Transcatheter Aortic Valve Implantation for a Failed Bio-Bentall in Patients with Marfan Syndrome

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 4, NO. 7, 2011 © 2011 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION PUBLISHED BY ELSEVIER INC. ISSN 1936-8798/$36.00 DOI: 10.1016/j.jcin.2011.05.007 Clinical Research Transcatheter Aortic Valve Implantation for Failing Surgical Aortic Bioprosthetic Valve From Concept to Clinical Application and Evaluation (Part 2) Nicolo Piazza, MD,* Sabine Bleiziffer, MD,* Gernot Brockmann, MD,* Ruge Hendrick, MD,* Marcus-André Deutsch, MD,* Anke Opitz, MD,* Domenico Mazzitelli, MD,* Peter Tassani-Prell, MD, PHD,† Christian Schreiber, MD,* Rüdiger Lange, MD, PHD* Munich, Germany Objectives This study sought to review the acute procedural outcomes of patients who underwent transcatheter aortic valve (TAV)–in–surgical aortic valve (SAV) implantation at the German Heart Center, Munich, and to summarize the existing literature on TAV-in-SAV implantation (n ⫽ 47). Background There are several case reports and small case series describing transcatheter aortic valve implantation for a failing surgical aortic valve bioprosthesis (TAV-in-SAV implantation). Methods From January 2007 to March 2011, 20 out of 556 patients underwent a TAV-in-SAV implantation at the German Heart Center Munich. Baseline characteristics and clinical outcome data were prospectively entered into a dedicated database. Results The mean patient age was 75 ⫾ 13 years, and the mean logistic European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons’ Risk Model scores were 27 ⫾ 13% and 7 ⫾ 4%, respectively. Of the 20 patients, 14 had stented and 6 had stentless surgical bioprostheses. Most cases (12 of 20) were performed via the transapical route using a 23-mm Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, California). Successful implantation of a TAV in a SAV with the patient leaving the catheterization laboratory alive was achieved in 18 of 20 patients. The mean transaortic valve gradient was 20.0 ⫾ 7.5 mm Hg. None-to-trivial, mild, and mild-to-moderate paravalvular aortic regurgitation was observed in 10, 6, and 2 patients, respectively. We experienced 1 intraprocedural death following pre-implant balloon aortic valvuloplasty (“stone heart”) and 2 further in-hospital deaths due to myocardial infarction. Conclusions TAV-in-SAV implantation is a safe and feasible treatment for high-risk patients with failing aortic bioprosthetic valves and should be considered as part of the armamentarium in the treatment of aortic bioprosthetic valve failure. (J Am Coll Cardiol Intv 2011;4:733– 42) © 2011 by the American College of Cardiology Foundation From the *Department of Cardiovascular Surgery, German Heart Center, Munich, Germany; and the †Department of Anesthesiology, German Heart Center, Munich, Germany. Dr. Piazza has reported that he is a consultant for Medtronic. Dr. Mazzitelli has reported that he is a proctor for Edwards Lifesciences. All other authors have reported that they have no relationships to disclose. Manuscript received March 24, 2011; revised manuscript received May 3, 2011, accepted May 12, 2011. 734 Piazza et al. TAV-In-SAV In 2007, Wenaweser et al. (1) reported the first case of a transcatheter valve (Medtronic CoreSAV ⴝ surgical aortic valve Valve system, Medtronic, MinTAV ⴝ transcatheter aortic neapolis, Minnesota) implanted valve into a degenerated surgical aortic TAVI ⴝ transcatheter aortic bioprosthesis. Since then, nuvalve implantation merous case reports of transcatheter aortic valve (TAV)–in–surgical aortic valve (SAV) implantation (TAV-in-SAV) have been described with either the Medtronic CoreValve or Edwards Sapien (Edwards Lifesciences, Irvine, California) bioprosthesis (2–19). TAV-in-SAV is typically reserved for high surgical risk patients requiring redo surgery. Nonetheless, the Medtronic CoreValve and Edwards Sapien devices were not designed nor indicated for failing surgical bioprostheses. Abbreviations and Acronyms JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 4, NO. 7, 2011 JULY 2011:733– 42 The aim of this paper is to report on the acute clinical results of 20 patients who underwent TAV-in-SAV implantation at the German Heart Center, Munich. Furthermore, we provide a review of published case reports and case series on TAV-in-SAV implantation (n ⫽ 47 cases). Methods Between June 2007 and March 2011, 556 patients underwent transcatheter aortic valve implantation (TAVI) at the German Heart Center, Munich. High surgical risk patients with severe native aortic valve stenosis or failing surgical aortic bioprostheses were referred for TAVI after a dedicated team of cardiac surgeons, cardiologists, and anesthesiologists reached consensus that TAVI was in the best Figure 1. Munich Case #299: Transapical 23-mm Edwards Sapien Implanted in a 22-mm Sorin Soprano Bioprosthesis (A) Fluoroscopic identification of the Sorin Soprano (Sorin, Saluggia, Italy) bioprosthesis. (B) Pre-implant balloon valvuloplasty. (C) Contrast aortography and positioning of the Edwards Sapien (Edwards Lifesciences, Irvine, California) valve 2 to 4 mm below the base ring of the Sorin Soprano valve. (D) Final contrast aortography demonstrated trivial aortic regurgitation. Piazza et al. TAV-In-SAV JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 4, NO. 7, 2011 JULY 2011:733– 42 735 Figure 2. Munich Case #371: Transapical 26-mm Edwards Sapien Implanted in a 23-mm CE Perimount (A) Fluoroscopic identification of the Carpentier-Edwards (CE) Perimount (Edwards Lifesciences, Irvine, California) bioprosthesis. (B) Positioning of the Edwards Sapien valve 2 to 4 mm below the base ring of the CE Perimount valve. (C) Mid-deployment phase of the Edwards Sapien valve (balloon has a “dumb-bell” appearance). (D) Final contrast aortography revealed no aortic regurgitation. interest of the patient. Patients with stented or stentless aortic valve prostheses with internal diameters between 18 and 27 mm were considered for TAV-in-SAV implantation. Anatomical criteria for TAV-in-SAV were confirmed by a combination of imaging modalities: transesophageal echocardiography, multislice computed tomography, and angiography. Informed consent was obtained from all patients. Device description and procedure. Details of the Medtronic CoreValve and Edwards Sapien devices and technical aspects of the procedure have been previously published. Procedures were performed in a hybrid surgical suite (20,21). Depending on underlying comorbidities, patients received either general anesthesia or local anesthesia (with mild sedation). Definition of outcomes. Procedural success was defined by successful implantation of a TAV in a SAV with the patient leaving the catheterization laboratory alive. Echocardiography and invasive hemodynamic pressure recordings provided in-hospital transaortic valve gradients. Aortic regurgitation was evaluated by echocardiography and contrast aortography and classified as none, mild, moderate, or severe. Statistical analyses. Continuous variables are described as mean ⫾ SD, and dichotomous or nominal variables are described as numbers and percentages. Statistical analyses were performed using SPSS (version 17.0 for Windows, SPSS Inc., Chicago, Illinois). Results Baseline characteristics. From January 2007 to March 2011, 556 patients underwent TAVI at the German Heart 736 Table 1. German Heart Center, Munich, Clinical Experience With the TAV-In-SAV Procedure Since 2007 (n ⴝ 20) Patient Characteristics Vascular Access, Type and Size of Transcatheter Valve/ Surgical Bioprosthesis/Presenting Pathology Procedural Details Immediate Results and Additional Comments 1 (#146) 83-year-old woman, LES 30%, STS 6% TA 23-mm Edwards Sapien ⫻2/23-mm Sorin Mitroflow implanted 7 years prior/AS (MG 46 mm Hg) 1. Pre-implant BAV With 20 mm balloon 2. Rapid pacing during deployment 3. Second 23-mm Edwards Sapien implanted Mild paravalvular AR/MG 44 mm Hg. Moderate-severe central AR after the first 23-mm Edwards Sapien implantation. After the second 23-mm Edwards Sapien, there was mild AR although the mean gradient was 44 mm Hg. 2 (#153) 40-year-old man, LES 6%, STS 3% TF 29-mm Medtronic CoreValve/Homograft implanted 1 year prior/AR 1. No pre-implant BAV 2. No rapid pacing during deployment Not successful. CoreValve prosthesis dislocated 2⫻ while semideployed. In both instances, CoreValve prosthesis was retrieved from the body. Procedure aborted and patient underwent successful surgical valve replacement. 3 (#286) 75-year-old woman, LES 24%, STS 16% TA 23-mm Edwards Sapien/23-mm Carpentier-Edwards Perimount/AR 1. No pre-implant BAV Mild-moderate paravalvular AR/MG 17 mm Hg. 4 (#299) 73-year-old woman, LES 33%, STS 3% TA 23-mm Edwards Sapien/22-mm Sorin Soprano implanted 6 years prior/AS (MG 64 mm Hg) 1. Pre-implant BAV with 20-mm balloon 2. Rapid pacing during deployment Trivial paravalvular AR/MG 15 mm Hg. 5 (#309) 79-year-old man, LES 30%, STS 8% TA 23-mm Edwards Sapien/21-mm Medtronic Mosaic implanted 5 years prior/AS (MG 66 mm Hg) 1. Pre-implant BAV with 22-mm balloon 2. Rapid pacing during deployment No AR/MG ⬍20 mm Hg. Left main occlusion following transcatheter aortic valve implantation followed by successful left main coronary stenting (in-hospital death within 30 days). 6 (#315) 75-year-old man, LES 28%, STS 6% TF 26-mm Medtronic CoreValve and TA 23-mm Edwards Sapien/24-mm Sorin Soprano implanted 4 years prior/AS (MG 64 mm Hg) 1. Pre-implant BAV with 22-mm balloon 2. No rapid pacing during deployment 3. Post-implant BAV with 22-mm balloon for moderate-severe AR 4. 23-mm Edwards Sapien implanted Mild-moderate paravalvular AR/MG ⬍20 mm Hg. Moderate-severe paravalvular AR was noted after implantation of the first 26-mm CoreValve. A 23-mm Edwards Sapien prosthesis was implanted within the CoreValve prosthesis and angiography subsequently demonstrated mild-moderate paravalvular AR. A myocardial infarction was diagnosed on day 2 after procedure (in-hospital death within 30 days). 7 (#342) 67-year-old man, LES 7%, STS 5% TA 26-mm Edwards Sapien/25-mm Carpentier-Edwards Perimount implanted 3 years prior/AS (MG 51 mm Hg) 1. Pre-implant BAV with 20-mm balloon 2. Rapid pacing during deployment Mild paravalvular AR/MG 25 mm Hg 8 (#355) 91-year-old man, LES 52%, STS 11% No attempt made to deploy transcatheter valve/23-mm Carpentier Edwards Perimount implanted 5 years prior/ AS (MG 53 mm Hg) 1. Pre-implant BAV 20-mm balloon Not successful. Following BAV, severe left ventricular dysfunction, hemodynamic instability, and cardiac arrest without recovery (intraprocedural death). 9 (#371) 75-year-old woman, LES 26%, STS 4% TA 26-mm Edwards Sapien/23-mm Carpentier-Edwards Perimount Magna implanted 7 years prior/AS (MG 77 mm Hg) 1. Pre-implant BAV with 20-mm balloon 2. Rapid pacing during deployment No AR/MG 24 mm Hg 10 (#376) 87-year-old woman, LES 27%, STS 8% TA 23-mm Edwards Sapien/21-mm Medtronic Mosaic implanted 8 years prior/AR 1. Pre-implant BAV with 20-mm balloon 2. Rapid pacing during deployment No AR/MG 14 mm Hg 11 (#401) 80-year-old woman, LES 28%, STS 6% TA 26-mm Edwards Sapien/25-mm BioValsalva implanted 4 years prior/AR 1. No pre-implant balloon dilation 2. Rapid pacing during deployment No AR/MG 20 mm Hg 12 (#415) 71-year-old woman, LES 13%, STS 6% TA 23-mm Edwards Sapien/21-mm Medtronic Freestyle [stentless] implanted 4 years prior/AR 1. Pre-implant BAV with 20-mm balloon 2. Rapid pacing during deployment No AR/MG 19 mm Hg Piazza et al. TAV-In-SAV Case Number 2. Rapid pacing during deployment JULY 2011:733– 42 JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 4, NO. 7, 2011 Continued on next page Case Number Patient Characteristics Vascular Access, Type and Size of Transcatheter Valve/ Surgical Bioprosthesis/Presenting Pathology Procedural Details Immediate Results and Additional Comments 13 (#416) 79-year-old woman, LES 58%, STS 7% TA 23-mm Edwards Sapien/23-mm Sorin Mitroflow implanted 7 years prior/combined AR and AS (MG 31 mm Hg) 1. No pre-implant balloon dilation 2. Rapid pacing during deployment No AR/MG 16 mm Hg 14 (#450) 71-year-old man, LES 17% STS 2% TA 23-mm Edwards Sapien 1⫻ and TF 23-mm Edwards Sapien 1⫻/23-mm St. Jude Medical Toronto, Freestyle [stentless] implanted 4 years prior/AR 1. No pre-implant BAV 2. Rapid pacing during deployment Mild paravalvular leak immediately following implantation. After transapical closure, echocardiography identified new severe central AR due to a malcoapting leaflet in the noncoronary sinus position. Patient underwent transfemoral implantation of a second 23-mm Edwards Sapien. No AR/MG 15 (#453) 71-year-old woman, LES 11%, STS 3% TA 23-mm Edwards Sapien/21-mm homograft implanted 14 years prior/AR 1. No pre-implant balloon dilation 2. Rapid pacing during deployment No AR/MG 17 mm Hg 16 (#464) 89-year-old man, LES 23%, STS 10% TA 26-mm Edwards Sapien/27-mm Biocor ⫹ aortic root replacement 16 years prior/AR 1. No pre-implant BAV 2. Rapid pacing during deployment Mild AR/MG 20 mm Hg 17 (#468) 82-year-old woman, LES 37%, STS 7% TA 23-mm Carpentier-Edwards Sapien/23-mm CarpentierEdwards Perimount Magna implanted 3 years prior/AS (MG 65 mm Hg) 1. Pre-implant BAV with 20 mm balloon 2. Rapid pacing during deployment Mild AR/MG N/A 18 (#481) 62-year-old man, LES 7%, STS 3% TF 29-mm CoreValve/Surgical stented bioprosthesis in 1985 and 27-mm homograft implanted 15 years prior/AR 1. No pre-implant BAV 2. Rapid pacing during deployment Mild AR/invasive PG 11 mm Hg 19 (#499) 79-year-old woman, LES 18%, STS 5% TA 23-mm Edwards Sapien XT/23-mm Carpentier-Edwards Perimount implanted 10 years prior/AS (MG 63 mm Hg) 1. Pre-implant BAV with 20-mm balloon 2. Rapid pacing during deployment No AR/MG 18 mm Hg 20 (#502) 76-year-old female, LES 7%, STS 3% TA 23-mm Edwards Sapien XT/21-mm Carpentier-Edwards Perimount/AS (MG 67 mm Hg) 1. Pre-implant BAV with 20-mm balloon 2. Rapid pacing during deployment No AR/MG N/A JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 4, NO. 7, 2011 JULY 2011:733– 42 Table 1. Continued Biocor and Toronto are products of St. Jude Medical (Minneapolis, Minnesota). BioValsalva (Vascutek, Terumo, Newmains, Scotland). CoreValve, Freestyle, and Mosaic are products of Medtronic CV Luxembourg s.a.r.l. (Tolochenaz, Switzerland) or Medtronic (Minneapolis, Minnesota). Mitroflow and Soprano are products of Sorin Group (Saluggia, Italy). Perimount and Sapien are products of Edwards Lifesciences (Irvine, California). AR ⫽ aortic regurgitation; AS ⫽ aortic stenosis; BAV ⫽ balloon aortic valvuloplasty; LES ⫽ logistic European System for Cardiac Operative Risk Evaluation; MG ⫽ mean gradient; N/A ⫽ not available; PG ⫽ peak gradient; SAV ⫽ surgical aortic valve; STS ⫽ Society of Thoracic Surgeons predicted risk of mortality score; TA ⫽ transapical; TAV ⫽ transcatheter aortic valve; TF ⫽ transfemoral. Piazza et al. TAV-In-SAV 737 738 Table 2. Summary Table of Published Case Reports and Case Series of TAV-In-SAV Procedures Since 2007 (n ⴝ 47) Patient Characteristics Vascular Access, Type and Size of Transcatheter Valve/ Surgical Bioprosthesis/Presenting Pathology Procedural Details Results TF 26-mm Medtronic CoreValve/23-mm Sorin Mitroflow/AR 1. No Pre-implant BAV 2. No rapid pacing during deployment No AR/MG 12 mm Hg Walther et al. (2) 82-year-old woman, LES 21%, STS 9.2% TA 23-mm cuffed Edwards Sapien/21-mm CarpentierEdwards Perimount/AS 1. Pre-implant BAV (balloon size N/A) 2. Rapid pacing during deployment No AR/MG 17 mm Hg Klaaborg et al. (3) 82-year-old woman, LES 53% TA 23-mm Edwards Sapien/21-mm Sorin Mitroflow/AS 1. Pre-implant BAV (23-mm balloon) 2. Rapid pacing during deployment Trivial transvalvular AR/PG 40 mm Hg Kelpis et al. (4) 80-year-old man, LES 37.3%, STS 27.5% TA 23-mm Edwards Sapien/25-mm St. Jude Toronto stentless/AR 1. Pre-implant BAV (20-mm balloon) 2. Rapid pacing during deployment No AR “good hemodynamic function” Rodés-Cabau et al. (22) 84-year-old woman, STS 48% TA 23-mm Edwards Sapien/23-mm Medtronic Freestyle [stentless]/AR 1. No pre-implant BAV 2. Rapid pacing during deployment Trivial AR/MG 17 mm Hg Attias et al. (5) 80-year-old man, LES 26%, STS 18% TF 29-mm Medtronic CoreValve/25-mm stentless Xenograft (manufacturer not reported)/AR 1. No pre-implant BAV 2. No rapid pacing during deployment No AR/MG 3 mm Hg Schmoeckel et al. (6) 72-year-old man, LES 26%, STS 18% TA 26-mm Edwards Sapien/24-mm aortic allograft as a miniroot (manufacturer not reported)/AR 1. Pre-implant BAV (balloon size N/A) 2. Rapid pacing during deployment Trivial paravalvular AR/PG 9 mm Hg Ussia et al. (7) 85-year-old woman, LES 45% TF 26-mm Medtronic CoreValve/21-mm St. Jude Biocor [stentless]/AR 1. No pre-implant BAV 2. Rapid pacing during deployment 3. Post-implant dilation with 25-mm nucleus balloon Moderate-severe paravalvular AR (reduced to moderate with postimplant dilation) Napodano et al. (8) 84-year-old woman, LES 31.8% TF 29-mm Medtronic CoreValve/25-mm St. Jude Biocor [stentless]/AR 1. No pre-implant BAV 2. Rapid pacing during deployment 3. Post-implant dilation with 25-mm nucleus balloon Trivial paravalvular AR “no transvalvular gradient” Attias et al. (9) 70-year-old man, LES 35% TF 26-mm Medtronic CoreValve/21-mm Carpentier-Edwards Perimount/AR Information not provided No AR/No information provided for gradient Ng et al. (10) 82-year-old man, LES 28% TA 26-mm Edwards Sapien/23-mm Medtronic Freestyle [stentless]/AR 1. No information about BAV 2. Rapid pacing during deployment 3. 2 Edwards Sapiens implanted Severe transvalvular AR after first valve implantation. A second 26-mm Edwards device was implanted and associated with mild transvalvular AR Olsen et al. (23) 86-year-old man, LES 30% (2 previous cardiac operations) Right subclavian artery 29-mm Medtronic CoreValve/ 23-mm homograft [stentless]/AR 1. No information about BAV 2. No information on rapid pacing No information available about postimplant AR or transvalvular gradient Dainese et al. (11) 48-year-old woman, LES 12% (3 previous cardiac operations) TA 23-mm Edwards Sapien/21-mm CryoLife Bravo 400 [stentless] for miniroot technique/AS 1. Pre-implant BAV 2. Rapid pacing during deployment No AR/PG 18 mm Hg Sharp et al. (12) 82-year-old man, LES 64%, STS 46% Left subclavian artery 23-mm Edwards Sapien/ 23-mm Medtronic Freestyle [stentless]/AR 1. No pre-implant BAV 2. Rapid pacing during deployment No AR/MG 10 mm Hg and PG 24 mm Hg Ferrari et al. (14) 80-year-old woman, LES 59% TA 23-mm Edwards Sapien/23-mm Sorin Mitroflow/AR 1. No pre-implant BAV 2. Rapid pacing during deployment No AR/MG 10 mm Hg and PG 18 mm Hg Maroto et al. (15) (n ⫽ 2) 84-year-old man, LES 25% TA 23-mm Edwards Sapien/25-mm Medtronic Hancock standard/combined AS and AR 1. No pre-implant BAV 2. Rapid pacing during deployment Minimal transvalvular AR/PG 17 mm Hg 84-year-old man, LES 18% TA 23-mm Edwards Sapien/25-mm Medtronic, Hancock standard/combined AS and AR 1. No pre-implant BAV 2. Rapid pacing during deployment Minimal transvalvular AR/PG 13 mm Hg Continued on next page JULY 2011:733– 42 80-year-old man, LES 36% JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 4, NO. 7, 2011 Wenaweser et al. (1) Piazza et al. TAV-In-SAV First Author (Ref. #) Khawaja et al. (16) (n ⫽ 4) Webb et al. (17) (n ⫽ 10)* Seiffert et al. (19) (n ⫽ 4) Patient Characteristics Vascular Access, Type and Size of Transcatheter Valve/ Surgical Bioprosthesis/Presenting Pathology Procedural Details Results TF 26-mm Medtronic CoreValve/21-mm Sorin Mitroflow/ combined AS and AR 1. No pre-implant BAV 2. Rapid pacing during deployment No AR/PG 30 mm Hg 76-year-old man, LES 19% TF 26-mm Medtronic CoreValve/23-mm Carpentier-Edwards Perimount/AR 1. No pre-implant BAV 2. Rapid pacing during deployment No AR/PG 39 mm Hg 85-year-old woman, LES 38% TF 26-mm Medtronic CoreValve/Carpentier-Edwards Perimount (size not available)/AR 1. No pre-implant BAV 2. Rapid pacing during deployment Mild paravalvular AR/PG 30 mm Hg 48-year-old woman, LES 12% TF 26-mm Medtronic CoreValve/25-mm CryoLife O’Brien [stentless]/AS 1. No pre-implant BAV 2. Rapid pacing during deployment 3. Post-implant dilation with 20-mm balloon Mild paravalvular AR/PG 35 mm Hg 87-year-old, LES 31%, STS 10% TA 23-mm Edwards Sapien/25-mm Carpentier-Edwards Perimount/combined AS and AR No specific details except that authors state that pre-implant BAV is avoided in patients with predominant AR and encouraged in those with AS No AR/MG 11 mm Hg 83-year-old, LES 38%, STS 10% TA 23-mm Edwards Sapien/23-mm Carpentier-Edwards Perimount/combined AS and AR No AR/MG 24 mm Hg 85-year-old LES 39%, STS 12% TA 23-mm Edwards Sapien/23-mm Carpentier-Edwards Perimount/AS No AR/MG 27 mm Hg 86-year-old, LES 33%, STS 11% TA 23-mm Edwards Sapien/21-mm Ionescu-Shiley standard/AS No AR/MG 23 mm Hg 86-year-old, LES 33%, STS 10% TA 26-mm Edwards Sapien/25-mm Carpentier-Edwards Perimount/AS No AR/MG 13 mm Hg 83-year-old, LES 46%, STS 11% TA 23-mm Edwards Sapien/21-mm Carpentier-Edwards Perimount/AS Mild AR/MG 24 mm Hg 78-year-old, LES 20%, STS 5% TA 23-mm Edwards Sapien/21-mm Shelhigh SuperStentless/AS No AR/MG 16 mm Hg 84-year-old, LES 24%, STS 12% TA 23-mm Edwards Sapien/21-mm Medtronic Freestyle/AR No AR/MG 11 mm Hg 82-year-old, LES 34%, STS 11% TA 23-mm Edwards Sapien/21-mm Medtronic Mosaic/combined AS and AR No AR/MG 30 mm Hg 67-year-old, LES 14%, STS 16% TF 23-mm Edwards Sapien/23-mm Carpentier-Edwards Perimount/combined AS and AR Mild AR/MG 21 mm Hg 83-year-old man, LES 89%, STS 35% TA 23-mm Edwards Sapien/23-mm St. Jude Biocor [stentless]/AS 1. No pre-implant BAV 2. Rapid pacing during deployment AR grade N/A/MG 20 mm Hg 78-year-old man, LES 52%, STS 30% TA 23-mm Edwards Sapien/21-mm Medtronic Hancock standard/AS 1. No pre-implant BAV 2. Rapid pacing during deployment No AR/MG 30 mm Hg 88-year-old man, LES 42%, STS 20% TA 23-mm Edwards Sapien/23-mm Medtronic Hancock standard/AR 1. No pre-implant BAV 2. Rapid pacing during deployment Mild paravalvular AR/MG 12 mm Hg 73-year-old man, LES 48%, STS 17% TA 23-mm Edwards Sapien/25-mm Medtronic Hancock II/AS 1. No pre-implant BAV 2. No rapid pacing during deployment No AR/MG 12 mm Hg Piazza et al. TAV-In-SAV 66-year-old man, LES 25% JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 4, NO. 7, 2011 First Author (Ref. #) JULY 2011:733– 42 Table 2. Continued Continued on next page 739 Piazza et al. TAV-In-SAV JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 4, NO. 7, 2011 Abbreviations as in Table 1. SuperStentless is a product of Shelhigh Inc. (Union, New Jersey). Other product information as in Table 1. *Gender information is not available. †Individual patient data is not available. Bravo 400 and O’Brien are products of CryoLife (Kennesaw, Georgia). Conforma and Hancock are products of Medtronic (Minneapolis, Minnesota). Epic is a product of St. Jude Medical (Minneapolis, Minnesota). Porcine is a product of Edwards Lifesciences (Irvine, California). No patient with ⬎ mild AR/average MG 11 ⫾ 4 mm Hg 1. Pre-implant BAV with 20-mm 2. Rapid pacing during deployment TA 23-mm Edwards Sapien implanted in 3 patients with 21-mm Carpentier-Edwards Perimount, a 21-mm Medtronic Mosaic, a 23-mm Medtronic Conforma, a 23-mm Sorin Mitroflow, and a 21-mm St. Jude Medical Epic. TA 26-mm Edwards Sapein implanted in 2 patients with 25-mm Carpentier-Edwards Porcine, 2 patients with 25-mm Medtronic Hancock Average age 78 ⫾6 yrs, mean LES 32 ⫾ 15%, mean STS 7 ⫾ 3% Kempfert et al. (18) (n ⫽ 11)† Patient Characteristics Vascular Access, Type and Size of Transcatheter Valve/ Surgical Bioprosthesis/Presenting Pathology Procedural Details Results JULY 2011:733– 42 First Author (Ref. #) Table 2. Continued 740 Center, Munich. Of those, 20 patients with a failing surgical bioprosthesis underwent a TAV-in-SAV procedure. Baseline and procedural characteristics and outcomes are summarized in Table 1. The mean patient age was 75 ⫾ 13 years and the mean logistic European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons’ Risk Model scores were 27 ⫾ 13% and 7 ⫾ 4%, respectively. Patients presented on average 5 ⫾ 2 years after their primary valve operation. Of the 20 patients, 14 had stented and 6 had stentless surgical bioprostheses. Primary aortic stenosis, aortic regurgitation, and combination aortic stenosis/regurgitation were present in 10, 9, and 1 patient, respectively. Procedural characteristics and clinical outcomes. Most cases (12 of 20) were performed via the transapical route using a 23-mm Edwards Sapien prosthesis. Pre-implant balloon aortic valvuloplasty was performed in those patients with primary aortic stenosis but not in those with primary aortic regurgitation. Procedural success was achieved in 18 of 20 patients (see “Unsuccessful TAV-in-SAV implantations” section). The mean post-procedural transaortic valve gradient was 20.0 ⫾ 7.5 mm Hg. Except for Case #146, who underwent implantation of 2 23-mm Edwards Sapien bioprostheses, all patients had a post-procedural transaortic valve gradient below 25 mm Hg. None-totrivial, mild, and mild-to-moderate paravalvular aortic regurgitations were observed in 10, 6, and 2 patients, respectively. No patient experienced a stroke or need for permanent pacemaking. Figures 1 and 2 demonstrate the fluoroscopic images of 2 successful TAV-in-SAV procedures. Unsuccessful TAV-in-SAV implantations. A TAV was not implanted in 2 of the 20 TAV-in-SAV patients. In the first patient with a failing homograft and severe aortic regurgitation (Case #153), the CoreValve prosthesis dislocated into the ascending aorta on 2 attempts; in both instances, the prosthesis was retrieved from the body in its semideployed state. The procedure was aborted and the patient underwent successful conventional aortic valve replacement. In this case, we did not use rapid pacing during valve deployment. The large stroke volumes likely contributed to the instability of the prosthesis during valve deployment. Rapid pacing during valve deployment is routinely used in patients with severe aortic regurgitation. In the second case (#355), a “stone heart” developed after pre-implant balloon aortic valvuloplasty leading to intraprocedural death despite immediate institution of cardiopulmonary bypass. In-hospital deaths. There were 2 in-hospital postprocedural deaths (Cases #309 and #315). In Case #309, immediate left main coronary occlusion occurred after deployment of the 23-mm Edwards Sapien within a 21-mm Medtronic Mosaic valve (Fig. 3). Despite successful left main coronary stenting, the patient died on Piazza et al. TAV-In-SAV JACC: CARDIOVASCULAR INTERVENTIONS, VOL. 4, NO. 7, 2011 JULY 2011:733– 42 741 Figure 3. Munich Case #309: A Transapical 23-mm Edwards Sapien Implanted in a 21-mm Medtronic Mosaic Bioprosthetic Valve (A) Parasagittal multislice computed tomography view demonstrates the stent post of the Medtronic Mosaic (Medtronic, Tolochenaz, Switzerland) bioprosthesis overlying the ostia of the left main coronary artery. (B) Contrast aortography demonstrates a large calcific mass (radiolucent) in the region of the left coronary sinus. (C) After deployment of the Edwards Sapien valve, there was immediate obstruction of the left main coronary ostia. (D) Short-axis multislice computed tomography view demonstrating normal orientation of bioprosthesis stent posts relative to coronary ostia. This examination is now routinely performed before transcatheter aortic valve–in–surgical aortic valve implantation. hospital day 2 from multiorgan failure. In fact, preprocedural imaging revealed “bulky calcifications” of the native aortic valve and a surgical stent post overlying the ostium of the left main coronary artery (Fig. 3). The orientation of the stent posts relative to the coronary ostia is now assessed regularly (Fig. 3D). In Case #315, moderate-to-severe paravalvular aortic regurgitation was documented after implanting a 26-mm CoreValve into a 24-mm Sorin Soprano (Sorin Group, Saluggia, Italy) bioprosthesis. A 23-mm Edwards Sapien was subsequently implanted within the 26-mm CoreValve. Despite a reduction in the aortic regurgitation grade, the patient died on hospital day 3 from cardiogenic shock; a myocardial infarction was suspected based on rising cardiac biomarkers. TAV-in-SAV implantation. A SUMMARY OF PUBLISHED CASE We performed a search in PubMed for peer-reviewed papers on TAV for failing SERIES AND CASE REPORTS. surgical bioprosthetic valves. From January 2007 to January 2011, 47 cases of TAV-in-SAV were identified in either case report or case series format (Table 2) (22,23). Salient features of these case reports can be summarized as follows. Patients were typically elderly and at high or prohibitive surgical risk. They presented 6 to 26 years after their primary valve operation. A significant number of patients presented with severe aortic regurgitation, which is atypical for patients currently undergoing TAVI. Patients had a prior history of either stented or stentless valve replacement (labeled valve size: 21 to 25 mm). The “smaller” 23-mm Edwards Sapien and “smaller” 26-mm CoreValve prostheses were implanted in the vast majority of reported cases. Heterogeneous practice patterns were apparent with respect to the use of pre-implant balloon aortic valvuloplasty and/or rapid pacing during valve deployment. Significant reductions in transvalvular gradients and/or aortic regurgitation 742 Piazza et al. TAV-In-SAV were observed with either the Edwards Sapien or CoreValve bioprosthesis. In some cases, however, the transvalvular gradient remained considerably elevated (⬎20 mm Hg). Nevertheless, the investigators noted that there was adequate improvement in valve function to positively influence the quality of life in these otherwise “high or prohibitive” surgical risk patients. The average transaortic valve gradient after primary aortic valve surgery with the Carpentier-Edwards Perimount bioprosthesis (Edwards Lifesciences) has been reported to be approximately 14 ⫾ 6 mm Hg (24). In our cohort, the average transaortic valve gradient following TAV-in-SAV was 20.0 ⫾ 7.5 mm Hg. Coronary obstruction following TAV-in-SAV implantation is a rare but life-threatening complication that requires immediate cardiopulmonary resuscitation and reinstitution of coronary blood flow. A recent publication described 2 cases of coronary obstruction during treatment of a degenerated Mitroflow (Sorin) bioprostheses (25). This may suggest that certain surgical bioprostheses may increase the risk of coronary obstruction in the setting of TAV-in-SAV implantation. In our experience, we observed coronary obstruction in treating a degenerated Medtronic Hancock bioprosthesis. We did not observe, however, coronary obstruction while treating 2 Sorin Soprano and 2 Sorin Mitroflow bioprostheses. Conclusions TAV-in-SAV implantation is currently considered an off-label indication. At this time, both Medtronic CoreValve and Edwards Lifesciences are pursuing TAV-inSAV expanded eligibility trials for CE mark approval. If the promising findings here are confirmed in larger studies with longer follow-up, TAV-in-SAV implantation may become an alternative in high risk redo surgery patients. Reprint requests and correspondence: Dr. Nicolo Piazza, Cardiovascular Surgery Department, German Heart Center Munich, Lazarettstrasse 36, 80636 Munich, Germany. E-mail: nicolopiazza@ mac.com. REFERENCES 1. Wenaweser P, Buellesfeld L, Gerckens U, Grube E. Percutaneous aortic valve replacement for severe aortic regurgitation in degenerated bioprosthesis: the first valve in valve procedure using the CoreValve revalving system. Catheter Cardiovasc Interv 2007;70:760 – 4. 2. Walther T, Kempfert J, Borger MA, et al. Human minimally invasive off-pump valve-in-a-valve implantation. Ann Thorac Surg 2008;85:1072–3. 3. Klaaborg KE, Egeblad H, Jakobsen CJ, et al. 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Results of percutaneous and transapical transcather aortic valve implantation performed by a surgical team. Eur J Cardiothorac Surg 2009;35:615–20. 22. Rodés-Cabau J, Dumont E, Doyle D, Lemieux J. Transcatheter valve-in-valve implantation for the treatment of stentless aortic valve dysfunction. J Thorac Cardiovasc Surg 2010;140:246 – 8. 23. Olsen LK, Engstrom T, Sondergaard L. Transcatheter valve-in-valve implantation due to severe aortic regurgitation in a degenerated aortic homograft. J Invasive Cardiol 2009;21:E197–200. 24. Yoganathan A, Heinrich R, Fontaine A. Fluid Dynamics of Prosthetic Valves. Philadelphia, PA: W. B. Saunders, 1997. 25. Gurvitch R, Cheung A, Bedogni F, Webb JG. Coronary obstruction following transcatheter aortic valve-in-valve implantation for failed surgical bioprostheses. Catheter Cardiovasc Interv 2011;77:439 – 44. Key Words: aortic regurgitation 䡲 aortic stenosis 䡲 surgical aortic valve 䡲 transcatheter aortic valve implantation 䡲 valve-in-valve.