Catheterization and Cardiovascular Interventions 85:657–664 (2015)
Percutaneous Paravalvular Leak Closure for Symptomatic Aortic Regurgitation after CoreValve Transcatheter Aortic Valve Implantation Satpal S. Arri,* MRCP, P. Poliacikova, MRCP, and D. Hildick-Smith, MD, FRCP Objectives: We present a case series of five patients in whom percutaneous paravalvular leak closure with the AVP4 device has been undertaken for symptomatic aortic reBackground: Significant post-procedure aortic gurgitation after CoreValve TAVI. regurgitation (AR) is often difficult to assess, and is an important predictor of adverse outcome following TAVI. Paravalvular leak closure is an established procedure for surgical aortic prostheses, and has been undertaken for Edwards TAVIs, but has not been described for closure of CoreValve paravalvular leaks. Methods and Results: Five patients were treated (mean age 81 6 4 years) with residual grade 3–4 AR following placement of a single CoreValve (n 5 2), double CoreValve (n 5 2) or CoreValve within a bioprosthetic AVR (n 5 1). The mean time post TAVI implantation was 308 6 269 days. All patients were symptomatic with persistent NYHA Grade III dyspnoea. 6 devices were deployed successfully, with mean procedure time of 109 6 23 min. There were no procedural complications and all patients were discharged home by Day 2. Residual AR after treatment was grade 0 (n 5 2), grade 1 (n 5 1), grade 2 (n 5 1) and grade 3 (n 5 1). Symptomatic improvement was noted in all 4 patients who have been reviewed in clinic since. Conclusions: This small series demonstrates the feasibility of paravalvular leak closure with the CoreValve TAVI, despite the adverse aortic lattice. The AVP4 device is ideally suited to this situation as it will pass through a 0.038’ lumen and can therefore be delivered down standard diagnostic catheters. VC 2014 Wiley Periodicals, Inc. Key words: transcatheter aortic valve implantation; paravalvular leak closure; aortic regurgitation
INTRODUCTION
Transcatheter Aortic Valve Implantation (TAVI) is widely accepted as a viable alternative to open Aortic Valve Replacement (AVR) for patients with symptomatic, severe aortic stenosis (AS) who are at high surgical risk [1–5]. Significant post-procedure aortic regurgitation (AR) is an important predictor of adverse outcome [6–14]. Paravalvular leak closure is an established procedure for surgical aortic prostheses [15–17], and has been undertaken for Edwards TAVIs [18–21], but has not been described for closure of CoreValve (Medtronic, Minneapolis) paravalvular leaks. We present a case series of five patients in whom percutaneous paravalvular leak closure was undertaken for symptomatic AR after CoreValve TAVI.
demographic, TAVI procedural, paravalvular leak closure procedural, and follow-up data were collected. A total of five patients with significant paravalvular leak following CoreValve TAVI underwent percutaneous paravalvular leak closure.
Sussex Cardiac Centre, Brighton and Sussex University Hospitals, United Kingdom Conflict of interest: Nothing to report. *Correspondence to: Dr. Satpal S Arri, Specialist Registrar in Cardiology, Sussex Cardiac Centre, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, East Sussex BN2 5BE, United Kingdom. E-mail: [email protected]
METHODS
Received 13 February 2014; Revision accepted 2 November 2014
We conducted a retrospective review of all cases of paravalvular leak closure following CoreValve TAVI (Medtronic, Minneapolis) at our institution. Baseline
DOI: 10.1002/ccd.25730 Published online 10 November 2014 in Wiley Online Library (wileyonlinelibrary.com)
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Fig. 1. (A) Aortography demonstrating AR secondary to paraprosthetic leak. (B) Aortography demonstrating reduction in AR following deployment of an Amplatzer Vascular Plug (AVP4) 8-mm device.
RESULTS Case 1
A 78-year old male presented with a 12-month history of exertional dyspnoea. He underwent CABG in 1991 and was now found to have symptomatic severe AS (AVA 0.8 cm2, PG 67 mm Hg, Aortic annulus 2.5 cm), and preserved LV systolic function. His case was reviewed by the heart team and given his high operative risk (logistic EuroSCORE 10%) he was referred for TAVI in April 2012. The procedure was performed under conscious sedation [22]. A 29-mm CoreValve was introduced and positioned under fluoroscopic guidance with concurrent pacing at 150 beats/minute. Aortography demonstrated moderate AR requiring post-dilatation of the valve initially with a 26 and then a 28 mm Z-Med balloon. Post procedure transthoracic echo confirmed a mild to moderate posterior paraprosthetic leak. He was referred for paravalvular leak closure one year after his initial valve implant due to ongoing exertional dyspnoea. The procedure was performed under general anaesthesia, via the right radial artery using a 6 French sheath. The paraprosthetic leak was posterolateral on TOE and fluoroscopically was visualised in the lateral and left cranial projections (Fig. 1). Aortography demonstrated Grade III aortic regurgitation. The lattice of the CoreValve was probed using a 5F AL1 catheter and an exchange length hydrophilic 0.035’ (Terumo, Tokyo) guide wire. The defect was crossed with difficulty and the AL1 catheter was exchanged for a 4F MPA (Cordis, Miami Lakes, Florida) catheter. An Amplatzer Vascular Plug (AVP4) 8-mm device, which
can pass down a 0.038” lumen, was then positioned and deployed in an optimal position parallel to the valve skirt, external to the valve structure. This gave an excellent result with only trivial AR persisting, confirmed on echocardiography and aortography (Figs. 1 and 2). Haemostasis was achieved using a TR band. The procedure time was 90 minutes and there were no peri-procedural complications. On follow-up in clinic 3 months later he reported significant symptomatic benefit with improved exercise tolerance. Case 2 A 77 year old male with a previous history of CABG in 1986 presented with syncope and was found to have severe AS (AVA 0.8 cm2, PG 59 mm Hg, aortic annulus 2.5 cm). Cardiac catheterisation demonstrated patent bypass grafts. He was referred for TAVI in December 2009. A 29-mm CoreValve was implanted via the right femoral artery using an 18F sheath. The valve unexpectedly shifted towards the ventricular aspect on release and AR was severe due to failed sealing at the annulus. The valve was therefore snared and traction exerted to lift the valve to an annular seal, and was post-dilated with a 28-mm Z-med balloon to maximise expansion. At the end of the procedure there was Grade II aortic regurgitation around a calcified left coronary cusp, which was considered acceptable. Reassessment due to ongoing dyspnoea suggested severe AR with a low prosthesis and he therefore underwent repeat TAVI via the left femoral artery. A
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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Fig. 2. (A1B) Moderate AR secondary to a paraprosthetic leak demonstrated on Transeosophageal echocardiography. (C) Reduction in AR following paravalvular leak closure with AVP4 8-mm device. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
second 29-mm CoreValve prosthesis was implanted 8 mm above the base of the previous valve and postdilated with a 26-mm Z-med balloon. Unfortunately the patient suffered further progressive reduction in exercise capacity and a TOE confirmed an at least moderate posterior paraprosthetic leak measuring (1.2 0.5 cm) and this was consistent with clinical examination. Paravalvular leak closure was subsequently attempted 24 months following his second TAVI. The procedure was performed under general anaesthesia, via the femoral approach. The upper lattice of the CoreValve prostheses was crossed using an AL1 catheter and an exchange length hydrophilic 0.035’ (Terumo, Tokyo) guide wire. This was directed retrogradely across the leak under fluoroscopic and TOE guidance. Once the wire was in the left ventricle, and imaging confirmed that it lay outside the CoreValve frames, the AL1 catheter was exchanged for a 4F MPA catheter (Cordis, Miami Lakes, Florida). An 8-mm Amplatzer Vascular Plug (AVP4) was then delivered down the catheter and deployed between the valve skirt and the aortic annulus. This reduced the AR from Grade 3 to Grade 0 (Fig. 3). There were no complications and on follow-up in clinic the patient’s symptoms were greatly improved with no persisting AR on TTE.
Case 3 This 82-year old male with a background of significant renal impairment presented with fatigue and exertional dyspnoea. He was found to have severe AS (AVA 0.7 cm2, PG 90 mm Hg, Annulus 26 mm) and subsequently underwent CoreValve (31 mm) implantation via the left femoral artery. Aortography demonstrated moderate AR with elliptical formation of the
valve skirt. Post-dilatation of the valve with a 28-mm Z-Med balloon improved the circularity of the prosthesis and reduced the AR. The AR index was calculated and found to be 24 with mild to moderate AR confirmed on TTE post procedure. He was discharged on Day 5. Unfortunately on follow-up review in clinic 8 weeks later he remained significantly breathless on exertion. Echocardiography suggested moderate paravalvular AR at worst with no flow reversal in the descending aorta and a pressure half-time of 500 ms. On the basis of the clinical findings however he was referred for paravalvular leak closure. This was performed via the right femoral artery using a 6 French sheath, 6 months after his initial valve implantation. Aortography and TOE demonstrated posterior, posterolateral and anterolateral leaks with Grade 4 angiographic AR (Fig. 4). The posterolateral leak was crossed with an exchange length hydrophilic 0.035’ (Terumo, Tokyo) guide wire and an AVP4 8-mm device deployed using a 4 French MPA (Cordis, Miami Lakes, FL) catheter into a significant paravalvular space with good resolution of the posterolateral jet. A second 8-mm AVP4 device was used to treat the anterolateral jet using a similar technique. Grade 2 AR remained by the end of the procedure. Given his renal impairment only 150 ml of Omnipaque 350 contrast was used. The procedure time was 140 minutes. There were no complications and he was discharged from hospital the next day. Case 4
An 85-year old male with a history of peripheral vascular disease initially presented with worsening exertional dyspnoea. Transthoracic echocardiography confirmed severe AS (AVA 0.85 cm2, PG 100 mm
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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Fig. 3. (A) Aortography demonstrating Grade 3 AR. (B) An exchange length hydrophilic 0.035’ (Terumo, Tokyo) guide wire directed across the leak into the left ventricle. (C) 8-mm Amplatzer Vascular Plug (AVP4) delivered down a 4F MPA catheter (Cordis, Miami Lakes, FL) between the valve skirt and aortic annulus. (D) Aortography demonstrating a reduction in AR to grade 0.
Hg) with preserved LV systolic function. The aortic annulus measured 2.7 cm on TOE. He underwent balloon aortic valvuloplasty using a 26-mm Z-Med balloon in November 2010. An aortogram during balloon inflation did not demonstrate any AR. His symptoms improved significantly but recurred 6 months later. His case was reviewed by the Heart Team and he was accepted for TAVI. The valve was crossed and predilated with a 25-mm Z-Med balloon. A 31-mm CoreValve prosthesis was positioned in an optimal position just under the aortic annulus. Unfortunately on release of the valve there was reorientation and upwards valvular movement by several millimetres, such that the prosthesis lay par-
tially supra-annular. A second valve was therefore deployed, but due to overcorrection we placed this valve a little lower than intended. The final angiographic result demonstrated apparently mild AR. Unfortunately on review in the outpatients clinic 1 month later he presented with peripheral oedema and worsening breathlessness. TTE demonstrated a moderate paravalvular leak with mild LV impairment. He responded very well to medical therapy over the next 9 months but then gradually redeveloped symptoms of breathlessness on minimal exertion. Clinical examination and echocardiography both suggested a severe paravalvular leak. The left ventricle was now dilated with severe LV systolic dysfunction and an ejection fraction
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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Fig. 4. (A) TOE demonstrating posterolateral and anterolateral leaks. (B) A second 8-mm AVP4 device delivered using a 4F MPA (Cordis, Miami Lakes, FL) catheter to treat the anterolateral jet. (C)-Reduction in AR seen following deployment of two AVP4 devices on TOE. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Fig. 5. The AVP4 device, courtesy of St. Jude Medical, Inc. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
of 20%. He subsequently underwent paravalvular leak closure in May 2013. This was performed via the right femoral artery using a 6F sheath. An anterior paravalvular leak was crossed with technical difficulty and a single 8-mm AVP4 device deployed with modest angiographic improvement (Grade 2 AR). On review 4 weeks later his symptoms had improved and his exercise capacity had increased to 150 m. Left ventricular function remained impaired and further intervention may be required.
Case 5 An 83-year old male was admitted with worsening exertional dyspnoea and heart failure requiring intravenous diuretics. Past medical history included coarctation repair in 1972 and single vessel CABG (LIMA to LAD) plus 25-mm Carpentier-Edwards AVR in 1996. Cardiac catheterisation demonstrated no targets for percutaneous revascularisation. Aortography demonstrated severe AR, confirmed on TTE. There was severe impairment of LV function (EF < 30%) and associated moderate mitral regurgitation. He was subsequently referred for TAVI. This was performed in June 2012 from the right femoral and right radial arteries. The site of previous coarctation repair was widely patent. The valve was crossed and a 26-mm CoreValve prosthesis implanted within the previous bioprosthesis in an excellent position. Surprisingly there was Grade II AR and on closer inspection there was a paravalvular leak in addition to the pre-existing transvalvular leak. The paravalvular leak was crossed with a Terumo wire and an AL-1 catheter confirming its suitability for treatment at a later date. The patient returned one month later for elective paravalvular closure. This was performed from the right femoral artery. The defect was crossed with a Terumo wire, however, neither a 4F MPA catheter, a 5F MPA catheter, a Terumo heart rail, a 5F Cook shuttle sheath nor a 5F multipurpose guide catheter could be encouraged to follow, possibly due to skirt expansion and the formation of some fibrous tissue. Eventually the defect was crossed with a 6F MPA guide catheter allowing us to deploy an 8-mm AVP4 device. Repeat TTE demonstrated only a trivial residual leak with PG 13 mm Hg across the valve. He has had no
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Procedural and clinical success: Grade I AR, NYHA 1 None
Procedural and clinical success: Grade III AR, NYHA II None
Procedural success: Grade II AR, Clinical review awaited None
AVP4 8 mm 25-mm Carpentier-Edwards AVR, CoreValve 26 mm 83, Male
Grade III, NYHA III
AVP4 8 mm 31-mm CoreValve (2) 85, Male
Grade IV, NYHA III
AVP4 8 mm (2) Grade IV, NYHA III 31-mm CoreValve 82, Male
AVP4 8 mm Grade III, NYHA III 29-mm CoreValve (2) 77, Male
Outcome
Procedural and clinical success: Grade 0 AR, NYHA I None
None
Complication Procedural characteristics
AL1- to cross defect erumo 0.035 guidewire 4F MPA- to deliver device AL1- to cross defect Terumo 0.035 guidewire 4F MPA- to deliver device AL1- to cross defects Terumo 0.035 guidewire 4F MPA- to deliver devices Posterolateral and anterolateral leaks requiring 2 devices AL1- to cross defect Terumo 0.035 guidewire 4F MPA – to deliver device AL1 to cross defect Terumo 0.035 guidewire 6F MPA required to deliver device -likely due to skirt expansion and fibrous issue formation. AVP4 8 mm
Device AR severity
Grade III, NYHA III 29-mm CoreValve
Previous prosthesis Patient
TABLE I. Patient and Procedural Characteristics
Procedural and clinical success: Grade 0 AR, NYHA I
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78 y, Male
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further cardiac hospitalizations with decompensated heart failure and remains asymptomatic at follow-up 3 months later. DISCUSSION
In this case series, five patients were treated (mean age 81 6 4 years) with residual grade 3–4 AR following placement of a single CoreValve (n ¼ 2), double CoreValve (n ¼ 2) or CoreValve within a bioprosthetic AVR (n ¼ 1). The mean time post TAVI implantation was 308 6 269 days. All patients were symptomatic with persistent NYHA Grade III dyspnoea. Six devices were deployed successfully, with mean procedure time of 109 6 23 min. There were no procedural complications and all five patients were discharged home by Day 2. Residual AR after treatment was grade 0 (n ¼ 2), grade 1 (n ¼ 1), grade 2 (n ¼ 1), and grade 3 (n ¼ 1). Symptomatic improvement was noted in all four patients who have been reviewed in clinic since. AR morphology and aetiology was complex in two cases, with multiple leaks in one patient and a long semilunar segment in another requiring a second AVP device. This exemplifies the need for careful case evaluation and selection. This small series demonstrates the feasibility of paravalvular leak closure with the CoreValve TAVI, despite the adverse aortic lattice. The AVP4 device is ideally suited to this situation as it will pass through a 0.038’ lumen and can therefore be delivered down standard diagnostic catheters. Our study draws attention to the difficulty of assessing the degree of AR at the time of TAVI implantation. Recognition of this fact, and of the probable prognostic importance of residual AR [6–14] has led to increasing use of multiple modalities to assess procedural AR, including use of LV end-diastolic pressure, presence or absence of dichrotic notch on the aortic waveform, aortography, echocardiography and use of the more recently described AR index [23]. Even when all these modalities are used however, assessing the impact of residual AR on a given patient’s symptoms can be hard to predict. Patients with good diastolic volumes and pre-existing AR tend to tolerate a leak well; patients with small stiff ventricles and no pre-existing AR tend to tolerate a leak badly. All these factors need to be considered when assessing the impact of AR for a given patient. Post-procedure and during follow-up, echocardiography is not necessarily reliable in assessing post-TAVI AR. Reasons for this are not clear, but it is not unusual for an echocardiogram to suggest relatively mild AR using standard echocardiographic parameters including pressure half-time, while the clinical condition of the
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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patient suggests more severe AR. Under these circumstances, clinical examination of the patient, including pulse character and pressure width, can be very useful. Not all of our cases were successfully treated by paravalvular closure, although all had some degree of reduction of leak. Case selection is therefore very important. If, for example, the AR is due to valve position being too high or too low, so that there is no seal at the annular level, then a crescentic leak will remain and will not be fixed with a vascular plug. Ideal cases for plug closure are where the valve is definitely well placed but there is eccentric expansion of the valve due usually to a rigidly calcific nodule holding the skirt of the valve off the annulus in a specific location. When there is a paravalvular leak of a bioprosthetic valve as well as valve failure, it can be difficult to pick up pre-procedure, as for Case No. 5 in our series. Under these circumstances a second procedure may be required, though if the equipment is available on-site, it may be more prudent to complete closure at the time of the CoreValve implant. We found the leak to be easy to cross at the time, but less easy to cross one month later when the patient was readmitted for the procedure. Our case series shows the feasibility of considering patients for paravalvular leak closure after CoreValve implantation. Guidewire passage through the lattice and outside the skirt of the valve can require both persistence and good fluoroscopic and echocardiograhic orientation. Delivery of an AVP4 plug may be optimal due to the ability to pass this down a diagnostic catheter, but case selection must be carefully made, to avoid those with partial failure of annular coverage.
4.
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6.
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9.
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CONCLUSIONS
This small series demonstrates the feasibility of paravalvular leak closure with the CoreValve TAVI, despite the adverse aortic lattice. The AVP4 device is ideally suited to this situation as it will pass through a 0.038’ lumen and can therefore be delivered down standard diagnostic catheters.
11.
12.
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Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: The U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol 2011;58:2130–2138. Rihal CS, Sorajja P, Booker JD, Hagler DJ, Cabalka AK. Principles of percutaneous paravalvular leak closure. J AM COLL CARDIOL. Cardiovasc Interv 2012;5:121–130. Ruiz CE, Jelnin V, Kronzon I, Dudiy Y, Del Valle-Fernandez R, Einhorn BN, Chiam PT, Martinez C, Eiros R, Roubin G, Cohen HA. Clinical outcomes in patients undergoing percutaneous closure of periprosthetic paravalvular leaks. J Am Coll Cardiol 2011;58:2210–2217. Sorajja P, Cabalka AK, Hagler DJ, Rihal CS. Long-term followup of percutaneous repair of paravalvular prosthetic regurgitation. J Am Coll Cardiol 2011;58:2218–2224. Sinning JM, Vasa-Nicotera M, Werner N, Nickenig G, Hammerstingl C. Interventional closure of paravalvular leakage after transcatheter aortic valve implantation. Eur Heart J 2012; 33:2498. Martinez CA, Singh V, O’Neill BP, Alfonso CE, Bilsker MS, Martinez Clark P, Williams D, Cohen MG, Heldman AW,
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O’Neill WW. Management of paravalvular regurgitation after Edwards SAPIEN transcatheter aortic valve replacement: Management of paravalvular regurgitation after TAVR. Catheter Cardiovasc Interv 2013;82:300–311. Luu J, Ali O, Feldman TE, Price MJ. Percutaneous closure of paravalvular leak after transcatheter aortic valve replacement. JACC Cardiovasc Interv 2013;6:e6–e8. Estevez-Loureiro R, Salgado-Fernandez J, Vazquez-Gonzalez N. Percutaneous closure of paravalvular leaks after transcatheter aortic valve implantation with Edwards SAPIEN prosthesis: A report of two cases. J Invasive Cardiol 2013;25:92–95. Behan M, Haworth P, Hutchinson N, Trivedi U, Laborde JC, Hildick-Smith D. Percutaneous aortic valve implants under sedation: Our initial experience. Catheter Cardiovasc Interv 2008;72: 1012–1015. Sinning JM, Hammerstingl C, Vasa-Nicotera M, Adenauer V, Lema Cachiguango SJ, Scheer AC, Hausen S, Sedaghat A, Ghanem A, M€uller C, Grube E, Nickenig G, Werner N. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol. 2012;59: 1134–1141.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Percutaneous Paravalvular Leak Closure for Symptomatic Aortic Regurgitation after CoreValve Transcatheter Aortic Valve Implantation Satpal S. Arri,* MRCP, P. Poliacikova, MRCP, and D. Hildick-Smith, MD, FRCP Objectives: We present a case series of five patients in whom percutaneous paravalvular leak closure with the AVP4 device has been undertaken for symptomatic aortic reBackground: Significant post-procedure aortic gurgitation after CoreValve TAVI. regurgitation (AR) is often difficult to assess, and is an important predictor of adverse outcome following TAVI. Paravalvular leak closure is an established procedure for surgical aortic prostheses, and has been undertaken for Edwards TAVIs, but has not been described for closure of CoreValve paravalvular leaks. Methods and Results: Five patients were treated (mean age 81 6 4 years) with residual grade 3–4 AR following placement of a single CoreValve (n 5 2), double CoreValve (n 5 2) or CoreValve within a bioprosthetic AVR (n 5 1). The mean time post TAVI implantation was 308 6 269 days. All patients were symptomatic with persistent NYHA Grade III dyspnoea. 6 devices were deployed successfully, with mean procedure time of 109 6 23 min. There were no procedural complications and all patients were discharged home by Day 2. Residual AR after treatment was grade 0 (n 5 2), grade 1 (n 5 1), grade 2 (n 5 1) and grade 3 (n 5 1). Symptomatic improvement was noted in all 4 patients who have been reviewed in clinic since. Conclusions: This small series demonstrates the feasibility of paravalvular leak closure with the CoreValve TAVI, despite the adverse aortic lattice. The AVP4 device is ideally suited to this situation as it will pass through a 0.038’ lumen and can therefore be delivered down standard diagnostic catheters. VC 2014 Wiley Periodicals, Inc. Key words: transcatheter aortic valve implantation; paravalvular leak closure; aortic regurgitation
INTRODUCTION
Transcatheter Aortic Valve Implantation (TAVI) is widely accepted as a viable alternative to open Aortic Valve Replacement (AVR) for patients with symptomatic, severe aortic stenosis (AS) who are at high surgical risk [1–5]. Significant post-procedure aortic regurgitation (AR) is an important predictor of adverse outcome [6–14]. Paravalvular leak closure is an established procedure for surgical aortic prostheses [15–17], and has been undertaken for Edwards TAVIs [18–21], but has not been described for closure of CoreValve (Medtronic, Minneapolis) paravalvular leaks. We present a case series of five patients in whom percutaneous paravalvular leak closure was undertaken for symptomatic AR after CoreValve TAVI.
demographic, TAVI procedural, paravalvular leak closure procedural, and follow-up data were collected. A total of five patients with significant paravalvular leak following CoreValve TAVI underwent percutaneous paravalvular leak closure.
Sussex Cardiac Centre, Brighton and Sussex University Hospitals, United Kingdom Conflict of interest: Nothing to report. *Correspondence to: Dr. Satpal S Arri, Specialist Registrar in Cardiology, Sussex Cardiac Centre, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, East Sussex BN2 5BE, United Kingdom. E-mail: [email protected]
METHODS
Received 13 February 2014; Revision accepted 2 November 2014
We conducted a retrospective review of all cases of paravalvular leak closure following CoreValve TAVI (Medtronic, Minneapolis) at our institution. Baseline
DOI: 10.1002/ccd.25730 Published online 10 November 2014 in Wiley Online Library (wileyonlinelibrary.com)
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Fig. 1. (A) Aortography demonstrating AR secondary to paraprosthetic leak. (B) Aortography demonstrating reduction in AR following deployment of an Amplatzer Vascular Plug (AVP4) 8-mm device.
RESULTS Case 1
A 78-year old male presented with a 12-month history of exertional dyspnoea. He underwent CABG in 1991 and was now found to have symptomatic severe AS (AVA 0.8 cm2, PG 67 mm Hg, Aortic annulus 2.5 cm), and preserved LV systolic function. His case was reviewed by the heart team and given his high operative risk (logistic EuroSCORE 10%) he was referred for TAVI in April 2012. The procedure was performed under conscious sedation [22]. A 29-mm CoreValve was introduced and positioned under fluoroscopic guidance with concurrent pacing at 150 beats/minute. Aortography demonstrated moderate AR requiring post-dilatation of the valve initially with a 26 and then a 28 mm Z-Med balloon. Post procedure transthoracic echo confirmed a mild to moderate posterior paraprosthetic leak. He was referred for paravalvular leak closure one year after his initial valve implant due to ongoing exertional dyspnoea. The procedure was performed under general anaesthesia, via the right radial artery using a 6 French sheath. The paraprosthetic leak was posterolateral on TOE and fluoroscopically was visualised in the lateral and left cranial projections (Fig. 1). Aortography demonstrated Grade III aortic regurgitation. The lattice of the CoreValve was probed using a 5F AL1 catheter and an exchange length hydrophilic 0.035’ (Terumo, Tokyo) guide wire. The defect was crossed with difficulty and the AL1 catheter was exchanged for a 4F MPA (Cordis, Miami Lakes, Florida) catheter. An Amplatzer Vascular Plug (AVP4) 8-mm device, which
can pass down a 0.038” lumen, was then positioned and deployed in an optimal position parallel to the valve skirt, external to the valve structure. This gave an excellent result with only trivial AR persisting, confirmed on echocardiography and aortography (Figs. 1 and 2). Haemostasis was achieved using a TR band. The procedure time was 90 minutes and there were no peri-procedural complications. On follow-up in clinic 3 months later he reported significant symptomatic benefit with improved exercise tolerance. Case 2 A 77 year old male with a previous history of CABG in 1986 presented with syncope and was found to have severe AS (AVA 0.8 cm2, PG 59 mm Hg, aortic annulus 2.5 cm). Cardiac catheterisation demonstrated patent bypass grafts. He was referred for TAVI in December 2009. A 29-mm CoreValve was implanted via the right femoral artery using an 18F sheath. The valve unexpectedly shifted towards the ventricular aspect on release and AR was severe due to failed sealing at the annulus. The valve was therefore snared and traction exerted to lift the valve to an annular seal, and was post-dilated with a 28-mm Z-med balloon to maximise expansion. At the end of the procedure there was Grade II aortic regurgitation around a calcified left coronary cusp, which was considered acceptable. Reassessment due to ongoing dyspnoea suggested severe AR with a low prosthesis and he therefore underwent repeat TAVI via the left femoral artery. A
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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Fig. 2. (A1B) Moderate AR secondary to a paraprosthetic leak demonstrated on Transeosophageal echocardiography. (C) Reduction in AR following paravalvular leak closure with AVP4 8-mm device. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
second 29-mm CoreValve prosthesis was implanted 8 mm above the base of the previous valve and postdilated with a 26-mm Z-med balloon. Unfortunately the patient suffered further progressive reduction in exercise capacity and a TOE confirmed an at least moderate posterior paraprosthetic leak measuring (1.2 0.5 cm) and this was consistent with clinical examination. Paravalvular leak closure was subsequently attempted 24 months following his second TAVI. The procedure was performed under general anaesthesia, via the femoral approach. The upper lattice of the CoreValve prostheses was crossed using an AL1 catheter and an exchange length hydrophilic 0.035’ (Terumo, Tokyo) guide wire. This was directed retrogradely across the leak under fluoroscopic and TOE guidance. Once the wire was in the left ventricle, and imaging confirmed that it lay outside the CoreValve frames, the AL1 catheter was exchanged for a 4F MPA catheter (Cordis, Miami Lakes, Florida). An 8-mm Amplatzer Vascular Plug (AVP4) was then delivered down the catheter and deployed between the valve skirt and the aortic annulus. This reduced the AR from Grade 3 to Grade 0 (Fig. 3). There were no complications and on follow-up in clinic the patient’s symptoms were greatly improved with no persisting AR on TTE.
Case 3 This 82-year old male with a background of significant renal impairment presented with fatigue and exertional dyspnoea. He was found to have severe AS (AVA 0.7 cm2, PG 90 mm Hg, Annulus 26 mm) and subsequently underwent CoreValve (31 mm) implantation via the left femoral artery. Aortography demonstrated moderate AR with elliptical formation of the
valve skirt. Post-dilatation of the valve with a 28-mm Z-Med balloon improved the circularity of the prosthesis and reduced the AR. The AR index was calculated and found to be 24 with mild to moderate AR confirmed on TTE post procedure. He was discharged on Day 5. Unfortunately on follow-up review in clinic 8 weeks later he remained significantly breathless on exertion. Echocardiography suggested moderate paravalvular AR at worst with no flow reversal in the descending aorta and a pressure half-time of 500 ms. On the basis of the clinical findings however he was referred for paravalvular leak closure. This was performed via the right femoral artery using a 6 French sheath, 6 months after his initial valve implantation. Aortography and TOE demonstrated posterior, posterolateral and anterolateral leaks with Grade 4 angiographic AR (Fig. 4). The posterolateral leak was crossed with an exchange length hydrophilic 0.035’ (Terumo, Tokyo) guide wire and an AVP4 8-mm device deployed using a 4 French MPA (Cordis, Miami Lakes, FL) catheter into a significant paravalvular space with good resolution of the posterolateral jet. A second 8-mm AVP4 device was used to treat the anterolateral jet using a similar technique. Grade 2 AR remained by the end of the procedure. Given his renal impairment only 150 ml of Omnipaque 350 contrast was used. The procedure time was 140 minutes. There were no complications and he was discharged from hospital the next day. Case 4
An 85-year old male with a history of peripheral vascular disease initially presented with worsening exertional dyspnoea. Transthoracic echocardiography confirmed severe AS (AVA 0.85 cm2, PG 100 mm
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Fig. 3. (A) Aortography demonstrating Grade 3 AR. (B) An exchange length hydrophilic 0.035’ (Terumo, Tokyo) guide wire directed across the leak into the left ventricle. (C) 8-mm Amplatzer Vascular Plug (AVP4) delivered down a 4F MPA catheter (Cordis, Miami Lakes, FL) between the valve skirt and aortic annulus. (D) Aortography demonstrating a reduction in AR to grade 0.
Hg) with preserved LV systolic function. The aortic annulus measured 2.7 cm on TOE. He underwent balloon aortic valvuloplasty using a 26-mm Z-Med balloon in November 2010. An aortogram during balloon inflation did not demonstrate any AR. His symptoms improved significantly but recurred 6 months later. His case was reviewed by the Heart Team and he was accepted for TAVI. The valve was crossed and predilated with a 25-mm Z-Med balloon. A 31-mm CoreValve prosthesis was positioned in an optimal position just under the aortic annulus. Unfortunately on release of the valve there was reorientation and upwards valvular movement by several millimetres, such that the prosthesis lay par-
tially supra-annular. A second valve was therefore deployed, but due to overcorrection we placed this valve a little lower than intended. The final angiographic result demonstrated apparently mild AR. Unfortunately on review in the outpatients clinic 1 month later he presented with peripheral oedema and worsening breathlessness. TTE demonstrated a moderate paravalvular leak with mild LV impairment. He responded very well to medical therapy over the next 9 months but then gradually redeveloped symptoms of breathlessness on minimal exertion. Clinical examination and echocardiography both suggested a severe paravalvular leak. The left ventricle was now dilated with severe LV systolic dysfunction and an ejection fraction
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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Fig. 4. (A) TOE demonstrating posterolateral and anterolateral leaks. (B) A second 8-mm AVP4 device delivered using a 4F MPA (Cordis, Miami Lakes, FL) catheter to treat the anterolateral jet. (C)-Reduction in AR seen following deployment of two AVP4 devices on TOE. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Fig. 5. The AVP4 device, courtesy of St. Jude Medical, Inc. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
of 20%. He subsequently underwent paravalvular leak closure in May 2013. This was performed via the right femoral artery using a 6F sheath. An anterior paravalvular leak was crossed with technical difficulty and a single 8-mm AVP4 device deployed with modest angiographic improvement (Grade 2 AR). On review 4 weeks later his symptoms had improved and his exercise capacity had increased to 150 m. Left ventricular function remained impaired and further intervention may be required.
Case 5 An 83-year old male was admitted with worsening exertional dyspnoea and heart failure requiring intravenous diuretics. Past medical history included coarctation repair in 1972 and single vessel CABG (LIMA to LAD) plus 25-mm Carpentier-Edwards AVR in 1996. Cardiac catheterisation demonstrated no targets for percutaneous revascularisation. Aortography demonstrated severe AR, confirmed on TTE. There was severe impairment of LV function (EF < 30%) and associated moderate mitral regurgitation. He was subsequently referred for TAVI. This was performed in June 2012 from the right femoral and right radial arteries. The site of previous coarctation repair was widely patent. The valve was crossed and a 26-mm CoreValve prosthesis implanted within the previous bioprosthesis in an excellent position. Surprisingly there was Grade II AR and on closer inspection there was a paravalvular leak in addition to the pre-existing transvalvular leak. The paravalvular leak was crossed with a Terumo wire and an AL-1 catheter confirming its suitability for treatment at a later date. The patient returned one month later for elective paravalvular closure. This was performed from the right femoral artery. The defect was crossed with a Terumo wire, however, neither a 4F MPA catheter, a 5F MPA catheter, a Terumo heart rail, a 5F Cook shuttle sheath nor a 5F multipurpose guide catheter could be encouraged to follow, possibly due to skirt expansion and the formation of some fibrous tissue. Eventually the defect was crossed with a 6F MPA guide catheter allowing us to deploy an 8-mm AVP4 device. Repeat TTE demonstrated only a trivial residual leak with PG 13 mm Hg across the valve. He has had no
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Procedural and clinical success: Grade I AR, NYHA 1 None
Procedural and clinical success: Grade III AR, NYHA II None
Procedural success: Grade II AR, Clinical review awaited None
AVP4 8 mm 25-mm Carpentier-Edwards AVR, CoreValve 26 mm 83, Male
Grade III, NYHA III
AVP4 8 mm 31-mm CoreValve (2) 85, Male
Grade IV, NYHA III
AVP4 8 mm (2) Grade IV, NYHA III 31-mm CoreValve 82, Male
AVP4 8 mm Grade III, NYHA III 29-mm CoreValve (2) 77, Male
Outcome
Procedural and clinical success: Grade 0 AR, NYHA I None
None
Complication Procedural characteristics
AL1- to cross defect erumo 0.035 guidewire 4F MPA- to deliver device AL1- to cross defect Terumo 0.035 guidewire 4F MPA- to deliver device AL1- to cross defects Terumo 0.035 guidewire 4F MPA- to deliver devices Posterolateral and anterolateral leaks requiring 2 devices AL1- to cross defect Terumo 0.035 guidewire 4F MPA – to deliver device AL1 to cross defect Terumo 0.035 guidewire 6F MPA required to deliver device -likely due to skirt expansion and fibrous issue formation. AVP4 8 mm
Device AR severity
Grade III, NYHA III 29-mm CoreValve
Previous prosthesis Patient
TABLE I. Patient and Procedural Characteristics
Procedural and clinical success: Grade 0 AR, NYHA I
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78 y, Male
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further cardiac hospitalizations with decompensated heart failure and remains asymptomatic at follow-up 3 months later. DISCUSSION
In this case series, five patients were treated (mean age 81 6 4 years) with residual grade 3–4 AR following placement of a single CoreValve (n ¼ 2), double CoreValve (n ¼ 2) or CoreValve within a bioprosthetic AVR (n ¼ 1). The mean time post TAVI implantation was 308 6 269 days. All patients were symptomatic with persistent NYHA Grade III dyspnoea. Six devices were deployed successfully, with mean procedure time of 109 6 23 min. There were no procedural complications and all five patients were discharged home by Day 2. Residual AR after treatment was grade 0 (n ¼ 2), grade 1 (n ¼ 1), grade 2 (n ¼ 1), and grade 3 (n ¼ 1). Symptomatic improvement was noted in all four patients who have been reviewed in clinic since. AR morphology and aetiology was complex in two cases, with multiple leaks in one patient and a long semilunar segment in another requiring a second AVP device. This exemplifies the need for careful case evaluation and selection. This small series demonstrates the feasibility of paravalvular leak closure with the CoreValve TAVI, despite the adverse aortic lattice. The AVP4 device is ideally suited to this situation as it will pass through a 0.038’ lumen and can therefore be delivered down standard diagnostic catheters. Our study draws attention to the difficulty of assessing the degree of AR at the time of TAVI implantation. Recognition of this fact, and of the probable prognostic importance of residual AR [6–14] has led to increasing use of multiple modalities to assess procedural AR, including use of LV end-diastolic pressure, presence or absence of dichrotic notch on the aortic waveform, aortography, echocardiography and use of the more recently described AR index [23]. Even when all these modalities are used however, assessing the impact of residual AR on a given patient’s symptoms can be hard to predict. Patients with good diastolic volumes and pre-existing AR tend to tolerate a leak well; patients with small stiff ventricles and no pre-existing AR tend to tolerate a leak badly. All these factors need to be considered when assessing the impact of AR for a given patient. Post-procedure and during follow-up, echocardiography is not necessarily reliable in assessing post-TAVI AR. Reasons for this are not clear, but it is not unusual for an echocardiogram to suggest relatively mild AR using standard echocardiographic parameters including pressure half-time, while the clinical condition of the
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Percutaneous Paravalvular Leak
patient suggests more severe AR. Under these circumstances, clinical examination of the patient, including pulse character and pressure width, can be very useful. Not all of our cases were successfully treated by paravalvular closure, although all had some degree of reduction of leak. Case selection is therefore very important. If, for example, the AR is due to valve position being too high or too low, so that there is no seal at the annular level, then a crescentic leak will remain and will not be fixed with a vascular plug. Ideal cases for plug closure are where the valve is definitely well placed but there is eccentric expansion of the valve due usually to a rigidly calcific nodule holding the skirt of the valve off the annulus in a specific location. When there is a paravalvular leak of a bioprosthetic valve as well as valve failure, it can be difficult to pick up pre-procedure, as for Case No. 5 in our series. Under these circumstances a second procedure may be required, though if the equipment is available on-site, it may be more prudent to complete closure at the time of the CoreValve implant. We found the leak to be easy to cross at the time, but less easy to cross one month later when the patient was readmitted for the procedure. Our case series shows the feasibility of considering patients for paravalvular leak closure after CoreValve implantation. Guidewire passage through the lattice and outside the skirt of the valve can require both persistence and good fluoroscopic and echocardiograhic orientation. Delivery of an AVP4 plug may be optimal due to the ability to pass this down a diagnostic catheter, but case selection must be carefully made, to avoid those with partial failure of annular coverage.
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5.
6.
7.
8.
9.
10.
CONCLUSIONS
This small series demonstrates the feasibility of paravalvular leak closure with the CoreValve TAVI, despite the adverse aortic lattice. The AVP4 device is ideally suited to this situation as it will pass through a 0.038’ lumen and can therefore be delivered down standard diagnostic catheters.
11.
12.
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