ORIGINAL ARTICLE – ADULT CARDIAC
Interactive CardioVascular and Thoracic Surgery 21 (2015) 169–175 doi:10.1093/icvts/ivv110 Advance Access publication 8 May 2015
Cite this article as: Vola M, Ruggieri VG, Campisi S, Grinberg D, Morel J, Favre J-P et al. Sutureless 3f Enable valve implantation concomitant with mitral valve surgery. Interact CardioVasc Thorac Surg 2015;21:169–75.
Sutureless 3f Enable valve implantation concomitant with mitral valve surgery
a b
Cardiovascular Surgery Unit, Cardiovascular Diseases Department, University Hospital, Saint-Etienne, France Cardiology Unit, Cardiovascular Diseases Department, University Hospital, Saint-Etienne, France
* Corresponding author. Service de Chirurgie Cardiovasculaire, Pôle Cardiovasculaire, Hôpital Nord, Centre Hospitalier Universitaire de Saint-Etienne, 42055 Saint-Etienne Cedex, France. Tel: +33-4-77828750; fax: +33-4-77828453; e-mail: [email protected] (M. Vola). Received 5 January 2015; received in revised form 22 March 2015; accepted 2 April 2015
Abstract OBJECTIVE: Interest in aortic sutureless bioprostheses is growing. Here, we evaluate the feasibility of performing aortic sutureless valve replacement concomitant with mitral valve surgery using the 3f Enable prosthesis. METHODS: Of the 198 3f Enable® valve implantation procedures carried out in our unit between March 2011 and October 2014, 15 were performed concomitant with mitral valve surgery (8 bioprosthetic replacements and 7 annuloplasties). RESULTS: The mean age and logistic EuroSCORE were 76 ± 6 years and 10.2 ± 4.8, respectively. The procedural success rate of aortic sutureless valve implantation was 100%. Mean cross-clamping and cardiopulmonary bypass times were 113.9 ± 35 and 150- ± 43 min, respectively. No reclamping in response to a sutureless paravalvular leakage (PVL) was needed. One grade 1 leak was observed at the time of discharge. There was no perioperative mortality. Pacemaker implantation was required in 1 case (6.6%). Initial follow-up (median = 8 months, range 1–6) showed no new aortic PVL; mean and peak transprosthetic gradients and the orifice area were 11.1 ± 2.5 and 18.4 ± 4.9 mmHg and 1.7 ± 0.4 cm2, respectively. One grade 2 and two grade 1 mitral valve leaks were detected following annuloplasty. CONCLUSIONS: 3f Enable® sutureless valve implantation combined with mitral valve surgery appears feasible and the results presented here are encouraging. This procedure has the potential to simplify surgery in a cohort of high-risk patients for whom transcatheter aortic valve replacement is not an effective option. Larger studies should be conducted to confirm these observations. Keywords: Sutureless heart valve prosthesis • Transcatheter aortic valve implantation • Aortic and mitral valve replacement
INTRODUCTION Sutureless (SU) valves appear to enable shorter cross-clamping times when compared with conventional sutured bioprostheses and thus have the potential to produce better outcomes in high-risk patients [1–3] and in surgical settings where suture placement is challenging [4, 5]. The use of SU valves could lead to improved outcomes for the subset of complex procedures combining aortic and mitral valve surgery, which require longer ischaemic times. A recent study reported on the first-time use of the Sorin Perceval® (Sorin, Saluggia, Italy) SU bioprosthesis [6] in 10 consecutive patients. Here, we report our experience with the 3f Enable® SU device used concomitantly with mitral valve replacement or repair in 15 consecutive cases.
valve were aneurysmal dilatation of the ascending aorta requiring surgical correction, recent endocarditis, known hypersensitivity to nickel alloys, non-elective surgery and patient age 1 Mean gradient [(mean ± SD), mmHg] Peak gradient [(mean ± SD), mmHg] EOA [(mean ± SD), cm2] Mitral valve Absence of MR MR ≤grade 1 MR ≥grade 1 Transmitral gradient [(mean ± SD), mmHg] PM implantation
Discharge
Follow-up
14 1 0 11.06 ± 2.7 20.05 ± 0.8 1.6 ± 0.5
13 1 0 11.16 ± 2.5 18.4 ± 4.9 1.7 ± 0.4
11 3 1** 4.2 ± 1.5 0
10 4 1 5.4 ± 1.9 1
PVL: paravalvular leakage; EOA: effective orifice area; MR: mitral regurgitation; PM: pacemaker. ** Grade 2 leakage.
Figure 3: The SU 3f Enable® valve removed in the context of acute endocarditis.
in to their potential benefits in a variety of situations when thoracic access is less invasive (during mini-sternotomy, minithoracotomy and thoracoscopic surgery [8–12]). SU valves can enhance the feasibility and reproducibility of the approach; when surgery is conducted via a full sternotomy, SU valves may reduce operative myocardial ischaemic times, especially in the subset consisting of complex procedures and high-risk patients. Using the Perceval valve, Santarpino et al. [13] reported no deaths and a cross-clamping time of 38 ± 13 min in a cohort of 37 high-risk patients. Muneretto et al. [14] recently reported a cross-clamping time of 30.8 ± 13.6 min and no deaths in a subgroup of 53 patients, with a logistic EuroSCORE of 16 ± 11.7. Eichstaedt et al. [15] reported on a cohort of 120 consecutive 3f Enable® valve implantations with a mean cross-clamping time of 37 ± 11 min in the isolated AVR subset and 47 ± 19 min in combined procedures (CABG). Overall, very encouraging haemodynamic results using SU technology have been observed in initial reports [15–17]. For reasons mentioned above, there are good grounds for expanding the use of SU valves within current surgical practice. Moreover, transcatheter aortic valve implantation (TAVI) has proved to be still limited in the presence of a mitral prosthesis; only a few cases have been described [18–20]. TAVI appears to be safe only in patients with an aorto-mitral curtain exceeding 9 mm in height, as determined by preoperative TEE [21]. It is essential to anatomically screen patients and assess their suitability for SU valve implantation combined with aorto-mitral surgery. Minh et al. [6], for example, have proposed preoperative TEE assessment of the aorto-mitral curtain. Since the height of the 3f Enable® valve flange at the nadir of the cusps is 5 mm, when a mitral ring or prosthesis has been previously implanted, a minimal aorto-mitral curtain height of 5 mm is required at the nadir of the non-coronary cusp of the native aortic valve annulus. In fact, the
173
mitral prosthesis—by impeding deeper deployment of the SU prosthesis—could result in suboptimal sealing. Thus, we considered a curtain height under 5 mm to be a potential contraindication of concomitant 3f Enable® valve implantation. In theory, this restriction becomes less relevant when suturing an open mitral annulus, but our institutional policy, up to now, favours the use of closed rigid mitral annuli. It was our preference to intraoperatively assess the distance (the curtain) after suturing the mitral valve prosthesis or annulus; particularly since when there is heavy calcification of the mitroaortic trigon, preoperative echocardiographic measurement of the aorto-mitral curtain is less precise. Moreover, two of our surgeons carried out the procedures with different techniques of positioning the mitral prostheses: in one case by suturing the mitral prosthesis in the intra-annular position by everting the U stitches, and in the second case by use of the supra-annular position with ventricular U patched stitches. In theory, these two anchoring techniques can differently impact the length and surface area of the aorto-mitral curtain after mitral valve prosthesis suturing. Additional potential contraindications to SU valve implantation in the context of mitral valve repair include the presence of a damaged annulus—after removal of heavy calcifications—that leaves an irregular and frail curtain surface and a lower probability of correct sealing and the association of mitral repair with an enhanced risk of immediate reclamping, since that could require— despite the experience shown with the 2 cases in the study— SU valve removal to re-expose the mitral apparatus. Finally, in addition to the other aforementioned general exclusion criteria for SU valve implantation, it seems prudent to avoid any cases of bicuspid anatomy with this particular use of the 3f Enable® valve. In the current study, the technical feasibility of implanting the SU 3f Enable® aortic valve concomitant with mitral valve surgery was assessed in a high-risk population who would benefit from reduced cross-clamping times. The median cross-clamping time of our cohort is subject to interpretation, considering that it is inclusive of the 2 patients who underwent a reclamping procedure due to immediate leakage of the mitral annuloplasty. Also, 4 additional patients underwent combined CABG and another patient had a tricuspid valve repaired. Nevertheless, after excluding the aforementioned patients and exclusively focusing on the subset of cases (n = 8) consisting of aortic and mitral valve procedures, without reclamping for correction of residual mitral valve leakage and without any further associated procedure, the mean clamping time was reduced to 106 ± 18 min. A survey by the French registry of Cardiac Surgery (EPICARD) of 533 patients who underwent mitro-aortic surgery replacement with conventional sutured bioprostheses between 2012 and 2013 reported a mean cross-clamping time of 115 ± 37 min. In our institution, from 2010 to 2014, 83 patients received mitral and aorticsutured valves with a mean cross-clamping time of 117 ± 36 min. According to the data on 161 mitral and aortic replacement procedures performed between 2011 and 2012 extracted from the Puglia adult cardiac surgery registry [22], the mean cross-clamping time was 130.2 ± 38.2 min. This present report shows a moderate reduction (ranging from 9 to 24 min) in cross-clamping times when compared with the aforementioned cohorts. In our experience, when considering the limitation of the myocardial ischaemic time, the use of SU valves appears more effective during minimally invasive procedures [23] when compared with sternotomy. Nevertheless this can still be improved. One has to consider that although these combined off-label procedures were
ORIGINAL ARTICLE
M. Vola et al. / Interactive CardioVascular and Thoracic Surgery
174
M. Vola et al. / Interactive CardioVascular and Thoracic Surgery
undertaken following consistent experience (n > 100) with isolated 3f Enable® valve implantation, accurate intraoperative assessment of the length of the aorto-mitral curtain (after prosthesis deployment) and control of the sealing zone required between 10 to 15 min. We estimate that, in the future, these intraoperative assessments will proceed more rapidly, enabling further reduction of cross-clamping times. The specific duration of the deployment and positioning of the SU valve did not appear longer when compared with sternotomy 3f Enable® procedures without concomitant mitral valve surgery [17]. It is well known that the 3f Enable® valve must be surgically positioned and requires a step-by-step delivery technique that takes more time to be mastered than using the Sorin Perceval® model. Nevertheless, we had perfected this technique once concomitant implantations began. One grade 1 PVL was detected using immediate TEE control. In this case, implantation of the SU valve served as a bailout procedure for a heavily calcified aortic annulus where the use of surgical stitches posed an extreme risk. The patient underwent an incomplete decalcification of the aortic annulus, which remained irregular around the flange of the SU prosthesis; therefore, sealing did not proceed ideally. Immediate TEE control detected grade 1 regurgitation at the left aortic annulus where the most significant annular calcifications were present. We did not address the leakage due to the technical impossibility of repositioning the valve and the patient’s advanced age (84 years) and potential comorbidities. The grade of the leakage appeared stable during FU controls. Overall, periodic FU TTE controls indicated no device migration, no new PVLs and no significant PVL increments. This demonstrates the initial satisfactory stability of the 3f Enable® prosthesis in this selected subset of mitro-aortic surgery cases. No redo surgery was required. The satisfactory anchoring of the 3f Enable® prosthesis in this double-valve surgery setting is corroborated by the fact that, in both cases requiring immediate mitral valve replacement, the procedure was accomplished without resorting to removal or repositioning of the 3f Enable®. Proper device placement was just verified immediately after mitral valve replacement by reopening the aortotomy and checking the seal around the prosthesis flange with a nerve hook, without having to adjust the device’s position. When drawing comparisons with the technique of Minh and colleagues who used the Perceval Sorin® SU bioprosthesis, it should be emphasized that the 3f Enable® valve positioning technique requires the surgeon to knot the guiding stitch in the region of the shortest distance between the mitral and the aortic prostheses. This detail points to the benefits, in theory, that would derive from enhancing prosthesis stability in the area where the sealing of the SU valve is more critical, particularly when taking into account the potential interactions of the aortic and mitral prostheses. The height of the 3f Enable® flange is 5 mm. Its protrusion towards the mitral valve prosthesis below the level of the aortic annulus is similar to that of the Sorin Perceval® model. During surgery, it may be possible to make adjustments following valve expansion without removing the device from the root. Conversely, we know that there is a steeper learning curve involved in mastering the technique for the expansion and positioning of the 3f Enable® valve. We did not modify, in consideration of SU valve implantation, our current use of a close and rigid instead of open mitral annular prosthesis. At this time, we have not observed any obvious increment of PVLs related to this option.
The PM implantation rate is in line with other 3f Enable® SU valve cohorts [15, 24], with no increase attributable to concomitant mitral valve surgery.
Limitations of the study This is a retrospective study on a specific cohort of patients; the sample size is limited and FU is still in the initial stages. Proper assessment of the reproducibility of the results and the clinical benefits of using the 3f Enable® valve in this subset of patients will require a larger cohort and quite possibly a multicentric study.
CONCLUSIONS Our results suggest that 3f Valve® implantation concomitant with mitral valve surgery is technically feasible, and that the device remains satisfactorily stable throughout the early FU period, provided that the adequacy of the distance of the native aortic annulus from the mitral prosthesis is intraoperatively assessed. Further studies are needed to better evaluate the risk–benefit ratio of the SU valves in this subset of patients. Conflict of interest: Marco Vola reports consulting and lecture fees from Medtronic. Jean-Francois Fuzellier reports lecture fees from Medtronic.
REFERENCES [1] Sepehripour AH, Harling L, Athanasiou T. What are the current results of sutureless valves in high-risk aortic valve disease patients? Interact CardioVasc Thorac Surg 2012;14:615–21. [2] Santarpino G, Pollari F, Fischlein T. Sutureless versus transcatheter aortic valve implantation: an unresolved dilemma. J Thorac Cardiovasc Surg 2014;148:364–5. [3] Lorusso R, Gelsomino S, Renzulli A. Sutureless aortic valve replacement: an alternative to transcatheter aortic valve implantation? Curr Opin Cardiol 2013;28:158–63. [4] Santarpino G, Pfeiffer S, Fischlein T. Perceval sutureless approach in a patient with porcelain aorta unsuitable for transcatheter aortic valve implantation. Int J Cardiol 2012;155:168–70. [5] Villa E, Messina A, Cirillo M, Brunelli F, Mhagna Z, Dalla Tomba M et al. Perceval sutureless valve in freestyle root: new surgical valve-in-valve therapy. Ann Thorac Surg 2013;96:e155–7. [6] Minh TH, Mazine A, Bouhout I, El-Hamamzi I, Carrier M, Bouchard D et al. Expanding the indication for sutureless aortic valve replacement to patients with mitral disease. J Thorac Cardiovasc Surg 2014;148:1354–9. [7] Vola M, Campisi S, Anselmi A, Faure M, Fuzellier JF, Gerbay A. Video-assisted minithoracotomy approach: technical developments towards totally endoscopic sutureless aortic valve replacement. J Card Surg 2014;29:494–6. [8] Martens S, Zierer A, Ploss A, Sirat S, Miskovic A, Moritz A et al. Sutureless aortic valve replacement via partial sternotomy. Innovations (Phila) 2010; 5:12–5. [9] Glauber M, Miceli A, Gilmanov D, Ferrarini M, Bevilacqua S, Farneti PA et al. Right anterior minithoracotomy versus conventional aortic valve replacement: a propensity score matched study. J Thorac Cardiovasc Surg 2013;145:1222–6. [10] Cerillo AG, Bevilacqua S, Farneti PA, Concistrè G, Glauber M. Sutureless aortic valve replacement through a right minithoracotomy. J Heart Valve Dis 2012;21:168–71. [11] Gilmanov D, Farneti PA, Miceli A, Bevilacqua S, Glauber M. Perceval S sutureless aortic valve prosthesis implantation via a right anterior minithoracotomy. Multimed Man Cardiothorac Surg 2013; doi:10.1093/ mmcts/mmt012.
[12] Vola M, Fuzellier JF, Chavent B, Duprey A. First human totally endoscopic aortic valve replacement: an early report. J Thorac Cardiovasc Surg 2014; 147:1091–3. [13] Santarpino G, Pfeiffer S, Jessl J, Dell’Aquila AM, Pollari F, Pauschinger M et al. Sutureless replacement versus transcatheter valve implantation in aortic valve stenosis: a propensity-matched analysis of 2 strategies in highrisk patients. J Thorac Cardiovasc Surg 2014;147:561–7. [14] Muneretto C, Bisleri G, Moggi A, Di Bacco L, Tespili M, Repossini A et al. Treating the patients in the ‘grey-zone’ with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement. Interact CardioVasc Thorac Surg 2015;20:90–5. [15] Eichstaedt HC, Easo J, Härle T, Dapunt OE. Early single-center experience in sutureless aortic valve implantation in 120 patients. J Thorac Cardiovasc Surg 2014;147:370–5. [16] Shrestha M, Maeding I, Höffler K, Koigeldiyev N, Marsch G, Siemeni T et al. Aortic valve replacement in geriatric patients with small aortic roots: are sutureless valves the future? Interact CardioVasc Thorac Surg 2013;17: 778–82; discussion 782. [17] Englberger L, Carrel TP, Doss M, Sadowski J, Bartus K, Eckstein FF et al. Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3F Enable® long-term follow-up study. J Thorac Cardiovasc Surg 2014;148:1681–7.
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[18] Beller CJ, Bekeredjian R, Krumsdorf U, Leipold R, Katus HA, Karck M et al. Transcatheter aortic valve implantation after previous mechanical mitral valve replacement: expanding indications? Heart Surg Forum 2011;14: E166–70. [19] Bruschi G, De Marco F, Oreglia J, Colombo P, Barosi A, Einaudi A et al. Transcatheter self-expandable aortic valve implantation after undersized mitral annuloplasty. Ann Thorac Surg 2011;92:1881–3. [20] Moon SW, Ko YG, Hong GR, Lee S, Chang BC, Shim JK et al. Transcatheter aortic valve implantation in a patient with previous mitral valve replacement. Korean Circ J 2014;44:344–7. [21] Testa L, Gelpi G, Bedogni F. Transcatheter aortic valve implantation in a patient with mechanical mitral prosthesis: a lesson learned from an intraventricular clash. Catheter Cardiovasc Interv 2013;82:E621–5. [22] Paparella D, Guida P, Bisceglia L, Caparrotti S, Carbone C, Cassese M et al. Development and results of Puglia adult cardiac surgery registry. J Cardiovasc Med (Hagerstown) 2014;15:810–6. [23] Vola M, Campisi S, Gerbay A, Fuzellier JF, Ayari I, Favre JP et al. Sutureless prostheses and less invasive aortic valve replacement: just an issue of clamping time? Ann Thorac Surg 2015;99:1518–23. [24] Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH et al. Clinical experience with the ATS 3f Enable® Sutureless Bioprosthesis. Eur J Cardiothorac Surg 2011;40:749–55.
ORIGINAL ARTICLE
M. Vola et al. / Interactive CardioVascular and Thoracic Surgery
Interactive CardioVascular and Thoracic Surgery 21 (2015) 169–175 doi:10.1093/icvts/ivv110 Advance Access publication 8 May 2015
Cite this article as: Vola M, Ruggieri VG, Campisi S, Grinberg D, Morel J, Favre J-P et al. Sutureless 3f Enable valve implantation concomitant with mitral valve surgery. Interact CardioVasc Thorac Surg 2015;21:169–75.
Sutureless 3f Enable valve implantation concomitant with mitral valve surgery
a b
Cardiovascular Surgery Unit, Cardiovascular Diseases Department, University Hospital, Saint-Etienne, France Cardiology Unit, Cardiovascular Diseases Department, University Hospital, Saint-Etienne, France
* Corresponding author. Service de Chirurgie Cardiovasculaire, Pôle Cardiovasculaire, Hôpital Nord, Centre Hospitalier Universitaire de Saint-Etienne, 42055 Saint-Etienne Cedex, France. Tel: +33-4-77828750; fax: +33-4-77828453; e-mail: [email protected] (M. Vola). Received 5 January 2015; received in revised form 22 March 2015; accepted 2 April 2015
Abstract OBJECTIVE: Interest in aortic sutureless bioprostheses is growing. Here, we evaluate the feasibility of performing aortic sutureless valve replacement concomitant with mitral valve surgery using the 3f Enable prosthesis. METHODS: Of the 198 3f Enable® valve implantation procedures carried out in our unit between March 2011 and October 2014, 15 were performed concomitant with mitral valve surgery (8 bioprosthetic replacements and 7 annuloplasties). RESULTS: The mean age and logistic EuroSCORE were 76 ± 6 years and 10.2 ± 4.8, respectively. The procedural success rate of aortic sutureless valve implantation was 100%. Mean cross-clamping and cardiopulmonary bypass times were 113.9 ± 35 and 150- ± 43 min, respectively. No reclamping in response to a sutureless paravalvular leakage (PVL) was needed. One grade 1 leak was observed at the time of discharge. There was no perioperative mortality. Pacemaker implantation was required in 1 case (6.6%). Initial follow-up (median = 8 months, range 1–6) showed no new aortic PVL; mean and peak transprosthetic gradients and the orifice area were 11.1 ± 2.5 and 18.4 ± 4.9 mmHg and 1.7 ± 0.4 cm2, respectively. One grade 2 and two grade 1 mitral valve leaks were detected following annuloplasty. CONCLUSIONS: 3f Enable® sutureless valve implantation combined with mitral valve surgery appears feasible and the results presented here are encouraging. This procedure has the potential to simplify surgery in a cohort of high-risk patients for whom transcatheter aortic valve replacement is not an effective option. Larger studies should be conducted to confirm these observations. Keywords: Sutureless heart valve prosthesis • Transcatheter aortic valve implantation • Aortic and mitral valve replacement
INTRODUCTION Sutureless (SU) valves appear to enable shorter cross-clamping times when compared with conventional sutured bioprostheses and thus have the potential to produce better outcomes in high-risk patients [1–3] and in surgical settings where suture placement is challenging [4, 5]. The use of SU valves could lead to improved outcomes for the subset of complex procedures combining aortic and mitral valve surgery, which require longer ischaemic times. A recent study reported on the first-time use of the Sorin Perceval® (Sorin, Saluggia, Italy) SU bioprosthesis [6] in 10 consecutive patients. Here, we report our experience with the 3f Enable® SU device used concomitantly with mitral valve replacement or repair in 15 consecutive cases.
valve were aneurysmal dilatation of the ascending aorta requiring surgical correction, recent endocarditis, known hypersensitivity to nickel alloys, non-elective surgery and patient age 1 Mean gradient [(mean ± SD), mmHg] Peak gradient [(mean ± SD), mmHg] EOA [(mean ± SD), cm2] Mitral valve Absence of MR MR ≤grade 1 MR ≥grade 1 Transmitral gradient [(mean ± SD), mmHg] PM implantation
Discharge
Follow-up
14 1 0 11.06 ± 2.7 20.05 ± 0.8 1.6 ± 0.5
13 1 0 11.16 ± 2.5 18.4 ± 4.9 1.7 ± 0.4
11 3 1** 4.2 ± 1.5 0
10 4 1 5.4 ± 1.9 1
PVL: paravalvular leakage; EOA: effective orifice area; MR: mitral regurgitation; PM: pacemaker. ** Grade 2 leakage.
Figure 3: The SU 3f Enable® valve removed in the context of acute endocarditis.
in to their potential benefits in a variety of situations when thoracic access is less invasive (during mini-sternotomy, minithoracotomy and thoracoscopic surgery [8–12]). SU valves can enhance the feasibility and reproducibility of the approach; when surgery is conducted via a full sternotomy, SU valves may reduce operative myocardial ischaemic times, especially in the subset consisting of complex procedures and high-risk patients. Using the Perceval valve, Santarpino et al. [13] reported no deaths and a cross-clamping time of 38 ± 13 min in a cohort of 37 high-risk patients. Muneretto et al. [14] recently reported a cross-clamping time of 30.8 ± 13.6 min and no deaths in a subgroup of 53 patients, with a logistic EuroSCORE of 16 ± 11.7. Eichstaedt et al. [15] reported on a cohort of 120 consecutive 3f Enable® valve implantations with a mean cross-clamping time of 37 ± 11 min in the isolated AVR subset and 47 ± 19 min in combined procedures (CABG). Overall, very encouraging haemodynamic results using SU technology have been observed in initial reports [15–17]. For reasons mentioned above, there are good grounds for expanding the use of SU valves within current surgical practice. Moreover, transcatheter aortic valve implantation (TAVI) has proved to be still limited in the presence of a mitral prosthesis; only a few cases have been described [18–20]. TAVI appears to be safe only in patients with an aorto-mitral curtain exceeding 9 mm in height, as determined by preoperative TEE [21]. It is essential to anatomically screen patients and assess their suitability for SU valve implantation combined with aorto-mitral surgery. Minh et al. [6], for example, have proposed preoperative TEE assessment of the aorto-mitral curtain. Since the height of the 3f Enable® valve flange at the nadir of the cusps is 5 mm, when a mitral ring or prosthesis has been previously implanted, a minimal aorto-mitral curtain height of 5 mm is required at the nadir of the non-coronary cusp of the native aortic valve annulus. In fact, the
173
mitral prosthesis—by impeding deeper deployment of the SU prosthesis—could result in suboptimal sealing. Thus, we considered a curtain height under 5 mm to be a potential contraindication of concomitant 3f Enable® valve implantation. In theory, this restriction becomes less relevant when suturing an open mitral annulus, but our institutional policy, up to now, favours the use of closed rigid mitral annuli. It was our preference to intraoperatively assess the distance (the curtain) after suturing the mitral valve prosthesis or annulus; particularly since when there is heavy calcification of the mitroaortic trigon, preoperative echocardiographic measurement of the aorto-mitral curtain is less precise. Moreover, two of our surgeons carried out the procedures with different techniques of positioning the mitral prostheses: in one case by suturing the mitral prosthesis in the intra-annular position by everting the U stitches, and in the second case by use of the supra-annular position with ventricular U patched stitches. In theory, these two anchoring techniques can differently impact the length and surface area of the aorto-mitral curtain after mitral valve prosthesis suturing. Additional potential contraindications to SU valve implantation in the context of mitral valve repair include the presence of a damaged annulus—after removal of heavy calcifications—that leaves an irregular and frail curtain surface and a lower probability of correct sealing and the association of mitral repair with an enhanced risk of immediate reclamping, since that could require— despite the experience shown with the 2 cases in the study— SU valve removal to re-expose the mitral apparatus. Finally, in addition to the other aforementioned general exclusion criteria for SU valve implantation, it seems prudent to avoid any cases of bicuspid anatomy with this particular use of the 3f Enable® valve. In the current study, the technical feasibility of implanting the SU 3f Enable® aortic valve concomitant with mitral valve surgery was assessed in a high-risk population who would benefit from reduced cross-clamping times. The median cross-clamping time of our cohort is subject to interpretation, considering that it is inclusive of the 2 patients who underwent a reclamping procedure due to immediate leakage of the mitral annuloplasty. Also, 4 additional patients underwent combined CABG and another patient had a tricuspid valve repaired. Nevertheless, after excluding the aforementioned patients and exclusively focusing on the subset of cases (n = 8) consisting of aortic and mitral valve procedures, without reclamping for correction of residual mitral valve leakage and without any further associated procedure, the mean clamping time was reduced to 106 ± 18 min. A survey by the French registry of Cardiac Surgery (EPICARD) of 533 patients who underwent mitro-aortic surgery replacement with conventional sutured bioprostheses between 2012 and 2013 reported a mean cross-clamping time of 115 ± 37 min. In our institution, from 2010 to 2014, 83 patients received mitral and aorticsutured valves with a mean cross-clamping time of 117 ± 36 min. According to the data on 161 mitral and aortic replacement procedures performed between 2011 and 2012 extracted from the Puglia adult cardiac surgery registry [22], the mean cross-clamping time was 130.2 ± 38.2 min. This present report shows a moderate reduction (ranging from 9 to 24 min) in cross-clamping times when compared with the aforementioned cohorts. In our experience, when considering the limitation of the myocardial ischaemic time, the use of SU valves appears more effective during minimally invasive procedures [23] when compared with sternotomy. Nevertheless this can still be improved. One has to consider that although these combined off-label procedures were
ORIGINAL ARTICLE
M. Vola et al. / Interactive CardioVascular and Thoracic Surgery
174
M. Vola et al. / Interactive CardioVascular and Thoracic Surgery
undertaken following consistent experience (n > 100) with isolated 3f Enable® valve implantation, accurate intraoperative assessment of the length of the aorto-mitral curtain (after prosthesis deployment) and control of the sealing zone required between 10 to 15 min. We estimate that, in the future, these intraoperative assessments will proceed more rapidly, enabling further reduction of cross-clamping times. The specific duration of the deployment and positioning of the SU valve did not appear longer when compared with sternotomy 3f Enable® procedures without concomitant mitral valve surgery [17]. It is well known that the 3f Enable® valve must be surgically positioned and requires a step-by-step delivery technique that takes more time to be mastered than using the Sorin Perceval® model. Nevertheless, we had perfected this technique once concomitant implantations began. One grade 1 PVL was detected using immediate TEE control. In this case, implantation of the SU valve served as a bailout procedure for a heavily calcified aortic annulus where the use of surgical stitches posed an extreme risk. The patient underwent an incomplete decalcification of the aortic annulus, which remained irregular around the flange of the SU prosthesis; therefore, sealing did not proceed ideally. Immediate TEE control detected grade 1 regurgitation at the left aortic annulus where the most significant annular calcifications were present. We did not address the leakage due to the technical impossibility of repositioning the valve and the patient’s advanced age (84 years) and potential comorbidities. The grade of the leakage appeared stable during FU controls. Overall, periodic FU TTE controls indicated no device migration, no new PVLs and no significant PVL increments. This demonstrates the initial satisfactory stability of the 3f Enable® prosthesis in this selected subset of mitro-aortic surgery cases. No redo surgery was required. The satisfactory anchoring of the 3f Enable® prosthesis in this double-valve surgery setting is corroborated by the fact that, in both cases requiring immediate mitral valve replacement, the procedure was accomplished without resorting to removal or repositioning of the 3f Enable®. Proper device placement was just verified immediately after mitral valve replacement by reopening the aortotomy and checking the seal around the prosthesis flange with a nerve hook, without having to adjust the device’s position. When drawing comparisons with the technique of Minh and colleagues who used the Perceval Sorin® SU bioprosthesis, it should be emphasized that the 3f Enable® valve positioning technique requires the surgeon to knot the guiding stitch in the region of the shortest distance between the mitral and the aortic prostheses. This detail points to the benefits, in theory, that would derive from enhancing prosthesis stability in the area where the sealing of the SU valve is more critical, particularly when taking into account the potential interactions of the aortic and mitral prostheses. The height of the 3f Enable® flange is 5 mm. Its protrusion towards the mitral valve prosthesis below the level of the aortic annulus is similar to that of the Sorin Perceval® model. During surgery, it may be possible to make adjustments following valve expansion without removing the device from the root. Conversely, we know that there is a steeper learning curve involved in mastering the technique for the expansion and positioning of the 3f Enable® valve. We did not modify, in consideration of SU valve implantation, our current use of a close and rigid instead of open mitral annular prosthesis. At this time, we have not observed any obvious increment of PVLs related to this option.
The PM implantation rate is in line with other 3f Enable® SU valve cohorts [15, 24], with no increase attributable to concomitant mitral valve surgery.
Limitations of the study This is a retrospective study on a specific cohort of patients; the sample size is limited and FU is still in the initial stages. Proper assessment of the reproducibility of the results and the clinical benefits of using the 3f Enable® valve in this subset of patients will require a larger cohort and quite possibly a multicentric study.
CONCLUSIONS Our results suggest that 3f Valve® implantation concomitant with mitral valve surgery is technically feasible, and that the device remains satisfactorily stable throughout the early FU period, provided that the adequacy of the distance of the native aortic annulus from the mitral prosthesis is intraoperatively assessed. Further studies are needed to better evaluate the risk–benefit ratio of the SU valves in this subset of patients. Conflict of interest: Marco Vola reports consulting and lecture fees from Medtronic. Jean-Francois Fuzellier reports lecture fees from Medtronic.
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ORIGINAL ARTICLE
M. Vola et al. / Interactive CardioVascular and Thoracic Surgery
