Master Universitario di II livelIo Cardiologia Interventistica Cardiovascolare e Strutturale
Anno Accademico
2017/2018
Closure of paravalvular leak following
valve-in-valve TAVI in a calcified
homograft aortic root replacement
Autore
Dott.ssa Roberta Serdoz
Tutor Scientifico
Prof. Claudio Passino
Tutor Aziendale
TABLE OF CONTENTS 1. Introduction……….…..1 2. Percutaneous Approach………...3 3. Current Devices………...4 4. Clinical Case……….………...7 4.1 Echocardiogram……….……..8 4.2 CT Scan……….…………9 4.3 TAVI Procedure……….…10
4.4 Paravalvular Leak Closure………12
5. Conclusion………..…………13
6. Key Issues………...………14
1. INTRODUCTION
Bioprosthetic valves are frequently used in the surgical treatment of patients with aortic stenosis. However, these valves have limited durability. Reoperation is the current standard of care for a failing aortic bioprosthesis. However, ‘‘redo’’ surgery can be associated with substantial mortality and morbidity, particularly in elderly patients and those with significant comorbidities.1-2 ‘‘Valve-in-valve’’ (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a less-invasive alternative to conventional redo surgery for bioprosthetic valve 3-4 dysfunction. According to the latest Global Valve-in-Valve International Data (VIVID) Registry,5 most world-wide ViV-TAVI procedures have been performed in failing stented bioprosthetic valves. Fewer than 100 patients in this registry have had a ViV-TAVI for a failing stentless bioprosthesis. Several technical difficulties may be associated with ViV-TAVI for a degenerate stentless bioprostheses, notably the absence of radiopaque landmarks from a stent frame or sewing ring, the use of various implantation techniques among surgical operators, and proximity of the coronary ostia. These factors increase the risk of complications such as device migration, embolization, and coronary obstruction.6
Duncan et Al. have demonstrated that 30-day mortality after ViV-TAVI was zero, mortality at 4 months and 1 year was low, respectively at 4.8% and 14.3%. Paravalvular leak occurs when there is a persistent defect between the native annulus and a surgically or percutaneously implanted prosthetic heart valve. It is of most concern for aortic and mitral valve replacements in which small defects can cause hemolysis, and moderate to severe defects can cause symptoms of congestive heart failure and are associated with increased mortality 7. Paravalvular leak occurs in 6 to
15% of all valve replacements, but only 1 to 5% of PVLs require intervention 8. For decades, surgical closure was the only treatment option9. As experience with minimally invasive structural heart interventions has developed, percutaneous closure has increasingly become the first line treatment for most patients10. The ever-increasing number of post-TAVI patients are usually elderly and at prohibitive surgical risk: a significant PVL leading to severe aortic regurgitation and congestive heart failure represents a considerable management challenge. In order to try and mechanically solve the problem without surgical (re)intervention, several occlusion devices, otherwise used for different indications in interventional cardiology, may be considered for percutaneous insertion across the PVL to try and seal the regurgitant flow. Small series of high-risk patients treated with such devices after surgical aortic or mitral valve replacement, but none after TAVI, have been published11. Others have advocated the use of percutaneous valve-in-valve placement.
2. PERCUTANEOUS APPROACH
The femoral access is most commonly used for closure of both mitral and aortic leaks. Aortic leaks are less frequent than mitral and in most cases can be closed directly via the retrograde approach from aorta to left ventricle. In cases of very calcified and/or tortuous leaks it might be necessary to use a transseptal approach and catch the wire passed through the leak in the left ventricle making an arteriovenous loop to facilitate the passage of the delivery sheath. Closure procedures are performed under general anaesthesia or deep sedation with fluoroscopic and 2-D or 3-D transoesophageal echocardiographic guidance 12. Aortic PVLs are closed using the retrograde technique except in cases where aortic and mitral PVLs were simultaneously closed in the same procedure. In the retrograde technique, a hydrophilic wire is used to cross the defect. After the defect is crossed with the wire, the delivery sheath is advanced into the LV and the closure device is finally deployed in standard fashion. In patients with simultaneous aortic and mitral PVLs, the retrograde approach is used to cross both, with a hydrophilic wire snared in the left atrium and exteriorised through the femoral vein, establishing an arteriovenous (AV) loop. The delivery sheath is advanced anterogradely over the AV loop from LA to LV and to aorta (Ao), and both leaks are closed deploying the first device in the aortic PVL, and then the second device in the mitral PVL, consecutively through the same sheath.
3. CURRENT DEVICES
There is no specific device specially designed to repair paravalvular leaks. The first procedures were performed using the Rashkind double-umbrella device with total or partial success in three of the four patients in whom closure was attempted. Subsequently, various devices from the Amplatzer family (AGA Medical, Plymouth, MN, USA) have been used13. These devices were designed for closure of atrial septal defects (ASD), ventricular septal defects (VSD) and patent ductus arteriosus (ADO) and, occasionally, vascular coils have been used. Lately, Amplatzer Vascular Plugs II (AVP II) and III (AVP III) are considered to be the most adequate devices to close these defects. With the use of these multiple devices, clinical results are sometimes difficult to interpret because of the different definition the various authors give to clinical success (Figure1) 14,15,16.
Figure 1. Several devices used in the early PVL closure experiences. Garcìa E. et al. Eurointervention 2012;8:Q41-Q52.
In both the United States and Europe, the most frequently used devices are the Amplatzer family of devices19. Most plugs have a waist and disc structure with two flat discs linked together by a narrower waist. Devices such as the Amplatzer Septal Occluder and Amplatzer VSD Occluder have variably sized
waists connecting larger diameter flat discs which stabilize and anchor the device but may make the delivery of a second plug difficult, or result in encroachment on mechanical leaflet excursion.
Figure 2. Square-shaped and rectangular-shaped
designs of the Occlutech Occluder device.Goktekin O. et Al EuroIntervention 2016;11:1195-1200 .
Newer devices, including the AVP II and AVP III, have the same diameter for both the disc and waist. These devices also have a lower-profile which reduces the risk of impingement of mechanical valve discs. The AVP II is circular whereas the AVP III is more ovoid, making it potentially better suited for crescentic or oblong defects. Hence, the AVP III has become the most commonly used device for percutaneous PVL repair in Europe19,20,21.The only device specifically developed for PVL closure is the Occlutech PLD17,18. The Occlutech device was granted CE mark approval in 2014, but is not FDA approved in the United States
22,23
. The Occlutech PLD is constructed of braided nitinol and contains a polyethylene terephthalate patch to further reduce regurgitation through the nitinol mesh. It is available in a variety of sizes and shapes, including square or rectangular discs, and with either a narrow or wide waist. The profile of the conjoined discs is low (<3 mm high) to minimize the risk of valve encroachment. In the first published case series of 21 patients treated with the Occlutech, a transapical approach via minithoracotomy was used24.
Procedural success was 100% with 1 reported hemothorax and 1 reported pneumothorax. All patients had ≥1 grade reduction in regurgitation. The largest cohort to date included 30 patients with mitral or aortic PVL. Procedural success was higher in the aortic position (100%) compared to the mitral (88.2%) with one case of device failure due to exacerbation of hemolytic anemia. There were no major adverse cardiac or cerebrovascular events23.
4. CLINICAL CASE
Female, 66 years old.
Background: Aortic Homograft Root Replacement (22mm Homovital aortic root) in 1999. Redo sternotomy and quadruple coronary bypass grafts in 2013. Sarcoidosis treated with steroids. SLE. Cutaneous scleroderma. Beta thalassaemia trait with microcytosis. Chronic kidney disease. Osteopaenia. Hyperuricaemia.
Medication: Alendronic acid 70mg tabs, Aspirin 75mg OD, Bendroflumethiazide 5mg OD, Enalapril 20mg OD, Bisoprolol 1.25mg OD, Hydroxychloroquine 200mg OD, Prednisolone 6mg OD, Lansoprazole 15mg OD, Allopurinol 100mg OD, Calichew tablets x2 OD, Atorvastatin 40mg ON, Furosemide 20mg OD, Prasugrel 10mg OD.
Presentation: Patient presented with chest infection and developed pulmonary oedema -required pulmonary intubation but unable to wean. Moderate to severe aortic regurgitation. Previously symptomatic with slight dizziness and palpitations, usually during the night.
ECG: Sinus rhythm at a rate of 78bpm.
Blood Test: Hb 91 g/L, PLT 111 10^9/L, INR 0.8 ratio, Creatinine 87 umol/L, ALP 315 U/L, GGT 424 IU/L, AST 50 IU/L, Total Protein 39 g/L, Albumin 15 g/L, Amylase 314 U/L, CRP 25 mg/L.
4.1 ECHOCARDIOGRAM
A
Left ventricle: Normal biventricular cavity size and systolic function (Fig.A). Moderate LVH. LVEF 40%.
Aortic Valve: AV homograft appears well seated, peak AVG 35mmHg, mean 16mmHg, DI 0.34, AVA 1.2 cm2. Regurgitation severity appears moderate-severe (PHT 430ms) (Fig.B-C-D).
Mitral valve: Mild MR.
Left atrium: Moderate dilated (54 ml, 21.6 cm2). Tricuspid Valve: RVSP estimate 37mmHg
A Ba
D
C
C
4.2 CT SCAN
The calcification is circumferential and extends from the sinuses to above the sino-tubular junction.
- Annulus: 19 mm x 16 mm.
- Circumference of the aortic valve annulus: 67 mm; minimum and maximum diameters are 20 mm x 24 mm.
- Trans-sinus diameters are 31 mm x 29 mm.
- Sinus-to-commissure diameters are 28 mm x 31 mm x 32 mm. - Sino-tubular junction measures 26 mm x 26 mm.
Bypass grafts patent.
Femoral Access routes borderline for TAVI.
6.42 mm 6.79 mm
4.3 TAVI PROCEDURE
Opted for Evolut R (Medtronic):
–Repositionability for valve in valve case
–In-line sheath allows for better access in narrow femoral arteries
Transfemoral Tavi: Left
General Anaesthesia: TEE guidance
4 F balloon tipped pacing wire inserted to LIJV via 5F sheath 5F atrial J-Pacing wire inserted to LIJV via 5 F sheath
6F sheath to right femoral artery
Unable to pass 18F cook sheath via left common femoral artery Switched inline sheath (14F equivalent)
Release Medtronic Evolut R 23 mm positioned in AV (Fig B) Valve expanded with rapid pacing (120-140 bpm)
Valve recapture because too low(Fig. C) Evolut R valve deployment completed (Fig. D)
Delivery system removed with rapid pacing 180 bpm Surgical suture to left femoral artery (Fig. E)
B
A
C
D
After the valve’s deployment, aortogram and 3D TOE showed moderate regurgitation, at the level of the left coronary cusp towards the non-coronary cusp. We decided not to post-dilate because the aortic root was heavily calcified, from the sinuses to above the sino-tubular Junction.
Bouts of atrial fibrillation detected in association with significant pauses upon termination and a relatively narrow complex left bundle branch block intra-ventricular conduction pattern noted with 1:1 AV conduction and normal PR interval in sinus rhythm.
A dual-chamber rate adaptive permanent pacing system programmed to a base rate of 80 bpm in the AAI/DDD mode (without rate response) was inserted.
(*) Figure A. Sinning J. et Al. J Am Coll Cardiol 2013;62:11–20.
4.4 PARAVALVULAR LEAK CLOSURE
One week later, patient underwent paravalvular leak closure because of ongoing pulmonary oedema not responding to Furosemide and GTN.
6 F sheath to right femoral artery 0.035 J wire Multipurpose catheter
Amplatzer Vascular plug 4, 8 mm x 13.5 mm deployed under left coronary cusp
Sheath removed and manual pressure was applied to RFA
3D TOE showed a good result with a minimal regurgitation after paravalvular leak
5. CONCLUSION
Significant PVL complicates between 1 and 5% of valve replacements and the incidence is highest among patients with mechanical mitral valve replacement. Symptoms include congestive heart failure and hemolysis. Multimodality imaging including both transesophageal echocardiography and cardiac CT are critical in establishing the diagnosis and defining the size, location, and mechanism of PVL. Surgery is appropriate for patients with PVL due to endocarditis or valve dehiscence. Increasingly, percutaneous treatment is the first line treatment for many cases of PVL. Percutaneous interventions are associated with less morbidity and mortality when compared to reoperation. However, persistent leak, hemolysis, device embolization, and disc impingement continue to present significant challenges, in large part because currently used devices are not designed for PVL closure. The creation of dedicated devices for leak closure is needed to improve procedural success rates. In summary, treatment of PVL regurgitation in patients after TAVI remains one of the most challenging and difficult procedures in interventional cardiology.
6. KEY ISSUES
. Paravalvular leak occurs in 6 to 15% of all valve replacements, but only 1 to 5% of PVLs require intervention.
. Surgical closure was the only treatment option until minimally invasive structural heart interventions were developed; percutaneous closure has increasingly become the first line treatment for most patients.
. Establishing the etiology of paravalvular leak with imaging including transthoracic and transesophageal echocardiogram and CT is critical in determining the appropriate repair technique.
. In most patients it is appropriate to attempt percutaneous PVL closure and proceed to surgery only in patients who do not receive benefit from the less invasive approach.
. There are many devices used “off-label” for PVL closure, however there is only one device which has been designed specifically for PVL closure. The size and characteristics of the defect determine which type of device is appropriate.
. Future advances in imaging, device materials, and 3D printing will be critical in moving the field forward and improving outcomes in this patient population.
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FIGURE 1. Garcìa E. et al. Several devices used in the early PVL closure experiences.
Eurointervention 2012;8:Q41-Q52.
FIGURE 2. Omer Goktekin, MD; Mehmet Akif Vatankulu, MD; Hakan Ozhan, MD; Yasin Ay,
MD; Mehmet Ergelen, MD; Abdurrahman Tasal, MD; Cemalettin Aydin, MD; Ziya İsmail, MD; İsmail Ates, MD; Ziyad Hijazi, MD. Early experience of percutaneous paravalvular leak closure using a novel Occlutech Occluder. Eurointervention 2016;11:1195-1200.
FIGURE A. Jan-Malte Sinning, Mariuca Vasa-Nicotera, Derek Chin, Christoph Hammerstingl,
Alexander Ghanem, Johan Bence, MD,y Jan Kovac, Eberhard Grube, Georg Nickenig, Nikos Werner. Evaluation and Management of Paravalvular Aortic Regurgitation After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2013;62:11-20.
