than surgical closure and might become the first choice treatment in selected patients. Key words: transcatheter closure, ventricular septal defects

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Transcatheter closure of perimembranous ventricular septal defects with Amplatzer occluder assessed by real-time three-dimensional echocardiography

European Journal of Echocardiography ◽

10.1016/j.euje.2006.02.008 ◽

2007 ◽

Vol 8 (2) ◽

pp. 110-115 ◽

Cited By ~ 26

Author(s):

P ACAR ◽

S ABADIR ◽

Y AGGOUN

Keyword(s):

Real Time ◽

Transcatheter Closure ◽

Three Dimensional ◽

Ventricular Septal Defects ◽

Septal Defects ◽

Amplatzer Occluder ◽

Dimensional Echocardiography ◽

Three Dimensional Echocardiography

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Transcatheter closure of perimembranous ventricular septal defects with the Amplatzer Vascular Plug-II

Cardiology in the Young ◽

10.1017/s1047951115002206 ◽

2015 ◽

Vol 26 (6) ◽

pp. 1194-1201 ◽

Cited By ~ 7

Author(s):

Nancy Hua ◽

Paolo Aquino ◽

Carl Y. Owada

Keyword(s):

Transcatheter Closure ◽

Left Ventricular ◽

Defect Size ◽

Amplatzer Vascular Plug ◽

Ventricular Septal Defects ◽

Vascular Plug ◽

Effective Treatment Option ◽

Septal Defects ◽

Amplatzer Vascular Plug Ii

AbstractObjectiveThe aim of this study was to evaluate the safety and efficacy of the Amplatzer Vascular Plug-II used for the closure of perimembranous ventricular septal defects.BackgroundThere are no FDA-approved transcatheter devices for the closure of perimembranous ventricular septal defects. Several studies have reported on the use of various devices either off-label or under clinical trial protocols. However these reports have described significant adverse events including residual shunts, complete heart block, arrhythmia, and new valve regurgitations. Thus far, no study on the Amplatzer Vascular Plug-II has been reported.MethodsWe conducted a 4-year retrospective chart review from August, 2010 to August, 2014, of patients with perimembranous ventricular septal defects associated with ventricular septal aneurysm who underwent transcatheter closure using the Amplatzer Vascular Plug-II.ResultsA total of 16 patients underwent Amplatzer Vascular Plug-II transcatheter closure of their perimembranous ventricular septal defects. The median age was 2.56 years (range: 0.5–27.3). Their median weight was 13.0 kg (range: 6.9–71.6). The left ventricular median defect size was 9.3 mm (range: 5.9–14.4). The right ventricular median defect size was 3.6 mm (range: 2.3–5.8). All the patients underwent successful device implantation with 83% of the patients having complete echocardiographic closure at the 1-year follow-up; however, one procedure was complicated by early device embolisation. The device was successfully retrieved and replaced with a larger device. There were no device-related outflow tract obstructions, rhythm abnormalities, or haemolysis.ConclusionApplication of the Amplatzer Vascular Plug-II for closure of perimembranous ventricular septal defects appears to be a safe and effective treatment option. Prospective clinical trials and longer follow-up periods are warranted.

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Transcatheter closure of single muscular ventricular septal defects using the Amplatzer muscular VSD occluder: Initial results and technical considerations

Catheterization and Cardiovascular Interventions ◽

10.1002/(sici)1522-726x(200002)49:2<167::aid-ccd11>3.0.co;2-s ◽

2000 ◽

Vol 49 (2) ◽

pp. 167-172 ◽

Cited By ~ 101

Author(s):

Ziyad M. Hijazi ◽

Fakhri Hakim ◽

Fadel Al-Fadley ◽

Jasim Abdelhamid ◽

Qi-Ling Cao

Keyword(s):

Transcatheter Closure ◽

Ventricular Septal Defects ◽

Septal Defects ◽

Initial Results ◽

Muscular Vsd ◽

Technical Considerations

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Spontaneous Resolution of Residual Shunting in 2 Compromised Patients after Amplatzer Occlusion of Postinfarction Ventricular Septal Defects

Texas Heart Institute Journal ◽

10.14503/thij-17-6416 ◽

2019 ◽

Vol 46 (1) ◽

pp. 44-47

Author(s):

Takashi Yanagiuchi ◽

Norio Tada ◽

Taro Suchi ◽

Yukiko Mizutani ◽

Takashi Matsumoto ◽

...

Keyword(s):

Heart Failure ◽

Septal Defect ◽

Transcatheter Closure ◽

Severe Heart Failure ◽

Effective Management ◽

Ventricular Septal Defects ◽

Surgical Closure ◽

Septal Defects ◽

Gradual Disappearance ◽

Intensively Managed

Ventricular septal defect (VSD) is a rare, potentially fatal complication of acute myocardial infarction. When surgical closure is contraindicated, transcatheter closure may be an alternative. Residual shunting after transcatheter closure of postinfarction VSDs has been reported; however, we found few cases of this in patients who also had severe heart failure or hemolysis. We report 2 closures of postinfarction VSDs with use of the Amplatzer Septal Occluder. Both elderly patients—one with severe heart failure, one with persistent hemolysis, and neither a surgical candidate—had high-velocity residual shunting through the occluders. We intensively managed the patients' conditions and used angiography and transthoracic echocardiography to record the gradual disappearance of each shunt over 4 months—the first such serial monitoring of which we are aware. We think that even substantial shunting in the presence of severe heart failure or hemolysis can eventually resolve spontaneously, assuming effective management of the concomitant medical conditions.

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Transcatheter closure of doubly committed subarterial ventricular septal defects with the Amplatzer ductal occluder: initial experience

Cardiology in the Young ◽

10.1017/s104795111900009x ◽

2019 ◽

Vol 29 (5) ◽

pp. 570-575

Author(s):

Yu Huang ◽

Xiaoping Yan ◽

Linxiang Lu ◽

Jun Fang ◽

Xudong Sun ◽

...

Keyword(s):

Hospital Stay ◽

Aortic Regurgitation ◽

Transcatheter Closure ◽

Ventricular Septal Defects ◽

Residual Shunt ◽

Septal Defects ◽

Device Implantation ◽

Limited Experience ◽

New Onset

AbstractBackground:There is limited experience about transcatheter closure of doubly committed subarterial ventricular septal defects with Amplatzer ductal occluder.Methods:Between March, 2015 and July, 2017, a total of 22 patients with doubly committed subarterial ventricular septal defects received transcatheter closure using Amplatzer ductal occluder and underwent clinical follow-up for at least 6 months.Results:Device implantation was finally successful in 21 (95.4%) patients despite failed occlusion in one patient and intra-procedural replacement of unsuitable occluders in four (19.0%) patients. In mean 12.3 months of follow-up, there were no major complications (death, aortic valve or sinus rupture, device dislocation or embolisation, grade 2 new-onset aortic regurgitation, etc.), resulting in clinical occlusion success of 95.4%. Mechanical haemolysis occurred in one patient and resolved with medication. Residual shunt was observed in 11 (52.4%) patients (9 mild, 2 moderate-severe) post-procedurally, 14 (66.7%) patients (12 mild, 2 moderate-severe) in hospital stay, and 2 (9.5%) patients (2 mild, 0 moderate-severe) at the last follow-up. Device-induced new-onset aortic regurgitation was found in nine (42.8%) patients (9 mild, 0 moderate-severe) post-procedurally and in hospital stay, which was resolved in two (9.5%) patients and unchanged in seven (33.3%) patients at the last follow-up. Another four (19.0%) patients newly developed mild aortic regurgitation during follow-up.Conclusions:Transcatheter closure of doubly committed subarterial ventricular septal defects with Amplatzer ductal occluder is technically feasible in the selected patients. However, further study is needed to confirm its long-term clinical outcomes.

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The Feasibility and Safety of Interventional Occlusion Treatment of Intracristal Ventricular Septal Defects: Clinical Report of 56 Cases

Cardiology ◽

10.1159/000464319 ◽

2017 ◽

Vol 137 (4) ◽

pp. 218-224 ◽

Cited By ~ 2

Author(s):

Ting Cui ◽

Wanfeng Sun ◽

Yanhong He ◽

Guopei Zhang ◽

Dajie Wang ◽

...

Keyword(s):

Septal Defect ◽

Clinical Report ◽

Valve Regurgitation ◽

Ventricular Septal Defects ◽

Residual Shunt ◽

Bundle Branch Block ◽

Severe Aortic Regurgitation ◽

Septal Defects ◽

Surgery Department

Background: To investigate the feasibility and safety of the O eccentric shape occluder in the interventional occlusion treatment of intracristal ventricular septal defect (IVSD). Methods: A retrospective analysis of the clinical data of 56 IVSD patients treated by interventional occlusion at our center, as well as recording of their intraoperative and postoperative status, was performed. Results: Of the 56 patients, a total of 48 patients underwent successful occlusion during the first surgical attempt. Four patients were transferred to the Surgery Department after occlusion when the largest occluder failed because of large defects. Two patients exhibited aortic valve regurgitation; 1 patient had mild regurgitation, which was not worsened after 6 months of follow-up. One patient had severe aortic regurgitation, and 2 days after the operation, the patient underwent a second operation. One patient exhibited a residual shunt, which was above the occluder; after 1 year of follow-up, re-occlusion was successful and eliminated the shunt. One patient developed complete right bundle branch block. Conclusion: Most IVSD interventional occlusion treatments are feasible and safe.

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Transcatheter closure of muscular ventricular septal defects using the Cardi-O-Fix plug

Cardiology in the Young ◽

10.1017/s1047951121000482 ◽

2021 ◽

pp. 1-4

Author(s):

Zhisong Chen ◽

Zhuo Yu ◽

Li Su ◽

Huasheng Zhang ◽

Wei Hu

Keyword(s):

Transcatheter Closure ◽

Left Ventricular ◽

Defect Size ◽

Ventricular Septal Defects ◽

Chordae Tendineae ◽

Effective Treatment Option ◽

Septal Defects ◽

Device Implantation ◽

The Right

Abstract Objective: The aim of this study was to evaluate the safety and efficacy of the Cardi-O-Fix plug used for the treatment of muscular ventricular septal defects. Methods: We retrospectively reviewed the medical records of five patients with muscular ventricular septal defects who underwent transcatheter closure using the Cardi-O-Fix Plug, from November 2017 to August 2019. The median age was 5.1 years (range: 3.2–6.5). Their median body weight was 18.1 kg (range: 13.4–21.8). All the patients underwent detailed two-dimensional Doppler and colour flow imaging by transthoracic echocardiography. The left ventricular median defect size of the muscular ventricular septal defects was 5.6 mm (range: 5.3–7.0). The right ventricular median defect size of the muscular ventricular septal defects was 3.9 mm (range: 3.3–4.7). All the procedures were performed on beating hearts. Results: All the patients underwent successful device implantation with no displacement or detachment, they have complete echocardiographic closure at the 1-year follow-up. There were no occluder-related arrhythmia, chordae tendineae rupture, tricuspid insufficiency, aortic regurgitation, haemolysis, or embolisation. Conclusions: Application of the Cardi-O-Fix plug appears to be a feasible, safe, and effective treatment option for patients with muscular ventricular septal defects. Longer follow-up periods are warranted to prove the conclusion for long-term outcomes.

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Percutaneous Closure of Ventricular Septal Defects in 116 Patients

Sultan Qaboos University Medical Journal [SQUMJ] ◽

10.18295/squmj.2020.20.04.012 ◽

2020 ◽

Vol 20 (4) ◽

pp. e352-359

Author(s):

Khalfan S. Al Senaidi ◽

Salim Al Maskary ◽

Eapen Thomas ◽

Boris Dimitrov ◽

Abdullah Al Farqani

Keyword(s):

Heart Block ◽

Percutaneous Closure ◽

Cardiac Complications ◽

Closure Device ◽

Ventricular Septal Defects ◽

Septal Defects ◽

Amplatzer Occluder ◽

Adjacent Structures

Objectives: This study aimed to review the experience with percutaneous closure of ventricular septal defects (VSDs) at the National Heart Center (NHC) in Muscat, Oman. Methods: This retrospective study was conducted from November 2008 to December 2017. Patients’ electronic medical records were reviewed to identify their clinical, imaging and interventional data before and after the procedure and on the last followup. Results: A total of 116 patients, the majority of which were female (58%), underwent 118 percutaneous procedures for VSD closure at a median age of 3.54 years (range: 0.25–33 years) and a median weight of 12 kg (range: 3.5–78 kg). The mean diameter of the VSDs as determined by transoesophageal echocardiogram was 5.6 ± 1.9 mm (n = 105). The commonest type of VSD was perimembranous (n = 75, 63.5%). Devices were successfully placed during 111 (94.1%) procedures in 109 (94.0%) patients, with the commonest device being a Amplatzer™ duct occluder I (St. Jude Medical, Little Canada, Minnesota, USA; n = 39, 35.1%). There was no mortality. Early major cardiac complications occurred in six patients (5.5%) with device embolisation being the commonest (n = 4, 3.7%). The median follow-up period was 19 months (range: 1–84 months) in 89 (81.7%) of the patients. One patient (0.9%) required a permanent pacemaker for a complete heart block. Conclusion: This study has demonstrated a good rate of VSD closure with low morbidity and no mortality using the percutaneous approach with different devices. Long-term follow-up is needed to specifically evaluate the function of adjacent structures and the long-term effects on conduction systems. Keywords: Ventricular Septal Defect; Percutaneous Coronary Intervention; Amplatzer Occluder Device; Vascular Closure Device; Heart Block; Oman.

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