Catheterization and Cardiovascular Interventions 84:1202–1208 (2014)
Transcatheter Valve-in-Ring Implantation After a Failed Surgical Mitral Repair Using a Transseptal Approach and a Veno-Arterial Loop for Valve Placement € seyin Ince,1 MD, PhD, and Nina C. Wunderlich,1,2* MD, Stephan Kische,1 MD, PhD, Hu 1 -Turan, MD Ilkay Bozdag A failure of a mitral valve repair, which includes the implantation of a mitral annuloplasty ring in the majority of cases, is associated with relevant mortality. Surgery is considered as the standard treatment for these patients. For patients who have an unacceptable high peri-surgical risk a transcatheter valve-in-ring (TVIR) procedure might be an option. Isolated case reports and small case series report on the feasibility of a TVIR implantation in mitral position. We present a case where a 29-mm Edwards Sapien valve was placed in a 32-mm Carpentier Edwards ring. To our knowledge no valve has been implanted so far in this ring size and this is the first case where a veno-arterial loop was used as guide rail for valve implantation and helped considerably to position the valve properly. VC 2013 Wiley Periodicals, Inc. Key words: percutaneous mitral intervention; transcatheter valve-in-ring procedure; failed mitral repair
INTRODUCTION
Mitral valve repair, which includes the implantation of a mitral annuloplasty ring in the majority of cases, has become the preferred treatment option when feasible in patients with mitral regurgitation (MR) irrespective of the cause of valve dysfunction [1]. However, failure of the repair and recurrence of significant MR—associated with relevant mortality—may occur [2,3]. For these patients surgery is considered the standard treatment option; however may be associated with an unacceptable high peri-operative risk especially in elderly patients with multiple comorbidities. A less invasive approach may be an alternative for some of these patients. The percutaneous transcatheter concept of a valvein-valve procedure has been shown to be a viable option and clinically effective in patients with either degenerated aortic bioprosthesis [4,5] or failed mitral bioprostheses [6–9]. In addition, a few studies suggested the feasibility of a transcatheter mitral valve replacement after a mitral valve repair with different kinds of annuloplasty rings in an animal model [10,11]. Furthermore, isolated case reports and small case series reported the feasibility of a transcatheter valve-inring (TVIR) implantation in mitral position in patients with a failed mitral valve repair [12–16]. C 2013 Wiley Periodicals, Inc. V
In the majority of these cases a transapical approach was used. When a transseptal access was chosen, a curved stiff wire was placed in the left ventricle apex to serve as guide rail for valve implantation. We report a case where a 29-mm Edwards Sapien XT valve was placed in a 32-mm Carpentier Edwards (CE) ring. To our knowledge no valve has been implanted so far in this ring size and this is the first case in which a veno-arterial loop was created and used as guide rail for valve implantation and helped considerably to position the valve properly.
1
University Hospital Rostock, Rostock, Germany Cardiovascular Center Darmstadt, Darmstadt, Germany
2
Conflict of interest: Nothing to report. Nina C. Wunderlich and Stephan Kische contributed equally to this article *Correspondence to: Nina C. Wunderlich, MD, Kardiologisches Zentrum Darmstadt, Dieburgerstrasse 31 c, 64287 Darmstadt, Germany. E-mail: [email protected] Received 21 August 2013; Revision accepted 28 November 2013 DOI: 10.1002/ccd.25309 Published online 4 December 2013 in Wiley Online Library (wileyonlinelibrary.com)
Transcatheter Valve-in-Ring Implantation
CASE REPORT Patient History and Valve Assessment
A 62-year-old man was admitted due to increasing dyspnea NYHA III and recurrent congestive heart failure since January 2013. In June 2007 dilated cardiomyopathy with severely impaired systolic left ventricular function (ejection fraction 20%) was diagnosed with severe functional MR. Subsequently, the patient underwent mitral valve reconstruction and a CE Physio semirigid ring sized 32 mm (Edwards Lifesciences Inc; Irvine, CA) was implanted in July 2007. The post-operative course was complicated by a stroke with mild persisting symptoms, prolonged respiration therapy over 3 months due to pneumonia, and the need for a re-operation due to a large chest hernia. A single chamber implantable cardioverter-defibrillator (ICD) was implanted in June 2010 after the detection of non-sustained ventricular tachcardia (VT)s. A transthoracic (TTE) and a transesophageal echocardiographic (TEE) study in May 2013 (Fig. 1) revealed an improved ejection fraction of 55% and relevant MR mainly due to a severe restriction of the posterior mitral leaflet (Fig. 1A and C). Further, a mild paravalvular leakage in antero-lateral position due to a suture dehiscence was detected. The regurgitant volume was calculated to be 62 ml, the pulmonary artery pressure was 60 mm Hg, and the mean gradient across the mitral valve was 9 mm Hg (Fig. 1B). The calculated logistic EuroSCORE was 14.3%. As the patient denied redo surgery transcatheter treatment options were discussed. Due to the 3D measurements which showed a mitral valve area of only 3.54 cm2 (lateral–medial diameter: 2.76 cm, anterior–posterior diameter: 1.8 cm) (Fig. 2) and the severe restriction of the posterior leaflet, the patient was not considered a R procedure and possible candidate for a MitraClipV therefore a ring-in-valve procedure was scheduled. Procedure The procedure was performed under general anesthesia. Two-(2D) and three-dimensional (3D) TEE guidance supported fluoroscopy. Via femoral access (18 Fr sheath; Edwards Lifescience), a transseptal puncture using standard techniques was performed in the superior more posterior part of the interatrial septum. As opposed to previously published cases, a veno-arterial loop was created in order to achieve enhanced stability and steerability for valve implantation (Fig. 3A). Therefore, a long diagnostic wire supported by a catheter was advanced in the left atrium, directed through the mitral valve in the left ventricle, and then retrograde through the aortic valve. The wire was finally placed in the ascending aorta. A 25-mm Amplatzer
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Goose snare was advanced via an appropriate sheath from the opposite groin. The femoral artery served as access. In the ascending aorta the wire was snared with the Amplatzer Goose snare and externalized via the femoral artery. This maneuver completed the venoarterial loop. In a next step, the interatrial septum was pre-dilated with a Fox Plus 12/60 mm balloon (Abbott) (Fig. 3B). The decision was made to implant a 29-mm Edwards SAPIEN XT valve. The valve was mounted reversely on a standard 18 Fr Novaflex catheter (Edwards Lifescience), which is usually used for transfemoral valve delivery. The Novaflex catheter was then directed toward the mitral valve in a projection that showed the CE Physio ring in an orthogonal projection. The SAPIEN XT valve was advanced and placed within the mitral ring (Fig. 3C). The deployment of the valve was performed under rapid pacing (180 bpm) by slow, controlled balloon inflation (Fig. 3D and E). During valve deployment, fluoroscopy and TEE guidance showed that the valve opened slightly oblique within the mitral ring which could be corrected by pulling on the veno-arterial loop. The final result and the correct position of the SAPIEN XT valve within the mitral ring was assessed carefully by fluoroscopy (Fig. 3F) and 2D and 3D TEE. The implanted CE Physio ring adapted well to the round shape of the SAPIEN XT valve and no residual MR was seen through the valve (Fig. 4). As expected, minor regurgitation was detected between the mitral ring and the surrounding native tissue which was caused by the small paravalvular leakages in antero-lateral position, already described in pre-procedure evaluation. Follow-up
A clinical follow-up, a transthoracic echocardiography, and a multislice computed tomography (CT) (Figs. 5 and 6) were performed before discharge. During 1-month follow-up the patient was evaluated clinically. In addition, TTE and 2D and 3D TEE were performed. Dyspnea decreased considerably (NYHA III to NYHA I), no hemolysis occurred, the regurgitant volume was calculated to be 18 ml and the calculated pulmonary artery pressure was 40 mm Hg. The position of the Edwards SAPIEN XT valve within the mitral ring was stable and unchanged and there was still no MR through the valve. DISCUSSION
There is only very limited experience of percutaneous treatment after a failed mitral valve repair with the implantation of a ring. The only available percutaneous R , is not technique, the implantation of a MitraClipV
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. 1. Evaluation of the mitral valve pre-procedure. In (A) a long axis TEE view (120 ) in systole is shown without (left panel) and with (right panel) color Doppler. White arrows point at the Carpentier Edwards Physio ring. The red arrow points at the posterior mitral leaflet. As it is very thin and nearly invisible it is visualized by a red dashed line. It becomes evident that the posterior leaflet is not involved in the coaptation. The resulting MR jet is visible on the right panel. In (B) the Doppler tracing of the mitral inflow is shown. The calculated mean gradient is 9 mm Hg. In (C) an enface 3D TEE view of the mi-
tral valve is seen in systole. The white arrows point at the posterior leaflet which cannot be seen because it is severely retracted. The white stars mark the two small paravalvular leakages in antero-lateral position between the 32-mm CE Physio ring and the surrounding native tissue. A suture bridge can be identified between the small paravalvular leaks. LA 5 left atrium, LV 5 left ventricle, CE 5 Carpentier Edwards, Ao 5 aorta. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
applicable in most cases due to small ring areas and unfavorable anatomy. Several case reports and small series have reported the feasibility of a TVIR procedure [10–16]. A present annuloplasty ring has the advantage to serve as a stable anchor zone for a valve prosthesis. However, a major concern is that the CE Physio ring is more oval shaped whereas the implanted valve has a round shape. The question arises whether the ring adapts to the configuration of the implanted valve as any distortion of the valve itself may lead to regurgitation through the torn leaflets and/or to paravalvular regurgi-
tation due to suboptimal apposition to the ring. Dahle et al. [15] described a bench test, in which a 34-mm CE Physio ring adapted well to a 29-mm Edwards SAPIEN XT valve and became a round shape. With the case described above we confirmed that a 32-mm CE Physio ring changed its configuration from oval to round once the 29-mm Edwards SAPIEN XT valve is in place. So far only the balloon expandable Edwards SAPIEN XT valve was used for TVIR procedures in R humans. However, the implantation of a MelodyV transcatheter valve (Medtronic, Minneapolis, MN) in
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Fig. 2. 3D TEE measurements of the Carpentier Edwards Physio ring in a post-processing step (Qlab; Philips). The upper left panel shows an intercommissural view, the corresponding long axis view is seen on the right side. The left panel at the bottom shows an enface view of the mitral ring.
The measurements done in this view showed an anterior–posterior diameter of 1.8 cm and a lateral-medial diameter of 2.76 cm. The ring area was 3.54 cm2. A-P 5 anterior–posterior, LM 5 lateral medial. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Fig. 3. Fluoroscopic images showing the procedural steps. In (A) the white arrows follow the veno-arterial loop coming from the inferior vena cava leading through the septum to the left atrium, then to the left ventricle and retrogradely through the aorta. In (B) the pre-dilation of the interatrial septum with a 12/60 Fox Plus balloon (Abbott) is demonstrated. C: Shows
the SAPIEN XT valve which is positioned within the Physio ring. The ring is visualized in an orthogonal projection. In (D, E) the inflation of the balloon can be observed stepwise. In (F) the final position of the valve within the mitral ring is shown. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
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Fig. 4. Evaluation of the mitral valve post-procedure. A: Shows a 2D TEE image (96 ) without (left panel) and with color Doppler (right panel). The three cusps of the SAPIEN XT valve can be identified. There is no regurgitation through the valve, but a mild paravalvular regurgitation can be identified (white arrow). B: Shows an enface 3D TEE view of the implanted
valve. The Physio ring adapts to the round shape of the valve. In (C) gradients are calculated by tracing the Doppler diastolic mitral flow profile. Post-procedure the mean gradient was 1 mm Hg. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Fig. 5. CT images after implantation of a 29-mm Edwards SAPIEN XT valve in a 32-mm CE Physio ring. The implanted valve can be seen in a conventional long axis CT image on the left side and in a CT reconstruction on the right side where the relationship between the implanted valve and the mitral ring can be better appreciated. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
different mitral annuloplasy rings was also shown to be feasible in an animal model [11] but there may be limitations due to available sizes. Published data [16] suggest that Physio ring sizes up to 26 mm may be treated with a 23 mm, ring sizes
from 26 to 31 mm with a 26 mm, and ring sizes of 34 mm with a 29-mm balloon expandable Edwards SAPIEN valve. To our knowledge no valve has been implanted in a 32-mm Physio ring so far and the choice was between a 26 mm and a 29 mm valve.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Transcatheter Valve-in-Ring Implantation
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and in valve design may improve results. Randomized studies with longer follow-up duration are needed to evaluate the stability and the durability of TVIR procedures. REFERENCES
Fig. 6. 3D CT reconstruction showing the implanted 29-mm Edwards SAPIEN XT valve within 32-mm CE Physio ring in detail. Note how well the Physio ring adapts to the round shape of the Edwards SAPIEN XT valve. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
However, the decision was made to implant a 29-mm Edwards SAPIEN XT valve as a valve which is too small carries the potential risk of device embolization. Finally this size turned out to fit appropriately into the 32-mm CE Physio ring. The positioning of the valve prosthesis within the mitral ring is challenging. Careful fluoroscopic and TEE guidance is needed and the prosthesis is expanded under right ventricular rapid pacing and slow, controlled balloon inflation as described previously [16]. However, steerability is limited specifically when only a stiff wire is placed in the left ventricular apex as described in all previously published cases. In this present case, positing of the valve was optimized and facilitated by pulling on the venoarterial loop which enabled to correct the position of the valve at a point where other technical options for optimization were no longer available. CONCLUSION
Redo surgery remains the standard treatment for patients with failed mitral valve repair. Nevertheless, percutaneous TVIR procedures are feasible and may be a promising alternative treatment option for patients who are having an unacceptable high surgical risk. Our case example suggests that a 29-mm Edwards SAPIEN XT valve fits well in a 32-mm CE Physio ring and a veno-arterial loop may be helpful for final valve adjustments during balloon inflation. The optimal approach for this procedure has not yet been evaluated in larger series. However, transseptal access appears advantageous because of less complication rates due to a venous femoral access, an easily performed antegrade crossing of the valve and a more coaxial alignment to the mitral ring. Further improvements in technology
1. Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Sch€afers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M. Guidelines on the management of valvular heart disease (version 2012): The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology(ESC) and the European Association for Cardio- Thoracic Surgery (EACTS). Eur J Cardiothorac Surg 2012;42:1–42. 2. Crabtree TD, Bailey MS, Moon MR, Munfakh N, Pasque MK, Lawton JS, Moazami N, Aubuchon KA, Al-Dadah AS, Damiano RJ Jr. Recurrent mitral regurgitation and risk factors for early and late mortality after mitral valve repair for functional ischemic mitral regurgitation. Ann Thora Surg 2008;85:1537–1542. 3. Ciarka A, Braun J, Delgado V, Versteegh M, Boersma E, Klautz R, Dion R, Bax JJ, Van de Veire N. Predictors of mitral regurgitation recurrence in patients with heart failure undergoing mitral valve annuloplasty. Am J Cardiol 2010;106:395–401. 4. Dvir D, Webb J, Brecker S, Bleiziffer S, Hildick-Smith D, Colombo A, Descoutures F, Hengstenberg C, Moat NE, Bekeredjian R, Napodano M, Testa L, Lefevre T, Guetta V, Nissen H, Hernandez JM, Roy D, Teles RC, Segev A, Dumonteil N, Fiorina C, Gotzmann M, Tchetche D, AbdelWahab M, De Marco F, Baumbach A, Laborde JC, Kornowski R. Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: Results from the Global Valve-inValve Registry. Circulation 2012;126:2335–2344. 5. Makkar RR, Jilaihawi H, Chakravarty T, Fontana GP, Kapadia S, Babaliaros V, Cheng W, Thourani VH, Bavaria J, Svensson L, Kodali S, Shiota T, Siegel R, Tuzcu EM, Xu K, Hahn RT, Herrmann HC, Reisman M, Whisenant B, Lim S, Beohar N, Mack M, Teirstein P, Rihal C, Douglas PS, Blackstone E, Pichard A, Webb JG, Leon MB. Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: A study of multiple valve implants in the US PARTNER trial. J Am Coll Cardiol 2013;62:418–430. 6. Cheung AW, Gurvitch R, Ye J, Wood D, Lichtenstein SV, Thompson C, Webb JG. Transcatheter transapical mitral valvein valve implantations for a failed bioprosthesis: a case series. J Thorac Cardiovacs Surg 2011;141:711–715. 7. Seiffert M, Conradi L, Baldus S, Schirmer J, Knap M, Blankenberg S, Reichenspurner H, Treede H. Transcatheter mitral valve-in-valve implantation in patients with degenerated bioprostheses. J Am Coll Cardiol Interv 2012;5:341–349. 8. Elmariah S, Arzamendi D, Llanos A, Margey RJ, Inglessis I, Passeri JJ, Mehrotra P, Baker JN, Rosenfield K, Agnihotri AK, Vlahakes GJ, Palacios IF. First experience with transcatheter valve-in-valve implantation for a stenotic mitral prosthesis within the United States. J Am Coll Cardiol Interv 2012;5:e13–e14. 9. Wilbring M, Alexiou K, Tugtekin SM, Sill B, Hammer P, Schmidt T, Simonis G, Matschke K, Kappert U. Transapical transcatheter valve-in-valve implantation for deteriorated mitral valve bioprostheses. Ann Thorac Surg 2013;95:111–117. 10. Kempfert J, Blumenstein J, Chu MWA, Pritzwald-Stegmann P, Kobilke T, Falk V, Mohr FW, Walther T. Minimally invasive
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off-pump valve-in-a-ring implantation: The atrial transcatheter approach for re-operative mitral valve replacement after failed repair. Eur J Cardiothorac Surg 2009;35:965–969. 11. Kondo N, Shuto T, McGarvey JR, Koomalsingh KJ, Takebe M, R Valve-in-ring Gomran RC, Gorman JH, Gillespie MJ. MelodyV procedure for mitral valve replacement: Feasibility in four annuloplasty types. Ann Thorac Surg 2012;93:783–788. 12. de Weger A, Ewe SE, Delgado V, Bax JJ. First-in-man implantation of a trans-catheter aortic valve in a mitralannuloplasty ring: novel treatment modality for failed mitral valve repair. Eur J Cardiothorac Surg 2011;39:1054–1056. 13. Casselman F, Martens S, De Bruyne B, Degrieck I. Reducing operative mortality in valvular reoperations:The “valve in ring” procedure. J Thorac Cardiovasc Surg C 2011;141:1317–1318.
14. Himbert D, Brochet E, Radu C, Iung B, Messika-Zeitoun D, Enguerrand D, Bougoin W, Nataf P, Vahanian A. Transseptal implantation of a transcatheter heart valve in a mitral annuloplasty ring to treat mitral repair failure. Circ Cardiovasc Interv 2011;4:396–398. 15. Dahle G, Fiane AE, Rein K-A. Transapical 29-mm Edwards SAPIEN-XT aortic valve in a 34-mm mitral annuloplasty ring. Innovations 2012;7:290–294. 16. Descoutures F, Himbert D, Maisano F, Casselman F, de Weger A, Bodea O, Van der Kley F, Colombo A, Giannini C, Rein K-A, De Bruyne B, Petronio AS, Dahle G, Alfieri O, Vahanian A. Transcatheter valve-in-ring implantation after failure of surgical mitral repair. Eur J Cardiothorac Surg 2013;44: e8–e15.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Transcatheter Valve-in-Ring Implantation After a Failed Surgical Mitral Repair Using a Transseptal Approach and a Veno-Arterial Loop for Valve Placement € seyin Ince,1 MD, PhD, and Nina C. Wunderlich,1,2* MD, Stephan Kische,1 MD, PhD, Hu 1 -Turan, MD Ilkay Bozdag A failure of a mitral valve repair, which includes the implantation of a mitral annuloplasty ring in the majority of cases, is associated with relevant mortality. Surgery is considered as the standard treatment for these patients. For patients who have an unacceptable high peri-surgical risk a transcatheter valve-in-ring (TVIR) procedure might be an option. Isolated case reports and small case series report on the feasibility of a TVIR implantation in mitral position. We present a case where a 29-mm Edwards Sapien valve was placed in a 32-mm Carpentier Edwards ring. To our knowledge no valve has been implanted so far in this ring size and this is the first case where a veno-arterial loop was used as guide rail for valve implantation and helped considerably to position the valve properly. VC 2013 Wiley Periodicals, Inc. Key words: percutaneous mitral intervention; transcatheter valve-in-ring procedure; failed mitral repair
INTRODUCTION
Mitral valve repair, which includes the implantation of a mitral annuloplasty ring in the majority of cases, has become the preferred treatment option when feasible in patients with mitral regurgitation (MR) irrespective of the cause of valve dysfunction [1]. However, failure of the repair and recurrence of significant MR—associated with relevant mortality—may occur [2,3]. For these patients surgery is considered the standard treatment option; however may be associated with an unacceptable high peri-operative risk especially in elderly patients with multiple comorbidities. A less invasive approach may be an alternative for some of these patients. The percutaneous transcatheter concept of a valvein-valve procedure has been shown to be a viable option and clinically effective in patients with either degenerated aortic bioprosthesis [4,5] or failed mitral bioprostheses [6–9]. In addition, a few studies suggested the feasibility of a transcatheter mitral valve replacement after a mitral valve repair with different kinds of annuloplasty rings in an animal model [10,11]. Furthermore, isolated case reports and small case series reported the feasibility of a transcatheter valve-inring (TVIR) implantation in mitral position in patients with a failed mitral valve repair [12–16]. C 2013 Wiley Periodicals, Inc. V
In the majority of these cases a transapical approach was used. When a transseptal access was chosen, a curved stiff wire was placed in the left ventricle apex to serve as guide rail for valve implantation. We report a case where a 29-mm Edwards Sapien XT valve was placed in a 32-mm Carpentier Edwards (CE) ring. To our knowledge no valve has been implanted so far in this ring size and this is the first case in which a veno-arterial loop was created and used as guide rail for valve implantation and helped considerably to position the valve properly.
1
University Hospital Rostock, Rostock, Germany Cardiovascular Center Darmstadt, Darmstadt, Germany
2
Conflict of interest: Nothing to report. Nina C. Wunderlich and Stephan Kische contributed equally to this article *Correspondence to: Nina C. Wunderlich, MD, Kardiologisches Zentrum Darmstadt, Dieburgerstrasse 31 c, 64287 Darmstadt, Germany. E-mail: [email protected] Received 21 August 2013; Revision accepted 28 November 2013 DOI: 10.1002/ccd.25309 Published online 4 December 2013 in Wiley Online Library (wileyonlinelibrary.com)
Transcatheter Valve-in-Ring Implantation
CASE REPORT Patient History and Valve Assessment
A 62-year-old man was admitted due to increasing dyspnea NYHA III and recurrent congestive heart failure since January 2013. In June 2007 dilated cardiomyopathy with severely impaired systolic left ventricular function (ejection fraction 20%) was diagnosed with severe functional MR. Subsequently, the patient underwent mitral valve reconstruction and a CE Physio semirigid ring sized 32 mm (Edwards Lifesciences Inc; Irvine, CA) was implanted in July 2007. The post-operative course was complicated by a stroke with mild persisting symptoms, prolonged respiration therapy over 3 months due to pneumonia, and the need for a re-operation due to a large chest hernia. A single chamber implantable cardioverter-defibrillator (ICD) was implanted in June 2010 after the detection of non-sustained ventricular tachcardia (VT)s. A transthoracic (TTE) and a transesophageal echocardiographic (TEE) study in May 2013 (Fig. 1) revealed an improved ejection fraction of 55% and relevant MR mainly due to a severe restriction of the posterior mitral leaflet (Fig. 1A and C). Further, a mild paravalvular leakage in antero-lateral position due to a suture dehiscence was detected. The regurgitant volume was calculated to be 62 ml, the pulmonary artery pressure was 60 mm Hg, and the mean gradient across the mitral valve was 9 mm Hg (Fig. 1B). The calculated logistic EuroSCORE was 14.3%. As the patient denied redo surgery transcatheter treatment options were discussed. Due to the 3D measurements which showed a mitral valve area of only 3.54 cm2 (lateral–medial diameter: 2.76 cm, anterior–posterior diameter: 1.8 cm) (Fig. 2) and the severe restriction of the posterior leaflet, the patient was not considered a R procedure and possible candidate for a MitraClipV therefore a ring-in-valve procedure was scheduled. Procedure The procedure was performed under general anesthesia. Two-(2D) and three-dimensional (3D) TEE guidance supported fluoroscopy. Via femoral access (18 Fr sheath; Edwards Lifescience), a transseptal puncture using standard techniques was performed in the superior more posterior part of the interatrial septum. As opposed to previously published cases, a veno-arterial loop was created in order to achieve enhanced stability and steerability for valve implantation (Fig. 3A). Therefore, a long diagnostic wire supported by a catheter was advanced in the left atrium, directed through the mitral valve in the left ventricle, and then retrograde through the aortic valve. The wire was finally placed in the ascending aorta. A 25-mm Amplatzer
1203
Goose snare was advanced via an appropriate sheath from the opposite groin. The femoral artery served as access. In the ascending aorta the wire was snared with the Amplatzer Goose snare and externalized via the femoral artery. This maneuver completed the venoarterial loop. In a next step, the interatrial septum was pre-dilated with a Fox Plus 12/60 mm balloon (Abbott) (Fig. 3B). The decision was made to implant a 29-mm Edwards SAPIEN XT valve. The valve was mounted reversely on a standard 18 Fr Novaflex catheter (Edwards Lifescience), which is usually used for transfemoral valve delivery. The Novaflex catheter was then directed toward the mitral valve in a projection that showed the CE Physio ring in an orthogonal projection. The SAPIEN XT valve was advanced and placed within the mitral ring (Fig. 3C). The deployment of the valve was performed under rapid pacing (180 bpm) by slow, controlled balloon inflation (Fig. 3D and E). During valve deployment, fluoroscopy and TEE guidance showed that the valve opened slightly oblique within the mitral ring which could be corrected by pulling on the veno-arterial loop. The final result and the correct position of the SAPIEN XT valve within the mitral ring was assessed carefully by fluoroscopy (Fig. 3F) and 2D and 3D TEE. The implanted CE Physio ring adapted well to the round shape of the SAPIEN XT valve and no residual MR was seen through the valve (Fig. 4). As expected, minor regurgitation was detected between the mitral ring and the surrounding native tissue which was caused by the small paravalvular leakages in antero-lateral position, already described in pre-procedure evaluation. Follow-up
A clinical follow-up, a transthoracic echocardiography, and a multislice computed tomography (CT) (Figs. 5 and 6) were performed before discharge. During 1-month follow-up the patient was evaluated clinically. In addition, TTE and 2D and 3D TEE were performed. Dyspnea decreased considerably (NYHA III to NYHA I), no hemolysis occurred, the regurgitant volume was calculated to be 18 ml and the calculated pulmonary artery pressure was 40 mm Hg. The position of the Edwards SAPIEN XT valve within the mitral ring was stable and unchanged and there was still no MR through the valve. DISCUSSION
There is only very limited experience of percutaneous treatment after a failed mitral valve repair with the implantation of a ring. The only available percutaneous R , is not technique, the implantation of a MitraClipV
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
1204
Wunderlich et al.
Fig. 1. Evaluation of the mitral valve pre-procedure. In (A) a long axis TEE view (120 ) in systole is shown without (left panel) and with (right panel) color Doppler. White arrows point at the Carpentier Edwards Physio ring. The red arrow points at the posterior mitral leaflet. As it is very thin and nearly invisible it is visualized by a red dashed line. It becomes evident that the posterior leaflet is not involved in the coaptation. The resulting MR jet is visible on the right panel. In (B) the Doppler tracing of the mitral inflow is shown. The calculated mean gradient is 9 mm Hg. In (C) an enface 3D TEE view of the mi-
tral valve is seen in systole. The white arrows point at the posterior leaflet which cannot be seen because it is severely retracted. The white stars mark the two small paravalvular leakages in antero-lateral position between the 32-mm CE Physio ring and the surrounding native tissue. A suture bridge can be identified between the small paravalvular leaks. LA 5 left atrium, LV 5 left ventricle, CE 5 Carpentier Edwards, Ao 5 aorta. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
applicable in most cases due to small ring areas and unfavorable anatomy. Several case reports and small series have reported the feasibility of a TVIR procedure [10–16]. A present annuloplasty ring has the advantage to serve as a stable anchor zone for a valve prosthesis. However, a major concern is that the CE Physio ring is more oval shaped whereas the implanted valve has a round shape. The question arises whether the ring adapts to the configuration of the implanted valve as any distortion of the valve itself may lead to regurgitation through the torn leaflets and/or to paravalvular regurgi-
tation due to suboptimal apposition to the ring. Dahle et al. [15] described a bench test, in which a 34-mm CE Physio ring adapted well to a 29-mm Edwards SAPIEN XT valve and became a round shape. With the case described above we confirmed that a 32-mm CE Physio ring changed its configuration from oval to round once the 29-mm Edwards SAPIEN XT valve is in place. So far only the balloon expandable Edwards SAPIEN XT valve was used for TVIR procedures in R humans. However, the implantation of a MelodyV transcatheter valve (Medtronic, Minneapolis, MN) in
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Fig. 2. 3D TEE measurements of the Carpentier Edwards Physio ring in a post-processing step (Qlab; Philips). The upper left panel shows an intercommissural view, the corresponding long axis view is seen on the right side. The left panel at the bottom shows an enface view of the mitral ring.
The measurements done in this view showed an anterior–posterior diameter of 1.8 cm and a lateral-medial diameter of 2.76 cm. The ring area was 3.54 cm2. A-P 5 anterior–posterior, LM 5 lateral medial. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Fig. 3. Fluoroscopic images showing the procedural steps. In (A) the white arrows follow the veno-arterial loop coming from the inferior vena cava leading through the septum to the left atrium, then to the left ventricle and retrogradely through the aorta. In (B) the pre-dilation of the interatrial septum with a 12/60 Fox Plus balloon (Abbott) is demonstrated. C: Shows
the SAPIEN XT valve which is positioned within the Physio ring. The ring is visualized in an orthogonal projection. In (D, E) the inflation of the balloon can be observed stepwise. In (F) the final position of the valve within the mitral ring is shown. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
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Fig. 4. Evaluation of the mitral valve post-procedure. A: Shows a 2D TEE image (96 ) without (left panel) and with color Doppler (right panel). The three cusps of the SAPIEN XT valve can be identified. There is no regurgitation through the valve, but a mild paravalvular regurgitation can be identified (white arrow). B: Shows an enface 3D TEE view of the implanted
valve. The Physio ring adapts to the round shape of the valve. In (C) gradients are calculated by tracing the Doppler diastolic mitral flow profile. Post-procedure the mean gradient was 1 mm Hg. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
Fig. 5. CT images after implantation of a 29-mm Edwards SAPIEN XT valve in a 32-mm CE Physio ring. The implanted valve can be seen in a conventional long axis CT image on the left side and in a CT reconstruction on the right side where the relationship between the implanted valve and the mitral ring can be better appreciated. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
different mitral annuloplasy rings was also shown to be feasible in an animal model [11] but there may be limitations due to available sizes. Published data [16] suggest that Physio ring sizes up to 26 mm may be treated with a 23 mm, ring sizes
from 26 to 31 mm with a 26 mm, and ring sizes of 34 mm with a 29-mm balloon expandable Edwards SAPIEN valve. To our knowledge no valve has been implanted in a 32-mm Physio ring so far and the choice was between a 26 mm and a 29 mm valve.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
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and in valve design may improve results. Randomized studies with longer follow-up duration are needed to evaluate the stability and the durability of TVIR procedures. REFERENCES
Fig. 6. 3D CT reconstruction showing the implanted 29-mm Edwards SAPIEN XT valve within 32-mm CE Physio ring in detail. Note how well the Physio ring adapts to the round shape of the Edwards SAPIEN XT valve. [Color figure can be viewed in the online issue, which is available at wileyonlinelibrary.com.]
However, the decision was made to implant a 29-mm Edwards SAPIEN XT valve as a valve which is too small carries the potential risk of device embolization. Finally this size turned out to fit appropriately into the 32-mm CE Physio ring. The positioning of the valve prosthesis within the mitral ring is challenging. Careful fluoroscopic and TEE guidance is needed and the prosthesis is expanded under right ventricular rapid pacing and slow, controlled balloon inflation as described previously [16]. However, steerability is limited specifically when only a stiff wire is placed in the left ventricular apex as described in all previously published cases. In this present case, positing of the valve was optimized and facilitated by pulling on the venoarterial loop which enabled to correct the position of the valve at a point where other technical options for optimization were no longer available. CONCLUSION
Redo surgery remains the standard treatment for patients with failed mitral valve repair. Nevertheless, percutaneous TVIR procedures are feasible and may be a promising alternative treatment option for patients who are having an unacceptable high surgical risk. Our case example suggests that a 29-mm Edwards SAPIEN XT valve fits well in a 32-mm CE Physio ring and a veno-arterial loop may be helpful for final valve adjustments during balloon inflation. The optimal approach for this procedure has not yet been evaluated in larger series. However, transseptal access appears advantageous because of less complication rates due to a venous femoral access, an easily performed antegrade crossing of the valve and a more coaxial alignment to the mitral ring. Further improvements in technology
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Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
