Periprosthetic Leak Closure - Transapical Approach

Pan Xin

Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University,Shanghai,China,200030

Disclosures

Nothing to disclose with regard to commercial support!

Background

• PVL is one of the most important complications after surgical valve replacement or transcatheter valve implantation.

• Typically this is associated with dehiscence of sewing ring sutures, often

precipitated by infection, annular calcification or technical factors.

• The majority of these leaks are trace to mild and are asymptomatic; moderate to severe PVL can lead to significant hemodynamic and clinical consequences.

Background

1% to 3% of patients with symptomatic paravalvular leak require intervention:

• Heart failure（larger the size of the leak）

• Hemolytic anemia（multiple leaks）

• Both

• infective endocarditis

• pulmonary hypertension

All of those effect on patient’s quality of life,

cause an increase in mortality

Background

• Medical treatment is largely palliative, Including heart failure therapy, repeated blood transfusions or erythropoietin injections

• Open Surgical reoperation is the gold standard of therapy for PVLs Options so far ,which include resuturing or replacing

- higher morbidity and mortality - re-PVL: because of underlying tissue friability, inflammation, or

calcification

Pre－surgery

Post-surgery

Intraoperative inspection：

LA view 4 to 6 o’clock,suture rupture

Operation mode： resuturing

Pre-surgery

Transcatheter Umbrella Closure of Valvular

and paravalvular leaks.

Houihan et ,al. J Am Coll Cardiol

1992;20:1371–7.

Transcatheter closure involves obstructing the flow

through the PVL by delivering occluders at the site of

leak,preventing or reducing the amount of

regurgitation

Technical success :the correct deployment of a stable

occlusive device through the PVL with a lack of

significant residual regurgitation and prosthetic valve

malfunction or interference

Clinical success: an improvement in ≥1 NYHA-FC

and/or improvement in mechanical haemolysis

Comparison of Current Devices Most Commonly Used in Transcatheter

PVL Closure:① low profile ② stability ③resistance to hemolysis④delivery approach⑤ closure properties

Coil

Chioce of PVL closure device --- Amplatzer Family

The concept of multiple smaller devices rather than 1 or 2 larger

devices has been suggested to have better sealing within the PVL

and less interference with other cardiac structures

Techniques for PVL Closure

• Femoral Approach--aortic PVL and mitral PVL

• TS(Transseptal) Approach-- mitral PVL

Techniques for PVL Closure

Transapical(TA) Approach

The advantages of Transapical Approach

• Both valves are easily accessible

• Mechanical heart valve does not preclude the route

• Short and direct route to access both the mitral and aortic valve

• Allows a direct control and manipulation of the guidewire and cath

• Simultaneous occluder device implantation is easily performed

• Coaxial alignment of the catheter and the lesion are relatively easily accomplished

• Significant decrease in the procedural and fluoroscopy times for closure of mitral PVLs compared with conventional procedures

Contraindications to the TA access

• In patients with a hypocoagulable state, or any other bleeding

diathesis

• Undisturbed native pericardium

• LV thrombus, a calcified LV apex, or an unstable prosthesis due to significant dehiscence.

Factors that may favor the TA approach for mitral valve

• The presence of double mechanical valves

• Posterior and medial septal mitral PVLs(1-6 o’clock position)

• Tortuousity of the tract of PVL, which may surrounded by extensive annular calcification

• Multiple leaks or crescentic /irregular /large leak,which need multiple devices to seal the leakage simultaneously

• Peripheral atherosclerotic disease

• Transseptal route complicated(depending on operator and institutional experience and comfort)

• TS or femoral approach is either inadvisable or has been

previously unsuccessful

Case A man aged 40 years with previous aortic and mitral mechanical valve replacements

2 years before, had worsening symptoms of heart failure, despite maximal medical

therapy. From echo, moderate to severe mitral PVL was detected,which located at

medial septal around 1~4 o ′ clock, EuroSCORE II was13.4%

Technical Approach • Preprocedural Planning and Guidance

Such evaluation requires multimodality imaging with 2DTEE,3DTEE,CTA.

• 2DTTE- convenience for screening,and long-term follow-up

• 2DTEE-an approximate assessment of the morphology and extent of the leak

• 3DTEE-provides a precise picture of the location, size, extent, shape, and morphology of the defect, as well as the distance between the PVL and the valve struts and leaflets to avoid impingement of the device to the adjacent structures.

Technical Approach • For TA access, CTA is necessary to provide guidance of PVL closure and

avoid complications

CTA helps to label skin entry, LV entry, and angulation to PVL

location(s) such that they are in direct line with the target; combined

with coronary angiography to allow the route and site of entry to be

away from coronary arteries, lung parenchyma,papillary muscles

Technical Approach

Open Surgical TA • Hybrid approach with both interventional and surgical teams in the hybrid

operating room

• Minithoracotomy ; direct visualization;enable the use of multiple sheaths for simultaneous device implantation

• Surgical exposure helps to visualize the blood vessels and lung tissue,aids in avoiding or minimizing bleeding complications

• Fairly traumatic procedure

Direct Completely Percutaneous TA • Perform in the cath lab

• Minimize sheath(5F) size at the LV apex, externalize the apical wire and deliver the devices via the femoral or TS approach

• Less invasive

• Potential risk of bleeding

Major Complications for PVL closure - results from our experience

TA approach(n=10):

• Minithoracotomy in 8;Transcutaneous in 2

• Device selection: mVSD,PDA occluder, AVPⅡ

• Procedure Success 9(90%),one occured residual moderate to severe PVL requiring surgery

• No death, No device emboliaztion，No valve impingement.Major bleeding with Hemothorax(n=3),requiring thoracocentesis(n=2),rethoracotomy(n=1).Device-related hemolysis(n=2)

N=67

Current major Publications on Transapical Transcatheter PVL Closure

First

Author Year

Patients Approach Used

Occluder

Device

Procedure

Success

Early

Safety

Reoperatio

n Summary

(Mitral,

Aortic)

(Minithora

cotomy)

(Transcuta

neous)

Ruiz et al 2011 43 (33,10) 0 24

VSD, ASD,

PDA,

AVPⅡ

37 (86%) ? 1 (2%)

Sorajja et

al 2011 115 (90, 25) 0 13

VSD, ASD,

PDA,

AVPⅡ

11 (85%) 9 (69%) 0 (0)

Hematothorax (n=4)

requiring

thoracocentesis (n=2);

empyema (n=1)

Taramasso

et al 2014 139(100,39) 17 0

AVPⅢ,

AVPⅡ 16(94%) 14(82%) 1(6%)

Device embolization

requiring emergent

open heart

surgery(n=1)

Nijenhuis

et al 2014 37 (30, 7) 37 0

VSD, ASD,

AVP,

AVPⅢ

32 (86%) 30 (81%) 6 (16%)

Major bleeding (n=4);

prosthetic interference

requiring reoperation

(n=1); recurrent PVL

requiring reoperation

(n=1). Clinical efficacy

is 49% (n=18)

Conventional surgery and transcatheter closure via surgical transapical approach for paravalvular

leak repair in high-risk patients

Conclusions: A transcatheter closure via a surgical TAp approach appears to be a

safe and effective therapeutic option in selected high risk patients with PVL and is

associated with a lower hospital mortality than surgical treatment

European Heart Journal – Cardiovascular Imaging (2014) 15,

1161–1167

What can we learn from the recent literature about transcatheter closure of PVLs by systematic review?

Procedural Access Technical Success

Clinical Success

30-days safety

1-year cardiovascular mortality

Moderate or Severe residual regurgitation

Average procedural time

Transfemoral Approach & Transseptal Approach

82% 48% 91% 15% 14% 139± 47.0min

Tansapical Approach

88% 49% 84% 17% 7% 89± 31min

Major complications in different access of PVLs closure by systematic review

Transfemoral Approach & Transseptal Approach

Tansapical Approach

Access-site-related 1.Peripheral vascular events(0.7-2%)

1.Hemothorax(2.5-19%) 2.Coronary artery damage 3.Pneumothorax,Pericardial effusion

Device related and others

2.Device migration or embolization 3.Wire entrapped 4.Valve interference 5.Worsening haemolysis 6.Residual PVL 7. Pericardial effusion 8.Stroke

4.Device instability,recurrent PVL 5.Prosthetic interference 6.Worsening haemolysis 7.Residual PVL

Proper closure of TA access is Vital!

• Apical access site related hemothorax was the most frequent serious complication occurring in the procedure or post-procedure of PVL closure

• Perform either surgically by direct securing of the purse-string sutures or percutaneously by placing closure device

• Considered to be safe, preferred method is open surgical TA compared with direct percutanous TA

Summary

• Transapical approach might be a good or rather attractive alternative for PVL closure, especially for postero-medially located or anatomically hard to access calcified tracted mitral PVLs

• Because of the direct and short nature of the approach, the TA access has been shown to have a relatively high technical success, furthermore, to decrease fluoroscopy and procedure times in the selected patients

• Although there are several complications that potentially be associated with this route, there are have been advancements in multi-modality imaging and the technique of closure of TA access, which may guide the procedure and minimize these complications

If structural interventionalists master the technique of percutaneous

apical access and closure, this will open up a new port into the heart

and facilitate the development of new approaches and procedures.

--From Dr Charanjit S.Rihal

Thank you for your attending！