**8. Results from the literature**

#### **8.1. Cribrier-Edwards valve**

Cribier *et al.* did the first human implantation in 2002 [14]. The Edwards SAPIEN valve was approved for use in the European Union in November 2007 (for the transfemoral approach) and in January 2008 (for transapical delivery). In the Initial Registry of EndoVascular Im‐ plantation of Valves in Europe (I-REVIVE) trial, followed by the Registry of Endovascular Critical Aortic Stenosis Treatment (RECAST) trial, a total of 36 patients (mean (SD) Euro‐ SCORE 12 (2)) were included [15]. Twenty-seven patients underwent successful percutane‐ ous aortic valve implantation (23 antegrade, 4 retrograde). The 30-day mortality was 22% (6 of 27 patients), and the mean AVA increased from 0.60 ± 0.11cm2 to 1.70 ± 0.10cm2 (p<0.001). Importantly, this improvement in AVA was maintained up to 24 months followup [16]. Since these first trials, the Cribrier-Edwards prosthesis and the Edwards SAPIEN prosthesis have been used in numerous studies. Overall, acute procedural success is ach‐ ieved in 75–100% of the procedures, and 30-day mortality ranges between 8–50% in the pub‐ lished studies. Using the transapical technique and the Sapien valve, Walther et al. [17] has reported their initial multicenter results of 59 consecutive patients, which is the largest feasi‐ bility study published thus far. Procedural success using the transapical technique was ach‐ ieved in 53 patients. Thirty-day mortality was 13.6% and none of these were thought to be valve related as there was good valve function at autopsy. The overall procedural success of 1038 SAPIEN implants from 32 centers within the European SOURCE registry was 93.8%. The 30-day survival within SOURCE was 93.7% (transfemoral) and 89.7% (transapical) [18]. The 1-year survival of the cohort was 81.1% (transfemoral) and 72.1% (transapical), respec‐ tively. In cohort B of the PARTNER randomized trial, 179 patients receiving transfemoral SAPIEN aortic valve with 179 patients receiving standard medical therapy (including bal‐ loon aortic valvuloplasty), confirmed the superiority of transfemoral TAVI with regard to overall survival and cardiac functional status [19]. The Kaplan-Meier 1-year mortality from any cause was 30.7% (TAVI) versus 50.7% (standard medical therapy), corresponding to a 0.55 hazard ratio with TAVI (p<0.001). The fraction of surviving patients at 1-year, in New York Heart Association functional class III-IV, was lower in the TAVI group (25.2% versus 58%; p<0.001). Nevertheless, the TAVI group had a higher 30-day incidence of major stroke (5.0% versus 1.1%; p=0.06) and major vascular complications (16.2% versus 1.1%; p<0.001). Early and 1-year outcomes from the REVIVAL trial, which consisted of 55 patients with a mean AVA of 0.57±0.14cm2 and a mean logistic EuroSCORE of 33.5±17%, have been report‐ ed [20]. TAVI was successful in 87%. Mean echocardiographic AVA improved from 0.56±14 to 1.6±0.48cm2 after the procedure (p<0.0001). Thirty-day all-cause mortality and major ad‐ verse cardiac events (MACE) were 7.3% and 20%, respectively. These rates increased to 23.6% and 32.7%, respectively, at 1 year, with most late events related to underlying comor‐ bidities. The mean NYHA functional class improved from 3.22±0.66 at baseline to 1.50±0.85 at 1-year follow-up (p<0.001).

period of 5 months in 2009, reported 98.3% procedural success for both Edwars SAPIEN and Medtronic CoreValve (66% transfemoral, 5% subclavian, and 29% transapical) prostheses [13]. The 30-day mortality was 12.7%, and, at 1 month, 88% of patients were in NYHA class I-II. Buellesfeld *et al.* [23] reported on a 2-year follow-up of 126 patients who underwent TA‐ VI. Thirty-day all-cause mortality was 15.2%. At 2-years, all-cause mortality was 38.1%, with a significant difference between the moderate-risk group and the combined high-risk groups (27.8% versus 45.8%; p=0.04). This difference was attributable to an increased risk of noncar‐ diac mortality in high-risk groups. Hemodynamic results remained unchanged during fol‐ low-up (mean gradient: 8.5±2.5mmHg at 30 days and 9.0±3.5mmHg at 2 years) without any

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The larger CoreValve prostheses (26, 29 and 31 mm) were the only device for annulus be‐ tween 26 and 29 mm, before the currently available 29-mm SAPIEN XT valve for transapical implantation. The CoreValve prosthesis had previously been the only device suitable for transarterial implant in patients with limited iliofemoral artery access, but this has changed with the SAPIEN NovaFlex delivery system. The growing experience with the subclavian artery approach, however, allows the CoreValve prosthesis to be implanted in patients with unusable iliofemoral arteries. Because of these results, the indications for TAVI expanded (e.g. in patients with porcelain aorta, with previous cardiac surgery, etc.) [24] (Figure 11,12).

incidence of structural valve deterioration.

**Figure 11.** TAVI in a patient with a history of AVR

**Figure 12.** TAVI in a patient with a history of mitral valve replacement

#### **8.2. CoreValve ReValving**

Since the first implantation of the CoreValve prosthesis in a patient in 2005 [12], a large number of patients have been treated with this device. The feasibility and safety of this valve was studied in a prospective, multicenter trial [12]. A total of 25 symptomatic patients with an AVA < 1cm2 were enrolled in the study. The device was successfully implanted us‐ ing the retrograde technique in 22 of 25 patients. Procedural success and aortic mean pres‐ sure gradients were markedly improved immediately following implantations with preprocedure gradients 44.24 ± 10.79 mmHg to 12.38 ± 3.03 mmHg post-procedure, and were about the same at 30-day follow-up (11.82 ± 3.42 mm Hg). NYHA functional class improved by 1 to 2 grades in all patients. MACE, defined as death from any cause, major arrhythmia, myocardial infarction, cardiac tamponade, stroke, urgent or emergent conversion to surgery or balloon valvuloplasty, emergent percutaneous coronary intervention, cardiogenic shock, endocarditis, or aortic dissection, occurred in 8 of the 25 hospitalized patients. Recently, Grube *et al.* [21] reported the results with the three different generations of the CoreValve Revalving system in a non-randomized, prospective study of 136 patients. Ten patients were treated with first-generation devices, 24 patients with second-generation, and 102 patients with third-generation devices. At baseline, mean AVA was 0.67cm2 and mean logistic Euro‐ SCORE was 23.1% in the overall study population. With the new-generation devices, the overall procedural success rate significantly increased from 70.0% and 70.8% to 91.2% for the first-, second-, and third-generation prostheses, respectively (p = 0.003). Interestingly, us‐ ing newer devices, periprocedural mortality decreased from 10% (first-generation) to 8.3% (second-generation) to 0% (third-generation). Overall 30-day mortality for the three genera‐ tions was 40%, 8.3% and 10.8%, respectively. Pooled data demonstrated a significant im‐ provement in mean NYHA functional class (from 3.3 to 1.7, p<0.001), without a difference between the three generations. Importantly, NYHA functional class and mean pressure gra‐ dient remained stable up to 12 months follow-up in all three generations. In addition, the results of a multicenter registry with the third-generation CoreValve Revalving system have recently been reported [22]. A total of 646 patients from 51 centers were included in the reg‐ istry. It was a high-risk elderly population (mean age: 81 years) with a poor functional class (85% of the patients in NYHA class III or IV), and a high logistic EuroSCORE (mean: 23.1%). Procedural success was achieved in 628 of the 646 patients (97.2%). All-cause 30-day mortali‐ ty was 8%, and the combined end point of procedural related death, stroke, or myocardial infarction was reached in 60 patients (9.3%). After successful implantation, mean pressure gradient decreased from 49 mmHg to 3 mmHg [22]. The FRANCE real-world registry of 244 consecutive high-risk patients with symptomatic severe AS, enrolled from 16 centers over a period of 5 months in 2009, reported 98.3% procedural success for both Edwars SAPIEN and Medtronic CoreValve (66% transfemoral, 5% subclavian, and 29% transapical) prostheses [13]. The 30-day mortality was 12.7%, and, at 1 month, 88% of patients were in NYHA class I-II. Buellesfeld *et al.* [23] reported on a 2-year follow-up of 126 patients who underwent TA‐ VI. Thirty-day all-cause mortality was 15.2%. At 2-years, all-cause mortality was 38.1%, with a significant difference between the moderate-risk group and the combined high-risk groups (27.8% versus 45.8%; p=0.04). This difference was attributable to an increased risk of noncar‐ diac mortality in high-risk groups. Hemodynamic results remained unchanged during fol‐ low-up (mean gradient: 8.5±2.5mmHg at 30 days and 9.0±3.5mmHg at 2 years) without any incidence of structural valve deterioration.

The larger CoreValve prostheses (26, 29 and 31 mm) were the only device for annulus be‐ tween 26 and 29 mm, before the currently available 29-mm SAPIEN XT valve for transapical implantation. The CoreValve prosthesis had previously been the only device suitable for transarterial implant in patients with limited iliofemoral artery access, but this has changed with the SAPIEN NovaFlex delivery system. The growing experience with the subclavian artery approach, however, allows the CoreValve prosthesis to be implanted in patients with unusable iliofemoral arteries. Because of these results, the indications for TAVI expanded (e.g. in patients with porcelain aorta, with previous cardiac surgery, etc.) [24] (Figure 11,12).

**Figure 11.** TAVI in a patient with a history of AVR

mean AVA of 0.57±0.14cm2 and a mean logistic EuroSCORE of 33.5±17%, have been report‐ ed [20]. TAVI was successful in 87%. Mean echocardiographic AVA improved from 0.56±14 to 1.6±0.48cm2 after the procedure (p<0.0001). Thirty-day all-cause mortality and major ad‐ verse cardiac events (MACE) were 7.3% and 20%, respectively. These rates increased to 23.6% and 32.7%, respectively, at 1 year, with most late events related to underlying comor‐ bidities. The mean NYHA functional class improved from 3.22±0.66 at baseline to 1.50±0.85

Since the first implantation of the CoreValve prosthesis in a patient in 2005 [12], a large number of patients have been treated with this device. The feasibility and safety of this valve was studied in a prospective, multicenter trial [12]. A total of 25 symptomatic patients

ing the retrograde technique in 22 of 25 patients. Procedural success and aortic mean pres‐ sure gradients were markedly improved immediately following implantations with preprocedure gradients 44.24 ± 10.79 mmHg to 12.38 ± 3.03 mmHg post-procedure, and were about the same at 30-day follow-up (11.82 ± 3.42 mm Hg). NYHA functional class improved by 1 to 2 grades in all patients. MACE, defined as death from any cause, major arrhythmia, myocardial infarction, cardiac tamponade, stroke, urgent or emergent conversion to surgery or balloon valvuloplasty, emergent percutaneous coronary intervention, cardiogenic shock, endocarditis, or aortic dissection, occurred in 8 of the 25 hospitalized patients. Recently, Grube *et al.* [21] reported the results with the three different generations of the CoreValve Revalving system in a non-randomized, prospective study of 136 patients. Ten patients were treated with first-generation devices, 24 patients with second-generation, and 102 patients with third-generation devices. At baseline, mean AVA was 0.67cm2 and mean logistic Euro‐ SCORE was 23.1% in the overall study population. With the new-generation devices, the overall procedural success rate significantly increased from 70.0% and 70.8% to 91.2% for the first-, second-, and third-generation prostheses, respectively (p = 0.003). Interestingly, us‐ ing newer devices, periprocedural mortality decreased from 10% (first-generation) to 8.3% (second-generation) to 0% (third-generation). Overall 30-day mortality for the three genera‐ tions was 40%, 8.3% and 10.8%, respectively. Pooled data demonstrated a significant im‐ provement in mean NYHA functional class (from 3.3 to 1.7, p<0.001), without a difference between the three generations. Importantly, NYHA functional class and mean pressure gra‐ dient remained stable up to 12 months follow-up in all three generations. In addition, the results of a multicenter registry with the third-generation CoreValve Revalving system have recently been reported [22]. A total of 646 patients from 51 centers were included in the reg‐ istry. It was a high-risk elderly population (mean age: 81 years) with a poor functional class (85% of the patients in NYHA class III or IV), and a high logistic EuroSCORE (mean: 23.1%). Procedural success was achieved in 628 of the 646 patients (97.2%). All-cause 30-day mortali‐ ty was 8%, and the combined end point of procedural related death, stroke, or myocardial infarction was reached in 60 patients (9.3%). After successful implantation, mean pressure gradient decreased from 49 mmHg to 3 mmHg [22]. The FRANCE real-world registry of 244 consecutive high-risk patients with symptomatic severe AS, enrolled from 16 centers over a

were enrolled in the study. The device was successfully implanted us‐

at 1-year follow-up (p<0.001).

**8.2. CoreValve ReValving**

494 Calcific Aortic Valve Disease

with an AVA < 1cm2

**Figure 12.** TAVI in a patient with a history of mitral valve replacement

#### **9. Conclusion**

Transcatheter aortic valve implantation was developed to provide an alternative and less in‐ vasive method of treating aortic valve stenosis. Actually, it has been proved that the method is feasible, with results that have been reproduced by many physicians in many centers (ap‐ proximately 10,000 implantations to date). Today there are at least 10 new transcatheter aortic valves that have had their first implantation in humans, many more that have reached the level of animal experiments, and even more that are still in the initial design stage. As a new treatment tool, it has to be evaluated in randomized controlled trials with long-term follow-up in order to assess safety and efficacy. Therefore, TAVI should be restricted to a limited number of high-volume centers, that have both cardiology and cardiac surgery de‐ partments as well as expertise in structural heart disease intervention and high-risk valvular surgery. Because of excellent results with surgical valve replacement, patient selection, which should be done in multidisciplinary conferences, is of utmost importance. Like other interventional procedures, there is a learning curve with significant improvements in the success rate and the clinical results after the first 25 procedures, which implies that the TAVI procedure should initially be done by and thereafter supervised by a special team [25,26]. In addition to patient selection and intervention of TAVI, a close follow-up with assessment of clinical and objective parameters is mandatory for defining the indications of this technique.

[6] Vahanian A, Alfieri O, Al-Attar N, et al. Transcatheter valve implantation for pa‐ tients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Inter‐

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[7] Zegdi R, Ciobotaru V, Noghin M, et al. Is it reasonable to treat all calcified stenotic aortic valves with a valved stent? Results from a human anatomic study in adults. J

[8] Roques F, Nashef SA, Michel P, et al. Risk factors for early mortality after valve sur‐ gery in Europe in the 1990's: lesson from the EuroSCORE pilot program. J Heart

[9] Grossi EA, Schwartz CF, Yu PJ, et al. High-risk aortic valve replacement: are the out‐

[10] Babaliaros VC, Liff D, Chen EP, et al. Can balloon aortic valvuloplasty help deter‐ mine appropriate transcatheter aortic valve size. JACC Intv 2008;1(5): 580-6.

[11] De Robertis F, Asgar A, Davies S, et al. The left exillary arter-a new approach for transcatheter aortic valve implantation. Eur J Cardiothorac Surg 2009;36(5):807-12.

[12] Grube E, Laborde JC, Gerckens U, et al. Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: Sieg‐

[13] Eltchaninoff H, Prat A, Gilard M, et al. Transcatheter aortic valve implantation: early results of the France (French Aortic National CoreValve and Edwards) registry. Eur

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[15] Cribrier A, Elchaninoff H, Tron C, et al. Early experience with percutaneous trans‐ catheter implantation of heart valve prosthesis for the treatment of end-stage inoper‐ able patients with calcific aortic stenosis. J Am Coll Cardiol 2004;43(4): 698-703.

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[18] Thomas M, Schymik G, Walther T, et al. Thirty-day results of the SAPIEN aortic Bio‐ prosthesis Outcomes (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 2010;122(1): 62-9.

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#### **Author details**

Ibrahim Akin, Stephan Kische, Henrik Schneider, Tim C. Rehders, Christoph A. Nienaber and Hüseyin Ince

University of Rostock, Germany

#### **References**


[6] Vahanian A, Alfieri O, Al-Attar N, et al. Transcatheter valve implantation for pa‐ tients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Inter‐ ventions (EAPCI). Eur Heart J 2008;29(11): 1463-70.

**9. Conclusion**

496 Calcific Aortic Valve Disease

**Author details**

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[5] Ross J Jr, Braunwald E. Aortic stenosis. Circulation 1965;38(2): V61-7.

Christoph A. Nienaber and Hüseyin Ince

University of Rostock, Germany

2006;82(6): 2111-5.

Transcatheter aortic valve implantation was developed to provide an alternative and less in‐ vasive method of treating aortic valve stenosis. Actually, it has been proved that the method is feasible, with results that have been reproduced by many physicians in many centers (ap‐ proximately 10,000 implantations to date). Today there are at least 10 new transcatheter aortic valves that have had their first implantation in humans, many more that have reached the level of animal experiments, and even more that are still in the initial design stage. As a new treatment tool, it has to be evaluated in randomized controlled trials with long-term follow-up in order to assess safety and efficacy. Therefore, TAVI should be restricted to a limited number of high-volume centers, that have both cardiology and cardiac surgery de‐ partments as well as expertise in structural heart disease intervention and high-risk valvular surgery. Because of excellent results with surgical valve replacement, patient selection, which should be done in multidisciplinary conferences, is of utmost importance. Like other interventional procedures, there is a learning curve with significant improvements in the success rate and the clinical results after the first 25 procedures, which implies that the TAVI procedure should initially be done by and thereafter supervised by a special team [25,26]. In addition to patient selection and intervention of TAVI, a close follow-up with assessment of clinical and objective parameters is mandatory for defining the indications of this technique.

[1] Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart disease: a popula‐

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**Chapter 17**

**Aortic Valve Replacement for Calcified Aortic Valves**

Valve replacement has been the standard treatment for aortic stenosis until the develop‐ ment of transcatheter aortic valve implantation (TAVI). Although TAVI provides a treatment with fairly acceptable outcomes for patients with high surgical risk, aortic valve replacement remains essential even in the TAVI era, because surgical treatment is indicated when TAVI cannot be performed due to a small aortic annulus or inappropri‐ ate access route. In addition, surgical treatment may be necessary when complications develop during TAVI procedures. Therefore, a more meticulous procedure is required for surgeons. With an increasing number of elderly patients who need surgical treatment and are at high risk due to aging, comorbidities, or medications such as steroids or antiplate‐ let drugs, trivial pitfalls during surgery can lead to catastrophic results. Furthermore, many patients with hemodialysis and marked systemic calcification require aortic valve

Complications encountered during surgery for aortic stenosis can be associated with catastrophic events such as myocardial infarction, cerebral embolism or aortic dissection. This is because a calcified aortic valve rarely exists alone, but is often associated with marked and diffuse calcification in the aorta, coronary arteries, mitral valve or even cerebral vessels [2]. The goal of surgical treatment is to implant a prosthetic valve of adequate size in each individual patient without perivalvular leak, while avoiding undesirable complications such as stroke, cardiac events or bleeding. This chapter is devoted to the tips and pitfalls in aortic valve replacement of calcified aortic valves with a discussion of preoperative and intraoperative strategies to achieve the best possible

> © 2013 Orihashi; licensee InTech. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,

© 2013 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution,

distribution, and reproduction in any medium, provided the original work is properly cited.

and reproduction in any medium, provided the original work is properly cited.

Kazumasa Orihashi

**1. Introduction**

surgery in Japan [1].

outcomes.

http://dx.doi.org/10.5772/53418

Additional information is available at the end of the chapter

