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Ventricular Septal Defect Repair: What a parent should know about device closure

Redmond P. Burke The Congenital Heart Institute Miami Children’s Hospital and Arnold Palmer Hospital PICS 2008

How does my team decide on our approach to each patient?

Patients with VSD’s are usually diagnosed by pediatric cardiologists and referred to our surgeons or interventional cardiologists for treatment. For the past several years, at weekly program conferences, we have discussed every patient presented for VSD closure. Our approach is to treat each patient with the most effective, and least traumatic approach available.

Like you, we strive to make Evidence Based Decisions

“The Literature” is a nice guide, but we use our own results for clinical decision making whenever possible, finding them to be more relevant. Our outcomes are reported on our website at www.pediatricheartsurgery.com

Current MCH surgical Results for VSD closure: 1995-2008

Total Cases (N) Mortality (N) Transient CHB (N) Requiring Pacemaker (N) Median Weight (kg) Median Age (days) Median Post-op Stay (days) Includes: Perimembranous VSD Subarterial VSD Supracrystal VSD

387 1 3 1 7.1 269 4 (4d-24yrs) 0.25% 0.77% 0.25%

No instance of complete heart block in last 353 cases This experience similar to GOS review of >2000 pts (.6% CHB)
Ann Thorac Surg. 2006 Sep;82(3):948-56; discussion 956-7.

Is surgical heart block a real risk?

Absolutely, but this risk is clearly surgeon specific. Conduction disturbances (and most other complications) can be viewed as a marker of a surgeon’s gentleness, finesse, technique, and experience. You might have a program where the risk of surgical conduction problems and heart block after VSD repair will lead you to make different decisions than us.

Is the conduction system likely to be injured during surgical repair?

Terrifying history – AV node injury was lethal in early surgical experience. Surgeons are trained to avoid any contact with the septum during VSD repair Modern techniques – continuous suture in the endocardium, no touch technique on the septum • Shallow stitching close to the rim of the ventricular septal defect eliminates injury to the right bundle branch.  Ann Thorac Surg . 2004 Jun;77(6):2259-60; author reply 2260. No routine pacing wires, but easy to do if needed Spontaneous cardioversion is the rule in the OR If you’re seeing a lot of heart block, you don’t need a new approach, you need a new surgeon. Circulation. 2006;113:2775-2781.

So is our typical patient with PMVSD a candidate for device repair? No.
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Small baby 2.52 kg with FTT Large PMVSD Associated lesions (50%) All pericardial repair Never touch the conduction area Visualize and preserve the aortic and tricuspid valves Never put an instrument across the defect Never use circulatory arrest

What information is available on Device Closure? Not much.
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Pinto Kapoor Thanaopoulos Anil Li Carminati Arora Duronpisitkul Zabal Hijazi Walsh Pawelec-Woitalik

* Indicates prospective randomized study

Why do we have to be careful extrapolating these early device results? They picked the easy patients.

The early device experience is in very big patients with small defects, followed for a short period of time • 7.7y/25kg (Fu) In contrast, our surgical experience is in small babies with big defects, followed for decades:
• Our mean age/wt for surgical repair of PMVSD is 9mo/7kg, the defects are usually the size of the aortic valve annulus, and the patients have FTT.

As we have seen with ASD device closure, sex, and surgery, size affects performance

Is this experience with small defects in big patients misleading? Yes, I think smaller patients with larger defects are a serious challenge to device design and performance.
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Vascular access and catheter manipulation is easier. Older patients with small defects have had time to develop a cushion of tricuspid tissue around the defect, creating a buffer from the aortic valve. This is not the case in younger patients, where up to half of the defect diameter is aortic valve annulus.
7yo , LOS 3d small defect surrounded by fibrous scar 2 mo 4.2kg, LOS 5 days half the circumference of the defect is aortic valve annulus

Are Surgical materials safe over time? Absolutely.
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It’s free We have 5 decades of experience with the material, and no uncertainty about long term effects in the circulation. No erosion into adjacent structures Anchored by continuous suture, patch dehiscence is very rare, embolization never Residual leak rare Each patch is customized to the patient’s defect, very low profile No long term anticoagulation or antibiotic prophylaxis

Pericardial Patch

PMVSD Device (Amplatzer)

Will device materials be safe over time? No way to know, it will take decades to find out.
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Device closure is with Nitinol/fabric (cost - $4500 ) Early studies are encouraging at 14 months (Kong) Anchoring with radial pressure/double disc/fibrosis. Not always stable, embolization reported in several early series. Retrieval is traumatic. Residual leak common early, with subsequent closure over time The patient is forced to conform to the available device size. You must select from preset sizes and shapes. Will devices require anticoagulation or long term antibiotics?

My gut feeling

If you gave me any available device, and asked me to place it in a PM VSD under direct vision, with the heart arrested, and I could suture it in the best possible position, so that it didn’t touch the aortic valve, the tricuspid valve or the conduction system, and completely closed the defect… I couldn’t do it. (I could do it with a pericardial patch though, pretty damn fast too.)

Do devices work anywhere in the ventricular septum?
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Sure Picture a 39 week female born at 2.18 kg with a small PMVSD and a large muscular VSD, and coarctation with arch hypoplasia Repair at day of life 4.

We choose a hybrid procedure, Surgical arch repair, and Device Closure of the Muscular Defect, we’re not closed minded about this stuff.

So what’s my greatest concern? Devices could destroy the aortic valve.
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Most PMVSD are contiguous with the aortic valve annulus. PMVSD device engineers face a conundrum - how to secure a device in a high pressure flow zone with a low profile on the high pressure side (to avoid aortic valve injury) without increasing radial force (risk to conduction and aortic valve). What will be the long term effects of subvalvar turbulence and/or device abrasion on the aortic annulus or leaflets? ASD devices in proximity to the aorta have eroded into the aorta (Chun, 2003)

What is the surgical experience with foreign material under the aortic valve?

Subaortic stenosis after VSD repair is a rare progressive lesion (Cicini) We have seen several patients with subaortic obstruction and aortic insufficiency from fibrous reaction to Dacron VSD patches. We now use pericardium exclusively. Our experience with Subaortic membrane suggests that creating turbulence and fibrosis under the aortic valve can progressively damage the valve, and necessitate valve replacement.

Typical proximity of PMVSD to Aortic Valve observed during surgery: 17 Month old

How close is the aortic valve with a small defect? Very close.

Is there misperception of the conduction system anatomy?

EP studies might give the impression that there is a conduction area that can be avoided by device placement

What’s the real Achille’s Heel for device closure in the membranous septum? The risk of Permanent Heart Block.

Anatomic studies show discrete conduction bundles just under the endocardium, along the margin of a PMVSD

A device in contact with the margin of a PMVSD, will be in contact with the His Bundle

Why is the conduction system likely to be damaged during and after device closure?

Early device experience suggests the conduction system will be injured frequently. (Zhonghua, Kapoor, Fu, Carminati) Technique of dual wires and stiff sheath across the septum applies direct uncontrolled pressure trauma to the septum (violating surgical principles) The PMVSD device is then implanted directly on the conduction area with unmeasured and uncontrolled radial and compressive force This creates the potential for early (pressure) and late (fibrotic) injury to the conduction system Late CHB at 5 months and 1 year after device placement has been reported. (Caminiti)

How do we explain the delayed onset of CHB seen after device closure?
Chronic fibrosis of the AV node is a mechanism for CHB and has been related to compression

JACK L. TITUS Anatomy of the Conduction System Circulation, Jan 1973; 47: 170 177

Will the Tricuspid Valve be injured by PMVSD device closure?

During surgical repair, tricuspid valve chords are preserved. The TV septal leaflet chords are always near the margin of a PMVD and will always be in contact with the larger RV occluder disc. Over time, the discs could damage the TV leaflets and chords creating TS or TI. Acute TV chord rupture has been reported during device closure of PMVSD. (Fu) With all the attention on the left side of the septum to avoid the aortic valve and conduction system, the TV will take a beating.

5 y/o with Hx of VSD. TEE postop, no TR.

Does surgical closure of PMVSD create LVOT turbulence or obstruction?

Typical surgical repair: 1 mo, 2.52kg, pericardial patch repair of PMVSD, discharged home on POD 7.

Preop echo, PMVSD, no turbulence subAS or AI

Postop echo, no VSD, no turbulence under aortic valve. subAS or AI

Is LVOT turbulence and obstruction more likely to occur with PMVSD Device Closure?

Based on the device design requirements, devices are likely to protrude into the LVOT and create turbulence This could create immediate LVOTO, or late LVOTO with fibrous ingrowth and device shape changes Surgical Treatment will require device removal, which will create complete heart block
Simone Rolim, et al, Arq. Bras. Cardiol. v.86 n.2 São Paulo fev. 2006

Is procedural trauma so much less than surgery that we should accept these uncertainties regarding device closure?
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Surgery is performed in OR under GA/TEE Bypass subjects the body to inflammation, time related Small risk of cerebral embolization Incision creates a visible cosmetic injury unrelated to patient size Hospital stays from 2 to 5 days. Patients usually completely stable hemodynamically in the OR, episodes of uncontrolled hypotension very rare. Hemodynamically significant residual lesion is rare

Device closure in Cath Lab under GA/TEE Fluoroscopy, subjects the body to Ionizing radiation, with no safe duration of exposure Small risk of cerebral embolization Vascular access creates invisible functional injuries to major blood vessels, (DVT, ischemia) worse in small patients – arterial occlusion in 16% (Kulkarni) Hospital stays from 1 to 5 days. Patients reported to be unstable in OR due to arrhythmia/hypotension/bleedin g (Kapoor) Hemodynamically significant residual lesion also pretty rare

Conclusions
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Surgical closure of PMVSD is safe and effective. Early uncontrolled, non-randomized trials of device closure for selected older patients with small defects raise significant concerns about potential short and long term injury to the Aortic and Tricuspid valves, the left ventricular outflow tract, and the conduction system. There is no convincing evidence to suggest that device closure of PMVSD will produce less lifelong trauma or be more effective than surgical closure.

Thank You