Clin Res Cardiol (2012) 101:993–1001 DOI 10.1007/s00392-012-0488-3
ORIGINAL PAPER
Transcatheter Edwards Sapien XT valve in valve implantation in degenerated aortic bioprostheses via transfemoral access Martin Greif • Philipp Lange • Helmut Mair Christoph Becker • Christoph Schmitz • Gerhard Steinbeck • Christian Kupatt
•
Received: 2 April 2012 / Accepted: 8 June 2012 / Published online: 23 June 2012 Ó Springer-Verlag 2012
Abstract Objectives Surgical treatment of degenerated aortic bioprostheses is associated with an increased risk of morbidity and mortality, especially in elderly patients with significant co-morbidities. Therefore, transcatheter aortic valve implantation (TAVI) performed as valve in valve technique appears as an attractive alternative treatment option. We report of a case series of seven patients with dysfunctional bioprosthetic aortic heart valves who have been treated with TAVI via transfemoral access. Methods and results Valve in valve implantation using the Edwards Sapien XT bioprostheses (Edwards Lifesciences LLC, Irvine, CA, USA) was performed in eight patients (3 men, 5 women, mean age 85.3 ± 6.1 years) with a high operative risk (logistic euroSCORE 27.2 ± 7.3). Six patients underwent TAVI because of high grade stenosis of the aortic bioprostheses, whereas two patients presented with high grade regurgitation. All patients suffered at least from NYHA class III dyspnea during admission. TAVI was successfully
performed via transfemoral access under local anesthesia with mild analgesic medication in all cases. Mild aortic regurgitation occurred in three patients while no permanent pacemaker implantation was required. Major cardiac events or cerebrovascular events did not occur. One aneurysm spurium, with the need of one blood transfusion, occurred. All patients improved at least one NYHA class within 30 days. Conclusion TAVI for degenerated aortic bioprostheses, using the Edwards Sapien XT valve via transfemoral access is a feasible option for patients at high surgical risk. Keywords TAVI Valve in valve Transfemoral access Degenerated bioprostheses Abbreviations TAVI Transcatheter aortic valve implantation VIV Valve in valve
Introduction M. Greif P. Lange G. Steinbeck C. Kupatt Medizinische Klinik und Poliklinik I, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany M. Greif (&) Department of Cardiology, Klinikum Grosshadern, University Hospital of Munich, Marchioninistrasse 15, 81377 Munich, Germany e-mail:
[email protected] H. Mair C. Schmitz Herzchirurgische Klinik, Klinikum Grosshadern, University Hospital of Munich, Munich, Germany C. Becker Institut fu¨r Klinische Radiologie, Klinikum Großhadern, University Hospital of Munich, Munich, Germany
In contrast to mechanical heart valves, bioprosthetic valves are the preferred choice in patients at higher age, since they do not imply the necessity of long-term anticoagulation. However, although significant improvements have been reported [1–3], durability of bioprosthetic valves has limited their use in younger patient strata. The management of patients with failing bioprosthetic valves constitutes a major challenge [4], given the technical demands of repeated open heart surgery and graft replacement, and the usually advanced age at which they occur. On the other hand, TAVI has been demonstrated to offer an alternate treatment for elderly patients with native aortic valve stenosis who are at high risk for surgical
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treatment [5–7]. Even though TAVI was not designed for patients with degenerated bioprosthetic heart valves, it offers an attractive treatment option to this high-risk patient population by avoiding the increased risk of repeat heart surgery. The transfemoral access would offer the least invasive approach, in particular if the valve sizing is done by dual source computed tomography and the implantation is controlled fluoroscopically. The latter protocol enables this high-risk patient cohort to circumvent general anesthesia and transesophageal echocardiographic monitoring requiring catecholamine application. To date, reports on the success rate of this approach are scarce, since only a limited number of case series utilizing transluminal valve in valve technique have been reported for either the Medtronic CoreValve prostheses (Medtronic Inc., Minneapolis, MN, USA) [8–11] or the Edwards Sapien XT prostheses (Edwards Lifesciences LLC, Irvine, CA, USA) [12–18]. Of the latter, the Edwards Sapien XT valve, Webb et al. [12] reported two patients receiving the valve stent transfemorally during general anesthesia. Moreover, one of the two transfemorally implanted valves embolized and had to be deployed remotely, leading to a switch to the transapical access site. A more recent series of 16 transfemorally implanted valve in valve patients undergoing local anesthesia and mild analgesia was published by Latib et al. [13], suggesting the feasibility of the transfemoral approach. However, in this report, predilatation of the bioprosthesis was strongly discouraged. Here, we present a series of eight patients presenting with degenerated bioprosthetic aortic valves, who were treated by implantation of an Edwards Sapien XT valve via transfemoral access and stenosis predilatation. All procedures were performed in local anesthesia with only mild analgesic medication without conscious sedation [19].
Methods Patients Between October 2010 and December 2011, eight (3 male, age 83.8 ± 6.1) symptomatic (NYHA Class III) patients with degenerated aortic bioprostheses (6 high grade stenosis with an aortic valve area \1 cm2, two high grade regurgitation) were screened for possible valve in valve procedure in our center. Patient screening routinely included transthoracic echocardiography, dual source CT as coronary angiography. Before performing TAVI, the cases of all patients were discussed in our aortic board consisting of at least one cardiac surgeon, one radiologist, and two interventional cardiologists. All patients were considered as high-risk
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patients for repeat cardiac surgery (mean logistic euroSCORE 26.9.2 ± 4.3) and were evaluated as eligible for TAVI. During routine pre-implantation coronary catheterization, one patient displayed a proximal high grade coronary artery stenosis of the RCX and underwent PCI before TAVI. Dual source CT-scan (Definition Flash, Siemens Medical Solutions, Forchheim, Germany) was performed routinely before TAVI (Fig. 1). The collected data were used to determine the aortic annulus diameter as well as the calcification pattern of the aortic valve leaflets and the distance of the coronary arteries from the aortic annulus. Moreover, the accessability via the femoral and iliac arteries was scrutinized during the same diagnostic procedure (Fig. 2). Surgical reports of all patients were obtained to determine prosthesis type and internal diameter of the tissue valve. Anatomic characteristics of the implanted valves were discussed with our cardiac surgeons. Written informed consent was obtained from all patients before undergoing TAVI. Further patient characteristics are shown in Table 1. Device description and implantation procedure: Pretreatment medication consisted of acetylsalicylic acid (100 mg/day) and Clopidogrel 300 mg loading dose applied the day before intervention. After Edwards Sapien XT implantation, clopidogrel was recommended for 1 month and aspirin was recommended as a lifelong medication. 2.2 g amoxicillin/sulbactam was administered intravenously before the procedure and 6 h afterwards. All patients where treated with weight adjusted dose of bivalirudin during the procedure. Implantation was performed in local anesthesia with mild analgesic medication. Vascular access was obtained across the common femoral artery using a commercially available percutaneous closure system (Prostar XL structure device, Abbott Vascular, Abbott Park, III). Balloon valvuloplasty with a 20 or 23 mm balloon was performed before valve implantation, except for the patients with high grade aortic regurgitation without stenosis. Then, the aortic valve prosthesis (Edwards Sapien XT) was inserted retrogradely under fluoroscopic guidance. Valve implantation was performed under rapid pacing to lower cardiac output and blood pressure. According to the internal diameter of the degenerated bioprostheses, an Edwards Sapien XT valve of 23 or 26 mm was implanted such that the nominal external diameter of the implanted valve matched or exceeded the internal diameter of the degenerated bioprostheses. Peak-to-peak gradient was measured before and after valve in valve procedure. Aortic regurgitation after TAVI
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Fig. 1 Examples of valve in valve procedures. CT images on the two left panels, fluoroscopic images of before and after valve in valve implantation on the two right panels: 1 Edwards Lifescience (patient 1), 2 Edwards Lifescience (patient 2), 3 Medtronic Freestyle Stentless (patient 3), 4 Edwards Lifescience (patient 4), 5 Medtronic Mosaic (patient 5), 6 Mitroflow (patient 6), 7 Edwards Lifescience (patient 7), 8 Mitroflow (patient 8)
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Fig. 2 CT axial slices of patient 1. Notable the radio-opaque sewing ring of the degenerated bioprostheses Table 1 Baseline characteristics Patient 1
Patient 2
Patient 3
Patient 4
Patient 5
Patient 6
Patient 7
Patient 8
Age (years)
86
92
80
90
76
88
73
86
Sex
Female
Female
Male
Male
Female
Female
Male
Female
NYHA class
III
IV
IV
IV
III
III
IV
III
Kidney disease
Yes
Yes
No
Yes
Yes
No
Yes
Yes
Prior PCI
No
No
Yes
No
No
No
Yes
Yes
Atrial fibrilation
Yes
Yes
No
Yes
Yes
Yes
No
No
Logistic euroSCORE (%)
29.4
33.2
23.4
27.5
25.6
22.3
27.1
27.3
Diabetes
No
No
Yes
No
No
No
Yes
Yes
was evaluated angiographically. At the end of the procedure patients were transferred to our intensive care unit and were monitored for 48 h to exclude new onset of heart block or femoral bleeding. Before clinical discharge all patients had a concluding echocardiography. Follow-up information was obtained during routine ambulatory visits and/or by telephone interview. Statistical analysis Statistical analyses were performed using the SPSS software package (version 18.0, SPSS Inc. Chicago, IL, USA). The continuous variables are expressed as the mean ± SD and compared using Student’s t test. The categorical date are expressed as numbers and percentages and compared by Fisher’s or Chi-square exact test as appropriate. A p value \0.05 was considered as significant. All values illustrated in the figures are given as mean ± SD.
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Results Degenerated aortic bioprostheses were diagnosed in all patients. Six valves had high grade stenosis with a mean aortic valve area of 0.71 ± 0.04 cm2, and two patients had high grade regurgitation (grade III–IV of IV). Characteristics of degenerated bioprostheses are shown in Table 2. Valve in valve procedure was accomplished in all eight patients without major complications such as neurological events (stroke or TIA), myocardial infarction due to coronary obstruction, major groin bleedings or significant aortic regurgitation. The implantation level was chosen according to the nature of the previously implanted bioprosthesis and their varying closure planes. Immediate post-implantation assessment excluded a residual aortic pressure gradient [15 mmHg in all patients. Four patients had mild paravalvular regurgitation (grade I), whereas four patients did not display any aortic regurgitation.
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Table 2 Characteristics of degenerated bioprostheses Type of prostheses
Patient 1 Edwards Lifescience Perimount
Patient 2 Edwards Lifescience Perimount
Patient 3 Medtronic Freestyle Stentless
Patient 4 Edwards Lifescience Perimount
Patient 5 Medtronic Mosaic
Patient 6 Mitroflow
Patient 7 Edwards Lifescience Perimount
Patient 8 Mitroflow
Labeled size (mm)
23
21
25
25
25
25
23
25
Internal diameter (mm)
22
20
21.5
24
22.5
21
22
21
Aortic valve area (cm2)
0.68
0.75
0.7
0.69
1.3
0.6
1.4
0.68
Aortic regurgitation grade (0–IV)
0–I
I–II
0
0
III–IV
0–I
III
0
Age of bioprostheses (years)
10.5
10
9
11
9
13
9
5
Transvalvular Gradient before TAVI mmHg
104
71
95
55
66
61
28
81
Transvalvular Gradient after TAVI mmHg
16
13
15
16
26
19
10
29
Fig. 3 Transfemoral valve in valve implantation in a degenerated Medtronic Mosaic bioprostheses with high grade regurgitation (patient 5, left panel). Notably, after implantation of an Edwards Sapien XT 23 mm valve aortic regurgitation was eliminated (right panel)
In particular, the two patients treated for aortic regurgitation of the failed surgical bioprosthesis revealed no residual aortic regurgitation. (Fig. 3). After TAVI one new left bundle branch block occurred but there was no atrioventricular block with any need for permanent pacemaker implantation. Mean intervention time from arterial puncture until percutaneous closure was 102 ± 34 min, with a mean fluoroscopy time of 21.9 ± 10.2 min and a mean contrast agent use of 126.1 ± 57.7 ml. Mean stay at the intensive care unit was 3 ± 3.7 days, mean in-hospital stay was 16 ± 7.3 days. Echographic findings and follow-up After successful valve in valve procedure the mean aortic peak gradient of the five stenotic bioprostheses decreased from
70.2 ± 23.8 to 17.6 ± 7.3 mmHg (p = 0.0002). The aortic valve area increased from 0.71 ± 0.04 to 1.34 ± 0.12 cm2 (p \ 0.0001). There was no change in left ventricular ejection fraction before (59.5 ± 7.4 %) and after (59.8 ± 8.5 %) TAVI (see Table 3). In two patients presenting with high grade bioprosthesis regurgitation, aortic regurgitation was absent after successful valve in valve procedure. At discharge from the hospital, all patients improved at least one NYHA class (two patients from NYHA IV to NYHA III, four patients from NYHA III to NYHA II and two patients from NYHA IV to NYHA II) (Fig. 4). None of the eight patients had acute kidney injury or need of renal replacement therapy. These findings were consistent at 30 days follow-up visits. All eight patients were alive after 30 days. All patients met the VARC combined safety endpoints at 30 days [20].
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Table 3 Echographic findings and follow-up After TAVI
Aortic valve area (cm2)
0.71 ± 0.04
1.34 ± 0.12 \0.0001
Aortic valve peak gradient (mmHg)
70.2 ± 23.8
17.6 ± 7.3
0.0002
Aortic valve mean gradient (mmHg)
49.4 ± 14
7.2 ± 3.1
0.0001
LV ejection fraction (%)
59.5 ± 7.4
59.8 ± 8.5
NYHA Class
Before TAVI
IV
4
III
4
II
P value
0.9
2
6
I
Before TAVI
After TAVI
Fig. 4 Changes in NYHA class after TAVI
Discussion Surgical valve replacement is still the standard therapy in patients with highly stenotic aortic valves. Bioprostheses show advantageous hemodynamic results and satisfying long-term durability. In addition, bioprostheses do not require long-term anticoagulation which is of advantage especially in elderly patients with higher risk for bleeding complications. Nevertheless, degeneration of bioprosthetic valves is the most common complication leading to significant stenosis or regurgitation [21]. Repeat surgery in these patients often is associated with increased risk for complications. Therefore, TAVI is an attractive alternative treatment for these patients. Over the last 2 years several small case series have been reported for valve in valve procedure using either the Medtronic Core Valve or the Edwards Sapien valve [8–18]. While the Medtronic Core Valve was—due to the lack of an alternate transapical approach—consistently implanted via the transfemoral approach, the preferred approach for Edwards Sapien valves was transapical implantation. Although the transapical access was reported to be feasible without particular procedural hurdles [12, 15, 17, 18],
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general anesthesia, mini-thoracotomy and left ventricular apical access are still needed. Transfemorally, a case series of Latib et al. [13], was performed under local anesthesia with conscious sedation or under general anesthesia. Kempfert et al. [17] stated that the transapical approach could be of clinical advantage due to the direct access that allows immediate and precise positioning of the valve. In our transfemoral series positioning of the valve was uneventful, allowing for accurate valve deployment in all cases. Performing the transfemoral approach in local anesthesia with mild analgesic medical treatment avoids the risks of general anesthesia and surgical procedures in a population with a substantially elevated euroSCORE. In this context, we demonstrated that the transfemoral approach for valve in valve procedure using the Edwards Sapien XT valve is feasible with excellent periprocedural and 30 day success. As opposed to the Latib [13] series, we performed valve predilatation in all patients presenting with aortic stenosis (n = 6) and could not detect major disadvantages of cautious predilatation. Moreover, Eggebrecht et al. [16] reported a multicenter series of valve in valve implantation for degenerated bioprosthetic heart valves. In this series—the largest published so far—47 patients were treated by valve in valve TAVI procedures including both Medtronic Core valves and Edwards Sapien valves, either the transapical or the transfemoral approach. Beside two unsuccessful attempts requiring bail-out implantation of a second TAVI prosthesis because of severe regurgitation, they report a mortality rate of 17 % at 30 days. These findings may well reflect a particularly difficult cohort with a logistic euroSCORE of 35.0 %, differing in this respect to our cohort (euroSCORE 27.2 %) and to most case series in literature [12, 13, 17, 18]. On the other hand, this multicenter series highlights the fact that patients undergoing valve in valve TAVI mainly are elderly patients with significant co-morbidities and therefore at high risk. Particularly these patients benefit from less invasive procedures as possible as described in the present study with transfemoral access without general anesthesia and use of inotropic agents. In order to ensure successful implantation, the diameter of the surgically implanted bioprosthesis is taken into account for selecting the correct size of the Edwards Sapien XT (23 or 26 mm) valves, which in all cases could also be confirmed by multi-slice CT measuring of the annular diameter of the degenerated bioprostheses. Although we performed predilation to avoid valve protrusion through a stenotic bioprosthesis into the left ventricle, we found similar to the Latib’s study [13] that the external diameter of the transcatheter heart valve does not necessarily have to exceed the bioprostheses internal diameter. On the other hand it is important to avoid over-
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sizing the transcatheter heart valve, since the rigid bioprostheses can lead to incomplete stent expansion and consequently to inadequate valve function. Latib et al. [13] avoided ballon valvuloplasty due to concerns that ballon dilatation may disintegrate the valve and result in torrential regurgitation or embolisation of debris. We did not experience either high grade regurgitation or debris embolisation resulting in neurological events (stroke or TIA) in our series, even though we performed mild predilatation in all stenotic degenerated bioprostheses, without inducing major adverse cardiac or cerebral events. Azadani et al. [22] reported of inadequate hemodynamic effects when a 23 mm Sapien XT valve was implanted in a degenerated bioprostheses of 19 mm internal diameter. In our series, two 23 mm Sapien XT valves were implanted into two degenerated bioprostheses with 21 and 20 mm internal diameter with favorable hemodynamic effects (decrease of peak pressure gradient measured by echocardiography from 71 to 13 mmHg and from 61 to 19 mmHg, respectively). Nevertheless, long-term follow-up is needed to exclude faster degeneration of these presumably not fully extended valves. Interestingly the two Mitroflow valves even not having the smallest internal diameters resulted in having the highest echocardiographic rest-gradient after valve in valve procedure. Also Wilberg et al. [18] reported of an elevated transvalvular gradient after transapical valve in valve TAVI using an Edwards Sapien valve in a degenerated Mitroflow 23 mm valve. The authors speculated that at least part of this gradient was due to a subvalvular pannus of the primarily implanted valve. We did not observe a strong ‘‘Venturi effect’’ in our two Mitroflow patients in post-procedural echocardiography but valve design of the Mitroflow aortic bioprostheses could influence post-procedural residual gradient after valve in valve treatment. Embolization of the transcatheter aortic valve is a potential complication during valve in valve procedure [12], which in a reported case happened due to the positioning of the transcatheter heart valve within the outflow portion of the bioprostheses without overlapping the sewing ring. Therefore, particular care was taken to ensure overlapping of the proximal valve stent edge with the sewing ring, which was facilitated by the predilatation step allowing for a more precise movement of the valve stent in the stenosed area. Moreover, protrusion of the valve stent from its premounted location, which may theoretically occur after complete passage through a high grade stenosis and subsequent retraction, was completely avoided. Latib et al. [13] suggest implantation of the transcatheter heart valve slightly more toward the ventricle in order to secure fixation. Alternately, we ensured overlapping of the
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Edwards Sapien XT stent with the sewing ring, and oriented the transcatheter valve toward the closing plane of the degenerated valve. Following this strategy combined with predilatation, we neither experienced valve protrusion into the left ventricle nor loss of the transcatheter valve into the aorta. Gurvitch et al. [23] reported of coronary obstruction following aortic valve in valve implantation in a degenerated Mitroflow valve (Sorin group, Vancouver, BC, Canada). The Mitroflow design differs from other bioprostheses as the leaflet tissue is mounted externally over the stent. In addition, the sinuses of the reported patient were relatively small and the distance toward the coronary orifices was short. This case highlights the necessity of three-dimensional reconstruction of aortic root imaging, in our case by multi-slice computed tomography, and adaptation of the implantation strategy according to the bioprosthesis type and precise localization. Taken these features into account, we could safely implant two Edwards Sapien XT valves into two Mitroflow valves in our series. Generally, high grade aortic regurgitation is a contraindication for TAVI because in many cases the insufficient valves do not have extended calcifications and are not capable of anchoring the transcatheter heart valves safely. In contrast, in degenerated bioprostheses the transcatheter heart valve can be fixed in the sewing ring of the bioprostheses. In our series we could successfully treat two degenerated aortic bioprosthesis with high grade regurgitation with valve in valve implantation. After successful implantation, in both cases the aortic regurgitation was absent. It is notable that aortic regurgitation is rare or mild after valve in valve implantation. This can be explained by the fact that bioprostheses have an almost circular landing zone which can be filled completely by the circular stent of the Sapien XT transcatheter heart valve. Finally in our series after valve in valve procedure only one new left bundle branch block occurred, whereas no incidence of a new atrioventricular block with the need of permanent pacemaker implantation was observed. These findings go in line with the reports of Kempfert et al. [17] and Wilbring et al. [18] who also did not display an atrioventricular block after transapical valve in valve TAVI using the Edwards Sapien valve. In contrast, Bedogni et al. [11] reported three new atrioventricular blocks with the need of permanent pacemaker implantation after valve in valve using the Medtronic Core Valve. Also Eggebrecht et al. [16] reported of a trend toward more permanent pacemaker implantations after valve in valve procedure with the Medtronic Core valve. It is tempting to speculate that the sewing ring of the bioprostheses is protecting the heart’s impulse conducting system against pressure forces, but again the size limitation of our series does not allow for a definitive interpretation of this finding.
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Conclusion Transcatheter valve in valve implantation using the Edwards Sapien XT valve via transfemoral access is feasible with favorable hemodynamic results. This approach may become an alternative for patients with degenerated aortic bioprostheses being at high risk for repeat surgery.
Limitations The main limitation of our study is the small sample size and the mono-centric character. However, so far there is only one further monocentric case series of transcatheter valve in valve implantation using the Edwards Sapien XT valve exclusively via transfemoral access. As the transfemoral access represents the least invasive approach, more experience is needed to establish this approach for highrisk patients to avoid redo valve surgery.
References 1. Hammermeister K, Sethi GK, Henderson WG, Grover FL, Oprian C, Rahimtoola SH (2000) Outcomes 15 years after valve replacement with a mechanical versus a bioprosthetic valve: final report of the Veterans Affairs randomized trial. J Am Coll Cardiol 36(4):1152–1158 2. Khan SS, Trento A, DeRobertis M, Kass RM, Sandhu M, Czer LS, Blanche C, Raissi S, Fontana GP, Cheng W, Chaux A, Matloff JM (2001) Twenty-year comparison of tissue and mechanical valve replacement. J Thorac Cardiovasc Surg 122(2): 257–269 3. Kassaı¨ B, Gueyffier F, Cucherat M, Boissel JP (2000) Comparison of bioprosthesis and mechanical valves, a meta-analysis of randomised clinical trials. Cardiovasc Surg 8(6):477–483 4. Jones JM, O’kane H, Gladstone DJ, Sarsam MA, Campalani G, MacGowan SW, Cleland J, Cran GW (2001) Repeat heart valve surgery: risk factors for operative mortality. J Thorac Cardiovasc Surg 122(5):913–918 5. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators (2010) Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 363(17):1597–1607 (Epub 2010 Sep 22) 6. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators (2011) Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 364(23):2187–2198 (Epub 2011 Jun 5) 7. Figulla L, Neumann A, Figulla HR, Kahlert P, Erbel R, Neumann T (2011) Transcatheter aortic valve implantation: evidence on safety and efficacy compared with medical therapy. A systematic review of current literature. Clin Res Cardiol 100(4):265–276
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Clin Res Cardiol (2012) 101:993–1001 8. Gotzmann M, Mu¨gge A, Bojara W (2010) Transcatheter aortic valve implantation for treatment of patients with degenerated aortic bioprostheses–valve-in-valve technique. Catheter Cardiovasc Interv 76(7):1000–1006. doi:10.1002/ccd.22738 (Epub 2010 Nov 17) 9. Khawaja MZ, Haworth P, Ghuran A, Lee L, de Belder A, Hutchinson N, Trivedi U, Laborde JC, Hildick-Smith D (2010) Transcatheter aortic valve implantation for stenosed and regurgitant aortic valve bioprostheses CoreValve for failed bioprosthetic aortic valve replacements. J Am Coll Cardiol 55(2):97–101 10. Wenaweser P, Buellesfeld L, Gerckens U, Grube E (2007) 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 70(5):760–764 11. Bedogni F, Laudisa ML, Pizzocri S, Tamburino C, Ussia GP, Petronio AS, Napodano M, Ramondo A, Presbitero P, Ettori F, Santoro G, Klugman S, De Marco F, Brambilla N, Testa L (2011) Transcatheter valve-in-valve implantation using Corevalve Revalving System for failed surgical aortic bioprostheses. JACC Cardiovasc Interv 4(11):1228–1234 12. Webb JG, Wood DA, Ye J, Gurvitch R, Masson JB, Rode´s-Cabau J, Osten M, Horlick E, Wendler O, Dumont E, Carere RG, Wijesinghe N, Nietlispach F, Johnson M, Thompson CR, Moss R, Leipsic J, Munt B, Lichtenstein SV, Cheung A (2010) Transcatheter valve-in-valve implantation for failed bioprosthetic heart valves. Circulation 121(16):1848–1857 (Epub 2010 Apr 12) 13. Latib A, Ielasi A, Montorfano M, Maisano F, Chieffo A, Cioni M, Mussardo M, Bertoldi L, Shannon J, Sacco F, Covello RD, Figini F, Godino C, Grimaldi A, Spagnolo P, Alfieri O, Colombo A (2012) Transcatheter valve-in-valve implantation with the Edwards SAPIEN in patients with bioprosthetic heart valve failure: the Milan experience. EuroIntervention. pii: 20120109-00 (Epub ahead of print) 14. Azadani AN, Tseng EE (2011) Transcatheter heart valves for failing bioprostheses: state-of-the-art review of valve-in-valve implantation. Circ Cardiovasc Interv 4(6):621–628 15. Seiffert M, Franzen O, Conradi L, Baldus S, Schirmer J, Meinertz T, Reichenspurner H, Treede H (2010) Series of transcatheter valve-in-valve implantations in high-risk patients with degenerated bioprostheses in aortic and mitral position. Catheter Cardiovasc Interv 76(4):608–615 16. Eggebrecht H, Scha¨fer U, Treede H, Boekstegers P, Babin-Ebell J, Ferrari M, Mo¨llmann H, Baumgartner H, Carrel T, Kahlert P, Lange P, Walther T, Erbel R, Mehta RH, Thielmann M (2011) Valve-in-valve transcatheter aortic valve implantation for degenerated bioprosthetic heart valves. JACC Cardiovasc Interv 4(11):1218–1227 17. Kempfert J, Van Linden A, Linke A, Borger MA, Rastan A, Mukherjee C, Ender J, Schuler G, Mohr FW, Walther T (2010) Transapical off-pump valve-in-valve implantation in patients with degenerated aortic xenografts. Ann Thorac Surg 89(6): 1934–1941 18. Wilbring M, Sill B, Tugtekin SM, Alexiou K, Simonis G, Matschke K, Kappert U (2012) Transcatheter valve-in-valve implantation for deteriorated aortic bioprosthesis: initial clinical results and follow-up in a series of high-risk patients. Ann Thorac Surg 93(3):734–741 19. Motloch LJ, Rottlaender D, Reda S, Larbig R, Bruns M, Mu¨llerEhmsen J, Strauch J, Madershahian N, Erdmann E, Wahlers T, Hoppe UC (2012) Local versus general anesthesia for transfemoral aortic valve implantation. Clin Res Cardiol 101(1):45–53 20. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW
Clin Res Cardiol (2012) 101:993–1001 (2011) Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. Eur Heart J 32(2):205– 217 21. Rahimtoola SH (2003) Choice of prosthetic heart valve for adult patients. J Am Coll Cardiol 41(6):893–904 22. Azadani AN, Jaussaud N, Matthews PB, Ge L, Chuter TA, Tseng EE (2010) Transcatheter aortic valves inadequately relieve
1001 stenosis in small degenerated bioprostheses. Interact Cardiovasc Thorac Surg 11(1):70–77 (Epub 2010 Apr 15) 23. Gurvitch R, Cheung A, Bedogni F, Webb JG (2011) Coronary obstruction following transcatheter aortic valve-in-valve implantation for failed surgical bioprostheses. Catheter Cardiovasc Interv 77(3):439–444. doi:10.1002/ccd.22861 (Epub 2011 Jan 4)
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