Transcatheter endovascular closure of perimembranous ventricular septal defect (interventional procedures consultation)

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

Interventional procedure consultation document

Transcatheter endovascular closure of perimembranous ventricular septal defect

Ventricular septal defect (VSD) is a defect of the heart, where there are one or more holes in the wall (called the septum) that separates the two chambers of the heart (called the ventricles). This is the most common birth defect of the heart, but it is not known what causes it. A VSD lets blood leak back from the left to the right ventricle.

Endovascular closure of a perimembranous VSD involves inserting a small device (called an occluder) into the heart to block the hole. This is inserted via blood vessels so that there is no need for open heart surgery. A fine wire is put into a blood vessel at the top of the leg and a second wire is put into another blood vessel at the top of the leg. Both wires are passed along the blood vessels into the heart. The two wires are then used to guide the blocking device into place to block the hole. 

The National Institute for Health and Clinical Excellence (NICE) is examining transcatheter endovascular closure of perimembranous ventricular septal defect and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about transcatheter endovascular closure of perimembranous ventricular septal defect.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

  • comments on the provisional recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

  • The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
  • The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 21 December 2009

Target date for publication of guidance: March 2010

 

1       Provisional recommendations

1.1   Current evidence on the safety and efficacy of transcatheter endovascular closure of perimembranous ventricular septal defect (VSD) is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.

1.2   Patient selection is important, especially in children and in asymptomatic patients. Patient selection should be carried out by a multidisciplinary team including an interventional cardiologist and a cardiac surgeon with specific expertise in the management of congenital heart disease.

1.3   When carried out on children, this procedure should only be undertaken in specialist paediatric cardiology units. For all patients there should be arrangements for access to cardiac surgical facilities if necessary.

1.4   Clinicians should enter details about all patients undergoing transcatheter endovascular closure of perimembranous VSD onto the UK Central Cardiac Audit Database (www.ccad.org.uk).  

1.5   NICE encourages publication of further long-term follow-up data, specifically on the occurrence of heart block compared with open surgery.

2       The procedure

2.1    Indications and current treatments

2.1.1  Ventricular septal defect is the persistence of one or more holes in the septum that separates the left and right ventricles of the heart. VSD is the most common congenital heart defect.

2.1.2  The cause of congenital VSD is unknown. Most infants have small VSDs that are asymptomatic and that usually close spontaneously after birth. However, if a VSD is large, surgical closure may be recommended.

2.1.3  In adults, a VSD may be acquired as a complication of a myocardial infarction or trauma. These are generally muscular VSDs and therefore not addressed in the guidance.

2.2    Outline of the procedure

2.2.2  In transcatheter endovascular closure of perimembranous VSD, a guidewire is introduced into the femoral artery and vein in the groin, to establish an arteriovenous wire loop. A delivery sheath is advanced over the wire across the VSD, via the right side of the heart. Echocardiographic and fluoroscopic guidance are used to guide the occluder device as it is advanced through the delivery sheath, and expanded to close the defect.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/IP286aoverview.

 

2.3    Efficacy

2.3.1  Case series of 430, 412, 210, 186, 182, 100 and 65 patients reported final follow-up closure rates of 83% (absolute figures not stated), 97% (398/412), 97% (200/206), 98% (175/178), 98% (173/176), 84% (46/55) and 94% (46/49), respectively, at follow-ups ranging from 1 postoperative day to 1 year. In the same case series, immediate closure rates of 40% (absolute figures not stated), 93% (382/412), 35% (72/206), 92% (172/186), 91% (160/176), 58% (54/93) and 82% (40/49) were reported, respectively.

2.3.2  The Specialist Advisers listed key efficacy outcomes as successful closure of VSD, symptomatic improvement post procedure, abolition of left-to-right interventricular blood flow and reduction in left ventricular diastolic diameter.

2.4    Safety

2.4.1  The case series of 430 patients reported that 1 patient with multiple VSDs died during the procedure from cardiac arrest after a second occluder was implanted.

2.4.2  A prospective register of 160 patients treated by transcatheter endovascular closure of perimembranous VSD reported 3 postoperative deaths: 1 after additional surgery for complications that occurred during the procedure (timing of event not stated), 1 at 476 postoperative days and 1 at 536 postoperative days.

2.4.3  Case series of 430, 186, 182 and 100 patients reported the occurrence of complete atrioventricular (AV) block in 4% (16/430), 1% (2/186), 1% (1/182) and 2% (2/100) of patients, respectively. Of these 21 patients, 2 had surgery, 12 were fitted with a permanent pacemaker, 1 was fitted with a temporary pacemaker and 6 were managed medically. A case series of 412 patients reported third-degree AV block on the third or fourth postoperative day in 1% (6/412) of patients. All patients were managed with dexamethasone and a temporary pacemaker and all recovered within 3 weeks.

2.4.4  A case series of 210 patients reported high-degree AV block in 3% (6/210) of patients; in 2 patients it occurred during the procedure: both patients recovered as soon as the procedure was discontinued (dexamethasone was administered for 3 days) and later had surgical repair of VSD. In the other 4 patients the AV block occurred 23–76 hours after the procedure with a mean recovery time of 8 days.

2.4.5  The prospective register reported complete heart block in 3% (5/160) of patients. Of these 5 patients, 2 were fitted with a pacemaker before VSD closure and subsequently died (they had undergone previous unsuccessful surgical VSD closure). The remaining 3 patients were fitted with a pacemaker 9, 269 and 399 days after the procedure.

2.4.6  The non-randomised comparative study of 23 patients reported complete right bundle branch block in 18% (2/11) and 33% (4/12) of patients in the transcatheter occluder group and surgical group, respectively. In the case series of 186 patients, electrocardiogram (ECG) showed that 5% (9/186) of patients had left anterior hemiblock, 4% (8/186) had complete right bundle branch block and 4% (7/186)  had incomplete right bundle branch block at least 3 months postoperatively (all patients showed preoperative normal ECG or ECG signs of left ventricular enlargement).

2.4.7  Infective endocarditis requiring mitral and aortic valve replacement was reported in 1 patient 7 months after surgery in the case series of 210 patients.

2.4.8  Embolisation rates of 1% (4/430), 2% (2/100) and 4% (2/54) were reported in case series of 430, 100 and 65 patients, respectively. In the case series of 430 patients, all devices were retrieved (1 by open surgery).

2.4.9  The Specialist Advisers listed theoretical adverse events as device displacement/misplacement, cardiac tamponade, interference with the mitral or aortic valve (specifically including aortic incompetence), venous bleeding, the need to convert to open surgery, and alteration to the morphology of the heart which may become more pronounced with growth.

2.5 Other comments

2.5.1  The Committee noted that there is a lack of evidence comparing the incidence of heart block following this procedure with that following open surgery for VSD.

3     Further information

3.1   For related NICE guidance see www.nice.org.uk.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
November 2009

Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.

 It is the responsibility of consultees to accurately cite academic work in order that they can be validated.

This page was last updated: 30 March 2010