Author + information
- Received March 24, 2011
- Revision received May 3, 2011
- Accepted May 12, 2011
- Published online July 1, 2011.
- 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⁎ and
- Rüdiger Lange, MD, PhD⁎
- ↵⁎Reprint requests and correspondence:
Dr. Nicolo Piazza, Cardiovascular Surgery Department, German Heart Center Munich, Lazarettstrasse 36, 80636 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.
- aortic regurgitation
- aortic stenosis
- surgical aortic valve
- transcatheter aortic valve implantation
In 2007, Wenaweser et al. (1) reported the first case of a transcatheter valve (Medtronic CoreValve system, Medtronic, Minneapolis, Minnesota) implanted into a degenerated surgical aortic bioprosthesis. Since then, numerous 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.
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).
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 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.
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).
From January 2007 to March 2011, 556 patients underwent TAVI at the German Heart 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-to-trivial, mild, and mild-to-moderate paravalvular aortic regurgitations were observed in 10, 6, and 2 patients, respectively.
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.
There were 2 in-hospital post-procedural 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 hospital day 2 from multiorgan failure. In fact, pre-procedural 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.
A Summary of Published Case Series and Case Reports
We performed a search in PubMed for peer-reviewed papers on TAV for failing 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 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.
TAV-in-SAV implantation is currently considered an off-label indication. At this time, both Medtronic CoreValve and Edwards Lifesciences are pursuing TAV-in-SAV 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.
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.
- Abbreviations and Acronyms
- surgical aortic valve
- transcatheter aortic valve
- transcatheter aortic valve implantation
- Received March 24, 2011.
- Revision received May 3, 2011.
- Accepted May 12, 2011.
- American College of Cardiology Foundation
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